Document Type

Article

Publication Date

2015

Keywords

clinical trial, compensation, compensatory justice, no-fault compensation, research injury, remedy

Comments

The most recent version of this article will be available at the publisher's site.

http://jlb.oxfordjournals.org/content/early/2015/08/12/jlb.lsv034.full.pdf?keytype=ref&ijkey=5X8zvSxvGX6zjCS

Abstract

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.

Publication Citation

Journal of Law & the Biosciences (2015). doi:10.1093/jlb/lsv034

Disciplines

Bioethics and Medical Ethics | Health and Medical Administration | Health Law and Policy | Health Services Administration | Health Services Research | Public Law and Legal Theory