IRB Reliances


When a GVSU faculty member, staff member or student is collaborating with a researcher from another institution, the GVSU Institutional Review Board (IRB) will consider relying on the IRB review completed by the other institution.  This typically occurs when the research is being conducted at a hospital, in a K-12 school system, or at another university.  If the research is associated with a federal grant, the researchers may be required to use a single IRB.

Upon receiving the request to rely, ORCI will contact the reviewing IRB to determine if they will allow the GVSU IRB to rely upon their review.  If they agree, both IRBs will sign an IRB Authorization Agreement and the GVSU IRB will issue a formal letter accepting the other IRB’s review.  If the reviewing IRB does not agree to the reliance, the GVSU researcher will need to submit for GVSU IRB review.  In this case, ORCI will contact the GVSU researcher with the next steps.

This process can be time-consuming, and may take one week to several months to be completed.  Plan your research accordingly.

To request the GVSU IRB rely on another IRB’s review:

  1. Go to IRBManager:  https://gvsu.my.irbmanager.com/.
  2. Enter your GVSU network ID and password.  This will take you to your IRBManager dashboard.
  3. Select, “Start xForm” under the “Actions” menu in the left column.
  4. A new window will open.  Select, “IRB New Protocol Submission Form.”
  5. Start completing the form.  The second question asks if another IRB has or will review the study.  Select ‘yes.’
  6. A new question will appear, asking if you would like GVSU to rely on the other IRB’s review.  Select ‘yes.’
  7. Proceed through the form, answering the questions as they appear.  Per GVSU IRB Policy 310, the principal investigator (PI) must be a GVSU faculty or staff member.
  8. Ensure all relevant documents are attached, such as the protocol, IRB application from the reviewing IRB, consent form, IRB approval letter, grant, etc.
  9. When the form is complete, submit it for PI review and approval.
  10. Upon PI approval, the form will be automatically routed to the PI’s Authorizing Official for approval before coming to the Office of Research Compliance & Integrity (ORCI) for processing.

GVSU as the Reviewing IRB

The GVSU IRB will consider acting as the reviewing IRB for other institutions.  To request this, follow the process above, except answer ‘no’ in step 6.  Complete the application as usual.  ORCI will contact the other IRB during the review process to execute the IRB Authorization Agreement.  If the research already has GVSU IRB approval, submit an Amendment Request form in IRBManager to request approval to add an external researcher/research location.  ORCI will then proceed with executing the IRB Authorization Agreement.

 

Research at Spectrum Health

The GVSU and Spectrum Health IRBs have an existing agreement that covers most faculty and student research conducted collaboratively by the two institutions.  If the research will be conducted at Spectrum Health, they will serve as the reviewing IRB.  When submitting the Research Intake Form at Spectrum Health, indicate the research falls under the existing reliance agreement so that it is routed appropriately.  Spectrum Health requires that their Reliance Screening Form be completed and attached to the Research Intake Form.  Once the Spectrum Health IRB review is complete, follow the above steps to request that GVSU rely upon the completed Spectrum Health review.  All GVSU researchers must complete the GVSU-required CITI training, as well as any additional training required by the Spectrum Health IRB.  The research cannot begin until the research team has received approval letters from both IRBs.

Clock tower and reflection in pond at sunrise

Research and Quality Improvement Activities at Mercy Health Saint Mary’s

The GVSU and Mercy Health Saint Mary’s IRBs have an existing agreement that covers student research only.  The GVSU student will need to start the Mercy Health research process with the Mercy Health Research and Innovation Department by submitting a consultation request form. Once the Mercy Health IRB review is complete, follow the above steps to request that GVSU rely upon the completed Mercy Health IRB review. 

The Mercy Health IRB also requires student quality improvement activities be reviewed before being conducted. The GVSU student will need to start the Mercy Health quality improvement review process with the Research and Innovation Department by submitting a consultation request form. Student quality improvement activities cannot begin until the quality improvement team has received the Mercy Health IRB determination letter.  These QI projects do not need to be submitted to the GVSU IRB for review.

Individual Investigator Agreements

Individual Investigator Agreements (IIA) are used when a GVSU researcher is collaborating with an external researcher who is not covered by a Federalwide Assurance (FWA).  Most commonly, this occurs when the external collaborator is an independent consultant or works for a non-profit organization. IIAs allow the GVSU IRB to extend its FWA to provide oversight of the research activities of the external collaborator.  By entering into the IIA, the external collaborator is agreeing to comply with all applicable federal and state research regulations as well as all GVSU research policies and IRB determinations.

If the external collaborator is associated with an institution that has an IRB, an IIA cannot be used and the above process for reliance will instead be considered. 

 

Questions on IRB Reliance Agreements or IIAs?

The Office of Research Compliance and Integrity is available to answer questions regarding these processes:  rci@gvsu.edu or 616-331-3197.

To request an IIA, complete the following steps:

  1. The external researcher needs to complete and sign the IIA
  2. The external researcher must complete the required CITI training.
  3. The GVSU researcher will complete the New Protocol Submission form in IRBManager, ensuring the external researcher is listed as a member of the research team.   The signed IIA will be attached to question 2f.   

After receiving the submission, ORCI will obtain the signature of the Research Integrity Officer.  The fully executed agreement will be returned to the GVSU researcher and the external researcher.