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102. * CONCEPTION AND BIRTH withdraw at any time, for any reason, with no penalty or withholding of necessary care. In case a volunteer feels unfairly treated, the informed con- sent document provides names and phone numbers of people he or she can contact in order to complain. While negotiating with the university committees, I also began work- ing with the two United States federal agencies that formed the final, and more formidable, regulatory barriers. They held in their hands the ulti- mate decisions. The first was the U.S. Drug Enforcement Administration (DEA). They had a local Albuquerque office, but their headquarters were in Washing- ton, D.C. The DEA would decide if I would be allowed to possess DMT. If granted, this permission would take the form of a Schedule Ipermit. The other federal regulatory agency was the U.S. Food and Drug Ad- ministration (FDA), which also is based in Washington, D.C. The FDA would decide if it was safe and worthwhile to give DMT to human re- search volunteers in my study. If granted, the FDA's permission would take the form of an Investigational New Drug (IND) permit. When submitting the protocol to the university committees, I told them the study would not begin until the-FDA and DEA both gave their permission to administer DMT. However, these federal agencies first re- quired local approval. The informed consent document would be a major hurdle, and I was di- rect with the ethics committee about the expected effects of DMT. I did not want to lull volunteers into thinking it would be an easy day, but I also did not want to scare them away by emphasizing potential negative ef- fects. On page two of the consent, this is what the volunteer read: I understand that the primary effects of this drug are psychological. Visual and/or auditory hallucinations or other perceptual distortions may occur. My sense of time may be altered (short lengths of time passing slowly or vice versa). I may experience very powerful emotions, pleasurable or unpleasant. Opposite feelings or thoughts may be experienced at the same time. I may be extremely sensitive