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University of Nebraska – Lincoln Office of Research Responsibility

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. Becky Freeman IRB & Research Compliance Manager bfreeman2@unl.edu 472-8127.

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University of Nebraska – Lincoln Office of Research Responsibility

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  1. University of Nebraska – LincolnOffice 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. Becky Freeman IRB & Research Compliance Manager bfreeman2@unl.edu 472-8127 Institutional Review Board – irb@unl.edu - 402.472.6965

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

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

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

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

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

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

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

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

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

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

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

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

  15. 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 Institutional Review Board – irb@unl.edu - 402.472.6965

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

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

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

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

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

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

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

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