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Why Regulations

PROTECTING RESEARCH VOLUNTEERS

 

Why Do We Have Regulations to Protect Research Participants?

The regulations we have to protect people in research came about after a series of events in the twentieth century in which doctors and scientists abused the trust that society placed in them.


Examples of Unethical Research in the Past

 
The Nuremberg Doctors' Trial, in 1946, was an international military tribunal that tried and convicted Nazi doctors who conducted horrific unethical experiments on concentration camp prisoners during the Holocaust. It resulted in the Nuremberg Code, a set of international ethical guidelines for conducting research with humans.
 

There also were examples of research with questionable ethics going on in the United States. In 1966, Henry Beecher, an anesthesiologist and researcher, published a widely cited New England Journal of Medicine article (1966; vol. 274, p.1354-1360) detailing numerous examples of unethical experiments involving human subjects that were conducted at various U.S. institutions.
 

the New York TimesIn 1972, there was widespread media coverage of the Syphilis Study in Tuskegee, Alabama. Beginning in the 1930s and continuing for decades, U.S. government doctors studied the progression of untreated syphilis in poor African American men. The doctors did not tell the men they had syphilis, prevented them from learning their diagnosis, and did not offer treatment, even after penicillin became available.
 
All of which resulted in
 

The Need for Rules to Protect Research Participants

As a result of the public outcry from publicized cases of unethical research, Congress passed a law requiring federal rules to protect people who participate in research. The rules rely on ethical principles that were laid out in the Belmont Report, which was written by an advisory committee created by Congress and published in 1979.
 
HHS and OHRP
Protecting Human Subjects in Research
Content created by Office for Human Research Protections (OHRP)
Content last reviewed on September 26, 2017