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NIH Updates Policies on Sharing of Genomic Data

September 5, 2014— The National Institutes of Health (NIH) published in the Aug. 26 Federal Register its final Genomic Data Sharing policy (GDS), effectively extending and building upon norms for sharing information dating back to the earliest days of the Human Genome Project.  The new policy will apply to all NIH-funded, large-scale human and non-human projects that generate genomic data beginning with applications submitted for a Jan. 25, 2015, receipt date.

According to NIH, “a key tenet of the GDS policy” is the expectation that researchers obtain informed consent of study participants for potential future use of their de-identified data for research and for broad sharing, including for de-identified cell lines or clinical specimens.  “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 NIH GDS policy also expects investigators and their institutions to provide basic plans for following the GDS policy as part of funding proposals and applications.”

In its Nov. 2013 comments  to the originally proposed GDS policy, the AAMC strongly endorsed NIH’s support for data sharing in genomic and other research.  The AAMC expressed concerns that the GDS informed consent requirements for use of de-identified data differ from what is required by the Common Rule and related regulations.

The AAMC also echoed input from patient advocates that the then-proposed policy would not take into account innovations in the consent process, such as dynamic informed consent, which may better establish patient and study participant trusting in on-going research.

In the final GDS policy, the NIH acknowledged these concerns:  “Regarding the alternative forms of consent, the [GDS] policy does not prohibit the use of dynamic or tiered consents.  It promotes the use of consent for broad sharing to enable the greatest potential public benefit.  However, NIH recognizes that changing technology may enable more dynamic consent processes that improve tracking and oversight and more closely reflect participant preferences.  NIH will continue to monitor developments in this area.”

The AAMC strongly urged NIH to formalize a commitment to include diverse populations in genomic research in a final policy, in hopes that future research will help address, and not exacerbate, health disparities.

The NIH again acknowledged concerns that requirements for broad consent could potentially bias studies “if certain populations were less likely to consent to broad use of their data.”  The agency agreed that “consent for future research uses and broad sharing may not be appropriate or obtainable in all circumstances” and that NIH institutes and centers may continue to accept data from studies with consents that stipulate limitations on future uses and sharing.  NIH will maintain the data access system that enables more limited sharing and secondary use.

NIH has established a website to assist investigators and the public with sharing data.


Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488


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