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.
- SOP (HRP-001) - Definitions
- SOP (HRP-012) - Observation of Consent Process
- SOP (HRP-013) - LARs, Children and Guardians
- SOP (HRP-020) - Incoming Items
- SOP (HRP-021) - Pre-Review
- SOP (HRP-023) - All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Review
- SOP (HRP-024) - New Information
- SOP (HRP-025) - Investigations
- SOP (HRP-026) - Suspension or Termination Issued Outside of Convened IRB
- SOP (HRP-027) - All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Post-Review
- SOP (HRP-030) - Designated Reviewers
- SOP (HRP-031) - Non-Committee Review Preparation
- SOP (HRP-032) - Non-Committee Review Conduct
- SOP (HRP-040) - IRB Meeting Preparation
- SOP (HRP-041) - IRB Meeting Conduct
- SOP (HRP-042) - IRB Meeting Attendance Monitoring
- SOP (HRP-043) - IRB Meeting Minutes
- SOP (HRP-044) - Not Otherwise Approvable Research
- SOP (HRP-050) - Conflicting Interests of IRB Members
- SOP (HRP-051) - Consultation
- SOP (HRP-052) - Post-Review
- SOP (HRP-054) - Institutional Conflicts of Interest
- SOP (HRP-055) - Financial Conflicts of Interests
- SOP (HRP-063) - Expiration of IRB Approval
- SOP (HRP-070) - IRB Records
- SOP (HRP-071) - Toolkit Management
- SOP (HRP-072) - IRB Records Retention
- SOP (HRP-080) - IRB Formation and Registration
- SOP (HRP-081) - IRB Removal
- SOP (HRP-082) - IRB Membership Appointment
- SOP (HRP-083) - IRB Membership Removal
- SOP (HRP-084) - IRB Meeting Scheduling and Notification
- TEMPLATE CONSENT DOCUMENT
- TEMPLATE IRB MInor Subject Assent
- TEMPLATE Biomedical PROTOCOL
- TEMPLATE Social Behavioral (SBS) PROTOCOL
- HIPAA Authorization - FOR NCI-CIRB ONLY WITH SIGNATURE PANEL
- HIPAA Authorization - WITH SIGNATURE PANEL
- HUMAN RESEARCH PROTECTION PROGRAM PLAN (HRPP) (HRP-101)
- INVESTIGATOR MANUAL (HRP-103)
