The IACUC Administrator’s Guide to Animal Program Management assists IACUC administrators charged 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.
"The National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) is pleased to endorse this volume of best practices for operation of animal care and use programs (ACUP) at Public Health Service (PHS)-assured institutions. But more than this static collection of operational practices, we support your practice of coming together to share your methods of operating programs at your institutions—large and small, academic, government, nonprofit, and for-profit organizations."
—Susan Brust Silk, MS, Director, Division of Policy and Education, NIH Office of Laboratory Animal Welfare
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?