Involved in human subject research in such a way (or to the extent) that the ethical and regulatory requirements for human subject protection are applicable. An individual (or organization) becomes engaged in human subject research when for the purposes of non-exempt research the individual (or organization’s employee or agent) obtains any of the following:
- Data about research participants through intervention or interaction
- Identifiable private information about research participants
- Informed consent of research participants.
Note: An organization is also engaged in human subject research whenever it receives a direct federal award to support the research.
