Document Type
Article
Publication Title
Vanderbilt Law Review
Publication Date
Summer 2009
ISSN
0042-2533
Page Number
219
Keywords
social change, literature and society, sociological jurisprudence
Disciplines
Health Law and Policy | Law | Medical Jurisprudence
Abstract
Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem - how should incidental find- ings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant's physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require? An IF is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conduct- ing research but is beyond the aims of the study. This means that IFs may be on variables not directly under study and may not be anticipated in the research protocol.
Recommended Citation
Ellen Wright Clayton, Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, and et al.,
Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 37 Vanderbilt Law Review. 219
(2009)
Available at: https://scholarship.law.vanderbilt.edu/faculty-publications/1682