NIH Genomic Data Sharing (GDS) Certification The GDS Policy applies to all National Institutes of Health (NIH) funded research that generates large-scale human or nonhuman genomic data and of these data for subsequent research. If your research involves large-scale genomic data and the NIH is funding it through a grant, contract, or cooperative agreement, you must comply with the policy. Large-scale data include: Contact your NIH Program Officer as early as possible to discuss data-sharing expectations and timelines for a proposed study. OVPRS and IRB Roles Under the GDS Policy, individuals who provided the samples for the research must know that the research will use their samples for genetic and genomic research. They must also know that researchers will share data from the research broadly for secondary research. The IRB and institutions must certify that the consent document adequately informed research participants. Consent Form Requirements The Institutional Review Board (IRB) and institution must also consider whether sharing the data will place individuals at risk because they are part of: Investigator Requirements
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