NIH Data Management and Sharing Policy

While the NIH expects that researchers will attempt to maximize scientific data sharing in their DMS Plans, they acknowledge that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Investigators are required to still follow federal regulations for the protection of human research participants, other NIH expectations for the use and sharing of scientific data derived from human participants as well as any other applicable laws, regulations, statutes, guidance or institutional policies related to research with human participants and the protection of participant privacy. 

For research on human subjects, the NIH encourages award recipients to:

• Address data management and sharing issues during the informed consent process to ensure prospective participants understand how their data will be managed and shared.
• Outline steps investigators will take to protect the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification, Certificates of Confidentiality, and other protective measures).
• Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing data.
• Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing through controlled access may be specific by certain funding opportunity announcements of the funding NIH Institutes or Centers. 

Informed Consent and Data Sharing

The NIH has released informed consent resources which provide suggested language to include in informed consent documents regarding the storage and sharing of research data for future use. Though specific informed consent language is not required in DMS Plans, it is important to consider what may be included in the informed consent form (ICF) for your study when developing your DMS Plan. NYU Langone Institutional Review Board (IRB)’s template language includes the following areas you may need to address:

• Time frame for data and biospecimen storage
• Who will manage control of and access to data and biospecimens or if data will be made available without restrictions
• Whether identifiers will be retained and the likelihood of re-identification
• Whether sharing data and biospecimens will be optional
• What happens when consent is withdrawn
• Associated risks and benefits of storing and sharing data and biospecimens 
• Potential commercial uses or applications that may result from stored and shared data and biospecimens

Please Keep in Mind:

• The sample language provided by the NIH is generic. The NYU Langone IRB will be releasing standard language by January 2023.
• The sample language is intended to be incorporated in to the main informed consent document, not to replace or serve as a separate document, and its use does not obviate the need for IRB review of the ICF and study protocol.
• The NYU Langone IRB will provide sample template language that will distinguish between the sharing of data and of biospecimens. Participants may feel differently about the storage and sharing of each data type, and you might consider allowing participants to consent separately to each.

All informed consent elements above should also be described in the study protocol.

How does the 2023 DMS Policy impact research proposals that are also subject to the Genomic Data Sharing (GDS) Policy?

The NIH is working on harmonizing the requirements of the DMS and GDS policies. To that end, after January 25, 2023, the NIH will not collect separate GDS Plans and GDS Plans will no longer be reviewed by peer reviewers. Genomic data sharing considerations should be described in DMS Plans using the DMS Plan elements and will be reviewed by NIH Program Staff. Compliance and enforcement for research funded by awards that are subject to the GDS Policy will be handled in accordance with the DMS Policy. More details can be found in NIH notices NOT-OD-22-198 and NOT-OD-22-029.

Some scientific data generated with NIH funds may be proprietary. The NIH has provided guidance on proprietary data for the following groups: 

SBIR and STTR Awardees

Some data generated with NIH funds may be proprietary. Under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive (effective May 2019), SBIR and STTR awardees may without applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals. SBIR and STTR awardees are still expected to submit a DMS Plan per new policy requirements. 

Investigators co-funded by the private sector

For research co-funded by the private sector (for example, the pharmaceutical or biotechnology industries), the extent of data sharing may be limited by restrictions imposed by licensing limitations attached to materials needed to conduct research. The NIH suggests that applicants should discuss projects with proposed collaborators early to avoid agreements that prohibit or unnecessarily restrict data sharing. NIH staff will evaluate the justifications of investigators who believe that they are unable to share data.