May 25, 2023
NATIONAL INSTITUTES OF HEALTH (NIH)
This Notice describes minor updates to NIH Institutional Certification forms and instructions for completing those forms, which are required for submission of human genomic data subject to the NIH Genomic Data Sharing (GDS) Policy. The Institutional Certification form assures NIH that submission of large-scale human genomic data and subsequent sharing for research purposes to an NIH-designated data repository is consistent with applicable laws, regulations and institutional policies, the informed consent of research participants from whom data was obtained, and that risks to participants and others have been considered.
Updates have been made to the Institutional Certification forms to add clarifying questions and to request additional information related to applicability of Certificates of Confidentiality (CoC) to data described in the forms.
The updated Institutional Certification forms have a new OMB approved expiration date of March 31, 2026, and will be marked as “Ver 03/23”. Effective July 1, 2023, only requests submitted with an Institutional Certification form marked “Ver. 03/23” or later will be accepted. Requests submitted on prior versions will be rejected. The Institutional Certification must be submitted and accepted before the award can be issued.
This notice does not change the Institutional Certification form submission process (e.g., Institutional Certifications for data associated with grant applications will continue to be submitted using the standard Just-in-Time process.)