After the extensive discussions and good feelings of the January 28, 2003 in-person meeting, at which we seemingly discussed all the outstanding issues, the totally surprising reply sent by the IRC-IRB came with several scientifically misguided new demands. One of these (hiring a Contract Research Organization to take over the conduct of the study to avoid “unconscious bias”) was unusual, exorbitantly expensive and unnecessary since the study was already a placebo-controlled, double-blind pilot study, with blinded, independent raters. Another (redesigning the study into a multi-site study with two different therapeutic teams) would probably not even be approved by the FDA since single-site studies to standardize the intervention precede multi-site studies. The IRC-IRB response, which included quite a few other requirements, indicated a profound misunderstanding by the IRC-IRB of the generally-accepted scientific research process and communicated that the IRC-IRB was deeply fearful of approving this protocol.
Though I (Rick Doblin) am by nature happy and optimistic (which some friends of mine have teasingly referred to as evidence of MDMA brain damage), the IRC-IRB response resulted in two days of a dark depressive funk, the likes of which I haven’t felt for almost 30 years, back when I was working through early difficult LSD experiences. The resolution of the depression came with the decision to throw myself into responding in detail to the IRC-IRB letter, in the hopes that a clearer presentation on our part of the qualifications of our research team members, the logic behind our protocol design choices, and a willingness to give the IRC-IRB whatever information it asked for, would result in a return to generally-accepted scientific research principles.