Greer / Banks The IACUC Administrator’s Guide to Animal Program Management

Setting Up and Directing an IACUC Office
Erscheinungsjahr 2016
ISBN: 978-1-4398-4908-8
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 315 Seiten

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.

Zielgruppe

Animal Facility Manager, Laboratory Manager or Director, Laboratory Facility Manager, Supervisor/Area Leader, Lab Animal Technologist, Staff Veterinarian, Department Chairperson; Veterinary and Biomedical Research Managers and Quality Assurance Professionals at Pharmaceutical and Biotech Industries; IACUC members Animal Resource Departments/ Animal Care Units at Universities, Medical Universities/Hospital Research Institutes, and Government Organizations; Professionals aspiring to move into management/administration such as veterinarians, lab technicians, and research assistants.

Autoren/Hrsg.

Greer, William G.

Banks, Ron E.

Fachgebiete

• Naturwissenschaften Biowissenschaften Toxikologie
• Naturwissenschaften Biowissenschaften Tierkunde / Zoologie Tierphysiologie

Inhaltsverzeichnis

An Introduction to Best Practices Meetings
Introduction
History of Best Practices Meetings
IACUC Administrators’ Association
BP Meetings

The IACUC Administrator’s Office Structure
Scenario
Office Models
How Many Full-Time Employees Does It Take to Effectively Operate an IACUC Administrative Office?
Funding Implications
Summary
Hiring IACUC Administrative Staff Members
Reporting Lines: Who Reports to Whom?
Performance Data
Improving Efficiency and Working Smart

The IACUC Administrator’s Role and Responsibilities
Scenario
The IACUC Administrator
What Are the Common Duties of the IACUC Administrator?

The Animal Care and Use Program
Scenario
Introduction
Key Members of the Organization’s Animal Care and Use Program
The IACUC

Protocol Review and Approval
Scenario
Prescreening Protocols (Administrative and Veterinary Reviews)
Initiating the IACUC Review Process

Protocol Noncompliance
Scenario
Investigating and Reporting Animal Welfare Concerns

Protocol and Grant Congruency
Scenario
Background
Is Congruence Required?
Collaborations and Protocol and Grant Congruency
Common Practices
How Does a Grant Modification Affect the IACUC Approval?
Oversight at Collaborating Organizations

Animal Care and Use Program Review
Scenario
The Program Review
Illustrating the Animal Care and Use Program Review Process
Documenting the Program Review

Semiannual Facility Inspection
Scenario
The Facility Inspection
Conducting Semiannual Inspections
Identifying, Documenting, and Correcting Deficiencies

Monitoring the Animal Care and Use Program
Scenario
Introduction
Monitoring Approved IACUC Protocols
Post-Assessment Activities (Follow-Ups)

Facilitating Communication
Scenario
Effective Communication

Field Studies
Scenario
IACUC Review of Field Studies

Personnel Qualifications and Training Programs
Scenario
Establishing a Training Program
Common Training Employed by Organizations Using Animals

Tracking Animal Use on Protocols
Scenario
Animal Use

Veterinary Care Programs
Scenario
The Veterinary Care Program
Evaluating the Veterinary Care Program

Whistle-Blower Policy
Scenario
The Policy
Investigating Whistle-Blower Policy Reports

Occupational Health and Safety Program
Scenario
The OHSP and Accreditation
Personal Dispositions (Personal Risk Assessments)

Emergency Disaster Plans
Scenario
Developing an Emergency Disaster Plan
The EDP Program Structure

The Role of a Primary Grantee
Scenario
AAALAC Accreditation
PHS Assurance Ramifications
Securing Animal Welfare Assurance Coverage
Collaborations and Contracts

FOIA, Sunshine Laws, and Confidential Information
Scenario
Freedom of Information Act
Responding to FOIA Requests
State Sunshine Laws
Institutional Access to Information

DOD and VA Regulations—Know the Differences
Scenario
Federal Funding and PHS Assurance
USDA Oversight
Definition of Terms
Unit Structure
DOD and VA Training
Semiannual Review Processes
IACUC Minutes
Protocols
Unique Aspects of VA and DOD Programs
Memorandum of Understanding
Models of Interaction and Relationship

Data Management and Electronic Systems
Scenario
Methods of Telecommunications
Recordkeeping
Records Management
Using Electronic Systems for the Protocol Review Process

Policies, Guidelines, and Standard Operating Procedures
Scenario
Policies, SOPs, and Guidelines—What Is the Difference?
Policy Formats
Sample Policies

Appendices

Über Autor(innen)

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.