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).
Guidance for 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.
Final
Issued by: National Institutes of Health (NIH)
Issue Date: July 11, 2019
Informed Consent for Genomic Data Sharing
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).
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Overview
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 that are generated after January 25, 2015.
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.
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 (Section M. Exceptions, FAQs 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 Submission).
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, see Exceptions and Alternatives.
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 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.
Last updated: September 18, 2019
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