IRB Reliance Documentation

Hi All,

My apologies if this was asked before and I missed it in my search. 

Our IRB is in a situation where we are requesting clarification on acceptable IRB reliance documentation.

Our clinicians are conducing study visits in their home institution office for a project where the main sponsor contract is with another Academic Medical Center. As our clinicians are conducting study related therapy visits and completing limited study documentation per contract with our organization. They will help inform the lead site of AEs, complete questionnaire and conduct therapy following a protocol specific manual and at protocol specified times. As such, our site was requesting to rely on the lead IRB. It turns out, the lead institution has relied on a commercial IRB. Understandably, they suggest we work with the sponsor to do the same. Upon discussion with the sponsor they note the commercial IRB has suggested the following:

• We have the lead PI add our site’s location to their list of research locations in the commercial IRB portal. 
• This in turn would generate a letter from the commercial IRB acknowledging that health system is involved in the research for the sponsored study. 
• The sponsor, and commercial IRB, are denying our request for completion of a traditional reliance agreement and all of its suggested components.

This seems unusual to us.

Would a simple letter from the commercial IRB cover our requirements for reliance documentation? Our thought is no, but maybe there is more flexibility in the requirements than I’m thinking.

With appreciation,

Jenn