Title: Ethical Care and Use of Animals
1Ethical Care and Use of Animals
James W. Hicks, Ph.D. Chair Institutional Animal
Care and Use Committee
2Why Worry about Animals?
- Emotionally-charged issue
- Opinions sometimes based on emotion or
misinformation - Required by Law
- Its the right thing to do
- Morally and Ethically
- Scientific Validity
3Animal Rights vs. Animal Welfare
Animal Rights vs. Animal Welfare
- Animal Rights
- Animals and man share equal rights-- personhood
for animals - All sentient beings deserve equal moral
consideration - Animal-based research is never justified, nor is
pet ownership, food or fiber production, etc. - A rat is a pig is a dog is a boy. Theyre all
animals. Ingrid Newkirk, PETA
4Animal Rights vs. Animal Welfare
Animal Rights vs. Animal Welfare
- Animal Welfare
- Animals and man are not equal, animals do not
have the same rights as people - Stewardship Man has an obligation to protect the
welfare of animals (ie provide food and shelter,
limit pain and suffering, treat when injured,
etc.) - Foundation of contemporary animal welfare
regulations and guidelines
5Ethical Arguments for Animal Use
- Nuremberg Code of Ethics in Medical Research
- ... be designed and based on results of animal
experimentation and a knowledge of the natural
history of the disease - Declaration of Helsinki
- Medical research involving human
subjectsgenerally accepted scientific
principlesand, where appropriate, animal
experimentation. - -World Medical Association, 1964
6Animals in Research
- The use of animals is a privilege, not a right
- Society grants permission to use animals with the
expectation that health benefits may be derived,
and - The perceived value to society must balance the
adverse effects imposed on individual animals.
7Animal Welfare Laws, Regulations Standards
- Animal Welfare Act (AWA) USDA Animal Welfare
Regulations - PHS Policy - Health Research Extension Act (HREA)
- The Guide for the Care and Use of Laboratory
Animals (The Guide) - AAALAC Accreditation
81966
91966
101966
11Life Magazine--1966
- Raid of a Baltimore, MD animal dealer by Humane
Society of the United States (HSUS) - 29 charges of animal cruelty brought against
Lester Brown - Congress put forth eight bills to outlaw inhumane
treatment of animals
12Pet Protection Act
- 1966 Congress enacted the Pet Protection Act
- Protected against theft of pets by research
dealers - Gave authority to USDA to enforce and administer
the Act - Provided protection to dogs, cats, rabbits,
monkeys, guinea pigs and hamsters
13Pet Protection Act (contd)
- Established humane standards for treatment of
animals - Set licensing requirements for animal dealers
- Required annual USDA inspections of dealers and
research institutions
141985 Animal Welfare Act Amendment
- Establishment of an Institutional Animal Care and
Use Committee (IACUC) - Requirements for veterinary consult and oversight
- Requirements for canine exercise and non-human
primate psychological enrichment - Requirements for consideration of alternatives to
animal use and painful procedures and avoidance
of unnecessary duplication of already-conducted
studies
15United States Department of Agriculture
- Enforces and administers the Animal Welfare Act
(AWA) - Enforces the AWA through Animal Welfare
Regulations (AWRs) - 9 CFR Chapter 1, Parts 1-3
- Provides clarification of AWRs through Animal
Care policies
16USDA Regulations
- Set requirements for committee (IACUC)
composition and function - Provide performance standards for
- veterinary care
- animal husbandry
- animal transportation
- Covers all warm-blooded animals
- excludes rats, mice and birds
17NIH Office of Laboratory Animal Welfare
- Health Research Extension Act is the legislative
mandate for Public Health Service (PHS) policy - Covers all vertebrate animals
- NIH funded institutions must adhere to the PHS
Policy - Office of Laboratory Animal Welfare is
responsible for assuring compliance with PHS
policy
18Key Elements of the Federal Regulations
- Justify why animals are necessary
- Minimize pain and distress
- Personnel must be qualified to perform their
duties - Provide appropriate husbandry and care
- Use of appropriate euthanasia methods
19Ethical Guidance
- 1996 NASA Principles for Ethical Care Use of
Animals - Sundowner Report
- Principles of Humane Experimental Technique by W.
M. Russell and R. L. Burch, 1959
20NASA Principles - Sundowner Report
- Respect for Life
- All living creatures deserve respect
- Societal Benefit
- Some valuable return in exchange for the
sacrifice of the animals life - Non-maleficience
- Do no harm
- Pain, distress and discomfort to the animals must
be minimized
21Principles of Humane Experimental Technique
- The 3 Rs
- Replacement
- Use of live animals as the research model should
be replaced if possible - Refinement
- Procedures should be refined to minimize pain,
distress and discomfort - Reduction
- Number of animals should be reduced to the
minimum necessary to achieve scientific
significance without increasing pain and distress
22The Guide
- Performance Standards
- Institutional policies and responsibilities
- Animal environment, housing, and management
- Veterinary medical care
- Physical plant (facilities)
23AAALAC Accreditation
- Association for the Assessment and Accreditation
of Laboratory Animal Care (AAALAC, International) - Private, non-profit organization that promotes
the humane treatment of animals in science
through a voluntary accreditation program - AAALAC International uses The Guide for the Care
and Use of Laboratory Animals as the basis for
assessing and accrediting animal care and use
programs. - Accreditation represents quality in an
institutions animal care program, promotes
scientific validity, and demonstrates a
commitment to the humane care and use of lab
animals
24UCI Policies
- Campuswide General Policies
- Use of Vertebrate Animals in Research and
Teaching - Offsite Research Activities
- Regulatory Noncompliance Policy
- IACUC Policies and Guidelines
- ULAR Guidance
25ORA and the IACUC
- Office of Research Administration
- Research Graduate Studies
- Sponsored Projects
-
- Research Protections
- Administrative and technical support to the
regulatory committees and the Institutional
Official - Office of Record for UCI
- Education, training, and compliance oversight
26Institutional Animal Care and Use Committee
(IACUC)
- Required by the AWRs, PHS Policy and The Guide
- Provides local (institutional) oversight of
animal use in research, teaching and testing - Members appointed by the Institutional Official
(Vice Chancellor for Research)
27Institutional Animal Care and Use Committee
- Campus committee charged with oversight of UCIs
animal program - Member Composition
- Faculty with animal expertise
- Attending Veterinarian
- Non-scientific member
- Unaffiliated member
- Biosafety officer
28The IACUCs Role
- Review and approve activities involving animals
at UCI (protocol review) - Review the animal program and inspect all
facilities every 6 months - Review concerns involving animal use
- Investigate issues of non-compliance
- Report to regulatory agencies
29Why Do We Review Protocols?
- The protocol is
- The written documentation of all procedures to be
performed on live animals - The means by which adherence to the federal
animal welfare regulations is assessed - The document that confirms the ethical treatment
of animals used in the research
30What Activities Require Review?
Definition
- Any live, vertebrate animal used or intended for
use in research, research training,
experimentation, or biological testing or for
related purposes. - -PHS Policy
31IACUC Protocol Review
- Rationale for the use of animals
- Justification of the species and number of
animals - Conduct of experiments
- Unnecessary duplication of experiments
- Appropriate sedation, analgesia, anesthesia
- Adequate training of personnel
32Top Ten Reasons Protocols are Tabled or Deferred
- 10. Three-Year Renewals No progress report or
other rationale for continuing the research. - 9. Project overview is too technical or does not
describe the potential benefits of the research. - 8. Database searches for alternatives to animal
use and painful procedures and to rule out
unnecessary duplication are not adequately
documented. - 7. Responsibilities, experience and/or training
of research team members is not described.
33Top Ten Reasons (continued)
- 6. Incomplete descriptions of the surgical and
non-surgical procedures . - 5. Inadequate detail about the post-procedural
monitoring and care, including the use of
post-procedural analgesics. - 4. Inadequate description of expected clinical
signs, potential for pain and distress, and
assessment criteria.
34Top Ten Reasons (continued)
- 3. Use of animals, the species selection or the
requested number of animal is not justified in
relation to the overall design of the study. - 2. The actual procedures to be performed
involving live animals are unclear or
inconsistent with the experimental design. - 1. Experimental design is not adequately
described, based on the underlying hypothesis of
the project.
35Other IACUC Responsibilities
- Modifications to Existing Protocols
- Annual and three-year renewals
- Program Evaluation
- Facility Inspections
36The IACUC Website
- Start at http//www.rgs.uci.edu/ora/
- Click on Animal Care and Use Program
- Website includes
- Forms
- Instructions
- Contact information
- Links to University Lab Animal Resources and
Environmental Health Safety
37University Laboratory Animal Resources (ULAR)
- Functions
- Veterinary care health surveillance
- Daily husbandry/care
- Animal procurement
- Facility maintenance
- Including vivarium access
- Transgenic Mouse Facility
38Veterinary Services
- Veterinary care of all research animals on campus
- Report to the IACUC regarding issues related to
the animal care program - Training for research personnel in animal
handling, basic procedures, etc. - Complete listing of services at ULAR website
http//www.rgs.uci.edu/ular/index.htm
39Animal Procurement
- Approved commercial vendors
- Reliable colony health information and low risk
of contamination to other research animals on
campus - Animals may enter vivaria directly upon arrival,
no quarantine required - Animals from Unapproved Sources
- High risk of infectious agents
- Quarantine required
40Environmental Health and Safety
- Lab Animal Occupational Health Program
- Health Surveillance for Researchers
- Required for all personnel with ANY exposure to
lab animals - Animal Research Health Surveillance Form
http//www.ehs.uci.edu/occhlth.html - Personal Protective Equipment
- Controlled Substances Monitoring
- http//www.ehs.uci.edu/programs/occhlth/control.ht
ml
41RGS On-Line Tutorial
- Fulfills the federal requirement for investigator
education - Covers the basics of animal care and use
- Required for submission of animal protocols
- all research personnel, including faculty
sponsor, must complete tutorial - Requires log-in as an authenticated user
(UCINetID and password)