E03 - All Things Subpart C

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Prisoners who participate in research are considered a vulnerable population and are afforded additional protections under subpart C of HHS regulations, 45 CFR 46. It's critical that IRB members understand the historical and ethical basis of the regulations in order to make informed decisions around the challenges associated with including individuals who are incarcerated. For example, what are the regulatory requirements when a subject becomes a prisoner during the course of the study? Are parolees considered prisoners under Subpart C? What types of activities can and cannot be conducted inside a prison, and what requirements and expectations exist around privacy and confidentiality for people who are incarcerated? Speakers will provide an ethical, regulatory, and historical foundation in order to equip attendees to address such questions.