Informed Consent Overview - Module 1m Sec 4


Module 1 Objectives
The Process
Basic Principles
A Brief History
What Research Must Be Reviewed
IRB Review Criteria

A Brief History

ere are some significant dates in the development and history of informed consent.
Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics).
A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses are revealed in 1972.
The Kefauver-Harris Bill is passed to ensure greater drug safety in the United States after thalidomide (a new sleeping pill) is found to have caused birth defects in thousands of babies born in Western Europe.
The 18th World Medical Assembly meets in Helsinki, Finland, and issues recommendations to guide physicians in biomedical research involving human subjects.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and the National Research Act is passed by Congress. This Act prompted the establishment of IRB's at the local level and required IRB review and approval of all federally funded research involving human participants.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research -- a guide for U.S. research with human subjects.
The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment.
President Clinton creates the National Bioethics Advisory Commission (NBAC).
The President's Advisory Committee on Human Radiation Experiments concludes that some of the radiation experiments from the 1940s were unethical.
President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy
The NIH has suspended all gene therapy research on human subjects due to the controversial death of Jesse Gelsinger during a phase II drug dosage trial.

These events and others have prompted federal action to protect human subjects involved in all types of research. In December 1971, the U.S. Department of Health, Education, and Welfare began to require the creation of Institutional Review Boards (IRBs).

The proposed research design of a University faculty, staff, or student must be reviewed by the IRB. The California State University, Los Angeles IRB is charged with reviewing plans that protect your participants. The IRB ensures that human subjects do not bear any inappropriate risk and have properly consented to their involvement.

The Cal State L.A. IRB consists of 11 representatives of faculty, students, and the local community. The Cal State L.A. IRB reviews all research involving human subjects, irrespective of the funding source. This includes research that is funded by federal agencies, state government, foundations, internal grants, departmental funds, etc., as well as research that is not funded.

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