Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

Abstract:     
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.

Number of Pages in PDF File: 30

Keywords: incidental findings, human subjects research, bioethics, health law

Accepted Paper Series