Reminder for the Extramural Scientific Community: Implementation of the Genomic Data Sharing Policy Begins January 25, 2015
Release Date: December 4, 2014
National Institutes of Health (NIH))
This Notice serves to remind the NIH extramural scientific community that the NIH Genomic Data Sharing Policy becomes effective with NIH grant applications submitted for the January 25, 2015, due date and thereafter.
The National Institutes of Health (NIH) 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 specified the effective implementation date of January 25, 2015, for NIH grant application submissions.
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.
With implementation of the GDS Policy, submission of the Institutional Certification for human genomic data will become part of the standard Just-in-Time process. Additional guidance for, researchers and institutions submitting grant applications and contract proposals involving large-scale genomic data is available on the Genomic Data Sharing website: (http://gds.nih.gov/).
Please direct all inquiries to:
Genomic Data Sharing Policy Team
NIH Office of Science Policy