Elderly population is on the rise globally
and so is the situation in India too which is projected to 173
million in 2026 according to a report by United Nations
Population Fund and Helpage India. According to population
Census of 2011 elderly above the age of 60, famales outnumber
males. In Kerala elderly form 12.6% of the ppulation, highest
for India. More emphasis needs to be laid on ethical aspect of
care of this group which is vulnerable in many ways, more so
where women are concerned.
Bioethics includes adherence to ethical principles in practice
and research. In dealing with the elderly we can classify them
into mainly four groups – mentally and physically active,
mentally agile but physically weak, cognitively impaired,
terminally ill. As their condition deteriorates, vulnerability
and disabilities increase relatively or absolutely when they
become incapable of protecting their own interests due to
dependence, lack of understanding and communicating ability,
power and family support. Plans for treatment or
research involving the geriatric age group has to take these
facts into consideration and build safeguards to protect its
welfare and rights. This section will concentrate on research
aspects when using the elderly as research participants. The
points to be considered are given below:
1. The elderly have equal rights to be included in
study if it applies to them and addresses their needs.
2. If mentally agile the participants should be able to
decide whether to get enrolled in a study or not.
3. For those who are dependent or cognitively impaired the
legally authrised/acceptable representative (LAR) should be
made to understand the implications before getting her/his
consent.
4. The potential participant should not be pressurised by
LAR to enroll so researcher should take care of such a
conflicting situation, especially when it comes to
palliative care patients.
5. Care may be taken to ensure privacy and confidentiality.
6. Informed consent process should be well documented and
recorded whenever applicable as in audio, audio/visual
process and an impartial witness if applicable (see ICMR
guidelines 2017).
7. There should be no coercion or undue inducement.
8. Arrangements for support systems should be made to take
care of associated medical and social problems.
9. If possible ancillary care in the form of proper walking
and sitting supports, resting rooms and counselling centres
should be made available.
10. Permission of appropriate authorities in case of
institutionalised persons, specific social and religious
communities and tribal communities and treating physician
may be required depending on the type of research.
11. Withdrawing consent should be allowed without any
negative repercussions.
12. Avoidance of therapeutic misconception.
13. Look out more diligently for adverse events.
14. Only when designing proposals on sensitive topics like
abuse of the elderly, deception technique may be used but
care should be taken to use only aggregate data for
debriefing or publishing without stigmatising the
participants.
15. In limited resources scenario as in pandemics, lesser
intensive interventions could be tried to balance ethical
justice.
16. Functional status and frailty of elderly patients should
be scaled carefully for inclusion in studies.
Role of Ethics Committee (EC)
1. It would be desirable to have empowered
representatives in the EC either as member or as coopted
member only to review proposals involving the elderly.
2. Only full committee of EC should do intial and continuing
review.of such proposals.
3. EC should critically examine it for inclusion/exclusion
criteria, conflict of interest issues, benefit-risk
assessment, risk minimization,.
4. Minimize exceptions with regard to consent and review
which if required should be clearly justified in the
proposal.
5. Do more frequent monitoring if required.
6. A separate SOP is required for doing research on the
vulnerable group.
7. Whenever possibe consider post-trial access to medication
if it shows beneficial effects
8. EC should carefully review the proposal where deception
technique is to be used.
Role of Sponsors
1. The sponsor, whether Government, Private,
Pharmaceutical company, researcher initiated should justify
inclusion of elderly in a research project and make
provisions to ensure/protect their safety.
2. Ensure frequent monitoring.
3. If the topic is sensitive, besides the participants
should also provide for protection of the
reseachers/research team.
Suggested Readings
1. National Guidelines for Biomedical and Health
Research involving Human Participants, 2017.
2. Ethical considerations in conducting clinical trials for
elderly cancer patients. 2008 available at DOI:
10.2217/1745509X.4.3.253
3. COVID-19: BGS statement on research for older people
during the COVID-19 pandemic. 2020 available at
https://www.bgs.org.uk/resources/covid-19-bgs-statement-on-research-for-older-people-during-the-covid-19-pandemic