Genomic Data Sharing Policy

Whenever possible, NHGRI strongly encourages studies involving human data to use data generated from sources with participant consent for unrestricted access or for general research uses through controlled access. Similarly, consent language should avoid restrictions on the types of users who may access the data. NHGRI acknowledges that this 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.

When the policy applies

NHGRI encourages sharing of all data types. However, at this time the NIH GDS Policy and NHGRI implementation plans apply particularly 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.

Examples of projects subject to GDS Policy

Examples of research or research-related activities funded or supported by NHGRI that are outside the scope of the NIH GDS Policy include, but are not limited to, projects that do not meet the criteria specified in the NIH GDS Policy Supplemental Information.

Per the NIH GDS Policy, NHGRI will consider requests for exceptions to standard data sharing plan expectations. When consistent with program priorities, NHGRI may accept well-justified data sharing plans that do not include broad data sharing or that include more narrow data use limitations for future research.

Basic criteria that NHGRI will use to assess exception requests include an IRB or equivalent determination that informed consent materials preclude broad data sharing, or an IRB assessment that there are additional participant protection concerns related to the nature or character of the study population (e.g., geographical location or small study designs focused on a rare disease).

Investigators may also submit a justification within a data sharing plan demonstrating that data sharing costs (e.g., financial or personnel resources) outweigh the potential for broad scientific value of access to the data.

In all cases where alternative data sharing plans are determined to be appropriate, information on how to request access to the data and a basic summary of the study and study data will be listed in dbGaP (or other appropriate NIH-designated data repository). Timelines for data submission and access under alternative data sharing plans should be consistent with those for standard data sharing under the NIH GDS Policy.

Information about any additional elements to consider in requesting exceptions from data deposition in NIH-designated data repositories will be added to this page as they are developed

Per the NIH GDS Policy, informed consent documents for prospective data collection after January 25, 2015 should state what data types will be shared (e.g., genomic, phenotype, health information, etc.), for what purposes (e.g., general research use, disease-specific research use, etc.), and whether sharing will occur through open (unrestricted) or controlled access databases (or an approved alternative sharing plan). This and other information that NIH expects to be conveyed in documents obtaining explicit consent for future research use and broad data sharing are defined in the NIH Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy. These expectations also apply to data to be produced from cell lines or clinically derived samples if generated after January 25, 2015.

Once again, whenever possible, NHGRI strongly encourages studies involving human data to use data generated from sources with participant consent for unrestricted access or for general research uses through controlled access. Similarly, consent language should avoid restrictions on the types of users who may access the data. NHGRI acknowledges that this 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. 

For research involving samples collected prior to January 25, 2015, NHGRI recognizes that informed consent processes may not have explicitly anticipated future broad data sharing or research use. In these instances, submitting institutions should assure that the future research use and data sharing plans are not inconsistent with the informed consent provided by study participants. Relevant issues to consider in these situations are reviewed in the NIH Points to Consider for Institutions and IRBs (part 2, page 2) regarding genomic data sharing. Please note that NIH will be updating this document.

If established or commercially available cell lines or clinical specimens created prior to January 25, 2015, are included as data sources in a study, investigators should seek whenever possible to use samples where consent for future research use and data sharing can be documented.

If established or commercially available cell lines or clinical specimens created prior to January 25, 2015, are included as data sources in a study, investigators should seek whenever possible to use samples where consent for future research use and data sharing can be documented.

For guidance in following the expectations surrounding Informed Consent under GDS Policy, refer to the following diagram:

NIH and NHGRI acknowledge that broad data sharing may not always be appropriate. In these instances, investigators should request an exception from data deposition (M, 1-4) in an NIH-designated data repository prior to initiating research activities, if appropriate samples with broader data sharing consent are not available. Exceptions from data deposition should be justified through a data sharing plan submitted with the funding request (see Data Sharing Plans).

Similarly, there may be cases involving cell lines or specimens collected after January 25, 2015, where requesting explicit consent for future research use and broad data sharing was not possible but where there are compelling scientific reasons to conduct the research with those data sources. In those cases, and consistent with any NIH guidance issued, an exception from obtaining explicit consent may be requested from NHGRI in a data sharing plan.

For more information, refer to the "Exceptions to the Policy" section above.

By January 25, 2020, NHGRI expects that all human data used by NHGRI-funded or -supported research will be generated from specimens or cell lines for which explicit consent for future research use and broad data sharing can be documented. This NHGRI expectation which goes beyond the basic NIH expectation with regard to grandfathered data sources. Research proposing to use samples lacking such consent should be accompanied by an alternative data sharing plan supported by a compelling scientific reason for using the specified data sources. Exceptions to this expectation will continue to be granted when there is a compelling scientific reason, as provided for in the NIH GDS Policy.

For more in-depth discussion of principles and best practices for drafting informed consent documents for genomics research, see the NHGRI Informed Consent Resource.

Investigators can access human genomic data through a tiered model of unrestricted- and controlled-data access mechanisms. Data stored in NIH-designated data repositories (e.g. NIH database of Genotypes and Phenotypes (dbGaP), Sequence Read Archive (SRA), or NIH Established Trusted Partnerships, such as the National Cancer Institute's Genomic Data Commons) are submitted and accessed under the principles and procedures outlined in the NIH Genomic Data Sharing (GDS) Policy.

Access requests for specific research purposes using controlled-access data are reviewed by NIH Data Access Committees (DACs). A listing of DACs and DAC Chairs can be found here. The NHGRI DAC Chair can be reached via email or by phone at the contact information found here. Investigators are asked to refer to the NIH extramural data access flowchart for information on the process of requesting access. Requesters are expected to adhere to the Genomic Data Users Code of Conduct. The NIH Position Statement on Cloud Computing provides direction for those utilizing cloud computing services for storage and analysis of controlled-access data.