IRB Guidance and Consent Form Language re: 2023 NIH Data Management and Sharing Plan Policy

As mentioned in previous announcements (July and December), the National Institutes of Health (NIH) now requires all researchers seeking grant funds that result in the generation of scientific data to submit a Data Management and Sharing (DMS) plan as a condition of funding. This policy applies to grant applications submitted to the NIH on or after January 25, 2023.

This policy has minimal impact on IRB submission requirements.

  • There are no changes to the IRB application regarding this NIH policy
  • You do not need to submit the NIH DMS plan with your IRB submission
  • Studies subject to the policy must include an additional statement in the consent form

In preparation, we have developed a 2023 NIH Data Management and Sharing Policy page with policy resources and consent form guidance for researchers.

As it takes several months for grants to be awarded by the NIH, the IRB does not expect to receive IRB applications for studies subject to this policy until Summer/Fall 2023. Our consent form templates will be updated with new instructions and language regarding the NIH DMS policy in the coming months. We will issue a separate announcement when the templates are ready.


Questions about the IRB website guidance and consent form language: Please ask the IRB by submitting an Ask Andy request.

Questions about the NIH Policy and/or Data Management Sharing Plans: Visit the UCSF library’s NIH DMS Policy webpage or contact Data Services Librarian Ariel Deardorff at [email protected].