title: Recovering from research: a no-fault proposal to compensate injured research participants.
abstract: 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.
authors.affiliation: Department of Bioethics, National Institutes of Health, USA.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Pike
mesh_terms: D026683:Advisory Committees; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D006801:Humans; D007348:Insurance, Health; D038622:Internationality; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014481:United States