Authors: Carol Saunders, RN, Arna Shefrin, MS, Eileen Rusnak, CIP, Anna J. DeMarinis, M.A., MT (ASCP) SBB, CQA (ASQ).

Policies and Standard Operating Procedures for the Institutional Review Board is designed to be customized to fit the requirements of your IRB and reflect your institution’s philosophy and standards. The template is based on the Code of Federal Regulations, guidance and ICH/GCP Consolidated Guideline and the Association for the Accreditation of Human Research Protection Program’s (AAHRPP) standards for human subject protection.

This SOP template is provided in a 3-ringed binder with a CD-ROM containing an MS Word program for Windows users only. Once installed on your computer, it is easy to use and can be customized to reflect your company’s philosophy, standards and innovations.

For any institutional IRB that is accreditation, or simply strives to adhere to such standards, these SOPs are the most efficient and reliable way to achieve that level of compliance.

SOP template includes:

• Sample letters
• Submission forms
• 50+ SOPs
• Templates for IRB minutes, agendas, review worksheet
• Sample job descriptions for staff and IRB members

• General Administration
• IRB Organization
• Functions and Operations
• Review of Research
• Reviews Requiring Special Consideration
• IRB Communication and Notification
• Informed Consent
• Responsibilities of Investigators and Sponsors
• Quality Assurance
• Waiver of Authorization 

Table of Contents

Introduction

List of Attacments

IRB Policies and Procedure Maintenance