An institution is considered engaged in a particular human subjects research project when its employees or agents for the purposes of a non-exempt research project obtain:

1. Data about the subjects of the research through intervention or interaction with them;
2. Identifiable private information about the subjects of the research; or
3. The informed consent of human subjects for the research.

An institution is also considered engaged when the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor.

An individual is considered engaged in human research when he/she for the purposes of the non-exempt research project, obtains:

1. Data about the subjects of the research through intervention or interaction with them
2. Identifiable private information about the subjects of the research; or
3. The informed consent of human subjects for the research.