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J. Pers. Med. 2018, 8(1), 2; https://doi.org/10.3390/jpm8010002

Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience

1
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN 55905, USA
2
Center for Individualized Medicine and Department of Medical Genomics, Mayo Clinic, Rochester, MN 55905, USA
3
Department of Health Sciences Research, Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN 55905, USA
4
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA
5
The Children’s Hospital of Philadelphia, Center for Applied Genomics, Philadelphia, PA 19104, USA
6
Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 45229, USA
7
Department of Medicine, Division of Nephrology, Columbia University Medical Center, New York, NY 10027, USA
8
Department of Pediatrics, Columbia University Medical Center, New York, NY 10032, USA
9
Irving Institute for Clinical and Translational Research, Columbia University Medical Center, New York, NY 10032, USA
10
Departments of Pediatrics and Medicine, Columbia University Medical Center, New York, NY 10032, USA
11
Genomic Medicine Institute, Geisinger, Danville, PA 17822, USA
12
Brigham and Women’s Hospital and Harvard Medical School, Boston, MA 02115, USA
13
Boston Children’s Hospital, Boston, MA 02115, USA
14
Center for Genetic Medicine, Northwestern University, Chicago, IL 60611, USA
15
Kaiser Permanente, Seattle, WA 98101, USA
16
Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA
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Department of Medicine, Division of Genomic Medicine, Vanderbilt University Medical Center, Nashville, TN 37212, USA
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National Human Genome Research Institute, Rockville, MD 20892, USA
19
Department of Medicine, Vanderbilt University Medical Center, Nashville, TN 37203, USA
20
Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA 02114, USA
*
Author to whom correspondence should be addressed.
Received: 6 November 2017 / Revised: 19 December 2017 / Accepted: 20 December 2017 / Published: 3 January 2018
Full-Text   |   PDF [232 KB, uploaded 3 January 2018]

Abstract

We examined the Institutional Review Board (IRB) process at 9 academic institutions in the electronic Medical Records and Genomics (eMERGE) Network, for proposed electronic health record-based genomic medicine studies, to identify common questions and concerns. Sequencing of 109 disease related genes and genotyping of 14 actionable variants is being performed in ~28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study participants. We examined each site’s research protocols, informed-consent materials, and interactions with IRB staff. Research staff at each site completed questionnaires regarding their IRB interactions. The time to prepare protocols for IRB submission, number of revisions and time to approval ranged from 10–261 days, 0–11, and 11–90 days, respectively. IRB recommendations related to the readability of informed consent materials, specifying the full range of potential risks, providing options for receiving limited results or withdrawal, sharing of information with family members, and establishing the mechanisms to answer participant questions. IRBs reviewing studies that involve the return of results from genomic sequencing have a diverse array of concerns, and anticipating these concerns can help investigators to more effectively engage IRBs. View Full-Text
Keywords: Institutional Review Board; return of results; electronic health Record; informed consent; genome sequencing Institutional Review Board; return of results; electronic health Record; informed consent; genome sequencing
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).
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Fossey, R.; Kochan, D.; Winkler, E.; Pacyna, J.E.; Olson, J.; Thibodeau, S.; Connolly, J.J.; Harr, M.; Behr, M.A.; Prows, C.A.; Cobb, B.; Myers, M.F.; Leslie, N.D.; Namjou-Khales, B.; Milo Rasouly, H.; Wynn, J.; Fedotov, A.; Chung, W.K.; Gharavi, A.; Williams, J.L.; Pais, L.; Holm, I.; Aufox, S.; Smith, M.E.; Scrol, A.; Leppig, K.; Jarvik, G.P.; Wiesner, G.L.; Li, R.; Stroud, M.; Smoller, J.W.; Sharp, R.R.; Kullo, I.J. Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience. J. Pers. Med. 2018, 8, 2.

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