an introduction to conducting animal research at tulane university institutional animal care &...
TRANSCRIPT
An Introduction to Conducting Animal Research at Tulane
University
Institutional Animal Care & Use Committee (IACUC)
IACUC MISSION
The charge of an Institutional Animal Care and
Use Committee as mandated by NIH’s Office of
Laboratory Animal Welfare and the USDA is to
ensure the humane care and use of animals
used in research and compliance with
guidelines and regulations.
Define an IACUC
The IACUC helps investigators conduct ethical research by implementing
guidelines and policies for the humane care and use of research animals
and for the safety of research personnel.
These guidelines are based on:
• Animal Welfare Act,
• Public Health Service Policy, • Association for the Assessment and Accreditation of Laboratory Animal
Care – International (AAALAC-I) requirements
All animal research must be approved by the IACUC.
Federal Animal Welfare Act
• Passed in 1966; many amendments since 1966; amendment from 1985 considerably
improved the standards for laboratory animals
• Requires research facilities to register with the United States Department of Agriculture
(USDA)
• Administered by USDA - Animal and Plant Health Inspection
Service (APHIS)
• Provisions include:- Handling, housing, feeding, watering, sanitation, ventilation, transportation, and adequate
veterinary care for covered animals- Use of tranquilizers, anesthetics, and analgesics to minimize pain or distress- Periodic, unannounced visits - Annual reports to USDA- Requires research institutions with covered species to have an IACUC- Personnel training- Detailed records- Penalties for violation - fines or revocation of funding
What is a “covered species”?
USDA defines ‘covered species’ as any live or dead dog, cat, nonhuman primate, guinea
pig, hamster, rabbit, or any other warm blooded animal, which is being used, or is
intended for use for research, teaching, testing, experimentation, or exhibition
purposes, or as a pet.
This term excludes birds, rats of the genus Rattus, and mice of the genus Mus bred for use
in research; horses not used for research purposes; and other farm animals, such as, but
not limited to, livestock or poultry used or intended for use as food or fiber, or livestock or
poultry used or intended for use for improving animal nutrition, breeding, management, or
production efficiency, or for improving the quality of food or fiber.
Frequently Used at Tulane: rabbits, pigs, NHPs
Guide for the Care and Use of Laboratory Animals
• PHS-funded Institutions required to follow• Basis for AAALAC-I accreditation• The “Guide for the Care and Use of Laboratory Animals” was first
published in 1963 under the auspices of the Animal Care Panel as the “Guide for Laboratory Animal Facilities and Care”. It provides standards for the care and use of research animals. (Laboratory Animal Medicine ACLAM series). It has become THE reference for the operation of animal care and use programs and has undergone many revisions, the most recent in 2011.
The Guide focuses on- - Animal Care and Use Program
(Responsibilities of the Institutional Official, Attending Veterinarian, IACUC, Occupational Health/Safety)
- Animal Environment, Housing, and Management - Veterinary Medical Care
- Physical Plant
Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
Applies to any institution receiving PHS funds for vertebrate animal research and all investigators must
comply regardless of their funding
Institutions provide the Office of Laboratory Animal Welfare (OLAW) with a document which describes in
detail how all components of the program are run with respect to conducting research with animals.
These activities should be based on the “Guide”. The approved Assurance provides the basis for the
institution’s self-regulation.
Institutions with an “Assurance” must:
Establish an appropriate line-of-authority Maintain an IACUC Maintain records Report annually to OLAW Submit to on-site visits Use the “Guide” as a basis for operating their animal care program
PHS policy implements the nine general principles of the “United States Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training.”
Assessment and Accreditation of Laboratory Animal Care International
(AAALAC-I)
• A non- profit corporation directed by its member organizations (educational, health and research groups concerned about animal care)
• Conducts a voluntary program of accreditation of laboratory animal facilities and programs to encourage high standards for the care and use of lab animals, assure control of variables that may adversely affect research and protect the health of animal research workers
• Conducts site visits for assessment and accreditation• Accreditation is strongly encouraged by many funding
agencies
OUR TEAM
• Institutional Official (IO)
• Institutional Animal Care and Use Committee (IACUC)
• Principal Investigator (PI)
• Department of Comparative Medicine (DCM) UT and DT Campus
• Division of Veterinary Medicine (DVM) at the TNPRC
• Office of Biosafety (OBS)
• Office of Environmental Safety (OEHS)
• Institutional Biosafety Committee (IBC)
• Research Compliance Office (RCO)
Who is an IACUC member?
• Chair (AWA )
• Scientist experienced in animal research (PHS)
• Non-scientific member (PHS)
• Non-affiliated member (PHS and AWA)
• Veterinarian with training or experience in laboratory animal science ( PHS and AWA)
PHS policy requires a minimum of five members Animal Welfare Act requires a minimum of three members
What does an IACUC do?
• Review and consider for approval all proposed animal research
• Review animal care facilities and programs (report to IO) at least on a
semiannual basis
• Make recommendations to IO regarding program and facilities
• Ensure personnel training and safety
• Review concerns about animal care and use
• Suspend non-compliant animal care and use activities
What is in the animal use protocol?
• Summary of ongoing research if a renewal protocol (every three years need to renew protocol)
• Species, Animal numbers and USDA pain category (B,C,D,E)
• Regulatory Information
• Personnel Hazards (physical, chemical, biohazard)
• Non-technical Summary (goal of research written so that a high school senior without any scientific background is able to understand)
• Complete Description of Animal Use (concise description, plus table, of the experimental course from start to endpoint)
• Proposed Treatments (includes agent, route, volume, concentration)
USDA Pain Categories
Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes. Examples: Breeding colonies, holding protocols, observational studies of wild animals.
Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs. Examples: Blood collection, manual restraint for short periods and euthanasia if it produces rapid unconsciousness and subsequent humane death.
Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used.Examples: Surgical procedures, more invasive blood collection techniques, administration of drugs, chemicals or organisms that would be expected to produce pain or distress.
USDA Pain Categories continued• Category E: Animals upon which teaching, experiments, research,
surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. Examples: Toxicity studies, radiation sickness, and research on stress, shock or pain.
NOTE REGARDING CLASSIFICATION E: An explanation of the procedures producing pain or distress in these animals and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided. This information is required to be reported to the USDA, will be available from USDA under the Freedom of Information Act, and may be publicly available through the Internet via USDA's website.
What is in the animal use protocol? continued
• Adverse Effects/Clinical Endpoints
• Endpoints to the Study
• Euthanasia Method
• Rationale for Animal Use, Appropriateness of Species and Justification for the Animal Numbers
• Alternatives to Painful and Distressful Procedures
• Environmental Enhancement- housing and enrichment
• Personnel handling animals and their training for specific procedures
• Facilities outside the animal housing areas where LIVE animals are taken for procedures
Russell and Burch and The Three R’s
Report by Russell and Burch in 1959 proposed the Three R’s as principles to achieve the goal of humane experimental techniques
• Replace the use of animals with alternative techniques to avoid the use of live animals either in part or altogether.
• Reduce the number of animals used to a minimum, to obtain information from fewer animals or more information from the same number of animals with precision. If reducing the numbers of animals makes it impossible to reach a valid conclusion from the experiment, this does NOT achieve the goal of reduction.
• Refine the way experiments are carried out, to make sure animals suffer as little as possible. This includes better housing and improvements to procedures which minimize pain and suffering and/or improve animal welfare.
The Three R’s continuedTo assist with consideration of the Three R’s prior to instituting animal research:
• PI assures that the work is not duplicative
• PI performs an alternatives search for procedures that are painful or stressful
• PI provides a justification to support the number of animals requested
• Veterinarians knowledgeable with laboratory animals sit on the IACUC and introduce new techniques or refining practices aimed at reducing the impact on the well-being of the animal.
What happens after IACUC review?
Protocols are reviewed at a meeting and after discussion by the
committee, a motion is made for the action on the protocol.
• Approved as Submitted
• Approved with Administrative Notations
• Modifications to Secure Approval
• Deferred
• Withhold approval
What do we do when the research changes?
A protocol is approved for a period of three years. If over the course of the three years, the principal investigator needs to change anything in the approved protocol, he/she is required to submit an amendment to the protocol. Activities associated with the change cannot take place until approved by the IACUC. Some examples of changes:
• Animal numbers• Addition of procedure• Repeat an Experiment• Change in anesthetic/analgesic • Change in method of euthanasia• Change in Title • Change in Principal Investigator• Addition of sample collection times
Other forms for PIs
Annual Reviews - On the first and second year anniversary of approved protocols, PIs are required to complete an Annual Review form. This form is sent prior to the 1st and 2nd anniversary of the approval date.
Expiration Notices – The IACUC office sends out courtesy notices 120 days, 90 days and 60 days prior to the protocol expiration date. The PI should return this form so the IACUC can provide assistance in making sure the renewal is in place prior to expiration of the current protocol.
Personnel Additions - Personnel added to the protocol after initial approval should be added with the Addition of Personnel form.
Semiannual Inspection
The IACUC is required to evaluate the Institution’s Animal Care and Use program every 6 months. The evaluation is done with inspections of central animal care facilities and labs where animals are taken for procedures.
Inspections are conducted by committee members and findings are reviewed by the full committee. Recommendations for corrections are made to PIs or to the DCM/DVM.
Program reviews are provided to the committee for review and comment. Recommendations for corrections are made to the respective offices listed below. • DCM/DVM • Occupational Health and Safety/Office of Environmental Health and Safety• Office of Biosafety• IACUC Administrative Office• Behavioral Management (TNPRC only)
…after protocol approval?In addition to semiannual inspections, the Tulane IACUC conducts monitoring of experimental animal procedures post-approval. This is another method that we use to assure regulatory agencies that animal studies are conducted in accordance with approved protocols. We also see it as a way to to interact with the researchers and their staff to see how we can be of assistance in their study. We can offer advice, recommendations, training or provide information that will enhance the research.
PIs are contacted by the IACUC office to arrange a time when procedures will be performed. We use this opportunity to learn more about the research and to ask questions related to the research project. We also ask questions relating to general information about animal care and use. The procedures are also monitored for consistency with the approved protocol.
PIs and their staff can use this visit as an opportunity to ask the IACUC questions on policies, procedures or other animal issues that may have been forgotten or poorly understood.
What happens if you have a concern about animal use? The Whistleblower Policy can be found under Reporting Animal Concerns at: http://tulane.edu/asvpr/research-compliance.cfm.
Helpful sitesTulane University Office of Research – can navigate to all research support officeshttp://tulane.edu/asvpr/index.cfmTulane University IACUC office – Find deadlines, forms, FAQs and able to navigate to other research supporthttp://tulane.edu/asvpr/iacuc/index.cfmOffice of Laboratory Animal Welfare - The Office of Laboratory Animal Welfare (OLAW) provides guidance and interpretation of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training, thereby contributing to the quality of PHS-supported activities.http://grants.nih.gov/grants/olaw/olaw.htmAAALAC International – Association for Assessment and Accreditation of Laboratory Animal Care The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International) is a voluntary accrediting organization that enhances the quality of research, teaching, and testing by promoting humane, responsible animal care and use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards.http://www.aaalac.org/USDA APHIS - USDA Animal Care is responsible for upholding and enforcing the Animal Welfare Act and the Horse Protection Act. The Animal Welfare Act and its associated regulations require that federally established standards of care and treatment be provided for certain warm-blooded animals bred for commercial sale, used in research, transported commercially or exhibited to the public.http://www.aphis.usda.gov/wps/portal/aphis/home/
When in doubt….contact us
Tidewater Suite 1707
504-988-6868 (office)
504-988-1445 ( fax)
504-481-9684 (cell)
985-871-6636 (TNPRC)