How the "ethics" of research using human subjects has changed since the Nuremberg Code.

Dianne N. Irving
March 28, 2018
Reproduced with Permission

  • March 28, 2018

  • How the "ethics" of research using human subjects has changed since the Nuremberg Code

    The Nuremberg Code

    Subsequent to the discriminatory Nuremberg Laws passed by the Nazis in Germany 1935 and the massive atrocities involving the torture and deaths of millions of innocent human beings that ensued, the Nuremberg Code was finally issued at the Nuremberg Trials at the end of World War II. The Nuremberg Code is a voluntary international guideline listing ten basic principles that must be met to satisfy moral, ethical and legal concerns involving the use of any human subjects in research -- including those participating in research in education. The Code consists of the following principles (paraphrased), focusing on the physical and mental safety of the human subjects involved:

    1. The voluntary consent of the human subject is essential.
    2. The experiment must be necessary for the good of society unattainable by other means, not random or unnecessary
    3. The experiment should be designed based on results of animal experimentation and knowledge of the disease, and that results will justify the performance of the experiment.
    4. The experiment should avoid all unnecessary physical and mental suffering and injury.
    5. If reason exists that death or disabling injury will occur the experiment should not be conducted -- except perhaps when the physician researchers themselves are the subjects.
    6. The degree of risk should never exceed the humanitarian importance of the problem to be solved.
    7. Proper preparations and adequate facilities should be provided to protect the human subject against even remote possibilities of injury, disability or death.
    8. The experiment should be conducted only by scientifically qualified and skilled persons.
    9. The human subject should be free to bring the experiment to an end if he/she determines the continuation of the experiment is impossible.
    10. The scientist in charge must be prepared to end the experiment at any stage if he/she has probably cause to believe that a continuation of the experiment is likely to result in injury, disability or death to the human subject.

    Since informed consent was considered so ethically fundamental, research on children and others not capable of deciding for themselves (e.g., the mentally ill) is prohibited.

    In 1964 the Nuremberg Code was followed by the voluntary international Declaration of Helsinki guidelines issued by the World Medical Association and have been revised multiple times since then. In 1991 the United States Department of Health and Human Services issued its own guidelines for the Protection of Human Subjects in research involving federal funding, also revised over time. Critics warn that the latter two efforts have seriously diluted the Nuremberg Code's protection of human subjects in research and are thus unethical. Given that there is an inherent tension between the search for scientific answers and concern for the rights and welfare of human subjects, they note the shift of focus from the protection of human subjects to the interests of governments, organizations and industry -- often justified by the utilitarian-based bioethics created by Congress in the 1978 Belmont Report . As many critics point out, including Dr. Marcia Angell , a member of the faculty of Global Health and Social Medicine at Harvard Medical School and former Editor-in-Chief of The New England Journal of Medicine , the long history of blatantly unethical research in clinical trials on human subjects by the government and private organizations since World War II to the recent past is testament to their concerns .

    Professor Dr. Dianne Nutwell Irving, M.A., Ph.D.

    See also 45 CFR part 46, Belmont Report, Conflict of Interest, Declaration of Helsinki, Falsified Data Historical Cases of, Federally Sponsored Research and Programs, Human Subjects Protections, Informed Consent

    Further Readings