Institutional Review Boards
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Institutional Review Boards
An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes. A key goal of IRBs is to protect human su ...
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Committee
A committee or commission is a body of one or more persons subordinate to a deliberative assembly. A committee is not itself considered to be a form of assembly. Usually, the assembly sends matters into a committee as a way to explore them more fully than would be possible if the assembly itself were considering them. Committees may have different functions and their types of work differ depending on the type of the organization and its needs. A member of a legislature may be delegated a committee assignment, which gives them the right to serve on a certain committee. Purpose A deliberative assembly may form a committee (or "commission") consisting of one or more persons to assist with the work of the assembly. For larger organizations, much work is done in committees. Committees can be a way to formally draw together people of relevant expertise from different parts of an organization who otherwise would not have a good way to share information and coordinate actions. They may ...
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Doctors' Trial
The Doctors' Trial (officially ''United States of America v. Karl Brandt, et al.'') was the first of 12 trials for war crimes of high-ranking German officials and industrialists that the United States authorities held in their occupation zone in Nuremberg, Germany, after the end of World War II. These trials were held before US military courts, not before the International Military Tribunal, but took place in the same rooms at the Palace of Justice. The trials are collectively known as the " subsequent Nuremberg trials", formally the "Trials of War Criminals before the Nuremberg Military Tribunals" (NMT). Twenty of the twenty-three defendants were medical doctors and were accused of having been involved in Nazi human experimentation and mass murder under the guise of euthanasia. The indictment was filed on 25 October 1946; the trial lasted from 9 December that year until 20 August 1947. Of the 23 defendants, seven were acquitted and seven received death sentences; the remaind ...
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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 ...
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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 ...
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Bona Fide
In human interactions, good faith ( la, bona fides) is a sincere intention to be fair, open, and honest, regardless of the outcome of the interaction. Some Latin phrases have lost their literal meaning over centuries, but that is not the case with ''bona fides'', which is still widely used and interchangeable with its generally-accepted modern-day English translation of ''good faith''. It is an important concept within law and business. The opposed concepts are bad faith, ''mala fides'' (duplicity) and perfidy (pretense). In contemporary English, the usage of ''bona fides'' is synonymous with credentials and identity. The phrase is sometimes used in job advertisements, and should not be confused with the ''bona fide'' occupational qualifications or the employer's good faith effort, as described below. ''Bona fides'' ''Bona fides'' is a Latin phrase meaning "good faith". Its ablative case is ''bona fide'', meaning "in good faith", which is often used as an adjective to mean " ...
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Belmont Report
The ''Belmont Report'' is a report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the ''Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research''. The report was issued on September 30, 1978 and published in the Federal Register on April 18, 1979. The report took its name from the Belmont Conference Center where the document was drafted in part. The Belmont Conference Center, once a part of the Smithsonian Institution, is in Elkridge, Maryland, 10 miles south of Baltimore, and until the end of 2010 was operated by Howard Community College. The ''Belmont Report'' summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas ...
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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 ...
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Central Intelligence Agency
The Central Intelligence Agency (CIA ), known informally as the Agency and historically as the Company, is a civilian foreign intelligence service of the federal government of the United States, officially tasked with gathering, processing, and analyzing national security information from around the world, primarily through the use of human intelligence (HUMINT) and performing covert actions. As a principal member of the United States Intelligence Community (IC), the CIA reports to the Director of National Intelligence and is primarily focused on providing intelligence for the President and Cabinet of the United States. President Harry S. Truman had created the Central Intelligence Group under the direction of a Director of Central Intelligence by presidential directive on January 22, 1946, and this group was transformed into the Central Intelligence Agency by implementation of the National Security Act of 1947. Unlike the Federal Bureau of Investigation (FBI), which is a ...
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Mind Control
Brainwashing (also known as mind control, menticide, coercive persuasion, thought control, thought reform, and forced re-education) is the concept that the human mind can be altered or controlled by certain psychological techniques. Brainwashing is said to reduce its subjects' ability to think critically or independently, to allow the introduction of new, unwanted thoughts and ideas into their minds, as well as to change their attitudes, values and beliefs. The term "brainwashing" was first used in English by Edward Hunter in 1950 to describe how the Chinese government appeared to make people cooperate with them. Research into the concept also looked at Nazi Germany, at some criminal cases in the United States, and at the actions of human traffickers. In the late 1960s and 1970s, there was considerable scientific and legal debate, as well as media attention, about the possibility of brainwashing being a factor when Lysergic acid diethylamide (LSD) was used, or in the convers ...
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Project MKULTRA
Project MKUltra (or MK-Ultra) was an illegal human experimentation program designed and undertaken by the U.S. Central Intelligence Agency (CIA), intended to develop procedures and identify drugs that could be used in interrogations to weaken individuals and force confessions through brainwashing and psychological torture. It began in 1953 and was halted in 1973. MKUltra used numerous methods to manipulate its subjects' mental states and brain functions, such as the covert administration of high doses of psychoactive drugs (especially LSD) and other chemicals, electroshocks,National Public Radio (NPR), 9 Sept. 2019"The CIA's Secret Quest For Mind Control: Torture, LSD And A 'Poisoner In Chief'"(On-air interview with journalist Stephen Kinzer) hypnosis, sensory deprivation, isolation, and verbal and sexual abuse, in addition to other forms of torture. MKUltra was preceded by two drug-related experiments, Project Bluebird and Project Artichoke. It was organized through the ...
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Stanford Prison Experiment
The Stanford prison experiment (SPE) was a psychological experiment conducted in the summer of 1971. It was a two-week simulation A simulation is the imitation of the operation of a real-world process or system over time. Simulations require the use of Conceptual model, models; the model represents the key characteristics or behaviors of the selected system or proc ... of a prison environment that examined the effects of Variable and attribute (research), situational variables on participants' reactions and behaviors. Stanford University psychology professor Philip Zimbardo led the research team who administered the study. Participants were recruited from the local community with an ad in the newspapers offering $15 per day to male students who wanted to participate in a "psychological study of prison life." Volunteers were chosen after assessments of psychological stability, and then randomly assigned to being prisoners or prison guards. Critics have questioned th ...
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Milgram Experiment
The Milgram experiment(s) on obedience to authority figures were a series of social psychology experiments conducted by Yale University psychologist Stanley Milgram. They measured the willingness of study participants, 40 men in the age range of 20 to 50 from a diverse range of occupations with varying levels of education, to obey an authority figure who instructed them to perform acts conflicting with their personal conscience. Participants were led to believe that they were assisting an unrelated experiment, in which they had to administer electric shocks to a "learner". These fake electric shocks gradually increased to levels that would have been fatal had they been real. The experiment found, unexpectedly, that a very high proportion of subjects would fully obey the instructions, with every participant going up to 300 volts, and 65% going up to the full 450 volts. Milgram first described his research in a 1963 article in the ''Journal of Abnormal and Social Psychology''
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