HomeDirections for Determining the Extent of Changes in Animal Research Protocols
Approved on November 12, 2024
- In accordance with Article 4, Subparagraph 1 of Regulations on the Establishment and Management of the Committee or Subcommittee for the Care and Use of Laboratory Animals of the Ministry of Agriculture, and Article 6 of Guidelines for the Establishment of Institutional Animal Care and Use Committee of Academia Sinica, any proposed changes to an approved Animal Use Protocol must be submitted as a modification application.
- In accordance with the regulations of the Ministry of Agriculture, any change to the project PI or the project title requires resubmission of the Animal Use Protocol application. However, changes to the project title that do not alter the original intent of the project are exempt from this requirement.
Any change to the research objectives or the animal species used shall require submission of a new Animal Use Protocol application. - The committee shall determine the category of a modification case based on the extent of the proposed changes. Such determinations may be classified as requiring either committee review or administrative review.
- The following matters shall be subject to committee review (general review):
- Change of animal strain that alters the experimental procedures.
- Modification of the number of animals used, where the change within the same strain exceeds the originally approved quantity.
- Change from a non-survival surgery to a survival surgery.
- Change in procedures that may cause substantial pain, distress, or a higher level of invasiveness to the animals.
- Changes in procedures that may affect personnel safety.
- Matters involving the following items shall be submitted to veterinarian review after document examination by the Executive Secretary:
- Changes to anesthesia, analgesia, sedation, or experimental substances.
- Modification of the duration, frequency, type, or number of experimental procedures involving animals.
- Addition of invasive experiment procedures.
- Addition of experiments involving biohazards.
- Changes in euthanasia methods.
- Experiments involving animal welfare concerns.
- Change of animal strain that does not affect the content of the experimental procedures.
- Changes in the source and/or housing of animals.
- Changes of the location or facility of animal experiments to a place beyond the oversight of the Institutional Animal Care and Use Committee (IACUC) of Academia Sinica.
- Matters involving the following items shall be subject to Administrative Review by the Executive Secretary:
- Addition or removal of research personnel.
- Changes in contact information.
- Changes in the source of project funding.
- Change in the number of animals used, where the modification within the same strain is less than the originally approved number.
- Transfer or reassignment of animals within or between institutions.
- The following matters shall be subject to committee review (general review):
- Upon approval, the Animal Use Consent Form shall be updated online.
