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| A 'human subject' is defined by the Common Rule as a "living individual about whom an investigator... (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates indentifiable private information or identifiable biospecimens". | A 'human subject' is defined by the Common Rule as a "living individual about whom an investigator... (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates [[UnitedStates/InformationLaw/PersonallyIdentifiableInformation|indentifiable private information]] or identifiable biospecimens". Importantly, this definition excludes collection of factual or administrative data that isn't ''about'' the interviewee. |
Human Subject Research
A legal definition of human subject research is necessary for establishing enforceable ethics law.
Contents
Definition
'Research' is defined by the CommonRule as a "systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge". The Common Rule specifically excludes:
- scholarly and journalistic activities
- public health surveillance activities
- collection and analysis activities by a criminal justice agency
- national defense activities
A 'human subject' is defined by the Common Rule as a "living individual about whom an investigator... (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates indentifiable private information or identifiable biospecimens". Importantly, this definition excludes collection of factual or administrative data that isn't about the interviewee.