Table 1 The identification of human research subjects: a definition and a set of criteria.
From: Who is the research subject in cluster randomized trials in health research?
Definition | A human research subject is an individual whose interests may be compromised as a result of interventions in a research study. |
|---|---|
Criteria | A human research subject is: |
| Â | 1. An individual who is directly intervened upon by an investigator; |
| Â | 2. An individual who is deliberately intervened upon via manipulation of the individual's environment by an investigator; |
| Â | 3. An individual with whom an investigator interacts for the purpose of collecting data; or, |
| Â | 4. An individual about whom an investigator obtains identifiable private information for the purpose of collecting data. |