Table 1.

Definitions of “Human Research Subject” (Common Rule) and “Research Participant” (Ottawa Statement).

45 CFR 46.102(f) (Common Rule)3	Recommendations on Regulatory Issues In Cluster Studies (SACRP, March 13, 2014)5	Ottawa Statement7
Human Research Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains Data through intervention or interaction with the individual, or Identifiable private information.	When the individual s environment has a reasonable possibility of being manipulated by the existence of the research, then the individual is a research subject.	CRT Research Participant: An individual whose interests may be affected as a result of study interventions or data collection procedures, that is, an individual (1) who is the intended recipient of an experimental (or control) intervention; or (2) who is the direct target of an experimental (or control) manipulation of his/her environment; or (3) with whom an investigator interacts for the purpose of collecting data about that individual; or (4) about whom an investigator obtains identifiable private information for the purpose of collecting data about that individual. Unless one or more of these criteria is met, an individual is not a research participant.