Informed Consent Overview - Module 1s Sec 4


Module 1 Objectives
The Process
Basic Principles

A Brief History
What Research Must Be Reviewed
IRB Review Criteria

A Brief History

Here 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
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.