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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.Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research.The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information ( "Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [ Ethical guidelines that govern the use of human subjects in research are a fairly new construct.In 1906 some regulations were put in place in the United States to protect subjects from abuses.After the passage of the Pure Food and Drug Act in 1906, regulatory bodies were gradually institutionalized such as the Food and Drug Administration (FDA) and the Institutional Review Board (IRB).The policies that these institutions implemented served to minimize harm to the participant's mental and/or physical well being.

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Established by the World Medical Association, the declaration recommended guidelines for medical doctors conducting biomedical research that involves human subjects.Lastly, respect for persons explains that at any point a person who is involved in a study can decide whether they want to participate, not to participate or withdraw themselves from the study altogether.Two rules of respect for persons involve the person being autonomous and persons with diminished autonomy and entitled to protection.Human subject research is used in various fields, including research into basic biology, clinical medicine, nursing, psychology, sociology, political science, and anthropology.As research has become formalized, the academic community has developed formal definitions of "human subject research", largely in response to abuses of human subjects.

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