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Timothy F Brewer, MD, MPH;* and S.Jody Heymann, MD, PhD^
The ethics of clinical trials involving patients with infectious diseases has received a great deal of attention recently in both the lay and the scientific press. In the Spring of 1997, President Clinton publicly apologized to the survivors and families of the US Public Health Service-sponsored Tuskegee Syphilis Study, recognizing that the study investigators wrongly had violated both the subjects' rights and the ethics of scientific conduct.1 More recently, Lurie and Wolfe described why they believed that many of the current placebo-controlled trials to evaluate the prevention of perinatal human immunodeficiency virus (HIV) transmission in developing countries are unethical. In their opinion, new "standards of research" were needed to preclude similarly designed studies in the future.2 Their article and the accompanying editorial, which linked the justification of these trials with those used for the Tuskegee study,3 have engendered a heated debate concerning the ethics of recent placebo-controlled clinical trials.4 The same editorial also raised ethical concerns about a placebo-controlled tuberculosis (TB) prevention study.3 Though the Tuskegee study, the HIV-prevention trials, and the TB-prevention study had disparate locations, patient populations, and time-frames, all involved groups of underserved individuals who otherwise did not have access to the highest standards of clinical care.
ETHICAL STANDARDS
Ever since Beecher described abuses in clinical research in 1966,5 a number of national and international guidelines for clinical research have been instituted and reviewed.6-10 A consensus has developed that, for a trial to be ethical, there must exist an honest uncertainty in the medical community, or equipoise, between treatment options in a study that has a reasonable chance of resolving this controversy.9 Freedman defined "clinical equipoise" as "an honest, professional disagreement among expert clinicians about the preferred treatment" in a defined group of patients.9
For a clinical trial to be considered ethical, additional criteria must be met besides the existence of an informed disagreement among experts as to the best treatment. Patients must have free choice and access to all information necessary to make an informed decision whether or not to participate in a study, and the protocol must be reviewed by appropriate independent review boards.11 Furthermore, the importance of including patients in the design of clinical trials has been...