Davies Grant, Gillam Lynn
Centre for Health and Society, University of Melbourne, Parkville, Victoria.
Monash Bioeth Rev. 2007 Jan-Apr;26(1-2):46-56. doi: 10.1007/BF03351465.
In this paper, we argue that Human Research Ethics Committees (HRECs) have an obligation to clearly articulate, document and be accountable for the reasons for their decisions, and to make their documentation available for external scrutiny. We advance two arguments to support this claim. The first is that this is a legal obligation--that HRECs, by virtue of the way they are established under legislation, are required by law to provide statements of reasons. The second is an ethical argument--even if the legal argument is flawed, there are still compelling ethical reasons for HRECs to operate in this way. We then give an example of what a statement of reasons from an HREC might look like, and urge HRECs to consider whether their decision-making and documentation could meet this model.
在本文中，我们认为人类研究伦理委员会（HRECs）有义务清晰地阐明、记录并对其决策理由负责，且要使其文件可供外部审查。我们提出两个论点来支持这一主张。第一个论点是这是一项法律义务——鉴于人类研究伦理委员会依据立法设立的方式，法律要求它们提供理由陈述。第二个论点是伦理方面的——即便法律论点存在缺陷，仍有令人信服的伦理理由促使人类研究伦理委员会以这种方式运作。接着，我们给出了一份人类研究伦理委员会的理由陈述可能的样子，并敦促人类研究伦理委员会考虑其决策过程和文件记录是否能符合这一模式。
