The NIH Genomic Data Sharing Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of the data for subsequent research. The policy ensures the broad and responsible sharing of genomic research data. Under this policy, an Institutional Certification outlining the data sharing provisions in an NIH-funded study must be provided by the Authorized Institutional Official(s) of the submitting institution, prior to the award of funding.
An Institutional Certification ensures that the plans for submission of large-scale human genomic data to the NIH meet the expectations of the Genomic Data Sharing Policy. This certification must be provided to the funding Institute or Center prior to award and accompany the submission of data to NIH Database of Genotypes and Phenotypes (dbGaP).
A Provisional Institutional Certification may be issued for a prospective study when the IRB has not yet completed its review of the protocol and cannot attest to all of the elements of the formal Institutional Certification.