Functions and Operations Policies & Forms

FO 301 Research Submission Requirements

• FO 301-A IRB Application for Initial Review
• FO 301-B IRB Application for Renewed Approval
• FO 301-C Application for Revision and/or Amendment
• FO 301-D Data Security Guidelines
• FO 301-E Investigator Delegation of Responsibility (word document)

FO 302 Research Exempt from IRB Review

• FO 302-A Exemption Screening Questions (word document)
• FO 302-B Claim of Exemption (word document)
• FO 302-C Claim of Exemption Checklist for Staff

FO 303 IRB Meeting Administration

• FO 303-A IRB Agenda/Minutes Template

FO 304 Administrative Review and Distribution of Materials

FO 305 Documentation and Document Management

Policies & Form: General Administration IRB Organization Functions and Operations Review of Research Review Requiring Special Consideration IRB Communication and Notification Informed Consent Responsibilities of Investigators Quality Assurance

Appendix: A Belmont Report with Acknowledgement Form B Statement Authorizing the IRB (FWA) C Studies Requiring IRB Review D List of Committees E Expedited Review Procedures F Significant Risk and Nonsignificant Risk Medical Device Studies

FO 306 IRB Reliance and Central IRB Submitted Protocols

• FO 306-A IRB Reliance Review Process (SHS/MSU Agreement)
• FO 306-B Application for IRB Reliance Project Review
• FO 306-C IRB Member Review Form

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