Human Experimentation

Human Experimentation

• Use of human beings as experimental subjects for medical or non medical research.

• Observational Research: investigators record their observations and analyze data without administering intervention.

• Interventional Research: investigators manipulate the subjects or their environments in order to modify processes or results

Ethical Issues

• Pseudoscience framework

• Torturing people under the guise of research

• Violating medical ethics

Regulations

• 1976 - FDA issued that an Institutional Review Board must review all studies involving institutionalized subjects

• Informed consent regulations were put in place to also ensure all research subjects are informed and willing participants of the test, health and safety not endangered

Smallpox Experiment

• Example of human experimentation

• 1796 - Edward Jenner was aware milkmaids did not catch smallpox, but often cowpox. He hypothesized the cow pox provided immunity against the small pox, and injected cow pox into his son. He found he was immune to small pox.

Tuskagee Airmen Experiment

• These African American airmen had participated in a study that examined the progression of syphilis and were not treated.

Nuremburg Code

• Ten point statement delimiting permissible medical experimentation on human subjects.

• Essential voluntary consent

• Study should yield meaningful results

• Designed and based on animal experimentation results

• Avoiding unnecessary physical or mental suffering

• No experimentation if permanent disablement or death is known to occur, exception if scientists are in the study

• Degree of risk that the subjects in the study should undertake should not exceed the risk by the humanitarian importance

• Proper preparation for protection

• Experiments must be conducted by those qualified

• Participants can leave at any time

• Experiment must be terminated if death, injury, or disability can occur to participant

Declaration of Helsinki

• Statement of ethical principles for medical research involving human participants following the atrocities by physicians conducting unethical medical research during the Second World War.

• Developed by the World Medical Association (WMA)

Clinical Trials

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