Institutional Certification
Genetic/Genomic Data Sharing

Effective January 25, 2015, all NIH-supported research that generates large-scale genomic data must include the following:

• NIH proposal applications: A Genomic Data Sharing Plan must be included as part of NIH funding proposals. When human genomic data are included, the Data Sharing Plan must describe how data will be de-identified; how consent was/will be obtained, and the consent language specifying broad data sharing.
• Just-in-Time: Institutional Certification will be required including IRB approval, limitations or restrictions to data sharing, and indication of whether data submission is to an unrestrictive-or controlled-access repository

If the genomic data sharing pertains to an NIH or sponsored project, School of Medicine PIs must complete, sign, and then submit an Extramural Institutional Certification form to IRB Education (irbeducation@stanford.edu). The IRB will review the form and send approval confirmation to OSR Intake.  

• OSR Intake will initiate the RRA, reassign the RRA transaction to the investigator, and assign a RRA Officer.
• Investigator completes the RRA SeRA request, and it will route to RRA Officer
• RRA Officer will sign the document and return it to the investigator.
   

If the genomic data sharing does not pertain to a sponsored project, School of Medicine PIs must still submit the information to the IRB for review.

Questions? Contact Dianne Ferris (dianne.ferris@stanford.edu) or IRB Education (irbeducation@stanford.edu) in the Research Compliance Office.