PAM

PAM Overview

Pursuant to Article 55 of the Animal Protection Act and Article 22 of its Enforcement Decree, Post-Approval Monitoring (PAM) of approved research is conducted at least once a year to verify that the research plans or experiments approved by the Committee are carried out at the research site in compliance with the relevant guidelines and regulations.

Animal Protection Act

(1) The head of an animal testing facility shall request the chairperson referred to in Article 53(1) to supervise, as prescribed by Presidential Decree, whether the animal experiment is being conducted as deliberated.

(2) Where an experiment that has not been deliberated by the ethics committee is being conducted, the chairperson shall immediately demand the suspension of the experiment. However, the chairperson may refrain from demanding the suspension of the experiment in cases prescribed by Presidential Decree, such as where the suspension of the experiment is feared to cause serious harm to the welfare of the relevant laboratory animals.

(3) The head of an animal testing facility who has received a demand to suspend an experiment under the main clause of paragraph (2) shall suspend the relevant animal experiment.

(4) Where the head of an animal testing facility has received a demand to suspend an experiment under the main clause of paragraph (2), he or she may resume the animal experiment after being deliberated under Article 51(3) or (4).

(5) Where any violation is discovered as a result of the supervision under paragraph (1), the head of an animal testing facility shall, without delay, notify the Minister of Agriculture, Food and Rural Affairs thereof.

(1) The head of an animal testing facility shall request the chairperson of the ethics committee to supervise the following matters at least once a year pursuant to Article 55(1) of the Act. In such cases, the timing of the supervision request shall be determined in consultation with the chairperson of the ethics committee.

  1. 1. Whether the animal experiment is being conducted as deliberated
  2. 2. The housing environment of the animals used in the animal experiment
  3. 3. The veterinary care of the animals used in the animal experiment
  4. 4. Whether measures to mitigate the pain of the animals used in the animal experiment are taken

(2) "Cases prescribed by Presidential Decree, such as where serious harm to the welfare of the relevant laboratory animals is feared to occur" in the proviso to Article 55(2) of the Act means any of the following cases.

  1. 1. Where the suspension of the animal experiment would cause the relevant laboratory animal to die
  2. 2. Where the suspension of the animal experiment would aggravate the pain of the relevant laboratory animal

PAM Guidance

1. Selection Criteria for Protocols Subject to PAM

  1. 1

    Protocols falling under pain/distress category D or E

  2. 2

    Animal study protocols in which the number of laboratory animals increased by 100% or more upon amendment or continuation submission

  3. 3

    Animal study protocols involving different animal species

  4. 4

    Animal study protocols with frequent external transport

  5. 5
    Animal study protocols deemed likely to cause excessive stress to laboratory animals

    e.g.) Food/water restriction of 48 hours or more, prolonged restraint

  6. 6

    Animal study protocols using hazard-inducing substances and biohazardous materials

2. PAM Visit Checklist

  1. 1
    Research Participants and Training
    • Actual attendance of research participants and placement of the relevant animal study protocol in the experiment space
    • Level of training on experimental methods and wearing of appropriate personal protective equipment
  2. 2
    Research Procedures
    • IACUC approval number labeling status on housing cages, and protocol approval and labeling for single-housing cages
    • Verification that the species, strain, age, quantity, etc. of animals match the approved items
    • Verification that the experiment is conducted using the approved methods
  3. 3
    Anesthesia
    • Recording of anesthetic dosage, frequency, and route of administration, and monitoring of anesthetized animals
    • Exhaust and treatment of gas when inhalation anesthetics are used
  4. 4
    Surgery
    • Verification of the location and method described in the approved protocol
    • Whether aseptic surgery is performed and the incision site is sutured in the case of survival surgery
    • Maintenance of the animal's body temperature during the surgical procedure
    • Whether major surgery is performed redundantly
  5. 5
    Post-Operative Care
    • Whether analgesics are administered (dosage, frequency, duration) by the method described in the protocol
    • Post-operative care records and the marking method used to identify operated subjects