1. The Institutional Review Board (IRB) Brief Overview

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3. The Institutional Review Board (IRB) reviews research involving human participants to assure their rights and welfare are protected. Ethical research Meeting federal regulatory requirements Meeting University requirements Meeting accreditation standards ALL research involving human participants MUST be approved by the IRB BEFORE it may begin. 3

4. What needs IRB review? NO review required  QA/QI purpose only  Pedagogy (will not be used beyond the class)  Facts about a topic or company (policies, etc.)  The IRB reviewer needs enough detail to determine “generalizability.”  Submit request for “Not Human Research Determination” through ePAS. Review IS required  Intended to produce “generalizable” knowledge, to “impact the field”  Preliminary to future research  Opinions about a topic or company  Submit proposal for IRB review through ePAS. 4

5. IRB Web Site http://researchcompliance.uc.edu/irb  Both Medical and Social/Behavioral studies  General information and definitions  Current forms, instructions and templates ePAS protocol & consent templates CITI instructions  IRB meeting schedules  IRB staff contact information  Links to ePAS (new submissions & Progress Reports) CITI (training) Researcher Gateway (modifications if study is not in ePAS yet) 5

6. Research Categories and Review Types Research category: Exempt / Expedited Review type: expedited (minimal risk, on the list in the regulations, one or more selected reviewers) Research category: Full-Board Review type: full-board (everything else, all IRB members, at convened meeting) 6

7. CITI Training  Online modules, assigned based on registration answers  Print instructions from IRB website!!  Greater Cincinnati Academic and Regional Health Centers  Say Yes to at least these questions: Doing research at UC? Involved in human subject research? Interact with living individuals?  Valid for 3 years  VA researchers: contact Cincinnati VA R&D Office 7

8. IRB Review Process 1.PI submits proposal a.ePAS assigns number 2.Pre-review a.Completeness b.Determine review type c.Assign reviewer(s) 3.Review process a.Board member review b.Reviewer comments to PI c.PI’s responses to reviewer d.Repeat until all reviewer concerns are resolved 4.Approval sent to PI a.email approval letter 5.Post-approval monitoring a.Good research practices b.Regulatory binder c.Documentation is critical! 6.Amendment/Modification a.Researchers Gateway or ePAS b.Description and rationale c.Revised documents d.email approval letter 7.Continuing Review/Prog Rpt a.Convert study into ePAS if continuing b.OK to use paper if closing c.Due a month before expiration date d.NO “grace period” allowed e.email approval letter 8

9. Common Problems 1.Incomplete documentation  ePAS blank questions, missing documents  COI forms (blank Responsibilities, blank Yes/No)  No recruitment materials (flyers, emails, etc.)  No data collection tools (surveys, interview or observation guides) 2.Protocol lacks detail  Who, What, When, Where, Why, How 3.Informed consent document  Missing required sections / not in required format  Reading level is too high  Typing or grammatical errors 4.Researcher fails to recognize risk or coercion 5.Not enough time for IRB review prior to start date 6.CITI requirement not met 9

10. What about Students/Residents as Researchers? Expected to meet the same standards as other researchers o CITI training o Follow format and template instructions o Scientific or scholarly research design Must have faculty advisor as co-investigator The advisor’s role is to advise. If there is a time factor, notify the IRB right away, not at the last minute. Review time is affected greatly by completeness of submission. Call the IRB with questions 10

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12. IRB Contact Information http://researchcompliance.uc.edu/irb.uc.edu/irb Training and Education about IRB: Claudia Norman, 558-5784 (claudia.norman@uc.edu)claudia.norman@uc.edu Department Dedicated IRB Staff – CECH: Tara Knipp, 558-3731 (tara.knipp@uc.edu)tara.knipp@uc.edu Department Dedicated IRB Staff – other non-medical: Deborah Quinones-Stewart, 558-6915 (quinonda@ucmail.uc.edu) quinonda@ucmail.uc.edu IRB office main phone: 558-5259 12