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Global Improvement of Laboratory Animal Standards-- 50 Years of Success
Kathryn Bayne, MS, PhD, DVM, DACLAM, DACAW, CAAB
Global Director
“The scientific enterprise has become
highly collaborative both within and
across countries. These trends
present great opportunities and
increasing obligations for the scientific
community….”
Globalization
In the face of increasing connectivity of
animal-based research across institutions
and countries, harmonization of animal
care and use standards and practices
becomes essential.
Improved animal welfare
Refined animal model
More reliable data
Proper care and use of laboratory animals
(from breeding to end of experiments)
Better quality of science
No repetition of
experiments
Reduction nº animals
Internat’l. recognition
Papers, funding
Efficiency
Reduced research costs,
Faster development
ALN World, Fall 2014, pg. 24
Animal Care Standards
Care Standards
Societal Influences
Science
Ethics
Societal Influences
Science as the Basis for
Standards-Setting
If the standards proposed for laboratory
animal care in one country or group of
countries are not scientifically based, their
global acceptance will be more limited.
Science is objective, verifiable, based on
facts
Science-Based Metrics
to Improve Research Animal
Welfare…
…thereby providing objective,
evidence-based criteria for
standards.
“Can guidelines be based totally
on science? In a word, no. Even
though science can provide a
foundation, professional judgment
and value judgments always
come into play.” (Mench &
Swanson, 2000)
Ethics “Counts” in Our Guidance
Documents
Animal Welfare Reference Reference to “Ethic”
The Guide
16
European Directive
6
OIE Terrestrial Animal Code Chapter 7.8
22
CIOMS International Guiding Principles for Biomedical Research Involving Animals
3
FAQ #3
Harm-benefit analysis
On page 28, the Guide for the Care and Use of Laboratory Animals (NRC 2011) indicates that for studies that have the potential for unrelieved pain or distress, there are special considerations for IACUC review. Specifically, the Guide indicates that “the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns." This seems to indicate that for studies involving the potential for pain and distress, the IACUC should conduct a “harm/benefit” analysis. What does AAALAC expect with regard to Committee evaluation of these kinds of studies?
The 2011 Guide specifies that the Committee is obliged to weigh study objectives against animal welfare concerns in accordance with the tenets of the Three R’s. This analysis is typically already performed by IACUCs in their reviews of proposed animal studies. AAALAC International expects that IACUC’s (or comparable oversight body), as part of the protocol review process, will weigh the potential adverse effects of the study against the potential benefits that are likely to accrue as a result of the research. This analysis should be performed prior to the final approval of the protocol, and should be a primary consideration in the review process. For studies potentially involving unrelieved pain and distress, the AAALAC International site visitors will assess whether the Committee has conducted this analysis.
FAQ #7
Reporting animal welfare concerns
My institution is located outside the United States and there is no government requirement for our institution to develop a mechanism for reporting animal welfare concerns, though we have good lines of communication within our institution so that we are certain that any concerns would be discussed with management. The Guide for the Care and Use of Laboratory Animals (NRC 2011) describes a number of specific elements of a reporting system. Are all of these required?
AAALAC International recognizes that the regulatory requirement for a defined method for reporting animal welfare concerns is primarily limited to the United States. However, as noted in the Guide, it is the responsibility of everyone associated with the animal care and use program to ensure animal welfare. In some instances, this may involve having to make a formal report regarding a welfare concern. Providing a method by which such reports can be made anonymously and without fear of reprisal, and enhancing staff awareness of the importance and means of reporting animal welfare concerns through training, the posting of signage, and other communication modalities are critical elements of the reporting program. It is AAALAC's expectation that such reports will be investigated by the appropriate oversight body (e.g. , the IACUC or comparable oversight body) and that any necessary corrective actions will be taken. In addition, AAALAC International should be informed of the results of the investigation and any subsequent corrective measures.
ILAR Journal, 2007
International Convergence of…
Animal welfare standards
Animal care and use practices
Areas of
Harmonization/Convergence
Implementation of the 3Rs
Harm-benefit analysis
Ethical review process
Humane endpoints
Assurance of training and competency
Program of adequate veterinary care
Harmonization of animal care
and use standards and
expectations
Efforts of:
OIE (World Organisation for Animal
Health)
CIOMS - ICLAS
AAALAC International
http://web.oie.int/eng/normes/mcode/en_chapitre_1.7.8.htm
OIE Terrestrial Animal Health Code
Chapter 7.8
Implementation of the 3Rs
Harm-benefit analysis
Ethical review process
Humane endpoints
Assurance of training and competency
Program of adequate veterinary care
Topics Included in the 2012
International Guiding Principles
Contribution of animals to the advancement of knowledge
Care and responsibility for animals
The Three Rs
Appropriate models and justification of use
Environment, husbandry, and management
Veterinary care
Training of personnel
Alleviation of pain and distress
Humane endpoints
Oversight and harm-benefit analysis
CIOMS-ICLAS
International Guiding Principles
Decisions regarding the welfare, care,
and use of animals should be guided by
scientific knowledge and professional
judgment, reflect ethical and societal
values, and consider the potential benefits
and the impact on the well-being of the
animals involved.
CIOMS-ICLAS
International Guiding Principles
The use of animals for scientific and/or
educational purposes is a privilege that
carries with it a moral obligation and
ethical responsibility for institutions and
individuals to ensure the welfare of these
animals to the greatest extent possible.
CIOMS-ICLAS
International Guiding Principles
This is best achieved in an institution with
a culture of care and conscience in which
they willingly, deliberately, and
consistently act in an ethical, humane and
compliant way.
CIOMS-ICLAS
International Guiding Principles
Individuals working with animals have an
obligation to demonstrate respect for
animals, to be responsible and
accountable for their decisions and
actions pertaining to animal welfare, care
and use, and to ensure that the highest
standards of scientific integrity prevail.
Challenges to Harmonization
Widely applicable standards flexibility consistency substantive performance-based
Sensitivity to the context legal political cultural/social
Moving standards into practices
Taking standard practices to best practices AAALAC’s role
Quality level
Legal requirements…
Harmonization
Engineering
Standards
International Accreditation
Performance
Standards
Why Has AAALAC Accreditation
Become Increasingly Important
Over Time?
Global nature of science International collaboration or outsourcing International meetings Peer-reviewed journals
Scientific imperative for: Reproducibility of results Transferability of results Statistical validity of data
Animal care = scientific variable Demonstrates highest tier institution
Tiers of Assessment Standards
Three Primary
Standards
Scientific Literature, Expert
Guidance
Regulations, Laws, Policies
The four major components of the
animal care and use program assessed
by AAALAC International:
Institutional policies and responsibilities
Animal environment, housing and management
Veterinary medical care
Physical plant
Improved animal welfare and high quality science
Scope of AAALAC’s Impact
Over 950 Accredited Units in 41 Countries
500
550
600
650
700
750
800
850
900
950
1000
0
20
40
60
80
100
120
140
160
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
AAALAC International Accredited Units in Pacific Rim
Accredited Units
Pacific Rim Growth (Includes May 2015 Results)
Pacific Rim Section
41 Countries/
Regions with
Accredited
Units
Australia
Austria
Barbados
Belgium
Brazil
Cambodia
Canada
Chile
P.R. China/Hong Kong
Croatia
Denmark
Egypt
England
Fed. of St. Kitts & Nevis
Finland
France
Germany
Hungary
India
Indonesia
Israel
Italy
Japan
Korea
Malaysia
Mauritius
Mexico
The Netherlands
Norway
Peru
Philippines
Russia
Scotland
Singapore
Spain
Sweden
Switzerland
Taiwan R.O.C.
Thailand
U.S.A.
Vietnam
149 Accredited Institutions in 13 Pacific Rim Countries
(Pending Sept 2015 AAALAC Council Meeting)
P.R. China (56) + 1 in process
Japan (23) + 1 in process
India (17) + 1 in process
Korea (16) + 1 in process
Taiwan R.O.C. (14)
Singapore (7)
Thailand (6)
Indonesia (2)
Australia (2)
Malaysia (2)
Cambodia (2)
Philippines (1)
Vietnam (1)
P.R. China 38%
India 11%
Indonesia 1%
Japan 16%
South Korea 11%
Philippines 1%
Singapore 5%
Taiwan R.O.C. 9%
Thailand 4%
Vietnam 1%
Cambodia 1%
Malaysia 1%
Australia 1%
Proportion of Accredited Units
by Industry Sector
28%
42%
14%
11% 5%Academic
Commercial
Government
Non-Profit
Hospital
Trends Findings – 2011 Guide
Mandatory Item
vs.
Suggestion For Improvement
Mandatory Item = a deficiency which must be corrected for Full Accreditation to be awarded or continued
Suggestion for Improvement (SFI) = item which the Council feels is desirable to upgrade an already acceptable or even commendable program
Program Components - Findings
26%
22%
18%
14% 10% 10%
Animal Environment
OHS
IACUC
Veterinary Care
Physical Plant
InstitutionalAdministration
Animal Environment - Findings
0% 10% 20% 30% 40% 50% 60%
Macroenvironment
Microenvironment
Sanitation
Husbandry
Behavioral/ SocialManagement
Mandatory
SFI
Occupational Health & Safety Findings
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
Medical Service
Hazard usage
Personal riskassessment
Job risk/ safetyassessment
Personnel protection
Mandatory
SFI
IACUC-Related Findings
0% 5% 10% 15% 20% 25% 30% 35% 40%
Committee Composition/Participation
Oversight/ PAM
Program Review/ FacilitiesInspections
Protocol review process
Policies
Protocol ReviewConsiderations
Mandatory
SFI
Vet Care Findings
0% 10% 20% 30% 40% 50% 60%
Procurement
Transportation
Preventive medicine/biosecurity
Surgery & post op
Pain & distress
Euthanasia
Veterinary Medical Care
Mandatory
SFI
Institutional Administration - Findings
0.00% 10.00% 20.00% 30.00% 40.00%
Commitment
Organizational Structure
Annual Report
Authority/Responsibility
Disaster plan
Program Description
Training
Documentation/Records
Mandatory
SFI
Physical Plant Findings
0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00%
Security
Design/ layout
Power
Special facilities
Satellites
Construction/maintenance
HVAC
Mandatory
SFI
Top Five Mandatory Issues
1. OHSP
2. IACUC/OB
3. Institution/Administration
4. Physical Plant
5. Animal Environment
1. IACUC/OB
2. Institution/Administration
3. Veterinary Care
4. OHSP
5. Animal Environment
Global Pacific Rim**
Percent Mandatory Items by Geographical Region (Fall 2011 to Dec 2013)
0%
10%
20%
30%
40%
50%
60%
70%
80%
NorthAmerica
Pacific Rim Europe Other
Occupational Health & Safety
Physical Plant
IACUC/OB
Animal Environment
Institution/Administrative
Veterinary Medical Care
Most findings at exit briefing are corrected by PSVCs
87.6%
12.4%
Findings correctedby PSVC
Findings retainedin the letter
The Value of AAALAC International Accreditation
Incidence of Immediate Success in Accreditation (No Mandatory Findings)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
P E R C E N T A G E
1986 2014
Accreditation Success Improved Over Time (1986-2014)
~96% of institutions are in a
Full Accreditation status
Evidence of the positive impact of
AAALAC International accreditation
on animal care and use programs
High Quality Standards
High Quality Science
High Level of Animal Welfare
Global Collaborations
