Title |
Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations
|
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Published in |
The Journal of Law, Medicine & Ethics, January 2021
|
DOI | 10.1111/j.1748-720x.2008.00266.x |
Pubmed ID | |
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 |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Germany | 1 | 17% |
United States | 1 | 17% |
Australia | 1 | 17% |
Poland | 1 | 17% |
United Kingdom | 1 | 17% |
Unknown | 1 | 17% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 5 | 83% |
Practitioners (doctors, other healthcare professionals) | 1 | 17% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 9 | 2% |
Canada | 4 | 1% |
Germany | 2 | <1% |
United Kingdom | 2 | <1% |
Sweden | 1 | <1% |
Australia | 1 | <1% |
Italy | 1 | <1% |
Unknown | 342 | 94% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 72 | 20% |
Student > Ph. D. Student | 53 | 15% |
Student > Master | 46 | 13% |
Other | 33 | 9% |
Student > Bachelor | 30 | 8% |
Other | 76 | 21% |
Unknown | 52 | 14% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 98 | 27% |
Agricultural and Biological Sciences | 40 | 11% |
Social Sciences | 29 | 8% |
Biochemistry, Genetics and Molecular Biology | 25 | 7% |
Psychology | 25 | 7% |
Other | 73 | 20% |
Unknown | 72 | 20% |