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104. * CONCEPTION AND BIRTH Confidentiality and anonymity were important issues I had to work out with the ethics committee, the Research Center, and the university hospi- tal administration. Nearly all the DMT volunteers had jobs and families, neither of which they cared to endanger by admitting to the use of illegal drugs. Confession to having broken the law was a prerequisite for enroll- ing in the study, since only experienced psychedelic drug users could participate. I met with staff from the hospital's medical records depart- ment and admitting offices, the head nurse and administrator of the Re- search Center, and the hospital's attorney. Together we worked out a complicated but effective arrangement. Records of the medical screening performed in the outpatient clinic of the Research Center would hold important medical information. This might be extraordinarily helpful if the volunteer at some future date de- veloped health problems for which the treating physician needed baseline values, for example, regarding heart function. Therefore, we placed the volunteer's real name on the chart containing results of the physical ex- amination and screening laboratory tests. In this chart was no mention of drug use, nor a linking of the volunteer to my drug studies. The signed informed consent document, which was usually attached to the chart, required the volunteer's real name on the signature line. To pro- tect confidentiality, I kept all signed informed consents under lock and key in my home office. All that was necessary for the "real name" chart was the comment: "Consent signed. Held by Principal Investigator." Each volunteer then received a code number, such as DMT-3. From that point on, this anonymous identification was the only one they pos- sessed, and I was the only person who knew the key. They each received a new hospital chart labeled only with their DMT number. The first time we used the code number was for the psychiatric examination detailing their history of drug use and emotional problems. There was one final concern. This related to outside agencies looking at charts in order to assess long-term effects of exposure to experimental drugs. In my melatonin studies, I included a phrase in the informed con- sent stating that the manufacturer of melatonin and the FDA might review patient files in order to investigate any risks or problems associated with