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Understanding the IRB Process

Understanding the IRB Process . University of Tennessee Health Science Center Institutional Review Board. Overview . UTHSC IRB application What happens after you submit your application Types of IRB reviews PI Response Form How to track your application. IRB Application Process.

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Understanding the IRB Process

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  1. Understanding the IRB Process University of Tennessee Health Science Center Institutional Review Board

  2. Overview • UTHSC IRB application • What happens after you submit your application • Types of IRB reviews • PI Response Form • How to track your application

  3. IRB Application Process

  4. IRB Application

  5. IRB Application

  6. IRB Application

  7. IRB Application

  8. IRB Application • The application will guide you through the required sections depending on the type of research you are conducting; • Be sure to click Save and Continue to Next Section to save your responses and move to the next section of questions in the application; • Required questions of the application will be marked with an *; • If you forget to respond to a question the system will send you a prompt; • If you are unsure about a question, please contact the IRB office; • Once you have completed the electronic application, the system will prompt you in the Routing Form to upload any study documents (informed consent form, protocol, questionnaires, etc).

  9. Routing Application for Signatures

  10. Routing Application for Signatures

  11. Routing Application for Signatures

  12. Routing Application for Signatures

  13. IRB Receives Submission • IRB assigns IRB Analyst • IRB assigns reviewer(s) for submissions requesting exempt or expedited review • IRB assigns a submission to an upcoming IRB meeting if the submission requires review by the full convened IRB

  14. Institutional Review Boards • HHS Regulations (45 CFR 46) apply to research conducted by or supported by NIH • FDA Regulations (21 CFR parts 50, 56, 312, and 812) apply to research of unapproved drugs and devices • HIPAA Regulations (45 CFR parts 160 and 164)

  15. IRB Review • Selection of subjects is equitable • Risks to subjects are minimized • Risks are reasonable in respect to the anticipated benefits • Informed consent will be secured from subject or LAR

  16. IRB Review • Informed Consent will be properly documented • Data will be monitored to ensure safety of subjects • Adequate provisions are made to protect subject privacy and confidentiality • Appropriate additional safeguards are used to protect vulnerable subjects

  17. Federal Regulations for Vulnerable Populations • Pregnant Women and Fetuses • Children • Prisoners

  18. IRB Review Process –Exempt & Expedited Applications

  19. IRB Review Process – Full Board Review

  20. PI Response Form

  21. PI Response Form

  22. PI Response Form

  23. PI Response Form

  24. Tracking Your Application

  25. Tracking Your Application

  26. Tracking Your Application

  27. Tracking Your Application

  28. Tracking Your Application

  29. IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/

  30. IRB Websitehttp://www.uthsc.edu/research/research_compliance/IRB/guides.php

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