Meeting the challenges facing research ethics committees: some practical suggestions

British Medical Journal,  Jan 3, 1998  by Jennifer Blunt,  Julian Savulescu,  Alastair J.M. Watson

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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 table).[2-10]

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.

Multicentre research studies

Improving the competence and uniformity of approach in relation to the increasingly complex field of multicentre research is a further challenge. Local research ethics committees have been criticised for delaying good research, particularly in multicentre studies.[13-16] The efficiency of the committee s ethical review, the diversity of practice, and the waste of research time and funds (often from charitable sources) in seeking ethical approval have also been criticised.[3-10] To meet these criticisms the Department of Health has created a multicentre research ethics committee system to provide independent advice on the science and general ethics of multicentre research.[16]

Challenges from research synthesis

The third challenge derives from failure to do research synthesis--to aggregrate and integrate the results of related primary studies.[1] Some researchers have failed to undertake adequate systematic reviews of existing research at the outset and some have failed to report the results of their research subsequently; both can lead to unnecessary, sometimes harmful, research.

Detection of scientific malpractice and fraud

The fourth challenge relates to the detection of fraud in clinical research. Concern is growing over scientific fraud and misconduct in medicine.[17-25] Husson defines fraud as an "intentional act aimed at misleading someone--in general for personal advantage, but other less deliberate acts may equally affect the quality of scientific research.[26] Carelessness, overcommitment, and overambition can all contribute to second rate, even unethical, practices. Each investigator has a duty to check research before accepting responsibility for it.[27]

Some have called for research ethics committees to have a more pivotal role in the detection and management of suspected fraud.[28] In 1995, the General Medical Council struck a consultant off the Medical Register for fraudulent claims.[27] n 1996, two general practitioners were struck off for fraudulent activities in drug trials--one had forged consents--from patients; the other had repeatedly forged ethics committee approval.[25 29-31]

Possible solutions to key challenges

Committee membership

Research ethics committees must have an appropriate membership with a diverse range of expertise and experience.[12 16 32] Committees should include at least one member with a thorough knowledge of the scientific aspects of clinical research and of methods of research synthesis.[1 14] Valuable contributions can be made by biostatisticians, bioethicists, lawyers, and lay people from community groups. Committees have power to co-opt members. This is especially important when dealing with new technologies such as genetic research.[16 32 33] Bodies such as the Gene Therapy Advisory Committee and the United Kingdom Xeno-transplantation Interim Regulatory Authority advise local research ethics committees and are required to approve research proposals in their areas of expertise.[16] Published guidance for the evaluation of complex new research is increasingly available. One example is the IRB:A Review of Human Subjects Research, a journal devoted to research ethics.[34]

Resources

Ethical review is a key function of health authorities. Authorities should ensure that local research ethics committees have adequate support and administrative help.[33] We suggest this should be from trained staff working solely for the local committee. Core material for members and continuing training for new and existing members should be budgeted for.[35] This support has been recognised for multicentre research ethics committees.[16]

Training

Documents have been developed that promote consistency in decision making among local research ethics committees.[11 12 36] Members need time to assimilate this material. Training courses have been organised in various ways, and should include the evaluation of systematic reviews of existing research.[1] These skills can be taught to lay people through the critical appraisal skills programme.[37] Administrators, who are the first points of contact for researchers, also need training alongside members.