Department of General Practice, Academic Medical Centre, University of Amsterdam, The Netherlands.
Sociol Health Illn. 2012 Sep;34(7):1039-52. doi: 10.1111/j.1467-9566.2012.01458.x. Epub 2012 Feb 14.
Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively and categorised these codes in two repertoires of evaluation: a repertoire of rules and a repertoire of production. In the repertoire of rules the REC applies rules, weighs scientific value and burdens to the participants and makes a final judgment on a research proposal in a meeting. In the repertoire of production, REC members check documents and forms and advise researchers on how to improve their proposals and can use informal communication. Based on these findings, we think that evaluations of the practice of ethical review should take into account the fact that RECs can use a repertoire of rules and a repertoire of production to evaluate research proposals. Combining these two repertoires can be a viable option so that the REC gives researchers advice on how to improve their proposals to prevent rejection of valuable research.
评估研究伦理委员会（REC）的实践可以帮助保护人类参与者的利益并促进科学进步。为了便于进行此类评估，我们对 REC 在会议期间如何审查研究提案进行了民族志研究。我们观察了一个荷兰 REC 的 13 次会议，并研究了 REC 文件。我们对这些材料进行了归纳编码，并将这些代码分为两个评估剧目：规则剧目和生产剧目。在规则剧目中，REC 应用规则，权衡科学价值和对参与者的负担，并在会议上对研究提案做出最终判断。在生产剧目，REC 成员检查文件和表格，并就如何改进提案向研究人员提供建议，还可以进行非正式沟通。基于这些发现，我们认为对伦理审查实践的评估应该考虑到 REC 可以使用规则剧目和生产剧目来评估研究提案的事实。结合这两个剧目是一种可行的选择，这样 REC 就可以就如何改进提案向研究人员提供建议，以防止有价值的研究被拒绝。
