NIH Releases Final Genomic Data Sharing Policy

The National Institutes of Health has released a final genomic data sharing policy that promotes sharing of large-scale human and non-human genomic data generated from NIH-funded research.

“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,” states an Aug. 28 Federal Register notice.

Starting with funding applications submitted for a Jan. 25, 2015, receipt date, the policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data. This includes research conducted with the support of NIH grants and contracts and within the NIH Intramural Research Program.

The goal of the final policy, which is based on public comments the agency received on its draft policy published in September 2013, is to promote data sharing as a way to “speed the translation of data into knowledge, products and procedures that improve health while protecting the privacy of research participants.”

According to NIH, a key tenet of the final 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 expects any institution submitting data to certify that the data were collected in a legal and ethically appropriate manner and that personal identifiers, such as name or address, have been removed.

“The collective knowledge achieved through data sharing benefits researchers and patients alike, but it must be done carefully,” says Kathy Hudson, Ph.D., NIH deputy director for science, outreach and policy, in a written statement. “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.”

In particular, NIH encourages investigators to seek the “broadest possible sharing permissions” from participants for future research use of their data. In addition, the agency states that the policy is “intentionally general enough” to accommodate the evolving nature of genomic technologies. “Everyone is eager to see the incredible deluge of molecular discoveries about disease translated into prevention, diagnostics, and therapeutics for patients,” adds Hudson.

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