Just compensation: a no-fault proposal for research-related injuries
Just compensation: a no-fault proposal for research-related injuries
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DOI：
10.1093/jlb/lsv034
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发表时间：
2015-11-01
影响因子：
3.4
通讯作者：
Pike, Elizabeth R.
中科院分区：
文献类型：
--
作者：
Henry, Leslie Meltzer;Larkin, Megan E.;Pike, Elizabeth R.
生物医学研究，无论如何精心设计和道德进行，都带有不确定性，并使参与者面临受伤的风险。研究伤害的范围可以从相对较小的到导致住院治疗，永久性残疾甚至死亡的伤害。参与者还可能遭受与其受伤有关的一系列经济损失。与绝大多数实施无过错赔偿制度的发达国家不同，美国继续依靠侵权制度来赔偿受损害的研究参与者--这种做法在道德上不再站得住脚。尽管数十年来美国顾问团一直倡导无过错赔偿，但几乎没有取得进展。因此，本文提出了一个新的和必要的无过错赔偿制度，基于补偿正义的伦理观念。这是首个具体的建议，目的是一视同仁，提供公平的赔偿，并以最高的效率和最低的行政成本支付赔偿。它还协调了国家和国际方法-随着研究变得更加全球化，多中心试验数量增加，以及美国的机构和申办者转向单一IRB审查，这是一个越来越重要的目标。
Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants-an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been made. Accordingly, this article proposes a novel and necessary no-fault compensation system, grounded in the ethical notion of compensatory justice. This first-of-its-kind concrete proposal aims to treat like cases alike, offer fair compensation, and disburse compensation with maximum efficiency and minimum administrative cost. It also harmonizes national and international approaches-an increasingly important goal as research becomes more globalized, multi-site trials grow in number, and institutions and sponsors in the United States move to single-IRB review.