The Nuremberg Code (1947)

Summary

The Nuremberg Code is a ten-point ethical document that emerged from the verdict of the 1947 Nuremberg Doctors’ Trial, in which twenty-three German physicians and administrators were tried before a United States Military Tribunal for conducting lethal experiments on concentration camp prisoners. The Code established that the voluntary, informed consent of every research subject is not a procedural nicety but an absolute moral and legal requirement. No scientific objective, however important, can override it. The Code is the founding document of modern Western research bioethics, and its requirement of voluntary consent has been absorbed into every subsequent international standard, from the Declaration of Helsinki (1964) to the Belmont Report (1979) and the institutional review board systems that govern human research worldwide.

Background: The Doctors’ Trial

The Nuremberg Doctors’ Trial (formally, United States of America v. Karl Brandt et al., Case No. 1 before Military Tribunal I) opened on December 9, 1946, and concluded with verdicts on August 19, 1947. It was one of the twelve Nuremberg Military Tribunals that followed the main International Military Tribunal, lesser in scope than the principal Nuremberg trials but equal in gravity of subject matter.

The tribunal’s task was to assess responsibility for what had been done to prisoners in the camps. As Jonsen’s history of bioethics summarizes the tribunal’s own finding, the evidence had shown that “beginning with the outbreak of World War II, criminal medical experiments on non-German nationals, both prisoners of war and civilians, including Jews and ‘asocial’ persons, were carried out on a large scale in Germany and the occupied countries.”(Jonsen, 2000) The Jackson Oxford Handbook places the total number of victims of these experiments at over 8,000, drawn from Jewish, Roma, Russian, and Polish prisoners among others.(Jackson (ed.), 2011)

The experiments themselves were documented in the courtroom in unusual clinical detail. Jonsen’s account records the categories: high-altitude research depriving victims of oxygen until death; deliberate freezing; infection with malaria treated with experimental drugs, many dying from disease or drug complications; infection with jaundice, typhus, cholera, smallpox, and diphtheria to develop vaccines; simulation and deliberate infection of battlefield wounds; and sterilization experiments on men and women to identify the most efficient methods for large-scale population application.(Jonsen, 2000) These were not rogue operations conducted by isolated aberrants. They were bureaucratically organized, carried out by physicians with conventional medical training, and in several cases directed by figures who held academic appointments at German universities.

The pre-history of regulatory consent in medicine is not entirely blank. Jackson’s survey notes that as early as 1900, Prussia had issued guidelines (likely the first such regulation worldwide) requiring that experiments be conducted only on “informed and explicitly consenting adults,” a direct response to the scandal over Albert Neisser’s 1892 non-consensual injection of syphilitic blood serum into hospital patients, some of them minors.(Jackson (ed.), 2011) That these regulations existed and failed to prevent what followed is itself a fact the Nuremberg tribunal was in a position to observe. Rules on paper do not constitute safeguards in the absence of enforcement and institutional culture.

The Document: Ten Principles

The Nuremberg Code is appended to the tribunal’s verdict, not issued as a standalone statute or treaty. The tribunal first acknowledged that certain types of medical experiments, conducted under proper conditions, conform to the ethics of the medical profession generally, and then specified what those conditions were. Ten principles were articulated. They are public-domain primary text and are presented here directly before analysis.

The ten principles, as recorded in the tribunal’s verdict:

1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

[Nuremberg Code (1947), Principles 1–10]

The weight of the Code sits in Principle 1. The tribunal was explicit in its formulation: voluntary consent is not merely preferable or generally required but “absolutely essential.” The word “absolutely” carries legal force: it forecloses balancing against other considerations. No research benefit, however great, can justify the absence of genuine, free, informed consent. This is not a claim borrowed from pre-existing medical ethics codes. It is a response to what happened when that principle was absent.

Principle 1 also contains, in its first articulation, most of what later bioethics would require: legal capacity, freedom from coercion, and sufficient understanding. The subsequent elaboration of these elements, into the threefold structure of disclosure, comprehension, and voluntariness that Beauchamp and Childress later formalized, is prefigured in the Code’s language.(Tom L. Beauchamp, James F. Childress, 2013)

Principles 2 through 10 address the design and conduct of experiments: the requirement of scientific justification and prior animal testing (3), the avoidance of unnecessary suffering (4), the exclusion of experiments likely to produce death or disabling injury (5), the proportionality of risk to humanitarian importance (6), qualified personnel (8), and the twin rights of termination: by the subject at any time (9) and by the investigator when evidence of harm emerges (10). These provisions translate the consent requirement from a threshold condition into an ongoing obligation throughout the research relationship.

Reception: The Code’s Slow Uptake

The Nuremberg Code was formulated by a military tribunal, not a medical professional body or a legislative assembly. This procedural origin became the basis for an argument that many American researchers made, sometimes explicitly, sometimes tacitly, in the decade following the verdict: that the Code had been written to govern what the Nazis did to prisoners, and therefore applied to extreme cases of nonconsensual experimentation on captive populations, not to ordinary clinical research involving willing American subjects who could decline to participate.

The Code did not immediately transform the culture of American medical research. The Tuskegee Syphilis Study, begun in 1932 by the United States Public Health Service and not terminated until 1972, demonstrates the failure of the Code’s principles to penetrate routine public health research in the postwar period. As Jonsen documents, of the 600 research subjects in that study, 400 had diagnosed syphilis but were never told and never treated. They were never informed that they were research subjects or that treatment for their condition could have been provided. The study, initially planned for one year, persisted for forty years, even after effective treatment with penicillin became available.(Jonsen, 2000) Jackson’s survey states the point directly: Tuskegee is “only the most prominent example” demonstrating that “Western countries’ researchers routinely failed to meet Nuremberg Code requirements,” raising the question, which the Code itself could not resolve, of whether ethical codes have any force absent legislative enforcement.(Jackson (ed.), 2011)

Hope’s analysis frames this limitation structurally. The entire edifice of current international research ethics regulation, Hope argues, “grows, distorted by the long shadow of the Nazi past.” Its character is reactive: “obsessed with one main concern,” in Hope’s phrasing, “to protect research participants from being abused.” The Code, and the frameworks it generated, established a necessary floor but left unanswered the constructive question of how the benefits of research can be maximized justly.(Hope, 2004) This is not a critique of the Code’s core requirements; it is an observation about the limits of a framework built in response to atrocity rather than designed from first principles for the full range of research situations that followed.

Influence: Helsinki, Belmont, and the IRB System

The Code’s direct institutional descendants form the regulatory architecture within which all biomedical research now operates in Western medicine.

The Declaration of Helsinki (1964), adopted by the World Medical Association, was the medical profession’s own codification of research ethics, drawing its provisions directly from the Code. It extended the Nuremberg requirements from experimental subjects broadly construed to the specific context of clinical research: trials conducted on patients in therapeutic settings. Hope’s account describes the Code’s ten principles as having been “incorporated by the medical profession into the Declaration of Helsinki, which was first published by the World Medical Association in 1964 and last updated in 2000.”(Hope, 2004) The Declaration introduced a four-fold framework of issues that the Code had handled together: respect for autonomy, risk of harm, value and quality of the research, and aspects of justice.(Hope, 2004)

The Belmont Report (1979), commissioned by the United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in direct response to the Tuskegee revelations, systematized three organizing principles (respect for persons, beneficence, and justice) that have structured bioethics pedagogy in American research medicine since. It was the Tuskegee scandal, not the Nuremberg Code, that catalyzed the specific legislative and regulatory apparatus: the National Research Act (1974), the Commission itself, and eventually the federal regulations governing IRBs.

Beauchamp and Childress, whose Principles of Biomedical Ethics has been the dominant bioethics textbook since 1979, trace the centrality of consent in contemporary ethics directly to the Code. Roughly since the Nuremberg trials, they observe, “ethics in medicine and in research has increasingly placed consent at the forefront of its concerns.” The term “informed consent” itself did not appear in the bioethics literature until a decade after the trials and did not receive detailed examination until the early 1970s.(Tom L. Beauchamp, James F. Childress, 2013) The Code generated the concept before the concept had a name.

Jackson’s survey confirms the chain of influence: the Code’s provisions “formed a basis for the Helsinki Declaration of 1964 of the World Medical Association.”(Jackson (ed.), 2011) The institutional review board system, the committee structure that reviews and approves research protocols involving human subjects before they begin, traces its lineage to the same postwar sequence.

Limitations and Critiques

Several structural criticisms of the Code have been developed by bioethicists and historians.

The “war crimes” framing. The Code was articulated by a military tribunal in response to atrocities committed by a totalitarian state on captive and coerced subjects. This origins argument was used, as noted above, to bracket the Code’s applicability to ordinary civilian research involving consenting volunteers. The argument is logically weak: the Code’s principles are not contingent on the political context of the experiments that prompted them. But it was sociologically effective in delaying the Code’s uptake in American research culture.

Codes without enforcement. Jackson’s survey poses the problem directly: Tuskegee demonstrates the limits of ethical codes “as long as they are not sufficiently endorsed and enforced by legislation.”(Jackson (ed.), 2011) The Code is a set of moral and legal principles appended to a verdict; it has no enforcement mechanism and no body charged with its application. The Declaration of Helsinki and the Belmont Report are similarly hortatory rather than coercive. The regulatory force came only through subsequent national legislation.

Character versus procedure. Pellegrino and Thomasma’s virtue ethics analysis identifies a deeper limitation: the Nazi physician atrocities demonstrate that rule-following cannot substitute for moral character, because “neither one, nor the other, nor both conjoined, guarantee good behavior.”(Pellegrino, 1993) The Code specifies what must be done; it cannot specify who must do it. Henry Beecher, analyzing American research ethics in the postwar decades, concluded that informed consent procedures are necessary but not sufficient: “there is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator.”(Pellegrino, 1993) Pellegrino and Thomasma cite this observation to argue that virtue (integrity, objectivity, honesty, freedom from bias) is not replaceable by consent procedure alone, even an absolutely required one.

The reactive frame. Hope, following Benatar and Singer, identifies the Code’s reactive character as a limitation for research in the contemporary global health context. Research ethics built around protecting subjects from abuse does not answer the constructive question of how to design equitable international research collaborations that genuinely benefit populations in resource-poor settings.(Hope, 2004) This critique does not contest the Code’s requirements; it argues that those requirements are a necessary but insufficient foundation for the ethics of research in the twenty-first century.

Scholarly Assessment

The Code’s place in the history of Western medicine is now settled in its broad outlines. It is the founding document of the bioethics tradition in research, specifically the foundation of the rule that human subjects must consent to what is done to them. It is not the founding document of medical ethics broadly, which traces to Hippocratic texts and the early modern professional codes from Percival forward.

The Code did not emerge from within the medical profession. It was produced by a legal tribunal assessing war crimes. This is itself a fact about the state of pre-Code medical ethics: the principle of voluntary consent in research was not a settled professional norm before 1947. It required a military verdict to articulate it explicitly.

The Code’s reception history shows how a foundational document can exist and be ignored simultaneously. Between 1947 and the early 1970s, the Code was formally part of the postwar bioethics vocabulary while being functionally set aside by American researchers who judged it inapplicable to their work. The Tuskegee exposure ended that suspension. What the Code required in principle, the national legislative apparatus that followed Tuskegee required in practice.

See Also

• holocaust — the medical experiments that produced the Doctors’ Trial
• world-war-ii — the broader wartime context
• belmont-report — the 1979 successor document systematizing bioethics principles
• tuskegee-syphilis-study — the forty-year American study that demonstrated the Code’s inadequacy without enforcement
• informed-consent — the doctrine the Code inaugurated
• medical-ethics — the broader tradition of professional ethics in Western medicine
• declaration-of-helsinki — the World Medical Association’s 1964 codification, directly descended from the Code

Sources

• Jonsen, Albert R. (2000). A Short History of Medical Ethics. Oxford University Press. (source_id: jonsen-short-history-medical-2000)
• Jackson, Mark (ed.). (2011). The Oxford Handbook of the History of Medicine. Oxford University Press. (source_id: jackson-oxfordhandbook-2011)
• Hope, Tony. (2004). Medical Ethics: A Very Short Introduction. Oxford University Press. (source_id: hope-medical-ethics-very-2004)
• Pellegrino, Edmund D., and David C. Thomasma. (1993). The Virtues in Medical Practice. Oxford University Press. (source_id: pellegrino-thomasma-virtues-1993)
• Beauchamp, Tom L., and James F. Childress. (2013). Principles of Biomedical Ethics, 7th ed. Oxford University Press. (source_id: beauchamp-childress-principles-of-biomedical-2013)

Editorial Notes

Gaps the encyclopaedia compiler flagged for future evidence work, collected from inline markers in the body and frontmatter.

Scholarly Assessment