Data Management and Sharing

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 and additional MSU resources about data management and sharing, please visit the MSU Sponsored Programs Administration's Data Management webpage. 

Data Management and Sharing Plan

If a data management and sharing plan is required by the study sponsor, researchers should follow the sponsor’s requirements for development of the plan. If a researcher will or may share their data, even if sharing is not required, they should develop a data management and sharing plan. Any data management and sharing plan should be submitted with any related Institutional Review Board (IRB) submissions.

Consistency

If there is a data management and sharing plan, researchers will need to assure that the plan is consistent with any related IRB submission(s) and consent processes and document(s). For example, if the plan describes privacy and confidentiality provisions, that description needs to be consistent with the IRB submission and what is described in the consent document(s) related to privacy and confidentiality.

During the IRB submission’s review, changes may be requested or required that impact the data management and sharing plan. If those changes create inconsistencies in the data management and sharing plan, the plan should be updated following any required sponsor processes.

Consent

Unless consent will not be obtained, the consent process and document(s) should explain whether the data collected in the research study will be shared. If there are plans to share the data, the participant or their legally authorized representative should consent to the sharing of their data. If the study sponsor requires data sharing (and the study has not been granted an exception to the requirement to share the data), the consent cannot indicate that the data will not be shared.

Researchers should carefully consider informed consent language and its impact on data sharing, such as:

• Is data sharing required?
• Could any consent language limit researchers’ ability to share data?
• Is the consent information consistent with the DMS Plan and IRB submission?

U.S. National Institutes of Health

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

For more information about human research considerations related to the NIH data management and sharing requirements, please visit the MSU HRPP Data Management and Sharing: National Institutes of Health webpage.