Research on older people: Some ethical issues Association for Research Ethics: Research and Vulnerable Groups 27.5.15 Professor Anthea Tinker, Professor of Social Gerontology and Chair of the College Research Ethics Committee 2001 – 2011 [email protected]

Outline of presentation 1. 2. 3. 4. 5. 6. 7 8

How do we define older people? The affect of the exclusion of older people from research Are there special issues for certain groups such as those at the end of life? Practical issues e.g. gatekeepers Challenges and issues to do with technology Challenges and issues to do with longitudinal studies Guidance Conclusions

i

1. How do we define older people? a. Chronological age? It is argued that this is ‘fairer’. In most government documents/policies this is the criteria e.g. it is 50+ for employment policies, and for services often pensionable age (60+ for women and 65+ for men but becoming higher for both)

i

1. How do we define older people? b. c. d. e.

Retirement from the workforce How people feel or look? Cultural differences Biological age

i

1. How do we define older people? f. Vulnerability? - This would apply to any age group and can be related to characteristics such as physical and/or mental incapacity - Physical frailty need not imply mental incapacity - But there may be a particular combination of circumstances which makes an older person more vulnerable e.g. female’ living alone, lives in a deprived area, living in an institution For many purposes including the delivery of services the choice is arbitrary

• The dangers of generalising – not practical or ethical • Particular problems for research on people with cognitive impairment including gaining assent and where they lose capacity during the research • ‘There is greater variation in biological characteristics, such as blood pressure, lung function and muscle strength and in health status than at younger ages’ (Ebrahim, 1996, p. 19)

i 2. The affect of the exclusion of older people from research • The lack of research on older people (especially very old people) • Older people are often not included in research or there is an upper age limit

i 2. The affect of the exclusion of older people from research • A serious issue is both ethically and for the provision of services are those older people who are not visible e.g. those who are homeless, from minority groups, others who are hard to reach (See Quality in Ageing Tinker et al, 2014, 15,4,187 – 196) • It is difficult to access older people in the community who are not in touch with services

Age bias – consequences in medicine • The lack of research on older (especially very old) people is practically and ethically unacceptable especially when the results of studies are then applied to older people • This is especially important over the use of drugs

Age bias • There may also be age bias in social research • For example some questions such as relating to employment may not be asked of people over a certain age • This can be age discrimination

Age bias – consequences in medicine - Uncertainty re risks and benefits of new treatment in older people - Under treatment of older people - Delays in bringing new treatments to older people - Possible adverse reactions (Dr Sinead O’Mahony, Cardiff University, presentation to Royal Society of Medicine, 26.10.06 quoting many studies summarised in Shekhar et al. JAGS 2006, S94 )

i 3. Are there special issues for certain groups such as at the end of life? Research on people at the end of life finds little justification for their exclusion from research Issues of: - Inclusion - Sensitivity - Ongoing consent - Attrition

i 4. Practical issues Gatekeepers Designing research

i 5. Challenges and issues to do with technology

1. What is Technology? Often called What is technology: often called Assistive Technology ‘An umbrella term for any device or system that allows an individual to perform a task they would otherwise be unable to do and increases the ease and safety with which the task can be performed’

(WHO 2004 A Glossary of Terms for community health care and services for older persons, WHO, Kobe)

Assistive Technology • This can cover a range of services and products including aids and adaptations and computers and their use in different situations such as primarily medical or non medical. However what is increasingly being adopted across the world in practice are the terms Telecare and Telemedicine but in academic circles the term used is Gerontechnology.

What is the role of technology a. For health i.e. medical reasons (and note that much of this started with younger age groups) • Diagnosis e.g. smart loos • Treatment e.g. drugs • Rehabilitation e.g. robots

What is the role of technology? (ctd) b. For contact: • Information • Reassurance (e.g. to help with memory problems) • Medication • Social • Practical

2. What is the role of technology (ctd)? What is the role of technology (ctd) c For help with these kinds of problems: • Personal (such as washing, bathing, feeding) • Domestic tasks (such as cleaning the home) • Mobility (such as walking, reaching) These problems may be related as well to sensory and motor (e.g. trembling) restrictions

What is the role of technology? (ctd) d. For surveillance*/sensor based lifestyle monitoring - To see if the person has fallen - To check on who is at the door and who is in the property - To check on carers - To monitor movements and patterns of behaviour Consent should of course be given

* For example the Feb 2015 Care Quality Commission ‘Thinking about using a hidden camera or other equipment to monitor someone’s care’

What is the role of technology? - Does it encourage the independence or isolation of older people? - Major issues of consent – balance between benefit and harm - Replacing humans with technology - Records – access, sharing data

6. Challenges and issues to do with longitudinal studies • ‘Longitudinal studies are increasingly being recognised as essential in gaining a understanding of the ageing process in older people, particularly as life expectancy and the proportion of older people in the population continues to increase (House of Lords Science and Technology Committee 2005, 2006). However, participation rates in such studies have been decreasing (Galea and Tracy, 2007, Nohr et al, 2006) and research has shown that drop-out is greater among older participants (Chatfield et al, 2005) ………..It is particularly important that they remain as representative of the population as possible’ (Bhamra, Tinker, Mein, Ashcroft and Askham 2008)

Longitudinal studies • Although it is important to retain participants in longitudinal research studies there are ethical issues over how far they should be encouraged/persuaded to remain in the study and not drop out e.g. should they be given an incentive to remain in?

• Many studies do not start out as longitudinal studies. Value in getting assent for continued participation at the start • Challenges in getting funding especially where there are different interests involved • Problems of recruitment • Problems of retention

An example of research on the retention of older people in research

Anthea Tinker, Gill Mein, Suneeta Bhamra, Richard Ashcroft, Clive Seale and the late Janet Askham See King’s College London Gerontology website for the report

Aim The main aim of the research was to provide guidance to research teams planning or carrying out surveys about ways of increasing retention of older participants and reducing drop out rates

1

• Literature review • Questionnaires to other researchers

2

• Secondary analysis of existing data • Quantitative and qualitative

3

• Collection of new data • Focus groups and telephone interviews

Conclusion • Our major conclusion was that longitudinal studies are facing serious problems of drop out and are anxious to find ways of avoiding this • Our contacts with other studies, including the Whitehall II study indicate their willingness to consider ways of retaining participants. We produced a short summary was widely distributed of ways in which this might be achieved

6. 7. Guidance • There should be no automatic presumption that older people are vulnerable and therefore cannot take part in research • The Department of Health* state that ‘It should never be assumed that people are not capable of making their own decisions, simply because of their age or frailty’ (p.1) and ‘age or frailty alone is not a reason for doubting a person’s capacity’ (p.4) •

DH (2004) Seeking consent: working with older people

6. 7. Guidance (ctd) There is much general guidance e.g. the updated Helsinki agreement, by the British Psychological Society and some on older people e.g. British Society of Gerontology More recently an attempt has been made to draw up guidelines across Europe on Medical Research for and with Older People by the European Forum for Good Clinical Practice: Geriatrics Working Group. AT was a member of the drafting committee (Hugenot-Diener et al, 2013, J of Nutrition, Health and Aging, 17,7,625 – 627)

6. 8. Conclusions There are major problems in recruiting for research and this is particularly the case for those who are unhealthy and those who are older How can it be made easier for people to participate? The Director of the National Institute for Health Research Clinical Research Network said ‘Ultimately we do believe that a more informed and aware patient and public community is going to volunteer more frequently’. (BMJ 18.6.11) He wants patients to ask their doctors what research they can be involved in. How realistic is this for older people in both clinical and non clinical research?

6. 8. Conclusions (ctd) These are common to most topics but there are some good examples from housing - Involving older people throughout the research - Older people as advisors - Older people as researchers - Older people as disseminators - Older people as members of ethics committees