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Auditing a research ethics committee.

J B Cookson1

  • 1Glenfield General Hospital, Leicester.

Journal of the Royal College of Physicians of London
|April 1, 1992
PubMed
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Research ethics committees (RECs) are crucial for human subject research oversight. This study found the Leicestershire REC generally aligns with guidelines, but faces increasing workloads and funding uncertainties.

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.
Keywords:
Biomedical and Behavioral ResearchNational Health ServiceRoyal College of Physicians

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  • 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.