Background

Background

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The establishment of IRBs was prompted by abuses in human medical experimentation over the past half a century. The Nuremberg Code was the first modern document to address human subjects rights. It was written after Nazi military doctors were put on trial for their unethical human experiments during World War II. It created an international standard to measure medical research ethics.

In the United States, the tragic consequences of the use of the drug thalidomide led to the strengthening of regulations in the Food and Drug Administration to protect patients receiving experimental drugs. Children were born with deformed and missing limbs when pregnant women were given the sedative thalidomide without being told it was an experimental substance. Although the investigators were unaware of the damaging effects of thalidomide on a fetus, the fact that they had experimented on pregnant women without their knowledge was particularly alarming to regulators.

Required review of research by Institutional Review Boards was mandated in the National Research Act of 1974. The United States Congress passed the act after a series of research scandals came to light, including the Tuskagee Syphilis Study. In this study, poor black men with syphilis unknowingly went untreated while doctors studied the course of the disease.

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have adopted regulations for the operation of IRBs based on the National Research Act and the Belmont Report, a statement of basic ethical principles in research. IRBs are charged in these regulations to protect the rights of human subjects from abuse, including violation of informed consent. It is in accordance with these regulations that the Carilion Clinic Institutional Review Board has been established.