1966

Henry Beecher’s Ethics and Clinical Research published in NEJM, providing 22 examples of investigators who risked “the health or the life of their subjects” without informing them of the dangers or obtain their permission (Rothman, chs 1 & 4; Howell III, 690). This led to new NIH guidelines, promulgated by the U.S. Public Health Service, covering all federally funded research involving human experimentation; at their core was the peer-review committee, known as the institutional review board (IRB), though, through the 60s, membership on the IRB generally restricted to fellow investigators (Rothman, 89-91). The FDA went further, setting down comprehensive rules re patient consent in clinical drug trials and spelling out the meaning of consent (93). Recognition that “the traditional ethics of medicine no longer held in the laboratory and that a fundamental conflict of interest characterized the relationship between the researcher and the subject and had an extraordinary impact on those outside of medicine” (95). Philosophers like Paul Ramsey and Hans Jonas moved into medical ethics and arrived at the conclusion that the only escape from the dilemmas in experimentation “was through a revitalization of the principle of consent. Human subjects had to become their own protectors” (98).