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:
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:
Please Keep in Mind:
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.