Transcript ALAT Chapter 2 - AZ Branch AALAS Homepage

Chapter Two
The Research Facility Environment
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The Research Facility Environment
 Research gains knowledge which improves the
future of people.
 Research requires personnel,
money, equipment and facilities.
 Most funding for research comes from
government or private organizations.
 Pharmaceutical, chemical
companies also do research
and testing.
The Research Program
 The scientist writes an outline of the research.
explains specific aims, expected results and methods
 Explanation of WHY animals are needed, what
procedures will be performed and how animals
will be housed and cared for.
 Protocols are reviewed by a committee.
If approved, it is sent to funding agency for review.
Funding organization reviews proposal to determine
whether the proposed research is important.
 Grants provide money carry out the study.
Granting agencies, institutions and scientists make
sure services, facility and staff appropriate and costeffective.
Members of the Team
 PI plans research and develops protocol.
PI & research techs perform experiments & interpret
data.
 Research techs:
Perform research, observations, tests; assist with
preparations; collect, organize and analyze the data
 Animal techs may perform some functions.
Animal techs control variables that affect data.
Variables = differences in schedules, procedures &
environment.
Variations => physiological changes, disease or debilitating
conditions.
Follow Standard Operating Procedures (SOPs)
(Image) Working in a Lab
More Members of the Team
 Animal Tech’s continued
Report to supervisors and PI about environmental
changes, changes in methods and errors.
Requires knowledge, confidence, maturity & honesty.
 Veterinarian coordinates animal care and advises
investigators on animal model.
Responsible for maintenance of animal colony and
assurance of compliance with regulations and policies.
 Animal suppliers / Equipment manufacturers
Equipment and feed meet or exceed minimum
requirements, laws and regulations.
Quality research = quality supplies.
(Image) Research and Animal Care
The IACUC
 CEO at a facility appoints IACUC
 IACUC reports to Institutional Officer (IO).
 AWA and PHS requirement
 IACUC:
Reviews protocols to assure compliance w/ regulations,
policies or SOPs.
Inspects facilities and program twice a year, and reports
findings and correction of deficiencies to the IO.
Serves as a resource on animal welfare.
Veterinarian, scientists, a nonscientist and a person not
affiliated with the institution
Legal and moral responsibilities rest with institution.
Failure to comply can cost research funding.
The Protocol
 Description of a research project
 IACUC reviews all protocols and approval is
required before any work begins.
 IACUC reviews protocols for scientific merit,
reasonable and appropriate use, or the well-being
portions of the protocol, leaving scientific merit to
the granting agency or other committees.
 IACUC bases its decisions on scientific
principles, laws and regulations.
 If a protocol fails these criteria, then it can either
be modified or refuse to let project begin.
Legislation and Guidelines
 “28 Hour Law” for humane treatment of animals
Sets the maximum length of time that “farm animals”
could be without food, water and rest.
 USDA administers the AWA and its amendments.
 Concern about biomedical research, teaching and
testing has increased.
Concerns prompted public awareness of animal issues.
Legislation and amendments reflect these concerns.
More Legislation and Guidelines
 Animal Welfare Act:
Groups that sell, auction, exhibit, transport, breed or
conduct research are covered by the AWA.
Regulates warm-blooded vertebrates in research
except birds, rats, mice and farm animals used or
intended for use as food or fiber.
Excludes farm animals in studies to improve animal
nutrition, breeding or production efficiency.
Covers all wild mammals.
Regulations deal with housing, handling, feeding,
watering, sanitation, ventilation, transportation,
separation of species and veterinary care for animals.
Animal Welfare Act Rules
 AWA covered facility must:
Register with the USDA.
Maintain records on dogs and cats by using
identification.
Submit a count by species of the number of animals
involved in projects.
House each species separately.
Meet or exceed standards for cages and facilities.
Provide adequate veterinary care.
Use proper shipping and receiving animal techniques.
More AWA Rules
 1985 changes:
Training for scientists, techs
& other animal users
Exercise of dogs
Providing PWB* of primates
*Physiological well being
Anesthetics and analgesics scientifically justified
Prohibit > 1 major survival surgical procedure
Consideration of alternatives to experiments
Establishment & inspection of facilities by IACUC
 USDA periodically inspects facility.
Violations are listed, and sent to the IO for correction.
Can stop research at an institution not in compliance.
Inspection records available to public through FOIA.
(Image) USDA Animal Care Web Site
PHS Policy
 Use of PHS funds = additional regulations
 IO sends an AWA Statement containing:
list of the components of the institution
lines of authority for administering research and
ensuring compliance
veterinarian(s) who will participate in the program
membership of the IACUC
description of the procedures for the IACUC review
description of the OH&S program
outline of training offered to scientists, tech’s & others
description of animal facility, gross square footage,
species housed and average daily inventory
(Image) Example of Animal Care Training
The Guide
 Prepared by ILAR
 Concerns care, use and maintenance of animals
veterinary care, environment requirements, personnel
qualifications, sanitation standards, surgical and post
surgical care, euthanasia techniques and facility
construction guidelines.
 The Guide, AWA, laws, and institutional policies
are the basis for evaluating animal programs.
 AAALAC International uses the Guide and other
documents as a basis to accredit programs.
 Funding agencies require accordance with the
Guide as a condition of funding.
Good Laboratory Practices
 For studies funded or reviewed by FDA
Include human or veterinary drug testing, food or
coloring additives for human or animal use, medical
devices and biological products
 GLP requirements:
SOPs for all husbandry and scientific procedures.
Train personnel and maintain a file for each employee.
Use proper sanitation techniques.
Provide daily husbandry, veterinary treatment, and
provide records for each animal.
House species separately and provide facilities that
prevent activities from interfering with the study.
Keep documentation for 2 yrs after project completed.
Laws and Policies
 State and local laws regulate research.
 Facility’s rules followed by staff research.
Director of the facility is responsible for compliance.
 Policies may limit the use of certain species,
require training of personnel, restrict animal
purchases or require special room for certain
materials.
Career Opportunities
 Organizations, research & teaching institutions,
pharmaceutical, manufacturers, & suppliers
 Experience & education may qualify ALAT for
promotions and higher certification.
 ALAT may advance to LAT.
 With experience & education, LAT
may have opportunity to pursue a more
specialized position.
 Experience, training and knowledge lead to
certification as LATG and possibility of a supervisory
or management position.
Employment in LAS
 Prospective employer asks:
previous work history, education, goals, specific skills,
and knowledge of the organization
 Applicant asks:
benefit package, available training, career
opportunities, salary scales, responsibilities, hours and
educational benefits
 Demonstrate good communication skills &
enthusiasm for the position.
 Be honest about self-appraisal & qualifications.
Exaggeration could lead to a poor evaluation that
could affect an employee’s credibility.
Performance Standards & Appraisals
 Standards = minimum acceptable performance
 Specific, measurable and attainable
 Tech responsible for performance standards
 Appraisal measures an employee’s performance.
 Performance appraisal:
employee’s current position description
performance standards
how well employee has met goals
 Performance appraisals factors in
determining salary and promotions.
Additional Reading
Animal Welfare Act. P.L. 89-544. Deputy Administrator,
USDA, APHIS-VS, 6505 Belcrest Rd., Hyattsville, MD.
20782.
Code of Federal Regulations, 1984. Titles 10, 29, 40. Office
of Federal Register, Washington, D.C., Deputy
Administrator, USDA, APHIS-VS, 6505 Belcrest Rd.,
Hyattsville, MD. 20782.
FDA Good Laboratory Practices for Non-Clinical Laboratory
Studies. Department of Health, Education, and Welfare,
1978.
Guide for the Care and Use of Laboratory Animals. National
Academy Press, 1996.