2023 NIH Data Management and Sharing Policy (NIH DMS Policy)

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:

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

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

New expedited and full committee studies that are subject to the NIH DMS policy must include specific language in the consent form(s). This is not required for exempt review level studies.

A study is subject to the NIH DMS policy if it meets all of the following criteria:

  1. The study receives funding from NIH
  2. The grant application was submitted to NIH on or after January 25, 2023
  3. The Data Management and Sharing plan approved by the NIH includes a plan to share scientific data from this study

Section 11 of the consent template Companion Document includes the following instructions and statements.

Instructions:

Choose 1 statement from the below options. Do not alter the statements in any way. Almost all studies should use one of the first 4 options. The options vary according to the following study characteristics:

If de-identified study information will never be shared, choose option 5 or 6. This should be very rare.

[Option 1— For studies that use data only (no specimens), and are not subject to NIH’s DMS policy*:]

Researchers will use your information to do this study. Once the study is done, we may use your information for other research studies in the future. We may share it with other researchers to be used in their studies. We will not share your name or 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.

[Option 2— For studies that use data AND specimens, and are not subject to NIH’s DMS policy*:]

Researchers will use your information and specimens to do this study. Once the study is done, we may use your information and specimens for other research studies in the future. We may share them with other researchers to be used in their studies. We will not share your name or 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.

[Option 3— For studies that use data only (no specimens), and which are subject to NIH’s DMS policy*:]

Researchers will use your information to do this study. Once the study is done, we may use your information for other research studies in the future. We will share it with other researchers to be used in their studies. We will not share your name or 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.

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.”

[Option 4— For studies that use data AND specimens, and are subject to NIH’s DMS policy*:]

Researchers will use your information and specimens to do this study. Once the study is done, we may use your information and specimens for other research studies in the future. We will share them with other researchers to be used in their studies. We will not share your name or 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.

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.”

[Option 5— For studies using data only. Only use if you are 100% sure that de-identified data will never be shared or used outside of this study:]

We will use your information to conduct this study. Information gathered during this research study will only be used for this study. They will not be shared with other researchers.

[Option 6—For studies using data and specimens. Only use if you are 100% sure that de-identified data will never be shared or used outside of this study:]

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.

Note: 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.

Last updated: November 21, 2023