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NIH: NIAAA Issues New Data Sharing Guidance Related to Human Subjects

Published April 11, 2022

The National Institutes of Health (NIH) announced new data-sharing guidance related to human subjects that applies to all NIAAA (National Institute on Alcohol Abuse and Alcoholism) grant applications (new and resubmitted) that include human subjects research and all Funding Opportunity Announcements (FOAs) in which NIAAA participates, regardless of the amount of direct costs requested in any year. The policy, however, does not apply to fellowships, SBIRs, STTRs, training, education and conference grants.

NIAAA expects investigators and their institutions to provide plans for submitting grant-related human subjects data to a NIAAA-sponsored data repository, the NIAAA Data Archive (NIAAADA). These plans should be included in a NIAAA Data Archive Data Sharing Plan (NIAAADA DSP) located in the Resource Sharing Plan section of grant applications. Applicants are strongly encouraged to use the NIAAADA DSP template for this purpose. The portion of that plan dealing with data must include: 

  • a brief summary of the assessment schedule
  • a listing of proposed data collection instruments (assessments) that do not currently exist in the NDA (if applicable)
  • the proposed schedule for running the data validation tool once data collection begins

Costs associated with submitting data to the NIAAADA should be included in grant applications. A cost estimation tool for data sharing is available for this purpose. Researchers should use that tool when preparing budgets for applications submitted to NIAAA.

Compliance with the NIAAADA DSP will become a special term and condition in the Notice of Award. The Institutional Certification (for sharing human data) should also be provided prior to award, along with any other Just-in-Time information.

This does not supersede the general NIH Genome Data Sharing Policy. However, it does mandate that the NIAAADA serve as the repository for all genomic data funded by NIAAA unless NIAAA agrees to a different data archive during the negotiation of the terms and conditions of the grant award. 

Please read the NIH notice for complete information.

If you have any questions, please contact the Office of Sponsored Research Services.