engagement

An institution becomes “engaged” in human subjects research when its employees or agents: (1) Intervene or interact with living individuals for research purposes; or (2) Obtain individually identifiable private information for research purposes; or (3) Obtain consent from subjects. When an institution is a direct recipient of federal funding (prime awardee) for a human subjects research project, even if it conducts no work with human subjects itself, the institution is engaged. Whether an institution is engaged in research is addressed in detail in the OHRP memo “Engagement of Institutions in Research” http://www.hhs.gov/ohrp/policy/engage08.html and in the SOP Engagement and WORKSHEET Engagement.