Ethical considerations related to return of results from genomic medicine projects: The eMERGE network (phase III) experience

Robyn Fossey, David Kochan, Erin Winkler, Joel E. Pacyna, Janet E Olson, Stephen N Thibodeau, John J. Connolly, Margaret Harr, Meckenzie A. Behr, Cynthia A. Prows, Beth Cobb, Melanie F. Myers, Nancy D. Leslie, Bahram Namjou-Khales, Hila Milo Rasouly, Julia Wynn, Alexander Fedotov, Wendy K. Chung, Ali Gharavi, Janet L. WilliamsLynn Pais, Ingrid Holm, Sharon Aufox, Maureen E. Smith, Aaron Scrol, Kathleen Leppig, Gail P. Jarvik, Georgia L. Wiesner, Rongling Li, Mary Stroud, Jordan W. Smoller, Richard R Sharp, Iftikhar Jan Kullo

Research output: Contribution to journalArticle

16 Scopus citations

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.

Original languageEnglish (US)
Article number2
JournalJournal of Personalized Medicine
Volume8
Issue number1
DOIs
StatePublished - Mar 1 2018

Keywords

  • Electronic health record
  • Genome sequencing
  • Informed consent
  • Institutional Review Board
  • Return of results

ASJC Scopus subject areas

  • Medicine (miscellaneous)

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    Fossey, R., Kochan, D., Winkler, E., Pacyna, J. E., Olson, J. E., Thibodeau, S. N., Connolly, J. J., Harr, M., Behr, M. A., Prows, C. A., Cobb, B., Myers, M. F., Leslie, N. D., Namjou-Khales, B., Rasouly, H. M., Wynn, J., Fedotov, A., Chung, W. K., Gharavi, A., ... Kullo, I. J. (2018). Ethical considerations related to return of results from genomic medicine projects: The eMERGE network (phase III) experience. Journal of Personalized Medicine, 8(1), [2]. https://doi.org/10.3390/jpm8010002