Presentation on theme: "Institutional Animal Care and Use Committee (IACUC)"— Presentation transcript:
1 Institutional Animal Care and Use Committee (IACUC) Post Approval Monitoring Training Module
2 This training module contains coverage of the following topics: Post Approval Monitoring Training ModuleContentsThis training module contains coverage of the following topics:What is Post Approval Monitoring?GoalsRegulatory basisProcessLogisticsQuestions
3 Post Approval Monitoring Training Module DefinitionsPost Approval Monitoring is a program through which the IACUC can ensure and document program integrity, compliance with regulations and guidelines, and adherence to the approved protocol. PAM can serve as a facilitator for information exchange between researchers, and the IACUC and vice versa. PAM can provide assurance to regulatory agencies and VA TECH that animal experiments are monitored for compliance with approved IACUC protocols.
4 PAM Goals Ensure animal well being Protect the Institution Post Approval Monitoring Training ModulePAM GoalsEnsure animal well beingProtect the InstitutionEnsure regulatory complianceResource for the research communityFacilitate science and help achieve compliance
5 PAM Goals This is what VT would like to avoid. Post Approval Monitoring Training ModulePAM GoalsThis is what VT would like to avoid.
6 Post Approval Monitoring Training Module PAM GoalsAnd this ….
7 What PAM is NOT the Animal Cops a replacement for the IACUC Post Approval Monitoring Training ModuleWhat PAM is NOTthe Animal Copsa replacement for the IACUCrequired by the USDA, PHS or AAALAC, but it is strongly recommended
8 Regulatory Basis for PAM Post Approval Monitoring Training ModuleRegulatory Basis for PAMUSDA Title 9; section 2.31 CFR: IACUC FunctionsPublic Health Service (PHS)The ‘Guide for the Care and Use of Laboratory AnimalsU.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training
9 Regulatory Basis for PAM Post Approval Monitoring Training ModuleRegulatory Basis for PAMUSDA Title 9; section 2.31 CFR: IACUC FunctionsReview, at least once every 6 months, the research facility’s and the program for the humane care and use of animals……Investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees…
10 Regulatory Basis for PAM Post Approval Monitoring Training ModuleRegulatory Basis for PAMPublic Heath Service (NIH)1. … Review at least once every 6 months the institution’s program for humane care and use of animals…2. … The IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the “Guide” unless acceptable justification for a departure is present. Further the IACUC shall determine that the research project conforms with the institution’s assurance…
11 Regulatory Basis for PAM Post Approval Monitoring Training ModuleRegulatory Basis for PAMPublic Heath Service (NIH)3. The IACUC shall conduct continuing review of activities covered by this Policy at appropriate intervals as determined by the IACUC…4. The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution’s Assurance…
12 PAM Process Who will be involved? Post Approval Monitoring Officer Post Approval Monitoring Training ModulePAM ProcessWho will be involved?Post Approval Monitoring OfficerPrincipal Investigator and Lab/Research Staff (always)Animal Care Technicians/VeterinariansIACUC Staff/Committee (rarely)
13 PAM Process Types of Audits For-Cause (Complaint Based) Random Post Approval Monitoring Training ModulePAM ProcessTypes of AuditsFor-Cause (Complaint Based)Random
14 Post Approval Monitoring Training Module PAM ProcessFor-CauseReporting concerns about animal use or abuse is provided at the IACUC website:The IACUC has an established procedure for investigating and resolving complaints.
15 Random, who will be selected? Post Approval Monitoring Training ModulePAM ProcessRandom, who will be selected?Any active protocol can be randomly selectedAny protocol at the discretion of the IACUC and Veterinary staffAny protocol complimentary to IACUC semi-annual inspections
16 Post Approval Monitoring Training Module PAM LogisticsPI’s and laboratories will be contacted and a visit scheduledA PAM visit generally takes 1 hour (if you are prepared)PAM Findings are documentedDiscuss findings with PI and research staffSuggestions on amendment submissions are made if necessary
17 Areas that will be reviewed Post Approval Monitoring Training ModulePAM LogisticsAreas that will be reviewedIs the Protocol Notebook Available to all study team members?Training of PersonnelStudy ProceduresAnimal NumbersEuthanasiaRecord KeepingAnimal Facility
18 PAM Logistics Care and Use Tool Post Approval Monitoring Training ModulePAM LogisticsCare and Use Tool
19 IACUC Record Keeping Requirements Post Approval Monitoring Training ModuleIACUC Record Keeping RequirementsHealth records must convey necessary information to all people involved in an animal’s care and must be sufficiently comprehensive to demonstrate the delivery of adequate health care. Health records must be held for at least 1 year after the disposition or death of the animal. Descriptions of any illness, injury, distress, and/or behavioral abnormalities and the resolution of any noted problem. Dates, details, and results (if appropriate) of all medically-related observations, examinations, tests, and treatments, including the name, dose, route, frequency, and duration of treatment with drugs or other medications.
20 PAM Logistics Sample Animal Use Log Post Approval Monitoring Training ModulePAM LogisticsSample Animal Use Log
21 PAM Logistics Sample Animal Use Log Post Approval Monitoring Training ModulePAM LogisticsSample Animal Use Log
22 PAM Logistics After the visit A final report is issued to the PI Post Approval Monitoring Training ModulePAM LogisticsAfter the visitA final report is issued to the PIIf findings are significant the IACUC Administrator, Attending Veterinarian, and IACUC will receive a report.Follow up and support:TrainingProtocol amendments if neededOccasional letters to agencies are issued
23 Common Problem Areas Exceeding animal numbers approved Post Approval Monitoring Training ModuleCommon Problem AreasExceeding animal numbers approvedUnapproved euthanasia methodProtocol driftFailure to add new personnelFailure to monitor animals post procedurallyFailure to maintain adequate breeding recordsFailure to post the protocol # in the animal holding area
24 Questions? http://www.researchcompliance.vt.edu/index.php Post Approval Monitoring Training ModuleQuestions?