Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations

Overview

Journal J Law Med Ethics

Publisher Cambridge University Press

Specialties Forensic Sciences
General Medicine
Health Services
Medical Ethics

Date 2008 Jun 13

PMID 18547191

Citations 331

Authors

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 Ness

Benjamin S Wilfond

Affiliations

Soon will be listed here.

Abstract

No consensus yet exists on how to handle incidental findings (IFs) in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are findings 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.

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