Purpose of the Protocol Review Committee

MAPS Bulletin Winter 1990/91 Vol. 2, No. 1

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This volunteer group will be composed of psychiatrists, neurologists, brain researchers, psychologists, and past government regulators not all from the community of previous supporters of psychedelic research. This group would ideally but not necessarily convene in one location. They would evaluate the MDMA protocol for methodological shortcomings, suggest improvements, suggest outcome measures that were valid cross-culturally, and assist in the political process of securing permission to conduct such studies.

Since the FDA would probably assemble a similar advisory committee to review the protocol, it would be beneficial to have a committee of equal reputation review and improve the experimental design before submission. With a committee of sufficient expertise and reputation, the FDA may feel comfortable approving the protocol without the need of convening their own advisory committee. If this occurs, the use of MDMA in human studies may be able to begin up to a year sooner.

Since it is hoped that this area of research will grow substantially over the years, creating an expert committee experienced in reviewing protocols might also improve the overall quality of subsequent research and ensure the wise use of MAPS resources in the future. In the development of MDMA into an approved medicine, fiscal efficiency is of utmost importance.

Overall, the conference was successful beyond the expectations of most participants. A new-found sense of cautious optimism regarding the development of this field is at hand.