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E-raamat: IACUC Administrator's Guide to Animal Program Management

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(Duke University, Durham, North Carolina, USA), (Pennsylvania State University, University Park, USA)
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  • Ilmumisaeg: 22-Feb-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781439849088
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IACUC Administrator's Guide to Animal Program ManagementSuurem pilt
  • Formaat: PDF+DRM
  • Ilmumisaeg: 22-Feb-2016
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9781439849088
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The IACUC Administrators 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 colleaguestheir successes as well as their failuresthat 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 functionit 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.

Arvustused

"The IACUC Administrators 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 IACUCs 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

Preface xvii
Introduction xix
Acknowledgments xxi
Authors xxiii
Acronyms and Common Terms xxv
Chapter 1 An Introduction to Best Practices Meetings 1(6)
Introduction
1(1)
History of Best Practices Meetings
2(2)
The BP Meeting Format
4(1)
Limitations of the Meeting Format
4(1)
IACUC Administrators' Association
4(1)
BP Meetings
5(2)
Chapter 2 The IACUC Administrator's Office Structure 7(14)
Scenario
7(1)
Office Models
8(1)
Research Compliance Office
8(1)
Administration through the Director of the ARP
8(1)
How Many Full-Time Employees Does It Take to Effectively Operate an IACUC Administrative Office?
9(4)
The Submission Variable
10(1)
The Variable for Number of Animal Users
11(1)
The "Other Factors" Variable
11(4)
PHS Assured
11(1)
AAALAC International Accreditation
12(1)
USDA Implications
13(1)
Funding Implications
13(1)
Summary
14(1)
Hiring IACUC Administrative Staff Members
15(2)
Credentials: What Is Important?
15(1)
Position Announcements
16(1)
Conducting Interviews
16(1)
Conducting Reference Checks
17(1)
Reporting Lines: Who Reports to Whom?
17(2)
Direct Reporting Lines
17(1)
Indirect Reporting Lines
18(1)
Performance Data
19(1)
Improving Efficiency and Working Smart
19(2)
Chapter 3 The IACUC Administrator's Role and Responsibilities 21(20)
Scenario
21(2)
The IACUC Administrator
23(5)
The IACUC Administrator's Experience and Background
23(1)
The Regulatory Role of the IACUC Administrator
24(1)
The IACUC Administrator and the IACUC
24(1)
The IACUC Administrator and the AV
25(1)
The IACUC Administrator and the IO
26(1)
The IACUC Administrator and Other Administrative Units
26(1)
The IACUC Administrator and Regulatory Agencies
27(1)
The IACUC Administrator and AAALAC International
27(1)
The IACUC Administrator and Principal Investigators
28(1)
Should the IACUC Administrator Be a Voting Member?
28(1)
What Are the Common Duties of the IACUC Administrator?
28(13)
Coordinate and Conduct Protocol Prescreening and Reviews
28(2)
Organize and Schedule Meetings, Inspections, and Program Reviews
30(1)
Prepare and Distribute Reports
30(2)
IACUC Record Maintenance
32(1)
OLAW (PHS) Assurance, USDA Registration, and AAALAC Accreditation
32(2)
Conduct Training and Orientations for IACUC Members and PIs
34(1)
Oversee Training Programs and Maintain Training Records
35(1)
Advise the IACUC and IO on Relevant Regulations and Policies
35(1)
Assist PIs with Preparing Protocols and Satisfying Regulatory Requirements
36(1)
Facilitate Communication
36(1)
Informational Resource to the AV, IACUC Chair, JO, and PIs
37(1)
Serve as Long-Term IACUC Participant and Provide "Institutional Memory"
37(1)
Manage IACUC Investigations
38(1)
Program/Facility Deficiencies and Corrections
39(1)
Conduct Protocol and Grant Congruency Reviews
39(1)
Develop and Maintain IACUC SOPs and Policies
39(1)
Develop and Maintain Websites
39(1)
Author and Distribute Newsletters
39(1)
Monitor Animal Rights Activism and Initiate Appropriate Responses
40(1)
Serve as a Point of Contact for USDA Officers and AAALAC Visitors
40(1)
Develop and Maintain Emergency Disaster Programs
40(1)
Chapter 4 The Animal Care and Use Program 41(16)
Scenario
41(2)
Regulatory Requirements and Guidance Documents
43(1)
Introduction
43(2)
Key Members of the Organization's Animal Care and Use Program
45(3)
The IACUC
48(9)
Committee Membership
48(1)
The Nonaffiliated Member
49(1)
Alternate IACUC Members
50(1)
Properly Constituted IACUC and Quorum
50(4)
Scenario 1
51(1)
Scenario 2
52(1)
Scenario 3
52(1)
Scenario 4
53(1)
IACUC Functions
54(1)
Conflicts of Interest
54(2)
Expectation of Member Confidentiality
56(1)
Chapter 5 Protocol Review and Approval 57(16)
Scenario
57(2)
Regulatory Requirements and Resources
59(1)
Prescreening Protocols (Administrative and Veterinary Reviews)
59(2)
IACUC Administrator Pre-Review
59(1)
Veterinary Pre-Review
60(1)
Initiating the IACUC Review Process
61(12)
Full Committee Review Process
62(2)
The Use of a Primary Reviewer
62(1)
Consultation with the PI during the FCR
63(1)
Table the Submission after the Next Full Committee Meeting
63(1)
The Use of a Designated Member Reviewer
63(1)
Designated Member Review Process
64(2)
Assigning the Designated Member Reviewer
65(1)
Benefits of Using the Designated Member Review Process
65(1)
Potential Pitfalls of the Designated Member Review Process
66(1)
Conducting Protocol Reviews Using Video and Teleconferencing
66(1)
Full Committee versus Designated Member Review
67(1)
Receiving Proposed Animal Activities
67(1)
Using Approved SOPS as Part of the Protocol
67(1)
Protocol Modifications
68(1)
Significant versus Nonsignificant (or Minor) Modifications
69(1)
Personnel Changes
69(1)
Annual and De Novo Reviews
70(1)
Expedited Reviews
70(1)
Reviewing Proposals for Custom Antibody Production
71(1)
Reviewing a Protocol for Scientific Merit
71(2)
Chapter 6 Protocol Noncompliance 73(8)
Scenario
73(2)
Regulatory Requirements and Resources
74(1)
Investigating and Reporting Animal Welfare Concerns
75(6)
Conducting Investigations
75(1)
Method 1
75(1)
Method 2
76(1)
Suspensions
76(1)
Reporting
77(1)
Corrective Actions
78(3)
Chapter 7 Protocol and Grant Congruency 81(10)
Scenario
81(2)
Regulatory Requirements and Guidance Documents
82(1)
Background
83(1)
Is Congruence Required?
84(1)
Collaborations and Protocol and Grant Congruency
85(1)
Common Practices
86(2)
Method 1
86(1)
Method 2
87(1)
Method 3
88(1)
How Does a Grant Modification Affect the IACUC Approval?
88(1)
Oversight at Collaborating Organizations
89(2)
Chapter 8 Animal Care and Use Program Review 91(12)
Scenario
91(2)
Regulatory Requirements and Resources
92(1)
The Program Review
93(7)
Preparing for the Program Review
93(1)
Proposed Best Practices for Conducting Program Reviews
94(9)
Program Review Best Practice 1
94(3)
Program Review Best Practice 2
97(2)
Program Review Best Practice 3
99(1)
Illustrating the Animal Care and Use Program Review Process
100(2)
Documenting the Program Review
102(1)
Chapter 9 Semiannual Facility Inspection 103(18)
Scenario
103(1)
Regulatory Requirements and Reference Resources
104(1)
The Facility Inspection
104(7)
What Facilities Must Be Inspected Semiannually by the IACUC?
105(2)
Housing Facilities
105(1)
Surgery Areas
105(1)
Specialized Animal Laboratories
106(1)
Support Areas
106(1)
Equipment Areas
106(1)
HVAC and Emergency Monitoring Systems
106(1)
Preparing for the Program Review
107(1)
Training/Refresher Training
107(1)
Establishing the Inspection Schedule
107(1)
Coordinating the Inspections
108(1)
Who Should Serve on the Inspection Teams?
108(2)
The Size of the Inspection Teams
110(1)
Announcing the Inspection
110(1)
Preparing for the Inspections
111(1)
Conducting Semiannual Inspections
111(7)
Inspecting Animal Housing Areas
111(5)
Laboratory Animal Facilities
112(3)
Agriculture Animal Facilities
115(1)
Field Stations
116(1)
Cage Wash and Support Areas
116(1)
Procedure and Specialized Areas
117(1)
Survival and Nonsurvival Surgery Suites
117(1)
Specialty Rooms or Labs
117(1)
Euthanasia Rooms
118(1)
Controlled Drug Storage Areas
118(1)
Identifying, Documenting, and Correcting Deficiencies
118(3)
Repeat Deficiencies
119(2)
Chapter 10 Monitoring the Animal Care and Use Program 121(14)
Scenario
121(1)
Regulatory Requirements and Guidance Documents
122(1)
Introduction
122(1)
Monitoring Approved IACUC Protocols
123(8)
Developing a Monitoring Program to Complement the Program
124(1)
A Simple Method for Conducting Focused Assessments
124(2)
Establishing a Postapproval Monitoring Program
126(3)
Funding the Program
126(1)
Identifying and Training the Compliance Liaisons
127(1)
Reporting Lines and the Compliance Liaison's Relationship with the IACUC
128(1)
Policy and Standard Operating Procedure Development
129(2)
Conducting the Visit
129(1)
Conducting the Interview
129(1)
Resolving Discrepancies
130(1)
Postassessment Activities (Follow-Ups)
131(4)
Sanctions
132(1)
Is Your PAM Working?
132(3)
Chapter 11 Facilitating Communication 135(6)
Scenario
135(2)
Effective Communication
137(4)
Communications among Groups Administering the Program
137(1)
Communicating with the 10
138(1)
Communicating with the AV and Veterinary Staff
139(1)
Communicating with Principal Investigators
140(1)
Communicating with the IACUC
140(1)
Chapter 12 Field Studies 141(10)
Scenario
141(2)
Regulatory Requirements and Resources
142(1)
IACUC Review of Field Studies
143(8)
Field Studies: What Information Does the IACUC Need?
144(1)
Protocol Review and IACUC Oversight
145(1)
Field Housing
146(1)
Vertebrate Animals as Bait in Field Studies
146(1)
Accounting for Animals Used in Invasive Research Field Studies
147(1)
Accounting for Animals Used in Noninvasive Research Field Studies
147(1)
OHSP and Field Research
148(1)
Permit Requirements
149(1)
What Should IACUC Administrators Know about Permitting Requirements?
149(1)
Providing Guidance to the PI
149(2)
State Regulations
149(1)
Federal Regulations
150(1)
Chapter 13 Personnel Qualifications and Training Programs 151(18)
Scenario
151(1)
Regulatory Resources
152(1)
Establishing a Training Program
152(1)
Common Training Employed by Organizations Using Animals
153(16)
Training for Individuals Handling Animals
153(5)
OHSP Training
158(2)
Refresher Training
160(1)
IACUC Member Training
160(2)
"Home Grown" Training
162(5)
A Web-Based Training Module
162(1)
Face-to-Face Orientation
163(1)
Protocol Review Training
164(1)
Continuing Education for IACUC Members
165(1)
Additional Training Programs Frequently Developed for Animal Users
166(1)
Evaluating the Effectiveness of Training Programs
167(1)
Final New Member Actions before New Members Go to Work
167(2)
Chapter 14 Tracking Animal Use on Protocols 169(6)
Scenario
169(1)
Regulatory Requirements and Guidance Documents
169(1)
Animal Use
170(5)
Identifying Use When Transferring Animals between Research Proposals
170(1)
Agricultural Production Animals
170(1)
Rodent Breeding Colonies
171(1)
Counting Hatched Species
172(1)
Methodologies for Tracking the Number of Animals Used on Each Protocol
172(3)
Electronic Reporting
172(1)
PI Reporting
173(1)
De Novo Reviews and Animal Numbers
173(2)
Chapter 15 Veterinary Care Programs 175(8)
Scenario
175(3)
Regulatory Guidance
177(1)
The Veterinary Care Program
178(1)
Evaluating the Veterinary Care Program
179(4)
Clinical Records
180(1)
Using Research Animals in More Than One Project
180(1)
Controlled Drug Records
181(1)
Pharmaceutical versus Reagent Grade Drugs
182(1)
Chapter 16 Whistle-Blower Policy 183(8)
Scenario
183(1)
Regulatory Requirements and Resources
183(1)
The Policy
184(3)
Publicize the Policy
184(1)
Sample Policy 1
184(1)
Reporting Noncompliance or the Misuse of Animals
184(1)
Sample Policy 1: Advantages and Disadvantages
185(1)
Sample Policy 2
185(1)
GEU's Whistle-Blower Policy
185(1)
Reporting a Concern
186(1)
Sample Policy 2: Advantages and Disadvantages
186(1)
Investigating Whistle-Blower Policy Reports
187(4)
Prescreening Reports
187(1)
IACUC Investigation of Reports
188(1)
Whistle-Blower Policy (Reporting Animal Welfare Concerns) Checklist
189(2)
Chapter 17 Occupational Health and Safety Program 191(12)
Scenario
191(2)
Regulatory References and Guidance Documents
191(2)
The OHSP and Accreditation
193(5)
The IACUC Administrator's Role
193(1)
Developing the OHSP
193(1)
Hazard Identification and Analysis
194(1)
Identifying Environmental Hazards
194(3)
Common Practice 1
194(2)
Common Practice 2
196(1)
Ongoing Hazard Identification and Assessment
197(1)
Common Practice 1
197(1)
Common Practice 2
197(1)
Quantifying Identified Environmental Hazards
198(1)
Personal Dispositions (Personal Risk Assessments)
198(5)
Risk Protection and Mitigation
200(1)
Program Participation
200(3)
What Constitutes Participation in the Occupational Health and Safety Program'
200(3)
Chapter 18 Emergency Disaster Plans 203(8)
Scenario
203(2)
Regulatory Requirements and Guidance Documents
204(1)
Developing an Emergency Disaster Plan
205(1)
Identifying Potential Disasters
205(1)
The EDP Program Structure
206(5)
Communication Plan
206(1)
The Written Plan
207(1)
Animal Disposition
208(1)
Relocation
208(1)
Euthanasia
209(1)
Evaluating and Testing Emergency Disaster Plans
209(1)
Continuing Program Business during a Disaster
210(1)
Chapter 19 The Role of a Primary Grantee 211(10)
Scenario
211(1)
AAALAC Accreditation
211(1)
AAALAC Option 1
212(1)
AAALAC Option 2
212(1)
PHS Assurance Ramifications
212(1)
Animal Welfare Assurance
213(1)
Securing Animal Welfare Assurance Coverage
213(4)
Negotiating an Assurance
213(3)
Interinstitutional Assurance
216(1)
Performance Site
217(1)
Collaborations and Contracts
217(4)
Collaborations When Research Is Funded through a PHS Agency
217(2)
AAALAC International Accreditation and Collaborations
219(1)
USDA and Collaborations
219(1)
International Collaborations
220(1)
Chapter 20 FOIA, Sunshine Laws, and Confidential Information 221(4)
Scenario
221(1)
Freedom of Information Act
222(1)
Responding to FOIA Requests
223(1)
State Sunshine Laws
223(1)
Institutional Access to Information
223(2)
Chapter 21 DOD and VA Regulations—Know the Differences 225(12)
Scenario
225(1)
Regulatory References and Guidance Documents
225(1)
Federal Funding and PHS Assurance
226(1)
USDA Oversight
227(1)
Definition of Terms
227(1)
Unit Structure
228(1)
DOD and VA Training
229(1)
Semiannual Review Processes
229(1)
VA
230(1)
DOD
230(1)
IACUC Minutes
230(1)
VA
230(1)
DOD
231(1)
Protocols
231(1)
VA
231(1)
DOD
232(1)
Unique Aspects of VA and DOD Programs
232(2)
VA
232(1)
DOD
233(1)
VA Memorandum of Understanding
234(1)
VA Models and Relationship to Sister Civilian Animal Care and Use Progams
235(2)
Model 1
235(1)
Model 2
235(1)
Model 3
235(1)
Model 4
235(2)
Chapter 22 Data Management and Electronic Systems 237(14)
Scenario
237(1)
Regulatory Guidance on the Use of Electronic Communications
238(1)
Methods of Telecommunications
238(4)
E-mail as a Method of Communication
239(2)
Appropriate and Effective Use of E-mail
239(1)
Inappropriate Use of E-mail
239(2)
Use of Video Conferencing Equipment
241(1)
Recordkeeping
242(3)
Hard Copies
242(1)
Electronic Systems
243(2)
PDF-Based Systems
243(1)
Microsoft Software
243(2)
Commercial Off-the-Shelf Systems
245(1)
Records Management
245(2)
Veterinary Care Records
245(1)
Program Records
245(1)
Meeting Minutes: What Must They Contain?
246(1)
Animal Care and Use Protocol Records
246(1)
Duration of Record Maintenance
247(1)
Using Electronic Systems for the Protocol Review Process
247(4)
Commercial Software
247(1)
Organization-Specific Electronic Processes
248(3)
Chapter 23 Policies, Guidelines, and Standard Operating Procedures 251(8)
Scenario
251(2)
Policies, SOPs, and Guidelines—What Is the Difference?
253(3)
Policy
254(1)
Standard Operating Procedure
254(1)
Guideline
255(1)
Policy Formats
256(1)
Sample Policies
256(3)
Adoption Policy
256(1)
Use of Hazardous Materials in Conjunction with Animal Activities Policy
257(2)
Appendix 1 259(2)
Appendix 2 261(2)
Appendix 3 263(2)
Appendix 4 265(2)
Appendix 5 267(2)
Appendix 6 269(2)
Appendix 7 271(2)
Appendix 8 273(2)
Appendix 9 275(2)
Appendix 10 277(2)
Appendix 11 279(2)
Index 281
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 Universitys 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.
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