Per the NIH GDS Policy, informed consent documents for prospective data collection for studies started after January 25, 2015 (the NIH GDS Policy effective date) 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 via an approved alternative sharing plan).
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.
NHGRI strongly encourages studies proposing to derive genomic data from human specimens and cell lines to obtain participant consent for General Research Use through controlled-access or for unrestricted 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 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.
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 Expectations for Explicit Consent for Future Research Use and Broad Data Sharing
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 the NIH GDS Policy expectation with regard to grandfathered data sources. Research proposing to use specimens and cell lines lacking such consent should be accompanied by a request for an exception, which describes the scientific reason(s) for using the specified data sources. More information, including the process for requesting an exception, can be found on the Alternatives and Exceptions to the NHGRI Genomic Data Sharing (GDS) Expectations and NHGRI’s Genomic Data Sharing Policy FAQs webpages.
Last updated: January 11, 2021