Managing incidental findings in human subjects research

Article offers first major consensus recommendations for IFs
An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance, is discovered in the course of conducting research, but is beyond the aims of the study. IFs are an increasingly common byproduct of research using powerful technologies that generate "extra" data. Because IFs can potentially save lives but also cause alarm, the decision on whether or not to disclose them to research participants has been a major dilemma. Little guidance currently exists on how to approach this problem. A two-year project supported by the National Human Genome Research Institute at NIH has now published the first major recommendations for how to anticipate and manage IFs in genetic, genomic, and imaging research, suggesting broader application to other research domains. This project, led by Prof. Susan Wolf at the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, involved a multidisciplinary group of leading experts from the U.S. and Canada. The project has published a 17-article symposium including the consensus paper, which appears in the Summer '08 issue of the Journal of Law, Medicine & Ethics.