Pike Elizabeth R
Department of Bioethics, National Institutes of Health, USA.
Am J Law Med. 2012;38(1):7-62. doi: 10.1177/009885881203800101.
National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants. This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants--those in federal research and those abroad--are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances. This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.
国家咨询委员会已经考虑了在研究相关伤害发生时对研究参与者应尽的义务。这些委员会多次得出结论，即受伤害的研究参与者有权就其伤害获得赔偿，侵权制度提供的补救措施不足，美国应采用无过错赔偿制度。但由于咨询委员会没有提出具体建议，也没有采取措施实施无过错赔偿，美国继续依靠侵权制度来赔偿受伤害的研究参与者。本文认为，最近的法律发展以及全球研究格局的转变使得维持现状在道德上站不住脚，在实际操作中也难以为继。最近的法律发展加剧了侵权制度作为一种赔偿方式所长期存在的困难；几乎每一位受伤害的研究参与者都难以获得损害赔偿，而某些类别的受伤害研究参与者——那些参与联邦研究的人和国外的研究参与者——则完全无法获得赔偿，这导致了严重的不公平。在过去十年中，许多大量参与研究的国家都规定了系统性赔偿。由于美国没有规定赔偿，它已成为道德上的异类，并有可能其不符合规定的研究被外国伦理委员会禁止，从而延误重要的生物医学进展。本文研究了替代赔偿机制，并基于现有的制度提出了一项具体的无过错赔偿建议。提议的制度可以在美国和世界各国实施，以帮助协调各国不同的赔偿制度，并更公平、有效地使因研究而受伤害的人得到补偿。
