An Introduction to An Introduction to Conducting Animal Conducting Animal

Research: Research: Oversight and the Oversight and the

IACUCIACUCInstitutional Animal Care & Use Institutional Animal Care & Use

CommitteeCommittee

iacuc@tulane.eduiacuc@tulane.edu

IACUCIACUC

The charge of an Institutional Animal The charge of an Institutional Animal Care and Use Committee as Care and Use Committee as mandated by NIH’s Office of mandated by NIH’s Office of

Laboratory Animal Welfare and the Laboratory Animal Welfare and the USDA is to ensure the humane care USDA is to ensure the humane care and use of animals used in research and use of animals used in research and compliance with guidelines and and compliance with guidelines and

regulationsregulations..

Animal Research has Animal Research has OversightOversight

All animal research at TU has official oversight All animal research at TU has official oversight provided by the Institutional Animal Care and provided by the Institutional Animal Care and Use Committee (IACUC)Use Committee (IACUC)

All animal research must be approved by the All animal research must be approved by the IACUCIACUC

The IACUC helps investigators conduct ethical The IACUC helps investigators conduct ethical research by implementing guidelines and research by implementing guidelines and policies for the humane care and use of policies for the humane care and use of research animals and for the safety of research animals and for the safety of research personnelresearch personnel

These guidelines are based on laws, These guidelines are based on laws, regulations and policies from federal agencies regulations and policies from federal agencies and other accrediting organizationsand other accrediting organizations

Laws, Regulations, and Policies Laws, Regulations, and Policies That Impact on the Care and Use That Impact on the Care and Use

of Animalsof Animals

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

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

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

Regulations and Regulations and StandardsStandardsFederal Animal Welfare ActFederal Animal Welfare Act

Passed in 1966Passed in 1966

Administered by USDA-APHISAdministered by USDA-APHIS

Provisions include:Provisions include:- Handling, housing, feeding, watering, sanitation, Handling, housing, feeding, watering, sanitation,

ventilation, shelter, and adequate veterinary careventilation, shelter, and adequate veterinary care- Use of tranquilizers, anesthetics, and analgesics to Use of tranquilizers, anesthetics, and analgesics to

minimize pain or distressminimize pain or distress- Periodic, unannounced visitsPeriodic, unannounced visits- IACUCIACUC- Personnel trainingPersonnel training- Detailed recordsDetailed records- Annual reports to USDAAnnual reports to USDA- Penalties for violation - fines or revocation of Penalties for violation - fines or revocation of

fundingfunding

Regulations Regulations and and

StandardsStandards

PHS Institutions required to followPHS Institutions required to follow

Basis for AAALAC-I accreditationBasis for AAALAC-I accreditation

Covers all aspects of animal care programs and facilitiesCovers all aspects of animal care programs and facilities

The “Guide for the Care and Use of Laboratory Animals” was first 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 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. (Facilities and Care” . It provides standards for the care and use of research animals. (Laboratory Laboratory Animal MedicineAnimal Medicine ACLAM series) ACLAM series)

It has become THE reference for the operation of animal care and use programs and has undergone It has become THE reference for the operation of animal care and use programs and has undergone many revisions, the most recent in 1996.many revisions, the most recent in 1996.

The Guide focuses on-The Guide focuses on- Institutional Policies and ResponsibilitiesInstitutional Policies and Responsibilities Animal Environment, Housing, and ManagementAnimal Environment, Housing, and Management Veterinary Medical CareVeterinary Medical Care Physical PlantPhysical Plant

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

Regulations and Regulations and StandardsStandards

Public Health Service (PHS) Policy Public Health Service (PHS) Policy

on Humane Care and Use of Laboratory on Humane Care and Use of Laboratory AnimalsAnimals

Applies to any institution receiving PHS Applies to any institution receiving PHS funds for vertebrate animal researchfunds for vertebrate animal research

Institutions with an “Assurance” mustInstitutions with an “Assurance” must:: Establish an appropriate line-of-authorityEstablish an appropriate line-of-authority Use the “Guide” as a basis for operating their Use the “Guide” as a basis for operating their

animal care programanimal care program Maintain an IACUCMaintain an IACUC Maintain recordsMaintain records Report annually to OLAW (Office of Laboratory Report annually to OLAW (Office of Laboratory

Animal Welfare)Animal Welfare) Submit to on-site visits Submit to on-site visits

Regulations and Regulations and StandardsStandards

United States Government Principles United States Government Principles for the Utilization and Care of for the Utilization and Care of Vertebrate Animals used in Vertebrate Animals used in

Testing, Research, and TrainingTesting, Research, and Training

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

Reinforced by the PHS PolicyReinforced by the PHS Policy

Serious Non-Serious Non-compliancecompliance

Examples of Reportable Examples of Reportable

SituationsSituationsconditions that jeopardize the health or well-being of animals, conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals;resulting in actual harm or death to animals;

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

failure to adhere to IACUC-approved protocols;failure to adhere to IACUC-approved protocols;

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

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

Serious Non-Serious Non-compliancecompliance

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

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

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

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

Serious Non-Serious Non-compliancecompliance

participation in animal-related activities by participation in animal-related activities by individuals who have not been determined by the individuals who have not been determined by the IACUC to be appropriately qualified and trained as IACUC to be appropriately qualified and trained as required by IV.C.1.f;required by IV.C.1.f;

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

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

Serious Non-Serious Non-compliancecompliance

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

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

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

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

Program Program AccreditationAccreditationAAALAC InternationalAAALAC International

A non- profit corporation directed by its A non- profit corporation directed by its member organizations (educational, health member organizations (educational, health and research groups concerned about animal and research groups concerned about animal care)care)

Conducts a voluntary program of Conducts a voluntary program of accreditation of laboratory animal facilities accreditation of laboratory animal facilities and programs to encourage high standards and programs to encourage high standards for the care and use of lab animals, assure for the care and use of lab animals, assure control of variables that may adversely affect control of variables that may adversely affect research and protect the health of animal research and protect the health of animal research workersresearch workers

Conducts site visits for assessment and Conducts site visits for assessment and accreditationaccreditation

Accreditation is strongly encouraged by Accreditation is strongly encouraged by many funding agenciesmany funding agencies

Oversight of Oversight of Animal Research Animal Research Conduct Provided Conduct Provided

By:By:Institutional OfficialInstitutional Official

Institutional Animal Care and Use Institutional Animal Care and Use Committee (IACUC)Committee (IACUC)

Principal InvestigatorPrincipal Investigator

Department of Vivarial Science and Department of Vivarial Science and Research (DVSR) Research (DVSR)

This division has the charge of being directly This division has the charge of being directly responsible for the care and well-being of the responsible for the care and well-being of the animalsanimals

Why does TU have Why does TU have an IACUC?an IACUC?

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

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

The IACUC MissionThe IACUC Mission

Oversee and evaluate the institution’s Oversee and evaluate the institution’s program for animal care and use including it’s program for animal care and use including it’s procedures and facilitiesprocedures and facilities

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

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

Minimal Required Minimal Required IACUC IACUC

MembershipMembershipA scientist experienced in animal researchA scientist experienced in animal research

A non-scientific memberA non-scientific member

A non-affiliated memberA non-affiliated member

A veterinarian with training or experience in A veterinarian with training or experience in laboratory animal sciencelaboratory animal science

A minimum of five membersA minimum of five members

IACUC MembershipIACUC Membership

Several faculty scientists actively Several faculty scientists actively involved with animal researchinvolved with animal research

This group constitutes the majority of the This group constitutes the majority of the committeecommittee

Non-affiliated memberNon-affiliated member

non-scientist membernon-scientist member

1 or more veterinarians experienced 1 or more veterinarians experienced in laboratory animal science and in laboratory animal science and primate medicineprimate medicine

Specific IACUC Specific IACUC FunctionsFunctions

Review and consider for approval all Review and consider for approval all proposed animal research annuallyproposed animal research annually

Review animal care facilities and programs Review animal care facilities and programs (report to Institutional Official) semi-(report to Institutional Official) semi-annuallyannually

Ensure personnel training and safety Ensure personnel training and safety

Make recommendations to Institutional Make recommendations to Institutional Official regarding program and facilitiesOfficial regarding program and facilities

Review concerns about animal care and useReview concerns about animal care and use

Suspend non-compliant animal care and use Suspend non-compliant animal care and use activitiesactivities

Protocol ReviewProtocol ReviewProcedures avoid or minimize Procedures avoid or minimize discomfort, distress, and paindiscomfort, distress, and pain

Investigator has considered alternativesInvestigator has considered alternatives

Proposed activities are not duplicativeProposed activities are not duplicative

Procedures that may cause pain or Procedures that may cause pain or distress will:distress will: incorporate pain-relieving measures unless well incorporate pain-relieving measures unless well

justifiedjustified include veterinary involvement in planninginclude veterinary involvement in planning not use paralytics without anesthesianot use paralytics without anesthesia

Animal will be euthanized if pain cannot Animal will be euthanized if pain cannot be relievedbe relieved

Protocol Protocol Review Review contcont..

Animal Numbers are the minimum possible to Animal Numbers are the minimum possible to achieve statistically significant data and are achieve statistically significant data and are well justified using the following criteria:well justified using the following criteria:

Citation of previous research, with sufficient Citation of previous research, with sufficient information provided to indicate that the information provided to indicate that the previous research is similar enough in concept previous research is similar enough in concept and methodology to make it reasonable to use and methodology to make it reasonable to use similar sample sizes in the proposed research similar sample sizes in the proposed research projectprojectPower analysis- with enough information to Power analysis- with enough information to show ability in analyzing data and using a power show ability in analyzing data and using a power analysisanalysisState clearly why a specific amount of material State clearly why a specific amount of material is needed and why the number of animals is needed and why the number of animals requested is appropriate to provide that amount requested is appropriate to provide that amount of materialof material

Protocol Protocol Review Review contcont..

Animal living conditions appropriate to species Animal living conditions appropriate to species and meet standardsand meet standards

Animals housed in approved facility for Animals housed in approved facility for approved time periodapproved time period

Medical care available and provided as Medical care available and provided as necessary by a qualified veterinariannecessary by a qualified veterinarian

Personnel appropriately qualified and trainedPersonnel appropriately qualified and trained

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

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

Acceptable methods of euthanasiaAcceptable methods of euthanasia

Researcher Researcher ResponsibilitiesResponsibilitiesExperimental design (appropriate Experimental design (appropriate species, alternative model, species, alternative model, numbers…)numbers…)

Ensure appropriate staff qualifications Ensure appropriate staff qualifications and training for animal care and useand training for animal care and use

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

Researcher Researcher ResponsibilitiesResponsibilities cont.cont.

Acquire nonprimate species through DVSR Acquire nonprimate species through DVSR approved vendorsapproved vendors

Schedule all animal activities through the Schedule all animal activities through the DVSR DVSR

Ensure staff performing procedures understands Ensure staff performing procedures understands what is outlined in the studywhat is outlined in the study

Wear proper personal protective Wear proper personal protective equipment and follow exposure guidelines 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 as significant implement changes categorized as significant prior to IACUC review and approvalprior to IACUC review and approval

Significant ChangesSignificant Changes -many times will require a new protocol -many times will require a new protocol

1. Changes in the objectives of a study1. Changes in the objectives of a study

2. Proposals to switch from nonsurvival to survival surgery 2. Proposals to switch from nonsurvival to survival surgery

3. Changes in the degree of invasiveness of a procedure or 3. Changes in the degree of invasiveness of a procedure or discomfort to an animaldiscomfort to an animal

4. Changes in species or in the approximate number of 4. Changes in species or in the approximate number of animals usedanimals used

5. Changes in anesthetic agent(s)5. Changes in anesthetic agent(s)

6. The use or withholding of analgesics6. The use or withholding of analgesics

7. Methods of euthanasia7. Methods of euthanasia

8. Changes in the duration, frequency, or number of 8. Changes in the duration, frequency, or number of procedures performed on an animalprocedures performed on an animal

AmendmentAmendment..

Minor Changes:Minor Changes:

Addition of another strain of the same animal speciesAddition of another strain of the same animal species

Change in sex of animal to be usedChange in sex of animal to be used

Need to repeat an experimentNeed to repeat an experiment

Small increase in animal numbers - review is based on approximately Small increase in animal numbers - review is based on approximately 10% of original number of animals and any other amendments filed for 10% of original number of animals and any other amendments filed for this protocolthis protocol

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

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

Addition of a faculty collaboratorAddition of a faculty collaborator

Additional noninvasive samplingAdditional noninvasive sampling

Addition of sample collection timesAddition of sample collection times

The New The New Form(s)Form(s)

Nonhuman primate formNonhuman primate formUpdated analgesic/anesthetic informationUpdated analgesic/anesthetic information

Updated behavioral management sectionUpdated behavioral management section

All other species formAll other species formSpecific analgesic/anesthetic information Specific analgesic/anesthetic information for commonly housed speciesfor commonly housed species

Specific behavioral management sectionSpecific behavioral management section

The New The New Form(s)Form(s)

Significant changesSignificant changes– Animal speciesAnimal species

• Drop down menuDrop down menu

– Regulatory informationRegulatory information• Only one question specific to multiple Only one question specific to multiple

survival surgery, do not outline survival survival surgery, do not outline survival surgery in this areasurgery in this area

– Progress ReportProgress Report• Specifically required for all renewal protocolsSpecifically required for all renewal protocols• Indicate animals continuing on study Indicate animals continuing on study

The New The New Form(s)Form(s)

• Significant changesSignificant changes

– Layperson’s summary is still requiredLayperson’s summary is still required– Scientific summaryScientific summary

• Area for text and chartArea for text and chart– Alternative searchAlternative search

• If hits are found, investigator must If hits are found, investigator must justify why those alternatives are not justify why those alternatives are not being usedbeing used

The IACUC Office The IACUC Office at TUat TU

Tidewater Suite 1707Tidewater Suite 1707

504-988-6868 (office)504-988-6868 (office)

504-988-1445 ( fax) 504-988-1445 ( fax)

504-481-9684 (cell)504-481-9684 (cell)

985-871-6636 (TNPRC Thursday)985-871-6636 (TNPRC Thursday)

iacuc@tulane.eduiacuc@tulane.edu