An institutional certification may be required if you plan to submit data and/or samples to a large database or repository for broad sharing with the research community. This requirement is most commonly triggered by the NIH’s genomic data sharing (GDS) policy. Scholarly journals may also require data sharing that could require an institutional certification. The purpose of an institutional certification is to verify that the collection of the data and/or samples was consistent with legal and ethical requirements. This includes an evaluation that informed consent for sharing and use of the data and/or samples was obtained from the research participant. While the certification process is completed by the IRB, the Institutional Official that has been designated the responsibility for certifications will serve as the final signatory.
A certification is not required for every database or a repository. If you are unsure of whether a certification is required, you should reach out to your program officer or the entity that manages the database or repository that will receive the data and/or samples.
Institutional Certification Request Forms
Institutional Certification Request Form
Institutional Certification Request Spreadsheet
Resources
Institutional Certifications (NIH)
NIH Genomic Data Sharing Policy
Content current as of 10/5/2022