30 Pages Posted: 8 Dec 2010 Last revised: 6 Feb 2014
Date Written: June 2, 2008
Tremendous debate surrounds the question of whether researchers owe back to human subjects information about incidental findings of potential clinical and reproductive importance to the individual. Historically, law, ethics, and practice have drawn a bright line between the duties of clinicians and the duties of researchers, imposing on researchers no duty to return information of clinical importance. Indeed, bioethics and health law are built on a dichotomy between clinical care (the domain of the doctor-patient relationship) and research (the domain of the researcher-subject relationship). Yet the debate over whether researchers have any duty to return incidental findings (and the related debate over whether they have a duty to return individual research results) challenges that fundamental dichotomy.
This article offers analysis and recommendations from a two-year project funded by the National Institutes of Health (NIH) and led by Susan M. Wolf (Principal Investigator) to determine how to manage incidental findings (IFs) in human subjects research, focusing on genetic and genomic research, with comparison to imaging research. This is the first national project funded by NIH on this issue. IFs are defined as findings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. IFs are frequently discovered in conducting research and can hold life-and-death importance (as when researchers stumble upon a genetic variant predicting life-threatening response to a commonly used anesthetic). The article argues that researchers have an obligation to address the possibility of discovering IFs and articulate how IFs will be managed. This information should be reflected in the researcher’s protocol and communications with the IRB, as well as in consent forms and communications with research participants. The article recommends a pathway for researchers to follow in addressing IFs. It categorizes IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.
This is the first comprehensive analysis and major set of recommendations on how to handle incidental findings in human subjects research including genomic research. It is the centerpiece of a symposium issue including sixteen articles from a multidisciplinary group of top scholars on this pressing issue.
Keywords: incidental findings, human subjects research, bioethics, health law
Suggested Citation: Suggested Citation
Wolf, Susan M. and Lawrenz, PhD, Frances P. and Nelson, Charles A. and Kahn, Jeffrey P. and Cho, Mildred K. and Wright Clayton, Ellen and Fletcher, Joel G. and Georgieff, Michael K. and Hammerschmidt, Dale and Hudson, Kathy and Illes, Judy and Kapur, Vivek and Keane, M.A., Moira and Koenig, Barbara and LeRoy, Bonnie and McFarland, Elizabeth and Paradise, Jordan and Parker, Lisa and Terry, Sharon and Van Ness, Brian and Wilfond, Benjamin, Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations (June 2, 2008). Journal of Law, Medicine and Ethics, Vol. 36, No. 2, pp. 219-248, 2008. Available at SSRN: https://ssrn.com/abstract=1721782