Intended for healthcare professionals

Education And Debate

Meeting the challenges facing research ethics committees: some practical suggestions

BMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7124.58 (Published 03 January 1998) Cite this as: BMJ 1998;316:58
  1. Jennifer Blunt, former chairman, Salford Research Ethics Committeea,
  2. Julian Savulescu, clinical ethicistb,
  3. Alastair J M Watson, senior lecturerc
  1. a Manchester M45 7PR
  2. b Oxford Radcliffe Hospitals, Oxford OX3 9RP
  3. c Department of Medicine, University of Manchester, Hope Hospital, Salford M6 8HD
  1. Correspondence to: Mrs J Blunt 53 Hawkstone Avenue, Whitfield, Manchester M45 7PR
  • Accepted 8 July 1997

Introdution

The local research ethics committee is the most independent body regulating the ethical conduct of research.1 The committee works on behalf of the subjects of research, to protect them from unacceptable risks and practices. However, the effectiveness of local research ethics committees in fulfilling their role has been challenged increasingly (see 1).2 3 4 5 6 7 8 9 10

View this table:

Key challenges for local and multicentre research ethics committees and possible solutions

Key challenges for research ethics committees

Volume and nature of research

Because of the volume and varied nature of the research reviewed, members of local research ethics committees have a demanding task maintaining a coherent approach.11 The committee workload varies considerably, from fewer than 10 to more than 40 protocols for review at each meeting. The workload also depends on the type of research community within which the committee operates.12 A snapshot of the work of the former Salford Local Research Ethics Committee (box) illustrates the difficulties.

Work of the Salford Local Research Ethics Committee

  • The Salford committee served a district health authority with four trusts, including tertiary referral centres, a medical school, and universities with health care and social science departments

  • A wide range of work was reviewed: it covered NHS patients and healthy volunteers; clinical trials in hospitals and general practice; records based research; qualitative and health services economic research; and surveys

  • Studies originated from: academic departments; researchers, as part of funding applications; and prequalifying and postqualifying students on courses with a research component that required access to patients or their records

  • Submissions doubled in 10 years. In 1995-6, 230 new applications were reviewed—44% were approved at first review and 46% after subsequent amendment; 3 were refused on grounds of safety, 12 were considered not to need ethical approval, and 8 were withdrawn. Applications for amendments or extensions were granted in 85 studies approved previously, and follow up reports were …

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