The Pharmaceutical Journal
Vol 271 No 7257 p36
12 July 2003

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Research ethics

Patients and other members of the public who participate in health care research, including pharmacy practice research, have a right to expect that it is carried out to the highest possible scientific and ethical standards. The Department of Health's Research Governance Framework for Health and Social Care, which was published in March 2001 after some high-profile research scandals, is intended to provide reassurance in England that ethical safeguards exist. Scotland and Wales have their own frameworks.

An updated edition of the English framework is expected in the autumn, so it is appropriate that we publish this week an article (PDF 120K), from the University of Manchester, which sets out the implications for pharmacy practice research of the updated governance framework (p51). An important point that is emphasised in the article — which is essential reading for everyone concerned with practice research — is that any study involving subjects recruited by virtue of their past or present treatment by the National Health Service, or research involving NHS staff, needs to be reviewed independently by a local research ethics committee to ensure that it meets established ethical standards.

This requirement applies equally to work carried out by experienced researchers, by preregistration trainees or by undergraduate students. This may cause problems — the long-term implications, for example, of research supervisors having to apply for ethical approval for individual undergraduate projects remain to be seen, as the authors of the article point out.

Although the framework will apply to research carried out in primary and secondary care, community pharmacy appears to be a grey area in terms of research ethics: an investigation conducted among patients presenting NHS prescriptions would require ethical approval but the requirements are less clear-cut where pharmacy customers purchasing over-the-counter medicines are being studied. However, the Royal Pharmaceutical Society takes the view that, since pharmacy is a profession working for the benefit of the public, the highest ethical standards must be seen to apply to research carried out with the help of the public, whether or not they are recruited by virtue of being NHS patients. It intends to modify its Code of Ethics to reflect this.

The Central Office for Research Ethics Committees sees the role of ethics committees as being to protect the dignity, rights, safety and well-being of research participants. The Journal supports this commendable aim, as well as the research governance framework and the principles behind it. This is an opportune time, therefore, to remind our contributors that we will not publish research papers where ethical approval for the studies is necessary but has not been sought.

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