U of Minn. spearheads guidance on incidental findings

When one thinks of byproducts of pharmaceutical research, biomedical waste might be the first thing that comes to mind for most, but an increasing area of concern is the leftover incidental health findings, says Susan Wolf, J.D., who chairs the University of Minnesota’s Consortium on Law and Values in Health, Environment and the Life Sciences.

August24th,2008
Jeffrey Bouley
MINNEAPOLIS—When one thinks of byproducts of pharmaceutical research, biomedical waste might be the first thing that comes to mind for most, but an increasing area of concern is the leftover incidental health findings, says Susan Wolf, J.D., who chairs the University of Minnesota's Consortium on Law and Values in Health, Environment and the Life Sciences. In its summer 2008 issue, the Journal of Law, Medicine & Ethics published a consensus paper that she and a multidisciplinary team of national experts developed to offer the first major guidelines on managing incidental findings in human research.

An incidental finding is an unexpected discovery concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research, but is beyond the aims of the study. Because incidental findings can potentially save lives but also cause alarm, the decision on whether or not to disclose them to research participants has been a longstanding dilemma.

To some degree, that dilemma had been something that could be pushed to the side, but with increasingly powerful technologies, particularly in the area of genomics, more and more "extra" data is being generated, including incidental findings, Wolf notes.

"Incidental findings are an unavoidable byproduct of pharmaceutical and medical research—and in drug discovery and development, they can crop up just as easily in preclinical work or in reviewing archived data as they can in clinical studies," Wolf says. "As methods and technologies become more advanced, we simply cannot ignore the ethical implications of incidental findings, nor the legal implications."

Researchers often stumble upon unexpected findings but have no idea whether to share this information with research participants, Wolf notes, and they have no way of knowing whether the information will prove highly significant or simply be a false alarm.

The University of Minnesota-led effort, a two-year project supported by the National Human Genome Research Institute at the NIH, is the first to truly look at the issue from the perspective of the research subject, Wolf believes.

The project members concluded that it is essential to address the possibility of incidental findings in the consent process. Researchers should set up a process for recognizing them and verifying whether there is indeed a suspicious finding of concern, and they should take steps to validate an incidental finding and confirm its health or reproductive importance before offering the finding to a research participant. Additionally, a re-searcher who lacks the expertise to make this assessment may need to consult with a clinical colleague. 

"This is going to take a lot of time, effort and money, but properly handling incidental findings and sharing those plans with research participants has to become a routine part of planning and budgeting," she says. DDN
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