“The Nuremberg Code” – Lessons learnt?

Stephan Klaschka, , , ,

(written in June 2004, updated March 2021, copyrights apply)

The Nuremberg Code

The Nuremberg Code was prompted in 1947 as a result of the International Military Tribunal held in Nuremberg (Nürnberg), Germany (1945-47) to apply the post-war introduced “crimes against humanity” law for German actions during WWII. The Nuremberg Code sets the frame for experimentation in humans and became part of the Declaration of Helsinki 1964 and laws internationally. The first point of the Nuremberg Code states: “The voluntary consent of the human subject is absolutely essential.”

Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War.

During the Nuremberg Medical Trial, German physicians were prosecuted for medical experimentation in humans during WWII. In particular, the gruesome and deadly experiments with humans in concentration camps under German governance were denounced.

On August 19, 1947, the judges of the American military tribunal in the case of the USA vs. Karl Brandt [Hitler’s personal physician] et. al. delivered their verdict. Before announcing the guilt or innocence of each defendant, they confronted the difficult question of medical experimentation on human beings. (Of the 23 accused, 7 received the death sentence, 9 were imprisoned between ten years and life sentence, and the remaining 9 were set free.)

Several German doctors had argued in their own defense that their experiments differed little from previous American or German ones. Furthermore, they showed that no international law or informal statement differentiated between legal and illegal human experimentation.

This follows a fundamental approach to all western law, where an accused may only be convicted if his action was an offense at the time it was committed (in Latin characterized as “nulla poena sine lege” which translates into “no punishment without a law”).

This argument worried Drs. Andrew Ivy and Leo Alexander, American doctors who had worked with the prosecution during the trial. On April 17, 1947, Dr. Alexander submitted a memorandum to the United States Counsel for War Crimes which outlined six points defining legitimate research. The verdict of August 19 reiterated almost all of these points in a section entitled “Permissible Medical Experiments” and revised the original six points into ten. Subsequently, the ten points became known as the “Nuremberg Code.” Although the code addressed the defense arguments in general, remarkably none of the specific findings against Brandt and his codefendants mentioned the code. Thus the legal force of the document was not well established. The uncertain use of the code continued in the half century following the trial when it informed numerous international ethics statements but failed to find a place in either the American or German national law codes. Nevertheless, it remains a landmark document on medical ethics and one of the most lasting products of the “Doctors Trial.”

At Nuremberg, a defendant was entitled to receive a copy of the indictment, to offer any relevant explanation to the charges brought against him, and to be represented by counsel and confront and cross-examine the witnesses. The tribunal rejected the major defenses offered by the defendants. First, it rejected the contention that only a state, and not individuals, could be found guilty of war crimes; the tribunal held that crimes of international law are committed by men and that only by punishing individuals who commit such crimes can the provisions of international law be enforced. Second, it rejected the argument that the trial and adjudication were ex post facto. The tribunal responded that such acts had been regarded as criminal prior to World War II.

  • Until the Nuremberg trials, there were no laws in place anywhere around the globe that would have regulated the conduct of human trials. The statutory offense of “crimes against humanity” was first introduced by the Military Tribunal and codified in what became the Nuremberg Code. This was used to prosecute accused Germans for all kinds offences under the new code in order to allow prosecution in the first place, as ‑otherwise‑ the accused would have to be set free due to inapplicable charges. This dilemma placed the Nuremberg trials and their –often deadly‑ sentences in an area of most questionable judicial procedure that was unprecedented at that time and never repeated due to its illegal practice, namely holding people accountable for actions that were not offences at the time they occurred.

Informed Consent

The first point of the Nuremberg Code reads “The voluntary consent of the human subject is absolutely essential.”

Clinical trials today are founded on this principle, referred to as “informed consent” of each subject, which is monitored and enforced strictly throughout the pharmaceutical industry internationally.

Obtaining informed consent is a delicate issue. It involves the initial visit, communicating the purpose of the study and ensuring that the subject understands what he/she is signing. This includes a consent form that is readable and addresses language and cultural issues. It should then follow that if the study subjects understand what the trial is about from the initial contact, retention rates will increase, as reported in several studies. A violation of the “informed consent” excludes the subject’s data from the trial immediately and may easily generate grave financial and serious legal consequences for both, the investigator as well as the sponsor of the study.

  • However, even after the Nuremberg Code was introduced, several severe violations against informed consent became public in the USA, the very country that has enforced its ruling at Nuremberg. The most recent example dates back less than one year – 56 year after the Nuremberg trials…

1932-1972  – The “Tuskegee” syphilis study

  • From 1932-1972 the “Tuskegee” syphilis study involved 600 low-income black males, 400 infected with syphilis are monitored for 40 years. Even though a proven cure (penicillin) became available in the 1950s, the study continues until 1972 with participants denied treatment. Perhaps as many as 100 died of syphilis during the study.

The study continued for decades after effective treatment became available. In some cases, when subjects were diagnosed as having syphilis by other physicians researchers intervened to prevent treatment.

Throughout the forty years of the study, it was periodically reviewed by U.S. Health Service officials. In each case, the study was extended based on the argument that stopping the study, while helping these individuals, would interfere with the benefits to medical science of studying this untreated disease […]. The study was stopped by the U.S. Department of Health, Education, and Welfare only after its existence was leaked to the public and it became a political embarrassment.

This study violated a number of ethical principles that are now applied to human subjects research.

  • The study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. This places all of the burdens of risk on that population when a much broader population benefits from the findings.
  • The study did not minimize risks to human subjects. In fact, it increased their risks. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.” (The Belmont Report, 1979)

The Tuskegee syphilis study is one of the most widely cited examples of research in which human subjects were not adequately protected. This study and other similar studies provided the impetus for federal regulations that now restrict the treatment of human subjects in research.

It took until 1997 for the US government to apologize to the seven survivors present that day. President Clinton stated that the “United States government did something that was wrong — deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens. […] It was a time when our nation failed to live up to its ideals when our nation broke the trust of our people that is the very foundation of our democracy. It is not only in remembering that shameful past that we can make amends and repair our nation, but it is in remembering that past that we can build a better present and a better future.”

Sacrificing few for the benefit of many

  • A second argument by the German defendants of the medical trial in Nuremberg presents some connections even to most recent politics: They argued that it was acceptable to sacrifice few for the greater good of many – a claim clearly denied by the Nuremberg Tribunal.

1950 – Atomic Energy Commission radioactivity

The Clinton administration’s first halting step toward taking responsibility for past government misdeeds occurred on Pearl Harbor Day 1993, when Department of Energy (DoE) Secretary Hazel O’Leary confirmed that the Atomic Energy Commission (AEC), her agency’s predecessor, had sponsored experiments in which hundreds of Americans were exposed to radioactive material, often without their consent.

That O’Leary had decided to break with her agency’s long tradition of secrecy and deception was something of a surprise. After all, she came to the job after a career in the nuclear power industry. But, confronted by a media firestorm over the government’s Cold War nuclear experiments, O’Leary was left with few options.

At least some officials knew what they were doing was unconscionable and were ducking the consequences and covering their tails. A recently leaked Atomic Energy Commission (AEC) document lays out in the most bare-knuckled manner the policy of cover-up. It is desired that no document be released which refers to experiments with humans and might have an adverse effect on public opinion or result in legal suits. Documents covering such work field should be classified `secret,’ wrote Colonel O.G. Haywood of the AEC. This letter confirms a policy of complete secrecy where human radiation experiments were concerned.

The Haywood letter may help explain a recently discovered 1953 Pentagon document, declassified in 1975. The two-page order from the secretary of defense ostensibly brought U.S. guidelines for human experimentation in line with the Nuremberg Code, making adherence to a universal standard official U.S. policy. Ironically, however, the Pentagon document was classified and thus was probably not seen by many military researchers until its declassification in 1975.

Against better knowledge and despite good intentions, the AEC has clearly violated informed consent on the subjects of nuclear testing, some of which for example were injected Plutonium.

As these and a steady stream of similar reports confirm, for decades, the U.S. government had not only used human guinea pigs in radiation experiments but had also followed a policy of deliberate deception and cover-up of its misuse of both civilians and military personnel in nuclear weapons development and radiation research. While the DoE has made some belated moves toward greater openness, there are clear indications that other federal agencies and the White House have not yet deviated from the time-honored tradition of deceit and self-serving secrecy.

More than 20 percent of Atomic Veterans [military participants at nuclear test locations] have fathered children with genetic birth defects as a result of their participation in the U.S. nuclear testing program. The U.S. government continues to stonewall and deny claims filed by Atomic Veterans who were exposed to high levels of radiation at nuclear test locations.

2003 – The Navy study

According to an article in the New York Times of September 28, 2003, the National Naval Medical Center has suspended all orthopedic and radiology research on patients while it investigates a study that violated standard ethical practice […]. Doctors who began the study of shoulder injuries two years ago had failed to seek approval from an ethics committee, as federal law requires, before injecting a chemical dye into 48 patients who then underwent M.R.I.’s […].

Dr. Michael Krentz, a Navy captain, […] is deputy commander of the center, which is the Navy’s flagship hospital and the hospital where President Bush gets his annual checkups. But subjecting a patient to both types of injections is investigational because the risks or benefits of an additional injection are not known, Dr. Krentz said in a telephone interview.

Navy officials have ordered a command-wide training of doctors and health workers in the ethics of human experimentation. A doctor training to become an orthopedic surgeon undertook the study without submitting a detailed scientific blueprint as required by an ethics committee known as an institutional review board, Dr. Krentz said. The ethical breach was reported in June.

Findings have not been reported at a scientific meeting or published because the number of patients in the study was too small for a meaningful statistical analysis. If the study design had been submitted to the review board, its members might have improved it before the first patient was enrolled, Dr. Krentz said.

The Navy has notified the federal Office for Human Research Protections and has not publicly released the names of the doctors involved. The medical center’s institutional review board has approved 177 research projects that are currently being conducted and is reviewing applications for an additional 50, Dr. Krentz said. The ban applies to five studies being conducted by radiologists and one other project being conducted by orthopedic surgeons.

  • The study was never published or presented because the number of enrolled subjects was too small to be statistically significant. Tragically, the study appears to have been conducted in vain and subjects treated without any scientific benefit, as no meaningful results are received. By the way, this in itself is an ethical violation.

It is quite surprising that something like this occurred in the Federal sector. How did the investigator or his medical facility not know this? Can we trust all those federally mandated rules and regulations devoted to the subject protection and human rights?

A review of the regulations that would disqualify a study came to the following evaluation: Failure to obtain IRB [Institutional Review Board] approval and comply with IRB regulation (21 CFR 54) stands right out there as a basis for disqualification. How did the investigator miss this?

The basis for disqualification list includes 21 CFR 50 — failure to obtain informed consent. Obtaining informed consent is a delicate issue. It involves the initial visit, communicating the purpose of the study and ensuring that the subject understands what he/she is signing. This includes a consent form that is readable and addresses language and cultural issues. It should then follow that if the study subjects understand what the trial is about from the initial contact, retention rates will increase […].

It is hard to believe this –still‑ happens in our time. There is only hope that the following words of Dr. Donald Arthur, a rear admiral, in this context hold true: “This is an isolated occurrence of not following well-prescribed research protocols; it is being fully investigated and reviewed to determine the cause of the oversight and to prevent recurrence.”

Sources used

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