Ethical Guidelines

Belmont Report:  The National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research was formed as one of the outcomes of the Syphilis Study at Tuskegee. The Commission drafted the Belmont Report, which is the foundation for the ethical principles and U.S. Department of Health and Human Services (HHS) regulations for the protection of research subjects. The three basic ethical principles are:

1)      Respect for persons
2)      Beneficence
3)      Justice

Helsinki declaration (pdf):  “The World Medical Association drafted the first international agreement recommending ethical standards for clinical research. Like the Nuremberg Code, the Declaration makes informed consent a central requirement for ethical research. The Declaration does, however, allow for surrogate consent when the research subject is incompetent, physically or mentally incapable of giving consent, or a minor. The Declaration, which has undergone multiple revisions, also states that research with these groups should be conducted only when the research is necessary to promote the health of the population represented and when this research cannot be performed on legally competent persons.”

Nuremberg Code (pdf)  The verdict from the Nazi Medical War Crimes Tribunal at Nuremberg included a section titled “Permissible Medical Experiments”, otherwise known as the Nuremberg Code. The Code provides ten Directives for Human Experimentation and was the first international code of research ethics:

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