Susan M. Wolf J.D.

McKnight Presidential Professor of Law, Medicine and Public Policy
Faegre Baker Daniels Professor of Law
Professor of Medicine
University of Minnesota
Email: swolf@umn.edu Discipline: Law Expertise: Bioethics, Genetics

Investigator Award

Translating Research Into Health Benefits: Returning Research Results & Incidental Findings
Award Year: 2011 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.

Background

Susan Wolf is the McKnight Presidential Professor of Law, Medicine & Public Policy, Faegre Baker Daniels Professor of Law, and professor of medicine at the University of Minnesota, and a faculty member in the University's Center for Bioethics. She is also founding chair of the University's Consortium on Law and Values in Health, Environment & the Life Sciences and founding director of the University's joint degree program in Law, Health & the Life Sciences. She received her A.B. summa cum laude from Princeton University and her J.D. from Yale Law School, with graduate work at Harvard University. Professor Wolf is an elected member of the National Academy of Sciences' Institute of Medicine (IOM); an elected fellow of the American Association for the Advancement of Science (AAAS); an elected fellow of The Hastings Center; a past-member (elected) of the American Society for Bioethics and Humanities (ASBH) Board of Directors; and former chair of the Association of American Law Schools' (AALS) Section on Law, Medicine and Health Care. She has served on a variety of governmental and institutional panels, including the IOM Committee for Review of the Appropriate Use of the Armed Forces Institute of Pathology's (AFIP's) Tissue Repository, American Bar Association (ABA) Coordinating Group on Bioethics and the Law, American Society for Reproductive Medicine (ASRM) Ethics Committee, New York City AIDS Review Panel, and Memorial Sloan-Kettering Cancer Center Ethics Committee. Professor Wolf has received numerous grants to support her work, including from the National Institutes of Health (NIH), National Science Foundation (NSF), and Greenwall Foundation. She has served as principal investigator (PI) on several funded projects focusing on return of results and incidental findings: "Managing Incidental Findings in Human Subjects Research" (NIH/NHGRI #1-R01-HG003178), "Managing Incidental Findings and Research Results in Genomic Biobanks & Archives", and "Disclosing Genomic Incidental Findings in a Cancer Biobank: An ELSI Experiment" (with Barbara Koenig (UCSF) and Gloria Petersen (Mayo Clinic), PIs). She is author or coauthor of over 100 articles and chapters, including in the New England Journal of Medicine; JAMA; Science; American Journal of Public Health; Hastings Center Report; Kennedy Institute of Ethics Journal; Journal of Law, Medicine & Ethics; law reviews; and other publications. She writes on a range of issues in health care, biomedical research, and oversight of emerging technologies.