When is an institution “engaged” in research involving prisoners?
In general, an institution is considered engaged in a particular human subjects research proposal involving prisoners when its employees or agents, for the purposes of the research proposal, obtain: (1) data about the prisoner subjects through intervention or interaction with them; or (2) identifiable private information about the prisoner subjects. Some examples of activities that would make an institution engaged in human subjects research involving prisoners are: (1) seeking the informed consent of prisoners to be subjects in research; (2) using, studying or analyzing, for research purposes, identifiable private information about prisoners, or identifiable specimens obtained from prisoners; and (3) surveying prisoners for a research study. In addition, institutions generally become engaged in research involving prisoners if they are the primary awardee of HHS funds to conduct such research, even where all activities involving prisoner subjects are carried out by agents or employees
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- Under what circumstances should an institution inform the Agencies about changes to its policy for research involving humans?
- When is an institution "engaged" in research involving prisoners?
