Managing incidental findings in human subjects research: analysis and recommendations.
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.
University of Minnesota, MN, USA.
Susan M
SM
Wolf
Frances P
FP
Lawrenz
Charles A
CA
Nelson
Jeffrey P
JP
Kahn
Mildred K
MK
Cho
Ellen Wright
EW
Clayton
Joel G
JG
Fletcher
Michael K
MK
Georgieff
Dale
D
Hammerschmidt
Kathy
K
Hudson
Judy
J
Illes
Vivek
V
Kapur
Moira A
MA
Keane
Barbara A
BA
Koenig
Bonnie S
BS
Leroy
Elizabeth G
EG
McFarland
Jordan
J
Paradise
Lisa S
LS
Parker
Sharon F
SF
Terry
Brian
B
Van Ness
Benjamin S
BS
Wilfond
D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D023281:Genomics / Q000639:trends*; D006801:Humans; D033162:Incidental Findings; D012017:Referral and Consultation / Q000941:ethics*; D035842:Research Subjects; D014342:Truth Disclosure / Q000941:ethics*