Unjust events such as the St. Louis tragedy or the Tuskegee syphilis experiment have prompted regulations in biomedical research.
[1] The issue of experimentation on human subjects gained prominence after World War II and the revelation of atrocities committed in the name of science.
In the United States, the 1962 Kefauver-Harris amendments to the FDA included for the first time a requirement for informed consent of participants.
[2] In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review.
These boards, generally composed of both scientific peers from the institution and lay persons, are tasked with assessing the risks and benefits associated with the use of human subjects, in addition to the adequacy of the protection and consent of the participants.
Noncompliance can also induce sanctions from the institution, such as revoked access to facilities and subjects, suspension, and dismissal.
The Center for Biologics Evaluation and Research (CBER) is responsible for implementing federal regulations of biopharmaceuticals such as vaccines, blood components, gene therapies, etc.
They approve new drugs on the basis of safety and effectiveness, and issue licenses, which allow companies to market their products.
[10] The Energy Reorganization Act of 1974 established the Nuclear Regulatory Commission (NRC), in charge of licensing and safety.
This Act allows public schools to use supplementary material that is critical of the scientific theories such as evolution and global warming in science classrooms.
It also states that experimentation on humans must be necessary to society, be preceded by studies on animals, and protect subjects from injury, disability and death.