Although I thank Dr. Butterworth for his comments concerning my commentary,1I do not agree with his opinion that US medical researchers consistently obtained informed consent from human subjects before the 1980s. The Nuremburg Code (1947), the Declaration of Helsinki (1964), and Beecher (1966)2describe research without consent from human subjects and were all published before the 1980s. However, printed copies of these documents were not readily available to US physicians. Until the 1980s, even fewer physicians thought that the Nuremburg Code or Helsinki Declaration had much to do with medical research or clinical practice within the United States.
The Nuremburg Code was composed subsequent to the conviction of Nazi physicians who defended their horrific research, claiming it was similar to medical research being done all over the world.3That code stated as its very first basic principle that human experimentation should involve the “voluntary consent of the subject.”
The World Medical Assembly meeting in Helsinki published what became known as the Declaration of Helsinki. It contained 22 “basic principles” for guiding human subject research. The Declaration was later revised in 1975 and 1983.
The medical community did not develop sanctions for researchers who disregarded the Nuremburg Code or the Helsinki Declaration.
Beecher's2comments in the New England Journal of Medicine were not welcomed by some in the medical research community because prominent researchers thought his ideas about obtaining informed consent from human subjects would stifle medical research. His article was originally refused publication in JAMA 4and the New England Journal of Medicine agreed to publish it only after more than half of the cases he described were removed.
I agree with Butterworth that Beecher—along with many of his distinguished anesthesiologist colleagues—rightly deserves a place of honor in the development of the understanding of clinical research ethics. However, I certainly did not know specifically of Beecher's New England Journal of Medicine article2when I started doing human subject research in 1976. It was not until I took the time and effort to research ethical issues in anesthesiology practice that I began to understand the development of medical ethics in the United States.
The medical literature of the 1970s is, unfortunately, replete with clinical studies that did not meet the standards of the Declaration of Helsinki.5Even today, many physicians do not value the study of medical ethics because they do not believe it is an academic discipline. Many surgeons believed that consent was not routinely required and that medical ethics was a waste of time that served only to “raise doubts where there were none before.”6Multidisciplinary panels that composed Federal regulations for human research had more ethicists and members of the public than physicians because US society wanted consistent treatment of human subjects of research.
The community of professional physicians failed to agree on required elements of consent or enforce consistency in obtaining patient consent. Beecher2himself stated that achieving truly “informed consent” was probably not possible. He acknowledged the pressure on researchers to publish combined and an explosion of research funds to coerce researchers to proceed without trying too hard to fully inform research subjects.2
Federal standards were defined in the late 1970s, published in 1981, and enforced thereafter. They defined the requirements for informed consent for research subjects, which, until that time, were pretty much up to individual researchers—some of whom had more defensibly ethical practices than others.
Oregon Anesthesiology Group, McKenzie-Willamette Medical Center, Springfield, Oregon. firstname.lastname@example.org