Ethical Codes After Nuremberg
The World Medical Association Struggles Toward a New Code of Ethics
Oct 6, 2009
Following the end of the Nuremberg Trials in 1947, the World Medical Association (WMA) struggled to come up with a code of ethics that would aid physicians in performing research on human subjects. The principles set forth in the Nuremberg Code were lofty, but restricted to National Socialist (Nazi) medical abuses during World War II. On August 19, 1947, the Nuremberg Military Tribunal admitted as much when it said that it was concerned solely with requirements that were “so clearly related to matters legal that they assist us in determining criminal culpability and punishment.”
The Nuremberg Code is Seen as Too Legalistic and Impractical
Physicians, however, are not lawyers. Legal codes may serve a purpose in the courtroom, where blame is assessed, but they do not give practical guidance about everyday medical decisions. After all, it is one thing to claim that “the voluntary consent of the human subject is absolutely essential” before any experiment can begin. It is quite another to come up with a code of ethics that allows for every unforeseen contingency that may arise when dealing with an issue as complex as informed consent.
There was also another problem. If read closely, the Code principles applied strictly to healthy volunteers — not vulnerable individuals most likely to be abused by unethical researchers, such as the mentally ill, illiterate immigrants, orphan children, or prisoners. Other protections were needed.
From the Physician's Oath to the Universal Declaration of Human Rights
In 1948, the WMA adopted the Declaration of Geneva. The Declaration consisted of a straightforward Physician’s Oath, much like that originally proposed by Hippocrates. Upon admission to the medical profession, all new doctors pledged that “the health of my patient will be my first consideration.”
The WMA also added a clause intended to distance physicians from the horrors of Nazi medicine: “Even under threat, I will not use my medical knowledge contrary to the laws of humanity.” Although the Declaration of Geneva had a laudatory aim, it was too imprecise to be useful in specific situations.
Some three months later, the United Nations adopted the Universal Declaration of Human Rights. The Universal Declaration contained even broader language, which was aimed at placing the concept of informed consent as a fundamental right within the framework of humanity. Only when human dignity was acknowledged would “human rights . . . be protected by the rule of law.”
The WMA Adopts the International Code of Medical Ethics
In 1949, the WMA adopted the first International Code of Medical Ethics. The International Code was divided into three brief sections:
- Duties of Doctors in General
- Duties of Doctors to the Sick
- Duties of Doctors to Each Other
The International Code reaffirmed the 1948 Physician's Oath (from the Declaration of Geneva), while promising the “patient complete loyalty and all the resources of . . . science.”
But even this was not enough in a world where science and medicine advanced so rapidly. Within a few years, the world would see the mysteries of DNA decoded, the first organ transplants performed, and the development of the polio vaccine. Suddenly, new complexities in ethics had to be considered.
The Declaration of Helsinki (1964)
In 1953, WMA members began exploring various guidelines that would help physicians in their role as clinical investigators. More than a decade passed, however, before the resulting Declaration of Helsinki (1964) was released.
The Declaration of Helsinki has been revised six times, beginning first in 1975, and then in 1983, 1989, 1996, 2000 (with clarifying notes added in 2002 and 2004), and 2008. In full, it now contains three separate sections with 35 separate paragraphs:
- Section A defines what human research is.
- Section B establishes basic principles for research, including informed consent.
- Section C affirms that research can only be combined with clinical care, where subjects are aware what part of their care is experimental.
Does the Declaration of Helsinki Weaken Nuremberg Code Principles?
Although the Declaration of Helsinki reaffirmed the need for informed consent within a more comprehensive set of guidelines for physicians, some critics felt that the intentions of the Nuremberg Code had been weakened. Instead of maintaining the absolute respect for the will of the human subject, the Declaration of Helsinki (1964–1996) differentiated between therapeutic and non-therapeutic research.
Once again, the physician became the final arbiter of what was best for the doctor-patient relationship. Thus, rather than emphasizing informed consent as the best protector of patient rights, the Declaration of Helsinki subtly shifted patient welfare back toward the paternalistic opinions of the physician.
In 2000, the WMA deleted the distinction between therapeutic and non-therapeutic research altogether, thereby muddying the waters even further by allowing physicians “to combine medical research with medical care.” Even with these protections, research abuses continued that finally would be exposed with the publication of an historic 1966 article by Dr. Henry K. Beecher.
References
World Medical Association (WMA). 1948. Declaration of Geneva. Adopted by the General Assembly of World Medical Association at Geneva, Switzerland, September 1948.
-------. 1949. International code of medical ethics. World Medical Association Bulletin. 1(3):109, 111.
-------. 1964. Declaration of Helsinki. 18th WMA General Assembly. Helsinki, Finland.
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