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 …
MDMA-Assisted Therapy
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 …
A Productive Dialogue
The January 28 meeting with the new IRB, at which Dr. Michael Mithoefer and Rick Doblin, Ph.D. appeared in person, involved a series of thoughtful questions about protocol design, risk assessment, confidentiality …
A Substantive Reply to IRB
MAPS submitted a series of documents today to the IRC-IRB, in response to their initial comments about the protocol which MAPS received on January 6. These documents represent a very substantial amount …
Renewed Hope
Today, MAPS received the initial set of comments of the IRC-IRB. My initial impression is that we will eventually be able to get some protocol approved, but that we might need to limit enrollment to more …
Maps Submitted the MDMA/PTSD Protocol for Review
MAPS submitted the MDMA/PTSD protocol for review to the Independent Review Consulting Institutional Review Board (IRC-IRB), with the protocol to be discussed by the review board on January 2, 2003. Officials …
A Shameful Conclusion
On November 20, after the Western IRB decided not to review MAPS’ MDMA/PTSD protocol, Rick Doblin spoke to James Baldwin, Ph.D., Executive Director of the Western IRB. Dr. Baldwin informed Rick that …
Pathetic News
Ron Warren, Senior Vice President of the Western IRB, wrote a letter to Dr. Michael Mithoefer, reporting the outcome of the November 19 meeting of the WIRB’s Executive Policy Committee. The WIRB …