NOTE: Greater than minimal risk included any biomedical (nontherapeutic) study; any medical therapeutic study (regardless of the existence of a standard of care); any social/behavioral therapeutic study; and any nontherapeutic study involving a manipulation that the research assistant (RA) judged to involve potentially serious physical or emotional stress (e.g., long sleep deprivation). Not greater than minimal risk included any study based on review of administrative records; any program evaluation study; any nontherapeutic social/behavioral study that involved either no manipulation (e.g., innocuous questionnaires and surveys) or involved a manipulation that the RA judged not to involve potentially serious physical or emotional stress (e.g., long sleep deprivation).
Ethical Considerations for Research Involving Prisoners.
Institute of Medicine (US) Committee on Ethical
Considerations for Revisions to DHHS Regulations for Protection of Prisoners
Involved in Research; Gostin LO, Vanchieri C, Pope A, editors.