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 bfreeman 2@unl. edu 472 -8127 Institutional Review Board – 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 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? 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 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 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 Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

How long will review take? Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

Exempt Protocols Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

Expedited Protocols Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

Full Board Protocols 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 Institutional Review Board (IRB) – 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 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 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 Institutional Review Board – irb@unl. edu - 402. 472. 6965

NUgrant • Online protocol submission process • http: //nugrant. unl. edu Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

RESOURCES Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

IRB Website: (Guidance and Forms Page) http: //research. unl. edu/orr/forms. shtml Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

Federal Guidance (45 CFR 46. 101) http: //www. hhs. gov/ohrp/humansubjects/gui dance/45 cfr 46. htm Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

NUgrant help tab: Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

IRB Office: Becky Freeman 472 -8127 bfreeman 2@unl. edu Patty Swanson 472 -6907 pswanson 2@unl. edu Melissa Meyer 472 -8196 mmeyer 7@unl. edu Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965

QUESTIONS? ? Institutional Review Board (IRB) – irb@unl. edu - 402. 472. 6965