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The commission developed the Belmont Report over a four-year period from 1974 to 1978, including an intensive four-day period of discussions in February 1976 at the Belmont Conference Center. [ 6 ] On September 30, 1978, the commission's report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research , was released. [ 7 ]
As such, the Belmont Report defines each term in order to help determine what constitutes what. Practice is defined as an established methodology designed to improve an individual's condition with confidence for success. [17] Research is defined as a procedure designed to test a hypothesis and draw conclusions in an experimental style. [17]
One of the earliest models for ethical human experimentation, preceding the Nuremberg Code, was established in 1931. [4] In the Weimar Republic of 20th century pre-Nazi Germany, the entity known as Reichsgesundheitsamt [5] (translating roughly to National Health Service), under the Ministry of the Interior [6] formulated a list of 14 points detailing these ethical principles.
[3] [14] The IRB Report endorsed the establishment and functioning of the Institutional Review Board institution, and the Belmont Report, the Commission's last report, identified "basic ethical principles" applicable to human subject experimentation that became modern guidelines for ethical medical research: "respect for persons", "beneficence ...
It was tasked with establishing the boundary between research and routine practice, the role of risk-benefit analysis, guidelines for participation, and the definition of informed consent. Its Belmont Report established three tenets of ethical research: respect for persons, beneficence, and justice. [63]
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Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
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