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转化研究的多样性伦理。

The diverse ethics of translational research.

机构信息

King's College London, Centre of Medical Law and Ethics, UK.

出版信息

Am J Bioeth. 2010 Aug;10(8):19-30. doi: 10.1080/15265161.2010.494214.

Abstract

Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1). Whether or not T1 has these features, translational research beyond approval (T2: phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor.

摘要

评论者认为转化研究的伦理学存在问题。据说,转化研究的类型涉及有问题的收益、特殊风险、知情同意的额外障碍,以及严重的利益冲突。对全球贫困人口进行的转化研究被认为是在剥削他们,加剧了国际差距。一些评论者支持特别严格的伦理审查。然而,这些担忧仅仅基于预先批准的转化研究(现在称为 T1)。无论 T1 是否具有这些特征,批准后的转化研究(T2:第四阶段、卫生服务和实施研究)都不太可能,而且当在全球贫困人口中进行时,可能有助于发展。因此,只要 T1 在道德上存在问题,而对 T2 没有独立的反对意见,转化研究的伦理学就是多样化的:尽管一些转化研究存在问题,但也有一些没有问题。资金和监督应该反映这种多样性,应该鼓励 T2 的开展,特别是在全球贫困人口中进行时。

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