No Decision Unless Unanimous

The IRC-IRB sends a letter indicating that it needs to receive the advice of consultants before making a decision on the issues of the CRO and the multi-site study. While the IRC-IRB does indicate that a majority of the members of the panel find MAPS’ arguments that a CRO is not needed to be “compelling” and that a majority are willing to consider abandoning the request for a multi-site study, we are told that no decision will be made unless it is unanimous, which MAPS is claimed to have previously agreed to though this was never mentioned before and is not standard practice.