Human subjects who participate in any type of research deserve respect for their rights and autonomy, protection from undue harm during their participation in research, and care that is free of injustice. The Teachers College Institutional Review Board (TC IRB) is committed to guiding investigators in developing their applications and to facilitating the approval process efficiently. Human subjects review is a federal requirement for all institutions engaged in human subject research. However, the IRB did not always exist. 

The modern story of human subjects' protections begins with the Nuremberg Military Tribunal and the Nuremberg Code and that “...voluntary consent of the human subject is absolutely essential.”

On December 9, 1946, criminal proceedings against 23 German physicians and administrators for their participation in war crimes and crimes against humanity began (United States Holocaust Memorial Museum, nd). During this trial, concerns about medical experimentation on human beings were raised. 

As WWII was coming to an end, the atrocities and horrors of Nazi Germany were revealed to the world, including the camp experiments committed by medical professionals on prisoners of war without permission, often harmful and deadly for victims. Some of these experiments included injecting victims with contagious diseases without subsequent treatment, exposure to extreme temperatures leading to conditions such as hyperthermia, and infecting wounds (Marks, 2006).

During the Nuremberg Trial, the defendants argued that their experimentation did not differ from other countries and no international law or statement differentiated between legal and illegal human experimentation. The defense’s argument brought awareness to the lack of policy on what is considered ethical research. Dr. Leo Alexander, one of the United States’ doctors on the prosecution, later submitted a memorandum to the United States Counsel for War Crimes to redefine legitimate medical research. 

 

The Nuremberg Code 

According to the Nuremberg Code, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that “satisfy moral, ethical, and legal concepts.”

—“Permissible Medical Experiments.” Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg October 1946 – April 1949, Washington. U.S. Government Printing Office (n.d.), vol. 2., pp. 181-182.

  1. Voluntary consent is essential
    1. A person should have legal capacity to give consent; 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. An affirmative decision should be informed about the nature, duration, and purpose of the study and the method and means by which it is to be conducted.
    3. With all inconveniences and hazards reasonably to be expected.
    4. Researchers are responsible for obtaining consent.
  2. The results of any experiment must be for the greater good of society
  3.  Human experiments should be based on previous animal experimentation.
  4. Experiments should be conducted by avoiding physical and mental suffering and injury.
  5. No experiments should be conducted if it is believed to cause death and/or disability.
  6. The risks should never outweigh the benefits.
  7. Adequate facilities should be used to protect human subjects even if there is a remote possibility of injury, disability, or death.
  8. Experiments should be conducted only by qualified investigators, researchers, and/or scientists.
  9. Subjects should be able to end their participation at any time free of judgment, burden, or harm.
  10. The qualified investigator, researcher, and/or scientist in charge must be prepared to terminate the experiment/study when injury, disability, or death is a concern or likely to occur.

Alongside the Declaration of Helsinki, the Nuremberg Code influences the ethical treatment of human research subjects in the United States Department of Health and Human Services. 

 

References:

Greenwald, R. A., Ryan, M. K., & Mulvihill, J. E. (Eds.). (1982). Human subjects research: A handbook for institutional review boards. Plenum Press.

International Military Tribunal. (1949). Trials of war criminals before the Nuernberg Military Tribunals under Control Council law no. 10: Nuernberg, October 1946–April 1949. U.S. Government Printing Office. https://lccn.loc.gov/2011525364

Marks, A. R. (2006). Doctors from hell: The horrific account of Nazi experiments on humans. Journal of Clinical Investigation, 116(1), 2. https://doi.org/10.1172/JCI27539

Seiber, J. E. (1992). Planning ethically responsible research: A guide for students and internal review boards. Sage Publications.

U.S. Department of Health and Human Services. (1991). Code of Federal Regulations Title 45 Part 46: Protection of human subjects (45 CFR 46).

United States Holocaust Memorial Museum. (n.d.). The Doctors Trial: The medical case of the subsequent Nuremberg proceedings. https://encyclopedia.ushmm.org/content/en/article/the-doctors-trial-the-medical-case-of-the-subsequent-nuremberg-proceedings

 

For more information on ethics and research consult these resources: 

— Mae Lu; MA, EdM

Tags: Ethics New to IRB IRB Reviewers Consent

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