- Policies and Procedures
- Introduction
- Scope of Authority
- Designation of the Institutional Review Board
- External Institutional Review Board – Western IRB
- IRB Administrative Office (OPPHI)
- IRB Executive Committee
- Materials Required for IRB Submission
- Informed Consent and Child Assent
- Administrative Review
- Human Subjects Research Determination
- Procedure for Determining Exemptions
- Procedure for Expedited Review
- Initial Review – Full IRB Review
- Institutional Review Board Meetings
- Procedure for Continuing Review
- Policy for Amendments
- Report of Adverse Events
- Investigational New Drug or Investigational Device
- Emergency Use of Experimental Drugs or Devices
- Advertisements
- Conflict of Interest
- IRB Communication with the Investigators
- Investigators Responsibilities
- Human Subjects Protection and HIPAA Training Requirements