Human Subject Research
Human subject research 2) identifiable private information (32 CFR 219.102.f). (Lim,1990)[2] As defined by DHHS regulations: “Intervention"- physical procedures by which data is gath- ered and the manipulation of the subject and/or their en- vironment for research purposes [45 CFR 46.102(f)[2] “Interaction"- communication or interpersonal contact between investigator and subject [45 CFR 46.102(f)])[2] “Private Information"- information about behavior that occurs in a context in which an individual can reason- ably expect that no observation or recording is taking place, and information which has been provided for spe- cific purposes by an individual and which the individual 1946 military human subject research on the effects of wind on humans can reasonably expect will not be made public [45 CFR 46.102(f)] )][2] Human subject research is systematic, scientific inves- “Identifiable information"- specific information that can tigation that can be either interventional (a “trial”) or ob- be used to identify an individual[2] servational (no “test article”) and involves human beings as research subjects. Human subject research can be ei- ther medical (clinical) research or non-medical (e.g., so- 1.1 Human subject rights cial science) research.[1] Systematic investigation incor- porates both the collection and analysis of data in or- In 2010, the National Institute of Justice in the United der to answer a specific question. Medical human sub- States published recommended rights of human subjects: ject research often involves analysis of biological speci- mens, epidemiological and behavioral studies and med- • Voluntary, informed consent ical chart review studies.[1] (A specific, and especially • Respect for persons: treated as autonomous agents heavily regulated, type of medical human subject re- search is the "clinical trial", in which drugs, vaccines and • The right to end participation in research at any medical devices are evaluated.) Human subject research time[3] in the social sciences often involves surveys, question- naires, interviews, and focus groups.
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