NIH DMS Policy
As of January 25, 2023, the National Institutes of Health (NIH) 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.
To learn more about this policy, please visit:
- The NIH DMS policy homepage
- The UCSF Library's NIH 2023 Data Managment and Sharing Policy page
See the “IRB Submission Requirements” section below for information about how this NIH policy impacts the IRB submission process.
*Go to the library’s FAQs for a definition of “scientific data” under this policy.
UCSF DMS Policies
The UCSF Library has published information and sharing guidelines on Sharing De-identified Data.
DMS Plan Templates
The UCSF Library offers several Data Management and Sharing Plan templates that researchers may download and modify according to the specific research.
IRB Submission Requirements
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. Once you receive your NIH funding and are ready to submit to the IRB, please follow the submission requirements outlined below.
IRB Application & Attachments
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.
Consent Forms
Studies meeting all of the following criteria must include specific language in the consent forms:
- The study receives funding from NIH
- The grant application was submitted to NIH on or after January 25, 2023
- The Data Management and Sharing plan approved by the NIH includes a plan to share scientific data from this study
The IRB consent form templates will be updated to include new instructions and a new statement regarding the NIH DMS policy in the “How will my specimens and information be used?” section. The newly added wording is shown here, in highlight:
How will my specimens and information be used?
[Instructions: (1) Delete the italicized references to “specimens and” if not applicable to this study, and (2) If you are 100% sure that de-identified data will not be shared outside of this study, replace the below statement with the following: “We will use your specimens and information to conduct this study. Specimens and information gathered during this research study will only be used for this study. They will not be shared with other researchers.”]
Researchers will use your specimens and information to do this study. Once the study is done using your specimens and information, we may use [them/it] for other research studies in the future. We may [or “will” (see instructions below)] share [them/it] with other researchers to be used in their studies. We will not share your name or any other information that could identify you. We cannot promise that this will prevent future researchers from figuring out who you are. We will not ask you for additional permission to share this de-identified information.
[Change “may” to “will” in the above statement if all of the following conditions apply: (1) this study receives funding from NIH, (2) the grant application was submitted to NIH on or after January 25, 2023, and (3) the Data Management and Sharing plan approved by the NIH includes a plan to share scientific data from this study. If these conditions apply, please also include the following statement:]
Your research data will be stored in a computer database. Other researchers and companies can use the database to do their own research. There are different types of databases. Some are available to the public. This is called “unrestricted access.” Others require special permission to use. This is called “restricted access.”
It is the UCSF Investigator’s responsibility to ensure that this statement is included in the consent form when needed. The IRB is unable to determine whether the statement is required for a given study, as this depends on the conditions of the NIH grant.
The remainder of the consent form templates meet all recommendations for notifying participants about sharing data per the NIH DMS policy.
Questions
The UCSF Library’s NIH 2023 Data Management and Sharing Policy page includes FAQs about the new policy.
For additional questions, contact UCSF Data Services Librarian [email protected] or [email protected] for help and guidance.