The IRB should focus its review on the specific findings that are included in the certification and confirm that these are explicitly addressed in the application, protocol, and consent documents. NIH has guidance on Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human Genomic Data under the National Institutes of Health Genomic Data Sharing Policy and FAQs on its Genomic Data Sharing Policy. Note that HS IRB has typically required use of a controlled-access database for individual-level data, but unrestricted access is usually acceptable for genomic summary results.  Additional modifiers are rarely applied. See NIH's step-by-step instructions for completing an Institutional Certification Form for more information on controlled v. unrestricted access and data use limitation modifiers.

The Toolkit documents related to genomic data sharing include HRP-064 NIH Genomic Data Sharing (GDS) Institutional Certification and HRP-332 NIH GDS Institutional Certification. Additional guidance is provided in the Investigator Manual and the Genomic Data Sharing Policy page.

If the study team requests Institutional Certification, IRB analysts should follow these steps:

1. Assess whether the information necessary to issue an Institutional Certification is immediately available by reviewing the guidance in the Investigator Manual and links.
   1. If all required information has been provided:
      1. Ask the study team to complete the appropriate Institutional Certification Form and upload it to the ARROW application. Note that if there is no Arrow application because the study was determined to be “not human subjects research" (see section 3 below) or the study involves data from multiple sources, or may require more than one certification template (e.g. if some data was collected with consent and some without), IRB analysts may request that study teams complete and upload the “Request for Institutional Certification for Depositing Specimens in NIH Repositories” form. This is optional and aims to more easily collect necessary information for complex scenarios. 
      2. If all required information has been provided:
         1. Ask the study team to complete the appropriate Institutional Certification Form and upload it to the ARROW application.
         2. If the study will be reviewed by the convened board, include a statement in the Pre-review checklist (HRP-401, section 6) that the study team is requesting institutional certification to share genomic data with a federal repository. Refer reviewers to Points to Consider for Institutions and Institutional Review Boards in Submission and Secondary Use of Human Genomic Data under the National Institutes of Health Genomic Data Sharing Policy and HRP-332 NIH GDS Institutional Certification.
      3. If Institutional Certification is being requested as part of a change and the change qualifies for expedited review, the recommendation for certification may be made by the expedited reviewer.
      4. Forward the completed form to the Office of Research Policy (ORP) at compliance@research.wisc.edu, after the IRB panel approves the request. ORP staff will obtain the Institutional Official’s (IOs) signature on the letter and return the signed form to the IRB analyst. 
         
         Example email: 
         
         Attached please find the Institutional Certification form for the study above.  I believe the form is complete and the necessary approvals are all in place: The HS IRB approved the study, including the submission of genomic data to a federal repository, on [date]. The study PI has signed the document electronically.
         
         Please contact me with any questions.
         
      5. Log a private comment in the main study workspace that an Institutional Certification for genomic data sharing has been issued and upload a copy of the completed, signed certification in ARROW as part of the comment.
      6. Forward the signed Institutional Certification to the study PI and main study point of contact (POC). The study team will send the form to the appropriate entity to satisfy the requirements of the NIH policy.
      7. Note that an IRB approval letter may be issued before the Institutional Certification is finalized.
   2. If the required information cannot be provided at the time of initial review, advise the study team to:
      1. Edit the ARROW application and protocol to describe the large-scale genomic data and their data sharing plan, in as much detail as possible or complete and upload the "Request for Institutional Certification for Depositing Specimens in NIH Repositories" form.
      2. Edit the consent document(s) to describe the research that will generate large-scale genomic data and describe sharing genomic data with federal repositories. Encourage study teams to use HS IRB genomic data sharing language in the consent template.
      3. When scheduling the item for a panel meeting, include a statement in section 6 of HRP-401 that the GDS policy applies, but that there is inadequate information available for institutional certification at this time and the study team will request certification via a future change of protocol.
         
         
2. If the study team needs Provisional Institutional Certification:
   1. Instruct the study team to complete the Provisional Institutional Certification form.
   2. Forward the completed form to the Office of Research Policy (ORP) at compliance@research.wisc.edu. ORP staff will obtain the Institutional Official’s (IOs) signature on the form and return the signed form to the IRB analyst.
   3. If an ARROW application has been started, log a private comment in the main study workspace that a Provisional Institutional Certification for genomic data sharing has been issued and upload a copy of the completed, signed certification on the Supplemental Information page of the ARROW application.
   4. If an ARROW application has not been started, the process can be handled outside of ARROW, meaning, it will not be associated with an ARROW application. Submit the completed form to the Office of Research Policy as described in 2.2.
   5. Forward the Provisional Institutional Certification to the study PI and main study point of contact (POC). The study team will send the signed form to the appropriate entity to satisfy the requirements of the NIH policy.
      
      
3. If Institutional Certification is being requested for a project not associated with an ARROW submission (e.g. the study is limited to obtaining de-identified specimens or cell lines from a commercial bank so it qualifies as "not human subjects research").
   1. Ask the study team to complete the “Request for Institutional Certification for Depositing Specimens in NIH Repositories" form via email.
   2. Ask the study team to complete the appropriate Institutional Certification Form
   3. Forward both completed forms to IRBDirector@hsirb.wisc.edu for sign off. 
   4. Once sign-off is received, send the completed Institutional Certification form to the Office of Research Policy (ORP) at compliance@research.wisc.edu ORP staff will obtain the Institutional Official’s (IOs) signature on the letter and return the signed form to the IRB analyst.
   5. IRB Analyst will provide finalized certification to the study team.
   6. Copy IRBDirector@hsirb.wisc.edu on email so that certifications made outside of ARROW can be tracked.

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