Background
The NIH GDS policy requires the submission of large-scale genomic data, as well as relevant associated data, to an NIH-designated data repository. The policy became effective January 2015 and expands the scope of the original 2007 policy that was specific to genome-wide association studies (GWAS) studies. The GDS policy applies to all NIH-funded research that generates large-scale genomic data, as well as the use of these data for subsequent research. Examples of large-scale genomic data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, metagenomic, epigenomic, and gene expression data.
Institutions are responsible for assuring, through an institutional certification, that plans for the submission of large-scale human genomic data to the NIH meet the expectations of the GDS policy. An Institutional Certification must accompany the submission of all large-scale human data to the NIH repository. Investigators are responsible for requesting this institutional certification from the IRB prior to the sharing of any data with the federal repository.
Investigators are responsible for ensuring that any specimens obtained that were originally collected on or after January 25, 2015, were collected with consent for broad sharing of genetic results, and that any specimens obtained under a waiver of consent or with consent that does not address broad sharing of results were obtained before January 25, 2015. This includes residual specimens as well as specimens obtained from a biobank or other source.
How do I know if the NIH GDS policy applies to my study?
If a study is NIH-funded and involves the creation of large-scale genomic data, the GDS policy applies. The policy requires that investigators provide a basic genomic data sharing plan in the Resource Sharing Plan section of grant applications at the time of submission. A more detailed plan should be provided prior to award. The Institutional Certification also should be provided prior to award, when possible. Guidance on genomic data sharing plans is available on the NIH GDS website.
If researchers are unclear whether the GDS policy applies to their study, they are encouraged to consult with their NIH program officer.
Requests for institutional certification may be submitted at the time of initial review, or, for already approved studies, as a full change of protocol. In either case, the investigator must provide certain information including details about when specimens were obtained and whether there was consent for broad sharing of information in order for the IRB to evaluate the request, along with a template certification letter. The NIH provides several single-site and multicenter template institutional certification forms depending upon when specimens were originally collected, which can be found at https://sharing.nih.gov/genomic-data-sharing-policy/institutional-certifications/completing-an-institutional-certification-form.
Study teams are responsible for identifying the correct certification template letter and providing the letter with applicable fields filled out to the IRB with the request for certification. Investigators who have been awarded grants through the NIH grant program should use the appropriate extramural template. Submit any documentation required in the supplemental information section of the IRB application. For additional information see: