Managing Incidental Findings in Human Subjects Research

Principal investigator Susan M. Wolf, JD, University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, in collaboration with co-investigators Jeffrey Kahn, PhD, MPH, Center for Bioethics; Frances Lawrenz, Department of Educational Psychology; and Charles Nelson, Children's Hospital, Harvard University and a working group of prominent national scholars, were awarded a grant from the National Institutes of Health (NIH)/National Human Genome Research Institute (NHGRI) to examine how researchers should handle incidental findings identified during research. Incidental findings are defined as unexpected findings beyond the domain of key interest in research that have potential clinical significance (such as a suspicious mass revealed in a functional MRI (fMRI) study or an incidental finding of nonpaternity in genetic research). What should consent forms say about this, and how should IRBs consider the potential for incidental findings in their review of protocols?

Project outcomes will include:

  • publication of the empirical analysis
  • publication of the consensus report and model consent form language
  • a conference presenting our empirical and normative work
  • papers on incidental findings; management in 4 targeted research areas; and analysis of the legal implications of incidental findings
  • a published symposium in a prominent journal collecting the empirical and narrative reports and the targeted papers
  • a website offering useful tools such as model consent form language and an annotated bibliography with web links