Auditing a research ethics committee.

Area of Science:

• Medical Ethics
• Health Services Research

Background:

• Research ethics committees (RECs) are responsible for approving human subject research.
• Concerns exist regarding the adequacy of REC performance in fulfilling this function.
• This study evaluates the Leicestershire REC against established guidelines.

Purpose of the Study:

• To examine the structure and processes of the Leicestershire Research Ethics Committee.
• To compare the committee's operations with guidelines from the Royal College of Physicians and the Department of Health.
• To identify areas for improvement in REC functioning and oversight.

Main Methods:

• Comparative analysis of the Leicestershire REC's structure and process against national guidelines.
• Review of committee operations, including workload, submission handling, and reporting.
• Assessment of adherence to recommendations from professional bodies and government departments.

Main Results:

• The Leicestershire REC's structure and function largely conform to Royal College of Physicians and Department of Health recommendations.
• An annual report to the health authority, previously absent, is now accepted as necessary.
• The committee has experienced a significant increase in workload, from 66 to 302 protocols annually.
• During a 12-month period, 277 research submissions were processed: 143 approved without amendment, 93 with minor amendments, and 41 rejected or requiring further information.
• A proposal for a lay chair or vice-chair was rejected.

Conclusions:

• The Leicestershire REC generally aligns with recommended practices, but faces challenges with increasing workload and potential underfunding.
• Implementing annual reporting and potentially investigator progress reports could enhance ethical oversight.
• Ensuring adequate funding and resources is critical for the continued effective operation of RECs within evolving healthcare structures.