Development of a consent resource for genomic data sharing in the clinical setting.
Genet Med. 2019 01;21(1):81-88
Authors: Riggs ER, Azzariti DR, Niehaus A, Goehringer SR, Ramos EM, Rodriguez LL, Knoppers B, Rehm HL, Martin CL, Clinical Genome Resource Education Working Group
PURPOSE: Data sharing between clinicians, laboratories, and patients is essential for improvements in genomic medicine, but obtaining consent for individual-level data sharing is often hindered by a lack of time and resources. To address this issue, the Clinical Genome Resource (ClinGen) developed tools to facilitate consent, including a one-page consent form and online supplemental video with information on key topics, such as risks and benefits of data sharing.
METHODS: To determine whether the consent form and video accurately conveyed key data sharing concepts, we surveyed 5,162 members of the general public. We measured comprehension at baseline, after reading the form and watching the video. Additionally, we assessed participants’ attitudes toward genomic data sharing.
RESULTS: Participants’ performance on comprehension questions significantly improved over baseline after reading the form and continued to improve after watching the video.
CONCLUSION: Results suggest reading the form alone provided participants with important knowledge regarding broad data sharing, and watching the video allowed for broader comprehension. These materials are now available at http://www.clinicalgenome.org/share . These resources will provide patients a straightforward way to share their genetic and health information, and improve the scientific community’s access to data generated through routine healthcare.
PMID: 29899502 [PubMed – indexed for MEDLINE]