Available for FREE to all readers as an Editor’s Choice article for May.
The recent movement toward returning individual research results to study subjects/participants generates ethical and legal challenges for laboratories performing research on human biospecimens. The concept of an individual’s interest in knowing the results of testing on their tissue is pitted against individual and systemic risks and an established legal framework regulating the performance of laboratory testing for medical care purposes. This article discusses the rationale for returning individual research results to subjects, the potential risks associated with returning these results, and the legal framework in the United States that governs testing of identifiable human biospecimens. On the basis of these considerations, this article provides recommendations for investigators to consider when planning and executing human biospecimen research, with the objective of appropriately balancing the interests of research subjects, the need for ensuring integrity of the research process, and compliance with US laws and regulations.
Mark E. Sobel, MD, PhD, Jennifer C. Dreyfus, MBA, Kelsey Dillehay McKillip, PhD, Christi Kolarcik, PhD, William A. Muller, MD, PhD, Gene P. Siegal, MD, PhD, Melanie Scott, MD, PhD, , Kristine Wadosky, PhD, Timothy J. O’Leary, MD, PhD