The results of recent empirical investigations in research synthesis imply that research ethics committees are behaving unethically by endorsing new research which is unnecessary and by acquiescing in biased under-reporting of research which they have approved. The performance and accountability of research ethics committees would be improved if they required those proposing research to present systematic reviews of relevant previous research in support of their applications; to summarise the results of these reviews in the information prepared for potential participants; to register new controlled trials at inception; and to ensure that the results of these trials are made publicly available within a reasonable period of time after completion of data collection.
This paper discusses some of the issues surrounding statistical review by research ethics committees (RECs). A survey of local RECs in 1997 revealed that only 27/184 (15%) included a statistician member at that time, although 70/175 (40%) recognized the need for such. The role of the statistician member is considered and the paper includes a summary of a meeting of the Royal Statistical Society to discuss statistical issues that frequently arise in the review of REC applications. A list of minimum quali®cations which RECs should expect from anyone claiming to be a statistician would be useful, together with a list of statisticians who are well quali®ed and willing to serve on RECs, and a list of training courses for REC members covering the appropriate statistical issues.
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][3][4][5][6][7][8][9][10]
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