Auditing a research ethics committee.

Research ethics committees approve research on human subjects performed locally. They have been criticised for failing to perform this function adequately. I have, therefore, examined the structure and process of the committee for Leicestershire and compared it with the guidelines for these committees produced by the Royal College of Physicians and the Department of Health. The structure and function of the committee are described and conform well with the recommendations of the Royal College of Physicians and the Department of Health. An annual report to the health authority has not previously been produced but the need for this is now accepted. The suggestion for a lay chairman or vice-chairman has, however, been rejected. The workload has steadily increased over the past 10 years, from 66 protocols a year to 302. During a recent 12-month period, 277 research submissions were received; 143 of them were agreed without amendment, 93 with minor amendments, and 41 were rejected or required further information before they could be reconsidered. Assessment of outcome is more difficult. In future, the committee may ask for annual reports from investigators on their research and on any ethical problems encountered. Ethics committees need to foster good ethical research and inform researchers of ethical issues. Most of the latter are highlighted on the Leicestershire application form but are supplemented by short guidelines on particular topics. The committee consumes time and money; it is not clear if it will be adequately funded under the new NHS structure.