Institutional Review Board - US Mandate

US Mandate

See also: Human subject research legislation in the United States

In the United States, IRBs are governed by Title 45 Code of Federal Regulations Part 46. These regulations implement provisions of the National Research Act of 1974, for example defining IRBs and requiring them for all research that receives support, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections within HHS. IRBs were developed in direct response to research abuses earlier in the 20th century. Two of the most notorious of these abuses were the experiments of Nazi physicians that became a focus of the post-World War II Doctors' Trial, and the Tuskegee Syphilis Study, a project conducted between 1932 and 1972 by the U.S. Public Health Service on black men in rural Alabama. The goal of the experiment was to understand the long term effects of syphilis on the human body. Men with syphilis were studied but were never told that they had syphilis. Many men died, and many of their family members also contracted syphilis with no knowledge of the risk they faced. This was an abusive case by the Public Health Service. Title 21 Part 56 has additional requirements for IRBs that oversee clinical trials of drugs involved in new drug applications.