Engaged

In general, an institution is considered to be engaged in human subjects research (HSR) when its agents or employees: 1) obtain data about living individuals for research purposes through intervention or interaction with them, 2) obtain individually identifiable private information for research purposes, 3) obtain the informed consent of human subjects, and/or 4) if the institution receives a direct Department of Health and Human Services (DHHS) award to support such research; even if all of the human subjects activities will be performed by agents or employees of another institution. In general, an institution is not engaged in human subjects research when its agents or employees are informing potential subjects about a research study or sharing the name of a potential participant with an investigator with the participant’s permission. Additional engagement exceptions are outlined in the following reference. OHRP: Engagement of Institutions in Human Subjects Research