NIH Funded Researchers must use LabArchives at UVA.

Effective July 1, 2025, all NIH federally funded research data related to published work at UVA must either be stored on the LabArchives platform or include a reference to its location if stored elsewhere. While not required if you are not NIH funded, all UVA investigators with federal funding are strongly encouraged to use LabArchives to store or point to a location where your research data is stored.

Requirements to use LabArchives fall under UVA Policy RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records. Specifically, "Electronic research records must be maintained on University-owned and/or University-managed devices, systems, or services which include deposit with external data repositories consistent with sponsor requirements (e.g., NIH Data Management and Sharing Plans). 

Safeguarding must be in accordance with IRM-003: Data Protection of University Information, the applicable data protection standard (i.e., for highly sensitive, sensitive, internal use, or public data), and any associated procedures. Unpublished research records are categorized as “sensitive data” or “highly sensitive data.”

Please note that while LabArchives is HIPAA compliant, UVA has decided that Protected Health Information (PHI) or other highly sensitive data may not be entered or stored in LabArchives at this time. In the future, UVA may consider making allowing HIPAA-protected information/data into the system, but storing PHI and/or other highly sensitive data it is not available at this time.

LabArchives supports compliance with sponsor data management and sharing policies, including the NIH DMSP. By utilizing LabArchives features to organize data, document data types and formats, create metadata for re-use, and store data in a secure location researchers will be better prepared to meet funder requirements. LabArchives supports documentation and management of a Data Management (and Sharing) Plan and allows the upload of plans created using the DMPTool.

For more information about how LabArchives supports key aspects of this requirement, please visit their page about Data Management and Sharing (DMS) Policy.

Minimum Requirements

To comply with new federal requirements , investigators with NIH-funded research must include a page in their LabArchives notebook that either stores the research data or provides the location where the data is stored and maintained (whether electronically or physically).

If your research requires hard copies, you must specify in LabArchives where this information is maintained and stored at the University of Virginia.

We strongly encourage researchers to use the "UVA | Electronic Lab Notebook Cover Page" (available in the UVA | LabArchives Resources site-wide notebook) as a template for the required information. Before accessing the site-wide notebook, users will need to sign-in to their approved account using their Netbadge credentials. 

Please note that this is the minimum requirement for NIH-funded researchers at this time. While it is likely that other federal sponsors are moving in this direction, LabArchives will not be required for data related to other federally-funded awards at this time.

Exceptions

  • Clinical trials are exempt from the LabArchives requirement. While you are welcome to use LabArchives, it is not mandatory at this time.

    • Clinical Trials are defined as "a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes" (per the NIH definition of a clinical trial). 

Classified Research, as well as some other situations may be exempt. If you would like an exception, please contact us. 

Data Repository Guidance (NIH-Funded Projects)

In accordance with an NIH directive issued in March 2025, all data repositories associated with NIH-funded projects must now include the following statement to comply with evolving federal guidelines:

“This repository is under review for potential modification in compliance with Administration directives.”

All NIH-funded researchers at UVA should add this statement to any publicly available (published) pages in LabArchives to ensure compliance with data repository requirements from the NIH. Additionally, this statement should be added to any other data repositories used by NIH-funded researchers at UVA. While not required if you are not NIH funded, all UVA investigators with federal funding are strongly encouraged to add this statement to any publicly available pages as well. 

Public Sharing Policy Update (NIH-Funded Projects)

New NIH Public Access Policy effective July 1, 2025

The National Institutes of Health (NIH) has advanced the implementation date of its updated Public Access Policy from December 31, 2025, to July 1, 2025. All other elements of the policy remain unchanged. It is imperative that researchers understand and comply with the new requirements to avoid jeopardizing their current and future funding opportunities.

This policy mandates that all peer-reviewed manuscripts resulting from NIH-funded research be made immediately and freely accessible to the public via PubMed Central upon publication, eliminating the previous 12-month embargo period.

Starting July 1, 2025, researchers must ensure that their NIH-funded manuscripts are publicly available in PubMed Central at the time of publication. This change applies to all peer-reviewed articles from research funded wholly or partially by the NIH, accepted for publication on or after July 1, 2025. Researchers should plan to submit their manuscripts to PubMed Central immediately upon acceptance to comply with the new policy. It's essential to coordinate with publishers to ensure that publication agreements allow for immediate open access in line with NIH requirements.

Supplemental Guidance on Government Use License and Rights (Notice NOT-OD-25-049) and Supplemental Guidance on Publication Costs (Notice NOT-OD-25-048) will continue to apply. For detailed guidance and support, researchers should consult the NIH Office of Science Policy's Public Access Policy page. You can also see the full timeline of the 2022 OSTP Public Access Policy Memo at the UVA Library website. 

Additional information can also be found on the Health Sciences Library's website. Consultations are available to help support researchers navigating these changes and ensuring compliance with the new NIH policy. Contact the library with questions or to schedule a consultation. 

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UVA Library and the Health Sciences Library

Both libraries have data management specialists who can provide support with creating and implementing Data Management and Data Management and Sharing Plans.  

You can find information about the University Library and the data management support they offer here: https://guides.lib.virginia.edu/RDM/planning 

You can find information about the Health Sciences Library and the data management support they offer here: https://guides.hsl.virginia.edu/nih-dmsp  

Data Repository Resources 

The iTHRIV Research Data Commons is a solution that provides health researchers and data stewards with a single interface to manage, share and use research data (including PHI and other restricted, highly sensitive data) throughout its lifecycle, from initial design and approval through data collection and analysis, and ultimately publication. Integration with other institutional research systems, such as the IRB-HSR database, ensures that data can only be accessed by the appropriate users.

To learn more, please email iTHRIVadmin@uvahealth.org to request a consult for use of the iTHRIV Commons for storage and private sharing of identified patient data with appropriate research team members.