Beyleveld Deryck
Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield, UK.
Med Law. 2002;21(1):57-75.
This paper examines the view of the operational management of the UK Research Ethics Committee (REC) system that RECs may not reject applications on purely legal grounds. Two arguments are offered for this view: the first rests on the contention that being lawful and being ethical are not the same thing; the second is that RECs lack expertise and authority to base their decisions on legal considerations. However, whatever the philosophical standing of the first argument, it is contrary to published guidance, the basis of RECs' official authority, unethical, and politically imprudent to permit RECs not to consider conformity with the law to be at least a necessary condition for REC approval. In any event, RECs can obtain competent and authoritative advice on the law (though the Department of Health has been remiss in this regard), and they do not exceed their authority by applying the law, because this is within their ethical remit. When current guidance to RECs about advising researchers on whether or not breaches of confidence are permissible in the public interest is linked to the view of the REC management that the role of RECs is to facilitate research (albeit ethical research), this raises serious doubts about the integrity of the system of ethical review currently in place, which is illustrated by a recent "agreement" of the Chairmen of the MRECs not to consider the Data Protection Act 1998 in their ethical review.
本文探讨了英国研究伦理委员会（REC）系统运营管理的一种观点，即伦理委员会不得仅基于法律理由拒绝申请。文中为这一观点提供了两条论据：第一条基于合法与合乎伦理并非同一回事这一论点；第二条是伦理委员会缺乏基于法律考量做出决策的专业知识和权威。然而，无论第一条论据在哲学层面的立场如何，允许伦理委员会不将符合法律视为批准申请的至少一个必要条件，这与已发布的指南相悖，而指南是伦理委员会官方权威的基础，是不道德的，且在政治上是轻率的。无论如何，伦理委员会可以获得关于法律的专业且权威的建议（尽管卫生部在这方面有所疏忽），并且它们依据法律行事并未越权，因为这属于其伦理职责范围。当目前针对伦理委员会就研究人员在公共利益方面违反保密规定是否可被允许提供建议的指南，与伦理委员会管理层认为伦理委员会的职责是促进研究（尽管是符合伦理的研究）的观点联系起来时，这引发了对当前伦理审查体系完整性的严重质疑，医学研究伦理委员会主席们最近“达成协议”，在其伦理审查中不考虑1998年《数据保护法》就说明了这一点。
