Regulation Of Science
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Regulation Of Science
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. United States Biomedical research 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 ...
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Academic
An academy (Attic Greek: Ἀκαδήμεια; Koine Greek Ἀκαδημία) is an institution of secondary education, secondary or tertiary education, tertiary higher education, higher learning (and generally also research or honorary membership). The name traces back to Plato's school of philosophy, founded approximately 385 BC at Akademia, a sanctuary of Athena, the goddess of wisdom and Skills, skill, north of Ancient Athens, Athens, Greece. Etymology The word comes from the ''Academy'' in ancient Greece, which derives from the Athenian hero, ''Akademos''. Outside the city walls of Athens, the Gymnasium (ancient Greece), gymnasium was made famous by Plato as a center of learning. The sacred space, dedicated to the goddess of wisdom, Athena, had formerly been an olive Grove (nature), grove, hence the expression "the groves of Academe". In these gardens, the philosopher Plato conversed with followers. Plato developed his sessions into a method of teaching philosophy and in 3 ...
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Dickey–Wicker Amendment
The Dickey–Wicker Amendment is the name of an appropriation bill rider attached to a bill passed by United States Congress in 1995, and signed by former President Bill Clinton, which prohibits the United States 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. HHS funding includes the funding for the National Institutes of Health (NIH). It is named after Jay Dickey and Roger Wicker, two Republican Representatives. Technically, the Dickey Amendment is a rider to other legislation, which amends the original legislation. The rider receives its name from the name of the Congressman that originally introduced the amendment, Representative Dickey. The Dickey amendment language has been added to each of the Labor, HHS, and Education appropriations acts for fiscal years 1997 through 2009. The original rider can be found in Section 128 of P.L. 104–99. ...
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Butler Act
The Butler Act was a 1925 Tennessee law prohibiting public school teachers from denying the Biblical account of mankind's origin. The law also prevented the teaching of the evolution of man from what it referred to as lower orders of animals in place of the Biblical account. The law was introduced by Tennessee House of Representatives member John Washington Butler, from whom the law got its name. It was enacted as Tennessee Code Annotated Title 49 (Education) Section 1922, having been signed into law by Tennessee governor Austin Peay. The law was challenged later that year in a famous trial in Dayton, Tennessee called the Scopes Trial which included a raucous confrontation between prosecution attorney and fundamentalist religious leader, William Jennings Bryan, and noted defense attorney and religious agnostic, Clarence Darrow. It was repealed in 1967. Provisions of the law The law, "An act prohibiting the teaching of the Evolution Theory in all the Universities, and all ot ...
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Nuclear Regulatory Commission
The Nuclear Regulatory Commission (NRC) is an independent agency of the United States government tasked with protecting public health and safety related to nuclear energy. Established by the Energy Reorganization Act of 1974, the NRC began operations on January 19, 1975, as one of two successor agencies to the United States Atomic Energy Commission. Its functions include overseeing reactor safety and security, administering reactor licensing and renewal, licensing radioactive materials, radionuclide safety, and managing the storage, security, recycling, and disposal of spent fuel. History Prior to 1975 the Atomic Energy Commission was in charge of matters regarding radionuclides. The AEC was dissolved, because it was perceived as unduly favoring the industry it was charged with regulating.John Byrne and Steven M. Hoffman (1996). ''Governing the Atom: The Politics of Risk'', Transaction Publishers, p. 163. The NRC was formed as an independent commission to oversee nuclear ene ...
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Energy Reorganization Act Of 1974
The Energy Reorganization Act of 1974 (, codified at 42 U.S.C.A. § 5801) is a United States federal law that established the Nuclear Regulatory Commission. Under the Atomic Energy Act of 1954, a single agency, the U.S. Atomic Energy Commission, had responsibility for the development and production of nuclear weapons and for both the development and the safety regulation of the civilian uses of nuclear materials. The Act of 1974 split these functions, assigning to the Energy Research and Development Administration (now the United States Department of Energy) the responsibility for the development and production of nuclear weapons, promotion of nuclear power, and other energy-related work, and assigning to the NRC the regulatory work, which does not include regulation of defense nuclear facilities. The Act of 1974 gave the Commission its collegial structure and established its major offices. A later amendment to the Act also provided protections for employees, whistleblowers, who ...
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Atomic Energy Act Of 1946
The Atomic Energy Act of 1946 (McMahon Act) determined how the United States would control and manage the nuclear technology it had jointly developed with its World War II allies, the United Kingdom and Canada. Most significantly, the Act ruled that nuclear weapon development and nuclear power management would be under civilian, rather than military control, and established the United States Atomic Energy Commission for this purpose. It was sponsored by Senator Brien McMahon, a Democrat from Connecticut, who chaired the United States Senate Special Committee on Atomic Energy, and whose hearings in late 1945 and early 1946 led to the fine tuning and passing of the Act. The Senate passed the Act unanimously through voice vote, and it passed the House of Representatives 265–79. Signed into law by President Harry S. Truman on August 1, 1946, it went into effect on January 1, 1947, and the Atomic Energy Commission assumed responsibility for nuclear energy from the wartime Manhatt ...
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Biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biological ...
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Center For Biologics Evaluation And Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks (physician), Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologic medical product, biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and Cell therapy, cell, tissue, and Gene therapy, gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER). Scope * Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- Blood plasma, plasma derivatives, including intravenous immunoglobulin, immunoglobulins, Hy ...
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Center For Drug Evaluation And Research
The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market. CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. The decisions on approval will often make or break a small company's stock pr ...
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Office Of Laboratory Animal Welfare
The Office of Laboratory Animal Welfare (OLAW) oversees the care and use of research animals in any public or private organization, business, or agency (including components of Federal, state, and local governments). The Public Health Service consists of the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration The Substance Abuse and Mental Health Services Administration (SAMHSA; pronounced ) is a branch of the U.S. Department of Health and Human Services. It is charged with improving the quality and availability of treatment and rehabilitative services ... (SAMHSA). The agencies of the PHS are a part of the U.S. Department of Health and Human Services. PHS Policy on Humane Care and Use of Laboratory Animals (Policy) requires institutions to establish and ...
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Institutional Animal Care And Use Committee
Institutional Animal Care and Use Committees (IACUCs) are centrally important in applying laws about animal research in the United States. Similar systems operate in other countries, but generally under different titles; for example, in Canada a typical title would be the University Animal Care Committee (UACC), while in the United Kingdom it would be the Animal Welfare and Ethical Review Body (AWERB). Most research involving laboratory animals in the United States is funded by the United States National Institutes of Health or, to lesser extents, other federal agencies. The NIH Office of Laboratory Animal Welfare (OLAW) has been directed by law to develop policies that describe the role of Institutional Animal Care and Use Committees. Every institution that uses certain animals for federally funded laboratory research must have an Institutional Animal Care and Use Committee (IACUC). Each local IACUC reviews research protocols and conducts evaluations of the institution's animal ...
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Animal Welfare Act Of 1966
The Animal Welfare Act (Laboratory Animal Welfare Act of 1966, ) was signed into law by President Lyndon B. Johnson on August 24, 1966. It is the main federal law in the United States that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act (otherwise known as the "AWA") as the minimally acceptable standard for animal treatment and care. The USDA and APHIS oversee the AWA and the House and Senate Agriculture Committees have primary legislative jurisdiction over the Act. Animals covered under this Act include any live or dead cat, dog, hamster, rabbit, nonhuman primate, guinea pig, and any other warm-blooded animal determined by the Secretary of Agriculture for research, pet use or exhibition. Excluded from the Act are birds, rats of the genus ''Rattus'' (laboratory rats), mice of the genus ''Mus'' (laboratory mic ...
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