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Institutional Review Board

Institutional Review Board. What is IRB? Who needs to go through review? What is the review process?. IRB: A Brief History.

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Institutional Review Board

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  1. Institutional Review Board What is IRB? Who needs to go through review? What is the review process?

  2. IRB: A Brief History • Today the federal government is extensively involved in regulating almost all aspects of the research process. Most federal agencies have adopted regulations that require IRB approval to conduct research that is under their authority. • As recently as 1950, the federal government had a relatively minor role in regulating research conduct. As a result subject’s rights were often violated.

  3. Research Regulation Milestones • 1948 – The Nuremburg Code • 1955 – The Wichita Jury Study • 1962 – The Thalidomide Experience • 1964 – NIH Ethics Committee • 1964 – The World Medical Association Declaration of Helsinki • 1966 – The Ethics of Clinical Research and The New England Journal of Medicine • 1973 – Congressional Hearings on the Quality of Health Care and Human Experimentation • Willowbrook Hepatitis Studies • Jewish Chronic Disease Hospital Studies • Milgram Studies of Obedience to Authority • San Antonio Contraception Study • Tearoom Trade Study • Tuskegee Syphilis Study

  4. Institutional Review BoardIRB • The Institutional Review Board reviews requests for research involving human subjects. • Purpose • Ensure participants are treated ethically according to federal and local guidelines • Protect the rights of human subjects

  5. Who Needs IRB Review? Most research involving people or their records requires IRB review. • Research may include • Intervention studies • Investigations using archival records • Research about teaching practices IRB approval is necessary regardless of the investigator’s role, the study’s funding, or the location of the research.

  6. What is the Review Process? • Typical review process • Investigator downloads IRB request form, completes it, and submits it to Research Administration(irb@email.wcu.edu). • Investigator completes WCU’s investigator training program (http://www.citiprogram.org/). • IRB request is then routed to an IRB member for initial review to determine which category of review the IRB falls under (expedited, full, or exempt).

  7. Review Process-Expedited Expedited Review • Primary reviewer completes the review • If there are conditions the primary reviewer advises the investigator on how to resolve those issues. • The primary then reviews the revised protocol for final approval.

  8. Review Process-Full Board • Full Board Review • If the study meets criteria for full board review, the protocol is forwarded to the entire committee for review. • It will be discussed at the next scheduled IRB meeting. • Investigator may be asked to provide more information prior to or during the IRB meeting. • If conditions for approval are noted by the board, the IRB chair will advise how to resolve conditions and will review the revised protocol to determine final approval.

  9. Review Process-Exempt • Exempt • Categories of research that involve little to no risk to participants • The primary reviewer forwards the protocol to the IRB chairperson to confirm that it qualifies for exemption.

  10. Process Time • How long does an IRB review take? • Studies that qualify as exempt or expedited are usually reviewed within two weeks. • Full review may take longer, depending on when the proposal is submitted relative to the IRB meeting schedule.

  11. Approval • Once notified of approval you may begin your research. • Approval is good for 1 year. • If you make any changes to the basic research design, instruments, etc., you will need to file an amendment with the IRB. • If you wish to collect data after the 1 year expiration date, you will need to file an IRB renewal request.

  12. What Else Does IRB Do? • IRB members help investigators learn more about ethical treatment of research participants. • IRB members are available to consult with individuals preparing protocols. • IRB also provides training to groups of faculty/staff and to classes.

  13. More About IRB • IRB website – http://www.wcu.edu/6801.asp • IRB Office Contact – Michelle Hargis, Research Administration 227-7212 or irb@wcu.edu • IRB Chairperson – Meagan Karvonen, Dept. of Educational Leadership & Foundations 227-3323 or karvonen@email.wcu.edu

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