知情同意的过程与受试者同意书.pdfVIP

Historical Events First human subject Vaccination trials in the 1700s. Edward Jenner (1749-1823) first tested smallpox vaccines on his son and on neighborhood children. Johann Jorg (1779-1856) swallowed 17 drugs in various doses to record their properties. San Antonio Contraception Study In San Antonio, Texas, a number of Mexican-American women participated in a 1971 study to determine side effects of an oral contraceptive. 10 of the 76 subjects became pregnant while using placebo. Tea Room Trade Study The study planned first to obtain information about homosexual practices in public restrooms and then to conduct further investigation on the men who took part in the acts. The researcher went undercover and gained the confidence of the men by acting as a look out.“ The researcher identified 100 active subjects by tracing their car license numbers. A year after he completed the initial study of direct observation of homosexual acts the researcher distributed a social health survey throughout the communities where he knew the subjects lived. The Public Health Service Syphilis Study (1932-1971) Initiated by the Public Health Service, this study was designed to document the natural history of syphilis in African-American men. At the time the study began there was no known treatment for syphilis. Hundreds of men with syphilis and hundreds of men without syphilis (serving as controls) were enrolled into the study. The men were recruited without truly informed consent. They were deliberately misinformed about the need for some of the