NIH 2023 Data Management and Sharing Policy: What you Need to Know

In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized Data Management and Sharing (DMS) policy, effective January 25, 2023. The policy is fundamentally intended to promote and expedite the “translation of research results into knowledge, products, and procedures to improve human health.”

The NIH data sharing principles are not new. Twenty years ago, the NIH released a policy statement on sharing research data, affirming their longstanding support for sharing NIH-funded research data with the public. The policy statement supported reusing existing scientific data and accessibility of high value datasets for use in future research studies.  

What is the 2023 NIH Data Management and Sharing Policy?

The current DMS policy establishes investigator and institutional requirements for creating, submitting, and ultimately complying with approved DMS plans.  

The new policy applies to scientific data generated from NIH-funded or conducted research. DMS plans will be a required component of all NIH funding applications and a condition of successful funding.   

The specific methods for managing or sharing data are not mandated in the policy because of the different types of scientific research the NIH supports. Rather, the DMS policy places an emphasis on following good data management practices and maximizing scientific data sharing with justified limitations or exceptions. These methods should be enacted in ways that are mindful of participant rights and interests as well as preserving public trust.  

What is Expected of Investigators and Institutions?

Under the DMS policy, NIH expects investigators and institutions will: 

• Create a DMS plan and budget for the management and sharing of data 
• Submit the DMS plan for review when applying for NIH funding 
• Comply with the approved DMS plan 

For educational purposes, NIH has provided nine sample DMS plans to assist grant applicants.    

Do the Different NIH Institutes, Centers, or Funding Opportunities Data Sharing Policies Also Apply?  

Yes. Many institutes, centers, and research programs have instituted additional specific data sharing policies that will also apply to certain funding opportunities. 

The DMS policy establishes the foundation for NIH’s data management and sharing expectations. If another applicable policy has more detailed expectations than what the DMS policy has, organizations should follow those expectations in addition to the DMS policy. 

For example, the Genomic Data Sharing Policy applies to NIH-funded research generating large-scale human or non-human genomic data. Such research is expected to be registered in the database of Genotypes and Phenotypes (dbGaP) and submitted to an NIH-designated repository.    

Additional data sharing policies are listed in the NIH table here.  

Researchers should pay close attention to the notice of funding opportunity, as it may also specify additional data sharing requirements or expectations to include in the application.   

Are Investigators and Institutions Expected to Share all Data?

No. Sharing is limited to scientific data, which is defined in the policy as:   

“The recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.” 

Not all data generated in a research study will constitute “scientific data.” Researchers are not expected to share data that are not necessary to, or not of sufficient quality to, validate and replicate the research findings. This includes documentation used to support research data, such as notebooks, lab specimens, case report forms, draft papers, and peer reviews.  

Further, there may be limitations on, or exceptions to, what scientific data can be shared. 

What are Examples of Data Sharing Limitations or Exceptions?

Not all scientific data may be appropriate to share based on ethical, legal, or technical factors. Decisions not to share may be determined by factors like: 

• Informed consent(s) include limitations on sharing or the scope of sharing and future use 
• Research participants’ privacy or safety would be compromised, or they may be placed at greater risk of re-identification or suffering harm if the data was shared (even with a Certificate of Confidentiality) 
• Explicit federal, state, local, or Tribal law*; regulation; or policy prohibits disclosure 
• Restrictions may be imposed by other agreements (e.g., with third party funders or licensing limitations attached to materials needed to conduct the research) 
• Datasets cannot practicably be formatted in a way enabling sharing without reasonable efforts 

*Note: The NIH has proposed additional considerations when with working with Native Tribes in the draft supplemental information on Responsible Management and Sharing of American Indian/Alaskan Native Participant Data. 

What Does This Mean for IRB Review?

The new policy does not assign a specific role for institutional review boards (IRBs). Nonetheless, the new policy could impact IRBs in different ways. 

The role of IRBs located in institutions (also known as local IRBs) varies by organization. IRBs may be asked to assist the institution in developing general guidelines for DMS plans, or to participate in pre-review of proposed DMS plans prior to NIH funding application. These reviews should keep an eye toward balancing the positives of data sharing with protecting the rights and interests of the participants in the research protocols the IRB oversees.   

More generally, both local and central IRBs may be asked to review language in consent forms describing the data sharing plans associated with particular studies. For this reason, IRBs may wish to request access to DMS plans themselves. Additionally, sites and sponsors should consider including DMS plans in the research protocols or otherwise facilitating their availability for IRBs.   

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