IRB Guidelines for Research

All links below open Microsoft Word documents.

1. General Administration

• 1.1 IRB Staffing
• 1.2 IRB Review Fees
• 1.3 The IRB
• 1.4 Development, Approval and Maintenance of IRB Standard Operating Guidelines
• 1.5 Procedures for Planning and Implementing IRB Meeting Agendas
• 1.6 Maintenance of IRB Office Records
• 1.7 Documentation of IRB Meeting Minutes
• 1.8 Health Insurance Portability and Accountability Act (HIPAA)

2. Review of Research

• 2.1 Administrative Review and Process for Differentiating Human Subjects Research from Non-human Subjects Research and for Determining Level of Review
• 2.2 Components of Protocol
• 2.3 Recruitment of Study Subjects (Updated 02/2013)
• 2.4 Full-Board Review
• 2.5 Expedited Review
• 2.6 Exempt Human Subjects Research
• 2.7 Continuing Review
• 2.8 How to Notify IRB of Changes/Updates to Research Projects
• 2.9 Reporting Adverse Events and Unanticipated Problems
• 2.10 Appeal Process
• 2.11 Study Completion; Ending IRB Oversight

3. Reviews Requiring Special Consideration

• 3.1 Quality Assurance / Quality Improvement Activities
• 3.2 NCI Studies
• 3.3 Western IRB
• 3.4 Reciprocal IRB Review
• 3.5 Case Reports
• 3.6 Vulnerable Populations
• 3.7 Collecting and Disbursement of Stored Data and Specimens Review
• 3.8 Wards of State and Emancipated Minors
• 3.9 Determining the Need for a DMC and the Requirements of a DMC
• 3.10 Grant Application Review
• 3.11 External Requests for Protected Health Information
• 3.12 International Research Added 5/8/2012

4. Investigational Drugs, Biologics and Devices

• 4.1 Emergency and Treatment Use of Investigational Drug
• 4.2 Significant/Non-Significant Risk Devices, Humanitarian Use Devices, Emergency Use, Compassionate Use (Updated 02/2013)
• 4.3 MRI

5. Informed Consent Process

• 5.1 Administrative Review of Consent Form
• 5.2 Consent, Waiver of Consent, Witness, Telephone Consent
• 5.3 Use of Legally Authorized Representative Updated 1/20/2012
• 5.4 Determining the Need for Assent
• 5.5 Non-English Consent
• 5.6 Decision Making Capacity Added 1/20/2012

6. Conduct of Research

• 6.1 Protocol Deviations Updated 1/20/2012
• 6.2 Procedure for Complaints Regarding Human Subjects Research
• 6.3 Conflict of Interest for Board Members
• 6.4 Non-Compliance
• 6.5 Research (Scientific) Misconduct
• 6.6 IRB Compliance Activities (Audits, Surveys)
• 6.7 Conduct of Research - Post-Approval Educational Activities
• 6.8 Notification of Regulatory Agencies
• 6.9 Suspensions and Terminations Added 1/20/2012

7. IRB Education and Training

• 7.1 Investigator and Key Study Personnel Training
• 7.2 IRB Member Training Updated 1/20/2012
• 7.3 IRB Member Duties
• 7.4 Principal Investigator Requirements
• 7.5 Student Projects