Research Methods & Ethics · 1947
The Nuremberg Code
The trial that produced the Nuremberg Code opened in December 1946 and concluded in August 1947. Twenty-three German physicians and administrators faced charges before an American military tribunal for conducting experiments on concentration camp prisoners at Dachau, Auschwitz, and other sites. The experiments included deliberate infection with malaria and typhus, high-altitude and hypothermia studies conducted without anesthesia, and testing of surgical wound treatments on prisoners who had no choice and no recourse. Sixteen of the defendants were convicted; seven were executed.
Before the verdicts were issued, American judges Harold Sebring, Walter Beals, and Johnson Crawford asked Leo Alexander, a Boston psychiatrist and war crimes investigator, to draft a memorandum on the standards that distinguish legitimate human experimentation from criminal conduct. His initial document proposed six criteria. Andrew Ivy, representing the American Medical Association, provided testimony on ethical standards in American research. The final Code, embedded in the August 19, 1947 verdict, expanded Alexander's criteria to ten points.
The first point was the longest and, in the tribunal's framing, the most fundamental: voluntary consent of the human subject is absolutely essential. The Code further required that experiments have valid scientific justification, that they be preceded by adequate animal studies, that unnecessary suffering be avoided, that no experiment be conducted where death or disabling injury is expected, and that subjects be free to end their participation at any time. The language was specific and uncompromising in a way no prior document had been.
The Code's practical influence was, for many years, remarkably thin. No nation immediately incorporated it into law. In the United States, the Tuskegee syphilis study, in which Black men with diagnosed syphilis were deliberately left untreated, continued for 25 years after the Code was written. Radiation experiments funded by the Atomic Energy Commission were conducted on hospital patients without disclosure through the 1950s. The gap between the Code's text and actual research practice was large and well documented.
The 1964 Declaration of Helsinki, issued by the World Medical Association, drew directly on the Code's framework but added physician responsibilities and provisions for vulnerable populations. After Tuskegee was exposed in 1972, the U.S. Congress passed the National Research Act, which created the National Commission for the Protection of Human Subjects and eventually produced the Belmont Report of 1979. That report established the principles underlying institutional review board oversight, the mechanism through which informed consent requirements are now operationalized in clinical research.
Key People
- Leo Alexander — Psychiatrist and war crimes investigator who drafted the initial ethics memorandum
- Andrew Ivy — American physician whose testimony helped define the ethical standards in the verdict
- Harold Sebring — American judge who presided over the Doctors' Trial and issued the verdict
Trials of War Criminals before the Nuremberg Military Tribunals, 1949 (Code issued 1947)
Related landmarks
- 1948 · MRC Streptomycin Trial for Pulmonary Tuberculosis (Research Methods & Ethics)
- 1962 · Kefauver-Harris Drug Amendments (Research Methods & Ethics)
- 1964 · Declaration of Helsinki (Research Methods & Ethics)
- 1972 · Cochrane, 'Effectiveness and Efficiency' (Research Methods & Ethics)