NIA Data Management and Sharing Guidance
On January 25, 2023 NIH’s new Final NIH Policy for Data Management and Sharing will take effect, replacing the 2003 NIH Data Sharing Policy. The policy requires NIH-funded researchers to submit a plan prior to award that outlines how scientific data from their research will be managed and shared. Upon approval, the plan becomes part of the terms and conditions of the grant award. To support implementation of the policy, NIH institutes and centers may provide institute-specific guidance, such as identifying preferred data sharing resources that are supported by the institute.
NIH has separate policies on Genomic Data Sharing and Model Organism Sharing that fall under the umbrella of the larger NIH Data Management and Sharing Policy. NIA developed the Alzheimer’s Disease Genomics Sharing Plan that provides specific genomic data sharing guidance to NIA grantees conducting ADRD research. For research related to these areas, investigators are advised to follow the appropriate policy. For all other NIA-funded research, follow the NIA-specific data sharing guidance outlined on this page.
NIA-Specific Guidance on Data Management and Sharing
Under the new NIH Policy almost all competing NIH awards will require a sharing plan that must be approved by the program officer prior to award. Intramural research is also required to have a Data Management and Sharing Plan.
NIA encourages data management and data sharing practices consistent with the FAIR (findable, accessible, interoperable, and re-usable) data principles. NIA requires all six elements identified in the NIH policy to be addressed in the data management and sharing plan, these include:
- Data type
- Related tools, software, and/or code
- Data preservation, access, and associated timelines
- Access, distribution, and reuse considerations
- Oversight of data management and sharing
Investigators should include funds for sharing as part of the competing application budget. Costs for data curation, deidentification, reconsenting, and other efforts related to data sharing can be substantial. Learn more about Allowable Costs for Data Management and Sharing and ensure that all possible costs are considered in proposed budgetsTo identify suitable repositories, investigators should consult the listing of biomedical data sharing resources curated by the National Library of Medicine and contact their NIA program officer for assistance.
Data management and sharing plans for NIA research may need to address different issues based on the type of study or data collected.
- Studies collecting human data must address issues related to consent and privacy.
- Consent forms: Institutional Review Board approved consent forms need to contain language that will allow the broadest possible sharing of deidentified data to investigators unaffiliated with the parent study. The language should avoid undue restrictions on sharing and be consistent with the data-sharing plan prepared for NIA.
- Protecting privacy: The NIH Policy element on Access, Distribution, or Reuse Considerations discusses the need to de-identify data when making them available for broad sharing. Some of the challenges to deidentifying data include software that can reconstruct faces from brain images or the possibility of re-identifying individuals by combining research data with administrative data. NIA expects data management and sharing plans to certify that no attempt will be made to reidentify participants from deidentified data.
- Longitudinal studies: Longitudinal studies present additional challenges in deidentification as a consistent record of participant identity must be maintained through multiple waves of data collection. In addition, participants may have been recruited using prior versions of consent forms that did not allow broad sharing. Data management and sharing plans should acknowledge instances where this might arise and indicate how potential issues may be mitigated (e.g., coding procedures, reconsenting participants, etc.).I
- Oversight of the DMS Plan: The approved DMS plan will become part of the terms and conditions of the grant award. TNIA staff will consider progress in sharing as part of the review of progress during an award. Lack of progress in sharing is a reason to consider delaying, restricting, or reconsidering approval of the next year of support. For renewal applications, prior progress in sharing will be a factor in considering whether to accept the application.
There are a variety of resources investigators may leverage to develop their data management and sharing plan, including their institutional data librarians. You may also explore:
- DMPtool: Find templates for NIH data sharing policy and genomic data sharing policy.
- NIA’s data sharing resources for researchers: Explore NIA-funded repositories and knowledge portals where you can submit and access data.
- Inside NIA Blog: Read recent blog posts from NIA staff on data sharing
If you have any questions, please contact your program officer.