Policies & Procedures

The Parkview Health Institutional Review Board (IRB) is compliant with all applicable federal and state laws and regulations governing IRBs and research with human subjects. The PH IRB maintains written procedures for initial and continuing review of clinical trials, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process. 

  1. Definitions
  2. Observation of Consent Process
  3. LARs, Children, and Guardians
  4. Incoming Items
  5. Pre-Review
  6. Emergency and Device Compassionate Use Review
  7. New Information
  8. Investigations
  9. Suspension or Termination
  10. Emergency and Device Compassionate Use Post-Review
  11. Designated Reviewers
  12. Non-Committee Review Preparation
  13. Non-Committee Review Conduct
  14. IRB Meeting Preparation
  15. IRB Meeting Conduct
  16. IRB Meeting Attendance Monitoring
  17. IRB Meeting Minutes
  18. Not Otherwise Approvable Research
  19. Conflicting Interests of IRB Members
  20. Consultation 
  21. Post-Review
  22. Institutional Conflicts of Interests
  23. Financial Conflicts of Interests
  24. Expiration of IRB Approval
  25. IRB Records
  26. Standard Operating Procedures
  27. IRB Records Retention
  28. IRB Formation
  29. IRB Removal
  30. IRB Membership Addition
  31. IRB Membership Removal
  32. IRB Meeting Scheduling and Notification
  33. TEMPLATE CONSENT DOCUMENT
  34. TEMPLATE IRB MInor Subject Assent
  35. TEMPLATE Biomedical PROTOCOL
  36. TEMPLATE Social Behavioral (SBS) PROTOCOL
  37. HIPAA Authorization - FOR NCI-CIRB ONLY WITH SIGNATURE PANEL
  38. HIPAA Authorization - WITH SIGNATURE PANEL
  39. HRP Investigator Manual
  40. Human Research Protection Program Plan