Reminder: Implementation of the NIH Genomic Data Sharing Policy Begins January 25, 2015

Dear Colleagues:

NIH has posted NOT-OD-15-027  as a reminder to  the extramural scientific community regarding the implementation of the NIH Genomic Data Sharing Policy that is effective with applications submitted on or after January 25, 2015. The National Institutes of Health (NIH) previously issued the NIH Genomic Data Sharing Policy (NOT-OD-14-124) and Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications and Awards (NOT-OD-14-111) on August 27, 2014. Both announcements were sent to UCI faculty by the UCI Human Research Protections office on September 11, 2014 via its list serve.  A copy of that communication is attached.

NOT-OD-15-027 provides the following reminders for grant applicants:

Investigators preparing grant applications for those due dates should prepare now if the work proposed involves the generation or use of large-scale genomic data. The following highlights should be noted:

  • Applicants preparing such grant applications are expected to:
    • state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data, and
    • include a genomic data sharing plan in the application. If sharing of human data is not possible, applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan.
  • Applicants who plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in the application should:
    • briefly address their plans for requesting access to the data, and
    • state their intention to abide by the NIH Genomic Data User Code of Conduct, in the Research Plan of the application.
  • Applicants preparing applications that involve research funded prior to the Policy’s effective date should:
    • make every effort to include a genomic data sharing plan in the application that outlines plans to comply with the expectations outlined in the Policy, and
    • plan to transition to a consent for future research uses and broad sharing, if possible, if the studies involve human participants and were initiated before the Policy’s effective date and used consents that do not meet the expectations of the GDS Policy.

If you have any questions regarding this policy, please contact the Contract and Grant Officer  assigned to your department.

Nancy
Nancy Lewis
Director, Sponsored Projects

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