Concept

Regulation of science

Summary
The regulation of science refers to use of law, or other ruling, by academic or governmental bodies to allow or restrict science from performing certain practices, or researching certain scientific areas. Science could be regulated by legislation if areas are seen as harmful, immoral, or dangerous. For these reasons science regulation may be closely related to religion, culture and society. Science regulation is often a bioethical issue related to practices such as abortion and euthanasia, and areas of research such as stem-cell research and cloning synthetic biology. Unjust events such as the St. Louis tragedy or the Tuskegee syphilis experiment have prompted regulations in biomedical research. Over the years, regulations have been extended to encompass animal welfare and research misconduct. The federal government also monitors the production and sale of the results of biomedical research such as drugs and biopharmaceuticals. The FDA and the Department of Health and Human Services oversee the implementation of these regulations. The Dickey–Wicker Amendment prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. 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. In 1966, a policy statement by the U.S Surgeon General required that all human subject research go through independent prior review. The National Research Act of 1974 institutionalized this review process by requiring that research centers establish Institutional Review Boards (IRBs). Universities, hospitals, and other research institutions set up these IRBs to review all the research done at the institution.
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