Medical Research: How to Cope with the Local Medical Research Ethics Committee
Dr Alan Morris
Molecular Medicine Research Centre
Department of Biological Sciences
University of Warwick
28th Novemeber 2002, 12pm Room 108/110, Medical School
The aim of this presentation is to describe the basis of medical research ethics, how ethical review is organised in the UK, and how to prepare a successful application to a research ethics committee. The viewpoint is of a biomedical researcher rather than an ethicist and is intended to be helpful in a practical way.
Medical research ethics is based on the twin principles of personal autonomy and the need to do no harm. Neither of these principles can be regarded as absolute if there is to be medical research, considered generally to be a good thing. There is a need to balance these principles against the need to expand medical knowledge, and this is done by independent ethical review of research proposals.
All research involving patients, their carers, or medical staff should be subjected to ethical review. In this country ethical review is carried out by a system of committees comprising lay and expert members appointed by the Health Authorities. There is no legal requirement for ethical review of medical research but obviously failure to have research approved by an ethics committee leaves the researcher open to serious problems should harm be done to the research subject. The definition of what is "research" may not be clear: clinical audit, for example, almost always is thought of as not research and does not require ethical review, but in situations of uncertainty it is obviously sensible to err on the side of caution and seek review.
Research proposals submitted to a committee should provide:
- sufficient background material to allow a judgement of the scientific quality of the research (or an adequate independent peer review);
- an account of the research subjects (e.g. patients) to be studied;
- a full description of what is to done to (and by) the subjects;
- a careful appraisal of the risks and benefits of the research.
In addition an Information Sheet, to be read by the research subject, must be provided. This should be couched in suitable language so that the subject may fully understand the implications of the research, so enabling informed consent: this consent must be recorded on a Consent Form, a copy of which also should be provided. The subject should never be pressured into taking part in a study, and this should be clearly indicated in the information sheet.
No medical research is risk-free, and of particular importance is that suitable compensation arrangements should be in place should injury occur as a consequence of the subject taking part in the research.
Financial issues are also a consideration and complete transparency here is essential. There is no difficulty in the research generating a profit (e.g. through payments from a drug company), provided that the committee is satisfied that the profits are used properly, e.g. in funding a research assistant for another project. Payment of expenses to research subjects is expected, but there should be no incentive to take part in the research.
Applications to a research ethics committee are often rejected, or at least delayed, because of poor presentation rather than because of ethical problems: if, for example, the information sheet is written in poor English or uses too many unexplained technical terms, revision will be required.
Consult the website of the Central Office for Research Ethics Committees for further information: http://www.corec.org.uk/
Alan Morris November 2002.
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