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Guidelines For Human Subject Research
Various organizations have created guidelines for human subject research for various kinds of research involving human subjects and for various situations. Instructions for the Directors of Clinics, Outpatient Clinics and Other Medical Facilities In 1892, Albert Ludwig Sigesmund Neisser, a German physician who is credited with the discovery of Neisseria gonorrhoeae, performed two sets of clinical trials attempting to find a method of prevention for syphilis. Neisser first inserted serum obtained from a single patient who had begun exhibiting the early signs of syphilis under the skin of four female patients,Vollmann, Jochen, and Rolf Winau. "Informed consent in human experimentation before the Nuremberg code." BMJ: British Medical Journal 313.7070 (1996): 1445. similar to the procedure for smallpox inoculation. Neisser did not obtain consent from these patients, but none of them developed the disease. Neisser then conducted the second set of trials on four prostitutes.Ligon, BL. A ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Penicillin
Penicillins (P, PCN or PEN) are a group of β-lactam antibiotics originally obtained from ''Penicillium'' moulds, principally '' P. chrysogenum'' and '' P. rubens''. Most penicillins in clinical use are synthesised by P. chrysogenum using deep tank fermentation and then purified. A number of natural penicillins have been discovered, but only two purified compounds are in clinical use: penicillin G (intramuscular or intravenous use) and penicillin V (given by mouth). Penicillins were among the first medications to be effective against many bacterial infections caused by staphylococci and streptococci. They are still widely used today for different bacterial infections, though many types of bacteria have developed resistance following extensive use. 10% of the population claims penicillin allergies but because the frequency of positive skin test results decreases by 10% with each year of avoidance, 90% of these patients can tolerate penicillin. Additionally, those with ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Ethics Committee
An ethics committee is a body responsible for ensuring that medical experimentation and human subject research are carried out in an ethical manner in accordance with national and international law. Specific regions An ethics committee in the European Union is a body responsible for oversight of medical or human research studies in EU member states. Local terms for a European ethics committee include: * A Research Ethics Committee (REC) in the United Kingdom * A Medical Research Ethics Committee (MREC) in the Netherlands. * A Comité de Protection des Personnes (CPP) in France. In the United States, an ethics committee is usually known as an institutional review board (IRB) or research ethics board (REB) and is dedicated to overseeing the rights and well-being of research subjects participating in scientific studies in the US. Similarly in Canada, the committee is called a Research Ethics Board (REB). In Australia, an ethics committee in medical research refers to a Human Rese ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Informed Consent
Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclosing a person's medical information. Definitions of informed consent vary, and the standard required is generally determined by the state. Informed consent requires a clear appreciation and understanding of the facts, implications, and consequences of an action. To give informed consent, the individual concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to reasoning an ... [...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] |
United States Department Of Defense
The United States Department of Defense (DoD, USDOD or DOD) is an executive branch department of the federal government charged with coordinating and supervising all agencies and functions of the government directly related to national security and the United States Armed Forces. The DoD is the largest employer in the world, with over 1.34 million active-duty service members (soldiers, marines, sailors, airmen, and guardians) as of June 2022. The DoD also maintains over 778,000 National Guard and reservists, and over 747,000 civilians bringing the total to over 2.87 million employees. Headquartered at the Pentagon in Arlington, Virginia, just outside Washington, D.C., the DoD's stated mission is to provide "the military forces needed to deter war and ensure our nation's security". The Department of Defense is headed by the secretary of defense, a cabinet-level head who reports directly to the president of the United States. Beneath the Department of Defense are th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Psychology
Psychology is the scientific study of mind and behavior. Psychology includes the study of conscious and unconscious phenomena, including feelings and thoughts. It is an academic discipline of immense scope, crossing the boundaries between the natural and social sciences. Psychologists seek an understanding of the emergent properties of brains, linking the discipline to neuroscience. As social scientists, psychologists aim to understand the behavior of individuals and groups.Fernald LD (2008)''Psychology: Six perspectives'' (pp.12–15). Thousand Oaks, CA: Sage Publications.Hockenbury & Hockenbury. Psychology. Worth Publishers, 2010. Ψ (''psi''), the first letter of the Greek word ''psyche'' from which the term psychology is derived (see below), is commonly associated with the science. A professional practitioner or researcher involved in the discipline is called a psychologist. Some psychologists can also be classified as behavioral or cognitive scientists. Some psyc ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
American Psychological Association
The American Psychological Association (APA) is the largest scientific and professional organization of psychologists in the United States, with over 133,000 members, including scientists, educators, clinicians, consultants, and students. It has 54 divisions—interest groups for different subspecialties of psychology or topical areas. The APA has an annual budget of around $115 million. Profile The APA has task forces that issue policy statements on various matters of social importance, including abortion, human rights, the welfare of detainees, human trafficking, the rights of the mentally ill, IQ testing, sexual orientation change efforts, and gender equality. Governance APA is a corporation chartered in the District of Columbia. APA's bylaws describe structural components that serve as a system of checks and balances to ensure democratic process. The organizational entities include: * APA President. The APA's president is elected by the membership. The president chairs th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Office For Human Research Protections
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH). The office's primary duty is the implementation of , a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule". Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was the first public national body to shape bioethics policy in the United States. Formed in the aftermath of the Tuskegee Study of Untreated Syphilis in the Negro Male, Tuskegee Experiment scandal, the Commission was created in 1974 as Title II of the National Research Act. It was part of the United States Department of Health, Education, and Welfare (DHEW) until 1978. Goals The Commission had four goals that it needed to analyze: 1) the boundaries between biomedical and behavioral research and what the accepted and routine practices of medicine were 2) assessing the risks and benefits of the appropriateness of research involving human subjects 3) determining appropriate guidelines for how human subjects can be chosen for the participation in such research 4) defining what informed consent is in each research setting. Work The Commission also had the task of making recommendat ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Common Rule
The Common Rule is a 1981 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018. It governed Institutional Review Boards for oversight of human research and followed the 1975 revision of the Declaration of Helsinki; it is encapsulated in the 1991 revision to the U.S. Department of Health and Human Services Title 45 CFR 46 (Public Welfare) Subparts A, B, C and D. Subpart A. The Common Rule is the baseline standard of ethics by which any government-funded research in the US is held; nearly all U.S. academic institutions hold their researchers to these statements of rights regardless of funding. Background The Common Rule is a 1981 rule of ethics (revised in 2018) regarding biomedical and behavioral research involving human subjects in the United States. The regulations governing Institutional Review Boards for oversight of human research followed the 1975 revision of the Declara ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
National Research Act
The National Research Act was enacted by the 93rd United States Congress and signed into law by President Richard Nixon on July 12, 1974, after a series of congressional hearings on human-subjects research, directed by Senator Edward Kennedy. The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to develop guidelines for human subject research and to oversee and regulate the use of human experimentation in medicine. The National Research Act issued Title 45, Part 46 of the Code of Federal Regulations: Protection of Human Subjects. The National Research Act is overseen by the Office of Human Research Protections. The Act also formalized a regulated IRB process through local institutional review boards, also overseen by the Office of Human Research Protections. The National Research Act gained traction as a response to the infamous Tuskegee syphilis study. See also *Human experimentation in the Unite ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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