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 …

EEG of Long-Term Ayahuasca Drinkers vs. Matched Controls

Investigators: Dr. Micheal Hessellink (Holland), Yatra da Silveira Barbosa (Brazil), Dr. Erik Hofmann (Denmark). Co-investigators are: Dr. Glacos Brito and Dr. Dartiu Xavier da Silveira both from Brazil. …

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 Request for A Decision

MAPS phones the IRC-IRB and requests that the panel make a definite decision on whether it would require MAPS to hire a CRO and/or move to a multi-site design, neither of which MAPS is willing to do, before …

IRB Review Tabled

The IRB informed MAPS that it cannot proceed with its review until it obtains the advice of two “qualified, objective psychiatric consultants,” with fees for the consultants required to be …

More Documents MAPS submitted

More Documents. MAPS submitted a document detailing our standardized procedures for responding to “agitated subjects, or those with suicidal ideation associated with study procedures.” We also …

MAPS Submitted a Twelve Page Basic Reply

MAPS submitted a twelve page basic reply (which included in a bit of comic relief a required menu of the snack foods and drinks that we would offer to subjects on the MDMA therapy days and our plans for …

A Rapid Response

MAPS submitted a six page response focusing just on the issues of the Contract Research Organization and the multi-site study requirements, to be following up within a week or so with a more detailed discussion …

An Astonishingly Depressing Response

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 …