@article{ee5118148a5e4b74a9252febd555d154,
title = "Ethical considerations related to return of results from genomic medicine projects: The eMERGE network (phase III) experience",
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{\textquoteright}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 = "Electronic health record, Genome sequencing, Informed consent, Institutional Review Board, Return of results",
author = "Robyn Fossey and David Kochan and Erin Winkler and Pacyna, {Joel E.} and Janet Olson and Stephen Thibodeau and Connolly, {John J.} and Margaret Harr and Behr, {Meckenzie A.} and Prows, {Cynthia A.} and Beth Cobb and Myers, {Melanie F.} and Leslie, {Nancy D.} and Bahram Namjou-Khales and Rasouly, {Hila Milo} and Julia Wynn and Alexander Fedotov and Chung, {Wendy K.} and Ali Gharavi and Williams, {Janet L.} and Lynn Pais and Ingrid Holm and Sharon Aufox and Smith, {Maureen E.} and Aaron Scrol and Kathleen Leppig and Jarvik, {Gail P.} and Wiesner, {Georgia L.} and Rongling Li and Mary Stroud and Smoller, {Jordan W.} and Sharp, {Richard R.} and Kullo, {Iftikhar J.}",
note = "Funding Information: Acknowledgments: The eMERGE Network was initiated and funded by NHGRI through the following grants: Phase III: U01HG8657 (Group Health Cooperative/University of Washington); U01HG8685 (Brigham and Women{\textquoteright}s Hospital); U01HG8672 (Vanderbilt University Medical Center); U01HG8666 (Cincinnati Children{\textquoteright}s Hospital Medical Center); U01HG6379 (Mayo Clinic); U01HG8679 (Geisinger Clinic); U01HG8680 (Columbia University Health Sciences); U01HG8684 (Children{\textquoteright}s Hospital of Philadelphia); U01HG8673 (Northwestern University); U01HG8701 (Vanderbilt University Medical Center serving as the Coordinating Center); U01HG8676 (Partners HealthCare/Broad Institute); and U01HG8664 (Baylor College of Medicine). Publisher Copyright: {\textcopyright} 2018 by the authors. Licensee MDPI, Basel, Switzerland.",
year = "2018",
month = mar,
doi = "10.3390/jpm8010002",
language = "English (US)",
volume = "8",
journal = "Journal of Personalized Medicine",
issn = "2075-4426",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "1",
}