The new IRB informed MAPS today that it has decided not to accept the protocol for review. MAPS was clearly told in writing a month ago that this IRB would accept the protocol for review. Now, after we spent all the staff time to prepare and submit the necessary documents and yet another month has gone by, that decision is reversed. We were told that the IRB believes that “the local IRB has to take responsibility.” However, there is no local IRB, since the project is not affiliated with any local institution. A fear of liability was also mentioned. This is also rather puzzling since MAPS has been able to arrange for an insurance policy for several million dollars that would indemnify the IRB from lawsuits, in the extremely unlikely event that a subject in the study would choose to sue the IRB.
Proposing to research a potentially beneficial use of one of the most demonized drugs in America, and around the world, could be considered a fool’s mission. But it’s not, it’s just extraordinarily difficult and extraordinarily important. After all, MDMA-assisted psychotherapy really can promote healing in a unique manner unlike any other prescription medicine. A moment of despair is now in order, after which MAPS will select a new strategy for moving forward with this project.