2. 1 Developed by: U-MIC 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.

3. PRISONERS AS RESEARCH SUBJECTS Part Two: Certification and IRB Review Developed by: U-MIC University of Michigan IRB Collaborative

4. Prisoners as research subjects: federal regulations 3 Developed by: U-MIC

5. Prisoners as research subjects: federal regulations 4 Developed by: U-MIC certification and IRB review

6. Prisoners as research subjects: certification and IRB review 5 Developed by: U-MIC

7. Prisoners as research subjects: certification and IRB review 6 Developed by: U-MIC

8. Prisoners as research subjects: certification and IRB review 7 Developed by: U-MIC 1.research must fall under one of the permissible categories CRITERIA FOR APPROVAL

9. Prisoners as research subjects: certification and IRB review 8 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence CRITERIA FOR APPROVAL

10. Prisoners as research subjects: certification and IRB review 9 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks CRITERIA FOR APPROVAL

11. Prisoners as research subjects: certification and IRB review 10 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks 4.subject selection must be fair CRITERIA FOR APPROVAL

12. Prisoners as research subjects: certification and IRB review 11 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks 4.subject selection must be fair 5.language must be clear to prisoners CRITERIA FOR APPROVAL

13. Prisoners as research subjects: certification and IRB review 12 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks 4.subject selection must be fair 5.language must be clear to prisoners 6.participation must not influence parole decisions CRITERIA FOR APPROVAL

14. Prisoners as research subjects: certification and IRB review 13 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks 4.subject selection must be fair 5.language must be clear to prisoners 6.participation must not influence parole decisions 7.follow-up must be feasible for prisoners CRITERIA FOR APPROVAL

15. Prisoners as research subjects: certification and IRB review 14 Developed by: U-MIC 1.research must fall under one of the permissible categories 2.appeal of benefits must not present undue influence 3.prisoners must not face extra risks 4.subject selection must be fair 5.language must be clear to prisoners 6.participation must not influence parole decisions 7.follow-up must be feasible for prisoners CRITERIA FOR APPROVAL

16. Prisoners as research subjects: certification and IRB review 15 Developed by: U-MIC federal Bureau of Prisons state Michigan Department of Corrections local warden federally funded research OHRP (federal government) certification

17. Prisoners as research subjects: certification and IRB review 16 Developed by: U-MIC causes, effects, and processes of criminal behavior and incarceration prisons as institutions or prisoners as inmates conditions common among prisoners direct benefit PERMISSIBLE CATEGORIES of research involving prisoners

18. Prisoners as research subjects: certification and IRB review 17 Developed by: U-MIC federal Bureau of Prisons state Michigan Department of Corrections local warden non-federally funded research OVPR (University of Michigan) certification

19. Prisoners as research subjects: certification and IRB review 18 Developed by: U-MIC waivers alterations expedited review exemptions permitted not permitted permitted full-board review recommended

20. THANK YOU. Brian Seabolt IRBMED 19 Developed by: U-MIC