Protocol Improvements Recommended by IRBs

Though MAPS’ long series of interactions with multiple IRBs was often frustrating, several improvements have been incorporated into the protocol design as a result of recommendations/requirements made by various of the IRBs.

MAPS has prepared a document listing these improvements, with the primary ones consisting of having patients remain overnight in the treatment facility which will be staffed by an RN, having data periodically reviewed by an independent Data Safety Monitoring Board (DSMB), requiring subjects to take a quiz after reading the informed consent form to make sure the primary risks were understood, and requiring a minimum score on the questionnaire assessing the severity of PTSD that reflects a “moderate” severity.