Note: After the effective date of the NIH DMS Policy, investigators will indicate an Alternative Data Sharing Plan or a request for an exception to the NHGRI expectation for explicit consent in their DMS Plan rather than in the Resource Sharing Plan.
For information on NIH’s genomic data sharing requirements, see the Genomic Data Sharing Policy webpage. For more on NHGRI’s expectations, see below.
Applicability of the Genomic Data Sharing Policy
The NIH Genomic Data Sharing (GDS) Policy (NOT-OD-14-124) and NHGRI’s implementation of the policy applies particularly to single nucleotide polymorphism (SNP) array data, genome sequence data, transcriptomic data, epigenomic data or other molecular data produced by array-based or high-throughput sequencing technologies.
NHGRI's Expectation Under the Policy
NHGRI values 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. See the Notice of Plans for NHGRI Implementation of NIH Genomic Data Sharing Policy (NOT-HG-20-011 and NOT-HG-15-038) for more information about NHGRI’s expectations for genomic data sharing.
Informed Consent Requirements
Per the NIH GDS Policy, for studies that started after January 25, 2015 (the NIH GDS Policy effective date), informed consent documents for prospective data collection should state what data types will be shared (e.g., genomic, phenotype, health information) and for what purposes (e.g., general research use, disease-specific research use) and whether sharing will occur through open (unrestricted) or controlled-access databases.
Information that NIH expects to be conveyed in informed consent documents 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.
For more in-depth discussion of principles and best practices for drafting informed consent documents for genomics research, see the NHGRI Informed Consent Resource.
NHGRI's Expectations Under the Policy
- NHGRI strongly encourages studies that propose to derive genomic data from human specimens and cell lines to obtain participant consent either for general research use through controlled access or for unrestricted access. Similarly, consent language should avoid both restrictions on the types of users who may access the data and restrictions that add additional requirements to the access request process. NHGRI acknowledges that this will not always be possible or appropriate. In addition, individual participants who do not consent to future research use or broad sharing of their data (i.e., submission of their data to a publicly accessible data repository) may still participate in the primary study if consistent with study design.
- As of January 25, 2021, NHGRI expects that all human data generated by NHGRI-funded or supported research will be derived from biospecimens or cell lines for which explicit consent for future research use and broad data sharing can be documented. This NHGRI expectation goes beyond those of the NIH GDS Policy; 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, but NHGRI’s expectation contains no such clause. Research that proposes to use specimens and cell lines that lack explicit consent for future research use and broad data sharing should be accompanied by a request for an exception that describes the scientific reason(s) for using the specified data sources.
The need for an exception should be documented in the Resource Sharing Plan of the grant application. Requests for exceptions should be submitted via Part VI (“Request for an Exception for Samples Lacking Explicit Consent for Future Research Use and Broad Data Sharing”) of the NHGRI Genomic Data Sharing Plan (GDSP) template. (See the “How to Register Controlled-Access Studies” section).
For more information on the explicit consent requirement, visit our FAQ.
Alternatives to the GDS Expectations
When consistent with program priorities, NHGRI may accept well-justified data sharing plans that:
- Are unable to deposit genomic data in an NIH-designated data repository.
- Propose to share genomic data via a non-NIH-designated data repository.
A detailed explanation of the alternative mechanism for data sharing should be documented in the Resource Sharing Plan of the grant application and via the Alternative Data Sharing Plan Template. (See the “How to Register Controlled-Access Studies” section.)
