1. University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965

2. Institutional Review Board – irb@unl.edu - 402.472.6965 Becky Freeman IRB & Research Compliance Manager bfreeman2@unl.edu 472-8127

3. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Categories of Review Exempt: less than minimal risk Expedited: minimal risk (risks encountered in everyday life) Full Board: greater than minimal risks

4. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Factors Considered in Risk Assessment Who are the participants? What will participants be doing? Are responses identifiable? How will results be reported? Who has access to the raw data?

5. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Adults completing an on-line survey through a link they find on the web (no identifiers) – asks about child abuse Same survey questions – identifiable Same survey questions– participants are children Same survey questions– teachers are asked to complete it & raw data given to superintendent

6. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Special Situations Secondary data Waivers of Informed Consent Research in Other Countries Oral History projects Journalistic Interviews Class Projects & Evaluations

7. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Examples of Research Internet Research Paper based surveys Interviews/Focus Groups Exercise Studies Student Research

8. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 How long will review take?

9. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Exempt Protocols

10. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Expedited Protocols

11. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Full Board Protocols

12. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Continuing Review Must occur annually – based off date of final approval Required for exempt, expedited, and full board review Form submitted via NUgrant

13. Institutional Review Board – irb@unl.edu - 402.472.6965 Change in Protocol Required for personnel changes (PI & SI), informed consent changes, addition/deletion of measures, etc Form submitted via NUgrant

14. Institutional Review Board – irb@unl.edu - 402.472.6965 Final Report Can be submitted any time Allows us to close the project Form submitted via NUgrant

15. Institutional Review Board – irb@unl.edu - 402.472.6965 Training CITI Complete the Human Research Curriculum (Group 1 or 2) Basic Course No need to complete the Responsible Conduct of Research (RCR) training http://www.citiprogram.org

16. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 NUgrant Online protocol submission process http://nugrant.unl.edu

17. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 RESOURCES

18. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 IRB Website: (Guidance and Forms Page) http://research.unl.edu/orr/forms.shtml

19. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 Federal Guidance (45 CFR 46.101) http://www.hhs.gov/ohrp/humansubjects/gui dance/45cfr46.htm

20. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 NUgrant help tab:

21. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 IRB Office: Becky Freeman 472-8127 bfreeman2@unl.edu Patty Swanson 472-6907 pswanson2@unl.edu Melissa Meyer 472-8196 mmeyer7@unl.edu

22. Institutional Review Board (IRB) – irb@unl.edu - 402.472.6965 QUESTIONS??