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DEPARTMENT OF PEDIATRICS o*-a sod. 904 392.3331 SELECTION OF VOLUNTEERS FCI (Florida Correctional Institution) records were first examined with the length of remaining prison sentence and past medical history as the first criteria. Also kept in view was the requirement that the final composition of the test group should resemble as nearly as possible the present troup profile in Southeast Asia. We rejected anyone who did not meet minimal preinduction requirements €or military service. The indicators used for review of FCI records are as follows: A) AGE - We screened for persons 21-45 years of age. One individual 49 years old, requested waiver of age, as he previously had participated in a malaria human challenge study. This was cleared through WRAIR. e) MEDICAL HISTORY - Volunteers were rejected who had a past history of: a. kidney or liver disease or any evidence of liver damage. e. any evidence of a neurological disorder or history of f. anyone taking chronic medication. C) LENGTB OF SENTENCE - Since the study duration is one year, we selected only those individuals who at that time were thought to be available for that period of time and for whom the probability for parole within that time seemed 2. INFORMED CONSENT, ETC. FOR PROSPECTIVE VOLUNTEERS From the above records review, a volunteer list was drawn up of all persons meeting the above requirements. Each prospective volunteer was interviewed on a personal basis and a thorough explanation of the nature of the study was given to each one of them, personally. Two information lectures were also presented to the entire group. The prospective volunteers vere also given the opportunity
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to ask questions about anything that was not clear to them, either public or in private if they so desired. Two sessions were held to obtain the required informed consent and the medical release signatures of the persons wishing to participate. The first session was held on September 11th. An uninvolved observer, a local clergyman, was present at this session to verify complete willingness on the part of each volunteer to participate. The second session was held on September 13th with another local clergyman acting in the same capacity. A total of 58 persons were selected to begin the program. These 58 persons represented only those who freely expressed desire to participate and for whom informed consent and medical release had been obtained. Accomplished a complete clinical laboratory evaluation and a complete physical examination on each of these as in the protocol and included complete urinalysis, hematology was pertinent chemistries. included fundoscopy and evaluation by an opthalmologist. Laboratory screening tests were performed On the basis of laboratory results and physical examinations four individuals were rejected. The reasons include: G-6-PD deficiency, irregular cardiac rhythm. It should be emphasixed here that for the total process of selection of volunteers, we followed the requirements of the University of Florida, the U.S. Army and the Food and Drug administration, the memorandum for Research of the State of Florida Division of Corrections. For any additional volunteers added to the study as replacements for those leaving, the same process was followed. We have informed consent and medical release from these additional volunteers, as well as physical examinations and laboratory screening.
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5. LABOR TORY TESTS PERF RMED ON A L L PROSPECTIVE VOLUNTEERS Complete Urinalsys, (pH; specific gravity; microscopic; and qualitative tests for occult blood, protein, ketone bodies, and sugar) Hematology: Hemoglobin, hematocrit, WBC count, platelet complete differential and RBC morphology, and Glucose-6phosphate dehydrogenase (G-6-PD) estimation. Chemistry: fasting blood sugar (FBS), blood urea nitrogen tase, serum glutamic oxalectetic transaminase (SGOT), and serum glutamic pyruvate transaminase (SGPT). All chemistry procedures are automated.