U of M leads research to manage incidental findings in human subjects research

June 30, 2008

Susan Wolf, J.D., professor and chair of the University of Minnesota's Consortium on Law and Values in Health, Environment, & the Life Sciences, led a multidisciplinary team of national experts to develop the first major guidelines on managing incidental findings (IF) in human subjects research which have just been published. The two-year project, supported by the National Human Genome Research Institute at National Institutes of Health, has now issued groundbreaking recommendations for how to anticipate and manage IFs in genetic, genomic, and imaging research, suggesting broader application to other research domains. The project has produced a 17-article symposium including the consensus paper, which appears in the Summer 2008 issue of the Journal of Law, Medicine & Ethics.

An incidental finding (IF) is an unexpected 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. They 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. "Researchers often stumble upon unexpected findings but have no idea whether to share this information with research participants," said Wolf. "The information may prove highly significant or a false alarm. And researchers have traditionally drawn a bright line between their research activity and the clinical care of patients;incidental findings challenge that line."

The project members concluded that it is essential to address the possibility of IFs in the consent process. Researchers should set up a process for recognizing IFs and verifying whether there is indeed a suspicious finding of concern, and they should take steps to validate an IF and confirm its health or reproductive importance before offering the finding to a research participant. Additionally, a researcher who lacks the expertise to make this assessment may need to consult a clinical colleague. The consensus paper also addresses the vexing problem of IFs discovered in reanalysis of archived data.

The consensus article distinguishes among three categories of IFs to determine when they should be disclosed. IFs with strong net benefits--ones revealing a condition likely to be life-threatening or revealing a condition likely to be grave that can be avoided--should be offered to research participants. An IF that offers possible net benefit-one that may offer more benefit than burden to the research participant--may be disclosed at the researcher's discretion. An IF that has unlikely net benefit or whose net benefit cannot be determined should not be offered to the research participant, because disclosure may well present more burden than benefit.

"These guidelines should have an enormous impact," Wolf said. "They should prompt federal authorities, universities, institutional review boards, and researchers to develop strategies for dealing with incidental findings and to discuss the plan with people signing up to participate in research."
The University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences links 17 top centers at the University to address the societal implications of the life sciences and biomedicine. For more information, visit www.lifesci.consortium.edu or call 612-625-0055.

University of Minnesota

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