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Human Subject Research Legislation In The United States
Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards. Early research and legislation Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulator ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug, And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Willowbrook State School
Willowbrook State School was a state-supported institution for children with intellectual disabilities located in the Willowbrook neighborhood on Staten Island in New York City from 1947 until 1987. The school was designed for 4,000, but by 1965 it had a population of 6,000. At the time, it was the biggest state-run institution for people with mental disabilities in the United States. Conditions and questionable medical practices and experiments prompted Senator Robert F. Kennedy to call it a "snake pit." The institution gained national infamy in 1972, when Geraldo Rivera did an exposé on the conditions there. Public outcry led to its closure in 1987, and to federal civil rights legislation protecting people with disabilities. A February 2020 ''New York Times'' investigation found that the alumni of Willowbrook continue to be abused in smaller group homes. A portion of the grounds and some of the buildings were incorporated into the campus of the College of Staten Island, which ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
New England Journal Of Medicine
''The New England Journal of Medicine'' (''NEJM'') is a weekly medical journal published by the Massachusetts Medical Society. It is among the most prestigious peer-reviewed medical journals as well as the oldest continuously published one. History In September 1811, John Collins Warren, a Boston physician, along with James Jackson, submitted a formal prospectus to establish the ''New England Journal of Medicine and Surgery and Collateral Branches of Science'' as a medical and philosophical journal. Subsequently, the first issue of the ''New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science'' was published in January 1812. The journal was published quarterly. In 1823, another publication, the ''Boston Medical Intelligencer'', appeared under the editorship of Jerome V. C. Smith. The editors of the ''New England Journal of Medicine and Surgery and the Collateral Branches of Medical Science'' purchased the weekly ''Intelligencer'' for $600 in 1 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Henry K
Henry may refer to: People *Henry (given name) *Henry (surname) * Henry Lau, Canadian singer and musician who performs under the mononym Henry Royalty * Portuguese royalty ** King-Cardinal Henry, King of Portugal ** Henry, Count of Portugal, Henry of Burgundy, Count of Portugal (father of Portugal's first king) ** Prince Henry the Navigator, Infante of Portugal ** Infante Henrique, Duke of Coimbra (born 1949), the sixth in line to Portuguese throne * King of Germany **Henry the Fowler (876–936), first king of Germany * King of Scots (in name, at least) ** Henry Stuart, Lord Darnley (1545/6–1567), consort of Mary, queen of Scots ** Henry Benedict Stuart, the 'Cardinal Duke of York', brother of Bonnie Prince Charlie, who was hailed by Jacobites as Henry IX * Four kings of Castile: **Henry I of Castile **Henry II of Castile **Henry III of Castile **Henry IV of Castile * Five kings of France, spelt ''Henri'' in Modern French since the Renaissance to italianize the name and to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vera Hassner Sharav
Vera Sharav, a medical activist, is the founder of the Alliance for Human Research Protection and an activist against some practices of the biomedical industry, particularly in matters of patient consent and children. Biography Sharav was born April 17, 1937 in Romania as Vera Roll and survived the Holocaust as a child; her father did not survive. Her mother emigrated to the United States while she was cared for by relatives; she rejoined her mother in New York City when she was 8. She attended City College of New York and studied art history and after marriage and two children she went back to school, to the Pratt Institute, where in 1971 she received her master's in library science. Sharav became an activist against aspects of biomedical research after her teenage son died of a reaction to clozapine, which he had been prescribed for schizoaffective disorder. In her blog she criticizes the industry saying it is profit-driven, lies to its consumers and misleads people into part ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Marketing
Marketing is the process of exploring, creating, and delivering value to meet the needs of a target market in terms of goods and services; potentially including selection of a target audience; selection of certain attributes or themes to emphasize in advertising; operation of advertising campaigns; attendance at trade shows and public events; design of products and packaging attractive to buyers; defining the terms of sale, such as price, discounts, warranty, and return policy; product placement in media or with people believed to influence the buying habits of others; agreements with retailers, wholesale distributors, or resellers; and attempts to create awareness of, loyalty to, and positive feelings about a brand. Marketing is typically done by the seller, typically a retailer or manufacturer. Sometimes tasks are contracted to a dedicated marketing firm or advertising agency. More rarely, a trade association or government agency (such as the Agricultural Marketing Servic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Thalidomide
Thalidomide, sold under the brand names Contergan and Thalomid among others, is a medication used to treat a number of cancers (including multiple myeloma), graft-versus-host disease, and a number of skin conditions including complications of leprosy. While it has been used in a number of HIV-associated conditions, such use is associated with increased levels of the virus. It is taken by mouth. Common side effects include sleepiness, rash, and dizziness. Severe side effects include tumor lysis syndrome, blood clots, and peripheral neuropathy. Use in pregnancy may harm the fetus, including resulting in malformation of the limbs. In males who are taking the medication, contraception is essential if a partner could become pregnant. It is an immunomodulatory medication and works by a number of mechanisms, including stimulating T cells and decreasing TNF-α production. Thalidomide was first marketed in 1957 in West Germany, where it was available over the counter. When first r ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Federal Food, Drug And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Nuremberg Code
The Nuremberg Code (german: Nürnberger Kodex) is a set of ethical research principles for human experimentation created by the court in '' U.S. v Brandt'', one of the Subsequent Nuremberg trials that were held after the Second World War. Though it was articulated as part of the court's verdict in the trial, the Code would later become significant beyond its original context; in a review written on the 50th anniversary of the ''Brandt'' verdict, Jay Katz writes that "a careful reading of the judgment suggests that he authorswrote the Code for the practice of human experimentation whenever it is being conducted." Background The origin of the Code began in pre–World War II German politics, particularly during the 1930s and 1940s. Starting in the mid-1920s, German physicians, usually proponents of racial hygiene, were accused by the public and the medical society of unethical medical practices. The use of racial hygiene was supported by the German government in order to promote ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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