Tens of millions of people enroll in research studies in the United States every year, making human subjects research a multi-billion-dollar industry in the U.S. alone. Research carries risks: although many harms are inevitable, some also arise from errors or mistreatment by researchers, and the history of research ethics is in many ways a history of scandal. Despite regulatory efforts to remedy these abuses, injured subjects nonetheless have little recourse to U.S. courts. In the absence of tort remedies for research-related injuries, the only venue for resolving such disputes is through alternative dispute resolution (ADR) – or more commonly, internal dispute resolution (IDR) through a process offered by the research institution. The federal regulations on human subjects are silent on resolving subject grievances, and to date, little is known about how institutions handle these disputes. This Article is the first empirical study of how U.S. universities and hospitals resolve subjects’ claims of physical injury, dignitary harm, non-compensation, deviations from research protocols, and maltreatment by research staff. I have conducted in-depth interviews with personnel from 30 hospitals and universities to understand how institutions respond to grievances involving research subjects. These interviews reveal highly flexible dispute resolution processes managed by institutional review boards (IRBs), the institutional authorities mandated by federal law to protect human subjects. Although many interviewees spoke intuitively of procedural justice – including elements such as voice, neutrality, and courtesy – these interviews also indicated problems with neutrality, expertise, representation of participants, one-sided appeals, and access to the dispute resolution process itself. This Article takes a close look at current practices, and then suggests strategies for improvement, addressing both the federal regulations and options for institution-led reforms.
Juvenile Law | Law | Science and Technology Law
Righting Research Wrongs: An Empirical Study of How U.S. Institutions Resolve Grievances Involving Human Subjects,
Yale J. Health Pol'y L. & Ethics
Available at: https://scholarship.law.columbia.edu/faculty_scholarship/2900