External IRB

External IRBs: Single IRB or reliance agreements and central IRBs are used for multi-site clinical trials to avoid multiple IRBs reviewing the same protocol and study documents.

Reliance Agreements or Single IRBs (sIRBs) are appropriate (and may be required on or after January 25, 2018) for investigator-initiated or NIH-funded multi-site clinical trials. 

The sIRB is a legal agreement setting up which site will be responsible for conducting the initial and continuing reviews and ensure regulatory compliance (s-site) and which sites will rely on, or cede to, the reviewing site (p-sites). 

The process for using an sIRB starts during the planning/ pre-proposal stage with an investigator submitting a request for determination on which site will serve as the s-site and whether the other sites are willing to be p-sites. While use of platforms like SMART IRB to set up agreements is free, the s-site may impose fees on p-sites for IRB review.

Two of the platforms for setting up reliance agreements with which UMASS Medical School is networked are the SMART IRB (for trials with any of the more than 300 research institution network members) and the SMART IRB Exchange  (for trials associated with the Trial Innovation Network members)

Central IRBs are appropriate for new industry-sponsored or NCI-sponsored Phase 3 or 4 multi-site clinical trials.

Central IRBs conduct the initial and continuing review and ensure regulatory compliance and the UMASS cedes to/relies upon the central IRB. 

Central IRBs may impose fees for use of their services. 

For more information about the central IRBs with which UMASS has entered into agreements select from the list below: