The IACUC Administrator’s Guide to Animal Program Management supports IACUC administrators who assist with developing, managing, and overseeing a program of animal care and animal use. It provides many options and possibilities for specific operational practices (e.g., how to build a well-functioning IACUC, what a functional protocol template looks like) to satisfy regulatory requirements.
The material provided is a compilation of several years of Best Practices (BP) meetings among IACUC administrators across the country. The BP meetings included representatives from the NIH/OLAW, AAALAC, and the USDA, whose presence and dialogue assured the BP discussion met or exceeded all regulatory or accreditation minimum standards. BP meeting attendees from private, public, governmental, and academic organizations have helped to shape and develop the information offered herein. It is through the insight of several hundred colleagues—their successes as well as their failures—that the authors have distilled suggestions and considerations for your local animal care and use program.
This handbook complements other useful references and manuals regarding programmatic function—it is not intended to replace them. The primary difference you will find is the transparent and open nature of describing processes that have been time tested and proven to help you and your organization satisfy the regulatory requirements.
Table of Contents
An Introduction to Best Practices Meetings
History of Best Practices Meetings
IACUC Administrators’ Association
The IACUC Administrator’s Office Structure
How Many Full-Time Employees Does It Take to Effectively Operate an IACUC Administrative Office?
Hiring IACUC Administrative Staff Members
Reporting Lines: Who Reports to Whom?
Improving Efficiency and Working Smart
The IACUC Administrator’s Role and Responsibilities
The IACUC Administrator
What Are the Common Duties of the IACUC Administrator?
The Animal Care and Use Program
Key Members of the Organization’s Animal Care and Use Program
Protocol Review and Approval
Prescreening Protocols (Administrative and Veterinary Reviews)
Initiating the IACUC Review Process
Investigating and Reporting Animal Welfare Concerns
Protocol and Grant Congruency
Is Congruence Required?
Collaborations and Protocol and Grant Congruency
How Does a Grant Modification Affect the IACUC Approval?
Oversight at Collaborating Organizations
Animal Care and Use Program Review
The Program Review
Illustrating the Animal Care and Use Program Review Process
Documenting the Program Review
Semiannual Facility Inspection
The Facility Inspection
Conducting Semiannual Inspections
Identifying, Documenting, and Correcting Deficiencies
Monitoring the Animal Care and Use Program
Monitoring Approved IACUC Protocols
Post-Assessment Activities (Follow-Ups)
IACUC Review of Field Studies
Personnel Qualifications and Training Programs
Establishing a Training Program
Common Training Employed by Organizations Using Animals
Tracking Animal Use on Protocols
Veterinary Care Programs
The Veterinary Care Program
Evaluating the Veterinary Care Program
Investigating Whistle-Blower Policy Reports
Occupational Health and Safety Program
The OHSP and Accreditation
Personal Dispositions (Personal Risk Assessments)
Emergency Disaster Plans
Developing an Emergency Disaster Plan
The EDP Program Structure
The Role of a Primary Grantee
PHS Assurance Ramifications
Securing Animal Welfare Assurance Coverage
Collaborations and Contracts
FOIA, Sunshine Laws, and Confidential Information
Freedom of Information Act
Responding to FOIA Requests
State Sunshine Laws
Institutional Access to Information
DOD and VA Regulations—Know the Differences
Federal Funding and PHS Assurance
Definition of Terms
DOD and VA Training
Semiannual Review Processes
Unique Aspects of VA and DOD Programs
Memorandum of Understanding
Models of Interaction and Relationship
Data Management and Electronic Systems
Methods of Telecommunications
Using Electronic Systems for the Protocol Review Process
Policies, Guidelines, and Standard Operating Procedures
Policies, SOPs, and Guidelines—What Is the Difference?
William G. Greer received his BS degree in microbiology and is currently earning an MS degree in adult education from The Pennsylvania State University, where he serves as associate director in the Office for Research Protections. He is a certified IACUC professional administrator, laboratory animal technician, and hazardous materials shipping professional. He established the IACUC Administrators Best Practices Meetings and led the team that formalized the IACUC Administrator Association (IAA). He also established the Committee on Institutional Cooperation IACUC Administrators’ working group (Big Ten Universities). In 2011, Bill was awarded the Penn State Vice President for Research Outstanding Leadership Award.
Ron E. Banks earned his veterinary degree from Auburn University’s School of Veterinary Medicine. He served 34 years in the United States Army Veterinary Corps and is currently the director of the Office of Animal Welfare Assurance at Duke University, Durham, North Carolina. He is a Fellow of the National Academies of Practice, and board-certified with the American College of Laboratory Animal Medicine, the American College of Veterinary Preventive Medicine, and the American College of Animal Welfare. Along with Bill Greer, he has facilitated Best Practices meetings since its inception in 2005 and continues to serve as a member of the Board of Directors of the IACUC Administrators Association.
"The IACUC Administrator’s Guide to Animal Program Management is tailored to meet the needs of IACUC Administrators, Attending Veterinarians (AVs) and/or Animal Research Directors involved with developing, managing, and overseeing a program of animal care and use. While the Federal regulations (AWA act) and standards such as the guide for "The care and use of laboratory animals" help set the expectations for lab animal programs they do not provide clear guidance on the methods that need to be in place especially at the IACUC level to help balance compliance and animal welfare adequately. The authors have tried to bridge this gap by compiling shared best practices from animal program administrators across a wide spectrum of institutions ranging from academia, government and private organizations. …
A special feature of the book is the inclusion of chapters on FOIA, Sunshine laws and the DOD/VA regulations. This has not been traditionally addressed in other books of this nature. We especially loved reading chapter 4, The Animal Care and Use Program and chapter 5, Protocol Review and Approval for the content and concise detail. …The authors have done a great job highlighting the issue as well as providing different practices that IACUC’s can adopt to overcome this situation. Chapter 8, Animal Care and Use Program Review was also very well written and could act as a significant resource for administrators to use when training IACUC members on how to conduct and participate in a program reviews.
Overall the details, real life scenarios and wide range of topics makes this a must have book for IACUC administrators and program directors. This could be especially valuable to individuals new to the field, lab animal residents and a resource book for those seeking certification as a professional IACUC administrator."
Jennifer McElroy, RVT, CPIA and Dr. Jeetendra Eswaraka, DVM, PhD, DACLAM in Laboratory Animal Practitioner