Policies and Procedures

The following policies have been approved by quorum of the IRB and are promulgated to the university community in addition to this manual:

Part I – IRB General Information

• Federal Wide Assurance
• IRB Authority
• IRB Membership

Part II – IRB Meetings and Operations

• IRB Record Requirements
• IRB Meeting Operations
• IRB Lead Reviewers
• IRB Levels of Review and Decisions
• Appeal of IRB Actions/Determinations
• Monitoring of Approved Research, Approval Duration, and Continuing Review
• Suspension and Termination of Research
• Unanticipated Problems and Adverse Event Reporting
• Amendments to Research
• Verification of Compliance with Approved Protocols From Sources Other Than Investigators
• Further Review/Approval of IRB Actions
• Changes to Policies
• Non-Compliance Policy

Part III – Investigator Responsibilities

• General Responsibilities of the Principal Investigator
• Informed Consent
• Financial Conflicts of Interest with Respect to Sponsored Projects

Part IV – Education and Training

• Human Subjects Research Training

Part V – General Research Items

• Research with Children
• Research with Prisoners
• Research with Pregnant Women, Neonates, and Fetuses
• Student Research
• Research Conducted with Students as Subjects

Part VI - HIPAA

• Research Uses and Disclosure Policy and Procedure