Foster C G, Marshall T, Moodie P
Centre of Medical Law and Ethics, King's College, London.
J Med Ethics. 1995 Aug;21(4):214-9. doi: 10.1136/jme.21.4.214.
Each Local Research Ethics Committee (LREC) is expected to produce an annual report for its establishing authority. Reports from 145 LRECs were examined with regard to (a) whether the committees were working within the terms of the most recent guidelines from the Department of Health and (b) observations on the role of LRECs with particular reference to accountability. Most LRECs had produced a report, although their length varied greatly. Most reports showed how seriously the committee took its task. Most committees met many of the guidelines; for example, almost all had two or more lay-members. The guideline most frequently not met was that committees should have no more than 12 members. Many committees review very large numbers of projects (maximum 351). Approximately two-thirds provide details in the annual report of individual project titles, their author and the committee decision; all reports should contain this information. Although it may in fact happen more generally, only 23 per cent of the reports referred to any form of monitoring of the eventual outcome of the research. A significant issue to arise from the reports is the extent to which the framework for the operation of LRECs has been confused by the development of the purchaser-provider split. The paper concludes with suggestions for remedying the situation.
每个地方研究伦理委员会(LREC)都需要为其设立机构撰写年度报告。对145个LREC的报告进行了审查,审查内容包括:(a)委员会是否按照卫生部最新指南的规定开展工作;(b)对LREC作用的观察,尤其涉及问责制。大多数LREC都撰写了报告,不过报告长度差异很大。大多数报告显示了委员会对其任务的重视程度。大多数委员会符合许多指南要求;例如,几乎所有委员会都有两名或更多的非专业成员。最常未达到的指南要求是委员会成员不应超过12名。许多委员会审查的项目数量非常多(最多351个)。约三分之二的委员会在年度报告中提供了各个项目的标题、作者及委员会决定的详细信息;所有报告都应包含这些信息。尽管实际上可能更普遍,但只有23%的报告提及了对研究最终结果的任何形式的监测。报告中出现的一个重要问题是,采购方与供应方分离的发展在多大程度上使LREC的运作框架变得混乱。本文最后提出了改善这种情况的建议。