Translating Research Into Health Benefits: Returning Research Results & Incidental Findings

Award Year:
Susan Wolf
Medical Ethics, Human Subjects Research
Tremendous debate surrounds the question of whether researchers have a duty to offer research participants incidental findings (IFs) or individual research results (IRRs) of potential health importance that are discovered in the course of conducting the research. When neuroscience researchers obtain an MRI scan of the brain, they risk stumbling upon a brain tumor or other IF of potential life-and-death significance. When researchers collect genetic data, they may discover unexpected findings ranging from chromosomal abnormalities to gene variants predicting a catastrophic reaction to common medications. There is no agreement on how to handle these findings and whether to offer them back to individual research participants and affected subpopulations. In the past, most researchers have declined to return individual findings, on the grounds that investigators are engaged in research, not clinical care. Yet an increasing number of researchers have become uncomfortable with this tradition of silence, and emerging data suggest that many people want and even expect to receive notice of clinically important research findings. A major controversy has thus arisen over return of IFs and IRRs. The question of whether researchers should return these research findings to individual participants for clinical benefit challenges the traditional line drawn between research and clinical care, a line historically fundamental to the structure of research practice, health law, and bioethics. Reconsidering how we draw that line by contemplating return of incidental findings and research results has enormous health policy implications. At stake is how we conduct human subjects research, its relationship to clinical care, and whether we can harvest the potential health benefits to individuals flowing from research without unduly burdening that research effort. Susan M. Wolf, J.D., who has led NIH-funded work on these issues, will use multiple research methods to generate a groundbreaking book, as well as journal articles on the public health, public policy, legal, and ethical implications. This project promises to shape public policy and research practice by asking what researchers owe individual research participants and how research findings can translate appropriately into clinical care.