On August 27, 2014 the National Institutes of Health
announced its final
Genomic Data Sharing (GDS) Policy. This policy is designed to promote sharing, for research purposes, of large-scale human and non-human genomic data generated from NIH-funded research.
The GDS Policy applies to all competing NIH grant applications and proposals for NIH contracts submitted for the January 25, 2015 deadline and thereafter if the proposed research will generate large-scale human or non-human genomic data or will use these data for subsequent research. In such cases, the GDS Policy applies regardless of the funding level.
Please Note: The following guidance is to assist Principal Investigators at the application stage only. PIs should review additional genomic data sharing requirements at the Just-in-Time (JIT)/post-award stages
provided by NIH. A RAC webpage also is being developed to provide the campus with additional guidance on how to indicate in Phoebe that genomic data sharing will be part of the research as well as procedures for obtaining institutional certification for the sharing of genomic data at the post-award stage.
WHAT RESEARCH PROJECTS ARE AFFECTED BY THIS POLICY?
Examples of large scale genomic research projects that are subject to the GDS Policy are available in
Supplemental Information to the NIH GDS.
The GDS Policy does not apply to:
- Institutional training grants (T32s, T34s, T35s, and TL2s);
- K12 career development awards (KL2s);
- Individual fellowships (Fs);
- Resource grants and contracts (Ss);
- Linked awards derived from previously reviewed applications (KL1, KL2, RL1, RL2, RL5, RL9, TL1, UL1);
- Facilities or coordinating centers funded through related initiatives to provide genotyping, sequencing, or other core services in support of Genome Data Sharing
- Smaller studies (e.g., sequencing the genomes of fewer than 100 human research participants) are generally not subject to this Policy.
APPLICATION REQUIREMENTS
Unless the Funding Opportunity Announcement states otherwise, applicants preparing grant applications are expected to:
- Contact the appropriate NIH Institute or Center (IC) Program Official or Project Officer as early as possible to discuss Genome Data Sharing expectations and timelines that would apply to their proposed research.
- State in the cover letter with the application that the research proposed will generate large-scale human and/or non-human genomic data.
- Include a Genomic Data Sharing plan in the Resource Sharing Plan section of the funding application or proposal. (A more detailed genomic data sharing plan will need to be provided to the funding IC prior to award.)
- Outline in the budget section of their funding application the resources they will need to prepare the data for submission to appropriate repositories. NIH will provide additional guidance on these resources, as necessary.
Note: In situations in which the sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan. Exceptions to NIH expectations for data submission to an NIH-designated data repository will be considered on a case-by-case basis by the NIH.
Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories (e.g.,
dbGaP) as a secondary user to achieve the specific aim(s) of the research proposed in the grant application should briefly address their plans for requesting access to the data and state their intention to abide by the
NIH Genomic Data User Code of Conduct in the Research Plan of the application.
Note: Researchers should be aware that access to these data is dependent on an
approval process that involves the relevant
NIH Data Access Committee(s). Researchers may wish to secure access to the data prior to submitting their application for NIH support. Secondary users of controlled-access data are not expected to deposit their findings into NIH-designated data repositories, unless appropriate.
RESEARCH FUNDED BEFORE THE EFFECTIVE DATE OF THE POLICY
Although the GDS Policy does not apply to research submitted prior to the Policy’s effective date, NIH, nonetheless, strongly encourages investigators to comply with the expectations outlined in the Policy. Investigators should provide an updated genomic data sharing plan to the funding IC in the submission of the research performance progress report. For studies involving human participants that were initiated before the Policy’s effective date and used consents that do not meet the expectations of the GDS Policy, investigators are expected to plan to transition to a consent for future research uses and broad sharing, if possible, particularly for new or additional collections of specimens. There will be reasonable accommodation, determined on a case-by-case basis by the funding IC, for long-term projects ongoing at the time of the Policy’s effective date to come into alignment with NIH’s expectations for consent and data sharing. The goal is to bring these projects into alignment, to the extent possible, in a reasonable timeframe.
QUESTIONS
Investigators with questions about whether the Policy applies to their current or proposed research should consult the relevant Program Official or Program Officer or the IC’s Genomic Program Administrator (GPA).
Names and contact information for GPAs are available through the
NIH GDS website.
August 27, 2014
Research Advocate:
NIH Issues Genomic Data Sharing Policy
