Managing incidental findings in human subjects research: Analysis and recommendations

Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van NessBenjamin S. Wilfond

Research output: Contribution to journalArticle

488 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)219-248
Number of pages30
JournalJournal of Law, Medicine and Ethics
Volume36
Issue number2
DOIs
StatePublished - Jun 2008

ASJC Scopus subject areas

  • Issues, ethics and legal aspects
  • Health Policy

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    Wolf, S. M., Lawrenz, F. P., Nelson, C. A., Kahn, J. P., Cho, M. K., Clayton, E. W., Fletcher, J. G., Georgieff, M. K., Hammerschmidt, D., Hudson, K., Illes, J., Kapur, V., Keane, M. A., Koenig, B. A., LeRoy, B. S., McFarland, E. G., Paradise, J., Parker, L. S., Terry, S. F., ... Wilfond, B. S. (2008). Managing incidental findings in human subjects research: Analysis and recommendations. Journal of Law, Medicine and Ethics, 36(2), 219-248. https://doi.org/10.1111/j.1748-720X.2008.00266.x