TY - JOUR
T1 - Managing incidental findings in human subjects research
T2 - Analysis and recommendations
AU - Wolf, Susan M.
AU - Lawrenz, Frances P.
AU - Nelson, Charles A.
AU - Kahn, Jeffrey P.
AU - Cho, Mildred K.
AU - Clayton, Ellen Wright
AU - Fletcher, Joel G.
AU - Georgieff, Michael K.
AU - Hammerschmidt, Dale
AU - Hudson, Kathy
AU - Illes, Judy
AU - Kapur, Vivek
AU - Keane, Moira A.
AU - Koenig, Barbara A.
AU - LeRoy, Bonnie S.
AU - McFarland, Elizabeth G.
AU - Paradise, Jordan
AU - Parker, Lisa S.
AU - Terry, Sharon F.
AU - Van Ness, Brian
AU - Wilfond, Benjamin S.
PY - 2008/6
Y1 - 2008/6
N2 - 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.
AB - 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.
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U2 - 10.1111/j.1748-720X.2008.00266.x
DO - 10.1111/j.1748-720X.2008.00266.x
M3 - Article
C2 - 18547191
AN - SCOPUS:44949211505
SN - 1073-1105
VL - 36
SP - 219
EP - 248
JO - Journal of Law, Medicine and Ethics
JF - Journal of Law, Medicine and Ethics
IS - 2
ER -