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. Non-Committee Review Conduct PRE-2018
  15. IRB Meeting Preparation
  16. IRB Meeting Conduct
  17. IRB Meeting Attendance Monitoring
  18. IRB Meeting Minutes
  19. Not Otherwise Approvable Research
  20. Conflicting Interests of IRB Members
  21. Consultation 
  22. Post-Review
  23. Institutional Conflicts of Interests
  24. Financial Conflicts of Interests
  25. Annual Evaluations of the HRPP
  26. Monthly Evaluations of the HRPP
  27. Daily Tasks
  28. Expiration of IRB Approval
  29. NIH GDS Institutional Certification
  30. IRB Records
  31. Standard Operating Procedures
  32. IRB Records Retention
  33. IRB Formation
  34. IRB Removal
  35. IRB Membership Addition
  36. IRB Membership Removal
  37. IRB Meeting Scheduling and Notification
  38. Informed Consent Process for Research
  39. Written Documentation of Consent
  40. TEMPLATE CONSENT DOCUMENT
  41. TEMPLATE Biomedical PROTOCOL
  42. TEMPLATE Social Behavioral (SBS) PROTOCOL
  43. HIPAA Authorization - FOR NCI-CIRB ONLY WITH SIGNATURE PANEL
  44. HIPAA Authorization - WITH SIGNATURE PANEL

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