The National Institutes of Health (NIH) seeks seeks public comments on a proposed update to the access procedures for genomic summary results under the Genomic Data Sharing (GDS) Policy. Genomic summary results, also known as “aggregate genomic data” or “genomic summary statistics” are primary analyses of genomic research that convey information relevant to understanding genomic associations with traits or diseases across entire datasets rather than data specific to any one individual research participant. The goal of this proposed update is to align NIH’s genomic data management procedures for genomic summary results with the current understanding of risks and benefits to research participants while at the same time trying to promote maximum public benefit from NIH-funded research investments.
To promote broad sharing of genomic summary results from most research studies with data held in an NIH-designated data repository, NIH proposes for such access to be made through a new “rapid access” tier. Rapid access will enable access to appropriate genomic summary results after interested users affirm agreement with a statement regarding responsible data use. It is possible that privacy risks related to broad access to genomic summary results may be heightened for study populations from isolated geographic regions, or with rare traits. It is also possible that certain study populations may be more vulnerable to group harm due to the potential for stigma related to traits being studied, or other participant protection concerns. To address these types of sensitivities, institutions submitting datasets to NIH-designated data repositories will be asked to indicate in the data sharing plan and the Institutional Certification if genomic summary results from such studies should be provided only through controlled access.
More information is available via the NIH website.