Informed Consent Policies & Forms

IC 701 General Requirements and Documentation

• IC 701-A Informed Consent Checklist - Primary Reviewer(s)
• IC 701-B Informed Consent - Guidelines and Basic Elements
• IC 701-C Informed Consent Template
• IC 701-D Glossary of Medical to Lay Terms

IC 702 Exceptions from General Consent Requirements

• IC 702-A Waiver or Alteration of Informed Consent Under 45 CFR 46.116(d) Decision Chart

IC 703 Assent

• IC 703-A Requirements Checklist for Consent/Assent of Minors
• IC 703-B Informed Consent Document Template: Assent (word document)

Policies & Forms: 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

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