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IRB Workshop I: IRB Process

IRB Workshop I: IRB Process. Carolyn Murdaugh, PhD, RN, FAAN Alice Pasvogel, PhD, RN Office of Nursing Research. Keep in mind: Ongoing changes. IRB changes are constant Forms Guidelines Staff. How do I begin the process?. Defend research proposal or scholarly inquiry project

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IRB Workshop I: IRB Process

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  1. IRB Workshop I: IRB Process Carolyn Murdaugh, PhD, RN, FAAN Alice Pasvogel, PhD, RN Office of Nursing Research

  2. Keep in mind: Ongoing changes • IRB changes are constant • Forms • Guidelines • Staff

  3. How do I begin the process? • Defend research proposal or scholarly inquiry project • Complete IRB Project Approval Form

  4. Steps in the approval process • Submit completed Project Approval Form to the College of Nursing Office of Nursing Research (Alice Pasvogel) • College of Nursing subcommittee review • UA IRB committee review • Non-UA IRB review (if relevant)

  5. When do review committees meet? • College of Nursing • First & third Mondays during academic year • UA IRB • Monthly

  6. Other Information Needed • Original signatures on Project Review Form • Completed Conflict of Interest form • Human subjects training documentation (CITI) • Site authorization

  7. How long does it take for review and approval? • College of Nursing review • 3 weeks minimum • University IRB review • 4 weeks minimum • Total average time • 2-3 months

  8. What will delay approval? • Delay in responding to needed revisions • IRB approval from external sites

  9. What does Approval mean? • Approval from UA IRB only • Non-UA approval will be needed • Approval for 1 year only

  10. What if I need to make changes after IRB approval? • Request an Amendment • Complete appropriate Amendment form • Submit to IRB • Timeframe for approval • 2 weeks minimum

  11. What if my project lasts more than 1 year? • Complete Continuing Review Report • Get Advisor’s signature • Submit 45 days before project one year expiration date

  12. I’m finished, now what? • Submit Concluded/Not Begun form to IRB • Submit consent forms to Office of Nursing Research • Submit data to Office of Nursing Research

  13. Summary: Key Points • Constant change • Multi-step process • Process takes time • Approval for 1 year • Approval may be needed at multiple sites • Keep Advisor and Office of Nursing Research informed • Know when amendment needed

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