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J Pers Med. 2018 Jan 3;8(1). pii: E2. doi: 10.3390/jpm8010002.

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

Author information

1
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN 55905, USA. rlfossey@yahoo.com.
2
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN 55905, USA. kochan.david@mayo.edu.
3
Center for Individualized Medicine and Department of Medical Genomics, Mayo Clinic, Rochester, MN 55905, USA. winkler.Erin2@mayo.edu.
4
Department of Health Sciences Research, Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN 55905, USA. pacyna.joel@mayo.edu.
5
Department of Health Sciences Research, Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN 55905, USA. olsonj@mayo.edu.
6
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN 55905, USA. sthibodeau@mayo.edu.
7
The Children's Hospital of Philadelphia, Center for Applied Genomics, Philadelphia, PA 19104, USA. ConnollyJ1@email.chop.edu.
8
The Children's Hospital of Philadelphia, Center for Applied Genomics, Philadelphia, PA 19104, USA. harrm@email.chop.edu.
9
The Children's Hospital of Philadelphia, Center for Applied Genomics, Philadelphia, PA 19104, USA. behrm@email.chop.edu.
10
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. Cindy.Prows@cchmc.org.
11
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. Beth.Cobb@cchmc.org.
12
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. Melanie.Myers@cchmc.org.
13
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. Nancy.Leslie@cchmc.org.
14
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. bahram.namjou@cchmc.org.
15
Department of Medicine, Division of Nephrology, Columbia University Medical Center, New York, NY 10027, USA. hm2673@cumc.columbia.edu.
16
Department of Pediatrics, Columbia University Medical Center, New York, NY 10032, USA. jw2500@cumc.columbia.edu.
17
Irving Institute for Clinical and Translational Research, Columbia University Medical Center, New York, NY 10032, USA. avf2117@cumc.columbia.edu.
18
Departments of Pediatrics and Medicine, Columbia University Medical Center, New York, NY 10032, USA. wkc15@cumc.columbia.edu.
19
Department of Medicine, Division of Nephrology, Columbia University Medical Center, New York, NY 10027, USA. ag2239@cumc.columbia.edu.
20
Genomic Medicine Institute, Geisinger, Danville, PA 17822, USA. jlwilliams3@geisinger.edu.
21
Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA. lspais@bwh.harvard.edu.
22
Boston Children's Hospital, Boston, MA 02115, USA. Ingrid.Holm@childrens.harvard.edu.
23
Center for Genetic Medicine, Northwestern University, Chicago, IL 60611, USA. s-aufox@northwestern.edu.
24
Center for Genetic Medicine, Northwestern University, Chicago, IL 60611, USA. m-smith6@northwestern.edu.
25
Kaiser Permanente, Seattle, WA 98101, USA. scrol.a@ghc.org.
26
Kaiser Permanente, Seattle, WA 98101, USA. leppig.k@ghc.org.
27
Division of Medical Genetics, University of Washington, Seattle, WA 98195, USA. gjarvik@medicine.washington.edu.
28
Department of Medicine, Division of Genomic Medicine, Vanderbilt University Medical Center, Nashville, TN 37212, USA. georgia.wiesner@vanderbilt.edu.
29
National Human Genome Research Institute, Rockville, MD 20892, USA. lir2@mail.nih.gov.
30
Department of Medicine, Vanderbilt University Medical Center, Nashville, TN 37203, USA. mary.stroud@Vanderbilt.edu.
31
Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA 02114, USA. jsmoller@partners.org.
32
Department of Health Sciences Research, Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN 55905, USA. Sharp.Richard@mayo.edu.
33
Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN 55905, USA. kullo.iftikhar@mayo.edu.

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.

KEYWORDS:

Institutional Review Board; electronic health Record; genome sequencing; informed consent; return of results

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