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Rethinking the Ethics of Clinical Research: Widening the Lens Alan Wertheimer

Published in print: 2010 Published Online: Publisher: Oxford University Press January 2011 DOI: 10.1093/ ISBN: 9780199743513 eISBN: 9780199827145 acprof:oso/9780199743513.001.0001 Item type: book

Clinical research requires that some people be used and possibly harmed for the benefit of others. What justifies such use of people? This book provides an in-depth philosophical analysis of several crucial issues in the ethics of clinical research. Much writing on the ethics of research with human subjects assumes that participation in research is a distinctive activity that requires distinctive moral principles. In most contexts, we allow people to choose the activities in which they engage. By contrast, people are permitted to participate in research only after IRBs determine that it is appropriate for them to do so. Although we assume that consent to participate in research must be preceded by an elaborate disclosure of information, we make no such assumption in many other areas of life. Although it is thought to be morally problematic to provide financial inducements to prospective subjects, we make no such assumptions when we hire people as loggers, fishermen, and fire fighters. Although we readily accept the “off-shoring” of manufacturing, many regard the off-shoring of medical research with great skepticism. This book seeks to widen the lens through which we consider such issues. When we do so, we will find that many standard principles of research ethics are difficult to defend.

Ethical Considerations of Randomized Controlled Trials Phyllis Solomon, Mary M. Cavanaugh, and Jeffrey Draine

in Randomized Controlled Trials: Design and Implementation for CommunityBased Psychosocial Interventions Published in print: 2009 Published Online: May Publisher: Oxford University Press 2009 DOI: 10.1093/ ISBN: 9780195333190 eISBN: 9780199864317 acprof:oso/9780195333190.003.0002 Item type: chapter

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The intention of Chapter 2 is not to review general research ethics, but rather to examine ethical issues particularly relevant to RCTs. The ethical justification for RCTs from both the perspectives of social work ethics and research ethics are explored, as well as overall ethical issues in designing RCTs. The development of well-executed RCTs as ethical research protocols involves thoughtful consideration of such factors as the following: the most appropriate questions to ask, who may be ethically eligible to be randomized, what are the most ethical comparisons to make, and how and when individuals should be randomized. Research ethics (that is, the proper conduct of scientific investigation based on cultural norms, as well as practice and professional ethics) must be taken into account in planning and designing an RCT. Special consideration is given to the ethics of internet RCTs given their increasing use.

Is a Little Pollution Good for You?: Incorporating Societal Values in Environmental Research Kevin Elliott

Published in print: 2011 Published Online: Publisher: Oxford University Press January 2011 DOI: 10.1093/ ISBN: 9780199755622 eISBN: 9780199827121 acprof:oso/9780199755622.001.0001 Item type: book

This book examines a variety of ways in which societal values can be more effectively integrated into the numerous judgments associated with policy‐relevant environmental research. It provides a detailed analysis of contemporary research on the hypothesis of hormesis (i.e., beneficial biological effects caused by low‐dose exposure to pollutants that are ordinarily toxic). On the basis of this analysis, as well as shorter case studies of endocrine disruption and multiple chemical sensitivity, the book proposes three lessons. First, university conflict‐of‐interest policies are significantly limited in their ability to prevent interest groups from “hijacking” academic research on sensitive policy‐relevant topics. Therefore, alternative strategies are needed to preserve science that serves the public interest. Second, concerned citizens and policy makers need to more carefully determine the most appropriate forms of broadly based deliberation to be employed in response to specific areas of sensitive, policy‐relevant research. Third, the principle of informed consent, which currently provides guidance in the medical field, suggests a promising ethical framework that can help environmental scientists who disseminate debated findings to the public. Throughout, the book highlights many of the crucial ethical and societal questions surrounding research on the hormesis hypothesis. It thereby constitutes the first book‐length manuscript to provide guidance to the concerned citizens, industry groups, scientists, and policy makers who are exploring ways to respond to this phenomenon. Page 2 of 6

Protecting human subjects in brain research: a pragmatic perspective Franklin G. Miller and Joseph J. Fins

in Neuroethics: Defining the issues in theory, practice, and policy Published in print: 2004 Published Online: Publisher: Oxford University Press September 2009 DOI: 10.1093/ ISBN: 9780198567219 eISBN: 9780191724084 acprof:oso/9780198567219.003.0009 Item type: chapter

This chapter elucidates ethical considerations in designing and carrying out clinical research on people with brain disorders based on an approach to research ethics derived from American philosophical pragmatism. Focusing on placebo-controlled trials of pharmacological treatments and deep-brain stimulation for psychiatric and neurological disorders, the chapter reflects how moral principles and standards can conflict when applied to contextually complex situations. To guide ethical judgment, it calls for a careful balancing of morally relevant considerations and an understanding of moral norms rather than categorical or absolute rules.

Facing up to Paternalism in Research Ethics 1 Alan Wertheimer

in Rethinking the Ethics of Clinical Research: Widening the Lens Published in print: 2010 Published Online: Publisher: Oxford University Press January 2011 DOI: 10.1093/ ISBN: 9780199743513 eISBN: 9780199827145 acprof:oso/9780199743513.003.0002 Item type: chapter

Although research ethics has generally emphasized the importance of autonomy and informed consent, it has not faced up to the fact that the reigning regulatory and ethical frameworks for human research emphasize the protection of research subjects and is paternalistic at its core. This chapter argues that this regulatory regime is best justified as a form of group soft-paternalism in which IRBs compensate for deficiencies in subject decision-making.

Responsible Conduct of Research Adil E Shamoo and David B Resnik

Published in print: 2009 Published Online: May Publisher: Oxford University Press 2009 DOI: 10.1093/ ISBN: 9780195368246 eISBN: 9780199867615 acprof:oso/9780195368246.001.0001 Item type: book

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Recent scandals and controversies—such as the falsification, fabrication, and plagiarism of data in federally funded science; the manipulation and distortion of research sponsored by private companies; human embryonic stem cell research; cloning; and the patenting of DNA and cell lines—illustrate the importance of ethics in scientific research. This book provides an introduction and overview of many of the social, ethical, and legal issues facing scientists today. The book includes chapters on research misconduct, conflicts of interest, data management, mentoring, authorship, peer review, publication, intellectual property, research with human subjects, research with animal subjects, genetic and stem cell research, international research, and ethical decision making. The book also features dozens of real and hypothetical cases for discussion and analysis and introduces the reader to important research regulations and guidelines. Now in its second edition, this book synthesizes the diverse talents and experiences. This second edition of this book includes new chapters and cases and has been brought up to date on the latest issues and problems in research ethics.

Humanity and Hyper-regulation: From Nuremberg to Helsinki Onora O'Neill

in Ethics and Humanity: Themes from the Philosophy of Jonathan Glover Published in print: 2010 Published Online: May Publisher: Oxford University Press 2010 DOI: 10.1093/ ISBN: 9780195325195 eISBN: 9780199776412 acprof:oso/9780195325195.003.0007 Item type: chapter

Contemporary work on research ethics often points to Nazi inhumanity and abuse of research subjects as a prelude to arguing that research on human subjects requires their fully informed consent. By contrast, the Nuremberg Code of 1947 demanded more robustly that fundamental obligations not to force, deceive, or use duress be respected, in order to ensure that research participation would be voluntary. Subsequent codes, such as the Declaration of Helsinki, set more exacting regulatory requirements aimed at securing highly specific and explicit consent. This supposed improvement may be neither feasible nor ethically superior.

The Ethics of Research in Infectious Disease:: Experimenting On This Patient, Risking Harm To That One Margaret P. Battin, Leslie P. Francis, Jay A. Jacobson, and Charles B. Smith in The Patient as Victim and Vector: Ethics and Infectious Disease Published in print: 2009 Published Online: May Publisher: Oxford University Press 2009 DOI: 10.1093/ ISBN: 9780195335842 eISBN: 9780199868926 acprof:oso/9780195335842.003.0010 Page 4 of 6

Item type: chapter

Research ethics has focused on protecting the autonomy of the individual research subject, insisting on informed consent and a reasonable risk/benefit ratio for a study to be ethical. At the same time, it has largely ignored the situation of the “indirect participant” in research: someone who might be adversely affected by another's participation in a research study. There are many historical examples of this failure: selfexperimentation with infectious disease, the Tuskegee syphilis study, and the Willowbrook study of infectious hepatitis, among others. And there are many more contemporary examples, too, such as tests of the oral polio vaccine or of short-course anti-retroviral therapy for HIV+ pregnant women. This chapter argues that risks to indirect participants must be considered in assessing the risk/benefit ratio of study designs. Where there are identifiable indirect participants and risks to them are significant, their informed consent should also be required for participation of the direct subject in research. Where indirect participants cannot easily be identified, but risks may be substantial, the chapter suggest employing models drawn from community consent to conduct of research.

Lesson #3: Ethics for Experts Kevin C. Elliott

in Is a Little Pollution Good for You?: Incorporating Societal Values in Environmental Research Published in print: 2011 Published Online: Publisher: Oxford University Press January 2011 DOI: 10.1093/ ISBN: 9780199755622 eISBN: 9780199827121 acprof:oso/9780199755622.003.0006 Item type: chapter

This chapter argues that, if scientists are to avoid railroading their own values into individual and societal decision‐making processes, they need to follow an ethics of expertise (EOE) when disseminating information. The chapter suggests that an EOE based on the principle of informed consent would help decision makers to formulate choices based on their own values and priorities, and it would also help them to evaluate the trustworthiness of various experts. On the basis of this principle, it advises proponents of hormesis to be as explicit as possible in acknowledging the major and controversial value judgments present in their work. Two of these crucial judgments are that hormesis is the predominant toxicological dose‐response relationship and that it should be the default dose‐response model in risk assessment. Clarifying these judgments would help decision makers to recognize the key sources of uncertainty and controversy in the information supplied to them, and Page 5 of 6

it would prevent interest groups from misusing the claims of hormesis proponents.

An Argument for Societal Values in Policy-Relevant Research Kevin C. Elliott

in Is a Little Pollution Good for You?: Incorporating Societal Values in Environmental Research Published in print: 2011 Published Online: Publisher: Oxford University Press January 2011 DOI: 10.1093/ ISBN: 9780199755622 eISBN: 9780199827121 acprof:oso/9780199755622.003.0003 Item type: chapter

This chapter argues that nonepistemic or contextual values should not be systematically excluded from any of the four categories of value judgments considered in Chapter 2. The argument rests on three major principles. First, the “ethics” principle is that scientists have ethical responsibilities to consider the major societal consequences of their work and to take reasonable steps to mitigate harmful effects that it might have. Second, the “uncertainty” principle is that those who are researching policy‐relevant topics often face situations in which scientific information is uncertain and incomplete, and they have to decide what standard of proof to demand before drawing conclusions. Third, the “no‐passing‐the‐buck” principle states that it is frequently socially harmful or impracticable for scientists to respond to uncertainty by completely withholding their judgment or providing uninterpreted data to decision makers. Based on this third principle, scientists cannot always leave difficult value judgments about interpreting uncertain evidence up to policy makers. Therefore, there are sometimes ethical reasons for scientists to factor societal considerations into their responses to uncertainty even when they address judgments about choosing scientific language or interpreting evidence. The upshot of this chapter is that administrators and policy makers need to find ways to limit the influences of powerful interest groups without naively trying to seal scientific research off from all societal influences and considerations.

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