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 Genomic Data Sharing Policy (examples of research within the scope of the GDS Policy can be found in the Supplemental Information to the Policy). An Institutional Certification must accompany the submission of all large-scale human data to the NIH Database of Genotypes and Phenotypes (dbGaP). The Institutional Certification (for sharing human data), should also be provided to the funding NIH Institute or Center prior to award, along with any other Just in Time information (for extramural researchers) or at the time of scientific review (for intramural researchers).
Institutions should work with the Genomic Program Administrator (GPA) from the funding NIH Institute or Center to register the study and submit data to the database of Genotypes and Phenotypes (dbGaP).
* Update: an Institutional Signing Official is now the signatory on the Extramural Institutional Certification form. Per the NIH GDS Policy, An Institutional Signing Official is generally a senior official at an institution who is credentialed through the NIH eRA Commons system and is authorized to enter the institution into a legally binding contract and sign on behalf of an investigator who has submitted data or a data access request to NIH. Please contact your GPA with any questions about this update.*
- For Studies Using Data Generated from Cell Lines Created or Clinical Specimens Collected AFTER January 25, 2015
- For Studies Using Data Generated from Cell Lines Created or Clinical Specimens Collected BEFORE January 25, 2015
- Provisional Institutional Certification – to be used in a situation such as for a prospective study where the IRB has not completed its review of the protocol and therefore the institution cannot attest to all of the elements of the formal Institutional Certification
NIH Intramural Investigators
- For Studies Using Data Generated from Cell Lines Created or Clinical Specimens Collected AFTER August 31, 2015
- For Studies Using Data Generated from Cell Lines Created or Clinical Specimens Collected BEFORE August 31,2015