External IRB and IRB Reliance

Listed on this page is an FAQ regarding External IRBs and IRB Reliance.

I Need to Submit My Study to an External IRB

Situations where a UToledo Principal Investigator (PI) might submit their study to an IRB other than a UToledo IRB include (but are not limited to):

Engaged in multisite research (such as a sponsored clinical trial) and the sponsor prefers to use a central IRB (such as WCG or Advarra) for efficiency and consistency
Engaged in federally funded collaborative research, and federal regulations require single IRB review (meaning one IRB reviews for all sites)
Research activities fully or mostly taking place at a ProMedica site and will be submitted to the ProMedica IRB using our IRB Reciprocal Agreement

If you are the PI of a study seeking to submit to an external IRB, you (or a delegate) must complete the Application to Use a Central IRB xForm before submitting to the external IRB.

I Want to Collaborate on Research Reviewed by an External IRB

If you are not the project PI but wish to join as study personnel for a study that has been or will be submitted to another institution's IRB, please complete the Application for IRB Reliance (Non-UToledo PI) xForm and list all UToledo faculty, staff and students who will be included as research personnel on the study.

Why are There Two xForms?

While both xForms allow us to verify trainings and assess conflicts of interest, we need a little more information when an external IRB is reviewing a study for a UToledo PI because of the PI's responsibilities for research oversight. We also need more information when the majority or entirety of the research is being conducted at a UToledo site.

Why Are These xForms Necessary?

Even though the research will be reviewed by another IRB, UToledo has a regulatory responsibility to:

Verify that the research appropriate for submission to an external IRB
Ensure that all institutional policy, state laws, and local context considerations are addressed in the IRB review and any approved documents
Document our agreement to rely on the external IRB and the conditions of the agreement (for example, we may need to execute an IRB authorization agreement (IAA) or complete steps via SMART IRB)
Ensure that our research personnel are up-to-date on required human subjects research training in accordance with our policies and procedures
Ensure that any potential conflicts-of-interest related to the research have been addressed per our policies and procedures and, if applicable, a COI management plan has been provided to the reviewing IRB
Communicate with the reviewing IRB regarding any other study-specific concerns or requirements, issues of noncompliance, reportable events, etc.

What if I am Submitting a Study to a UToledo IRB that Involves Personnel from Other Institutions?

Because each institution has its own requirements for IRB reliance situations, we can't predict what other institutions will require in these scenarios. If you are including personnel from other institutions on your study to be reviewed by a UToledo IRB, the HRPP office will need to work with those institutions to obtain appropriate authorization before we can send the study for review. At a minimum, we will need to:

Document the other institution's agreement to rely on UToledo for IRB review, via an existing reciprocal agreement, SMART IRB an IAA, etc.
Verify that the individuals are in compliance with the other institution's policies regarding trainings and conflicts of interest
Receive any relevant local context information to be considered during the IRB review

If you have any questions, please email IRB.Biomed@UToledo.edu or call 419.383.6904.

Human Research Protection Program

External IRB and IRB Reliance