Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects

Leslie Meltzer Henry

University of Maryland Francis King Carey School of Law; Johns Hopkins Berman Institute of Bioethics


Journal of Law, Medicine & Ethics, V. 41, No. 2, p. 411, 2013
U of Maryland Legal Studies Research Paper No. 2013-38

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone.

For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule's otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects.

This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees' articulation of multiple ethical principles – including humanitarianism, professional beneficence, and compensatory justice – results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects.

The publisher prohibits posting of the article to repositories and personal webpages. Access to the full text is available at the publisher's website.

Keywords: biomedical research, human subjects research, ANPRM, Common Rule, compensation, research injuries, bioethics, humanitarianism, compensatory justice, beneficence

JEL Classification: D62, D63, H4, I18, J28, J33, K32

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Date posted: July 10, 2013 ; Last revised: February 26, 2014

Suggested Citation

Henry, Leslie Meltzer, Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects (2013). Journal of Law, Medicine & Ethics, V. 41, No. 2, p. 411, 2013; U of Maryland Legal Studies Research Paper No. 2013-38. Available at SSRN: http://ssrn.com/abstract=2291993

Contact Information

Leslie Meltzer Henry (Contact Author)
University of Maryland Francis King Carey School of Law ( email )
500 West Baltimore Street
Baltimore, MD 21201-1786
United States
410-706-4480 (Phone)
Johns Hopkins Berman Institute of Bioethics ( email )
United States
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