August 27, 2014

NIH Issues Genomic Data Sharing Policy

The National Institutes of Health has issued the final NIH Genomic Data Sharing (GDS) Policy that “will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data,” effective for funding applications submitted for the January 25, 2015 receipt date and thereafter.

The NIH Office of Extramural Research has issued implementation guidelines for grant applications and awards. Dr. Sally Rockey, NIH Deputy Director for Extramural Research, states in her blog post that applicants “are expected to state in their cover letter if their proposed research will generate large-scale human or non-human genomic data. If so, applicants are expected to include a genomic data sharing plan, and NIH will ask peer reviewers to comment on this plan, though it will not factor into the overall impact score for the project (unless specified otherwise in the funding opportunity announcement).”

The NIH news release states, “A key tenet of the GDS policy is the expectation that researchers obtain the informed consent of study participants for the potential future use of their de-identified data for research and for broad sharing. NIH also has similar expectations for studies that involve the use of de-identified cell lines or clinical specimens.”