NIH Data Management and Sharing

Effective January 25, 2023, the Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) went into effect. This policy requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan (DMS Plan). Upon U.S. National Institutes of Health (NIH) approval of a DMS Plan, NIH expects researchers and institutions to implement data management and sharing practices as described in the DMS Plan. The Final NIH Policy is intended to establish expectations for DMS Plans, which applicable NIH Institutes, Centers and Offices (ICO) may supplement as appropriate. 

For more information and additional MSU resources, please visit the MSU Sponsored Programs Administration's Data Management webpage. 

Human Research Considerations

Researchers proposing to generate scientific data derived from human participants should outline in their DMS Plans how privacy, rights, and confidentiality of human research participants will be protected (e.g., through de-identification, Certificates of Confidentiality, and other protective measures).

NIH strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared.

Researchers should consider whether access to scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use.

The following sections include supplemental information and guidance regarding NIH requirements.

• Elements of an NIH Data Management and Sharing Plan

  The Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014) outlines elements to be addressed in a DMS Plan. 

  This document includes “Access, Distribution, or Reuse Considerations” related to human research, such as describing any applicable factors related to:

  • Informed consent

  • Privacy and confidentiality protections

  • Controlled or uncontrolled access

  • Restrictions

  • Any other considerations that may limit data sharing

  For more information and to view the full text of the document, please visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-014.html

• Protecting Privacy When Sharing Human Research Participant Data

  The Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (NOT-OD-22-213 ) assists researchers in addressing privacy considerations when sharing human research participant data.

  This supplmental information includes:

  • Operational principles for protecting participant privacy when sharing scientific data

  • Best practices for protecting participant privacy when sharing scientific data

  • Points to consider for choosing whether to designate scientific data for controlled access

  Operational principles for protecting participant privacy when sharing scientific data include:

  • Proactive assessment of protections

  • Clear communication of data sharing and use in consent forms

  • Consideration of justifiable limitations to sharing data

  • Institutional review of the conditions for data sharing

  • Protections for all data used in research

  • Remaining vigilant regarding data misuse

  Best practices for protecting participant privacy when sharing scientific data include:

  • Apply appropriate de-identification

  • Establish scientific data sharing and use agreements

  • Understand and communicate legal protections against disclosure and misuse

  The document provides points to consider for choosing whether to designate scientific data for controlled or uncontrolled access.

  Researchers should consider controlled access if data:

  • Have explicit limitations on subsequent use

  • Could be considered sensitive

  • Cannot be de-identified

  • Due to previously unanticipated approaches or technologies that become known, pose risks to participant privacy if released without controls on access

  Researchers should consider uncontrolled (open) access if:

  • Participants explicitly consent to share scientific data openly without restrictions

  • Scientific data are de-identified and institutional review has determined that they pose very low risk when shared and used, including any risks posed by the presence of information that can allow inferences to be made about a participant’s identity when combined with other information

  For more information and to view the full text of the document, please visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-213.html

• Informed Consent for Secondary Research with Data and Biospecimens

  The Informed Consent for Secondary Research with Data and Biospecimens: Points to Consider and Sample Language for Future Use and/or Sharing (May 2022) is a voluntary resource provided by NIH related to informed consent for future use and/or sharing.

  This document provides points to consider and sample informed consent language.

  This document does not address approval for use of the data in new research studies outside the scope of the primary protocol and consent.

  Please keep in mind that the consent process and language is dependent upon the specific circumstances of the research project.

  For more information and to view the full text of the document, please visit: https://osp.od.nih.gov/wp-content/uploads/Informed-Consent-Resource-for-Secondary-Research-with-Data-and-Biospecimens.pdf

• Responsible Management and Sharing of American Indian/ Alaska Native Participant Data

  The Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/ Alaska Native Participant Data (NOT-OD-22-214) describes considerations and best practices for the responsible and respectful management and sharing of American Indian and Alaska Native (AI/AN) participant data under the DMS Policy. This document was developed in response to Tribal Nations’ input received through Tribal Consultation and public comments from AI/AN organizations and community members, researchers, institutions, data providers and users, research participants, infrastructure developers, and others to further promote culturally respectful and effective research partnerships.

  This document includes considerations for researchers working with Tribal Nations and best practices for researchers.

  Considerations for researchers working with Tribal Nations include:

  • Tribal sovereignty

  • Tribal research laws, regulations, policies, preferences, and processes

  • Historical awareness

  • Health disparities

  Best practices for researchers include:

  • Proactively engage AI/AN Tribes in planning for data management and sharing

  • Establish mutual understandings of goals for data management and sharing

  • Incorporate AI/AN data management and sharing practices and preferences in Plans

  • Consider additional protections and appropriate limitations to future data sharing

  • Incorporate data management and sharing plans in the informed consent process

  • Safeguarding against future risk

  For more information and to view the full text of the document, please visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-214.html

• Genomic Data Sharing

  The Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 (NOT-OD-22-198) informs the research community of intent to establish a single Plan submission requirement for research subject to both the NIH GDS Policy and the NIH DMS Policy.

  The NIH Genomic Data Sharing (GDS) Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data as well as the use of these data for subsequent research. It sets forth expectations that ensure broad and responsible sharing of genomic research data. The responsible Institutional Signing Official of the submitting institution should provide an Institutional Certification to the funding institute or center prior to award consistent with the DMS plan submitted with the request for funding. The information provided in the Institutional Certification must be consistent with the DMS Plan, IRB submission(s), and informed consent.

  Implementation changes related to NIH GDS Policy include:

  • Plans for sharing genomic data as expected by GDS Policy are to be described in DMS Plan submitted at the time of application, and not in a separate GDS Plan or at Just-in-Time

  • After January 25, 2023, NIH will no longer be collecting separate GDS Plans

  • Genomic data sharing considerations, such as where and when genomic data will be shared, will be expected to be addressed in DMS Plans using the DMS Plan elements

  At this time, there is no change to the requirement for the GDS Institutional Certification.

  For more information and to view the full text of the document, please visit: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-198.html

• 2023 Data Management & Sharing Policy FAQs

  The 2023 Data Management & Sharing Policy FAQs (including Considerations for Scientific Data Derived from Human Participants) is an NIH website that includes Frequently Asked Questions (FAQs) related to the new 2023 Data Management and Sharing Policy.

  The FAQs include a section related to Considerations for Scientific Data Derived from Human Participants. It is anticipated that the FAQs will continue to expand. 

  For more information and to view the full text of the document, please visit: https://sharing.nih.gov/faqs#/data-management-and-sharing-policy.htm