23 - Research involving vulnerable participants: some ethical issues

Summary

One of the issues that causes concern and divergence of opinion for members of Research Ethics Committees is that of research involving vulnerable participants. Members of vulnerable groups are usually taken to include children, the mentally ill, people with cognitive impairment, elderly people and dying patients.

Common questions asked by REC members at the Centre of Medical Law and Ethics' Introductory Courses on the Ethics of Research on Humans have included whether research involving the terminally ill can ever be ethical, what constitutes minimal risk in the context of research involving children, how freely informed consent can be obtained in psychiatric studies and how effective research in dementia can be carried out.

Recognising the importance and complexity of these issues, the Centre of Medical Law and Ethics convened a series of Advanced Study Days bringing together practitioners and REC members to discuss the ethical issues raised in relation to paediatric research, psychiatric research, research into diseases of age and research into palliative care. Whilst in no way exhaustive, the following pages outline some of the interesting issues covered during these meetings.

This chapter has drawn on the presentations and discussions of all the plenary speakers, panel members and participants at the Centre of Medical Law and Ethics' Advanced Study Days on Paediatric Research, Psychiatric Research, Research into Diseases of Age, and Research into Palliative Care during 2000 and 2001.

The author would like to thank the following, in particular, for their presentations which have been adapted for this chapter: Dr Julia Addington-Hall, Mr Phil Bates, Dr Antony Bayer, Dr Calliope (Bobbie) Farsides, Professor Jonathan Glover, Professor Michael Gunn, Dr Vic Larcher, Dr Karen Le Ball, Dr Steven Luttrell, Dr Donald Portsmouth, Dr Diana Rose, Professor Sir Michael Rutter, Dr Nigel Sykes, Dr Teresa Tate.