DMS Human Research Considerations

Researchers may be required and/or plan to share data they obtain as part of their human research study. For example, some federal agencies that fund the research study may require data sharing as a term and condition of the award.  For more information, please visit the MSU Human Research Protection Program (HRPP) Data Management and Sharing webpage.  For information specific to NIH human subjects research, please see the MSU HRPP’s NIH Data Management and Sharing webpage.

Supplemental information and guidance regarding NIH requirements:

• 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.
• 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.  It 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.
• 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.
• 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.