MSc Med (Bioethics & Health Law) Information Handbook

Steve Biko Centre for Bioethics Faculty of Health Sciences School of Clinical Medicine University of the Witwatersrand 7 York Road Johannesburg South Africa 2190

Head of Centre Prof. Ames Dhai Tel: +27 011 717 2718 Email: [email protected]

Course Director (Academic) Prof. Donna Knapp van Bogaert: Tel: +27 011 717 2720 Email: [email protected] ; [email protected] Academic Staff Ms Jillian Gardner Tel: +27 011 717 2719 Email: [email protected]

Centre Administration (09h00-13h00) Tel: +27 011 717 2635 Email: Mrs. Eileen Skuy [email protected]

Postgraduate Office For queries concerning admission procedures, fees, and general postgraduate information please contact the postgraduate office at Wits Medical School, 7 York Road Parktown, 2193 Johannesburg. Telephone: + 27 011 717 2076 / 2399 / 2745 / 2075. Fax:+ 27 011 717 2119; Email: [email protected]; [email protected] DvBogaert 2007 update MSc Med (Bioethics & Health Law) 2

Table of Content Keynote Address Official Opening Steve Biko Centre for Bioethics

5

MSc Med (Bioethics & Health Law)

9

Aims Objectives Entry Requirements

10

Students with Disabilities NFQ Exit Level of Qualification Duration of Qualification

11

Minimum / Maximum Period of Study Coursework Format

12

Overview Research Report Types of Research Reports

13

Steps in Research Procedure

15

Tentative Dates Protocol Submission (2008)

16

Supervisors / Supervision

18

Principles of Postgraduate Supervision

20

The Supervisor The Student Grievance Procedures

22 23

Senate Policy on Plagiarism

23

Wording of Required Student Declaration of Work

25

Overview: Harvard Referencing System

26

MSc Med (Bioethics & Health Law) Assessments

40

Forms of Assessment Diagnostic Assessment Summative Assessment Continuous Assessment Integrated Assessment Self/ Peer Assessment Coursework & Assessments Supplementary Sub minimum Coursework Essay

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42

Declaration of One’s Own Work

43

Referencing System Essay Weight Core Unit Essay Sub-minimum Elective Unit Sub-minimum Supplementary Assessment Additional Assessment Types

45

Example Essay Marking Schemes

46

Delivery Modes & Teaching Methods

47

Learning & Attendance Learning contract University Policies & Guidelines

48

Lateral Integration Incomplete or Dropped Units Abeyance External Examiners and PG Examination Committee

49

Postgraduate Office Memo

49

Fee Payment

50

Unit Descriptions Introduction to Bioethics

51

Introduction to Health Law

53

Research Ethics

55

Reproduction - Ethics & the Law

57

HIV/AIDS - Ethics & the Law

59

Genetics- Ethics & the Law

61

Health and Human Rights

63

Environmental Bioethics

65

Clinical Bioethics

67

Policy, Public Health, Resource Allocation & Ethics

67

Schedule of Classes 2008

69

Examples of MCQ from Web CT

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Examples Essay Topics

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Examples “good” Essays

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The Steve Biko Centre for Bioethics MEDICAL ETHICS FOR A MODERN AGE N Barney Pityana, GCOB

Professor Pityana, GCOB Principal and Vice Chancellor, University of South Africa; Keynote address marking the official opening of the Wits University Medical School’s Steve Biko Centre for Bioethics, Constitution Hill, Johannesburg, 8 February 2007. The name of Stephen Bantu Biko, I suppose, gets associated with medical ethics out of the horror that many of us felt at the treatment he received as he was tortured and allowed to die, a lonely and painful death. Moral society was astounded at the depths to which the apartheid regime was prepared to go in its war to preserve white supremacy. Clearly the security operatives had sunk to such low levels of brutality and most base form of human conduct that they could hardly be called human. Of special interest to the medical community however, was the role of the medical doctors Lang and Tucker. Both had been called to examine the ailing prisoner who was being subjected to torture, and both had subordinated their clinical judgment to the will of the police. There were calls that they be appropriately disciplined and struck from the roll of medical practitioners. At the time I remember writing an essay, Medical ethics and the security laws of South Africa: The case of Steve Biko. Sadly, many of the same questions apply today. The matter of the clinical independence of medical doctors has been under scrutiny in our country in relation to HIV/AIDS and the availability of appropriate and affordable drug treatment, or in the light of the Ministry of Health’s reluctance, for administrative and political reasons, to make such drug treatment universally available. I can think of the case of Mr Shabir Shaik currently: who makes the decision about his continued residency at a medical clinic in Durban? Is it the medical doctors exercising their clinical independence, their medical expertise and duty of care, or is it the Minister of Correctional Services responding to public sentiment about preferential treatment, and in the exercise of his duty to enforce the law? Of course, applications of medical ethics go much further than the examples I have outlined above. There are questions about clinical trials, when and how these can be conducted. There is of course the current controversy about the microbicides trials in

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the continuing scientific research on HIV/AIDS: what amount of risk should ordinary healthy human being be subjected to, and what amount of information is necessary to give; or is it in any event ever justifiable even with whatever amount of information is given, for people to be allowed to put themselves at such levels of risk for the sake of scientific advancement? Indeed, should pharmaceutical companies be allowed to undertake clinical trials among poor people in Africa and Asia, for whom the lure of immediate financial gain can suspend judgment about the future consequences of the trials? It is, as always, a topical matter. I saw a film recently that examined the role of the pharmaceutical industry in the spread of disease in Kenya. Most medical ethics considerations, however, occur in the fine line that is the exercise of clinical judgment by the practitioner between what is in the best interests of the patient, and the extent of the risk that is appropriate to take in the light of the probable outcomes or benefits. Often this is a lonely decision that a surgeon might have to take at the spur of the moment in the light of the circumstances. There are matters of life and death in the separation of Siamese twins, or should it be the life of the baby or the mother that should be saved in instances of complications in childbirth. Of course, we have become familiar with the howling noise of the righteous right in matters of the termination of pregnancy, IVF or other derivatives of assisted pregnancy, euthanasia etc. Medical ethics, however, never happens in a vacuum. Ethics represents a society’s understanding of itself, its values, and acceptable levels of human behaviour and how much it is prepared to accept without raising revulsion. The British moral philosopher, Bernard Williams has a chapter in his little book on Morality (1972), entitled, “Moral Standards and the Distinguishing Mark of Man”. He says that the distinguishing mark of human nature is “his ability to shape his actions and dispositions by reason…” In other words practical reason should produce coherence rather than mental conflict within one; it addresses the desires of one’s conscience and eases one’s conscience that may be troubled by decisions and actions that conflict with one’s innermost senses. Drawing from Aristotle, Williams refers to these as “virtues of character”, dispositions to right actions which involve motivations of pleasure and pain. And yet human nature is not disposed merely to some forms of Manichean virtues, an excess of dependence on rational self-control. Human nature is capable of base desires and passions. The real balance and reconciliation most of us venture, therefore, is between our intellectual curiosities, our desire to dig deeper, to discover

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afresh, and the examination of a set of facts in their many-sidedness; but ultimately to come out with the best answer in the current or prevailing conditions. We can no longer assume like Plato did, that humanity has inherent values or a priori moral truths that form the foundations of our reasoning, of our moral standards or therefore, of the decisions we make. Likewise there are some who hold that scientific knowledge has unlimited possibilities for discovery which it is our duty as scientists to exploit. We know, of course, that the situation is much more complex. That actually we do not have such freedom as Plato might have desired. Or, to put it another way, such moral freedom as we have, must always be tempered by other considerations like cultural sensitivity, political awareness, and these days, ecological and environmental considerations. Williams therefore suggests that it cannot be said that because scientific knowledge is the highest form of theoretical reason, or in his words, “the highest form of human achievement”, and that in it lies the future of humanity and the environment, that it can be exploited without reserve or sensitivity.

Therefore, “its

development must have an unchallengeable claim on our moral approval.” The Steve Biko Centre for Bioethics, therefore, will make an important contribution to the moral formation of our nation, and consequently, to rooting our scientific enquiry within an ambit of ethics. My own view is that the purpose should never be that we come to a common mind about appropriate scientific action, but that we should never be in want about the application of moral insights in the hard decisions that scientists have to make. Of course, this does not just apply in the vexed matters of medical ethics, or scientific research, or in the denouement of public policy, I can see it in the manner in which judges in the Constitutional Court address and seek to resolve potentially difficult moral questions that masquerade as law or human rights. I can think of recent decisions like Soobramoney v Minister of Health, Kwazulu-Natal, even the more recent judgments on same-sex unions, to name only a few, where perhaps the judges might have benefited from expert opinion or tempered their reasoning with an ethical balance that shows the complex nature of the subjects they handle. Quite frankly, we need to be more aware of the moral ambiguity that human characteristics always evince, with our complex cultural, religious and social mores. It occurs to me that society’s foremost decision-makers should display sensitivity to and intentionality about the moral consequences of the decisions we make, or dispositions we take, and the actions we do.

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Medical scientists, many of us believe, are the ones confronted on a daily basis by these ethical questions. That is because much of their work affects life or death matters. But it is in fact a matter for all of us. We need to have a refined sense of the moral, a desire for virtue, a seeking after truth at all times. That is the foundation for the society we aspire to be, as the Preamble to our Constitution so eloquently states:

(to) Heal the divisions of the past and establish a society based on democratic values, social justice and fundamental human rights; Improve the quality of life of all citizens and free the potential of each person… These are the values Steve Biko stood for, and he died for. I congratulate the Wits Medical School on the establishment of this Centre. I trust that it will play a very central role in the training of future medical practitioners at all levels; will sensitize the scientific research community about the role and place of ethics in scientific enquiry; and, hopefully, will contribute to the raising of this society’s threshold on moral tolerance and self-understanding. Pretoria, 7 February 2007.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Aims MSc Med (Bioethics & Health Law) Aims The aim of the MSc Med (Bioethics & Health Law) course is to train bioethics and medical law experts who will display skill and proficiency in the fields of bioethics & health law. Application of the knowledge, skills and attitudes promoted in this course will capacitate further development in the fields of bioethics and health law teaching, research, and social policy development.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Learning Outcomes MSc Med (Bioethics & Health Law) Learning Outcomes At the end of the MSc Med (Bioethics and Health Law) course, graduates will display the ability to: ƒ Identify bioethical and legal issues arising in health care and research; and ƒ Interpret guidelines and policy related to bioethics, including research-related activities and the law; and ƒ Apply diverse knowledge in bioethics and health law to development of appropriate solutions of normative problems in health care delivery, biomedical and medico-legal research ; and ƒ Analyse bioethical and legal issues present in health care, the environment, and clinical research; and ƒ Conceptually distinguish between ethics and the law; and ƒ Assess ethical and legal concepts relative to contemporary life and suggest and evaluate new theories or principles; and ƒ Critically evaluate social issues through rigid assessment of available options and justifying same through critical reasoning content analysis; and ƒ Formulate guidelines and approaches to social issues based on sound theory and principles, which are ethically acceptable, and within the constraints of the law.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Entry Requirements Entry Requirements or Pre-requisites Post-Graduate level entry: special graduate acceptance by recommendation / motivation and acceptance by Centre and Postgraduate Committee. Co-requisite: Self-learning and reflection Anti-requisite: None

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Students with Disabilities Students with Disabilities All staff are committed to providing access to a full teaching and learning programme for all disabled students. The Centre is committed to implement the most appropriate ways to include students with a disability in all aspects of the MSc Med (Bioethics & Health Law) course and to ensure that they are not disadvantaged by the operational environments.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 NFQ Exit Level of Qualification NFQ Exit Level Qualification Successful completion of the MSc Med (Bioethics and Health Law) will represent a NFQ exit level of eight (8). MSc (by dissertation) Table: total credits, credits per NQF level and per content type NQF Level Credits Level 5 Level 6 Level 7 Level 8 - fundamental

TOTAL 0

- core 90 - elective 90 TOTAL

180 180 = total credit value of qualification

MSc (by coursework and research report)

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Table: total credits, credits per NQF level and per content type NQF Level Credits Level 5 Level 6 Level 7 Level 8 - fundamental

TOTAL 10

- core 85 - elective 85 TOTAL

180 180 = total credit value of qualification

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Duration of Qualification / Programme The programme’s duration Full-time students: (By dissertation) Not less than one (1) year, successful completion of the course attendance and requirements plus successful completion of research report or (By “in-residence”) successful completion of the course attendance and requirements in one year, and successful completion of research report (i.e. thesis) at the end of year one.

Part-time students: Not less than two years plus one year for completion of research report. Usually part-time students take two (2) core courses plus two (2) electives in year one year and then take the two (2) other required electives at the beginning of the second year. Upon successful completion of course work, in the remaining time, the thesis (research report) is completed.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Minimum / Maximum Period of Study Minimum / Maximum Period of Study: The minimum period of study (n) for each higher degree is set out in the rules for degrees and a period of study which may not normally be exceeded should be prescribed by each faculty in standing orders. Students who require specific information concerning minimum / maximum periods of study are encouraged to contact the Postgraduate office for further information. Generally, candidates must justify to the faculty’s higher degree committee

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why his or her registration should exceed the minimum period of study plus two years (n+2).

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Course work Format MSc Med (Bioethics & Health Law) Course work Format The MSc Med (Bioethics & Health Law) course work consists of two (2) core units and four (4) elective units which must be successfully completed to fulfil the required course work. The units will be taught in block release format.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 OVERVIEW: Research report/ Thesis Research Report / Thesis Thesis: Unless indicated otherwise ‘thesis’ should be taken to mean either thesis, dissertation or research report as may be appropriate (SSO Higher Degrees 2007) . In this document, we use the term ‘research report’ or research report / thesis interchangeably. The final phase of the MSc Med (Bioethics & Health Law) consists in a research report / thesis. The research report must demonstrate that you are familiar with a relevant subject matter, the pertinent literature and are capable of assessing and analysing the issues arising in the topic under discussion. The research report for a Master’s degree by coursework must be at least 10, 000 but no longer than 15,000 words in length. Candidates are supervised by Centre staff. In some cases, a co-supervisor may be drawn from outside the Centre but within the university. Such an initiation may be done only by the Centre which both approves and initiates the process. Topics for the research report are to be submitted to the Academic Director. The submission must be in the form of a plan with an introduction setting out the rationale, a statement of the ethical and/or legal problem, the research question, a literature review and bibliography. Once the Centre is satisfied that the proposal is acceptable, the proposal then proceeds through a systematic process of assessment e.g. the Internal Assessor’s Committee, the Postgraduate Committee and if so indicated, the Human Research Ethics

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Committee (Medical) for approval. Please note the dates for submission as well as the dates when the assessor committees sit are posted on the Centre’s bulletin board. Students and their supervisors must attend the assessor meetings. Successful completion of the course requirements and a research report will lead to the degree of Master of Medical Science in the field of Bioethics and Health Law.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Types of Research Reports Types of research reports The Centre utilises two types of research reports which are designed to reflect the uniqueness of the MSc Med (Bioethics & Health Law) course.

Both have their own

particular merits and either type is acceptable (1) Those in which an empirical component is present in addition to a normative / descriptive analysis of the problem (2) Those which are normative or descriptive for example: an ethical or legal issue is researched; current thought on a topic is re-examined; new theories, policies, or arguments developed concerning a particular issue.

Research Reports Involving Empirical Content The following is an excerpt by Dr. Anne Wright (Department of Family Medicine) which has been adapted as an overview of the research report which involves an empirical component (NB: many of the same comments applies to a normative / descriptive research report as well.) What is expected of a research report? The following is the list of faculty requirements for a research report: The report must: A.

be satisfactory as regards literary style and presentation

B.

shows that the candidate is acquainted with the methods of research and their application in that he or she: (a)

understands the nature and purpose of the investigations

(b)

is sufficiently acquainted with the relevant literature

(c)

commands the necessary techniques

(d)

has acquired an adequate understanding of scientific methods

(e)

is capable of assessing the significance of the findings

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The research report must constitute some contribution to knowledge, preferably through original research, or through an exceptionally high standard of research and presentation. Given these requirements, you may well feel daunted by the prospect of having to undertake a research project especially as for most of you this will be your first venture into research. Don’t be too perturbed: think of the process as a journey done in stages with a great deal of assistance available to you at each stage. This journey requires hard work and dedicated effort. It is a challenge, but is also rewarding and on completion of the journey you will look back and be amazed at the scope and variety of what you have learned along the way. It is said that researchers experience the same kind emotional responses through each stage of the research process. Below is a depiction from the book, "Epidemiology, a manual for South Africa" of the emotional roller-coaster journey of the researcher. The authors note: "Each stage of the research process tends to start on a positive note, but inevitably obstacles arise, with each stage having its own set of difficulties. Problem-solving abilities and persistence are tested to the utmost."

1

In the

graph the Y axis shows the emotional reactions to events during the research process (x axis).

Research in South Africa offers a wealth of opportunity for the enquiring, innovative, creative researcher. There is so much to be explored and so little has been done. Your own particular vocation or interest is the best place to begin thinking about a possible research topic. You may choose any area of research related to any topic you find to be of interest - your work, patients, clients, a topic in bioethics you wish to explore, policy or

1

Katzenellenbogen JM, Joubert G, Karim. (eds) Epidemiology, a manual for South Africa. Cape Town: Oxford University Press; 1999

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management protocols, etc. The choice of topic for the research project will be discussed during the course but the following general considerations are useful: •

Select a topic that you have noted to be an area of concern

•

Select a topic in which you are interested and will find stimulating to explore.

•

There is a tendency to select topics which are very wide-ranging and consequently, very difficult to investigate. Your research problem should be narrowly focused, clearly defined as a research question and be feasible to research.

In deciding upon a topic for research, you are urged to consult freely with staff members and others, for example, senior students and those with expertise in your field of interest. It is essential that you read relevant journals to get an understanding of current research. Note that while the Centre’s academic personnel are is very willing to discuss possible topics with you, the responsibility for selecting and defining a topic is your own.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Steps in the Research Procedure In this section, the steps in the research procedure are outlined. Note that: (i)

Preparation of the protocol and learning about research methodology will begin in first year. In addition to the knowledge gained during the units, the Centre will update students on the variety of courses offered by the University concerning research and writing activities.

(ii)

Submission of a protocol to the Internal Assessors Committee & Postgraduate Committee (an assessor group) (as well as the Human Research Ethics Committee (Medical) if indicated) are requirements.

(iii)

Under normal circumstances, for a part-time student, the maximum time allowed to complete both the coursework and the research component of the degree is 3 years.

Because bioethics and law have strong normative components, research reports may be designed to reflect critically on societal or other issues relevant to bioethics and or health law. For example, one may choose to analyse critically a particular topic e.g. maternal-fetal conflict, infectious disease control and human rights, develop a new theory, produce a policy, argue for or against a particular norm, or explore a relevant concern in view of new

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information. Both approaches are valid and both embed the requirements of discipline: honesty intellectually relevant and thoughtful topic investigation. The following information is applicable to both forms of the required research reports The investigation of a topic involves discipline and together they form the first steps in learning about a topic and will enable you to master a range of academic and technical skills as follows: (i)

define a topic and sub topics for a study

(ii)

define the aim and objectives

(iii)

do literature searches using e.g. Pro-Quest, Medline, PubMed, book & article reviews

(iv)

access the journals and books referred to in your literature search

(v)

use the literature to substantiate your ethical arguments, clarify or expand what you want to say

(vi)

collect and analyse relevant data

(vii)

present and discuss your findings (written report)

(viii) use the Harvard system of referencing to indicate references in the text (internal referencing) and list the references at the end of your document (ix)

do basic word processing using MS Word

(x)

formulate and learn about statistical analysis of your data if indicated.

(xi)

If using an empirical component, ensure that your research questions are drawn from and directly relevant to the ethical and legal content of your discussion.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 2008 Tentative Dates Submission of Protocols Committees Before beginning the research, your protocol must be approved by three committees: (a)The Internal Assessors Committee (b) The Post-Graduate Committee (c) (IF involving human participants this is mandatory) The Human Research Ethics Committee (HREC) NB: When – and only when – your protocol has been approved by the three (3) committees, may you begin the actual research or begin to write your thesis.

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You are required to consult regularly with your supervisor, we suggest monthly. By this stage, you will have signed a contract or agreement with your supervisor which will spell out your mutual responsibilities (see addendum 1). To Supervisors February 4, 2008 February 29, 2008 April 1, 2008 June 2, 2008 September 1, 2008 To Internal Assessors Committee March 21, 2008 May 15, 2008 July 15, 2008 November 15, 2008 To Human Research Ethics Committee (Medical) TBA Finally, after much hard work, the data will have been collected, analysed, discussed and written up in report form. You then, with Centre approval, submit your report for examining. Then after minor and major corrections have been done (if necessary), you receive an invitation to attend your graduation! Once you have graduated and had a rest, you are strongly encouraged to prepare an article to submit to a journal for publication.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Supervisors and Supervision Supervisors & Supervision Supervisors are appointed by the faculty on the recommendation of the Centre and after discussion with both student and the intended supervisor. Your supervisor will most often be a member of the Centre but a co-supervisor may be included who may be from the Centre or a Centre-approved person who is also within the university. Supervisors are appointed when adequate Topic and Scope papers have been submitted. No student may go outside of the Centre and “appoint” his or her own supervisor or co-supervisor. Concerning supervision, the following points are brought to your attention: (a)

For your research to develop satisfactorily you should maintain close contact with your supervisor. Always ensure you have made an appointment to visit with your supervisor well in advance. The Centre’s personnel are involved in a great amount of teaching and other responsibilities and are not available for unscheduled visits. Arrange to meet at regular intervals, for example, once a month or once every two months. Prepare for these meetings and wherever possible let your supervisor have written work in advance of the meeting so that discussion can centre on essential matters. Do not wait until you have a complete draft of the report before the supervisor reads it for the first time.

(b)

Remember that the ultimate responsibility for understanding what your project is about and ensuring that the work is completed rests with you, the student, not with your supervisor.

(c)

When you come to writing your report you can expect your supervisor to give you general guidance on drafting your work, discussing the results and conclusions and to read at least one full draft of the report.

(d)

You should not expect your supervisor to read more than two drafts to check for spelling and typing errors, correctness of data and references. You should not rely on your supervisor to correct your literary style or grammar. You are strongly advised to get someone to help you proof-read the document. The Wits Writing Centre is helpful in this regard and students are encouraged to use their expert facilities.

(e)

Give your supervisor adequate warning of when you will need to have extensive drafts read and discussed. It is unrealistic to hand in a draft of a report and expect

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comments “next week, please”. Careful planning throughout your period of research will avoid unnecessary and frustrating delays at the end. (f)

It is not the responsibility of your supervisor to ensure that you hand in an error free piece of work – that is your task. You (and not the supervisor) are responsible for the content and presentation of your report. Your supervisor will have to declare whether it was submitted with his or her approval or not.

In order to ensure that both student and supervisor have a common understanding of how supervision will proceed and what the mutual expectations are, the faculty has drawn up a formal “statement of principles” which outlines the obligations and responsibilities of both student and supervisor. This document will be discussed and signed by you and your supervisor at your first meeting. Read it carefully and note the contents:

In a context of academic freedom and within a framework of individual autonomy and the pursuit of knowledge, this agreement is written in the belief that there is a reciprocal relationship and mutual accountability between supervisor and student.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Principles of Post-Graduate Supervision Statement of Principles for Post-Graduate Supervision 1.

Will establish agreed roles and clear processes to be maintained by both parties. In the case of joint supervision everybody’s role needs to be clarified.

2.

Will meet regularly and as frequently as is reasonable to ensure steady progress towards the completion of the proposal, research report, or dissertation or thesis. This time varies but the normal minimum requirement for face-to- face contact spread across each year of registration is: 10 contact hours for an Honours project, 15 contact hours for a Masters by research report and 24 contact hours for a Masters by dissertation and a PhD.

3.

Will keep appointments, be punctual and respond timeously to messages.

4.

Will keep one another informed of any planned vacations or absences as well as changes in his or her personal circumstances that might affect the work schedule. Unplanned absences or delays should be discussed as soon as possible and arrangements should be made, to catch up lost time.

5.

Will ensure that research on animal or human subjects is conducted according to the procedures and the requirements of the relevant University Ethics committee.

6.

Will together complete progress reports on the research project, as requested by each Faculty Graduate Studies.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 The Supervisor The Supervisor : 1.

Undertakes to provide guidance for the student’s research project in relation to the design and scope of the project, the relevant literature, and information sources, and any research methods and techniques and methods of data analysis as indicated.

2.

Has a responsibility to be accessible to the students.

3.

Will be prepared for the meeting with the student. This includes being up-to-date on the latest work in his/her area of expertise.

4.

Will expect written work as jointly agreed, and will return that work with constructive criticism within a timeframe (a suggestion of 2-4 weeks) jointly agreed at the outset of the research.

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5.

Will provide advice that can help the student to improve his/her writing. This may include referrals for language training and academic writing. The supervisor will provide guidance on technical aspects of writing such as referencing as well as on discipline specific requirements. Detailed correction of drafts and instruction in aspects of language and style are not the responsibility of the supervisor.

6.

Will support the student in the production of a research report, dissertation or thesis. Provision should be allowed for adequate, mutually respectful, discussion around recommendations made.

7.

Will assist with the construction of a written time schedule which outlines the expected completion dates of successive stages of the work.

8.

Will advise within the framework of his or her knowledge, the student of opportunities to present work at postgraduate/ staff seminars/national/international conferences as appropriate.

9.

Will assist with the publication of research articles as appropriate.

10.

Will discuss the ownership of research conducted by the student in accordance with the University guidelines and rules on intellectual property, co-authorship, and copyright.

11.

Will ensure that the research is conducted in accordance with the University’s policy on plagiarism.

12.

Will ensure that the student is made aware in writing of the inadequacy of progress and/or of any work where the standard is below par. Acceptability will be according to criteria previously supplied to the student.

13.

Has a duty to refuse to allow the submission of sub-standard work for examination, regardless of the circumstances. If the student chooses to submit without the consent of the supervisor, then this should be clearly recorded and the appropriate procedures followed.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 The Student The Student 1.

Undertakes to work independently under the guidance of the supervisor. This includes reading widely to ensure that the literature pertinent to his/her chosen topic has been identified and consulted.

2.

Is obliged to make appointments to see the supervisor and will arrange meeting times well in advance.

3.

Will think carefully about how to get maximum benefit from these contact sessions by planning what he/she wants in these sessions.

4.

Should submit written work for discussion with the supervisor well in advance of a scheduled meeting. The kind and frequency of written work should be agreed with the supervisor at the outset of the research.

5.

Written work that is submitted should be

free from basic spelling mistakes,

incorrect punctuation and grammatical errors. Responsibility for the accuracy of language, the overall structure and coherence of the final research report, dissertation or thesis rests with the student. 6.

Undertakes to heed the advice given by the supervisor and to engage in discussion around suggestions made. Ultimately the student has to take responsibility for the quality and presentation of the work.

7.

Should strive, within reasonable bounds, to maintain a focus on his/her research area and to work within the agreed time schedule.

8.

Will prepare material for presentations at seminars and conferences.

9.

Undertakes to submit papers for publication.

10.

Agrees to honour agreements about ownership of the research and in accordance with the University’s guidelines and rules in relation to co-authorship, copyright and intellectual property.

11.

Will ensure that the work contains no instances of plagiarism and that all citations are properly referenced and that the list of references is up-to-date, accurate, complete, and consistent.

12.

Agrees to work in accordance with the criteria of acceptability as supplied by the supervisor.

13.

Undertakes not to place the supervisor under undue pressure to submit work for examination until the supervisor is satisfied that it has reached an acceptable level of quality.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Grievance Procedures Grievance Procedures It should be acknowledged that during the course of the research that both students and supervisors can feel aggrieved. In this event, these matters should be dealt with as swiftly as possible by the parties involved and, if necessary, the appropriate Postgraduate Coordinators and Committees. There is, in addition, a University Grievance Policy to help guide deliberations.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Senate Policy on Plagiarism University of the Witwatersrand, Johannesburg

S2003/351B

Replacing S2002/2038 and S2002/2039 Section One: Context of policy and procedures 1

PREAMBLE

Senate has approved the following policy on plagiarism.

A set of procedures for the

implementation of the policy is appended along with examples, and a suggested format for use by schools for a statement that student work has been unaided except where explicitly stated otherwise. ƒ What is plagiarism and is it different from copying/cheating? OVERVIEW Plagiarism is an issue of general concern that requires a standard University response that is sensitive to differences between academic disciplines and that provides sufficient developmental focus to ensure that students are given adequate opportunity for induction into the conventions of the academic community. This policy proposes that: • All academic staff should ensure that students are inducted into the values and practises of their discipline with respect to the conventions associated with acknowledging the work of others. • All schools are responsible for ensuring that adequate information, and opportunities to assimilate the information, are provided to new students.

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• Plagiarism in all its forms should be dealt with developmentally first, at school and individual academic level but that it is important that repeated or serious plagiarism be handled as a disciplinary offence. • A structured approach to plagiarism offers the best protection for the student and the best protection for the rights and thoughts of others. • All students should be required to sign a declaration that the work they have submitted is their own unaided work and acknowledging unacceptable in academe. 2

that plagiarism is

2

PLAGIARISM

This policy proposal focuses on plagiarism as the “failure to acknowledge the ideas of another” or “presentation of the ideas of another as one’s own” and should be read to cover intentional and unintentional failure to acknowledge the ideas of others. The School of Economic and Business Sciences uses the following definition: Plagiarism refers to the copying of passages in the written work of other people (e.g. authors of books or articles, other students) without acknowledgement. An essay or other assignment that is substantially copied from one or more sources, with little or no original contribution from the student submitting it, is plagiarised and represents a dishonest effort. Plagiarism does thus not incorporate poor or incomplete referencing – these are issues of convention (each referencing style requires very different amount of information from the user) and they are discipline related. Academic schools will need to manage inadequate referencing by the rules of fair administrative procedure – the expectations need to be made clear to students in written form in a document to which all students have access (such as a course outline or rule book) and the penalties for not conforming should also be stipulated (and enforced).

With respect to the management of referencing individual

schools and faculties will need to satisfy themselves that students have enough information (and training) to take on the conventions set out. If this is done then the schools will be in a stronger position to impose penalties (usually related to deduction of marks or refusal to mark work until it is properly referenced). Penalties are often on a continuum depending on the extent to which the referencing does not conform to requirements.

3

CURRENT WITS POLICY

2

Schools or faculties can best decide when to get such a signed acknowledgement from their students.

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Plagiarism (intentional failure to acknowledge the ideas of another) is currently handled under the misconduct rule in the Rules for Student Discipline. The definition of misconduct appears in Rule 18 of the Rules for Student Discipline and states as follows: “Misconduct comprises behaviour within or without the precincts of the University, without just excuse, which 1) constitutes a breach of any statute, regulation or rule of the University; or 2) constitutes a failure or refusal to comply with any punishment or order imposed under these rules; or 3) constitutes a failure or refusal to obey a lawful order; or 4) constitutes conduct that tends to bring the University or any part of it or a member of its staff or a student or any part of its student body into contempt or disrepute; or 5) interferes with the governance and proper administration of the University; or 6) interferes with the conditions necessary for teaching learning and research.”

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Wording of the Declaration of Own Work by Students Wording of the declaration by students (THIS DOCUMENT MUST BE SUBMITTED TO THE CENTRE WITH ANY AND ALL WRITTEN ASSIGNMENTS) (Per piece of submitted work) I ___________________________ (Student number: _________________) am a student registered for ______________________ in the year __________. I hereby declare the following: ƒ I am aware that plagiarism (the use of someone else’s work without their permission and/or without acknowledging the original source) is wrong. ƒ I confirm that the work submitted for assessment for the above course is my own unaided work except where I have explicitly indicated otherwise. ƒ I have followed the required conventions in referencing the thoughts and ideas of others. ƒ I understand that the University of the Witwatersrand may take disciplinary action against me if there is a belief that this in not my own unaided work or that I have failed to acknowledge the source of the ideas or words in my writing. Signature: _________________________ Date: ________________________

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Overview Harvard Referencing System Referencing Methods Referencing systems differ somewhat in their format. All formats are typically based on the Harvard or Vancouver methods. Usually, but not always, medical, dental, and scientific articles tend to use the Vancouver referencing system while the social sciences and humanities are inclined to use the Harvard system. That being said, whilst we will prescribe a particular format, when you go to publish your work in e.g. a journal, you are obliged to find which method and format that particular journal requires-usually they are all derivations of the Harvard or Vancouver methods. This is found in their ’Instructions to Authors’ section. If it is left up to your preference, a key point to remember is to be consistent. Never mix reference systems. We reiterate - consistency is the key.

The Harvard System of Referencing The Harvard method is a type of author-date-page referencing system. In the MScMed (Bioethics & Health Law) programme we require that students use the Harvard system of referencing and show competency in the use of footnotes or end-notes.

Internal referencing Generally, when using the Harvard style a citation in your work (internal or textual referencing) requires: 1) only the surname of the author (or authors) and 2) the year of publication (with no punctuation between the two items) and 3) the page number (s) on which you found the information, data, idea, etc. When reference is made to an author’s work in the text of your paper and you state the name of the author (e.g. Mazibuko states that the concept of personhood is complex.) this is followed by the date of the work in parentheses. It becomes part of the sentence structure: Mazibuko (1997: 454) states that the concept of personhood is complex. If you make reference to an article or research without mentioning the author in the text of your essay (e.g. The concept of personhood is complex.), then both the author’s name, year and page number are often placed at the end of the sentence in parenthesis: The concept of personhood is complex (Mazibuko 1997: 454). A sentence with the name of the person cited = (surname year published: page number) follows the person’s name.

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A sentence without the name of the person cited = (surname

year published: page

number) follows at the end of the sentence.

Example (1) of Internal Referencing Harvard Method: A similar view is adopted by Pellegrino and Thomasma (1988: 46-47) in their following statement: “The doctor should override the patient’s irresponsible refusal”. According to Gillon (1996: 23), respect for autonomy can be overridden in cases of “impaired volitional autonomy”, whether intrinsic (i.e. in cases such as neurosis or grief).. Beauchamp and Childress (1994:146), on the contrary, call such decisions paternalistic. However, one might ask if paternalism is even relevant in such cases (McLean 2001: 22).

Example (2) of Internal Referencing Harvard Method: As Hardin (1999: 338) says, The only way we can preserve and nurture each other and more previous freedoms is by relinquishing the freedom to breed, and that very soon. Freedom is the recognition of necessity” – and the role of education to reveal to all the necessity of abandoning the freedom to breed. Only so, can we put an end to this aspect of the tragedy of the commons.

Reference List (Bibliography) Example 2 (above) in Reference List Hardin, G. 1999. The Tragedy of the Commons. In: People, Penguins and Plastic Trees. C. Pierce and D. VanDe Veer (Eds.). New York and International: Wadsworth Publishing Company: 330-338.

Reference List Format (both Harvard and Vancouver methods) Author’s surname comma initials full stop / period. The year of the publication full stop / period. The title of the article or book full stop / period. The city of publication colon: The publisher’s name full stop / period. If you have cited (or read) read only a few pages in a book, then in your reference list you would write it this way: Example: Gillon, R. 1996. Philosophical Medical Ethics. Chinchester: J. Wiley and Sons: 32, 67.( ←These (p 32 & p 67) were the only pages cited.)

Citing Two Authors

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When you name two authors in your sentence, you follow the same format as with one author (above): Named in text: e.g. Naidoo (2001: 23) and Frebhois (1997: 88) agree that … Likewise, when you do not directly name them, the same format as above is followed: It is felt by some lawyers that ethics creates too many controversies (Mafu 2001: 34; Jones 1995: 92). Note: the latest year of the book / article publication always goes first – 2001 before 1995).

Citing two authors-writing jointly Naturally, there is often collaboration between two writers of articles / books, etc. The format for citing two authors is quite simple: Directly cited = van Bogaert and Dhai (2001: 55) argue that … Indirectly cited = It is argued that relativism is often misunderstood as a topic (Tangwa and Pierce 2003: 99).

Citing multiple authors in a book or article Assume that an article lists all these individuals as authors: Herbert, H., Mokoena, G., Pillay, R. Hanson, Y., Margulis, C., Randolph, M. A., Shabangu, B. , Mkize, D. 2005. The problem of malaria and DDT. Journal of Epidemiological Inquiry, 3 (4), 86-98.

Internal referencing of multiple authors Where there are several authors (more than two), only the first author should be used in your internal (textual) reference followed by et al.

Direct reference Green et al. (2005: 203) suggests that the foundations of law are built on … Indirect reference Recently research has identified that the majority of …(Green et al. 2005: 206). In your internal reference, you would write the surname of the first author and the term ‘et al’. (‘and others’) the date published, and the page number indicating the page from which you took the information / idea. If you reference the article in general, you are not obliged to include a specific page number, instead you put the page numbers of the article. Example (specific): Herbert et al. (2005: 94) state that one of the major problems in tackling malaria is the side effects of DDT use.

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Example (general): One of the major problems in tackling malaria is the side effects of DDT (Herbert et al. 2005: 94-99). Example: Many South African epidemiologists also enter the malaria-DDT debate (Herbert et al. 2005: 86-98; Mafu & Morrison 2000: 67). epidemiologists enter the malaria-DDT debate.

Here you have said that ‘many’

However, even though the article by

Herbert and his/her colleagues are many, it would not be fair to represent the debate by only those. So you need at least another reference to indicate that you are not biased.

Citing multiple authors in your reference list List in the sequence of the original article only the first three authors and write ‘et al’: Herbert, H., Mokoena, G., Pillay, R. et al. 2005. The problem of malaria and DDT. Journal of Epidemiological Inquiry, 3 (4), 86-98.

Internal referencing with no known author Use the title of the work or abbreviation of the title if it is long and cumbersome plus the date of publication, (or you may use Anonymous or Anon). The title should be written in italics. Every effort should be made to establish the authorship, particularly if you intend to use this work in an academic submission. Example: WHO reports indicate that there is an alarming increase in the reported incidence of drug resistance (Anon. WHO 1999).

Internal Referencing with no date known When there is no date, use n.d. as an abbreviation. Example: (direct) Hlongwane (n.d.) argued that … The argument that some illnesses have an environmental component may be persuasive (Tippen n.d.).

Use of page numbers in citations The use of page numbers helps readers to identify the precise source of the idea or quotation cited. Citing from one author who has written more than one book / article on a subject. When the author’s works have been published in the same year, add a lower case letter to the citation. Example: (direct) Nichoas (2006a: 34; 2006b:56) contends that …

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(indirect) Cloning will bring grave societal problems (Nichoas 2006a: 34; 2006b:56)

Quotations Where you are quoting portions of published text or if you think a particular quotation will adds resonance to your work, the sentence /s must be included within quotation marks. There are different stylistic means used to introduce such quotations such as: Randolph (2005: 56) states that … As stated by Malete (2003: 68): … In addition, it is common practice to place the quotation as an indented paragraph within your work and use quotation marks. Another practice is to put the quotation in an indented paragraph in italics (in this case, no quotation marks are necessary). The point is to identify the quotation as the work of someone else.

Citing from an edited work Often works are cited which are part of anthologies. When you use the work of an author of a chapter in a book which has been edited, within your text (internal reference) you cite the name of the author of that particular chapter. Example (Internal / textual reference): In his discussion about informed consent, Brody (2000: 419-424) suggests that … Example (Reference list) Your reference list should include details of both the part (e.g. page, chapter) and the entire document should be given. Brody, H. 2000. Transparency: Informed Consent in Primary Care. In: Intervention and Reflection. R. Munson (Ed). Australia and International: Wadsworth Thomas Learning: 419424. Citing joint authors in recognised associations, Government departments, Companies, etc. When you cite an article from such bodies (which have no specific author) the ‘author’ becomes the body that published or commissioned the publication. Example: The South African Medical Association (SAMA 2007) has issued a statement in this regard … As seen above, it is reasonable to use abbreviations for such entities in your text. You must ensure that you provide the full name (spell it out in full) once at the first citing within the text, putting the abbreviation in parenthesis.

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In your reference list, you spell out the full name and put the abbreviation in parenthesis, then follow the normal referencing format. Example: South African Medical Association (SAMA) 2007. Report on the Pay Dispute in Provincial Health Departments. Pretoria: The Association.

Citing secondary sources (Second-hand references) An author may mention someone else’s work, and you may wish to include that in your text. This type of citation is called a secondary source. You should first try to find the original article and read it for yourself. This is because as one’s person’s interpretation may differ from another’s. Example: (Indirect) The findings by Criggins (1999: 34 cited in Hastings 2006: 120) identified … (Direct) (Criggins 1999 cited in Hastings 2006: 44) …

Your Reference List or Bibliography Books Author(s) surname(s) and initials Year of publication of edition referred to (not printing or impression) Full title of book including sub-title (in Italics) Place of publication Publisher’s name Examples (note the punctuation placed in bold) Brody, M. 2000. Informed Consent in Primary Care. NY and International: McMillan and Company. Mazibuko, J. and Moloi, S.S, 1988. Narrative Analysis of Zulu Traditional Tales. 2nd ed. Johannesburg: University of the Witwatersrand Press Sinclair, W., 1999. Critical Heuristics of Social Planning. Philadelphia: University of Pennsylvania Press.

Reference list: Referencing format for books with two or three authors For books with two or three authors, their names should be included in the order they appeared in the cited work. The author’s surname and initials, listed in the order they appear in the document. Year of publication of edition referred to (not printing or impression) Full title of book including subtitle in italics Edition of book (if not first edition)

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Place of publication Name of publisher

Reference list: Referencing format for books with more than three authors For books with four or more authors, include the name of the first three authors Where names are omitted "and others" or "et al" should be added. That being said, there is a convention to include all authors in the Reference List/Bibliography. The first three authors only surname and initials, followed by "et al.", if other authors are omitted Year of publication of edition referred to (not printing or impression) Full title of work (including subtitle) in italics Edition of book (if not first edition) Place of publication Name of publisher Example: Domingo, S., Malvern, P. Nkosi, J. et al., 2003. A History of Obstetrics. NY: New York Medical University Press.

Reference list: Referencing format for books which are edited Editor (s) surname(s) and initials, followed by Ed. or Eds. Placed in parenthesis Year of publication of edition referred to (not printing or impression) Full title of book (including subtitle) in italics Edition of book (if not first edition) Place of publication Name of publisher Example: Keene, M. (Ed.), 1998. Natural Evolution. Cambridge: University of Cambridge Press. Silver, R. P. and Mann, J. (Eds.), 1999. The Coming Public Health Crisis. Sidney & International: Sage publications.

Reference list: Referencing format for an E-book Author(s) surname(s) and initials Year of publication of edition referred to (not printing or impression) Full title of work (including subtitle) in italics Type of medium should be indicated in parentheses or square brackets, ie. [e-book] Edition of book (if not first edition) Place of publication

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Name of publisher Available from, should include Web site address/URL and additional details of access, such as the routing from the home page of the source Accessed, or cited ….date (Day, month and year) in square brackets Example: Foster, J., 2006. The rise and fall of Hester Pyre. [e-book]. Chester: Castle Press. Available from :http://www.libweb.anglia.ac.uk / E-books. [cited 17 June 2006]. Employment law and practice. 2005. [CD-ROM]. London: SelfInc. Available from : libweb.anglia.ac.uk/ E-books. [cited 7 July 2005].

Reference list: Same author, multiple works. Annas, G.J. 1975. The Rights of Hospital Patients. NY: Avon Books. _________. 1977. Informed Consent to Human Experimentation: The Subject’s Dilemma. Cambridge, Massachusetts: Ballinger Press. _________. 1980. On the protection of human subjects. Bioethics Quarterly, 2 (1): 84-93. Ensure you display the works by the same author in chronological order, the earliest first.

Reference list: Journal articles Author(s) surname(s) and initials Year of publication Title of article (upper case first letter, lower case other) Name of journal, in italics Volume number, in bold Issue number in brackets (-) Page numbers (colon) first page and last page e. g. 12-19. Example: Annas, G. J. 1980. On the protection of human subjects. Bioethics Quarterly, 2 (1): 84-93.

Reference list: Newspaper articles Author(s) surname(s) and initials Year of publication Title of article Name of newspaper, in italics Date (day and month) Page number /s of article

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Example: Maldague, X., 2006. The Parliamentary casebook: new issues for lawyers. The Mail and Guardian, 3 Sep.: 4-5.

Reference list: Journal articles retrieved from an electronic source Author(s) surname(s) and initials Year of publication Title of article Name of journal in italics Indicate medium type in square brackets Volume number in bold Issue number in brackets (-) Page numbers, if these are part of the webpage presentation. Available from (URL or other location and source details) Accessed, or cited date in square brackets Example: Boughton, J.M., 2002. The Bretton Woods proposal, an in-depth look. Political Science Quarterly, [online]. 42 (6), Available from: http://www.pol.upenn/articles, Blackwell Science Synergy.[cited 12 June 2005].

Referencing miscellaneous documents There may be other types of documents you wish to cite in your work. The following are some suggestions for their citations.

Acts of Parliament The standard mode of citing an Act of Parliament is by its short name or title, which includes the year followed by the chapter number in brackets. Place of publication Name of Publisher Example: The Higher Education Act 2006. (c.8), Sidney: The Parliament Press. Road Transport Lighting Act 1957. (5&6 Eliz. 2, c.51), London : HMSO.

Law report Follow normal legal practice by including: Name of the parties involved in the law case Year of reporting Law reporting series

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Volume and number Page reference Example: R v White (John Henry) [2005] EWCA Crim 689, 2005 WL 104528 .

Annual report Corporate author Year of publication Full title of Annual Report Place of Publication Name of Publisher Example: Pfizer Corporation. 2001. 2001 Annual Report. Geneva: The Corporation.

General Layout Guidelines The Harvard method of referencing sets out standards for the order and content of information in the reference, not the format or layout on the page. Many variations of layout are acceptable provided they are used consistently. In this programme, we request that the title of the book or journal be placed in italics. The font should be Arial 11 pt or Times New Roman 12 pt. (No fancy fonts, or page borders). Graphics may be used only if they are necessary for explanatory purposes and add meaning to the work. When you adhere to a systematic form of referencing, the quality of your work is enhances. It enables the reader to identify the depth and breath of your understanding of the topic as well as accessing the information to which you refer.

Referencing Tips Document all your readings. Ensure you record: Who is responsible for the document, ask: is it an author or an organisation? Record the date published (in the case of e-documents, note when it was made available). Title – Record the title of the work. If article, note the article title and journal title. If a chapter, note the chapter title and book title. If a website, identify what part of the site you are looking at. Record publishers details: Note where published and by which publisher. For journal citations, record the volume and pages / page ranges for journals

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Website address, copy and paste the web address for easy reference. Sometimes you may have to use the home page address and provide routing to the page.

For electronic

sources, record the date accessed.

Footnotes and Endnotes Because extensive descriptive notes may be disturbing to readers, most academic style guidelines recommend limited use of footnotes/endnotes; however, certain publishers encourage or require note references in lieu of parenthetical references. In addition, there are times when foot or endnotes become of vital importance as supplementary explanations for your work. This is particularly applicable when evaluative comments are made or when you feel the reader may need some additional background information that would be awkward to include in your text. It is also possible to use endnotes or footnotes when you want to briefly explain something or provide additional information that might be too digressive if included in your text. It is also important (and interesting ) to note that some books and journal publications place great importance on having end or footnotes (and often reading them is more interesting than the actual paper!) The use of footnotes or endnotes is a required part of all essay submissions in the MSc Med (Bioethics & Health Law) course. Example: 1

See Pence, especially chapter two, for an insightful analysis of this ethical dilemma.

2

On the problems related to suppressed memory, see Wollencroft (2001: 120- 35); for a

contrasting view, see Pyle (1996: 45-46). Example: 3

Interestingly enough, in a 1998 interview, she reiterated this point even more strongly: "I

am an artist, not a politician!" (O’Keefe 1930: 124).

Formatting Footnotes Footnotes are indicated by consecutively-numbered superscript Arabic numbers in the main text after the punctuation of the phrase or clause to which the note refers. Example: Law scholars have argued for years that this claim has no basis,

7

so we would do well to

ignore it. However, it is important to remember that note references appear before dashes: Example:

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For years, law scholars have failed to address this point 8— a fact that suggests their cowardice more than their carelessness. Notes may be formatted on the same page as the text or on a separate Notes Page. If you need to format footnotes on the same page as the main text, they should follow this rule: Begin four lines (two double-spaced lines) below the main text. Single-space notes should be formatted as footnotes on the page, but double-space between individual notes.

Electronic Referencing General Guidelines for Referencing from the Internet The Internet contains a vast amount of data and information. However, unless you have some initial idea concerning a topic, using Internet sources unthinkingly can sometimes have disastrous consequences. In all your assignments or when you begin to write an article, indeed, a major objective is that you utilise all available information. The use of such information is meant to enrich your own thoughts through thinking through new ideas, arguments, data, facts, and information. NOTE: Search engines (Yahoo, Google, MSN, Ask Jeeves etc.) are NOT references.

Electronic Referencing Format Currently, there is no universal format for electronic referencing. Following international trends, we require the following basic format to be used in the MScMED Bioethics & Health Law Programme. The surname and initials of the author (s) (if available see below.) The date the article was published on the Internet website. The title of the article. The date you accessed / retrieved the article. Available from : The website’s address (URL).

E- Referencing an annual report document Information needed for a complete and accurate reference should normally include the following information: Author's name(s) and initials (if more than two authors, use first followed by et al.) Year of publication Title of document cited The title of a web page, normally this is the main heading on the page. Medium or type of resource, in square brackets [Internet] to show that this is not a printed item.

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Available from Location URL, Accessed or cited date in square brackets. Example: Charles, X., Rodriques, R., Jones, M.L., 2005. Focus: ‘Targetitis ails NHS. Times Online, [internet]. Available from : http://www.timesonline.co.uk/print/11-1506669.html. Accessed 1 June 2006.

E- Referencing a Journal Article Example (1): VandenBos, G., Knapp, S., & Doe, J. 2001. Role of reference elements in the selection of resources by psychology undergraduates. Journal of Bibliographic Research, (5): 117-123. Retrieved (or Accessed) June 23, 2005. Available at: http://jbr.org/articles.html. So, the format is Author’s (s) surname (s), Initials. Date published. Title of article. Name of journal, volume & issue of journal: page numbers of article. Date you accessed or retrieved the article. The site (webpage) on which this article is available.

E- Referencing an Internet only citation: On - line journals. Example: Mohlala, B. 2000 (March 7). Optimisation of Rural OPD Services. British Medical Journal (on-line) Article number 187b. Retrieved (or Accessed) June 4, 2005. Available at: http:(address) E-Referencing articles which are in an Internet- only newsletter Example: Mafu, B., and Grayson, C. 1997 (July). Mercury poison and amalgam use – project update. Dental

News,

3

(2)

Accessed

May

27,

2005.

Available

at:

http://dentalnews.net/subscribe/newsletter 3b.html.

E-Referencing of electronic articles which have no date or author given. If there is no author cited on the electronic source, then use the title of the article. Put in parenthesis ‘n.d.’ meaning ‘no date’ and ‘n.a.’ meaning ‘no author’. Then put in the name of the website, the date you retrieved the article, and the website/ page address. The title of the article and such information goes into your reference list at the end of your paper. Example The Unexamined Life. (n.d.)(n.a.) Grandpa Wayne’s Philosophy Site. Accessed May 29, 2005. Available at http://wwwgrandpawaysphilosphy/dontusethis/html

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Citing Electronic references in text (Internal or textual referencing). Under no circumstances write the webpage site or address in your text. To have a sentence with a website address included or following it is terribly distracting to the reader and represents a great amount of unnecessary work on your part. In your text a reference to an Internet site or page follows the same format as does the Harvard method. Example: Shimamura (1989) notes that there are problems in utilitarianism, which he says, are mainly due to assessing probabilities. Malpractice reports have reached an all-time high (HPCSA 2006:2). The examples shown in this guide were compiled for the purposes of illustration only - they are mainly fictional. We hope this brief overview will be useful and encourage you to seek further information from the Wits Library or the Wits Writing Centre which can provide importance guidance in this regard.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Forms of Assessment Forms of Assessment 1. Diagnostic assessment The purpose of diagnostic assessment is to determine the learner’s strengths and weaknesses and to determine the learner’s prior knowledge (Geyser, 2004). A diagnostic assessment will be conducted during the first week of each unit. \The purpose of this is for lecturers to adjust their lecturing accordingly and for students to develop the appropriate expectations of the course demands. This includes aspects of a formative assessment.

2. Summative assessment This assessment type is used to grade students at the end of a unit, or to accredit at the end of a programme (Biggs 2000). Wits’ Senate Policy (2004:4) recommends that “all summative assessments that contribute to a course/year mark should have a formative feedback element to them”.

3. Continuous assessment For students enrolled in the MSc Med (Bioethics & Health Law) as a course (as opposed to block / unit release), continuous assessment is utilised. Continuous assessment, according to the Senate Standing Orders (1.2.1: 4) this type of assessment provides a cumulative picture of a student’s progress over the duration of a course.

4. Integrated assessment This type of assessment is used throughout the curriculum, particularly at the degree exit level. It calls on the students to demonstrate that they are “...able to pull together and integrate the different bits of information, skills and attitudes that they have developed from across a [whole qualification]

as a whole. Integrated

assessment therefore involves the design and judgement of learner performances that can be used as evidence from which to infer capability (the integration of theory and practice) and to demonstrate that the purpose(s) of a programme as a whole has been achieved” (Luckett and Sutherland in Makoni 2000: 111).

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Diagrammatically, this can be represented as: Integrated assessment of knowledge in use Skills/practical competence (Knowing how, decisionmaking ability)

Attitudes& values/reflexive competence (the ability to learn and adapt through self-reflection and to apply knowledge appropriately and responsibly)

Knowledge/foundational competence (knowing & understanding that and why)

(After Luckett, K. and Sutherland, L. 2000.. Assessment practices that improve teaching and learning. In: Makoni, S. (ed). Improving Teaching and Learning in Higher Education: A Handbook for Southern Africa. Wits University Press, Johannesburg: 111)

Self-Peer assessment (part of Formative assessment) The aim of this type of assessment is to provide students with opportunities to develop the skills of thoughtful, critical self-reflection. Assessment tasks should engage students in monitoring, reviewing and editing their own and others’ performance. In the MSc Med (Bioethics & Health Law) course, self-peer assessments may take the form of student presentations on particular topics, “Moot Trials”, etc. Not all units lend themselves to peerassessment.

DvBogaert 2007 update MSc Med (Bioethics & Health Law)41

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Coursework Marks & Assessments Coursework Unit Mark Any given combination of assessment types will always equal a unit mark of one hundred percent (100%).

A mark of fifty percent (50%) or more is required on all assessment

types used in any given unit.

Supplementary If a student obtains a mark of between forty (40%) and forty-nine percent (49%) on any of his or her assessments, he or she will be eligible for a supplementary examination on a date prescribed by the Centre. The assessment type will be prescribed by the Centre.

Sub minimum Any assessment mark below a forty percent (40%) equals a fail and the student is excluded from the unit with the opportunity of repeating that unit the following year.

Coursework Essay A five thousand (5,000) word essay on an assigned topic (or otherwise as lecturerindicated) is required as an assessment type in each unit. All essays must be submitted on a specified date and time. The dates and times will be provided to students on the first day of the unit and posted on WebCT. Any essay submitted within two weeks past due date will receive an automatic 20% reduction in mark. No essay submitted after the two-week late submission date will be accepted and the student will receive a zero for the essay component (except in cases where a student was unable to hand in sufficient work in the unit because of documented medical or other serious problems e. g. bereavement).

Sub-Minimum & Supplementary Examinations A mark of 39% or below on the essay assignment will result in a fail for that particular unit. A mark of between 40% & 49% on the essay qualifies the student for a supplementary examination on the topic within a period specified by the Centre. The Centre reserves the right to give an oral examination in lieu of a written supplementary.

Only one

supplementary per unit is possible and the maximum pass mark possible on a resubmission or supplementary is fifty percent (50 %).

DvBogaert 2007 update MSc Med (Bioethics & Health Law)42

Declaration of One’s Own Work A signed and dated declaration that the submitted work represents one’s own is a standard requirement for all submissions. No essay will be accepted without this declaration. (Form included in booklet).

Referencing System The Harvard system of referencing is the required form of referencing for all written submissions. Use of footnotes or endnotes is required.

Essay Weight Although the breakdown of assessment types may vary from unit to unit, the essay weight always remains set at sixty per cent (60%) of the unit mark. The total unit mark for all assessment types utilised will always equal a mark of one hundred percent (100%) per unit.

Core Unit Essay Sub-minimum A sub minimum mark is set at 40% for the core-unit essay submission. Any student who receives a forty (40%) to forty–nine (49%) percent may be eligible for a supplementary exam at a date and time prescribed by the Centre. Any student who receives a thirty-nine percent (39%) or below as an essay mark automatically fails the unit and has the opportunity to repeat the core unit the following year. An elective unit may only be repeated one (1) time.

Should a student be unsuccessful in the second attempt, he or she is

excluded from the MSc Med (Bioethics & Health Law) course.

Elective Units Sub-minimum A sub minimum mark is set at 40% for the elective unit essay submission. Any student who receives a forty-(40%) to forty–nine (49%) percent may be eligible for a supplementary exam at a date and time prescribed by the Centre. Any student who receives a thirty nine percent (39%) or below as an essay mark automatically fails the unit and has the opportunity to repeat the unit the following year. NB: Should a unit not be available in any given year, the Centre will direct the repeating student to an appropriate alternative unit as a substitute.

Supplementary Assessment Students who score below a fifty percent (50%) on their supplementary essays or other assessments will automatically fail the unit (s) and may have the opportunity to repeat the following year.

Whilst core units are offered every year, should a supplementary

DvBogaert 2007 update MSc Med (Bioethics & Health Law)43

assessment be required in an elective unit not on current offer, the Centre will direct the student to an alternative unit.

Additional Assessment Types Dependent on the unit’s facilitator, the following types of assessments may be used. Students will be informed on the first day of each unit which type of assessment (s) will be utilised.

Short Answer Questions If used, short answer questions will be posted on WebCT and are due for completion within a period indicated on WebCT. Not all units use Short-answer questions as a type of assessment.

AND / OR

Multiple Choice Questions (MCQs) If used, MCQs will be posted on WebCT and are due for completion within a time frame indicated on WebCT. Not all units use MCQs as a type of assessment.

AND/ OR

Open Problem Questions If used, open problems will be posted on WebCT and are due for completion within a period indicated on WebCT. Not all units will use cases and open problems as a type of assessment. WEIGHT: The weight of the on-line MCQ, Short-answer questions and / or Open problem assessment is ten percent (10%) of the unit mark.

Self-Peer Assessment (see above) Peer-assessment may take the form of e.g. topic presentations, journal reports, or Moot Trial participation. WEIGHT: The weight of the self-peer assessment (if utilised) is five percent (5%) of the unit mark.

Diagnostic Assessment

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One diagnostic assessment may be utilised in each of the core units (Introduction to Bioethics & Introduction to Health Law).

In-class Assessment (e.g. Required Readings, Article Analysis, Case Study Assessment) One in-class assessment based on e.g. an article analysis, lecture, case study or required reading will be scheduled during each unit. NB: If an article, it is part of the required readings or it will be provided as a handout on the first day of the class. WEIGHT: The weight of the In-class assessment is twenty-five percent (25%) of the unit mark.

Oral Examination The Centre may offer a student an oral examination as a supplement or under special circumstances.

“Pop” quizzes The Centre reserves the right to assess students by an in-class impromptu quiz at the discretion of the facilitator.

Example: Breakdown of Assessments per X Unit In-class

Moot Trial

Essay

WebCT

Total

assessment

Weight 5%

Weight 60%

MCQ

mark

Weight 25% Student W

50%

Unit

Weight 10% 55%

45%*

65%

Mark

is

dependent on outcome

of

supplementary Student X

60%

70%

55%

65%

58.0% Pass

Student Y

50%

30%**

30%**

55%

Has failed unit

Student W

*Qualifies

supplementary as he/she

received

45%-49%

between

his/her essay

for a Student Y

**Has failed

assessments

and repeat

DvBogaert 2007 update MSc Med (Bioethics & Health Law)45

may the unit

the year

on

following

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Essay Marking Schemes 80-100%: The work demonstrates (most or all of): ƒ exceptional control of expression and logical argument in a skilfully structured paper ƒ evidence of significant insight and original thought in dealing with critical issues ƒ identification and sophisticated use of concepts and information, exemplary control of language and grammar ƒ superior conceptualisation and analysis of issues and their interconnections

75-79%: The work demonstrates (most or all of): ƒ outstanding control of a well-written, logical and generally well-structured argument ƒ noteworthy insight and evidence of original thought in dealing with the critical issues ƒ a comprehensive range of concepts/information, excellent control of language and grammar ƒ an ability to coherently interrelate important concepts/information

60-74%: The work demonstrates (most or all of): ƒ above average focus on the question as set ƒ competence and coherence in the writing, although some problems exist in the logical organisation of the text and supporting evidence, high level of control of language and grammar ƒ ideas of others referred to are stated clearly ƒ an ability to interrelate important concepts/information in a relatively coherent way

50-59%: The work demonstrates (most or all of): ƒ adequacy in command of syntax and expression throughout most of the paper ƒ a focus on the question as set ƒ concept of logical argument present, good to above-average grammar and level of language ƒ evidence of understanding of the issues ƒ ideas of others referred to are stated fairly and clearly

40-49%: (eligible for supplementary) The work demonstrates most or all of): ƒ major flaws in its logical structure ƒ poor expression in many places; marked flaws in grammar, language level which distract from meaning ƒ descriptive rather than evaluative/critical coverage of the issues and literature ƒ arguments offered in support of claims (if any arguments are given at all) are very weak ƒ ideas of others referred to are not stated clearly or the analysis of key ideas is unclear or non-existent.

0-39% (fail) The work demonstrates most or all of: ƒ lack of logical form or structure ƒ consistent errors in expression, extremely poor level of grammar, spelling & language use ƒ descriptive coverage of inconsistent quality ƒ weak or non-existent arguments ƒ insufficient or complete lack of referencing, non-existent analysis of issues

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Delivery Modes, Teaching Methods Delivery Modes Delivery modes for units include but are not limited to conventional lectures, film or other media presentations, group case-study analysis, and journal reports.

Methods of Teaching Lectures, seminars, tutorials, WebCT and email. Online lecture copies and presentations programs are used as reference aids to learning.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Learning & Attendance Learning Careful reading of required unit content and attention to lectures, seminars, tutorials, WebCT, and email discussion forums are the conventional modes of learning. CD ROMs containing required readings are provided as background materials intended to supplement unit lectures and presentations.

Attendance Students are obligated to attend all classes and failure to attend class may result in a reduction of the overall unit mark or dismissal from the course. Each day of class, students are obliged to sign the attendance register.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Learning Contract Specific Information on the Learning Contract Students are expected to sign a learning contract that covers e.g. anti-plagiarism, attendance, participation in lectures, seminars, and tutorials, the submission of essays as required and timely submission of work.

Student Comment and Anonymous Feedback Student comment and feedback forms will be provided at the end of each unit.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 University of the Witwatersrand Policies & Guidelines Policies and Guidelines University of the Witwatersrand All students are bound by the University of the Witwatersrand’s guidelines and principles of good conduct which may be found at the Wits website. Any breach of rules and regulations will result in disciplinary action as prescribed by the University.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Lateral Integration Lateral Integration The MSc Med (Bioethics & Health Law) course is structured so that whereas the core units provide foundational knowledge, all elective units continue to build on that knowledge whilst adding new legal and bioethical concepts and principles specific to their relative themes.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Incomplete or Dropped Units & Abeyance Guidelines Incomplete or Dropped Units If students register for a course and decide not to attend it or not to complete it, (e.g. submit the essay or other assignment), the course must be cancelled with the Postgraduate Office located on the fourth floor. If students fail to re-register formally, they are marked as FAIL / ABSENT and excluded from the degree. No units may be cancelled after 30 September.

Abeyance If students wish to put a unit or the entire degree in abeyance, this must be formally arranged with the Postgraduate Office. This is only allowed until 31 May.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 External Examiners & Examination Committee External Examiners As required by Senate, this course utilises external examiners for course, unit and research report examinations. External examiners are considered as experts in any given area and the weight of their input and support is valued by the Centre.

Postgraduate Office Examination Committee The Faculty of Health Sciences’ Postgraduate Examination Committee is the official body that meets with all departments at year’s end and officially determines all final marks in accordance with University / School / Division policy.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Post Graduate Office Memo

Postgraduate Office Memo Post-Graduate Office Contact details: Postgraduate Office Wits Medical School, 7 York Road Parktown, 2193 Johannesburg. Telephone: + 27 011 717 2076 / 2399 / 2745 / 2075. Fax: 011 717 2119 1)

You are not permitted to attend any class for which you have not registered.

2)

It is compulsory to register every year until you graduate even though you have

already submitted your research report / thesis/ dissertation and are awaiting the examination results. 3)

All candidates are required to obtain a Fees Clearance Certificate before coming to

register. 4)

Foreign graduates are required to obtain both a Fees Clearance Certificate and an

international Office clearance certificate before coming to register.

Fee-Paying Procedure: 1)

South African Nationals / Permanent residents: At Fees Office (in the Administration

Building on Wits Education Campus across the street from parking entrance) pay your full tuition and registration fees. 2)

Foreign / Non-South African candidates:

DvBogaert 2007 update MSc Med (Bioethics & Health Law)49

You are obliged to submit a valid study permit, proof of personal medical aid cover with a South African-based provider and an International Office clearance. The International Office telephone number is + 27 11 717 1050. Then you pay fees plus an additional international registration fee of R 2550.00 at the office 1) above. Fee Payment ONLY Fees Office personnel are authorised to process fee payments and no fee payments will be accepted in the Fees Office. Payment is acceptable in cash, cheque or by credit card. Electronic transfers are possible. NOTE: It is vital that you use your name or student number as your reference if paying electronically. Ensure you retain proof of payment (the original copy of your deposit slip). You are obliged to present this copy at the Fees Office in order to obtain a Clearance Certificate. The banking details are as follows: Holder: University of the Witwatersrand Bank: Standard Bank Branch: Braamfontein Branch Code: 004805 Account Number: 002891697 IBT Number: 131B The Postgraduate Office also wishes to inform you that: 1)

Late registrations cannot be processed on the Oracle student data

2)

A re-registration fee will be charged for any Master’s research report/ thesis/

dissertation which has been sent for re-examination (fee is indicated in Fees Booklet available from Fees Office). In the event you need to take a leave of absence or abeyance of registration please note the following points: 1)

Applications for abeyance must be submitted to the Postgraduate office NO LATER

THAN 31 May of the year in which abeyance is required. 2)

These applications must be supported by a full motivation from your supervisor and

Head of Department. 3)

The maximum period permitted for a leave of absence is two (2) years.

DvBogaert 2007 update MSc Med (Bioethics & Health Law)50

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 UNIT DESCRIPTIONS Introduction to Bioethics (core unit) Course Code Number FAMH 7014 Introduction to Bioethics (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims This unit will provide students with philosophical and factual knowledge and both abstract and practical skills. Introduction to Bioethics is designed to enable students to analyse and evaluate issues in bioethics within the context of a solid ethical framework. Major theoretical, non-theoretical and other ways of viewing the world will be taught. The unit intends to provide a foundational understanding of the relationship between concepts, logic & argumentation and fallacies of reasoning that may then be applied across all other units as well as in daily life. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended readings ƒ Introduction to Logic (read Chapters 1-5) Authors: Irving M. Copi and Carl Cohen Publisher: Prentice Hall; 12th edition (July 16, 2004) ISBN-10: 0131898345 ISBN-13: 978-0131898349 ƒ Ideology and Modern Culture: Critical Social Theory in the Era of Mass Communication Author: J. Thompson Publisher: Stanford University Press ISBN-10: 0804718466 ISBN-13: 978-0804718462 ƒ Bioethics: A Philosophical Introduction (Philosophy Today) Publisher: Polity Press (August 1, 2002) ISBN-10: 0745626181 ISBN-13: 978-0745626185 ƒ Bioethics: An Anthology Authors: Helga Kuhse & Peter Singer Publisher: Blackwell Publishing Limited; 2 edition (March 1, 2006) ISBN-10: 1405129484 ISBN-13: 978-1405129480 ƒ Classic Cases in Medical Ethics: Accounts of Cases That Have Shaped Medical Ethics, with Philosophical, Legal, and Historical Backgrounds Author: G. Pence Publisher: McGraw-Hill Humanities/Social Sciences/Languages; 5 edition (July 11, 2007) ISBN-10: 0073535737 ISBN-13: 978-0073535739

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Introduction to Bioethics (core unit) Course Code Number FAMH 7014 Outcomes Outcomes :At the end of this unit, students should be able to 1

Define and describe the term “bioethics”

2

Describe and differentiate between the major philosophical theories and worldviews which ground bioethics

3

Apply major philosophical theories and worldviews to practical cases in bioethics

4

Compare and contrast different approaches to bioethical dilemmas

5

Analyse a case in bioethics providing arguments pro or con a particular position and defending a logical conclusion

6

Recognise and diagram arguments indicating their premise (s) and conclusion(s), identify fallacies in moral reasoning, reconstruct opinions into arguments.

7

Compose and defend a position paper in bioethics applying logic, moral reasoning and critical thinking skills.

8

Articulate conflicts in values / principles/ standards and propose conceptually clear solutions to such problems

9

Discuss the role of ideology in the context of the creation of “meaning in the service of power”.

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Introduction to Health Law (core unit) Course Code Number FAMH 7013 (REQUIRED) Introduction to Health Law (Prof Ames Dhai)

Overview & Aims This unit covers sources of South African Law, the Constitution, statutory and common law in the context of health. Criminal, civil and family law and their interaction with health will be explored. The National Health Act will be discussed as well as the amendments to the Medicines Control Act. International law in relation to health is included in this unit. Specific issues such as medical malpractice, tort laws, legal aspects of relevant health law and topics such as informed consent, confidentiality and privacy will be addressed. This unit aims to provide a solid legal grounding for decision-making in the area of health law. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings Carstens P , Pearmain D. 2007. Foundational Principles of South African Medical Law. Durban: Lexis Nexis. Hassim A, Heywood M, Berger J. (Eds.) 2007 Health and Democracy . Cape Town: Siber Inc. Kennedy I, Grubb A. 2005. Medical Law. 3ed. Oxford: Oxford University Press. Mason JK, Laurie GT. 2006. Mason and McCall Smith’s Law and Medical Ethics. 7ed. Oxford: Oxford University Press.

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Introduction to Health Law (core unit) Course Code Number FAMH 7013 Outcomes Outcomes :At the end of this unit, students should be able to 1

Interpret selected aspects of the law relevant to health.

2

Describe relevant aspects of health law coherently and accurately.

3

Articulate answers to selected medico-legal problems.

4

Critically appraise and evaluate relevant health law.

5

Compose and present legal arguments on selected aspects of health law.

6

Conduct independent research on selected aspects of health law.

7

Describe ethical issues involved in the application of health law.

8

Compose and defend a position paper from the situation of health law applying logic and critical thinking skills.

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Research ethics (elective unit) Course Code Number: FAMH 7011 (Elective) Research Bioethics (Prof Ames Dhai & Prof Donna Knapp van Bogaert)

Overview & Aims This unit introduces and explains a number of topical ethical issues in research ethics, including what constitutes unethical research, relevant national and international regulations and guidelines for research ethics, protocol reviews, case studies and standards of care in a study, authorship guidelines and plagiarism. The role and modus operandi of Research Ethics Committees are outlined. Clearly articulated standards of good clinical practice in research relevant to local realities and contexts are provided. Some specific topics included are obtaining valid informed consent considering specific subgroups, standards of care for trial participants, access to study medications following completion of a clinical trial, issues pertaining to incentives affecting researchers and participants, releasing and publishing research results and the implementation of research findings.

Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ Penslar, R L. (Ed.) 1995. Research Ethics Cases and Materials. Bloomington, Indiana: University of Indiana Press. ƒ Emanuel E, Crouch, R., Arras, JD, Moreno, JD & Grady C. (Eds). 2003. Ethical and Regulatory. Aspects of Clinical Research: Readings and Commentary. Baltimore: Johns Hopkins University Press. ƒ Doyal, L & Tobias, JS (Eds) 2001. Informed Consent in Medical Research. London: British medical Association Books. ƒ Khan, JP, Mastroianni AC, & Sugerman, J. (Eds). 1998. Beyond Consent: Seeking Justice in Research. New York and Oxford: Oxford University Press

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Research ethics (elective unit) Course Code Number: FAMH 7011 Outcomes Outcomes :At the end of this unit, students should be able to : 1

Distinguish between responsible behaviour and misconduct in all types of research activities (e.g. social sciences, clinical, and academic).

2

Resolve conflicts in research ethics by engaging in open-minded discussion giving good reasons to support your argument

3

Debate contemporary legal moral and ethical issues associated with modern research activities

4

Identify and apply key research ethics and legal documents used to support and regulate good clinical practice in research

5

Utilise a systematic framework for evaluating the ethics present in research protocols

6

Define the purpose, function, and challenges faced by Human Research Ethics Committees (IRBs) / Animal Research Ethics Committees

7

Compose and defend a position paper on a contemporary issue ( e.g. vulnerable populations,

randomization,

international

research,

children

as

research

participants, etc.) in research ethics applying logic, moral reasoning and critical thinking skills 8

Identify, discuss and reach a logical conclusion concerning some of the challenges found in research activities

9

Discuss the impact of ideologies on pertinent research ethics topics e.g. “bad research”, “standards of care”, international collaborative research, etc.

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Reproductive Health Ethics and the Law (elective unit) Course Code Number FAMH 7012 Reproductive Health Ethics and the Law (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims This unit covers ethical and legal issues arising in such topics as: reproductive control, the issue of lesbian parenthood, ethics and law in fetal medicine, feto-maternal conflicts, reproductive choices, assisted reproductive technologies, prenatal diagnosis, maternal mortality, morbidity, sexual assault, and gender-based violence. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ Mathieu, D. 1996. Preventing Prenatal Harm: Should the State Intervene?, 2nd edition. Washington, D.C.: Georgetown University Press. ƒ Purdy, L. 1996 Reproducing Persons: Feminist Issues in Bioethics. NY: Cornell Univ. Press. ƒ Robertson, J. 1994. Children of Choice: Freedom and the New Reproductive Technologies. Princeton, NJ: Princeton University Press. ƒ Steinbock, B. 1992. Life Before Birth: The Moral and Legal Status of Embryos and Fetuses. NY: Oxford University Press. ƒ Tong, R. 1997. Feminist Approaches to Bioethics: Theoretical Reflections and Practical Applications. Boulder, CO: Westview Press.

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Reproductive Health Ethics and the Law (elective unit) Course Code Number FAMH 7012

Outcomes Outcomes :At the end of this unit, students should be able to 1. Identify core ethical and legal issues in current reproductive health debates. 2. Compose and defend a position paper in reproductive health, ethics & the law applying logic, moral reasoning and critical thinking skills. 3. Describe factors contributing to violence against women and its how it impacts on women’s health 4. Discuss the role of ideology and the mediasation of gender stereotypes 5. Debate the ways in which reproductive health management is an essential element in the overall development of any country; 6. Compare and contrast the different philosophies and ideologies, which underpin the concept of reproductive health.

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HIV/ AIDS Ethics and the Law (elective unit) Course Code Number FAMH 7007 HIV: Bioethics & Health Law (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims This unit will provide students with an understanding of the complex ethical and legal issues arising in the HIV/AIDS pandemic. Some of the topics include ethical legal and cultural issues such as conflicts raised in counselling, informed consent, confidentiality, ‘routine’ testing, social responsibility, duties or not to treat, access to drugs, care and vaccine research. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ Benatar, S. 2002. The HIV/AIDS Pandemic: A Sign of Instability in a Complex Global System. Journal of Medicine and Philosophy, 27 (20):163-177. ƒ Benotsch, E. 2004. HIV Prevention in Africa: Programs and Populations Served by NonGovernmental Organizations. Journal of Community Health, 29 (4 ): 319-336. ƒ Cheru, F. 2002. Debt, adjustment and the politics of effective response to HIV/AIDS in Africa. Third World Quarterly, 23(2): 299–312. ƒ Cohen, J. et al. 2005. AIDS in Uganda: the human-rights dimension. The Lancet, 365: (9477) : 2075-2076. ƒ Cox, PSV. 1992. Prevention vs Cure in Developing Countries: The Pendulum Syndrome. The Lancet, 339: (8794): 664-665. ƒ Farmer, P. 2005. Global AIDS: New challenges for health and human rights. Perspectives in Biology and Medicine, 48 (1): 10-16. ƒ Gostin, L.O. and Lazzarini, Z. 1997. Human rights and public health in the AIDS pandemic. Oxford: Oxford University Press. ƒ Gupta, GR 2004. Globalization, Women and the HIV/AIDS Epidemic. Peace Review, 16 (1): 79-83. ƒ Jardim,C. 2005. Prevention and Solidarity: Democratizing Health in Venezuela. Monthly Review, 56 (8): 35-39. ƒ Jones, PS. 2004. When ‘development’ devastates: donor discourses, access to HIV/AIDS treatment in Africa and rethinking the landscape of development. Third World Quarterly, 25 (2): 385-404.

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HIV/ AIDS Ethics and the Law (elective unit) Course Code Number FAMH 7007 Outcomes Outcomes :At the end of this unit, students should be able to : 1. Compose and defend a position paper in HIV/ AIDS and the law applying logic, moral reasoning and critical thinking skills 2. Discuss the role of ideology and the mediasation of HIV/ AIDS 3. Describe the links between violence against women and HIV infection 4. Analyse critical issues in HIV/AIDS treatment from perspectives such as economic, social and political. 5. Articulate, debate and discuss key problems rising in the ethical and legal areas concerning

healthcare & HIV/AIDS e.g. research, confidentiality, privacy, informed

consent, vulnerability, truth-telling, HIV/ AIDS infected healthcare practitioner, duties & responsibilities, etc.

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Genetics Ethics and the Law (elective unit) Course Code Number FAMH 7009 (2008 Elective) Genetics, Bioethics & Health Law (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims Is our destiny in our genes or do memes play a role as well? Do we face a new eugenics? In this unit, a core background concerning contemporary issues in genetics will be provided examining such issues from bioethical and legal perspectives. This unit aims to provide students with a background in bioethical and legal issues pertaining to genetic screening, testing, sex selection, criminal law & DNA, counselling and therapy, the Human Genome Project, genomics, eugenics and stem cell research. Examples of particular topics which will be highlighted are, e.g. Genetics, intervention, control and research, Pitfalls of genetic testing, Children and their (arguable) right to an open future, Genetics and reproductive risk: Can Having Children be Immoral?, & Germ-Line Therapy and Medical Imperatives. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ Andorno, R. 2004. The right not to know .Journal of Medical Ethics, 30: 435-440. ƒ Agar, N. 1999 Liberal Eugenics. In: Bioethics: An Anthology. P. Singer & H. Kuhse (Eds). Oxford: Blackwell Publishing: 171-181. ƒ Chadwick R & Berg K 2001. New ethical frameworks for genetic databases. Nature Genetics, 2 (April): 318. ƒ Clarke A. 1998. Genetic screening & counselling In: A Companion to Bioethics. P. Singer & H. Kuhse (Eds). Oxford: Blackwell Publishing: 215-228. ƒ De Melo-Martín, I 2004. On our obligation to select the best children: a reply to Savalescu. Bioethics, 18 (1):72- 82. ƒ Etzioni, D. 2004. A DNA databases in criminal justice: individual rights & the common good in DNA & the criminal justice system D. Lazer (ed). Massachusetts: MIT Press. ƒ Greeley, H. 2001 Human genome diversity: what about the other human gnome project Nature, 2 (March): 222-227. ƒ Johnston J & Thomas M The science of genealogy by genetics. Developing World Bioethics, 3 (2) 2003 103-108. ƒ Paul, D. & Spencer, H. 1995. The hidden science of eugenics. Nature, 374 (23). ƒ Purdy, L. 1999. Genetics & reproductive risk: can having children be immoral? In: Bioethics: An Anthology. P. Singer & H. Kuhse (Eds). Oxford: Blackwell Publishing: 123130. ƒ Warren, M. 1999. Sex selection: individual choice or cultural coercion. In: Bioethics: An Anthology. P. Singer & H. Kuhse (Eds). Oxford: Blackwell Publishing: 137-143. ƒ Räikkä, J. 1998. Freedom & a right (not) to know. Bioethics, (12) 1: 49-63. ƒ Reiss M. 2000. The ethics of genetic research on intelligence. Bioethics, 14 (1),

DvBogaert 2007 update MSc Med (Bioethics & Health Law)61

ƒ Sabir, S. 2003. Chimerical categories: caste, race & genetics. Developing World Bioethics, 3 (2). ƒ Savalescu, J 2001. Procreative Beneficence: why we should select the best children. Bioethics, 15 (5/6): 413-426.

Genetics Ethics and the Law (elective unit) Course Code Number FAMH 7009 Outcomes Outcomes :At the end of this unit, students should be able to : 1.

Debate general issues found in the topics of Genetics, Intervention, Control and Research

2.

Contrast social Darwinism with contemporary “new genetics” identifying the role of ideology in the creation of meaning.

3.

Compose and defend a position paper in genetics, ethics and the law applying logic, moral reasoning and critical thinking skills.

4.

Discuss some problems developing countries face when held to the latest gene technologies available in more developed countries.

5.

Demonstrate an understanding of the problems racists have when faced with some outcomes of gene technology.

6.

Explain how genetic knowledge was misused in coercive eugenics programmes and provide a reasoned analysis of the ways in which such coercive practices may be avoided in the future.

7.

Articulate a response to the statement: being a person”.

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“genes serve to re-define the meaning of

Health and Human Rights (elective unit) Course Code Number FAMH 7010 (2008 Elective) Health & Human Rights (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims This unit explores the philosophical grounding of the notion of human rights and relationship between health and the protection and promotion of human rights. This is accomplished through examining relevant international declarations & SA law. The unit includes topics such as the roles of sovereign states, refugee and migrant populations, forced migrations, human trafficking, the co-relativity of rights and responsibilities and the idea of social responsibility Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ International human rights conventions and other legal instruments ƒ Cherry, M.J. (ed) 1999. Persons and their bodies: rights, responsibilities, relationships. NY: Kluwer. ƒ Children’s rights: reality or rhetoric 2000. NY: International Save the Children Alliance Publication. ƒ Ghandhi, P.R. (ed) 2000. Blackstone’s International Human Rights Documents. NY & International: Blackstone Press. ƒ Gostin LO, Hodge JG Jr. 2002. Personal privacy and common goods: a framework. Minnesota Law Review, 86:1439-1480. ƒ Gostin L 2000. Human rights of persons with mental disabilities: The European convention of human rights. International Journal of Law and Psychiatry, 23(2):125-159. ƒ __________2004. International human rights law and mental disability. Hastings Centre Report , 34(2):11-12. Also available at: http://who.int/ethics/en/Gostin.pdf. ƒ Green T. 1997. Police as frontline mental health workers: The decision to arrest or refer to mental health agencies. International Journal of Law and Psychiatry, 20:469-486. ƒ Scheper-Hughes, N. 1995. Who's the Killer? Popular Justice and Human Rights in a South African Squatter Camp. Social Justice, 22(3):143-164. ƒ Schirmer, J. 1994. The Claiming of Space and the Body Politic within National-Security States. The Plaza de Mayo Madres and the Greenham Common Women. In: Boyarin (ed). Remapping Memory. The Politics of Time Space, Minneapolis: University of Minnesota Press.

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Health and Human Rights (elective unit) Course Code Number FAMH 7010 Outcomes Outcomes: At the end of this unit, students should be able to : 1

Articulate the different links between health and human rights from ethical and legal perspectives.

2

Discuss the philosophical underpinnings of the concept of human rights and various critiques of this concept.

3

Critically appraise important issues in health and human rights such as forced migration, war, civil unrest, children as soldiers, torture, etc.

4

Analyse, from ethical and legal perspectives, some contemporary challenges to the foundations of human rights.

5

Identify and locate key points supporting human rights as found in major international human rights documents.

6

Compose and defend a position paper in health and human rights applying logic, moral reasoning and critical thinking skills.

7

Critically evaluate issues in health and human rights in the South African Context

8

Discuss to role of ideology and the mediasation of human rights.

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Environmental Bioethics (elective unit) Course Code Number FAMH 7036 (2008 Elective) Environmental Bioethics & Law (Prof Donna Knapp van Bogaert, PhD, D. Phil & Prof Adriano Duse, MT, MBBCh, DTM&H, MMed, FCPath)

Overview & Aims This unit may be of particular interest to healthcare, occupational and environmental officers and others who are interested in the relationship of human health to the health of the environment, the need for environmental literacy and the belief that environmental ethics should form part of all university curricula. This unit is jointly coordinated by the Steve Biko Centre for Bioethics and the Department of Clinical Microbiology and Infectious Diseases. Topics included are e.g. emerging infectious diseases; “contested illnesses”, quarantine, hospital infection control, global drug resistance, global warming, biodiversity, emerging infectious diseases & bioterrorism. An overview of environmental ethical positions (Eco-philosophy) will be provided whilst overall the position from a reconstructive environmental ethics approach will be highlighted. This unit will also examine legal approaches to environmental protection and conservation from the perspectives of international & national law, hospital management & policy. Required: Your course readings (CD ROM / CLASS HANDOUTS) Recommended Readings ƒ Adamson, J., Evans, MM & Stein, R. (Eds). 2002. The Environmental Justice Reader: Politics, Poetics, and Pedagogy. Tucson: The University of Arizona Press. ƒ Brennan, A (Ed). 1995. The Ethics of the Environment. Brookfield, VT: Dartmouth Publishing Company. ƒ DesJardins, J R. 2001. Environmental Ethics: An Introduction to Environmental Philosophy, 3rd edition. Belmont, CA: Wadsworth/Thomson Learning. ƒ Harrison, FV. 2004. Global Apartheid, Environmental Degradation, and Women's Activism for Sustainable Well-Being: A Conceptual and Theoretical Overview, Urban Anthropology, 33 (1): 1-35. ƒ Hoffman, M W., Frederick, R. & Petry, ES (Eds). 1990. The Corporation, Ethics, and the Environment. Westport: Quorum Books, ƒ Jamieson, D (Ed.) 2001. A Companion to Environmental Philosophy. Malden, MA: Blackwell Publishers, Inc. ƒ Kaufman, A. 2003. Foundations of Environmental Philosophy. New York: McGraw-Hill. ƒ Light, A. & Rolston III, H. 2003. (Eds) Environmental Ethics: An Anthology. Malden, MA: Blackwell Publishing. ƒ Wenz, P S. 2001. Environmental Ethics Today. New York: Oxford University Press. ƒ Weston, A (Ed) 1999. An Invitation to Environmental Philosophy. New York: Oxford University Press. ƒ Zimmerman, M E., et al. 2005. Environmental Philosophy: From Animal Rights to Radical Ecology. Upper Saddle River, NJ: Pearson Prentice Hall.

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Environmental Bioethics (elective unit) Course Code Number FAMH 7036 Outcomes Outcomes :At the end of this unit, students should be able to: 1

Defend an ethical position from the perspective of respect for life.

2

Discuss the key points of some major approaches to environmental philosophy

3

Explain the links between human health and the health of the environment

4

Defend a weak anthropocentric approach to an issue in environmental bioethics such as the human-non human relationship, global warming, biodiversity, etc. Describe the importance of proper use of personal protective equipment, engineering controls, vaccinations, and other preventative measures concerned with the management and control of infectious disease outbreaks; provide legal and ethical arguments to defend your position and offer counterarguments. Interpret the current South African Environmental Law as it applies to a practical case. Summarise the key arguments made in environmental philosophical positions or relevant books, articles e.g. those concerning value from Rolston III, Agar; conservationism e.g. Callicott, Leopold; etc.; natural world e.g. Thoreau, Carson Articulate some of the ways in which healthcare practitioners, patients and consumers contribute to the rise in global drug resistance Outline, describe and discuss ways in which global warming will impact on human health

5

6 7 8 9

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Clinical Bioethics (elective unit) Course Code Number FAMH 7015 (2008 Elective) Clinical Bioethics (Donna Knapp van Bogaert, PhD, D. Phil)

Overview & Aims Students will learn about current controversies in biomedical ethics and the ways that different philosophical theories are used to shed light on conflicting beliefs. This will involve legal, medical and sociological facts about relevant issues such as, for example, the development of a fetus, pregnancy, abortion, genetics, disability, terminal illness, the process of dying, and the distribution of health care. Students will also develop a variety of skills. For example, through class discussion and case-study analysis they will improve their skills of expressing their understanding of the complexities in ethical dilemmas, and searching for satisfactory solutions to those dilemmas. This unit will acquaint the student with contemporary issues encountered in clinical practice such as patient / health care professional autonomy, euthanasia, advance directives, informed consent, confidentiality of medical records and information, doctor-patient privilege, allocation of scarce resources and professionalism. In the African context, traditional healers versus Western / Orthodox healthcare practitioner-approaches to patient care will be addressed.

Required readings: Your CD ROM / CLASS HANDOUTS

Recommended readings: ƒ John Arras, J. & Steinbock, B. 2002. Ethical Issues in Modern Medicine, 6 th Edition. Mountain View, CA: Mayfield Publishing Company. ƒ Beauchamp, TL & Childress, JF. 2000. Principles of Biomedical Ethics, 5th edition New York: Oxford University Press. ƒ Jonsen, AR, Siegler,M., Winslade,WJ. 2002. Clinical Ethics A Practical Approach to Ethical Decisions in Clinical Medicine, 5th edition. New York: McGraw Hill Companies.

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Outcomes Outcomes: At the end of this unit, students should be able to : 1. Articulate the expectations and obligations of the professional-patient relationship and discuss how the nature of this relationship may shape ethical decision-making. 2 Discuss factors such as distributive justice, gender inequalities, class which influence the healthcare worker / patient relationship 3 Investigate the range of conflicts of interest and conflict of value that may confront healthcare workers in their professional lives ( e.g. Dual loyalty) 4 Demonstrate an awareness of the use of language in the health care field and how this shapes our understandings of the concepts of “doctors”, “patients”, “health”, “disease” etc. 5 Compose and defend a position paper on an issue in clinical bioethics applying logic, moral reasoning and critical thinking skills. 6 Discuss the theoretical origins and illustrate the use of the principles of biomedical ethics in daily healthcare practice. 7 Justify the healthcare professions as moral enterprises 8 Provide sound clinical examples concerning the collision of ethical versus legal approaches to social problems.

Policy, Public Health, Resource Allocation, Ethics & the Law (elective unit) Course Code Number FAMH 7008 Presented by School of Public Health - limited access MScMed (Bioethics & Health Law) students. Course content, aims & objectives to be posted when received by Centre.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Schedule of Classes 2008 Some unit dates may be subject to change CORE (1) Introduction to Bioethics (FAMH 7014) Dates: January 21 – January 25 Venue: Wits Medical School Faculty of Health Sciences CORE (2) Introduction to Health Law (FAMH 7013) Dates: January 28 – February 1 Venue: Wits Medical School Faculty of Health Sciences Elective Units NOTE: All of the elective units are not necessarily offered every year. Students must indicate their second choice of electives at registration which will determine which ones will be held i.e. if sufficient students register for a particular course then it will be offered. (1) Policy, Public Health, Resource Allocation, Ethics and the Law (FAMH 7008) (offered through Public Health; limited MScMed (Bioethics & Health Law applicants accepted) Dates: Feb 4 – Feb 7 Venue: Wits Medical School Faculty of Health Sciences (2) Health and Human Rights (FAMH 7010) Dates: Feb 4 – Feb 7 Venue: Wits Medical School Faculty of Health Sciences (3) Research Ethics (FAMH 7011) Dates: Feb 18 – Feb 21 Venue: Wits Medical School Faculty of Health Sciences (4) Genetics - Ethics & Health Law (FAMH 7009) Dates: Feb 25 – Feb 28 Venue: Wits Medical School Faculty of Health Sciences (5) Reproductive Health-Ethics & the Law (FAMH 7012) Dates: Feb 25 – Feb 28 Venue: Wits Medical School Faculty of Health Sciences (6) HIV / AIDS -Ethics & the Law (FAMH 7007) Dates: Mar 17– Mar 20 Venue: Wits Medical School Faculty of Health Sciences (7) Clinical Ethics (FAMH 7015) Dates: Mar 17 – Mar 20 Venue: Wits Medical School Faculty of Health Sciences (8) Environmental Bioethics & the Law (FAMH 7036) Dates: April 14 – April 18 Venue: Wits Medical School Faculty of Health Sciences

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Examples of MCQ from WebCT Question

(1 point)

Katz: All gifts large & small. Choose the correct answer: a. It has been rpoven that physician - sales-rep interaction raises awareness of new products & benefits patients. b. In the US in 2002 the joint education campaign to foster adherence to guidelines on pharmaceutical gifts, was funded by the pharmaceutical inductry. c. The more gifts a physician receives the less prescribing behaviour is influenced. Save answer

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Question

(1 point)

Kopelman: medical futility Kopelman states that, when resolving disputes over medical futility a. the Patient or Surrogate Autonomy Model captures the insight that patients or surrogates should have a central role in shaping decisions b. the Best-interests Standard is an important guide in helping in helping people decide when treatments are futile or useful c. the professional equipoise version of the Physician Autonomy Model favors unilateral decision making and claims to eliminate values Save answer Question

(1 point)

Mary Ann Warren: Moral Status In her article Mary Ann Warren argues that a given entity’s moral standing depends on a. that entities dispositional capacities alone. b. that entities possible capacities alone. c. that entities relational capacities alone. d. that entities relational and dispositional capacities alone.

Question

(1 point)

Richard Hare in Survival of the Weakest Hare seems to suggest that we have a moral obligation to procreate. This rationale is based on a. A Christian ethical conviction.

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b. A utilitarian rationale. c. Kantian rationale. Save answer Question

(1 point)

Alice Domurat Dreger on Intersexuals Domurat Dreger concurs with Annas' ethical views on trying to normalise conjoined twins and believes this should also be applied to intersexed people. - This statement is correctly describing Domurat Drehger's stance on this matter. a. Yes. b. No. c. Sometimes. Save answer

Question

(1 point)

Christian Lawyers v Min Health Choose the correct answer(s).The Constitutional Court upheld the Minister of Health's exception to the Christian Lawyer's summons because:a. The word 'everyone' in the Constitution could not be intended to introduce a new class of rights-bearer b. The Choice on Termination of Pregnancy Act is overbroad & should be struck down in its entirety. c. Constitution Section 12(2) gives everyone the right to make decisions concerning reproduction and to security in and control over their body. d. Constitution Section 28 on the rights of the child makes no mention of the unborn child as a rights-bearer. Save answer

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Examples of Essay Topics

1. Should HIV and / or AIDS be made a notifiable disease? Analyse the South African legal position and the critiques of draft regulation R485. 2. Provide arguments for and against the claim that current intellectual property rights laws are inadequate and unenforceable in the electronic environment and will negatively affect the development of new technologies. 3.

Critically analyse the argument that HIV infection, as a consequence of voluntary risk taking by consenting adults, does not constitute a case of harm to others.

4. Develop an analysis of certain philosophical theories that reject the concept of human rights. 5. Analyse the pros and cons of research participant compensation in the context of “perverse incentives”.

MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Examples of Discussion / Short answer / Topic discussion Assessments 1. In a short discussion, address the topic of how it should be decided who receives scarce organs for transplantation (Be sure to include references from the articles by Rescher and Annas.) 2. Offer an argument pro or con the following question: Should terminally ill people have the right to control their own death? 3. Provide the core arguments concerning the following statements: (1) Animal testing is necessary to develop new medicines and advance scientific knowledge (2) Animal testing is unethical and should be outlawed. 4. Should HIV and/or AIDS be made a notifiable disease? Analyse the South African legal position and the critiques of draft regulation R485. 5. Argue from a consequentialist perspective the idea that the death penalty is an effective deterrent for heinous crimes.

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MSc Med (Bioethics & Health Law) Course Code Number MM C 070 Examples of “Good” Essays Examples of Essays that received above a mark of 55% (NB: some pre-date requirements for Harvard referencing system and use of end-notes or foot notes.) GENETICS ESSAY

Is there a right not to know if there is a possibility that one may be a carrier of genetic disease? What are the ethical implications for reproductive autonomy? Abstract The relational interest in genetic information and its implications for inherited medical diseases has been used to distinguish genetic information from other medical information, the right to which has been codified in terms of the legal and moral concept of informed consent, founded on the principle of autonomy. It has been argued that from informed consent follows a correlative right to not only refuse treatment (which supports the meaning of informed consent), but a right to refuse information. In this essay I look at this posited right predicated on autonomy, liberty and privacy to see whether these rights would support a right not to know genetic information. Introduction The right of competent patients to give voluntary informed consent and to refuse treatment is broadly accepted. That there follows a correlative right to refuse information is not certain. “It is much in dispute … what particular rights citizens have,” notes Ronald Dworkin.3 Bentham’s famous retort about natural rights being “nonsense upon stilts” notwithstanding, he also said “that any law whatsoever is an ‘infraction’ of liberty, and though some infractions might be necessary, it is obscurantist to pretend that they are not infractions after all.” Thomas Jefferson thought, equally famously, that we have a right to liberty – but it is widely understood to be a right that must jostle with equality – or the rights of others to an equal share of respect and resources. So in the wide sense of liberty as license, liberty and equality are competitors. In this way, laws or rules that are needed to protect equality are also inevitably compromises of liberty.4 Similarly claims to autonomy must occasionally yield to other principle-based rights such as beneficence or non-maleficence. Non-legal rules and principles are not immutable doctrines, and must submit to qualifications and limits:

3 4

Ronald Dworkin, Taking Rights Seriously (London: Duckworth, 1977), 184. Ronald Dworkin supra, note 1 at 266-267.

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“We are on the whole reconciled to the fact that rules may conflict and that they impose obligations which may be overridden in particular cases by contrary considerations”.5 Wary of the profligate appeal to rights that are ill-defined and unsupported by argument, R.M. Hare has cautioned that rights say to liberty, cannot simply be invoked when it means not doing something disadvantageous or distasteful, and that an appeal to one so called right can seldom not be countered by an opposing appeal to a conflicting right such that both rights cannot simultaneously be complied with.6

Moreover, an appeal to a right, such as the right to self-

determination by autonomous patients, can be claimed by opposing sides of an argument: The right “not to know” has been defended and opposed by an autonomy-based argument, in the first instance by Andorno as a function of patient choice, and in the second by David Ost as a function of rationality, essential to the deontological concept of autonomy.78 If for example, the right “not to know” is predicated on a right to freedom in the course of selfdetermination, then it must be understood what, in this context, is valuable about freedom, and why it is valuable. As well as autonomy and liberty, the right not to know has been based on the right to privacy which argument claims to have the autonomy right subsumed within it.9 I will describe the rights to privacy, autonomy and liberty, using examples from opposing views of the arguments for the right not to know to see whether such a claim would be justified.

If there is insufficient

justification for a right, then that right can only be maintained by watering down the idea of a right such that the right becomes barely useful or worth having.10 Interests in knowing and not knowing genetic information There are some arguments for the right not to know that have attempted to exploit a difference between genetic information and other medical information for which similar claims have foundered.11 Genetic information relates not only to an individual, but also to groups and families. This relational interest has been used to differentiate genetic information from other medical information that I think is in some respects misleading. For example Suter has commented that,

5

Joseph Raz, “Legal Principles and the Limits of Law,” The Yale Law Journal 81 (1972): 823. R.M. Hare, “What is Wrong With Slavery,” Philosophy & Public Affairs 8, no. 2 (1979): 103-104. 7 R. Andorno, “The right not to know: an autonomy based approach,” Journal of Medical Ethics 30 (2004): 435-439. 8 David E. Ost, “The ‘Right’ Not to Know,” The Journal of Medicine and Philosophy 9 (1984): 301312. 9 Graeme T. Laurie, “Challenging Medical-Legal Norms: The Role of Autonomy, Confidentiality, and Privacy in Protecting Individual and Familial Group Rights in Genetic Information,” The Journal of Legal Medicine, 22 (2001): 1-54. 10 Dworkin supra, note 1 at 268. 11 See for example Allen Buchanan, “Medical Paternalism” Philosophy & Public Affairs vol.7 no. 4 (1978) 370-390. 6

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“While contracting chicken pox has virtually no effect on identity, the knowledge that one carries a disease gene may influence one’s self-perception and definition of ‘one’s own concept of existence’ in a way most infectious diseases do not”.12 If awareness of some infectious diseases, such as HIV infection, implies similar harms for identity, then this cannot be used to distinguish genetic information from other information. It has also been noted that genetic information might only indicate future disease and illness that is also true of say HIV infection. The informed consent doctrine does not alter with the uniqueness of information, whether or not it is genetic; that is, it is not the fact that it is genetic information that would temper the duty on the doctor to disclose or not.13 Genetic knowledge and information can bring many of the benefits associated with early diagnosis, providing there are treatment benefits available. Where there is no cure, knowledge of a risk or predisposition can influence lifestyle choices, perhaps effectively delaying the onset of disease. Knowledge might prepare an individual to be alert to signs of, or otherwise prepare for, the onset of disease. However, empirical evidence suggests that knowledge of an individual’s affected as well as unaffected status can also be psychologically harmful. “Survivor guilt” has been recorded in families among members without a particular disease gene. A sense of an inescapable fate through knowledge of a risk of disease can cause depression, anxiety and a sense of stigmatisation.14 Again, this point cannot properly be used to distinguish genetic information as exceptional from knowledge for example of HIV/AIDS. Laurie cites a study in which it was found that the suicide rate among patients given a positive genetic test result for Huntingdon’s disease was ten times higher than the United States average. That the study focused on the period two years after disclosure, indicated that the deaths were associated with the test result rather than with the onset of symptoms. However, this rate of suicide is not significantly different among the population with symptomatic Huntingdon’s disease, nor with other debilitating and fatal diseases.

Therefore, if

paternalist withholding of medical information is justified only under exceptional circumstances, as I argued in the clinical ethics essay, and genetic information is not exceptional in terms of interests from other medical information, then a claim not to know information on the grounds that it is genetic is unfounded. It is also important to remember that exceptional circumstances do not establish rights! In terms of reproductive decision-making, it seems illogical to claim that mere knowledge of genetic information would be sufficiently harmful to justify avoiding it, and yet be prepared to transmit the risk of the disease to a child. It seems irrational to risk transmitting a disease to a child, knowledge

12

Sonia Suter, “Whose Genes Are These Anyway: Familial Conflicts Over Access to Genetic Information”, Michigan Law Review, 91 (1993): 1854-1893 in G. Laurie supra, note 7 at 8. 13 Maria Canellopoulou Bottis, “Comment on a View Favouring Ignorance of Genetic Information: Confidentiality, Autonomy, Beneficence and the Right Not to Know.” European Journal of Health Law 7 (2000): 175. 14 G. Laurie supra, note 7 at 13.

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of which is held to be too burdensome to the person considering pregnancy.

Of this type of

concealment, Sissela Bok says, “…we keep secret from ourselves the truth we cannot face”.15 There is a paradox contained in hiding information or choosing not to know, or keeping secret information one does not know. Bok questions how it is possible to simultaneously know and ignore the same thing, or conceal and remain “in the dark” about it. She suggests that the paradoxical nature of the self keeping secrets from the self undercuts reasoned choice about secrecy and further, that if there is a deceiving and deceived part in an individual, then which, if any, of these parts should be responsible for choices made in a state of self-deception. In other words, which part should be accepted as capable of moral decision-making – and how would it be known that it would not be deceiving it when doing so? Wertz and Fletcher have pointed out another paradox in terms of exercising the choice of not knowing “because in the very process of asking ‘do you want to know whether you are at risk..?’ the geneticist has already made the essence of the information known”.16 Rights Complaining about the infringement of a right or the assertion of a right requires an explanation of the wrongness of interfering with the proposed action, or the rightness of allowing the action. In other words, moral convictions are not self-certifying and must be explained and justified. A starting place would be a characterization of a right by Ronald Dworkin that, while it does not say what rights people have, or indeed guarantee that they have any rights, nonetheless does not suppose that rights have some special metaphysical character: “Individual rights are political trumps held by individuals. Individuals have right when, for some reason, a collective goal is not a sufficient justification for denying them what they wish, as individuals, to have or to do, or not a sufficient justification for imposing some loss or injury upon them”.17 A further complication in defining a right has do with the difficulties of definition and ambiguities of scope of concepts such as liberty, autonomy and privacy, which meanings are not unequivocal philosophically or semantically.

For example Dworkin has considered a range of definitions of

autonomy that are far from uniform.18 Moreover, their meaning has become somewhat expansive with so many limits and exceptions, as noted by Berlin on liberty:

15

Sissela Bok, Secrets: On the Ethics of Concealment and Revelation (New York: Vintage Books, 1989), 60-61. 16 Dorothy C. Wertz and John C. Fletcher, “Privacy and Disclosure in Medical Genetics Examined in an Ethics of Care,” Bioethics Vol. 5 No. 3 (1991): 221. 17 Dworkin supra, note 1 at xi-xii. 18 Gerald Dworkin, The Theory and Practice of Autonomy (1988), 5-6 in Laurie supra, note 7 at 36.

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“Almost every moralist in human history has praised freedom. Like happiness and goodness, like nature and reality, the meaning of this term is so porous that there is little interpretation that it seems able to resist.”19 Before each is dealt with on its merits, the concepts of liberty, autonomy and privacy are related and interdependent in degrees necessary to fulfil their function. In this way autonomy is impaired without freedom from coercion, liberty is devalued if autonomy or choices are not respected, and to have no sphere of privacy would compromise autonomy.20 Autonomy and the right not to know The right of competent persons to self-determination in so far as it is compatible with similar rights of others means that there is a correlative right to relevant medical information. Informed patients may accept or refuse treatment which right is given by the doctrine of informed consent. There is a view that a further correlative right is the right not to know, in this case, genetic information which might be expressed as a right to waive the right to information. In other words, in so far as the right to be informed is given by a person’s autonomy, so too does a right not to be informed. Denying that there is a duty on the doctor to always disclose information supports this view. Such paternalism would be justified, so it goes, when disclosure would entail harm to the patient, or when there is no effective treatment available. Evidence of harm from disclosure of genetic information must be treated differently from merely speculative predicted harm on the grounds that a physician might have to justify non-disclosure of materially significant information in a case of legal action framed in negligence or assault. The interest in knowing is informed by the view that knowledge and information enables moral choice, and the interest in not knowing, what Ibsen referred to as “life lies” would be as a shield from harmful information.21 Laurie argues that to presume that individuals will always and necessarily wish to know genetic information, that once known can never be unknown, would be to ignore the potentially damaging effects of such information, and to disrespect individuality by imposing on individuals a view of life that is not their own.22 Autonomy demands respect for persons as persons – so short-circuiting individuality would therefore be seen as autonomy diminishing. The right to be informed as a measure of promoting patient autonomy has been advocated by Beauchamp and Childress so that:

19

Isaiah Berlin, Four Essays on Liberty (1969), 131 in Laurie supra, note 7 at 36. Laurie supra, note 7 at 36. 21 Bok supra, note 13 at 60. 22 Laurie supra, note 7 at 14. 20

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“when a patient’s or subject’s autonomy is clearly limited by his own ignorance, as in the case of false belief, it may be legitimate to promote autonomy by attempting to impose the information”.23 In other words, autonomy might be promoted by violating autonomy. In the preceding page they argue contrarily that in the instance of a Jehovah’s Witness informing a doctor that he should do everything for him, including a blood transfusion, but that he would not want to know if such or similar procedures were used – “that it is hard to imagine a moral argument to the conclusion that he must be told”. Ost argues to the contrary, that acquiescence to treatment that might include a transfusion would constitute acquiescence to a transfusion and thus moral guilt could not be dodged, and that claiming the status of Jehovah’s Witness would be inconsistent with claiming a right not to know if a transfusion were used.24 (Moral guilt will be discussed later in the context of liberty.) Here the implication is that patient autonomy variously informs a right to be informed and a right not to be informed. In terms of the contractual doctor-patient relationship a doctor is obliged to respect a patient’s autonomy, and that pressing unwanted information on a patient would on the face of it, violate patient autonomy. Robert Veatch supports the notion of a contractual doctor-patient relationship, but has a view that apparently denies the patient a right not to be informed – that the patient has a duty to accept information, yet the doctor would be unjustified in forcing the information on the patient: “It is possible to grant that the principle of patient freedom would be sufficient to restrain a physician from imposing unwanted bad news upon such a patient and yet hold that human dignity requires responsible decision making by individuals especially about matters of such ultimate significance as life and death … there may still be a moral duty to know one’s self and one’s fate”.25 So, Beauchamp and Childress have claimed that a doctor should not respect the patient’s right to refuse information, where such a right exists in order to promote that patient’s autonomy. Veatch, on the other hand seems to hold that the doctor must respect the assertion of the autonomous patient’s right where no such right exists. David Ost has presented an argument that fundamentally supports the view by Veatch that to recognize a right not to know would be at odds with a lucid theory of autonomy, and that as rational free moral agents, patients have an obligation to be informed. A Kantian expression of autonomy requires freedom of will and rationality, between which principles there is a tension. Accordingly, if refusing information is shown to be irrational, and irrationality is

23

Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics (Oxford: Oxford University Press, 1979), 80. In David Ost supra, note 6 at 302. 24 David Ost supra, note 6 at 311. 25 Robert M. Veatch, Death, Dying and the Biological Revolution: Our Last Quest for Responsibility (New Haven: Yale University Press, 1976), 247. In David Ost supra, note 6 at 302.

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autonomy limiting, and autonomy is the basis on which a right not to know is claimed, then to refuse information would be to claim not to be autonomous and therefore not to be a bearer of this right.26 A variation on John Stuart Mill’s example of a man ready to cross a bridge that is known to be unsound is used by Ost to demonstrate irrationality in this respect. Mill claimed interference with liberty was justified only insofar as it sufficiently informed the man such that his decision to cross the bridge was autonomous. First, it is not the autonomy of the act of crossing the bridge that is under question, but assurance that it is in fact autonomous. Second, interfering with his crossing is both to assess whether he has relevant information and to give him the relevant information if it is unknown to him.

The implication being that interference is warranted because it would be the sort of

information relevant to a rational decision of whether or not to cross the bridge – a concept given legal and moral expression in terms of “the reasonable man”. In this scenario, say the man stopped any warning by declaring that any forthcoming information whatsoever was not wanted and would make no difference to his intention to cross the bridge. Ost likens this course to the one taken by the patient who refuses genetic information, and deems it to be irrational on either of two possible counts: First, if the individual’s motive is so fixed and unchangeable that it is immutable by any information, then like an obsession that it resembles, it is irrational. Second, if the individual is claiming to know that which he is refusing knowledge of, he is irrational. Therefore as Ost says: “a decision which refuses to admit any information as relevant is a decision which has no rational grounds of determination. Thus, the refusal of information is irrational,” and on this account “… is sufficient to show that there can be no right to refuse information.”27 Autonomy confers a moral status that justifies the predication of rights or duties, such as the right to informed consent and self-determination. Insofar as it is not possible to waive a status, or waive the foundation on which rights are founded, it does not seem possible to surrender an obligation that is conferred by such a status. In other words one cannot assume or waive a right to be autonomous – one either is or is not autonomous. In this sense autonomy is a mandatory right, and if autonomy includes rationality, then acts of irrationality are autonomy diminishing and as an irrational act, the right to refuse information cannot be claimed as autonomous. It is with similar consideration that Mill prohibited the surrender of freedom to slavery – that it is not a liberty to alienate one’s liberty.28 Liberty and the general welfare If there were a duty to be informed, then such a duty would be owed to either the patient or others – in the case of genetic information, family and children. Mill’s liberty principle holds that, interference with liberty would be justified only to prevent harm to others – not to prevent harm to the person whose liberty is it proposed is interfered with, or to coerce that person to serve his own happiness. (This account then would not consider the emotional and financial cost to a mother of a child with an

26

David Ost supra, note 6 at 302-303. David Ost supra, note 6 at 305-306. 28 David Ost supra, note 6 at 308-309. 27

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inherited genetic disease, but there would be costs to that child, other family members as well as society in a welfare state). Accordingly, the general welfare would best be served if as a matter of principle social interference were restricted to the prevention of social harm because the stakes in terms of harms by interfering ad hoc are considered to be high, and attempts to prevent persons from harming themselves frequently fail and are therefore counterproductive.29

In this way,

interests are evaluated in relation to happiness as an end. On Mill’s account, the wrongness of an act is judged by whether sanctions against it could be justified. In terms of breaches of moral obligations, at least where there is no overriding obligation, a sanction might be in the shape of guilt or public disapproval which Mill regards as “internal sanctions”. Within limits, self reproach and guilt can be triggered automatically and depend on the internalisation of certain values; the justification of “external sanctions” such as legal punishment require an extra step which requires justifying a distinct act by another person based on corresponding values. The point that I am trying to make is that on Mill’s view, to argue that an act, such as avoiding information, is wrong would be to see whether guilty feelings or familial disapproval would be warranted.30 There are many examples of regret and anger by family members that they were not disclosed genetic information; A report by the Nuffield Council on Bioethics has in this regard acknowledged that in some cases a third party’s interest is sufficient to sustain a right to know information.

One example cited is that of a man diagnosed with a mild form of

adrenoleukodystrophy (ALD), an X-linked condition that can be carried by healthy females, whose two nieces had between them three affected sons.31 Laurie questions the duty of care to third parties, of the authority in Tarasoff, by saying that genetic harm cannot be averted as the harm in terms of genetic disease has already been done, that the conduct of one relative cannot cause harm in another relative.32

However, in terms of reproductive choices, harms might be averted or

different choices made. Following Bentham’s theory of punishment, sanctions would not only apply after an act, but beforehand to inform decision-making and to prevent wrongdoing. If then, by this account there is a duty or moral obligation to receive genetic information, then there must be widespread acceptance of some value relevant to the particular duty that would inform the “internal sanctions” on most occasions. According to Mill, to say that a person has a right to something means that he has a claim on society to protect him in possession of it, by force of law or by education and opinion. In this way if his claim is sufficient that it is guaranteed by society, then it may be called a right. Further, such claims turn

29

David Lyons, “Human Rights and the General Welfare.” Philosophy &Public Affairs vol. 6 no. 2 (winter 1977): 116-117. 30 David Lyons supra, note 27 at 121. 31 Nuffield Council on Bioethics (1993): 42-53 in Jorgen Husted, “Autonomy and a Right not to Know,” in The Right to Know and the Right Not to Know, ed. R Chadwick, M. Levitt and D. Shickle (Aldershot: Avebury, 1997), 4. 32 Graeme T. Laurie, “Protecting and Promoting Privacy in an Uncertain World: Further Defences of Ignorance and the Right Not to Know,” European Journal of Health Law 7 (2000): 186.

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on reference to general welfare or as Mill puts it, utility. So, Lyons says of Mill’s theory of obligations and rights that: “Someone has a moral right when another person or persons are under a beneficial moral obligation towards him; or, in other words, when there are sufficient grounds for the widespread internalisation of a value that requires corresponding ways of acting towards him.”33 Because his account of rights is not contingent on maximising welfare, Mill is not committed to infringing rights whenever there is an apparent offer of an increase in welfare. Instead there are recognized moral obligations that may only be breached when other obligations override them. Freedom from constraint and coercion has been well defended in the context of informed choice and medical self-determination as having greatest overall welfare benefits for most patients. R.M. Hare has cautioned against the ad hoc use of principles with probable utility such as beneficence or nonmaleficence, because in a particular case it might have greater weight, relying instead on well-tried principles with known greater utility.34 A reasonable interpretation of general welfare added to the more plausible view of the moral obligation to be informed is a more convincing theory of a right to know information. No right to liberty Ronald Dworkin has proposed only a weak right to liberty in a sense that each act of constraint infringes or reduces that right, but it would yield to stronger rights such as equality. In the strong sense of a right, competitive with equality, there would be no right to liberty.35 Freedom of choice in the context of health care is qualified by similar rights of others to a fair share of resources and opportunity that is justified on utilitarian grounds, and a right to liberty is only defensible against fundamental or serious infractions such as security of person or property. Such a serious infraction, I propose, is where there is constraint on informed consent, where there is insufficient information or disclosure is withheld. In this way there is a right to liberty that is necessarily limited to important liberties or serious deprivations – that go further than an impact on liberty, which means then that it is not liberty but something else that would be defended – such as equal concern and respect.36 Dworkin favours a utilitarian argument in which community as a whole would be better off because most members would have more of what they want overall, although some would have less, each member being no more or less worthy of concern or respect than another. Such an argument turns on the fact that any restraint on liberty would make more people happier, or create greater preference satisfaction. He illustrates this point by supposing that some members of a community hold a racist view – in that a black person is to count for less than one, and a white person for more than one – rather than the utilitarian view in which each counts for one and no one for more than 33

David Lyons supra, note 27 at 124. R.M. Hare supra, note 4 at 109. 35 Ronald Dworkin supra, note 1 at 268-269. 36 Ronald Dworkin supra, note 1 at 270-273. 34

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one. Such a racist view is a genuine preference, the satisfaction of which would bring pleasure. However, if this pleasure or satisfaction is given the normal weight in the utilitarian calculation, and blacks suffer accordingly, then this would mean that their own assignment of goods and opportunities were contingent on the fact of their being thought unequally deserving of respect and concern. Now swap the example Dworkin gives of racist views for one that is sometimes given in the context of genetic information – that information about genetic disease could be grounds for disapproval or discrimination. If what Dworkin calls “these external preferences are counted, so as to justify a constraint on liberty, then those constrained suffer”, both because “their personal preferences have lost in a competition … with the personal preferences of others, but precisely because their conception of a proper or desirable form of life is despised by others”.37 Privacy and the right not to know Perceiving faults in the arguments from autonomy to a right not to know, Laurie has proposed a right to “spatial privacy”, or non-interference, to protect the right not to know – what Warren and Brandeis call “the right to be let alone”.38 This is less an assertion of a right than an acknowledgement that patients do not universally want to know genetic information, and that physicians should correspondingly gauge the wishes of their patients and mete information accordingly. Laurie points to the suggestion by Andorno, of a register as a means for patients to record their choice of whether they wish to know information or not, as incomplete. He suggests therefore that for those patients who have not exercised a prior wish, the physician should note various factors such as the availability of a therapy or cure and the nature of the disease and its consequences before making a disclosure. He submits that the burden of proof is on the doctor to justify utility in disclosure, paternalism being justified on the grounds of psychological harm.39

Paternalism save in

exceptional circumstances has been strongly refuted, and again, exceptional circumstances do not establish rights. (I covered this comprehensively in the clinical ethics essay). The appeal to nonmaleficence is generally made with reference to the Hippocratic mantra “primum non nocere” which duty I think is best translated as the giving of medical benefits with minimal harm instead of no harm at all. Conclusion If the view of Kant that “ought implies can” is accepted, and that moral accountability cannot be issued where there is failure to do what could not be done, then further, there should not be blame for not knowing what should have been done.40 In this way capacity to act and knowledge that an act is necessary are braced by a moral obligation and responsibility for its breach. However, as Bok points out, “between full responsibility to know and none at all the gradations are numerous;” and

37

Dworkin supra, note 1 at 277. Samuel D. Warren and Louis D. Brandeis, “The Right to Privacy,” Harvard Law Review Vol. IV no. 5 (December 15, 1890): 193. 39 Graeme T. Laurie, “A Response to Andorno,” Journal of Medical Ethics 30 (2004): 439-440. 40 Sissela Bok supra, note 13 at 66. 38

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she questions whether self-imposed ignorance adds to or removes responsibility, and that “where ignorance and avoidance of knowledge blend, the line is hard to draw.” This discussion has focused on rights and interests as they intersect with genetic information. The biggest group of genetic diseases that affect families and individuals is that of polygenic disorders, caused by the interaction of more than one defective gene, and so the chances of predicting disease or its onset are difficult. Further, these diseases are part of a broader group of conditions caused by the interaction of those genes with other, say environmental, factors – with a further reduced rate of predictability and onset – and a correspondingly lower value in genetic testing.41 The right not to know cannot convincingly be made on the grounds of autonomy, liberty or privacy. Autonomy is a status that cannot be waived, and to make an irrational claim on the basis of a right that is informed by rationality is inapposite. The right to liberty that is conjoined with consideration of general welfare fails to support a right not to know information. Alternatively, Dworkin has argued that the right to liberty, if it exists is weak and only functional inasmuch as would be allowed by the pressure of stronger rights such as equality or security of person that is served by the doctrine of informed consent. In practice, although refusing information cannot be an entitled right, neither should information be forcibly impressed on patients who are unwilling or resistant to receive it. Within the practice of giving medical benefits with minimal harm there is an occasional tension between what Ost refers to as humanism and humane. Patients, considered humanely, are treated compassionately, while humanism is motivated by respect for capacity to make moral choices. necessarily mutually exclusive, but do not always readily conflate.

These values are not

A capable patient, who is

unwilling to hear information initially, might by a process of education and understanding, as a function of respect, be helped to achieve optimal self-determination.42 References Dworkin, Ronald. Taking Rights Seriously. London: Duckworth, 1977. Raz, Joseph. “Legal Principles and the Limits of Law.” Yale Law Journal 81 (1971-1972): 823-854. Hare, R.M. “What is Wrong With Slavery.” Philosophy & Public Affairs 8, no. 2 (1979): 103-121. Andorno, R. “The right not to know: an autonomy based approach.” Journal of Medical Ethics 30 (2004): 435-439. Ost, David E. “The ‘Right’ not to know.” The Journal of Medicine and Philosophy 3 (1984): 301-312. Laurie, Graeme T. “Challenging Medical-Legal Norms, The Role of Autonomy, Confidentiality, and Privacy in Protecting Individual and Familial Group Rights in Genetic Information.” The Journal of Legal Medicine 22 (2001): 1-54. Buchanan, Allan. “Medical Paternalism,” Philosophy & Public Affairs 7 no. 4 (1978): 370-390. 41 42

Laurie supra note 7 at 4. David Ost supra, note 6 at 310.

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Bottis, Maria Canellopoulou. “Comment on a View Favouring Ignorance of Genetic Information: Confidentiality, Autonomy, Beneficence and the Right not to Know.” European Journal of Health Law 7 (2000): 173-183. Bok, Sissela. Secrets. New York: Vintage, 1989. Wertz, Dorothy C. and Fletcher, John C. “Privacy and Disclosure in Medical Genetics Examined in an Ethics of Care.” Bioethics 5 no. 3 (1991): 212-232. Lyons, David. “Human Rights and the General Welfare.” Philosophy & Public Affairs 6 no. 2 (Winter 1977): 113-129. Husted, Jorgen. “Autonomy And A Right Not To Know.” In The Right to Know and the Right Not to Know, edited by R. Chadwick, M. Levitt and D. Shickle, 3-16. Aldershot: Avebury, 1997. Laurie, Graeme T. “Protecting and Promoting Privacy in an Uncertain World: Further Defences of Ignorance and the Right Not to Know.” European Journal of Health Law 7 (2000): 185-191. Warren Samuel D. and Brandeis, Louis D. “The Right to Privacy.” Harvard Law Review Vol. IV no. 5 (December 15,1890): 193-220. Mill, John Stuart. On Liberty. London: Penguin Classics, 1974.

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INTRODUCTION TO HEALTH LAW ESSAY INFORMED CONSENT TO TREATMENT IN CHILDREN INTRODUCTION Voluntary informed consent in children is influenced by, among other things, the rights and interests of the child patient, the doctor, parents and sometimes community. Founded on the ethical principle of autonomy is the common law duty of the doctor to obtain informed consent. If a doctor should rely and act upon the informed consent of a child patient, in general, and particularly when the wishes of the child seem to threaten its own best interests, or are not the same as those of the parents or doctor, then the child must be acting autonomously, and therefore, must be capable of acting with autonomy. Following some discussion of the law, rights and interests bound in informed consent, I will consider some criteria for judging whether a child has the capacity to make an autonomous decision, and if so, whether the child should be given the right to self-determination. I will look at the rights and interests of children, doctors and parents alongside the law, and what these, sometimes conflicting, rights and interests might imply for informed consent to treatment in children. Among the case law that I will refer to is an appeal court judgement made in the English House of Lords that has fuelled the debate surrounding these rights and interests. 43 The purpose of the action brought by Mrs. Gillick in this case was to establish the extent of parental rights and duties in respect of girls under the age of 16 years – the age of consent to medical treatment in England. In conclusion, where there are competing claims to what is in the best interests of the child, I will look at whether the autonomous right of the child to self-determination ought to trump the clinical judgement of the doctor, and whether the parents’ right of autonomy should yield to the child’s right of autonomy. RIGHTS, INTERESTS AND LAW Joseph Raz has argued that “a law creates a right if it is based on and expresses the view that someone has an interest which is sufficient ground for holding another to be subject to a duty” and also that “to be a rule conferring a right it has to be motivated by a belief in the fact that someone’s (the right holder’s) interests should be protected by the imposition of duties on others”. 44 Informed consent to treatment in children creates a relationship between the rights and duties of the parent and doctor, and the rights and interests of the child. Constitutional law and public policy bear upon these rights and interests, but in some hard cases there are problems and uncertainties that arise from the difference between what is in place in terms of public policy or professional rules, and

43

Gillick v. West Norfolk and Wisbech Area Health Authority [1984] Q.B. 581 (Woolf J), [1985] 2 W.L.R. 413 (CA), [1985] 2 W.L.R. 830 (HL). 44 Joseph Raz, “Legal Rights, ” 4 Oxford Journal of Legal Studies 1, (1984): 13-14.

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needs that are created by social reality such as a conflict between the clinical judgement of a doctor, and the wishes of a parent or child. In South Africa the Child Care Act has provided that children over the age of 18 years can consent to an operation, and that children above the age of 14 years can consent to medical treatment.45 The principle of informed consent is founded in law, but is essentially an ethical imperative given by the right to autonomy – that capable persons are entitled to make health care decisions based on their own values and in furtherance of their personal goals. These rights are not absolute – in that “patients are not entitled to insist that medical treatment be given when to do so would breach the bounds of acceptable practice, subvert a doctor’s own held moral beliefs, or draw on limited resources to which the patient has no binding claim.”46 Below these respective ages parents, someone acting in loco parentis, a medical superintendent, or a delegate of the Minister of Health, when parents are absent or refuse to consent to necessary treatment, must give informed consent.47 Parents as custodians have duties towards their children, and to perform them must have certain powers that are parents’ rights. Parents are obliged to care both physically and morally for their children, the neglect of which can affect society, and is punishable in criminal law. In this way parents’ rights too are not absolute. Circumstances in which parents forfeit their right to give consent for a child include a refusal on religious grounds to consent to necessary blood transfusion. “A parent does not have the right to veto medical treatment as indicated as necessary to save the life or health of his minor child”. 48 It is a duty of a parent to provide a child with necessary medical treatment. If in the fulfilment of that duty, when a doctor has been consulted, there is conflict between the parent and the doctor to what the best interests of the child are, nor does the doctor have an absolute right to choose a course of treatment, save in an emergency. The duty of the doctor then in relation to the child is to help the parents to perform their duty, both duties being subject to the control of the courts. In the Gillick case it was submitted that a doctor might lawfully make a decision on behalf of a minor child, and in so doing, may overrule or ignore the wishes of the parent.49 In terms of the Bill of Rights for children: “28. (2) A child’s best interests are of paramount importance in every matter concerning the child. (3) In this section “child” means a person under the age of 18 years.”50

45

Child Care Act 96 (1996) S 39 (4). President’s Commission, “Studies of Health Care, Informed consent” Final Report on the ethical and legal problems in medicine and biomedical and behavioural research (March 1983): 19. 47 Child Care Act 96 (1996) S 39 (1) (2). 48 S.A.Strauss, Doctor, Patient and the Law: A Selection of Practical Issues. (Pretoria: J.L. van Schaik (Pty) Ltd, 1984). 29. 49 Gillick v. West Norfolk Area Health Authority [1986] 1 A.C. 201 D. 50 Constitution of the Republic of South Africa (1996), Chapter 2, Bill of Rights, Government Gazette, 18 December 1996. 46

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The law has created a duty on the doctor to obtain informed consent without which, under unexceptional circumstances, medical treatment may not be given. The exceptional cases, when treatment may proceed without informed consent of the patient, turn on whether or not the patient is capable of giving consent: when a patient is unconscious, mentally ill, or in the case of a minor child. Leaving aside for now the specific age of majority, it is unclear whether, by reaching an age so defined, also called the age of consent, a child automatically becomes capable of consenting. If it is not legal for a doctor to act on the consent of a minor child, and morally he is required to uphold the law, then ethically he must not treat that child without the consent of its parents or someone in loco parentis, unless it is in the case of an emergency. To be capable of giving informed consent requires an intellectual ability supplemented by sufficient maturity to understand and evaluate the implications – benefits and risks of the treatment. Although most children might be capable of giving informed consent by a certain age, some will not. The point is that an autonomous person has the right to refuse treatment whereas the minor child, who is not capable of making autonomous choices, does not. This implies that the “best” interests of two persons either side of adulthood, perhaps only technically by a birthday, are apparently different. In the example of a Jehovah’s Witness, an adult must have his refusal to receive life-saving blood transfusion respected, but not so a minor. In the case of the adult, autonomy is held to be the “best” interest, whereas in the case of a minor it is its health and life. This endows the question of capability with a great weight. An unlawful touching or cutting – that is without consent – is subject to the principle de minimus non curat lex – and will constitute a battery, for which damages may be awarded.51 Cardozo, J in the case of Schloendorff v. New York Hospital, classically expressed this concept: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without the patient’s consent commits an assault”.52 Referring to the same principle in the case of Stoffberg v. Elliott, Watermeyer, J held that: “A patient by entering a hospital does not submit himself to such surgical treatment as the doctors in attendance may consider necessary, and any operation performed without his consent is an unlawful infringement of his right to personal security entitling him to compensation for such damage as he has suffered.”53 A claim based on negligence is appropriate in English law when the plaintiff has given consent, but where the consent is flawed, for example when there has not been proper disclosure of risks such as happened in the case of Esterhuizen v. Administrator, Transvaal. In South African law assault is not qualified by the words “without consent” and applies to “the act of intentionally and unlawfully applying force to the person of another. … In South Africa it is always unlawful to invade the right of bodily safety of another.”

In this case, Bekker, J held that “Mere consent to undergo X-ray

51

J.K.Mason and R.A.McCall Smith, Law and Medical Ethics (London: Butterworths, 1987), 141142. 52 Schloendorff v. Society of New York Hospital 105 N.E. 92 (New York 1914). 53 Stoffberg v. Elliott (1923) C.P.D. 148.

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treatment, in the belief that it is harmless or being unaware of the risks it carries, cannot amount to effective consent to undergo the risks or the consequent harm.” 54 The difference between the two forms of action was made in the judgement on the Canadian case, Reibl v. Hughes by Laskin CJC: “I do not understand how it can be said that the consent was vitiated by the failure of disclosure of risks as to make the surgery or other treatment an unprivileged, unconsented to and intentional invasion of the patient’s bodily integrity.

I can

appreciate the temptation to say that the genuineness of consent to medical treatment depends on proper disclosure of the risks which it entails, but…unless there has been misrepresentation or fraud to secure consent to the treatment, a failure to disclose the attendant risks, however serious, should go to negligence rather than battery.”55 Legally valid consent then must flow from the right of patients to information regarding their conditions and treatments, including known risks. Consent is vitiated where a person either not reasonably informed of, or not capable of understanding and appreciating, the implications of the treatment supplies it. The Bill of Rights for children in many ways reflects a political ideal, a statement of the kind of society we would like to live in and towards which progress must be made. Anecdotal evidence suggests that informed consent in many situations in South Africa is inconsistent. Reasons given for this include language difficulties and resource pressures. Referring to a Bill of Rights for children advocated by Foster and Freed, which includes the right to receive love and be treated as a person, John Eekelaar says: “Of course such proclamations do not necessarily describe social reality.56 Rather they present public images about what social reality should be. They may influence peoples’ behaviour, although how far that influence extends beyond the official institutions of a society into personal relationships may be peculiarly difficult to discover.” 57 Still, a social perception that a person or group of people have certain interests might be said to be a starting place for the concept of rights.

In his essay, The Emergence of Children’s Rights, John Eekelaar states that these

interests must be capable of being isolated from the interests of others. The illustration he gives is that if it is in his child’s interests that he (not she) takes decisions concerning her medical welfare, which might be supported by objective evidence, his interest or right to take such decisions is not identical with her interests. He might make malicious or stupid decisions. He goes on to say that her interest is that he takes the best decision for her; that he is simply an agent for fulfilling her interests. He cautions: “Hence we should be careful to understand that when we talk about rights as protecting interests, we conceive as interests only those benefits which the subject himself or herself might plausibly claim in themselves.”58 Support for this notion is found in the judgement of Lord 54

Esterhuizen v. Administrator, Transvaal (1957) 3 S.A. 710,711. Reibl v. Hughes (1981) 114 DLR 3d 1. 56 Henry H. Foster and Doris J, Freed, “A Bill of Rights for Children”, 6 Family Law Quarterly (1972): 343. 57 John Eekelaar, “The Emergence of Children’s Rights,” 6 Oxford Journal of Legal Studies 2 (Oxford University Press, 1986): 163. 58 John Eekelaar, “The Emergence of Children’s Rights,” 6 Oxford Journal of Legal Studies 2 (Oxford: Oxford University Press, 1986): 169. 55

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Fraser: “…parental rights to control a child do not exist for the benefit of the parent. They exist for the benefit of the child and they are justified only in so far as they enable the parent to perform his duties towards the child, and towards other children in the family.”59 Again this view is given in Blackstone Commentaries where he wrote, “The power of parents over their children is derived from … their duty.”60 ETHICS Respect for autonomy, the moral principle from which informed consent is derived, flows from the Kantian Imperative of respect for persons as persons. Simply, to respect a person’s autonomy is to recognize that the person has a capacity to make choices, free from controlling influences and with an understanding of what those choices mean. Consent is valid ethically only if it is given as an expression of autonomy. Autonomy and respect for autonomy are not the same.61 Autonomous persons might not make autonomous choices, for example if they are coerced, or insufficiently informed. On the other hand, a child might be sufficiently mature as to be capable of making an autonomous choice, but not necessarily have its choice respected. In other words, autonomy in the context of medical treatment is a status that may or may not be granted by others. Because the capacity of a child to give informed consent is judged by others, a doctor say, it vests in that doctor an enormous power to grant or deny the child a right give informed consent and therefore to self-determination. Most discussion with respect to informed consent in children is around how this kind of judgement should be made even in the light of public policy and the age at which a child may legally consent. A report in the United States of the President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, entitled Making Health Care Decisions proposes some criteria by which capacity might be judged. 62

These proposed criteria

are as follows: 63 The “content” or “ outcome” approach In this view capacity is judged by the content of the decision, or what the likely outcome of that decision would be if autonomy were granted and the doctor were then to rely and act on the consent of the child. It follows then that the child would not be deemed capable and consequently autonomy not granted if the content or outcome is of a certain nature, which leads to a somewhat circular

59

Gillick v. West Norfolk Area Health Authority [1986] H.L.(E) 170. th William Blackstone, Commentaries on the laws of England 1.16 (1775, 7 edition) 450. 61 Ruth R. Faden and Tom L. Beauchamp, A History and Theory of Informed Consent (Oxford University Press, New York and Oxford, 1986), 7-9. 62 President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, Making Health Care Decisions, Washington DC, US Printing Office, 1982. 63 I have referred to the criteria in Ian Kennedy, “The Doctor, the Pill and the 15-year-old Girl” in Treat Me Right (Oxford: Clarendon Press, 1988), 55-61. 60

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argument pivotal on what content or outcomes are taken to be indicative of capacity. Capacity would probably not be in question if the doctor, the child and the parents were all in agreement about the treatment being proposed which then begs the question: would holding an unconventional view, or disagreeing with the doctor mean that the child was taken to be incapable? In other words different preferred value judgements of the doctor or parents might be substituted in different situations as being indicative of capacity. That a child might not be capable of understanding the nature of the treatment, and rationally weighing the risks and benefits, might be suggested by the content of a particular choice, or its likely consequences. But then this would mean that another criterion was not being satisfied – such as an inability to properly understand the implications of a treatment or immaturity. It is not content or outcome in themselves that should determine capability because it is not optimal outcome or content that is being established. The important issue is whether a child is capable of acting autonomously, and an autonomous person has a right to control his own destiny in accordance with his own value system. In the absence of an overriding social interest, (such as where there is a notifiable disease) S.A. Strauss records that this right, a person’s “selfbeskikkingsreg” must be rated higher than his health and life. In other words: “If there is a conflict between the desire of a person to go his own way, to forgo medical treatment and to expire in his own manner, on the one hand, and the desire of the doctor to cure him of his disease or to secure his health, on the other, the former should be accorded preference. There is neither a general right nor a general duty on the part of the person to protect another against himself”. 64 Regarding this respect for autonomy, Watermeyer, J ruled in the case of Stoffberg v. Elliott that: “In the eyes of the law, every person has certain absolute rights which the law protects. They are not dependent upon a statute or upon a contract, but they are rights to be respected, and one of those rights is the right of absolute security of the person”.65 The status approach This approach rests on the premise that having a certain status carries with it a lack of capacity. In this way, the mentally ill, by virtue of their illness, and minors, by virtue of their age are deemed incapable of giving meaningful informed consent. The fault with this approach is that belonging to a group of persons cannot rationally confer on that entire group capacity or incapacity, unless that group is defined by capacity. By corollary then, there is in this account no respect for the individual that is fundamental to the notion of autonomy. In fact, not all mentally ill persons are incapable of consenting at all times, and some decisions taken by children below the age of consent are accepted as theirs to make.

64 65

S.A.Strauss, Doctor, Patient and the Law (Pretoria: J.L. van Schaik, 1984), 28. Stofberg v. Elliott (1923) C.P.D. 148.

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This leads to a contradiction between ethics and the law with regard to informed consent. Ethically, an age is too crude a tool to cut off capability on the one side from incapability on the other; there is not proper respect of the individual as an individual. However legally it is necessary to fix a point at which a child can give valid informed consent, even if it is accepted that this point may be somewhat arbitrary, similar to the age at which it is argued a foetus develops personhood. It is however different in that capacity can and should be looked at in each individual case. It was one of the recommendations in the summing up of the commissions’ reports on informed consent that incapacity be viewed as specific to each particular decision, and that persons lacking decisional capacity should be consulted about their own preferences, to the extent feasible, out of respect for them as individuals.66 In France, for instance, minors (under the age of 18 years) are considered legally incapable. Nevertheless, “the 4 March 2002 law specifies that minors and adults under guardianship must be asked for their consent if they are able to express their preferences and participate in decision making. If the individual cannot express his or her preference, no intervention or investigation may be carried out.”67 This legislation allows for the preferences of a child to be acknowledged, but does not oblige the doctor to treat the minor child, relying on the consent of that child. In the US, informed consent applies in the usual way to patients who have reached the legal age of majority, except in cases of incompetence. In addition, however, the law has provided that there are two situations in which minors can give informed consent.

First, certain minors are given

“emancipation” and are treated as fully autonomous. These include those minors who are selfsupporting and or living away from home, married, pregnant or a parent, in the armed services or otherwise declared to be emancipated by a court of law. Second, some minors who are otherwise not emancipated are given the right to autonomy where they are judged capable – called “mature minors”, or who are seeking treatment for certain medical conditions such as pregnancy, drug or alcohol abuse, sexually transmitted infections or pregnancy. In this way the law can give clear direction to doctors to treat patients with adequate decision-making capacity. Capacity is defined by both status, for example independent living, or by having a medical condition that otherwise might not receive appropriate attention, for example a sexually transmitted infection or pregnancy.68 The functional approach

66

President’s Commission Final Report on the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, (Washington DC: US Government Printing Office, March 1983) 17-22. 67 Nora Moumjid and Marie-France Callu, “Commentary: informed consent and risk communication in France, “ British Medical Journal 327 (27 September 2003), 734. 68 Committee on Bioethics, “Informed Consent, Parental Permission, and Assent in Paediatric Practice,” 95 Paediatrics 2 (February 1995): 316.

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This approach is so called by the President’s Commission because it “focuses on an individual’s actual functioning in decision-making situations”.69 The only rational determinant of capacity is the ability of the individual child to comprehend and weigh the nature and the consequences of the treatment. This facility will develop on an individual basis, concomitant with a child’s maturity making maturity the crucial determinant, and maximising each person’s autonomy by respecting the individual. If a child is insufficiently mature then its purported consent may not be relied on because it will not be ethically valid. To ignore the consent, or to override a refusal of consent, of an incapable child is in fact autonomy enhancing. Paternalism would be ethically justified in preventing the child from doing an action that may adversely affect its ability to reach a state of autonomy free from avoidable harm.70 A mature child will have a set of values, by reference to which a considered decision might be reached. In this way a decision can be allowed to conform to the child’s values rather than an objective standard approved in the “content” approach.

Even so, the doctor, as an arbiter of

capacity, motivated by what he thinks best, might judge the child to be incapable by virtue of that child’s decision. The President’s Commission in the following phrase suggests therefore that the criterion of capacity alone is not enough: “The fact that a patient belongs to a category of people who are often unable to make general decisions for their own well-being or that an individual makes a highly idiosyncratic decision should alert health professionals to the greater possibility of decisional incapacity.

But it does not

conclusively resolve the matter.”71 Two additional criteria are suggested, and they are firstly that the doctor, out of respect for the child’s autonomy, should give an appropriate amount of time to help the child understand their condition and make treatment decisions, bearing in mind the imbalance of power that is a characteristic of patient-doctor relationships.

Secondly, to promote patient well-being and self-

determination, it should be presumed that children above the age of 14 years have decision-making capacity. Rather than deciding capacity, this would be a starting point for assessing capacity, and only in a small minority of cases should incapacity disqualify a child from making a decision about their health care. Incapacity should be viewed as specific to each particular decision.72

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President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, “Making Health Care Decisions”, (Washington DC: Government Printing Office, 1982) 170. 70 Ian Kennedy, “The Patient on the Clapham Omnibus” in Treat Me Right: Essays in Medical Law and Ethics (Oxford: Oxford University Press, 1988), 177. 71 President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, “Making Health Care Decisions”, (Washington DC: US Government Printing Office, 1982), 171-172. 72 President’s Commission Final Report on the ethical and legal problems in medicine and biomedical and behavioural research: Informed Consent, (Washington DC: US Government Printing Office, 1983), 17-22.

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By supplanting the age of 16 years as the age of consent with that of 14 years, the faults of the status approach are reintroduced, but to not have an age of consent would cause more cases to be tested in the courts – a costly and impractical option.

All systems of law distinguish between

minority and majority, the difference between them is in where adulthood begins and childhood ends. In Reg. v. D. it was established that a child’s capacity to consent is a factor to be considered, but is not the overall deciding factor. In this criminal case dealing with kidnapping, the court was not in favour of an arbitrary age of consent and found that the welfare principle will always override in the case of minor children.73 A final tool suggested by the President’s Commission is a “standardized mental status examination” designed by those with expertise in the field of maturity, to take account of a range of factors that would influence the intellectual capacity and understanding of a child. Such a test would be applied by the doctor, but would to an extent remove the subjective assessment by the doctor, removing some of the risk that unconventional and individual views of the child are rejected. Earlier I referred to a point, made by John Eekelaar, that for an interest to inform a right, that in turn holds others to a duty, it must be able to be isolated from the interests of others. This is an important point in the claim for a right to parent autonomy, which I will look at next. THE PARENT RIGHT TO CONTROL AND THE GILLICK CASE In Gillick v. West Norfolk Area Health Authority, Mrs Gillick claimed that guidance by the Department of Health and Social Security (D.H.S.S.) that contraceptive treatment and advice may be given to girls under the age of 16 years, on the clinical judgement of the doctor, without parent knowledge and consent was unlawful and wrong, and that it adversely affected the rights and duties of a parent. Mrs. Gillick argued that it was her right as parent and guardian of her children to be consulted about and give consent to (or veto) treatment of those children while they were below the age of consent.74 Ian Kennedy, in support of the D.H.S.S. said that her rights in respect of her children were only those necessary to perform parental obligations: “A parent is…the trustee of the interests of the child. This being so, the primary obligation of the parent is to bring the child to an enjoyment of autonomy, as free as possible from constraints on this enjoyment. In short, parental obligations are to be understood as being primarily autonomy enhancing. This means that the parent has an obligation initially to protect the child, while she is still immature, and thereafter, as the child acquires maturity, to leave her to make her own decisions and her own mistakes.”75 The poor laws of the sixteenth century began the legal duty of a father to educate his children by apprenticeship, primarily to protect the economic interests of the state. Further developments in laws, although appearing to protect the interests of children were in reality protecting the interests of 73 74

Reg. v. D. [1984] A.C. 778

75

Ian Kennedy, “The Doctor, the Pill, the 15-year-old Girl” in Treat Me Right: Essays in Medical Law and Ethics (Oxford: Oxford University Press 1988): 61.

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a father in whose interests or those of the church or state, the interests of the child were subsumed.76 The view that a father had near absolute authority over his minor child was expressed by Cockburn, C.J. in Reg. v. Howes; “We repudiate utterly, as most dangerous, the notion that any intellectual precocity in an individual female can hasten the period which appears to have been fixed by statute for the arrival of the age of discretion; for that very precocity, if uncontrolled, might very probably lead to her irreparable injury. The legislature has given us a guide, which we may safely follow, in pointing out 16 as the age up to which the father’s right to the custody of his female child is to continue; and short of which such a child has no discretion to consent to leaving him.”77 In the case of Hewer v. Bryant, Lord Denning rejected the notion of unquestioned parent control with the following words: “The common law can, and should, keep pace with the times. It should declare … that the legal right of a parent to the custody of a child ends at the 18th birthday: and even up till then, it is a dwindling right which the courts will hesitate to enforce against the wishes of the child, and the more so the older he is. It starts with the right of control and ends with little more than advice.”78 After the rule that a parent has absolute authority over minor children was abandoned, the Gillick case could not be resolved by referring to the legal age of consent alone, but to what were the best interests of the child. It was finally held that under some circumstances a child below the statutory age had the legal capacity to consent to medical examination and treatment, including contraceptive treatment, if she was mature and intelligent enough to understand the implications of the proposed treatment.79 Secondly, that the right of a parent to control a minor child, was a dwindling right that existed in so far as it protected and benefited the child; that the extent and duration of this right could not be ascertained by reference to a fixed age but depended instead on the maturity and understanding of the child and a judgement of what the best interests of the child were.80 Finally, a reasonable doctor acting in the best interests of his patient would not be acting unlawfully if he relied on the consent of such a capable child.81 CONCLUSION My opinion is that it would optimise the best interests of a minor child if its parents were consulted and were part of the decision-making process, where this was feasible. In the Gillick case Lord 76

John Eekelaar, “The Emergence of Children’s Rights”, 6 Oxford Journal of Legal Studies 2 (Oxford: Oxford University Press 1986): 166-167. 77 Reg v. Howes (1860) 3E. &E. 332, 336-337. 78 Hewer v. Bryant [1970] 1 Q.B. 357, 369. 79 Gillick v. West Norfolk Area Health Authority [1986] 1 A.C. 166D-E, 169A-E, H-170A, 195A-B 80 Ibid. 170D-E, 171D-E, 172G-H, 173D-H, 174A-B, 184D-F, 185D-E, 186C-E, 188H-189B, 190B, 195A-B. 81 Ibid. 174G-175B, 190F-191A, 194E-H.

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Scarman and Lord Fraser took the view that once a child was able to understand and evaluate the implications of its choice, and was sufficiently mature, the child was capable of legally and ethically giving informed consent. The judgement of Lord Scarman was clearly in support of the autonomy interest of the child, in that once a child had full capacity, the parents’ right “yielded” to the child’s right; that a parent should not impose their view even when it is apparently in the best interests of the child. In this way, children are given what John Eekelaar calls “that most dangerous but most precious of rights: the right to make their own mistakes”.82 REFERENCES Faden, Ruth R. and Beauchamp, Tom L. A History and Theory of Informed Consent. New York, Oxford: Oxford University Press, 1986. Beauchamp, Tom L. and Childress, James F. Principles of Biomedical Ethics, 4th edition. New York, Oxford: Oxford University Press, 1994. Strauss, S.A. Doctor, Patient and the Law: A Selection of Practical Issues. Pretoria: J.L. van Schaik (Pty) Ltd, 1984. Mason, J.K. and McCall Smith, R.A. Law and Medical Ethics, 2nd edition. London: Butterworths, 1987. Kennedy, Ian. Treat Me Right, Essays in Medical Law and Ethics. Oxford: Oxford University Press. 1988. Eekelaar, John. “The Emerrgence of Children’s Rights.” 6 Oxford Journal of Legal Studies 2, Oxford University Press: 161-182. Foster, Henry H. and Freed, Doris J. “A Bill of Rights for Children.” Family Law Quarterly 6 (1972): 343. Raz, Joseph. “Legal Rights.” 4 Oxford Journal of Legal Studies 1 (1984): 13-14. Committee on Bioethics. “Informed Consent, Parental Permission, and Assent in Pediatric Practice.” 95 Pediatrics 2 (February 1995): 314-317. Moumjid, Nora and Callu Marie-France. “Commentary: informed consent and risk communication in France.” British Medical Journal 327 (27 September 2003): 734 – 735. President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent on the Patient-Practitioner Relationship. Washington, DC: US Government Printing Office (1982). President’s Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioural Research, Summing up: Final Report on the ethical and legal problems in medicine and biomedical and behavioural research. Studies of Health Care (Informed consent). Washington, DC: US Government Printing Office (March 1983): 17-22. Constitution of The Republic of South Africa, 1996. Government Gazette, 18 December 1996. William Blackstone, Commentaries on the Laws of England, 1.16 (7th edition 1775).

82

John Eekelaar,”The Emergence of Children’s Rights,” Oxford University Press: 6 Oxford Journal of Legal Studies, 2: 182.

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Cases Gillick v. West Norfolk and Wisbech Area Health Authority [1984] Q.B. 581 (Woolf); [1985] 2 W.L.R. 413 (C.A.); [1985] 2 W.L.R .830 (H.L.) Esterhuizen v. Administrator, Transvaal. (1957) 3 S.A. 710. Stoffberg v. Elliott. (1923) C.P.D. 148. Schloendorff v. Society of New York Hospital, 105 N.E. 92 (New York) 1914. Reibl v. Hughes (1981) 114 D.L.R. 3d 1. Reg. v. Howes (1860) 3E. & E. 332 Hewer v. Bryant [1970] 1 Q.B. 357; [1969] 3 W.L.R. 425; [1969] 3 All E.R. 578, C.A. Reg. v. D. [1984] A.C. 778; [1984] 3 W.L.R. 186; [1984] 2 All E.R. 449, H.L. ( E.)

Introduction to Health Law Essay (author B. Patel) INTRODUCTION Res ipsa loquitur, sed quid in infernos dicet? (The facts speak for themselves, but what the hell does it say?) Hunter S Thompson (In: Res ipsa loquitur,n.d.) The evolution and transformation of medical care is rapidly advancing with newer technologies and modalities of treatment, which concomitantly increase the risks related to these new developments. There is also a changing perception of health and health services and a wealth of knowledge available to the public through books, newspapers and the Internet, which raises patient expectations and adds to the pressure that professionals are under. This has resulted in the need for ethicists and lawyers to face new issues of medical malpractice and the increase in the number of claims against practitioners.

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According to a Healthcare Commission Patient Survey (In: Herring 2004: 37), done in the National Health Service, United Kingdom, 90% of patients describe their care as being excellent, very good or good. Inevitably, it is the cases where things go wrong, that lawyers get involved and usually only exceptionally are the result of negligence or maliciousness. Medicine and the Law have been strange bed partners since ancient times with the interrelationship between the two seen in the Hippocratic Oath and the Hammurabis code83, which contain a number of legal and ethical provisions that guides the behaviour of medical practitioners. (van Dosten 1991: 23). Today the practice of medicine is regulated by medico legal principles from codes of conduct and guidelines to declarations that deal with environmental and social factors that affect health. In addition, the South African Constitution (1996), Bill of rights (1996) and various other acts, including the National Health Act (2004) provides a legal framework for the practice of medicine. In addition, the Constitution has created an expectation that health is a fundamental right. This has resulted in a greater demand for healthcare treatment at state hospitals, which faces many challenges with staff, budget and equipment shortages. Thus, there is an additional burden being placed on already overworked staff and hence the greater likelihood of mistakes. Mistakes are made in all areas of one’s professional life and following medical mishaps, the debates related to these misfortunes, both internally and with others, is something that can be damaging to one’s career, reputation and psychological well being. In some instances the mistakes are of such a nature that they may be considered as medical negligence and have legal and financial consequences. Strauss (In: Claasen and Verschoor 1992: 1) points out that the United States is by far the leader in the number of malpractice claims and that there has been an increase in England and many European countries. In South Africa, it has been stated that the numbers are increasing, as are requests for legal advice from protection societies. The Health Minister has also stated that malpractice claims cost the state R42 million during last year in compensation for both in and out of court settlements. (Quintal 2007). The Health Professions Council of South Africa (HPCSA) heard 134 cases of negligence during 2006 and 55 cases up to May 2007. These cases were either served with fines of up to R10 000 or received a suspended sentence. During 2006 alone, the council served fines up to R1.18 million. (HPCSA, 2007). It should be remembered that these are only the cases that were reported and subsequently acted upon, but that there are many more that occur everyday, but overlooked or never reported. Figures of how many cases were tried in the South African courts was not readily available but the problems noted from experience included the lengthy delays from the time of the incident to the actual court case; the massive expenses involved in the litigation process and a sense that the plaintiff starts off the process with a disadvantage, since practitioners are more likely to find support

83

The code (1760 BC) is one of the best preserved earliest set of legal guidelines for the settlement of disputed related to crimes and their various punishments.

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for their actions from expert testimony, while the plaintiff has to depend on the skill and expertise of the legal team representing his case to help prove negligence. The maxim res ipsa loquitur, which means “the facts speak for themselves”, is being used in other countries for negligence cases, but not in South Africa. This maxim would shift the advantage to the plaintiff in cases of negligence, since the mere occurrence of the incident that is not considered reasonable would now have to be defended. This essay discusses what is considered as medical negligence and the use of the res ipsa loquitur (the case speaks for itself) doctrine. A short overview of an international perspective is given followed by a discussion on how negligence matters are dealt with by the South African courts.

WHAT IS NEGLIGENCE Professional negligence is considered separately to medical malpractice, which broadly encompasses not only the former, but also intentional or negligent acts, including breach of confidentiality and fiduciary doctor-patient relationships. Sir William Blackstone was the first to use the word medical negligence in 1768 when he wrote about the great misdemeanour of when trust is broken between the patient and the practitioner, and tends to the patient’s destruction. (Healy 1999:39). The legal consequences of negligent actions could be either disciplinary action by the Health Professionals Council, a criminal prosecution – usually where there is gross misconduct causing intentional harm or manslaughter or civil action, where damages could be claimed for negligent or intentional wrongs. (McQuoid-Mason 2007). In essence, negligence is a form of culpable carelessness, where there is a risk of harming another. Being careless is not culpable, since there is no intention to harm, hence carelessness is not negligence on legal grounds. According to Herring (2006: 39), the model of fault liability is broken down into three components of proof. 1. The professional being sued owed the claimant a duty of care, which is a reasonable standard of care required by the law. Examples of this include the requirement of a general practitioner to provide or summon assistance if passing a roadside accident or owing a duty of care to a patient, but not to someone else in the household who may drink the medication and suffer an overdose. 2. The professional breached the duty of care, where the required action should be that acted in accordance with a practice accepted as proper and reasonable.

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3. The breach of duty of care caused the claimant loss, where just proving negligence is insufficient to confer blame. The patient needs to have suffered loss or injury as a result of the negligence, for example where the health leg is amputated instead of the gangrenous one. PROOF OF NEGLIGENCE The proof of negligence rests with the plaintiff in civil cases and must be based on a preponderance of probabilities. In criminal cases, the onus of proof rests with the state, and this has to be proven beyond any reasonable doubt. Expert evidence can be offered from both sides and for the practitioner can assist in determining what would be considered reasonable under the circumstances. (Claasen, N.J.B. and Verschoor, T, 1992: 26) Other than expert evidence, an exception to proving negligence can be used by the plaintiff to show that the defendant deviated from standard medical practice. This exception is based on the maxim res ipsa loquitur, which is latin for ‘the thing/facts/case speaks for itself’. The doctrine allows the plaintiff to infer negligence of the alleged wrongdoer merely from the fact that the incident, which was under the exclusive control of the defendant, actually happened, that the incident would not have happened in the absence of negligence and that the plaintiff did not contribute to the harm by his own negligence. The burden of proof then falls on the defendant to refute this prima facie inference of negligence that has been created. (res ipsa loquitur, n.d.) RES IPSA LOQUITUR Res ipsa is a rule of evidence, not a rule of substantive law, which permits a supposition of probable cause based on circumstantial evidence. The concept was first advanced in 1863 by Baron Pollock (Byrne v Boadle, In: Res ipsa loquitur, n.d.), when a barrel of flour rolled out of a second story warehouse window and fell upon a passing pedestrian. With no other explanation for the occurrence, the defendant was found to be negligent under res ipsa loquitur. The concept was then applied to other cases involving injury. MEDICAL NEGLIGENCE IN THE COURTS The American (USA), Australian and British (UK) legal systems by far exceed all other countries in medical negligence claims being heard in courts. A culture of compensation has resulted in increasing insurance premiums for practitioners, increasing lawyers’ fees as well as a tendency on the part of the practitioner to practice defensive medicine. Despite this, negligence claims against practitioners are increasing. According to Broughton and others (n.d.) the ball-park cost for compensation in the United Kingdom is about £10 billion per year, which accounts for 1% of the gross domestic product of the country. In the United States, compensation costs increased from 1.8% of the gross domestic product in 2000 to 2.4% in 2005 and in Australia, the amount is 1.1%.

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In the USA, cases may go through either the State system or the Federal system. The majority of civil trials are hears through the State system. In the UK, the county courts deal with low-level civil disputes, the High Courts with the more serious cases and then appeals are heard in the Court of Appeal and ultimately the House of Lords. Both countries processes are similar, involving lawyers, expert witnesses and mediation, which is non-binding. However, Barringer, P and Dauer, E (2007:36) state that the end result is more often than not a cost war, with legal and administrative fees accounting for 60% of the overall costs of the process and the benefit to the plaintiff being minimal. The system, they say, fails patients and providers in that, the cases take a long time to compensate patients for the losses suffered and that jury verdicts differ with respect to the patient’s needs or with the quality of care of the practitioner, sometimes resulting in a blame and shame situation. It is felt that the approach to litigation should be about learning from one’s errors and the collection of information in order to prevent harm in the future. Professor Phillip Peters (In:Daniels 2007) examined numerous studies of malpractice cases from 1989 to 2006 in three states in the USA. His findings showed that contrary to popular belief, the defendants and their hired experts were more successful at persuading juries in their favour than the plaintiffs. He states further "When the jury is in doubt after hearing the conflicting experts, the benefit of that doubt usually goes to the defendant." Most courts in the USA and the UK recognize the use of the res ipsa loquitur doctrine, which then creates an inference of negligence but in most cases, not necessarily a guilty verdict. The most common application of the doctrine is in cases where a swab, sponge or piece of instrument was left inside a patient’s body following surgery. The jury however, is still free to reject the inference created by the doctrine and the plaintiff carries the burden of proof, especially if the defendant does not produce evidence to rebut the inference. (van Dokkum. 1996: 228-229).84 In Canada on the other hand, Neff and Cook (1992: 575) showed in a study of malpractice cases from 1975 to 1988, that judges rejected the liberal use of the res ipsa loquitur evidentiary rule. Out of one hundred and forty two cases, the rule was proposed in thirty-seven of these, but was only applied to fourteen cases and the defendants found liable in only nine of the cases in which it was applied.85

84 The following cases were noted, where res ipsa loquitur was applied. (IN: van Dokkum 1996: 278) Easterling v Walton 208 (1967); Hestpeg v Hennepin county 297 (1975) – where a swab was left behind after surgery. Anderson v Sonberg 67 (1975) – where a piece of forceps broke off during surgery Hine v Fox 89 (1956) – where a cautery instrument broke and burnt the patient. 85

Of the nine cases where the defendant was held liable: - All the doctors were specialists from Anaesthetics, Internal Medicine and various surgical sub-specialities. - Four hospitals were also held liable.

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Thus, the international courts vary in their approach to medical negligence cases in terms of the verdict, the use of the res ipsa loquitur doctrine and the amount of compensation given. MEDICAL NEGLIGENCE IN THE SOUTH AFRICAN COURTS The evolution of medical malpractice in South Africa according to von Dokkum (1997: 175) would require progressive change, but this has not been evident in South African law. Some changes have related to an emphasis on informed consent, thereby moving away from the paternalistic approach, where the patient had to make a choice based on what the doctor decided to tell him to the current position, where the patient is autonomous and decides on the choice of treatment on the basis of being fully informed. Despite the changes to the South African law by the Constitution, the Bill of Rights, the Health Act, etc, the expectation that this would result in an increase in medical negligence cases has not happened in comparison to the annual trend in other countries. Reasons for this may be that the citizens are not aware of their rights, or if they are, then the whole process of litigation is too expensive for them to pursue. However, litigation in South Africa has been increasing with Tim Hegan (Medical Protection Society marketing manager) mentioning that payouts have increased 600% since the year 2000. (Venter 2005). As the manager of the Obstetric and Gynaecology section at a large Provincial hospital, mistakes are being made on a daily basis, sometimes resulting in the death of the patient. Procedures are followed and patients are counseled, but very few of these are taken forward as acts of negligence. Incidences of note are for example, when a medical officer injected Calcium Chloride into a neonate intravenously instead of Saline. The vessels immediately crystallized, resulting in the death of the baby. In another incident, where a claim was instituted, but settled out of court, a pregnant paraplegic woman who was only expected to deliver after two weeks was sent home because there were no available beds. She subsequently delivered that night, did not feel anything because of her paraplegia and the baby died because the cord was around the neck. Many more similar incidences can be quoted from experience, but very few of the patients even consider litigation and of those who do, settlements are more often than not reached out of court with small payouts in compensation, e.g. the paraplegic woman mentioned above received R50 000 in damages, when her initial claim was for R3 million. A third incident of note was when one of the nursing sisters unclipped the nasogastric tube in order to change the feed and at the same time, unclipped the intravenous line in order to give a baby medication. The lines were switched when replaced and only noted seven hours later, when there

-

In some cases, no evidence was provided to refute the claim. In others, the doctrine was accepted without requesting evidence and would have been considered negligent even if the principle was not applied.

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was a change of shift. Despite intensive investigation, the culprit did not own up and could not be identified, since the records were not entered. This baby too subsequently died as a result of clogging within the blood vessels. Can these three cases be considered negligent and how would the courts respond if any claims are made? Medical negligence in South Africa, according to Carstens and Pearmain (2007: 619) started with an Old Cape decision in Lee v Schönnberg.86 The details of the case are unclear except that the plaintiff lost both his legs in an accident and a physician was consulted. Judge C.J. de Villiers, brought medical negligence to the fore when he stated that: “There can be no doubt that a medical practitioner, like any professional man, is called upon to bring to bear a reasonable amount of skill and care in any case to which he has to attend: and that where it is shown that he has not exercised such skill and care, he will be liable in damages.” The case was referred to again only in 1910, in Kowalsky v Krige87 (In: Carstens and Pearmain 2007: 619) when the courts demanded that any surgeon should display a reasonable amount of care, skill and competency that would be considered fair, reasonable and competent in treating patients. The South African courts, in contrast to other countries, have declared that res ipsa loquitur is not applicable in medical situations. As stated earlier, the res ipsa loquitur principle was considered applicable in the USA and UK, mostly in cases where a swab or instrument had been left inside a patient. One such case, Mahon v Osborne88 (In: Claasen and Verschoor 1992: 28), where the surgeon left a swab in the patient’s stomach after an abdominal operation, was heard in the English Court of Appeal and a decision upholding the res ipsa principle was taken. The basis of this as explained in the judgement was that the surgeon did not exercise due care to prevent the swab from being left there and that the action itself could be considered negligent. In a similar case in South Africa, Van Wyk v Lewis89 (In: van Dokkum 1996: 229) an appendicectomy and gall bladder drainage was performed. Due to significant sepsis, the area had to be packed with swabs. There was some urgency for the patient to be removed from the operating table and the surgeon proceeded to close up the wound once he was satisfied and it was confirmed by the theatre sister that all the swabs were accounted for. Some months later, the patient pulled out 86

Lee v Schönnberg (1877) 7 Buch 136 (In: Carstens and Pearmain 2007: 619) Kowalsky v Krige supra 823 (In: Carstens and Pearmain 2007: 619) The case dealt with a nine month old baby who was bleeding following a circumcision performed for religious purposes. The surgeon did not wait for the bleeding to stop, left the patient unattended and did not follow up the case. The baby contracted gangrene to the penis and suffered permanent damage. 88 Mahon v Osborne (1939) 2 KB 14 (In: Claasen and Verschoor 1992: 28) 89 Van Wyk v Lewis (1924) AD 438 (In: van Dokkum 1996: 229) 87

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a piece of cloth similar in size to a swab with the tape still attached. In this case, the courts did not apply the doctrine of res ipsa loquitur, since the judge felt that the surgeon could not be held liable and it was the duty of the theatre sister to ensure that the swab count is correct. The courts felt that in determining negligence, all circumstances needs to be investigated and considered. In rejecting the res ipsa principle, Judge A.J.Wessels stated that: “The mere fact that a swab was left in a patient is not conclusive of negligence.” The doctrine was again explicitely rejected in Mitchell v Dixon90 (In: Claasen and Verschoor 1992: 29), where a doctor inserted a needle into the chest of the patient in order to aspirate a left-sided pneumothorax. During the procedure, the needle broke off and all attempts at retrieval, including by way of an incision were fruitless. The physician however exercised due care by ensuring that there were no puncture wounds as a result of the broken needle and the res ipsa principle was not applied because it was felt that there was no prima facie proof of negligence on the part of the doctor concerned. There were other South African cases where the courts were unwilling to apply the res ipsa loquitur principle for medical negligence.91 Both the Van Wyk v Lewis and the Mitchell v Dixon cases highlight that the test for medical negligence is fundamentally one of forseeability and preventability. According to van Oosten (In: Carstens and Pearmain 2007: 621) the standard of care is not that which can be expected from an exceptional practitioner, but what can be expected from an average practitioner with a general level of knowledge, skill, ability, experience and diligence practiced by the profession and with the understanding that human beings are fallible. The test for medical negligence is the same for civil and criminal cases. In Castell v de Greef92 (In: Carstens and Pearmain 2007: 711) the judgement made by J Scott reflected an appreciation for duty of care, diligence and skill, as well as the recognition that mishaps could occur. The operation was performed by a plastic surgeon for bilateral mastectomies and prosthetic breast implants, but subsequent infection resulted in necrosis and the need for repeat procedures to correct the problem. Despite the judge’s view of the lack of duty of care, he noted that

90

Mitchell v Dixon (1914) AD 519 (In: Claasen and Verschoor 1992: 29) - Webb v Isaac (1915) EDL 273 (In van Dokkum 1996: 230) – where a patients broken leg was shorter once healed - Coppen v Impey (1916) CPD 309 (In van Dokkum 1996: 230) – where a patient was seriously burned by an X-ray - Allot v Patterson and Jackson (1936) SR 221 (In van Dokkum 1996: 230) – where a patient’s shoulder was injured under anaesthesia while having a dental procedure done. - Pringle v Administrator (1990) (2) SA 379 (In van Dokkum 1996: 230) – where, during a mediastinoscopy, the patients superior vena cava was perforated. 92 Castell v de Greef (1993) SA 501 91

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since infection is a known risk of any surgical procedure, the fact that it happened (res ipsa loquitur) did not confer negligence on the part of the practitioner. Where there are different schools of thought or opinion related to specific therapeutic or diagnostic procedures, the accepted standard would be that generally accepted by that particular school of thought. In the case of Pringle v Administrator, Transvaal 93(In: Carstens and Pearmain 2007: 642) the surgeon said that he had “tugged too hard” when trying to remove a lymph node on the trachea during a mediastinoscopy procedure and in the process punctured the superior vena cava. The court relied heavily on expert testimony and the problem arose when the experts could not agree with one another, resulting in the courts deciding in favour of the defendant. This highlights that different practices do not necessarily indicate negligence, but that cases must be viewed in the context within which they occur. The same principle should apply to Herbalists, Traditional Health Practitioners and Faith Healers – the standard of care should be prescribed by the relevant school of practice to which the practitioner subscribes, provided that it is acceptable. (Carstens and Pearmain 2007: 642) The res ipsa loquitur principle could be applied to this case if it could have been shown that the outcome in question would not have resulted if there were not negligence. Negligence resulting in the death of a patient can be seen as culpable homicide, even if the standard of care deviates only slightly from what is expected of a reasonable medical practitioner. In S v Nel94 (In: Carstens and Pearmain 2007: 719) a general practitioner who lacked the necessary skill and expertise failed to refer a patient with a retained placenta to a specialist. The res ipsa loquitur principle could easily infer negligence. However, any accusation of negligence needs to be viewed in the context of the circumstances in which case there is evidence of the presence of a specialist on the site as well as an anaesthetist who could have assisted in the management of the shocked patient. Thus, the res ipsa principle would have been favourable for the plaintiff. Returning to the cases described in the department under my management – all three cases could be considered as negligent if the res ipsa principle is applied, since the actions were not that which a reasonable person in the same position would have done as standard practice. All cases resulted in the death of the babies. The only credible explanation would be that of an honest error, but could this be considered excusable. Another excuse used was the lack of and tiredness of the staff, but would a court consider this sufficient not to prove negligence. I believe that in these cases, the South African courts would have difficulty in proving negligence based on the balance of probabilities, but if the res ipsa was used, then the defendant would probably not be able to defend the claim. CRITICISM OF RES IPSA LOQUITUR

93 94

Pringle v Administrator (1990) (2) SA 379 S v Nel (1987) Unreported

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The South African courts have been applying res ipsa loquitur to other delictual claims for over a century, but on the basis of a ruling that the doctrine was not applicable in the Van Wyk v Lewis trial of 1924, it has not been used in medical negligence claims. Van den Heever (2002) in his thesis comparing the legal systems and the application of the doctrine of res ipsa loquitur in South Africa, England and the United States, showed that the three systems differ substantially. The United States system he notes as being too liberal and unstructured. The South African system, despite being outdated, shows more legal clarity, while the English approach appears to be one we can accept. He states further that the Constitutional principle of equality supports the application of res ipsa to medical negligence cases. In the case involving a claim made on behalf of South African miners against Cape PLC in England for Asbestos related diseases, Spoor (2001), an attorney, states that he was impressed by the English legal system, which he described as quick, fair and surprisingly modern in contrast to the South African, which he said was archaic, overly formal, fussy and governed by rules that are adhered to at the expense of justice. In the above quoted cases such as Van Wyk v Lewis (swab left in abdomen post surgery), Mitchell v Dixon (needle broke off during a procedure to treat a pneumothorax) Pringle vs Administrator, Transvaal (Puncture of the superior vena cava) and Castell v de Greef (Poor management of post operative sepsis) all provide prima facie evidence of negligence that would not have occurred as a standard practice. All that would be required in addition, would be evidence either exculpatory or from experts in order to confer blame, without losing the maxim of res ipsa loquitur, where the facts speak for themselves. However, it should also be noted that any surgical procedure carries with it inherent risks and merely the occurrence of an adverse event following such a procedure does not necessarily confer negligence. Thus, the principle must be viewed in context. The Supreme Court of India (In: Negligence per se – the doctrine of res ipsa loquitur) observed "The maxim does not embody any rule of substantive law, nor a rule of evidence. It is perhaps not a rule of any kind but simply the caption to an argument on the evidence- the maxim is only a convenient label to apply to a set of circumstances in which the plaintiff proves a case so as to call for a rebuttal from the defendant without having to allege and prove any specific act or omission on the part of the defendant. The principle function of the maxim is to prevent injustice which would result if the plaintiff were invariably compelled to prove the precise cause of the accident and that the defendant was responsible for it, even when the facts in the matter are at the outset unknown to the plaintiff and often within the knowledge of the defendant alone". Law, in general, is based on logic and common sense. As such, the application of res ipsa loquitur to cases of medical mishaps is a common sense approach to using the facts of the event and from early on in the process, circumstantially calling it negligent. This further allows the bearer of knowledge, the defendant, to then explain and clarify the context of the event.

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Van den Heever (In: Carstens and Pearmain 2007: 569 - 571) mentions that the setting of the precedent concerning res ipsa loquitur shifts the balance of power towards the provider in the doctor-patient relationship. In order to level the playing fields between the plaintiff and the defendant, Van den Heever suggests that most incidences occur while the patient is anaesthetized and therefore unaware as the sequence of events that caused the accident. Allowing the doctrine of res ipsa to enter into the equation, gives the plaintiff some advantages and hence satisfies the right to equality in terms of Section 9 and the right to fairness in litigation as stipulated in Section 34 of the South African Constitution. (1996). This however falters when the dimension of limited resources is considered. The South African health systems cannot sustain all citizens’ rights to health and healthcare. The res ipsa principle requires that the practitioner functions in terms of his duty of care as would a reasonable doctor. The test that will be used will consider what the reasonable standard was under those particular circumstances, thereby creating a ‘slippery slope’, where the practitioner could argue that due to resource constraints and inadequate facilities, there was no duty of care. The practitioner can only explain what happened at the time as would be reasonably expected and would have difficulty explaining any latent effects, which could have been caused by other reasons. A further problem may arise for the plaintiff, where if the defendant provides a reasonable explanation of not being negligent, then the burden of proving that a negligent action caused the event still rests with the plaintiff. The scales that according to res ipsa loquitur were supposed to place the burden of proof on the defendant once again is tipped towards the plaintiff having to prove negligence, thereby defeating the purpose. The plaintiff has the additional burden of finding an expert who is willing to speak against his peers in a court of law. In addition, the already heavily booked courts would be inundated with cases of negligence to be heard, which could result in more delays and expense. CONCLUSION In South Africa, the population profile is such that the majority of the population depends on cheap or free medical treatment. The burden of disease is rapidly changing with practitioners often having to “play god” in determining who will receive treatment and who not. This opens up a host of ethical and legal dimensions to the debate, but ultimately, the law is developed to protect the citizens of the country and its content should reflect this. Medical negligence will always be a part of medical practice. Some cases seem clearly unjust to either the defendant or the plaintiff, but more often than not, court rulings are made based on evidence and taking into consideration a balance of probabilities.

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However, just as our health services needs to be regulated and policy driven, so should our legal system and where they interlink, these policies must be jointly developed so that practitioners do not end up practicing defensive medicine, so that malpractice insurance does not cripple the profession with cost often being passed onto the patients and so that litigation is not viewed as a quick means of making money. The res ipsa loquitur principle has its merits in that it will protect the plaintiff to some extent by way of assisting to introduce the claim of negligence based solely on an inference, but on the other hand, could become another means of blocking the courts because of the demand that may be created. Its implementation in our legal system may be logistically more difficult that simply inferring negligence and therefore has to be considered cautiously. I an not saying that negligence should go unpunished, but rather that the means to get there should be made easier for patients, especially those who are unable to afford legal assistance. Practitioners are fallible, but the practice of medicine requires some precision, care and a constant reminder that patients’ lives are at stake. Processes and procedures are in place, but it is usually when short cuts are taken that things can go wrong and mistakes happen. The South African legal system in my view is still far from being able to satisfy the indigent patient and more needs to be done to prevent the sometimes non-caring attitude to mistakes being made and at times, this amounts to gross negligence. There are many lessons to be learnt from other countries, but we should not make the same mistakes, and our government needs to realize that merely writing law or policies does not mean that they are implementable. The gap between theory and practice needs to be narrowed before we can make any progress in South Africa. REFERENCES ƒ Anon. n.d. Negligence per se – the doctrine of res ipsa loquitur. [online]. Available from: http://www.healthlibrary.com/reading/law/part2.html. [cited 22 June 2007] ƒ Barringer, P. and Dauer, E. 2007. End the blame and shame. Modern Healthcare, [online]. 37(21): 36, Available from: http://cgood.org/healthcare-newscommentary-inthenews-349.html. [cited 20 June 2007]. ƒ Broughton, J., Gravelsons, B., Hensman, C. et al., n.d. The cost of compensation culture. Available from: Colleague Dr David Bass. ƒ Carstens, P. and Pearmain, D, 2007. Foundational principles of South African medical law. Durban: Lexusnexis ƒ Claasen, N.J.B. and Verschoor, T, 1992. Medical negligence in South Africa. Pretoria: Digma Publications ƒ Daniels,

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http://www.hpcsa.co.za/hpcsa/stats. [cited 20 June 2007]. ƒ Herring, J, 2006. Medical Law and Ethics. New York: Oxford University Press ƒ McQuoid-Mason, D., 2007. Professional Negligence and Medical Malpractice. Bioethics and Health Law lecture notes. 13 Apr.: 3 ƒ National Health Act 61 of 2003. [online] Available from

www.info.gov.za/documents/national

health act/index.htm. [cited 12 June 2007]. ƒ Neff, C. and Cook, R. 1992. Res ipsa loquitur in Canadian malpractice cases 1975-1988. Medicine and Law, 10(6): 575-600 ƒ Quintal, A., 2002. Medical malpractice cost state R42m last year. The Cape Times, 12 Jun.: 4. ƒ Res ipsa loquitur [online]. Available from: http://en.wikipedia.org/wiki/Res_ipsa_loquitur. [cited 13 June 2007]. ƒ Spoor, R., 2001. The Cape Asbestos claims: The implications for the South African mining industry. [online]. Available from: www.asbestosclaims.co.za/docs. [cited 13 June 2007]. ƒ The

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www.info.gov.za/documents/constitution/index.htm. [cited 12 June 2007]. ƒ Van den Heever P., 2002. The application of the doctrine of res ipsa loquitur to medical negligence actions: A comparative survey. (unpublished LLD thesis, University of Pretoria), Abstract available from: upetd.up.ac.za/thesis/available/etd-06212002-090830. [cited 14 June 2007].

[Additional

information per telephonic conversation with author] ƒ Van Dokkum, N. 1997. The evolution of medical malpractice in South Africa. Journal of African Law, 41(2): 175-191 ƒ Van Dokkum, N. 1996. Res ipsa loquitur in medical malpractice law. Medicine and Law, 15(2): 227-231 ƒ Van Dosten, F.F.W. 1991. The legal liability of doctors and hospitals for medical malpractice. South African Medical Journal, 80: 23-27 ƒ Venter, B., 2005. Malpractice suits lead to hike in doctor’s fees: Insurance premiums soar. The Cape Times, 04 Feb.: 4. Research Ethics ESSAY Debating Standards of Care in Global Research Ethics: Towards an Enabling Approach (author: R. Armstrong) It is now almost a decade since criticism emerged of standards used for HIV/AIDS research in developing countries by sponsoring agencies from developed nations. During this time, codes of research ethics at the national and international level have been re-examined, clarified and, in some cases, amended. While these changes may fall short of absolute clarity and agreement on a single, universal approach, it can be said that there has been progress toward greater awareness of the complexity involved in research collaboration between developed and developing nations and, more importantly, that there is now a greater sensitivity within the debate to the immense diversity of

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social, economic and cultural contexts where research takes place and research subjects live. One could characterize the developments of the last decade as a turning point in global research ethics, one that is as much reassuring and inspiring as it is troubling in terms of the vast inequities in health and wealth this vigorous debate has explored.

The aspect of the debate that brings into focus

these troubling inequities involves the issue of standards of care. Access to basic health care services is starkly unequal between the developed and the developing world. Research can both exploit and remedy these differences. This raises these questions: What are the ethical obligations of researchers and research endeavours in the face of such immense gaps? What types of research endeavours and what kinds of research designs are ethical given these disparities? And, finally, what role do international guidelines and codes of research conduct play in directing what is ethical while at the same time allowing for and not hindering swift action towards alleviating such inequity and injustice? This paper reflects on these questions through an exploration of the standards of care debate as it has evolved during the past decade. Fortunately it finds a growing international consensus that ethical research endeavours in the developing world can achieve progress towards reducing global health inequities. Although the ethical challenges of conducting research in developing world settings did not originate in 1997, they certainly received a significant amount of new attention with the publication of articles by Angell and others in the New England Journal of Medicine (Angell 1997; Lurie and Sidney 1997). Angell and colleagues took the bold step of declaring multi-centre trials of AZT regimens for the prevention of maternal-fetal HIV transmission unethical, primarily for being in violation of provisions of the Declaration of Helsinki (the standard at the time was that research subjects in the control arm were required to receive the best proven therapy, see below). These trials were being sponsored by agencies of the United States government. Angell’s charge was that the trials, to the extent that they used a randomized, placebo-control design, subjected participants to unacceptable conditions of risk, circumstances that would never have been tolerated if, for example, the trials had been run in the US. The use of a placebo control design was both unscientific and unethical in that a standard therapy, also using AZT, was known and in use at the time, albeit only in countries where such regimens were affordable. The defenders of the trial, notably Dr. Harold Varmus and Dr. David Satcher, titular heads respectively of two agencies sponsoring the trials, the National Institutes of Health and the Centres for Disease Control, argued cogently for both the scientific and ethical merits of the research design (Varmus and Satcher, 1997). They noted that the trials were developed collaboratively with the host countries, that the trial design was relevant to the host country setting, and that the trials themselves were conducted in accordance with standard procedural and ethical requirements. They also acknowledged that although standard practice in the host countries was no intervention, thereby arguing that research participants in the placebo arm were no worse off than they otherwise might have been, this is in itself was too simplistic a justification for the trial design. There were other compelling issues of scientific validity supporting the use of placebo controls. Regardless of one’s opinion on the sufficiency of their defence, it is hard not to disagree with their conclusion (1997: 1005): “The scientific and ethical issues concerning studies in developing

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countries are complex.” [It is worth noting that, in 2000, Angell singled out another HIV prevention study carried out in rural villages in Uganda (Angell 2000). Again, in the control arm of the study, participants were not offered what was considered standard treatment for health conditions that arose (in this case sexually transmitted infections other than HIV) while in the intervention arm they were. Additionally, where HIV discordant couples were identified, the investigators did not inform HIV-negative partners of their potential risk. Angells concerns were shared by Clark (2002). In their view, investigators and sponsoring organizations again exposed research participants in a developing country to unacceptable conditions of risk and more or less stood idly by while new instances of HIV transmission occurred that could have been prevented.] Both Hutton (2000) and Selgelid (2005) have written detailed accounts of the subsequent chain of events inspired or at least encouraged by the reaction to the AZT trials. Most significant among these was the process of amending the Declaration of Helsinki. The declaration had been amended before but not so specifically or amidst such controversy as those changes approved in 2000. Prior to this change, research subjects were required to receive “best proven” treatments, regardless of which part of the study they found themselves in.

This was changed to “best current” in the

amendment (Tangwa 2004: 64). In notes of clarification added to the Declaration in 2002 and 2004, conditions for the continued use of placebo-controlled design were articulated when a “best current” intervention for the health condition under study was known and available, at least in some parts of the world (WMA 2004).

Most of those who have commented on these amendments remain

dissatisfied. Some note the erosion of the binding power of the Declaration as a ‘universal standard’ governing all research (Lie et al. 2003). Others question the process that led to the amendment and are suspicious of vested interests and an imperfect governance process within the World Medical Association (Tangwa 2004). Most have agreed that the amendments did not necessarily serve to resolve the ethical complexity of what standard of care is appropriate in the control arm of a research project for any research subject in any location across the globe. It would appear then, that with regard to the standard of care issue, the power of the Declaration to direct ethical research conduct may have been weakened to some degree but this may be too drastic a conclusion. It may be that the attempt to address these complexities through amendments to the Declaration was not necessarily the right approach. While one may agree with Hutton (2000: 197) that, “[t]here is a single Universal Declaration of Human Rights, and it is appropriate to have a single standard of research ethics,” we have not yet arrived at a way of formulating and promoting a single ethic in a succinct, universally accepted statement, and there may indeed be justifiable reasons for this. Ruth Macklin (2001: 18-19), writing after the Declaration was amended, noted that, regarding the controversy, there are areas of concurrence as well as areas of ongoing disagreement. Research should be responsive to these needs of the populations in the developing countries where it is conducted and should address the many serious health priorities that exist there, including HIV, tuberculosis and malaria, whether or not these are priorities for developed nations. Impoverished or otherwise vulnerable populations should never be exploited by research and ethical standards

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should not be lowered or otherwise eroded whether the research setting is a developed or a developing country.

One can say that agreement holds on these issues even today while

consensus may still be lacking on how such protections are realized in each setting where research is carried out. Macklin (2001: 26-29) also noted, at the time, with implicit regret, the deep divisions in the argument about the appropriate standard of care to be afforded research participants in whatever setting. When does a variation on the standard of care that is responsive to a local need and that addresses a local health priority become unethical when it is part of a research project? Similarly, when are research subjects exploited if they are properly engaged to test these variations under prevailing local conditions? Finally, how does such an approach challenge prevailing views about trial designs and what constitutes scientific validity? A major issue to address at the outset in the search for a protective yet enabling approach to standards of care in research designs and research conduct is the role of documents like the Declaration of Helsinki and how the principles articulated there receive practical application in settings where research takes place.

It is difficult not to agree with Angell (1988: 1081) that,

“[h]uman subjects in any part of the world should be protected by an irreducible set of ethical standards.” In reaching for that standard, we must admit that there are complexities in the research environment that need to be taken into account. With respect to the developing world, and in particular health emergencies like HIV/AIDS in settings like the sub-Saharan African region where the epidemic is at its worst, while standards need to protect impoverished or otherwise vulnerable research subjects, they also need to be enabling. The challenge is as Luna (2001: 283) has noted, “A rigid universal standard without the possibility of considering these different cases may be nearly as harmful as lowering all standards.” Benatar and Singer (2000), writing in the midst of the process of amending the Declaration, point out flaws in both the methods of ethical analysis and the uses made of the Declaration itself. In their view, nothing can replace the process of “moral reasoning” in applying ethical principles in the context of practical action (2000: 825). On the specific issue of standards of care in the context of a vast global inequity in access to health resources and to the benefits of research endeavours, they state (2000: 824), Determining what is ethical goes beyond merely following prescriptions and requires moral reasoning: consideration of all relevant aspects of the case in its context, weighing and balancing competing moral requirements, and developing justifiable conclusions. Writing more recently on the same issue of how to define and apply ethical standards, Benatar (2004: 577) argues, It is widely acknowledged that it is not possible to spell out precisely in any particularly jurisdiction what is constitutional or unconstitutional in all situations at all times without judicial interpretation. Similarly, it is a fruitless exercise to attempt to write detailed “instruction manual” type directions spelling out precisely what is ethical or unethical in all situations at all times.

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Benatar is a proponent of “reasoned contextual universalism” or the application of universal principles within local contexts, taking into account morally relevant variations and limitations. He is careful to distinguish this from moral relativism (2004: 577): An essential requirement here is to have deeper insights (a difficult task) into when and how it is morally appropriate to take local context (ethos/mores) into consideration in applying universal ethical principles. There is then a reflexive relationship between a broad statement of principle and its application within a particular context. To admit variation, or what appears to be variation, is not to verge towards relativism and the absence of a universal standard. Rather, it is to have a more attuned awareness of complexities and situational factors and to have a heightened ability to discover universal relationships embedded in them. Ethical reasoning is a complex endeavour. While it can be guided and sustain by statements of principle it can never be pre-empted or replaced by such. Benatar’s views are echoed in broader concerns about the Declaration of Helsinki and the process by which such documents are both formulated and applied. Two authors from the African context, for example, note limitations in these processes that are both directly and indirectly exclusionary. Tangwa (2004: 63) is the more critical of the two.

While acknowledging the necessity and

importance of universal moral rules, he notes the equal importance of their “dynamic and dialectical relation with concrete particulars.” It is through this relationship that moral rules gain their ability to provide guidance that transcends the sometimes impenetrable complexity of particular situations. Tangwa (2004: 63) also notes that few moral rules are absolute.

Almost all admit justifiable

exceptions. “Obeying or applying an ethical rule, however, is necessarily done within the constraints of the particular place, circumstances, and perspective.”

Tangwa supports the necessity of

universal codes of ethics, research ethics included, but views international statements like the Declaration of Helsinki as part of a series concentric circles in relation to both national guidelines and the particular choices and compromises that are necessary to conduct research in local contexts.

He is very sceptical of too much detail in documents setting out principles and, for

example, notes the implicit contradictions in a document like the revised CIOMS guidelines (CIOMS 2002), where in guidelines 10 and 11, for example, statements of principle are followed be detailed rationales for making exceptions. This is where, in his view, an attempt to be too directive in setting international standards becomes too controlling (2004: 66): To attempt formulating such rules for the international community—given its immense cultural diversity and situational differentiation—is to distrust and to undermine the rational ability and/or moral sensitivity of some human beings in appreciating and acting in accordance with moral imperatives, norms, or rules. Tangwa’s criticism is founded on what he argues to be a partiality in this attempt to formulate universal rules. In his view, such efforts are not without complexities of power where certain world views predominate over others (2004: 67):

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Since the Nuremburg Code, and until the very recent revisions of the Helsinki and CIOMS guidelines, what had taken place in the formulation of “international” ethical guidelines were basically attempts to universalise and globalise a particularly powerful paradigm, a Western paradigm….The trend to involve other voices, perspectives, and cultures in the formulation of international ethical guidelines is one that needs encouraging and enhancing…. Tangwa (2004: 63) maintains that there can be universal ethical rules that “apply in similar circumstance regardless of time and place.” However, attempts to codify these rules and prescribe ethical conduct can receive too much emphasis (2004: 66):

“in ethics, correct action is more

important than correct language.” This is in no way to diminish the importance of ethical reasoning nor the importance of justifying one’s conduct in relation to moral rules and ethical principles. Like Benatar, Tangwa reaffirms that in trying to determine what is ethical and understand what is unethical, in particular with respect to research, constant, active dialogue can never be superseded by a false sense that documents of the status and import of the Declaration once and for all resolve, prescribe and direct without the need for further debate as to what is right or wrong in every situation one encounters. Hellsten (2005), writing from the perspective of research in Tanzania, takes a more pragmatic approach. International guidelines are interpreted and applied in local settings and this gives rise to variation. The challenge is to justify these variations in a way that is consistent with the spirit and force of the ethical rule the guideline seeks to promote. He notes (2005: 265) the necessity of compromise between strict applications of ethical rules and the necessity to make do with what is available within the local context: [T]he difficult questions about bioethics in Tanzania, for instance, are not primarily about potential cultural clashes or value conflicts….More widely, they are about the lack of resources or the unequal distribution of existing resources, whether we talk about material inequality, ethnic imbalance, or gender disparity in a global or local context. In Hellsten’s view, the dialogue has only begun in terms of elaborating what constitutes ethically acceptable variation in the application to local context of international guidelines. Given the growth of a more informed and shared global perspective on issues of equity and justice, he argues for the need for continued exploration of the very universality of existing codes of medical ethics and medical research in terms of cultural values and practices, and the availability of resources. There is little to be gained by insisting on specific interpretations of ethical rules that only result in either implicit or explicit interpretations of either research or medical practice as consistently unethical in resource-limited settings (2005; 265): Bioethics guidelines should bring together international guidelines, national laws, and local social ethics in coherent sets of norms, rather than leave them to compete with and contradict each other.

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Gambian researchers (Gambia 1997: 287) involved in the AZT prevention studies that generated such controversy have been even more direct: Stopping trials in Africa that are trying to help improve the health of poor people so that those in affluent countries can have peace of mind seems a tortured form of ethical logic. There are many now who share this view albeit the significant challenge that remains of reconciling vastly different beliefs, values and other aspects of social and economic context. One beneficial result of the standard of care debate over the last decade is that it has opened up these issues and challenged everyone involved in the bioethics enterprise to become more critical and aware of these global challenges. If, then, there is the possibility of some local variation that remains consistence with universally shared ethical principles, how does one situate the line between what is ethical and what is not? If too much contextual variation is allowed, Angell (1997: 847) has warned, With the most altruistic of motives, then, researchers may find themselves slipping across a line that prohibits treating human subjects as a means to an end. When that line is crossed, there is very little left to protect patients from a callous disregard for their welfare for the sake of research goals. The location of the line remains a subject of debate.

One can start the search at the outer

boundary. When is no treatment an ethically acceptable standard in a research intervention? The case where no previously known intervention exists is the easier one to identify.

From there,

however, the way is less clear. Angell and others (Angell 1997: 847; Clark 2005: E13) have been quite adamant that the prevailing principle in research must always be safeguarding the welfare of research subjects: One reason ethical codes are unequivocal about investigators’ primary obligation to care for the human subjects of their research is the strong temptation to subordinate the subjects’ welfare to the objectives of the study. The welfare of research participants is not safeguarded when, as an aspect of the research design, an available intervention is withheld from the research participants and this withholding allows a harm to occur. As Luna (2001: 277) states: “Generally speaking, not giving adequate care is an avoidable harm. When a person is ill, the treatment is needed, refusing it unnecessarily harms the subject.”

Luna’s standard here is ‘adequate’ care, as much to say some intervention that is

available in the research setting or reasonably obtainable as part of the research project. It is neither ethical nor appropriate to argue that since, in the research setting, the common practice is no intervention this suffices to protect the welfare of the research participants.

Research is an

opportunity to address these gaps even if in the course of doing so one cannot completely remedy the gap or provide either a universally best proven or best current intervention.

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If doing nothing is indefensible, the task remains to define how much effort is ethically sufficient. One can accept that it is unethical to require of a researcher or a research project something that is unachievable.

However, what would constitute an ethically adequate effort at remediation? First

and foremost, researchers must be aware of background conditions that influence what is and is not available in terms of health care resources within a research setting. As Schüklenk and Ashcroft (2000: 167) have argued, what is available is heavily influenced by global economic factors, including pricing policies of pharmaceutical manufacturers. Gaps in availability of treatment, for example, between one part of the globe and another are rarely about lack of knowledge and the need for scientific discovery. The causes are largely economic and it is uniformly agreed that it is unethical to propose research designs that seek to exploit this situation. While it may not be the research itself that is denying a treatment or intervention that is required, it is unacceptable to remain silent in this situation and to do nothing to either acknowledge or attempt to remediate the injustice that has occurred. Again, though, the issue of how far one has to go remains to be clarified. In addressing this issue, Lott (2005: 48), for example, has said, It is thus ethically unjustifiable to argue as though impoverished people must make do with what they have (i.e. doing without) simply because they are poor, since their diminished purchasing power is the direct result of morally arbitrary pricing schemes of the developed world. Clinical research involving impoverished people must therefore guarantee participants the best absolute standards of care available globally and should ignore the wealth of the participants themselves. The best absolute standard is very high indeed. There are many that argue that the trial setting can be a place where care is offered that participants would otherwise never receive. This is laudable but it still begs the question of whether it is always required everywhere that research occurs. Supposing that it is practically achievable, one must nevertheless question the ethical value of artificially changing the local context for the duration of a research intervention (supposing, for example, that the trial lasts six months) and then allowing the context to revert to its original condition once the trial is complete. Insisting that whatever therapeutic benefits the trial uncovers be provided post-trial does not fully address the issue. In most cases for research conducted in the developing world, permanent, sustained changes would be required to the local health system in order to achieve this requirement. While this would be fortunate indeed if it were possible, there would likely be few if any sponsoring organizations prepared to make such an intensive and longterm investment (there are many other things that can be done to improve local conditions in developing world settings and these are elaborated by Benatar (2004) below). A more reasonable approach has been proposed by London (2000). In unpacking the conceptual aspects of standards of care, he notes both the de facto (i.e. what actually occurs) and the de jure elements (i.e. what ought to occur) at both a global and a national or local level. While it would be laudable if research designs were to obtain the global de facto or de jure standards, practically speaking the challenge is great. On the other hand, accepting a local de facto standard is akin to

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standing silently by while participants experience unnecessary harm. The local de jure standard, an aspirational goal with a particular context, is, in the end, sufficiently robust to challenge researchers to help address health care inequities while at the same time not being so idealistic as to be practically unattainable.

The local de jure standard involves what is set out in national guidelines

whether or not such standard is actually delivered in the settings where research is conducted. As a minimum, researchers have an obligation to achieve the national standard regardless of the actual practice they confront around them. London (2000: 390) justifies this conclusion with the following, The fundamental goal of medical research is not to provide health care but to gather medical knowledge which, it is hoped, will result in the development or perfection of interventions that will benefit future patients. Because the design of a trial is the result of the exercise of such agency and choice, the researchers and agencies that sponsor clinical trials are responsible for the ramifications that trial designs have on the welfare of the people who submit themselves to scientific study. The requirement that clinical equipoise obtain is essential to the conduct of acceptable medical research because it ensures that researchers do not undertake trials in which the welfare of some individuals is knowingly sacrificed in exchange for knowledge, and ultimately, the welfare of future patients. By providing the de jure standard of care, researchers and their sponsoring agencies ensure that the subjects of clinical research are not exploited, even for what we can all agree is a noble end. Based on London, then, it would be rare indeed that a healthcare intervention could be compared against no intervention. This is based on a presumption that it would be a rare national, regional or local health care provider that would aspire to do nothing in response to what would otherwise be a treatable or avoidable health care condition. Yet it still leaves unresolved the problem of where a local de jure standard is not spelled out or where such a standard is seriously inadequate even after taking into account local conditions and resources.

Hyder and Dawson (2005: 151-152), in

describing a practical application of the local de jure standard approach, note the following: This does not imply that an individual research team is required to permanently correct health system deficiencies, either in a developing country or a developed one. However, neither is it permissible to provide sub-standard care and use the argument that study participants are at least not worse off than they were before. The normative standard is that researchers must compare new interventions to existing interventions that have been recommended at the national level even if this required providing medical care to study participants that they would not have received due to health system structure or inefficiency. Clearly, researchers and research project can do something to address problems of health care inequities in resource limited settings. In elaborating these more expansive ethical obligations for researchers and research projects, Benatar and Singer (2000: 825) have argued that, “the moral enterprise of research should take place with more awareness and essential connection to global inequities and play its part in alleviating rather than entrenching them.”

For this broader moral agenda, Benatar and Singer

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require that researchers become more engaged in addressing global inequities and that their research endeavours take a more expansive view of what benefits can be obtained both during and after a research intervention. With respect to the issue of standard of care, their view is more enabling than prescriptive. Rather than insisting on one universal standard of care, which too often reflects that of the United States or other wealthy, developed nations, these two authors ask researchers to take into account what is of benefit to the community being studied and to take great care to ensure that research findings are translated into accessible and sustainable improvements (2000: 825): The highest achievable standard of care should be the goal. Reasonable limits can be negotiated in specific contexts. The objective should be to ratchet the standard of care upward rather than to set utopian ideas that cannot be met. By focussing on local relevance and benefit within the broader enterprise of addressing and narrowing global health inequities, research will both adhere to and elaborate the realization of ethical principles in real world settings (2000: 826): Research ethics must be more deeply rooted in the context of global health.

It must more

forthrightly address the social, political, and economic forces that widen global inequities in health, and it must ultimately be concerned with reducing inequities in global health and achieving justice in health research and health care. So persuasive is this approach that is has been incorporated into the standards of care requirements in South Africa’s research ethics guidelines (DOH 2004: 7-8). Benatar has more recently elaborated on his position with his colleague Shapiro (Shapiro and Benatar 2005). While challenging the research community to do more in terms of global solidarity, they note (2005: 45-46) the paralysing affect that disparities and requirements to address them may have if the standard of ethical intervention is too dogmatic. We acknowledge the serious concerns of researchers that the immense need for improved care in resource-poor settings has the potential to engulf research priorities. But the moral imperative to do more is already deeply felt by many researchers, and there is merit in the idea that advancing scientific knowledge should not be given a higher priority than reversing gross injustices in global health that exist within the research setting. A paradigm shift is called for: a transformation of our whole idea of how research is conducted when entering into a relationship with an impoverished people. This paradigm shift requires the research enterprise to be both more aware and more active in addressing the needs of populations without access to health care resources. approach, or one that is overly idealistic, is more in hindrance than help (2005: 44):

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Too rigid an

That the ideal of first world health care cannot be achieved immediately in developing countries should not be a deterrent to efforts to raise existing levels of care. By setting high ideals and working towards them, the standard of care could be progressively ratched upwards. These authors provide case studies and numerous suggestions on how local conditions and local capacity can be changed or ‘ratched upwards’ over the course of a research intervention. It requires a more careful and complex approach to research planning and design. It also requires a greater degree of dialogue and collaborative effort between a sponsoring agency, a host country and a community where the research takes place. “[S]ince it is unlikely that an overall universal standard of care can be achieved, the goal should be reasonable standards that are significantly higher than what might currently exist in a host country.” (Benatar and Singer 2000: 825) In this respect, researchers behave ethically, adhere to both national and international guidelines and, most importantly, contribute in a variety of ways to lessening the gap between developed and developing worlds. There are and continue to be universal standards for the ethical conduct of research in any setting around the globe. As with all standards, the relationship between standard and practical application is a complex one. Surface variations in application can sometimes be viewed as double standards but this judgement is often reductive and unhelpful. Contrary to Schüklenk and Ashcroft (2000: 169) who state that, “[u]niversal ethical standards are ultimately undermined if they receive a context specific interpretation,” one must argue that standards are only relevant to the degree that they receive a context specific application. The more important issue to examine is what constitute morally relevant considerations between one context-specific application of the principle and another. With respect to standards of care in research designs, providing health care resources that are relevant and feasible and of true benefit to the community under study is a context specific application. Accepting that interpretations of the ethically appropriate standard of care can vary is to situate research within its real world context, however much anger or regret we may feel that a treatment available in one part of the world is not available in another. This is not necessarily to accept the status quo or to compromise ethical standards. It is in many respects to engage in the inequity and to begin to address and seek to remedy it. Fortunately, it is unlikely that the maternalfetal HIV prevention trials that took place almost a decade ago would need to be repeated using a similar placebo-control design. Effective interventions can now be provided that are relevant and sustainable to much of the developing world (the fact that they are still not provided, however, is another topic beyond the scope of this discussion). The acrimonious debate over the meaning of the certain parts of the Declaration of Helsinki and the value of subsequent amendments has led to a much richer and more inclusive discussion of global research ethics. The research paradigm is indeed changing and, remarkably, ethical research is still being conducted aimed at pragmatic, enabling solutions to global health challenges. References

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ƒ Angell M. 1988.

Ethical Imperialism? Ethics of International Collaborative Clinical Research. N

Engl J Med 319:1081-3. ƒ ________. 1997. The Ethics of Clinical Research in the Third World. N Engl J Med 337(12): 847849. ƒ ________. 2000. Investigators’ Responsibilities for Human Subjects in Developing Countries. N Engl J Med 342(13): 967-969. ƒ Benatar SR, Singer PA. 2000. A new look at international research ethics. BMJ 321(7264): 824826. ƒ Benatar SR. 2004. Towards Progress in Resolving Dilemmas in International Research Ethics. Journal of Law, Medicine & Ethics 32(4): 574-582. ƒ Clark, PA. 2002. AIDS research in developing countries: Do the ends justify the means? Med Sci Monit 8(9): ED5-ED16. ƒ Council for International Organizations of Medical Sciences (CIOMS) 2002. International Ethical Guidelines

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Processes. pp7-8. Available: http://www.doh.gov.za/docs/index.html [cited April 22, 2007]. ƒ Gambia Government Medical Research Council Joint Ethical Committee. 1997. Ethical issues facing medical research in developing countries. Lancet 350(9082): 897. ƒ Hellsten SK. 2005. Bioethics in Tanzania: Legal and Ethical Concerns in Medical Care and Research in Relation to the HIV/AIDS Epidemic. Cambridge Quarterly of Healthcare Ethics 14(3): 256-267. ƒ Hutton JL. Ethics of medical research in developing countries: the role of international codes of conduct. Statistical Methods in Medical Research 9(3): 185-206. ƒ Hyder AA, Dawson L. 2005. Defining Standard of Care in the Developing World: the Intersection of International Research Ethics and Health Systems Analysis. Developing World Bioeth 5(2): 142152. ƒ Lie R, Emanuel E, Grady C, Wendler D. 2003. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 30 (1): 190-193. ƒ London AJ. 2000. The Ambiguity and the Exigency: Clarifying ‘Standard of Care’ Arguments in International Research. Journal of Medicine and Philosophy 25(4): 379-397. ƒ Lott J. 2005.

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against the myth of an “international

consensus opinion.” J Med Ethics 30(1): 194-197. ƒ Selgelid M. 2005. Module Four: Standards of Care and Clinical Trials. Developing World Bioeth 5(1): 55-72. ƒ Shapiro K, Benatar SR. 2005. HIV prevention research and global inequality: steps towards improved standards of care. J Med Ethics 31(1): 39-47. ƒ Tangwa, GB. 2004. Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines. J Med Ethics 30(1): 63-67. ƒ Varmus H, Satcher D.

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CLINICAL BIOETHICS ESSAY The Ethics of Caring for “Difficult Patients” (author: M. O’Grady ) Introduction Caring for patients who are “difficult” has received attention in medical literature over the past few decades primarily focusing on strategies for physicians and nurses to use with such patients to make these interactions easier for health care providers. Only in the past 20 years or so has it been recognized that some of the difficulties found by health care providers in caring for “difficult patients” are due to the attitudes and actions of physicians and nurses themselves rather than those for whom they have the responsibility to care for.

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Yet the realm of caring for such patients is a complicated one, in which professional responsibility, patients’ rights, limited resources and human personalities are intertwined. This paper will examine a number of these issues with an emphasis on the ethics involved in caring for so-called “difficult patients.” It also will provide some useful strategies and tactics for providing good care to these patients in an ethical, productive and humane manner. Care for patients should be patient-centered rather than provider-centered. All patients should receive the highest possible standard of care available no matter how difficult their cases are or whether they are personally labeled as “difficult” by their health-care providers. Access to health care is a human right whether an individual is easy to treat, easy to interact with or difficult to treat and/or difficult to interact with. Definition of a “difficult patient” What is meant by a “difficult patient?” Many physicians agree that a “difficult patient” is an individual who engenders a negative reaction from them, including generating uncomfortable feelings such as anger, frustration or inadequacy (Brennan and Lee 2004:126 and Lechky 1991: 1793). There are many reasons why a physician might get angry toward such patients based on various behaviours physicians find frustrating or unacceptable. Yet being provoked to anger can leave a physician feeling inadequate about his or her interpersonal skills, the lack of an ability to control the situation on an emotional level, or the lack of effectively steering a patient toward a good health outcome in an efficient manner, to name a few reasons. Some physicians find such a situation extremely frustrating because they see themselves in the image of an ideal physician in accordance with medical tradition, according to Trotter (2002: 31), one that can be supported by many in society (the notion of physicians as “gods”). If physicians’ egos are heavily reliant on this image, a lack of its reflection through a bad interaction with a patient can be psychologically damaging, even sending him or her into a crisis mode. Other physicians are less threatened by encounters with such patients, but end up feeling puzzled and disappointed that their reactions have left them feeling “unprofessional” in their dealings with these patients (O’Dowd 1988: 530). The notion of the ideal physician, which seems central to both physicians’ and patients’ attitudes toward and feelings from these encounters, will be examined later in this paper from another point of view. What are some examples of so-called “difficult patients?” According to a number of physicians and a U.S.-based continuing medical education service provider, there are a wide variety of “difficult patients,” including (Elder, Ricer and Tobias 2006: 3 ; Pomm, Shahady and Pomm 2004: 467; TIV, Inc. no date: 1-4 ): The patient with multiple medical complaints who also exhibits difficult behaviours The patient who suffers from chronic pain, who wants drugs such as narcotics, hypnotics or tranquilizers The patient who seeks referrals, who always wants to be referred to a specialist or who wants care or treatment not indicated nor covered by his or her insurance

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The patient who malingers, who doesn’t seem to be getting any better for no apparent reason The patient who is self-destructive, who doesn’t seem to be able to take very good care of him or herself (including those who seem to be inviting disaster) The patient who is non-compliant, who doesn’t seem to be able to comply with the recommended treatment The patient who is demanding, who yells, orders staff around and can demand specific treatment(s) he or she may have heard of elsewhere The patient who is very anxious, who seems to express great anxiety that is out of proportion to the medical problem at hand The patient who is narcissistic, who just likes to talk about him or herself and doesn’t seem to really need (physical) health care The patient who is playful/seductive, who doesn’t seem to be taking the medical visit seriously and who tries to play games The patient who does not want to pay, who refuses to pay for treatment, or use his or her copayment or who is not insured. From the examples cited above, although they are not exhaustive, it is obvious that “difficult patients” present a wide variety of behaviours to clinicians, exhibit differing medical complaints and require varying treatment approaches, whether medical, psychological or only interpersonal. Clearly, there is no single type of “difficult patient.” Further, in an observational study of weekly clinical conferences on “difficult” patient-physician encounters between hospital physicians and patients conducted for several years at the hospital for the Yale University School of Medicine in the mid1990s, the findings were: “…No single diagnostic title or conceptual model could suitably characterize the complexity of the diverse phenomena that were regularly present” (Sledge and Feinstein 1997: 3 ). According to Sledge and Feinstein (1997:4), “The complex phenomena involved multiple variables, which included the individual attributes of each physician and patient before the encounter occurred, the setting of the encounter, and the meaning the encounter had for the participants.” According to O’Dowd (1988:528), such patients are a “disparate group of individuals whose only common thread seems to be the distress they cause the doctor and the practice,” which hardly lumps them together in a single treatment category. There is a vast difference between an elderly person who has multiple medical complaints who also may be suffering from depression or even dementia, a person with chronic pain due to an injury, and a young person who is uncomfortable openly discussing his or her symptoms of a sexually transmitted infection and instead flirts or plays games with the physician as a distracting tactic, to name only a few examples. Comprehensive guidelines for treating “difficult patients” because of the wide range of these types of physician-patient encounters, as well as disease indications, would

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have to be lengthy indeed to capture the full range of symptoms, behaviours and circumstances they should encompass. The moral component in care provision While there are no clear guidelines that are universally relevant and accepted for treating or dealing with “difficult patients,” what is clear is that these patients require ethical treatment just as each and every patient requires ethical treatment. It may be harder for some physicians to provide ethical treatment to “difficult patients,” yet according to Carrese and Sugarman (2006:1864), “Every interaction between a doctor and a patient has a moral component that may or may not be obvious.” Thus it is important for physicians and other health-care practitioners to realize they have ethical as well as professional responsibilities toward their patients in clinical care, even if it is routine. The same ethical principles apply to “difficult patients” as to “regular” patients, namely respect for autonomy, beneficence, non-maleficence and justice, highlighting the key principles discussed by Beauchamp and Childress (2001) in their influential book, Principles of Biomedical Ethics, now in its fifth edition (Adams 2006: 1). Because “difficult patients” can have fewer assets and treatment options due to their health status, socioeconomic status, age or gender, it is just as, if not more, important that they receive ethical care than the average patient. A study conducted in the Netherlands of patients with medically unexplained persistent symptoms found that such patients were more often female, significantly older, more often obese, with public health insurance and a lower educational level and more often widowed than patients without such symptoms (Dirkzwager and Verhaak 2007: 4 ). The study also found that such patients reported increased levels of psychological distress and greater functional impairments in various aspects of their lives than patients without medically unexplained persistent symptoms. Of special relevance is that these patients also reported distrust in medical specialists, and they were less positive than others about the quality of care they received from their general practitioners (GPs). They felt their GPs often didn’t take them seriously, often did not involve them in treatment decision-making, did not take sufficient time in their clinical care and seemed less prepared to talk about their problems or what had gone wrong. These patients also felt more socially isolated than others, and some 40% of them were estimated to potentially suffer from a psychological disorder. While it is unknown whether their particular life circumstances brought upon their distress and a psychological disorder, they reported that their GPs were less apt to refer them to medical specialists. Most of these patients were positive about the care they received from their GPs, but the results of the study show that the care at least some of them received did not appear to be of the highest standard. Some of these patients should have been referred for psychological evaluation and potential treatment, those who were obese should have been referred to nutritionists, and those expressing social isolation should have been encouraged to expand their social networks with referrals to relevant social services, where available.

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In reviewing the ethical principles of autonomy, beneficence, non-maleficence and justice in regard to the treatment of some of these patients with medically unexplained persistent symptoms, it seems that some of the GPs may have been negligent in practicing one or more or even all of them. For someone who is socially isolated to have the person with considerable power, the physician, in a very important interaction, a medical visit, perhaps one of only a few interactions with others in a given week, be perceived as not taking his or her patient seriously seems to call into question possible maleficence as well as a lack of autonomy (respect for the person) and a lack of beneficence. It is certainly in a patient’s best interest for the treatment provider to take him or her seriously. In regard to justice for someone with few economic assets and lack of access to private healthcare services, for a physician not to also take into account the person’s social isolation and what effect the lack of sensitive treatment and caring by a physician will have on them seems entirely unjust. In South Africa the majority of the population does not have access to private health care, which is some 80% of the total population according to Matisson (2000: 1 ), the educational levels vary widely, there are 11 national languages, and most do not have high socioeconomic status, making transportation costs to receive health care a burden for many. It seems obvious how important it is to provide ethical treatment to these patients in each and every clinical interaction, which for some can be very few and far in between, even though most of them might be considered “difficult patients” for varying reasons in a first world setting. Yet according to Luna (1995: 289), despite an illiterate person requiring more time to understand a physician’s treatment recommendations and guidance and therefore more time spent by a physician during a clinical visit, there is no adequate ethical justification for a healthcare provider not to take more time with such a patient. In fact, research shows that individuals at socioeconomic disadvantage are more likely to die sooner than others and exhibit more complications with chronic illnesses such as diabetes, cardiovascular disease, obesity and cancer, regardless of their access to healthcare (Greiner 2000: 10). Thus these patients need as high a standard of care as possible both professionally and ethically by physicians rather than a lesser one due to their lower socioeconomic status (which is, for the most part, beyond their control), or any other reasons based on their social, gender or personal vulnerability. “Medical practice requires and inspires physicians to help others, to put their talents and intellectual curiosity to good use, to ease suffering and provide comfort, and to serve the health needs of society,” according to Caldicott (2007: 138). Except for noting patient autonomy, this description more or less sums up the key principles of biomedical ethics, but also adds one especially relevant here: putting a physician’s “talents and intellectual curiosity to good use.” This requirement flies in the face of labeling patients as “difficult,” which is very common by physicians in many countries, or as “heartsink patients” by physicians in the U.K., according to Mathers, Jones and Hannay (1995: 293), and as summarized by O’Dowd in 1988 (528): “There are patients in every practice who give the doctor

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and staff a feeling of “heartsink” every time they consult. They evoke an overwhelming mixture of exasperation, defeat and sometimes plain dislike that causes the heart to sink when they consult.” Clearly, some physicians feel plagued by these patients and need to develop better attitudes and skills to be able to interact with and treat them efficaciously. As a number of studies have demonstrated that primary care physicians have reported between 15% to 30% of their patients as “difficult” or “troubling,” more attention needs to be paid not only to the ethical issues involved in providing care to these patients, but also the type of skills needed by physicians to be able to provide better treatment to them and provide mutual gain from more beneficial interactions (Brennan and Lee 2004: 126; Pomm, Shahady and Pomm 2004: 467). Rather than “turfing” them to other physicians or departments in hospitals as noted by Caldicott (2007: 136), all physicians need to develop more sensitivity to and understanding of physician-patient relationships and the many nuances the interdependence, respect, concern and affection (or dislike) embedded in these relationships can engender (Brennan and Lee 2004: 129). Brennan and Lee (2004: 129) have highlighted, “From the physician’s viewpoint, the duty to provide care tempers all the difficulties and frustrations of dealing with the irrational patient,” to name only one kind of “difficult patient” identified by physicians. Yet physicians—as human beings—are not perfect. As Caldicott (2007: 141) has noted, “It would be unrealistic to expect individual physicians to behave with complete moral neutrality towards their patients—just as no one behaves with complete moral neutrality in everyday life.” While it is understandable that physicians have feelings, too, and they should be allowed to express them in a reasonable and professional way toward and about their patients, the real problem arises when they allow their feelings to interfere with adequate treatment, which is unethical. The labeling used by many physicians for such patients can make them less caring for the individual and more concerned about getting through a pre-conceived “difficult” encounter. Such an attitude and type of approach to a patient renders physicians less vigilant and comprehensive in their discussions of symptoms and impact with the patient, as noted by a number of authors, including Caldicott (2007: 139), which can result in a missed diagnosis. In a study in Sweden and Slovenia that examined the attitudes of GPs toward demanding and reluctant patients and their ethical justifications for their treatment of them, the results showed that many Swedish GPs were uncertain about how to respond to a demanding patient (Bremberg, Nilstun, Kovac and Zwitter 2003: 260). Further, the study found that physicians gave different priorities to different ethical issues involved in treating their patients. For example, many of them did not prioritize the patient’s right to self-determination (or autonomy), focusing instead on the medical benefit (beneficence), protection from harm (non-maleficence), distributing resources fairly (justice), and maintaining or enhancing the patient-physician relationship (ibid.: 258). To many, this might smack of ‘paternalism,’ but it also might be based on differences in physicians’ training and what

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was emphasized as key ethical values—if indeed the physicians included in the study received training in medical ethics or bioethics, an emerging and evolving field—or simply exhibited their own views. What is evident in regard to physicians and other health care practitioners dealing with and treating “difficult” patients, whether they are demanding or otherwise, is the crucial importance of good communication. Some physicians are described as good doctors in general, but with poor “bedside manners,” which essentially means they are poor communicators and do not exhibit empathy, which is also described as “tender loving care” and/or “compassion” (Aung 2000: 2 ). Communication difficulties between physician and patient seem to arise most commonly in regard to problems of diagnosis, not involving a patient in discussion of a problem and how it can be managed, or not providing adequate information to a patient (Stewart 1995: 1424). The latter two issues reflect a lack of respect for patient autonomy. Problems with diagnosis can arise from problems with adequate history-taking by the physician, which also veers toward a lack of respect for patient autonomy and perhaps a lack of taking adequate time in discussion with the patient. Faulty diagnosis obviously can be a very serious issue resulting from poor communication skills or lack of proper respect for a patient. Stewart (1995: 1424) has emphasized how important good communication is between physician and patient, whether or not the patient is deemed “difficult:” “Studies have shown that 50% of psychosocial and psychiatric problems are missed, that physicians interrupt patients an average of 18 seconds into the patient’s description of the presenting problem, that 54% of patient problems and 45% of patient concerns are neither elicited by the physician nor disclosed by the patient, that patients and physicians do not agree on the main presenting problem in 50% of visits and that patients are dissatisfied with the information provided to them by physicians.” These statistics certainly highlight how important a role interactive communication plays in patient presentations, information exchange, diagnosis, and in the provision of comprehensive treatment. That the statistics are so high concerning communication and information problems and are not specific to “difficult” patients hints at how much higher they could be if only “difficult patients” had been included in the various studies from which they resulted. In Stewart’s (ibid.) review of the studies, she noted that they also pointed toward the significance of emotional support as one dimension of communication, and how important the distribution of power and control is in the physician-patient relationship, especially in regard to decision-making. Again, the ethical issue of patient autonomy comes to mind, as well as potentially non-maleficence if a physician is not practicing evidence-based medicine, which Adams (2006: 2 ) has highlighted as both a professional

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and ethical issue, by not seeking enough ‘evidence’ from the patient via good history-taking and information exchange regarding treatment options and potential adherence challenges. If a patient leaves a physician visit thinking the physician doesn’t really care about him or her because of their experience of a poor ‘bedside manner,’ this could result in the patient feeling insulted by a lack of respect or a negative interaction. This situation could be interpreted as maleficence, especially if it has an impact on a patient thereafter having difficulties adhering to treatment because of feeling the physician may not have taken him or her seriously and thus his or her condition isn’t serious, or by a patient showing a lack of treatment-seeking behavior in the future because of a bad interaction or indeed too little positive interaction with and empathetic expression by a physician. That most people probably do not enjoy going to see a physician doesn’t seem very questionable, even if they like their own doctor, as visits take time, can be expensive, transportation also can be complicated and/or expensive, and workplaces aren’t always as accommodating as they should be for such time off. If, on top of all these other issues, one’s physician has poor communication skills or doesn’t show empathy or respect, it is not hard to imagine why and how treatment-seeking behaviour might be affected. Specifically in regard to “difficult patients,” O’Dowd (1988: 530) has emphasized “the great danger that such illness may be poorly managed when the doctor would really prefer not to see the patient.” If a patient has sensed such an attitude by a physician in a previous visit, the physician’s “heartsink” patient has probably had his or her own heart sunk. The importance of good, positive communication by physicians cannot be underscored enough. According to Stewart (1995: 1426) in her analysis of randomized controlled trials and analytic studies of physician-patient communication in which patient health was an outcome, two of the studies showed statistically and clinically significant associations between increased communication, such as the physicians asking more questions and the patients making more statements, and symptom resolution. Obviously, if a physician and a patient aren’t communicating well, it’s unlikely that a patient’s symptoms will be relieved quickly, assuming they are based on real illness. If communication problems are compounded by a patient with multiple medical problems, such a situation is a difficult treatment situation indeed. Further, if communication problems are getting in the way of diagnosing psychological problems, timeous treatment will not be sought. The result of such a situation can be dire, although one hopes statistically that such a result is rare despite the eye-opening psychiatric statistics compiled by Stewart (1995:1424) in regard to missed “problems.” In addition to the importance of gauging a patient’s emotional health through good physician-patient communication, the communication studies examined by Stewart (1995:1429) noted the result of effective communication on functional and physiologic status and pain control. These findings are indeed salient to some examples of “difficult patients” listed previously in this paper. The need to shift the balance of power between the physician and patient also was emphasized by Stewart (1995: 1431) in regard to much more active patient participation in discussions surrounding

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their care (1995: 1429), and the need for physicians to take a more holistic approach to diagnosis and treatment, including taking the patient’s “expectations, feelings and ideas” into account (1995:1430). Given this type of mandate, it is easier to understand why some physicians might consider such a high percentage of their patients as “difficult.” Yet if they are not really attending to the full gamut of a patient’s health needs through their own diagnosis and treatment, or by making appropriate referrals in a timely and comprehensive way, physicians are not acting in either a professional or an ethical manner. If physicians do not take a holistic approach to care, whether the patient is normal or “difficult,” surely they are not practicing the ethical principle of beneficence. Many physicians in the U.S. say that because of time constraints, when they interact with a patient they can deal with only one or two complaints (Rosenow 2000: 1 ). But such an approach by physicians to clinical care most likely will not be effective in dealing with a “difficult” patient who may have multiple medical complaints, possible attitudinal problems about physicians and/or treatment, and communication issues. According to the recommendations of the American College of Physicians (ibid.), “Effective communication, especially active listening by the physician, and the provision of information and recommendations to facilitate informed decision making and patient education, are critical to the patient-physician relationship.” And, “Time is an important element of high quality clinical care, and a necessary condition for the development of the patient-physician relationship and trust between patient and physician.” In regard to the delivery of care, the American College of Physicians (ibid.) emphasizes, “ …fostering trust, maintaining fidelity, demonstrating patient advocacy, exhibiting respect for the patient as a person, and carrying out the individual and collective ethical obligations of physicians.” Obviously, the American College of Physicians has not limited its recommendations to well-behaved patients, ‘regular’ patients, or good patients. Its recommendations encompass all patients, “difficult,” or otherwise. That they specify trust, fidelity, respect, patient advocacy and ethics accentuate the importance of these approaches to and values within health care. Taking adequate time in patient discussions is necessary to promote well-being, which is the ethical principle of beneficence, and giving a patient due time supports the principle of justice in regard to the provision of limited resources (Braddock and Synder 2005: 4 ). “Difficult patients” require the same ethical standards of treatment as ‘regular’ patients, yet they need additional attention from the physician implementing the values of empathy, good

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communication and patience. Rosenow (2000: 1 ) has pointed out that, “unhappy physicians are not likely to provide high-quality care,” and certainly such physicians will be especially challenged by providing high-quality care to “difficult patients.” It is indeed very difficult to be empathetic, patient with, and open in communication toward another human being when one is unhappy oneself and probably more concerned with one’s own needs than the needs of others. Physicians are human beings and thus are not able to always rise above their own problems, feelings, and personal challenges despite societal and patients’ expectations. Yet they should strive for the ideal, and they should have enough self-awareness to seek advice or assistance in solving their own problems that get in the way of providing good patient care. Gillette (2000: 3 ) has noted that inexperienced physicians often have more problems interacting with patients and generally perceive more patients as being “difficult” until they gain more experience and become more tolerant of the wide variety of patients they treat. In addition, the results of studies examining physician characteristics have found the physicians with lower job satisfaction and poorer psychosocial attitudes also report more difficult patient encounters (Elder, Ricer and Tobias 2006: 1

). Certainly, interacting in a very positive way with all the different

manifestations of the human personality is an ideal to which no one can live up to all the time. This is particularly the case if one is young, inexperienced and is more focused on treating organic problems than psychological or emotional issues, which require specialized training and significant experience for most physicians to address effectively. Yet empathy goes a long way in bridging the physician-patient relationship and power gap. According to Rosenow (2000: 3 ), “Empathy is the foundation of the patient-physician relationship. Communicating empathy with words of understanding, like sadness, anger at your disease, suffering, “I think I understand what your illness is doing to you,” enhances the bonding necessary for a better outcome.” Rosenow (2000: 4 ) also emphasizes the importance of physicians leaving the impression with the patient, whether or not they explicitly state it, that they want to help the patient, care about the patient, and will help him or her address the problem until it is solved or the symptoms controlled. Treating a patient like one would like a member of one’s family treated by another physician is Rosenow’s (ibid.) basic guideline for patient care, which he has called, “the platinum rule of medicine.” What is extremely important for physicians to remember in regard to treating “difficult patients” and the importance of showing empathy is that many patients behave badly toward physicians and other health care practitioners because they are afraid (Lechky 1992: 1793). Thus they need empathy and good communication to disarm them and help them to understand they are not alone and without any assistance in addressing their illness. According to Lechky (ibid.), the three most common

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feelings that such patients have are fear over a serious illness, fear of abandonment by family and friends, and feelings of guilt or worthlessness because they are ill. Such feelings are easy to imagine in South Africa where so many adults are living with HIV, a very serious illness. A mother worrying about who will take care of her children if she dies, a father worrying about who will support his family if he becomes to ill to work and dies, and any South African worrying about the stigma and discrimination he or she may suffer if members of his or her community, workplace or even family find out he or she is are HIV-positive are easy reasons to understand as the cause of patient fears. One can deeply emphathize with individuals in such a situation and the “difficult” behaviors they may exhibit. The advice of Trotter (2002: 34) in dealing with “difficult patients,” is to take the Aristotelian approach and “ just do it:” act in accordance with one’s ideal, the ideal physician, even when it seems difficult, uncomfortable or unnatural, as eventually physicians will find that the ideal becomes normative. Specific strategies for dealing with unusually “difficult patients” in addition to practicing ethical principles and values include keeping visits short and focused, giving the patients specific things to do (such as exercise or dietary modifications), and working with colleagues and staff and patients’ families to address destructive or self-destructive attitudes and behaviors (Gillette 2000: 5 and 6 ). Flecky (2001: 3 ) has recommended following Purtilo’s (1999: 234-240) six steps for caring for “difficult patients” outlined in Ethical Dimensions in the Health Care Professions: (1) Do not blame the patient. (2) Avoid using “objectifying” labels for patients. (3) Remember that caring is a part of any intervention. (4) Develop a realistic view of power in patient relationships. (5) Engage in emotion self-care. (6) Work to change institutional and socio-cultural values that interfere with caring. Despite a physician’s best efforts with some “difficult patients,” however, it can be in the patient’s best interest to terminate the relationship if clinical visits are repeatedly unsuccessful. Lechky (1992: 1795) has advised that in such situations where a referral is advised or necessary because of “difficult” interactions, the physician should attempt to do it collaboratively with the patient by suggesting various options, including arranging for him or her to see another physician. But such decisions should be weighed carefully by the physician and the discussion with the patient held sensitively as according to Bursztajn, Gutheil and Brodsky (1998: 6 ), no matter how scrupulously the terminations, referrals and transfers are handled, the patient will feel rejection and abandonment. Moreover, such situations obviously are not easy for physicians either. That is why it can be highly beneficial for physicians to discuss “difficult” cases with colleagues either through fora regularly available in some hospital settings or via clinicians associations. Or, they can follow Pomm, Shahday and Pomm’s (2004: 469) advice by discussing the experiences with and the feelings such patients elicit with a trusted colleague. It is important for physicians in managing others and especially “difficult patients,” that they also practice self-management and learn how to accept their own emotional responses to patients and address their own personal well-being (Haas, Leiser, Magill and Sanyer 2005: 3).

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