Policies and Guidance
IRB policies
- Title Page and Log of Changes
- Chapter 1 - Ethical and Regulatory Mandate
- Chapter 2 - Human Subjects Research
- Chapter 3 - Commitment to Protection of Human Subjects in Research
- Chapter 4 - Commitment To and Shared Responsibility for the Protection of Research Participants
- Chapter 5 - IRB Roles and Resonsibilities
- Chapter 6 - IRB Structure and Membership
- Chapter 7 - Administrative Support
- Chapter 8 - Record Keeping and Documentation Requirements
- Chapter 9 - Procedures for IRB Review
- Chapter 10 - Criteria for IRB Approval of Research
- Chapter 11 - Required Elements of Informed Consent
- Chapter 12 - IRB Review of FDA-Regulated Research
- Chapter 13 - Social and Behavioral Research
- Chapter 14 - Research using Retrospective Review of Existing Materials
- Chapter 15 - IRB Review of Research Involving Children
- Chapter 16 - IRB Review of Reseach Involving Adults as Vulnerable Participants
- Chapter 17 - External Review and Prisma Health Reliance
- Chapter 18 - Conflict of Interest Requirements
- Chapter 19 - Emergency Preparadness
- Chapter 20 - Quality Improvement Program
- Chapter 21 - Legally Authorized Representatives in Research
- Appendix - Definitions
IRB guidance
Documents to support research protocol activity.
- Biosafety and Radiation Safety Review
- Case Study Review
- CITI Training Registration How-To
- Consent and HIPAA Waiver
- Continuing Review Not Required
- Devices
- Elements of Consent Disclosure
- Exempt Review
- Expedited Review
- Guidelines to Ensure Health Literacy in the Consent Process
- Clinical Research Glossary - Multi-Regional Clinical Trials (MRCT)
- Legally Authorized Representative Use
- Not Human Subjects Research
- Reportable Event Timing
- Required Elements Guide – New Project Submission
- Signing and Linking submission package in IRBNet
- sIND Expanded Access
- Vulnerable Population
- CEDE Review Request
- External Review Local Acknowledgment Submissions (non-WCG submissions)
- WCG Reviewed Submissions (External Review)
- Remote Consent