Genomic Data Sharing

Genomic Data Submission and Release Guidelines

Studies should follow data submission and release timelines defined in the NIH GDS Policy Supplemental Information and appendix, with the modification that NIAID expects non-human data to be shared similarly to human data:

Data release six months post submission for human and non-human data:

  • Non-human data release will follow the same timelines provided for human data as described in the NIH GDS Policy Supplemental Information and appendix.
  • Unless stipulated by the project’s funding opportunity announcement (FOA), investigators may anticipate a holding period of up to six months following the initiation of data submission or until the time of first publication submission, whichever comes first, before data are released for access by secondary investigators. The holding period will commence after the initiation of data submission.
  • Genomic, phenotypic, and any metadata submissions should be coordinated with program officers and the Genomic Program Administrators (GPAs) for extramural projects or the NIAID GPA directly for intramural research .  This supports timely study registration in dbGaP (or other suitable data repository) and conclusion of data submission before the end of the exclusivity period. 
  • Following any holding period as discussed with the NIAID program staff, data will be released through open or controlled access without restrictions on publication or dissemination of analyses by secondary investigators.
  • Secondary investigators are expected to reference the primary data source.

Unless otherwise specified by project FOAs, analyses that are performed by submitting investigators after initial data submission, final data sets, or any data updates should be submitted for release simultaneously with the initial publication analyzing the dataset.

Submitting the Data

NIAID expects that genomic data from NIAID-funded research will be deposited to NIH repositories and other NIAID-funded or approved repositories. The NCBI Submission Portal provides general guidance for depositing data to NIH data repositories. More specific instructions for data deposit, including data standards, are available for several NIH repositories:

If genomic data will be deposited in an alternative NIAID-approved data repository (such as the NIAID Bioinformatics Resource Centers), investigators should follow the respective guidelines for data deposition.

Genomic Data Sharing Plans for Extramural Investigators

Extramural investigators must submit a GDS plan for large-scale human or non-human data as part of the Resource Sharing Plan in the grant application or contract proposal as defined by the GDS policy. In the cover letter, the investigator should include a statement that informs NIH staff that the research project includes the generation of large-scale human or non-human genomic data and is subject to the GDS policy.

Beginning in January 2023, applicants will provide genomic data sharing information as part of the new Data Management and Sharing Plan, rather than submitting a separate Genomic Data Sharing Plan.  

Peer reviewers will evaluate the GDS plan for consistency with the GDS policy.  

In addition, NIH Program or Contract staff will determine whether the GDS plan is adequate based on the NIH Guidance for Investigators in Developing Data Sharing Plans. Any concerns regarding GDS plans will be resolved prior to making awards.

Genomic Data Sharing Plans for Intramural Investigators

Any intramural project that will generate large-scale human or non-human genomic data must be accompanied by a GDS plan. The scientific director or a delegate the GPA for the specific Division will review the plan at the time the funding decision is made. 

What Should Be Included in the GDS Plan?

Essential items for all GDS plans:

  • Data Type (including sample type, estimated numbers, and relevant metadata)
  • Data Repository (NIH Data Sharing Repositories)
  • Data submission and release timeline

For GDS including human genomic data:

  • Institutional Review Board (IRB) Assurance of GDS plan
  • Appropriate use of data (if necessary as outlined by IRB ruling)
  • Request for an exception to submission (if necessary as outlined in exception guidelines)

Sample Data Sharing Plans and Templates

See Genomic Data Sharing Plan Examples.

Informed Consent for Sharing Genomic Data from Human Samples

All NIAID-funded studies that will generate human subjects’ genomic data should explicitly seek consent for broad sharing of participant data through central data repositories such as dbGaP as well as consent for future research use of samples and data.

Important considerations:

  • Participants may decline broad sharing genomic data.
  • Participants who do not consent to broad data sharing or future use may still participate in the primary study, if consistent with study design.
  • For future research use purposes, whenever possible, studies should seek broad consent for general research use of the samples and consent should not limit the types of users who may access the data.

Find additional information on informed consent in the NIH Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human Genomic Data.

For research studies initiated after the effective date of the NIH GDS policy:

  • Investigators should obtain participants’ consent for their genomic and phenotypic data to be shared broadly and may be used for future research purposes, in an unrestricted- or controlled- access data repository.
  • Even if the samples are de-identified, consent for broad sharing and future research use is required.
  • Consent documents for prospective data collection should state what data will be shared, for what purposes (e.g., general research use, disease-specific research use), and whether sharing will occur through open or controlled-access data repositories (or an alternative sharing plan). Outlines are acceptable.
  • For prospective participant recruitment or re-contact processes, consent documents should state whether data can be withdrawn from collections or data repositories, what information or material can or cannot be withdrawn, and how participants can request withdrawal of their data.

For research studies generating genomic data from cell lines created or clinical specimens collected before implementation of the NIH GDS policy:

  • For studies using specimens or data from specimens that were collected before the effective date of the policy, an assessment by an IRB, privacy board, or equivalent body is needed to ensure that data sharing is consistent with the informed consent provided by the research participant.
  • Consent processes may not have anticipated future broad data sharing.  In these circumstances, review the NIH Points to Consider for Institutions and IRBs about genomic data sharing.
  • If the assessment determines that the standards for broad data sharing have not been met, then the institution should request an exception.
  • if the previously obtained consent for a specific dataset is inconsistent with broad data sharing, but the scientific value of the dataset is such that broad data sharing should be pursued, investigators may request funds may be requested to re-contact participants to seek consent for broad data sharing.
  • Investigators should request an exception for broad data sharing through established NIAID procedures (see below)  for existing samples collected without sufficient consent or for new samples where seeking consent is not feasible. Exceptions must be granted before NIAID funds are committed.

Institutional Certification for Extramural Investigators

NIAID-funded extramural investigators and their institutions that will share human genomic data through public repositories should submit an Institutional Certification with the just-in-time (JIT) documentation prior to the award. Read more at NIAID’s Respond to Pre-Award Requests (“Just-in-Time”).  The Institutional Certification provided by the principal investigator and the institutional signing official, assures that the investigator and the institution planning to submit human genomic data to NIH will meet the expectations of the NIH GDS policy. The certification also clearly delineates any data use limitations (DULs), as expressed in the informed consent documents signed by study participants.

For multicenter studies (with samples collected at several institutions), NIH understands that the submitting institution might not necessarily be the local institution or IRB of record for all sites. However, the submitting investigator and the institution should assure NIH that they, based on either its own review or assurance from other institutions, that the expectations of the GDS policy will be met for the entire dataset. Institutions may choose to collect and submit a single-site certification from each site contributing samples or submit a multi-site certification. Find single and multi-site Institutional Certifications for both intramural and extramural studies.

  • The responsible signing official of the submitting institution should provide an Institutional Certification to NIAID, consistent with the GDS plan submitted.
  • The Institutional Certification should state whether the data will be submitted to an unrestricted- or controlled-access database.

Institutional Certification for Intramural Investigators

Intramural researchers should submit the Institutional Certification to their corresponding NIAID Divisional GPA and scientific director. The Institutional Certification assures that NIAID will meet the expectations of the GDS policy. The certification, provided by the principal investigator, clearly delineates any data use limitations (DULs), as expressed in the informed consent documents signed by study participants. This Institutional certification will also document that the data are appropriate for sharing and consistent with the informed consent of the study participants.  Find single and multi-site Institutional Certifications for both intramural and extramural studies.

Exceptions to the GDS Policy

NIAID recognizes that there may be circumstances where broad sharing of genomic data sets will not be possible or may need to be delayed.  In most cases, NIAID expects that these limitations will be defined in the data sharing plan for the project. However, some limitations may also develop during the course of the research project. NIAID may grant exceptions to the GDS policy on rare occasions. To request an exception, investigators should contact the NIAID program officer or intramural scientific director as early as possible during planning of genomic projects.

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