Managing Incidental Findings in Human Subjects Research

Principal investigator(s)

  • Susan M. Wolf, JD (Consortium on Law and Values in Health, Environment & the Life Sciences)

Co-Investigators

  • Jeff Kahn, MPH, PhD (Center for Bioethics)
  • Frances Lawrenz, PhD (Dept. of Educational Psychology)
  • Charles Nelson, PhD (Children's Hospital Boston and Harvard University)

This project, led by researchers at the University of Minnesota collaborating with a working group of prominent national scholars, tackled how researchers should handle incidental findings identified during research. Incidental findings are defined as unexpected findings beyond the domain of key interest in the research that have potential clinical significance, such as a suspicious mass revealed in a functional MRI (fMRI) study or an incidental finding of non-paternity 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

  • symposium on "Managing Incidental Findings in Human Subjects Research" published in the Journal of Law, Medicine & Ethics, Summer 2008;
  • Publication of the empirical analysis;
  • Publication of the consensus report;
  • public conference on "Managing Incidental Findings in Human Subjects Research: From Imaging to Genomics" held on May 1, 2007.