Institutional Certification
Genetic/Genomic Data Sharing

Introduction

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

Processes and Procedures

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 the IRB and to their RPM. The IRB will review the form and notify the RPM when it may be signed.  The completed form should be sent via email attachment to the Research Process Manager and the IRB at IRBEducation@stanford.edu.

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 Chris Witwer in the Research Compliance Office.