NHGRI-Specific GDS Policy

Data Types

NHGRI encourages sharing of all genomic data and data types including, but not limited to, single nucleotide polymorphism (SNP) array data, genome sequence data, transcriptomic data, epigenomic data, or other molecular data produced by array-based technologies or high-throughput sequencing technologies.

Data pertinent to the interpretation of genomic data—such as associated phenotype data (e.g., clinical information relevant to the disease under study), exposure data, and descriptive information (e.g., protocols or methodologies used) — are expected to be shared. All data sets should include the appropriate metadata to allow efficient sharing and integration with other data sets.

Amount of Data/Type of Study Design

NHGRI finds value in and encourages the sharing of smaller project sizes that do not meet the definition of ‘large-scale’ according to the NIH guidance regarding scope of the GDS Policy. Investigators should consult with appropriate NHGRI Program Directors as early as possible to determine whether the GDS Policy applies to their research study.

NHGRI expects that all human data generated by NHGRI-funded or -supported research will be derived from specimens or cell lines for which explicit consent for future research use and broad data sharing can be documented. The NHGRI expectation goes beyond the expectation of the NIH GDS Policy. While the NIH GDS Policy does not require explicit consent for future use and broad data sharing when specimens or cell lines were created or collected before January 25, 2015, NHGRI’s expectation contains no such grandfather clause.

NHGRI determined it was most appropriate to encourage the genomics community to use data sources that are explicitly consented for future research use and broad data sharing whenever possible to increase transparency with researchers and participants and promote consistent data sharing expectations across genomics studies. It is important to note that exceptions to the consent expectation will continue to be granted on a case-by-case basis when there is a compelling scientific justification.

Which NHGRI grant mechanisms will be affected?  

This expectation for explicit consent applies to all grant mechanisms for all applications submitted on or after the January 25, 2021 receipt date. NHGRI Intramural projects initiated after January 25, 2021 are also expected to comply. 

How can I request an exception? What must a request include?

The need for an exception should be documented in the Data Management and Sharing (DMS) Plan of the grant application. At Just-in-Time, applicants should also submit the template for Requesting an Exception for Samples Lacking Explicit Consent for Future Research Use and Broad Data Sharing. (See the “How to Register Controlled-Access Studies” section)

Requests for exceptions should include the name of the specimen or cell line and a scientific justification for requesting the exception. For example, the research will replace or augment existing data from specimens or cell lines that are highly studied; or the research requires benchmarking of significantly improved, modified protocols generated using existing, standardized cell lines or specimens. If these reasons do not apply, an explanation as to why other existing resources or new samples with the appropriate consent cannot be obtained or used, and an explanation as to why the proposed specimen or cell line uniquely addresses the needs of the field should be provided (1-2 paragraphs). 

Who reviews and grants exceptions?

Requests for exceptions are reviewed by the NHGRI Genomic Program Administrator (GPA), in consultation with the Data Sharing Governance Committee and relevant Program Director as needed.  

What is the timeline for reviewing requests for exceptions? Can I appeal a decision to deny use of a proposed human specimen or cell line which lacks explicit consent?

Once the request is received by the GPA, it will take no more than one month for the Governance Committee to reach a decision and notify the applicant. 

If an exception request is denied, the request can be revised with additional information regarding the unique scientific value of the proposed specimen or cell line and re-reviewed by NHGRI. In this case, it may take up to an additional two weeks to complete the review process.

Data sharing plans for NHGRI-funded or -supported projects to generate non-human genomic data proposed after January 25, 2016 should include pre-publication timelines for data submission and release consistent with NIH GDS Policy expectations for human genomic data (including a possible holding period before data release not to exceed six months).

Progress on data sharing should be documented in annual research performance progress reports (RPRR) and NHGRI consortia reporting mechanisms, as applicable. Program directors will monitor progress according to the timelines established through the data sharing plans.

This expectation is consistent with the institute’s program priorities as it makes data available for access at the earliest appropriate point to promote maximum public benefit from federal investment in genomics research. As a leader in GDS Policy development and implementation, NHGRI supports timely data release through widely accessible data repositories.

NHGRI acknowledges that conforming with these two expectations will not always be possible or appropriate. In addition, individual participants who do not consent to future use or broad data sharing may still participate in the primary study, if consistent with study design.

Broad consent is an approach to obtaining consent that permits current and future access and use of samples or data for research without necessarily specifying what the focus of such studies might be. Consent for broad data sharing is specific to the sharing of data and indicates that data can be shared with others, often through data repositories (which can be open-access or controlled-access). Broad data sharing does not preclude the ability of participants to limit the future use of the data (e.g., data can only be used for cancer research). Per the GDS Policy, data submission and subsequent data sharing for research purposes must be consistent with the informed consent of study participants from whom the data were obtained.

‘General Research Use’ or GRU is an example of the broadest standard NIH consent group option for controlled-access data. Under GRU, use of data is limited only by the terms of the Data Use Certification. As a reminder, NHGRI supports the broadest appropriate genomic data sharing with timely data release through widely accessible data repositories.

For a discussion of considerations in developing informed consent processes for genomics research, see the NHGRI Informed Consent Resource and the section on Special Considerations for Genomics Research.

An NIH-designated data repository is any data repository maintained or supported by NIH either directly or through collaboration. In January of 2019, the NHGRI Analysis, Visualization, and Informatics Lab-Space (AnVIL) became an NHGRI-designated data repository. Currently, this does not change the process for submitting data to the NHGRI.

Per the NIH GDS Policy, submitting investigators and their institutions may request removal of data on individual participants from NIH-designated data repositories in the event that a research participant withdraws or changes his or her informed consent preferences. If a participant withdraws or changes his or her informed consent preferences, data are removed from any future data releases and a new version of the dataset is released. It’s important to know that some data that have been distributed for research cannot be retrieved.

The NHGRI Informed Consent Resource’s ‘Required Elements of the Consent Form’ webpage contains considerations and sample language that addresses the practical limits on the ability of participants to withdraw samples, genomic data, or health information that have been contributed to genomics research that can be useful to include when drafting informed consent documents.