Edwards Sarah J L, Stone Tracey, Swift Teresa
University College London/University of College London Hospitals, NHS Trust, Tottenham Court Road, London, UK.
Int J Technol Assess Health Care. 2007 Winter;23(1):17-23. doi: 10.1017/S0266462307051525.
To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).
We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.
There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.
The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater "consistency."
探讨研究伦理委员会（RECs）或机构审查委员会（IRBs）做出的伦理判断差异。
我们对文献进行了综述，纳入了任何试图比较不同RECs或IRBs在审查一项或多项方案时所做伦理判断的研究。
有26篇文章报道了欧洲、英国、西班牙和美国存在此类差异。在这些研究中，只有5份报告称一些RECs批准而另一些则拒绝了相同的方案。然而，所有研究都报告了在同意、招募、风险与收益、补偿安排以及科学问题等方面，RECs要求研究人员做出的澄清和修订存在差异。
这些研究大多是研究人员开展研究的轶事报道。至少在欧洲成员国，要求对多中心研究形成单一伦理意见的新规则可能只是掩盖了RECs决策中的问题。归根结底，如果要维持委员会审查制度，我们应该预期会存在一定程度的差异，尽管迫切需要调查RECs做出这些判断的方式。特别是，我们需要确定可能任意影响这些判断 的任何偏差、扭曲或混淆的来源。此外，当地情况仍然是重要的伦理考量因素，不应为了追求更大的“一致性”而被忽视。
