Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

Publication Date: June 2008

Publisher: American Society of Law, Medicine & Ethics

Author(s): Charles A. Nelson; Frances P. Lawrenz; Susan M. Wolf

Research Area: Health

Keywords: Incidental findings; Human subjects research

Type: Other

Coverage: United States

Abstract:

No consensus yet exists on how to handle incidental fnd-ings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research.

We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants.

We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed.

In Journal of Law, Medicine & Ethics, Summer 2008, Sec. 1, p.219-248.