Protecting Human Research Participants

Human subjects are essential to the conduct of research intended to improve human health. As such, the relationship between investigators and human subjects is critical and should be based on honesty, trust, and respect.

2008 Office of Extramural Research, National Institutes of Health

Nazi Medical War Crimes

Although not the first example of harmful research on unwilling human subjects, the experiments conducted by Nazi Physicians during World War II were unprecedented in their scope and the degree of harm and suffering to which human beings were subjected. “Medical experiments” were performed on thousands of concentration camp prisoners and included deadly studies and tortures such as injecting people with gasoline and live viruses, immersing people in ice water, and forcing people to ingest poisons.

In December 1946, the War Crimes Tribunal at Nuremberg indicted 20 physicians and 3 administrators for their willing participation in the systematic torture, mutilation, and killing of prisoners in experiments. The Nuremberg Military Tribunals found that the defendants had:

• Corrupted the ethics of the medical and scientific professions
• Repeatedly and deliberately violated the rights of the subjects

The actions of these defendants were condemned as crimes against humanity. Sixteen of the twenty-three physicians/administrators were found guilty and imprisoned, and seven were sentenced to death. In the August 1947 verdict, the judges included a section called Permissible Medical Experiments. This section became known as the Nuremberg Code.

nuremberg code 이미지 검색결과


Photo source: Photo Archive, United States
Holocaust Memorial Museum, courtesy of
Hedwig Wachenheimer Epstein

The Code provides ten Directives for Human Experimentation

  1. Voluntary consent of the human subject is absolutely essential
  2. The experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature
  3. Animal experimentation should precede human experimentation
  4. All unnecessary physical and mental suffering and injury should be avoided
  5. No experiment should be conducted if there is reason to believe that death or disabling injury will occur
  6. The degree of risk to subjects should never exceed the humanitarian importance of the problem
  7. Risks to the subjects should be minimized through proper preparations
  8. Experiments should only be conducted by scientifically qualified investigators
  9. Subjects should always be at liberty to withdraw from experiments
  10. Investigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject

Citation : © 2008 Office of Extramural Research, National Institutes of Health

Categories: Clinical, Journals