VII. 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
- 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
- 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
