provided for peer review of certain kinds of research (e.g., high-risk research, nontherapeutic research involving patients, and research involving healthy volunteers). They also directed attention to ethical questions in the review of research. According to Faden and Beauchamp, “[o]fficials at the Center expected these procedures to set the standard for other institutions … but [this] pioneering venture was an isolated and largely ignored event” (1986, p. 202). For example, as Faden and Beauchamp reported, a survey by researchers at Boston University, which was supported by a federal grant and published in 1962, suggested that few research centers had guidelines for clinical research or even accepted the concept of committee review of protocols.
With respect to research involving children, the 1995 report of the Advisory Committee on Human Radiation Experiments stated that “in the 1940s and 1950s there were apparently no written rules of professional ethics for pediatric research in general” (ACHRE, 1995, p. 203).11 In summarizing the discussion during a 1961 conference on Social Responsibility in Pediatric Research, the same report observed that it was not uncommon for “pediatric patients to be used as subjects of nontherapeutic research without the permission of their parents” (ACHRE, 1995, p. 202). The report also noted that some researchers, including researchers who failed to get parental permission, recognized that this was unethical (see Box 1.2).
In 1962, the U.S. Congress passed legislation that expanded the scope of FDA’s authority by passing amendments to the Federal Food, Drug, and Cosmetic Act (P.L. 87-781). The legislation included provisions that required investigators to obtain a subject’s consent to the use of an experimental drug unless it was not feasible or was not in the subject’s best interest (at Section 501(i)(4)). Four years later, the FDA commissioner issued explicit regulations providing for consent to participation in research, “at least partially in recognition of the widespread failure of the industry to obtain [it]” (Glantz, 1992, pp. 183–200; see also the discussion in Faden and Beauchamp, 1986).
After years of debate within NIH about the balance between ethical principles and scientific inquiry, the U.S. Surgeon General issued policy statements in 1966 that significantly expanded the conceptualization and application of informed consent for external clinical research funded by