An Introduction to An Introduction to Conducting Animal Conducting Animal Research at TNPRC: Research at TNPRC: Oversight and the Oversight and the IACUCIACUC

Institutional Animal Care & Use Committee

IACUCIACUC

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.

Animal Research has Animal Research has OversightOversightAll animal research at TNPRC has official

oversight provided by the Institutional Animal Care and Use Committee (IACUC)

All animal research must be approved by the 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 laws, regulations and policies from federal agencies and other accrediting organizations

Laws, Regulations, and Policies That Laws, Regulations, and Policies That Impact on the Care and Use of AnimalsImpact on the Care and Use of Animals

Animal Welfare Act (Animal Welfare Regulations and Animal Care Policies)

Public Health Service Policy on Humane Care and Use of Laboratory Animals

Association for the Assessment and Accreditation of Laboratory Animal Care – International (AAALAC-I) requirements

Regulations and StandardsRegulations and StandardsFederal Animal Welfare Act

Passed in 1966Administered by USDA-APHISProvisions include:

- Handling, housing, feeding, watering, sanitation, ventilation, shelter, and adequate veterinary care

- Use of tranquilizers, anesthetics, and analgesics to minimize pain or distress

- Periodic, unannounced visits- IACUC- Personnel training- Detailed records- Annual reports to USDA- Penalties for violation - fines or revocation of

funding

Regulations and Regulations and StandardsStandards

PHS Institutions required to follow Basis for AAALAC-I accreditation Covers all aspects of animal care programs and facilities 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 1996.

The Guide focuses on-

Institutional Policies and Responsibilities Animal Environment, Housing, and Management Veterinary Medical Care Physical Plant

Guide for the Care and Use of Laboratory AnimalsGuide for the Care and Use of Laboratory Animals

Regulations and Regulations and StandardsStandardsPublic Health Service (PHS) Policy

on Humane Care and Use of Laboratory Animals

Applies to any institution receiving PHS funds for vertebrate animal researchInstitutions with an “Assurance” must:

Establish an appropriate line-of-authorityUse the “Guide” as a basis for operating their

animal care programMaintain an IACUCMaintain recordsReport annually to OLAW (Office of Laboratory

Animal Welfare)Submit to on-site visits

Regulations and Regulations and StandardsStandards

United States Government Principles for the Utilization

and Care of Vertebrate Animals used in Testing, Research, and Training

A set of 9 general principles adhered to by institutions receiving federal funds for animal research

Reinforced by the PHS Policy

The IACUC MissionThe IACUC MissionOversee and evaluate the

institution’s program for animal care and use including it’s procedures and facilities

Implement regulations for the humane care and use of animals in research

Ensure researcher compliance with federal, state and local regulations and policies

Oversight of Animal Research Oversight of Animal Research Conduct Provided By:Conduct Provided By:

Institutional OfficialInstitutional Animal Care and Use

Committee (IACUC)Principal InvestigatorDivision of Veterinary Medicine

(DVM) at TNPRC ◦ This division has the charge of being

directly responsible for the care and well-being of the animals

Program AccreditationProgram AccreditationAAALAC International

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

Why does the TNPRC have an Why does the TNPRC have an IACUC?IACUC?

All research institutions that are registered under the provisions of the Animal Welfare Act are required by law to establish an IACUC

All research institutions that receive federal funding are required by law to establish an IACUC

Minimal Required IACUC Minimal Required IACUC MembershipMembership

A scientist experienced in animal research

A non-scientific memberA non-affiliated memberA veterinarian with training or

experience in laboratory animal science

A minimum of five members

IACUC MembershipIACUC Membership

Several faculty scientists actively involved with animal research◦This group constitutes the majority

of the committeeNon-affiliated, non-scientist member2 or more veterinarians experienced

in laboratory animal science and primate medicine

Specific IACUC FunctionsSpecific IACUC FunctionsReview and consider for approval all

proposed animal research annuallyReview animal care facilities and programs

(report to Institutional Official) semi-annually

Ensure personnel training and safety Make recommendations to Institutional

Official regarding program and facilitiesReview concerns about animal care and

useSuspend non-compliant animal care and

use activities

Protocol ReviewProtocol ReviewProcedures avoid or minimize discomfort,

distress, and painInvestigator has considered alternativesProposed activities are not duplicativeProcedures that may cause pain or

distress will:incorporate pain-relieving measures

unless well justifiedinclude veterinary involvement in

planningnot use paralytics without anesthesia

Animal will be euthanized if pain cannot be relieved

Protocol Review Protocol Review contcont..Animal Numbers are the minimum possible

to achieve statistically significant data and are well justified using the following criteria:◦ Citation of previous research, with sufficient

information provided to indicate that the previous research is similar enough in concept and methodology to make it reasonable to use similar sample sizes in the proposed research project

◦ Power analysis- with enough information to show ability in analyzing data and using a power analysis

◦ State clearly why a specific amount of material is needed and why the number of animals requested is appropriate to provide that amount of material

Protocol Review Protocol Review contcont..

Animal living conditions appropriate to species and meet standards

Animals housed in approved facility for approved time period

Medical care available and provided as necessary by a qualified veterinarian

Personnel appropriately qualified and trained

Surgical procedures performed aseptically, in approved facilities, and include appropriate pre-and postoperative care

Animals not used in more than one major, survival operative procedure

Acceptable methods of euthanasia

Researcher Researcher ResponsibilitiesResponsibilitiesExperimental design (appropriate

species, alternative model, numbers…)

Ensure appropriate staff qualifications and training for animal care and use

Conduct all research in accordance with protocols approved by the IACUC and institutional safety committees

Researcher ResponsibilitiesResearcher Responsibilities cont.cont.

Acquire primates from allocation process established at the TNPRC

Acquire nonprimate species through DVM approved vendors

Schedule all animal activities through the DVM ◦Ensure staff performing procedures

understands what is outlined in the study

Wear proper personal protective equipment and follow exposure guidelines

Review OutcomesReview Outcomes

AmendmentsAmendmentsIt is Tulane’s institutional policy that no one may It is Tulane’s institutional policy that no one may

implement changes categorized prior to IACUC review implement changes categorized prior to IACUC review and approvaland approval

Significant Changes -many times will require a new protocol

1. Changes in the objectives of a study 2. Proposals to switch from nonsurvival to survival

surgery 3. Changes in the degree of invasiveness of a

procedure or discomfort to an animal 4. Changes in species or in the approximate

number of animals used 5. Changes in anesthetic agent(s) 6. The use or withholding of analgesics 7. Methods of euthanasia 8. Changes in the duration, frequency, or number of

procedures performed on an animal

AmendmentsAmendmentsIt is Tulane’s institutional policy that no one may It is Tulane’s institutional policy that no one may

implement changes categorized prior to IACUC review implement changes categorized prior to IACUC review and approvaland approval .

Minor Changes: Addition of another strain of the same animal species Change in sex of animal to be used Need to repeat an experiment Small increase in animal numbers - review is based on

approximately 10% of original number of animals and any other amendments filed for this protocol

Addition of minor surgery- this addition cannot change the USDA category to a higher one. If this addition will change the pain category you must submit a new protocol.

Change in Principal investigator-if already listed as co-investigator on the protocol

Addition of a faculty collaborator Additional noninvasive sampling Addition of sample collection times

Serious Non-complianceSerious Non-complianceExamples of Reportable Examples of Reportable

SituationsSituations conditions that jeopardize the health or well-being of

animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals;

conduct of animal-related activities without appropriate IACUC review and approval;

failure to adhere to IACUC-approved protocols;

implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.;

conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years)

Examples of Reportable Examples of Reportable SituationsSituations

conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum

conduct of official IACUC business during a period of time that the Committee is improperly constituted

failure to correct deficiencies identified during the semiannual evaluation in a timely manner

chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification

Examples of Reportable Examples of Reportable SituationsSituations

failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO 2)

failure of animal care and use personnel to carry out veterinary orders (e.g., treatments)

IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide , or the institution's Animal Welfare Assurance.

Examples of Reportable Examples of Reportable SituationsSituationsparticipation in animal-related activities by

individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f

failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures)

failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry)

Penalties for Non Penalties for Non ComplianceCompliance

AWR’s

• Institution fined

• Cease & desist order issued

• Federal funding agencies requested to suspend or revoke funding

AWR’s

• Institution fined

• Cease & desist order issued

• Federal funding agencies requested to suspend or revoke funding

PHS Policy

• Revocation of assurance & loss of funding for entire institution

PHS Policy

• Revocation of assurance & loss of funding for entire institution

Scheduling Research Scheduling Research ProceduresProcedures

All IACUC approved research is scheduled through DVM

Only IACUC approved procedures can be scheduled

PI is responsible for ensuring that all procedures scheduled on an approved protocol are coveredIncludes all laboratory technicians

and students working in the PI’s laboratory

The New Form(s)The New Form(s)Streamlined and shorterNonhuman primate form

◦Updated analgesic/anesthetic information

◦Updated behavioral management sectionAll other species form

◦Specific analgesic/anesthetic information for commonly housed species

◦Specific behavioral management section

The New Form(s)The New Form(s)Significant changes

◦Animal species Drop down menu

◦Regulatory information Only one question specific to multiple

survival surgery, do not outline survival surgery in this area

◦Progress Report Specifically required for all renewal

protocols Indicate animals continuing on study

The New Form(s)The New Form(s)Significant changes

◦Layperson’s summary is still required◦Scientific summary

Area for text and chart Chart required for NHP form to define

all time points for sample collection and experiment design

◦Alternative search If hits are found, investigator must

justify why those alternatives are not being used

The IACUC Office at TNPRCThe IACUC Office at TNPRC

Tidewater Suite 1707

504-988-6868 (office)

504-988-1445 ( fax)

504-481-9684 (cell)

985-871-6636 (TNPRC Thursday)

iacuc@tulane.edu