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Compensation for Research-Related Injuries, Ethical and Legal Issues

David B. Resnik, J.D., Ph.D.* Journal of Legal Medicine 2006; 27: 263-87. INTRODUCTION The rapid increase in litigation related to biomedical research on human subjects has highlighted the importance of developing policies addressing compensation for researchrelated injuries. Although the United States federal research regulations do not require researchers, sponsors, or research institutions to offer subjects compensation for injuries, they do require researchers to discuss compensation for injury with subjects during the informed consent process, if the research is classified as more than minimal risk. According to the Common Rule, a regulation adopted by 17 federal agencies, one of the required elements of informed consent is, “For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or whether further information may be obtained.” Although all institutional review boards (IRBs) must deal with this issue when they review research classified as more than minimal risk, there has been not been a large amount of legal or ethical scholarship on the topic of compensation for research injuries. This article explores some of the legal and ethical issues in compensating subjects for research-related injuries and describes some of the policies adopted by different institutions. The article argues that the current system of compensation for research-related injuries in the United States is unjust, and that that federal government should revise the human subjects research regulations to set a minimum standard for compensation.