Preparing for the 2023 Data Management and Sharing Policy

Sharing scientific data has been a priority for NIH for decades — data sharing accelerates biomedical research discovery and innovation, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies. Ultimately, sharing data speeds up the process of turning research results into knowledge, products, and procedures to improve human health.
The NIH Data Management and Sharing (DMS) Policy was released October 29, 2020 and will take effect on January 25, 2023. Specifically, this date applies to:

• Competing grant applications submitted to NIH on or after January 25, 2023
• Proposals for contracts that are submitted to NIH on or after January 25, 2023
• NIH Intramural Research Projects conducted on or after January 25, 2023
• Other funding agreements (e.g., Other Transactions) that are executed on or after January 25, 2023, unless otherwise stipulated by NIH.

Under the NIH DMS Policy, NIH expects researchers to maximize the appropriate sharing of scientific data, and consider legal, ethical, or technical issues that may limit the extent of data sharing and preservation. All applicants planning to generate scientific data must prepare a DMS Plan that describes how the data will be managed and shared.
You can find a sample draft of a DMS Plan here.
Individuals receiving NIH funding to generate scientific data must comply with the DMS Policy. This compliance level differs from the 2003 DMS Policy: Previously, only awards totaling $500,000 per year or more had to comply with the policy. Be sure to check out the complete list of NIH activity codes subject to the DMS Policy, as well as the specific funding opportunity announcement to determine if the DMS Policy applies to an application.

• Scientific data includes any data needed to validate and replicate research findings, regardless of whether it is used to support scholarly publications.
• Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.

After scientific data has been collected, investigators should use an established repository to maximize the sharing of that data, including those found on this comprehensive list of NIH-supported data repositories. If no data repository is specified by NIH, researchers should select a data repository that is appropriate for the data generated from the research project. Be sure to review repositories for key considerations to keep in mind when selecting a repository.
Although NIH encourages sharing scientific data to the greatest degree possible, health care data often includes electronic health records (EHRs) and other identifiable information about patients that requires additional protections. For more information on the protection of human research subjects, please read 45 CFR 46.
Many NIH-funded investigators who collect scientific data work with outside institutions, funding agencies, or collaborators that have different data management and sharing guidelines. In these cases, these NIH award recipients need to make sure that their collaborating research partners comply with the NIH DMS Policy.
Although all researchers are encouraged to share their scientific data, there are a few reasons for limiting data sharing:

• The data submission is not consistent with applicable national, tribal, and state laws and regulations as well as relevant institutional policies
• Data limitations on the research use of the data, as expressed in the informed consent documents
• The identities of research participants would be disclosed to NIH-designated data repositories.
• An Institutional Review Board (IRB), and/or Privacy Board, and/or equivalent body, as applicable, has reviewed the investigator's proposal for data submission and will not assure that:
  • The protocol for the data is consistent with 45 CFR Part 46;
  • Data submission and subsequent data sharing for research purposes are not consistent with the informed consent of study participants from whom the data were obtained;
  • Consideration was not given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing,
  • To the extent relevant and possible, consideration was not given to risks to groups or populations associated with submitting data to NIH-designated data repositories and subsequent sharing,
  • The investigator’s plan for de-identifying datasets is not consistent with the DHHS and NIH standards and expectations.

Data sharing is not new and has been a part of the fabric of NIH-funded research projects for decades. However, if noncompliance becomes an issue for any NIH-funded research projects, the NIH Institutes, Centers, and Offices may add special terms and conditions or terminate award funding.
Several NIH Institutes and Centers have developed guidelines and FAQs for their grantees:

• NIGMS recently issued a feedback loop blog post,
• NCI developed guidance for their grantees,
• NIA released data sharing resources for their researchers and NIA data sharing guidelines,
• NIAID issued guidance for contracts under the DMS Policy,
• NICHD’s Office of Data Science and Sharing compiled a list of DMS Policy resources for their staff and researchers,
• NIDCR answered DMS Policy FAQs, and
• NINDS provided an interpretation of the NIH Genomic Data Sharing Policy and NINDS researcher guidance.

A comprehensive list of data sharing policies from NIH Institutes and Centers can be found here.
On behalf of NIH and ODSS, I am excited to see how the new DMS Policy will accelerate biomedical research discovery and the improvement of human health around the world.