Ethics approval for research in medical education

Abstract

The issue of obtaining ethics approval for research in medical education was recently raised in a letter to the editor. It asked questions about our editorial policy and our views. A review of 16 papers published under the heading ‘Research papers’ in the first 5 issues of volume 35 of this Journal (2001) revealed that only one paper stated that ethics approval had been obtained from a University Research Ethics Committee. One further team reported that their data collection was planned to comply with local regulations. The other 14 papers made no mention of ethical considerations. Is this good or bad? Is research in medical education exempt from the ethical considerations which govern other research involving human subjects? Should this Journal, which aims to stimulate and publish high quality research in medical education, offer guidance to researchers about when to seek ethical approval for their research? These are thorny questions which this editorial does not set out to answer. Rather, we hope to provoke a constructive debate which can be conducted via our letters page. It is clear that researchers have a responsibility to carry out research ethically.1 This means that among other things they should adequately inform potential participants of the nature of the research and its risks and benefits, and must not expose participants to unacceptable risks. In response to research assessment exercises and the imperative of obtaining grant-funded income, medical academics are pursuing research in greater quantity than ever before. Their ethics committees are finding their workloads increasing. Do we want to increase it further by suggesting that researchers in medical education must obtain ethics approval for much of their research? Yet at the same time we want to ensure that the investigative activities of medical educators, whether focused on research or ongoing programme evaluation, are conducted according to high ethical standards with due protection of the rights of participants. Arguably, it is ethically wrong not to evaluate educational interventions. We need to know the educational impact of our curricula to ensure that they are having the desired effects on our students. Medical schools demand this as part of their quality assurance procedures. There are a great variety of ways of evaluating curricula but it is generally accepted that the views of students as consumers of education should be sought as part of the process. It is difficult to see how students could be harmed by this process particularly if their responses remain confidential and care is taken not to request evaluation more frequently than necessary. When does evaluation become research? When do these students move from being consumers of education giving their opinions to becoming research subjects? Research aimed at producing generalisable results to be published in the refereed literature is another matter. These are the attributes that define the differences between evaluation and research and this is the kind of work which would find its way into the research section of this Journal and others like it. Why should this research be exempt from the same critical scrutiny expected of other research endeavours? Perhaps it is the type of ethics approval that needs consideration. Are biomedical ethics committees best equipped to deal with medical education proposals, or are such proposals likely to receive a more relevant appraisal at the hands of social and behavioural ethics committees? Perhaps a middle ground is possible. Rather than overburdening university ethics committees, faculties should appoint curriculum ethics committees. These could be composed of a range of faculty and an equal number of students representing each year of the curriculum. They would consider ethical issues relating to curricular research and evaluation such as aspects of confidentiality, and monitor the volume of evaluation activity to prevent overload and unreasonable demands being placed on students. They could also give advice on appropriate methodologies and approaches, on sampling strategies as alternatives to including whole year groups in all evaluations and on appropriate student support mechanisms. Your views on this issue are sought and those which significantly contribute to the debate will be published in our Letters to the Editor section. With thanks to Mark Chaput de Saintonge, who raised this issue in the first place.