A Decision to Let the Review Stay Tabled

Two weeks have passed without MAPS receiving an estimate for the costs of consultants from the IRC-IRB. In any case, MAPS has decided to let the review remain tabled, not to pay for consultants, and start over with another IRB. We didn’t immediately inform the IRC-IRB since we expected to hear any day about the costs of the consultants, at which time we planned to explain our decision. The proverbial straw that broke the camels back was that the IRB indicated that even though a majority of its members agreed that MAPS has offered persuasive arguments against the use of a CRO and the multi-site design, the panel will not withdraw those suggestions unless and until an unanimous decision is reached after a report from consultants on seemingly unrelated matters. After waiting until March 25 without being informed of the costs of the consultants, over a month after MAPS requested in writing that these costs be provided, MAPS sent a letter to the IRC-IRB saying that we were withdrawing the application. MAPS then learned that the staff person at the IRC-IRB with whom MAPS has primarily interacted has left the IRC-IRB for reasons unrelated to our protocol.