AALAS ALAT Chapter 2 Research Facility Environment

AALAS ALAT ManualChapter 2- The Research Facility Environment

Tamara Goodman Kuhel

RVT, RLATG, CPIA

Review of Chapter 2

The Research Program Members of the Team The Institutional Animal Care & Use Committee The Protocol Federal, State, & Local Legislation & Guidelines Career Opportunities

The Research Program

The Research Program

What are the specific aims & expected results?What methods will be used to accomplish aims?

The Research Program

Why are animals needed?What procedures will be performed?How will the animals be housed & cared for?

The Research Program

Is proposed research important & likely to produce significant results?

The Research Program

If IACUC protocol approved & project funded, experiment can begin!

Members of the Team

Principal Investigator Co-Investigators & Research Technicians

What about Management Team & Business Office?

Laboratory Animal Technicians Laboratory Animal Veterinarian Commercial Animal Suppliers

& Equipment Manufacturers

Members of the Team…Principal Investigator

PI is a scientist who plans &coordinates all phases of the research work.

Responsible for reporting the research findings to the scientific community.

Responsible for overall compliance with IACUC protocol.

Members of the Team…Co-Investigators & Research Technicians

Perform the specific research tasks. Observing experimental animals. Typically primary lab contact. Performing laboratory tests. Assisting with preparations.

Collect, organize, & analyze the data.

Members of the Team…Laboratory Animal Technicians

This includes Laboratory Animal Aides. Perform animal care functions critical to maintenance of

healthy animals. Follow SOPs to control undesirable variables that

adversely affect experimental data. Willing to learn as much as possible about animals under

their care & field of laboratory animal science. Report all changes & errors. Knowledgeable, confident,

mature, & honest.

Members of the Team…Laboratory Animal Veterinarian

Coordinates animal care activities. Advises on proper animal model selection &

procedural use. Overall maintenance of animal colony health

& assurance of compliance.

Members of the Team…Commercial Animal Suppliers & Equipment Manufacturers

Provide animals that meet specific research requirements (age, sex, strain/breed, etc.).

Supply products that meet/exceed minimum requirements (e.g. disease free).

Quality research depends on quality equipment, supplies, & animals.

AWARs & PHS Policy require IACUC. IACUC members appointed by CEO. CEO serves as Institutional Official (IO).

IO at UC is Dr. Sandra Degen. IACUC Chair is Dr. George Babcock. LAMS DVMs are IACUC members.

Learn more about UC’s

IACUC & research program:

http://researchcompliance.uc.edu

The Institutional Animal Care & Use Committee

The IACUC

Oversee animal research program. Review all research protocols involving animals. Inspect animal facilities at least every 6 months

(misleading to say “twice a year”) & report findings/corrective actions to IO.

Membership must include: Laboratory animal veterinarian Institutional scientist who uses animals Non-scientist Community member (unaffiliated with UC)

The Protocol

Provides detailed description of procedures involving animals for IACUC review: Scientific merit. Appropriate use of animals. Animal well-being. Compliant with laws & regulations.

Must be approved by IACUC before animals may be ordered or used.

Federal, State, & Local Legislation & Guidelines

Animal Welfare Act Public Health Service Policy on Humane

Care & Use of Laboratory Animals Guide for the Care & Use of Laboratory

Animals Good Laboratory Practices Regulations State & Local Laws & Institutional Policies

Animal Welfare Act

28 Hour Law

Pet Protection

ActAnimal

Welfare ActAWA

Amendment

Improved Standards for

Laboratory Animals

Protection of Pets

Farm Security & Rural

Investment

1873 1966 1970 1976 1985 1990 2002

Set maximum length of time “farm animals”

could be without food, water, &

rest during transport.

Intended to prevent cats &

dogs from being stolen &

sold to research labs.

Set humane standards.

Expanded animal

coverage to include

warm-blooded vertebrates

used in research.

Clarified animal

transport & commerce.

Addresses animal fighting

for 1st time.

Addresses exercise of

dogs & psychological well-being of

NHP.

Requires 5-day holding of

dogs & cats in shelters before

selling, etc.

New recordkeeping requirements.

Addresses bird fighting & ↑ $ for violations.

Again, explicitly excludes

birds, rats, & mice bred for

research.

Animal Welfare Act

Administered by USDA’s Animal & Plant Health Inspection Service (APHIS).

AWARs regulate all live or dead warm-blooded vertebrates in research except… Birds. Purpose-bred rats (Rattus) & mice (Mus). Farm animals used as food/fiber. Farm animals used in agricultural studies.

Covers all wild mammals.

USDA Regulated?

AWA Requirements

USDA Registration Maintain individual records on source/use of cats & dogs

using tattoo or tag. Annual report that includes number of animals used

classified by species & pain category.

Bonus question- When is this annual report due?

House by species, providing space & environment according to AWARs .

Meet or exceed cage & facility sanitation. Provide veterinary care. Proper transportation.

AWA 1985 Amendment

Personnel training. Dog exercise. Provide for psychological well-being of NHP. Pain management. Limiting major survival surgeries. IACUC facility inspections.

Unannounced & inspection report is public record. What is FOIA?

Animal alternatives.

Bonus question- Which “R” does this address?

IACUC.

Public Health Service Policy on Human Care & Use of Laboratory Animals

Applies to studies funded by PHS/NIH. PHS Policy enforced by the Office of Laboratory

Animal Welfare (OLAW), a branch of NIH. IO must submit Animal Welfare Assurance

Statement to OLAW. “Promise” to conduct animal research in

accordance with PHS Policy, the Guide, & other applicable laws/regulations (e.g. AWARs).

Animal Welfare Assurance Statement

Major components of UC & lines of authority. Description of veterinarians. IACUC membership. Protocol review process. Description of OH&S program. Outline of training program. Description of facilities.

Guide for the Care & Use of Laboratory Animals

1st published in 1963 & most recently 1996. Addresses humane care, use, & maintenance

of laboratory animals. Used by AAALAC as basis of evaluating quality

of animal care & use program & ultimately accrediting.

Compliance with Guide required by many funding agencies.

Good Laboratory Practices Regulations

GLP Regulations apply to studies funded by FDA. SOPs for all husbandry & scientific procedures. Train personnel & maintain record. Proper sanitation techniques. Proper husbandry & records of such. Separately house species & provide facilities to

prevent interference in surrounding studies. Keep records for at least 2 years after.

Federal, State, & Local Legislation & Guidelines

IACUC policies. Any additional applicable internal policies

(e.g. Radiation Safety, Institutional Biosafety Committee).

Completion of IACUC training every 3 years is example of internal policy/guideline.

Career Opportunities

Starting & Advancing ALAT LAT LATG Additional education through AALAS publications

Seeking Employment in Laboratory Animal Science Seek positions that allow for professional growth. Interview performance is critical.

Performance Standards & Appraisal Must be specific, measurable, & attainable. How well have you met the performance standards?

Definitions

Research Proposal Animal Use Protocol Grant Principal Investigator (PI) Institutional Animal Care & Use Committee (IACUC) Institutional Official Guide for the Care & Use of Laboratory Animals

Acronyms

SOP CEO FOIA PHS NIH OLAW ILAR AAALAC GLP FDA EPA ALAT LAT LATG

Acknowledgements

AALAS 2005 ALAT Manual Guide for the Care and Use of Laboratory Animals Animal Welfare Act Regulations Congressional Research Service “The Animal Welfare Act: Background

& Selected Legislations”, 12/08/2009 Numerous websites for images!