Policies and Procedures

Institutional Review Board

Policies and 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. 

IRB forms are available for initial study submission and reporting other activities through the course of research studies.

  1. 2013 PH IRB Meeting Dates

  2. 2014 PH IRB Meeting Dates

  3. IRB Contact List

  4. Amendments

  5. Continuing Review

  6. Deviation and Noncompliance Reporting

  7. Electronic Submission and Review Process

  8. Emergency Use of a Drug, Biologic, or Medical Device

  9. Exempt Research List of Categories of Research

  10. Exempt Research Protocols

  11. Expedited Review-Categories of Research That May Be Reviewed by An IRB through an Expedited Review

  12. Expedited Review of Research

  13. Humanitarian Use Device (HUD)

  14. PH IRB Introduction

  15. PH IRB Authority, Membership, Board Positions

  16. PH IRB Fee Schedule and Charging Policy

  17. PH IRB Meetings

  18. PH IRB Member Roster

  19. PH IRB Operations

  20. New Protocol Submission

  21. Principal Investigator Statement of Principles

  22. Presenters Format

  23. Research Conflicts of Interest

  24. Reportable Events

  25. Reporting Procedure

  26. Review of Medical Devices-SR vs NSR

  27. Review of Research

  28. Study Closure

  29. Submission Flow Chart

  30. Training Requirements for Individuals Involved in Human Subject Research

  31. Use of a Centralized IRB

  32. Use of a Centralized IRB − Approved List of Centralized IRBs

  33. Vulnerable Populations

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