NIH releases final genomic data-sharing policy

The National Institutes of Health (NIH) has released the final genomic data sharing policy which promotes sharing, for research purposes, of large-scale human and non-human genomic data generated from NIH-funded research.

“Sharing research data supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products and procedures that improve human health,” according to the agency’s Federal Register notice. “The NIH has longstanding policies to make a broad range of research data, in addition to genomic data, publicly available in a timely manner from the research activities that it funds.”

The final policy follows a draft proposal published in September 2013. The agency received 107 public comments, which in general were supportive of the principles of sharing data for research but requested clarity on specific aspects of the draft policy.

For example, commenters wanted more specifics on the types of research to which the policy would apply. The final policy includes a list of examples of the types of research project that are within its scope. Also, the final policy now explicitly states that smaller studies (e.g., sequencing the genomes of fewer than 100 human research participants) are not subject to this policy but may be subject to other NIH data sharing policies.

The NIH also stressed the importance of informed consent of study participants for the potential future use of their de-identified data for research. All institutions submitting data must certify that the data were collected in a legal and ethical manner and that personal identifiers have been removed.

The policy applies to all funding applications starting on Jan. 25, 2015.

“Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics and therapeutics for patients,” said Kathy Hudson, PhD, NIH deputy director for science, outreach and policy, in a statement. “The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully. The GDS policy outlines the responsibilities of investigators and institutions that are using the data and also encourages researchers to get consent from participants for future unspecified use of their genomic data.”