Historical Context: Government Inhumanity to EPA Regulation

Despite Doctors’ trial and the resultant Nuremberg Code, not all researchers got the message about conducting proper scientific experiments with humans — notably, the U.S. Public Health Service.

Beginning in 1932, the U.S. Public Health Service and the Tuskegee Institute recruited about 600 poor, African-American farmers for the purpose of studying the natural progression of syphilis in the men. The men volunteered under the impression that they were to receive free medical care for life. They were not informed that they had syphilis and their syphilis was never treated, even though by 1947, penicillin had become the standard treatment.

The story of the so-called Tuskegee syphilis experiment broke in July 1972, where upon the study was immediately terminated, before which however, many of the men had died and had communicated syphilis to their wives and children.

The Tuskegee syphilis experiment and other U.S. government-sponsored human research horrors prompted Congress to enact with the National Research Act of 1974, which created a commission to develop principles for the protection of human subjects in scientific experimentation.

Four years later, the commission produced the so-called Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (Belmont Report).

In 1991, the Belmont Report was incorporated into federal regulations at 45 CFR Part 46 and is known as “the Common Rule.”

The U.S. Environmental Protection Agency aalso adopted the Common Rule into its regulations at 40 CFR Part 26.

NEXT: The Common Rule

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