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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter . prisoners as research subjects. Part One: Federal Regulations. Prisoners as research subjects: federal regulations.
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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC
prisoners asresearch subjects Part One: Federal Regulations Developed by: U-MIC University of Michigan IRB Collaborative
Prisoners as research subjects: federal regulations in a penal institution 45 CFR 46.303(c) involuntarily confined or detained prisoner: any individual substance abuse facility psychiatric institution treatment facilities (parole) jail prison juvenile facility RESIDENTIAL Developed by: U-MIC
not Prisoners as research subjects: federal regulations prisoners: • non-residential drug treatment • psychiatric institutions (voluntarily or involuntarily) not due to arrest or conviction • on parole • electronic tether • (check with IRB) Developed by: U-MIC
Prisoners as research subjects: federal regulations MINIMAL RISK prisoners non-prisoners Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Developed by: U-MIC
Prisoners as research subjects: federal regulations MINIMAL RISK prisoners non-prisoners Minimal risk means that the probability and magnitude of harm or discomfort anticipatedin the research are not greater in and of themselvesthan those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Minimal risk is the probability and magnitude of physical or psychologicalharm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination, of healthy persons. Developed by: U-MIC
Prisoners as research subjects: federal regulations TYPES OF RESEARCH in which prisoners may participate • causes, effects, and processes of criminal behavior and incarceration • prisons as institutions or prisoners as inmates • conditions common among prisoners • direct benefit • prisoners as controls no more than minimal risk to prisoners if study is federally funded, DHHS Secretary must consult with experts Developed by: U-MIC
certification and IRB review Prisoners as research subjects: federal regulations Developed by: U-MIC
certification and IRB review Prisoners as research subjects: federal regulations Developed by: U-MIC
Brian Seabolt IRBMED thank you. Developed by: U-MIC