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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]
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.
The Belmont Report is a 1978 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 later revision in 2000 would go on to require monitoring of scientific research on human subjects to assure ethical standards were being met. [20] In 1997 Lurie and Wolfe published their seminal paper on HIV trials, [21] raising awareness of a number of central issues. These included the claims that the continuing trials in developing ...
The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Biomedical and Behavioral Research (1979) These reports contained their recommendations, [ 10 ] the underlying deliberations and conclusions, [ 11 ] a dissenting statement and additional statement by commission members and summaries of materials presented ...
The Common Rule is a 1991 rule of ethics (revised in 2018) [2] 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 Declaration of Helsinki, and are encapsulated in the 1991 revision to the U.S. Department of Health and Human Services ...
Research ethics is a discipline within the study of applied ethics. Its scope ranges from general scientific integrity and misconduct to the treatment of human and animal subjects. The social responsibilities of scientists and researchers are not traditionally included and are less well defined.
A research participant, also called a human subject or an experiment, trial, or study participant or subject, is a person who voluntarily participates in human subject research after giving informed consent to be the subject of the research. A research participant is different from individuals who are not able to give informed consent, such as ...