chapter  14
12 Pages

IACUC Issues in Industry

In the life sciences arena, several industry sectors are involved in research to improve human and animal health, including biotechnology and pharmaceutical companies, as well as contract research organizations (CRO) and preclinical drug development services. The biotechnology and pharmaceutical companies run the gamut from small, biotech start-ups to global companies often referred to as “big Pharma.” CROs range from large, international full-service organizations to small, niche specialty companies that provide support to the pharmaceutical, biotechnology, and medical device industries by providing research services on a contract basis. This chapter will provide an overview of Institutional Animal Care and Use Committees (IACUCs) in industry and will review and discuss issues that may impact how these

CONTENTS

14.1 Introduction .................................................................................................. 237 14.2 Background: The Regulatory Framework .................................................... 238 14.3 IACUC Responsibility, Composition, and Membership Requirements ....... 238

14.3.1 Ensuring an Adequate Number of Members .................................... 239 14.3.2 Recruiting, Training, and Engaging Nonaffiliated IACUC

Members ........................................................................................... 241 14.3.3 Alignment of IACUCs across Multiple Sites .................................... 243

14.4 Other Issues in Industry ................................................................................ 243 14.4.1 Toxicology Studies and Animal Welfare ..........................................244 14.4.2 Outsourcing Studies to CROs ...........................................................245