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

Robyn Fossey, David Kochan, Erin Winkler, Joel Pacyna, Janet Olson, Stephen Thibodeau, John Connolly, Margaret Harr, Meckenzie Behr, Cynthia Prows, Beth Cobb, Melanie Myers (+21 others)
2018 Journal of Personalized Medicine  
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 iñ 28,100 participants from the 9 sites. Pathogenic/likely pathogenic variants in actionable genes are being returned to study
more » ... s. 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.
doi:10.3390/jpm8010002 pmid:29301385 pmcid:PMC5872076 fatcat:ylmuujr7xvalnddxhm57rmyxzm