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SCDMH Documents Governing Human Subject Research
Institutional Review Board Manual
SCDMH Documents Governing Human Subject Research
What Constitutes Human Subject Research?
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to common knowledge. Some demonstration and service programs may include research activities which must be reviewed by the Institutional Review Board.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
- Identifiable private information.
Individuals can reasonably expect that observations, notes, and/or recordings about their behavior will be kept private. If the individual can be identified by the researcher or anyone else (directly or indirectly through a coding system linking the research subject to the information), the information is deemed private.
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