MUOT IRB HANDBOOK

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MUOT Policy on Human Subjects Protection (#02-001)

MUOT Assurance of Compliance

OHPR IRB Guidebook
Forward
Acknowledgements
Preface

Introduction

Chapter I: Institutional Administration

Chapter II: Regulation and Policies

Chapter III: Basic IRB Review

Chapter IV: Considerations of Research Design

Chapter V: Biomedical and Behavioral Research: An Overview

Chapter VI: Special Classes of Subjects

Guidebook Appendices

Glossary of Terms

Code of Federal Regulations

PHS: 45 CFR 46 - The Common Rule

FDA: 21 CFR 50 - Protection of Human Subjects

FDA: 21 CFR 56 - Institutional Review Boards

FDA Guidance for Institutional Review Boards and Clinical Investigators

Significant Differences in FDA and HHS Regulations for Protection of Human Subjects

The Belmont Report

 

Appendices

A - Federal Definitions of RESEARCH and HUMAN SUBJECT

B - When is an Institution Engaged in Research?

C - Continuing Review - OPRR Reports

D - Common Findings and Guidance - OHRP

E - IRB Reviewer Instructions and Checklist

 

 

Page Updated: 2/13/2002

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