Criteria for IRB Approval of Research: 45 CFR 46.111 November 9, 1998 Federal Register list of research eligible for expedited IRB review FDA Regulations & Guidance Criteria for IRB Approval of Research: 21 CFR 56.111 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research: 21 CFR 56.110 OHRP Guidance Guidance on the Use of Expedited Review Procedures August 11, 2003 – Guidance on Written IRB Procedures July 1, 2011 – Guidance on IRB Continuing Review of Research November 10, 2010 – DU HRPP Guidance Post Approval Reporting Requirements (PAR). • IRB Review Process and Communication of Results of IRB Review • Materials Required for IRB Review • Questions Direct questions about an expedited review request to: (303) 871-2121 or through IRBAdmin@du.edu •
Criteria for IRB Approval of Research: 45 CFR 46.111 November 9, 1998 Federal Register list of research eligible for expedited IRB review FDA Regulations & Guidance Criteria for IRB Approval of Research: 21 CFR 56.111 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research: 21 CFR 56.110 OHRP Guidance Guidance on the Use of Expedited Review Procedures – August 11, 2003 Guidance on Written IRB Procedures – July 1, 2011 Guidance on IRB Continuing Review of Research – November 10, 2010 DU HRPP Guidance • Post Approval Reporting Requirements (PAR). • IRB Review Process and Communication of Results of IRB Review • Materials Required for IRB Review Questions Direct questions about an expedited review request to: • (303) 871-2121 or through IRBAdmin@du.edu
guidance_expedited_review.docx