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University of Charleston’s

University of Charleston’s. Institutional Review Board And how it affects you. Why do we need an IRB?. To ensure the institution is in compliance with the HHS Protection of Human Subjects (Federal Regulation 45 CFR part 46).

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University of Charleston’s

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  1. University of Charleston’s Institutional Review Board And how it affects you.

  2. Why do we need an IRB? • To ensure the institution is in compliance with the HHS Protection of Human Subjects (Federal Regulation 45 CFR part 46). • To be eligible for a Federalwide Assurance (FWA), a commitment that we will comply with this regulation. • To be eligible for grant money.

  3. What is an IRB? • A review committee established to help protect the rights and welfare of human research subjects. • Research is a systematic investigation designed to contribute to generalizable knowledge. • Human subjects are those about whom an investigator obtains data, or from whom identifiable private information is obtained.

  4. Authority of the IRB

  5. Composition of the IRB Additionally, the board must be culturally diverse, be sensitive to community issues, and have members that understand the research being done.

  6. UC’s IRB Board • Juliana Serafin, Chair • Brad Deel • Debra Mullins • Renee McCafferty • Dean Reardon • Jennifer Pack • Lynn Gunnoe * • Diana Long * • Dennis Flaherty, ad hoc * Denotes an outside representative who is not affiliated with UC

  7. IRB Meetings • The IRB meets quarterly: • August 21, 2012, 12:00 pm • November 30, 2012, 12:00 pm • February 22, 2013, 12:00 pm • May 10, 2013, 12:00 pm • The IRB may hold additional, Special Meetings, based on need.

  8. Types of IRB Submissions

  9. Faculty Information

  10. NIH Training – Protecting Human Research Participants

  11. Application Preparation

  12. Types of IRB Reviews

  13. Full Review

  14. Expedited Review

  15. Exempt Review

  16. Exemptions Do Not Apply To

  17. Joint Studies

  18. Submission of Application

  19. Approval

  20. Renewals

  21. Complete Closure Report

  22. Timeline for IRB Decision

  23. Questions?

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