To this day, human rights in medical research can be traced back to the Nuremberg Code. Drafted in response to the atrocities committed by Nazi physicians during World War II, the code continues to influence conversations about ethical research practices.
This guide will help outline the history of how the Nuremberg Code was created, and its subsequent influence on protecting human rights in research and experimentation. A description of key terms will lay the groundwork for an understanding on ethical experimentation and point to additional sources of information.
Critical Components of the Code
Protecting human rights through informed consent is at the core of the Nuremberg Code and is generally accepted and adopted as a pillar of research the world over.
The code was the first to state that “the voluntary consent of the human subject is absolutely essential” with an understanding that subjects have “sufficient knowledge and comprehension” of the experiments prior to giving their consent, in order “to make an understanding and enlightened decision.. absence of coercion in any form.” In today’s world this concept seems commonplace, but at the time it was a groundbreaking step.
Similar to guidelines like the Hippocratic Oath, which also requires healthcare professionals to practice medicine ethically and honestly, the Nuremberg code requires that the researcher act in the best interest of the subject. This enables the subject to end the experiment at any time, according to The New England Journal of Medicine.
By stipulating that the experiment must be “for the good of society” and results “unproduceable by other means” review boards have stronger grounds to eliminate experiments without clear scientific rationale.
It is important to note, however, that the Nazis were not the only group who was willing to harm subjects in the name of research. The U.S. also conducted medical experiments, for example, on four-hundred African American men with syphilis in 1932 in Tuskegee, Alabama. Many of these men eventually lost their lives, despite a readily available treatment option, because the researchers wanted to watch the natural course of the disease, according to the University of Alaska Office of Research Integrity in Fairbanks, Alaska.
The creation of the code was the first concrete set of guidelines or regulations created to protect human rights through experimentation. The American military tribunal who convened the “doctors’ trials” in 1947 Nuremberg, Germany prosecuted twenty-three doctors and administrators, according to the Harvard Law School Library summary of the legal case. The trials testified, in painful detail, the atrocities committed through research on inmates of the concentration camps, and disabled citizens.
The research experiments included infecting inmates with viruses, treating some with vaccines and observing the natural course of the disease in others; testing poison bullets to improve killing efficiency; testing survival rates at high altitude; and bone, muscle and nerve transplantation and regeneration, according to the Indiana University-Purdue University Indianapolis.
As a result of these trials the code was created to prevent such atrocities and provide ethical regulations for research. While the Nuremberg Code isn’t an adopted or official law for any country or major medical association, it continues to be one of the most important influences in human medical research laws and ethics to this day.
According to the Claremont University history of ethics, there were no regulating bodies or guidelines on the ethical use of human participants prior to 1906. The passage of the Pure Food and Drug Act, an early version of today’s Food and Drug Administration (FDA) was the first attempt. Some experts claim that the 1931 Guidelines for Human Experimentation passed by the German Government are the earliest guidelines, which the Nuremberg guidelines were eventually adapted from.
It was quickly determined, following the “doctor’s trials” that an independent board would be a more efficient means to govern research. By the year 1953, the National Institutes of Health required that all research projects obtain approval from a protection of human subjects review panel, according to Simpson University. As the years progressed, additional research organizations, such as the United States Public Health Service in 1966, required a methods review prior to the start of experimentation. Eventually these rules were revised in the 1970s and adopted formally as institutional review boards (IRBs), which are now commonplace and required at the hundreds of research institutions receiving federal research funding.
The Nuremberg Code was the primary impetus for many documents attempting to define the relationship between medical research and human experiments. One such document is the Declaration of Helsinki adopted by the World Medical Association (WMA) at the WMA General Assembly in Helsinki in 1964. Its aim was to provide physicians with guidance on their responsibilities to their research subjects, according to the World Health Organization.
The Belmont Report of 1978 is another document with roots in the Nuremberg Code. Created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice, according to the University of Wisconsin Health Sciences (WSH).
The report provides the outline for the way IRBs should weigh the risks to research subjects as justified by research gains. The goal, according to WSH, was to create a more rigorous assessment and communication process between the IRB and the researcher.
The legacy of the Nuremberg Code is deeply rooted in the literature governing the ethics of medical research to this day. Though the code in its entirety may not be the adopted standard, it still pays homage to those who lost their lives at the hands of researchers, and protects the innocent carrying forward.