Notice Number: NOT-HG-20-011
Release Date: December 12, 2019
National Human Genome Research Institute (NHGRI)
On August 27, 2014, NIH published the Genomic Data Sharing (GDS) Policy to promote sharing, for research purposes, of large-scale human and non-human genomic data generated from NIH-funded research. On October 9, 2015, NHGRI released its Notice of Plans for NHGRI Implementation of NIH GDS Policy (NOT-HG-15-038). To increase transparency with researchers and participants, and promote consistent data sharing expectations across genomics studies, NHGRI set the expectation that by January 25, 2020 all human data generated by NHGRI-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 purpose of this Notice is to reaffirm NHGRI’s expectation and to provide further guidance on its implementation.
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. 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.
Timeline of Implementation
Many funding opportunity announcements (FOAs) developed by NHGRI that include generation of genomic data with receipt dates on or after January 25, 2020 will include this expectation that human data generated by NHGRI-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. NHGRI will expand this expectation to all other applications submitted on or after the January 25, 2021 receipt date. NHGRI Intramural projects are also expected to comply with this expectation no later than January 25, 2021.
NHGRI recognizes that not all NHGRI-supported research is able to meet this expectation, and that, in some cases, there are compelling scientific reasons for using human data sources that lack explicit consent for future research use and broad data sharing.
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 NHGRI’s Genomic Data Sharing Policy FAQs webpage.
NHGRI welcomes community feedback on this Guide Notice. Questions and feedback should be sent to firstname.lastname@example.org. NHGRI will re-evaluate this update in the future to determine the effectiveness and impact on our grantees and the genomics community.
Please direct all inquiries to:
National Human Genome Research Institute