Department of Bioethics, National Institutes of Health, Bethesda, Maryland, USA.
Bioethics. 2013 Feb;27(2):105-16. doi: 10.1111/j.1467-8519.2011.01892.x. Epub 2011 Jul 4.
What I call 'the standard view' claims that IRBs should not regard financial payment as a benefit to subjects for the purpose of risk/benefit assessment. Although the standard view is universally accepted, there is little defense of that view in the canonical documents of research ethics or the scholarly literature. This paper claims that insofar as IRBs should be concerned with the interests and autonomy of research subjects, they should reject the standard view and adopt 'the incorporation view.' The incorporation view is more consistent with the underlying soft-paternalist justification for risk-benefit assessment and demonstrates respect for the autonomy of prospective subjects. Adoption of the standard view precludes protocols that advance the interests of subjects, investigators, and society. After considering several objections to the argument, I consider several arguments for the standard view that do not appeal to the interests and autonomy of research subjects.
我所谓的“标准观点”主张,IRB 不应将财务支付视为风险/收益评估中受试者的受益。尽管标准观点被普遍接受,但在研究伦理的规范文件或学术文献中,几乎没有对该观点的辩护。本文主张,只要 IRB 应该关注研究对象的利益和自主权,他们就应该拒绝标准观点并采用“纳入观点”。纳入观点更符合风险收益评估的潜在软家长主义理由,并证明了对未来受试者自主权的尊重。采用标准观点会排除那些有利于受试者、研究者和社会利益的方案。在考虑了对该论点的几个反对意见之后,我考虑了几个不诉诸研究对象利益和自主权的标准观点的论点。