Modifications to Approved Projects

In accordance with Clause 2.2.23 of the Australian Code for the Care and Use of Animals for Scientific Purposes 8th Edition 2013), the ACEC can consider minor amendments to approved projects or activities. Such amendments, termed "Modifications" in Animal Ethics Online, can take the form of "Personnel" or "Application" modifications.

Modification requests at the Spokesperson and Executive level may be reviewed out-of-session by the Spokesperson for the application before being forwarded to the ACEC Executive, and subsequently the ACEC Chair for review. Recommendation for approval is then forwarded to the DVCR for final sign off, if appropriate. 

If a modification request is referred to the full ACEC for review, the Chief investigator will be advised of this decision made by the Executive with reasons provided and that the modification will need to be assessed by the ACEC at the next scheduled meeting. The Chief Investigator can decide whether they want to proceed with the modification being reviewed at the ACEC meeting, withdraw the modification or submit a new application. 

Modifications requiring ACEC review are to be assigned to the original Committee that reviewed the initial application (e.g., Committee ‘A’ or ‘B’) at the monthly meeting. It is important to note that these modifications may be rejected by the ACEC if the proposed change does not fall under the original aims of the project or is deemed ethically unacceptable for example. The Committee may also ‘defer’ the modification if there are outstanding queries for the CI to address. The resubmission of the modification will be tabled at the next scheduled Committee meeting. 

It is noted that this process will not contravene the requirements of the Code.  

Examples of modification requests to be reviewed at the level of the Spokesperson and Executive: 

• change in personnel; 

• extension of the project expiry date by up to six weeks; 

• increase in animal numbers originally approved; 

• change in location for animal holding or procedures; 

• change in animal supplier; 

• change in animal strain; 

• change in procedure that aligns with the original aims and is unlikely to cause additional impact on the animals. 
   

Examples of modification requests to be reviewed by the full ACEC: 

• change in animal species; 

• any substantial increase in impact on animal welfare. 

Modifications should be applied for using Animal Ethics Online

Changes to an approved application other than the addition or removal of personnel

Application modifications apply when the CI wishes to request changes to the original approved experimental procedures and/or animal numbers. The ACEC Executive will consider minor amendments to procedures and animal numbers, where the proposed change is not likely to cause harm to the animals, including pain and distress. All requests for minor amendments will be considered on an individual basis, but requests for major deviations from the original protocol are unlikely to be approved and the researcher will be asked to submit a new application. Modifications that are not major deviations from the original protocol but which may be considered more than 'minor' will initially be considered by the ACEC Executive, and may be referred to the full ACEC for review. The Chief Investigator can decide whether to proceed with the modification being reviewed at the ACEC meeting, withdraw the modification or submit a new application. Modifications referred to the ACEC for review may not be approved by the ACEC if the proposed change does not fall under the original aims of the project or is deemed ethically unacceptable.

Modifications should not deviate from the originally proposed aims, procedures or animal numbers. The increase in animal numbers should be no more than 10% of those originally approved; changes greater than 10% may be considered on a case by case basis with strong justification. Justification must be provided for all modification requests in the appropriate section of the modification online form.

Modification requests are initially reviewed out of session by the spokesperson, the ACEC Executive, and the ACEC Chair. Recommendation for further Committee review is then forwarded to the ACEC, while recommendation for approval is forwarded to the DVCR for final approval. The final decision of the Chair and Executive is ratified by the ACEC at the next scheduled meeting.

Addition or removal of personnel

Personnel modifications apply when the CI wishes to add new participant(s) to an approved project. As for application modifications, personnel modifications are reviewed out-of-session.

Personnel should have relevant training and be competent in the procedures they will be conducted or be supervised by a competent individual. In addition, RECS Animal Care provide online and in person training: https://research.unsw.edu.au/animal-care-and-ethics-training.

The personnel modification process may also be used to remove participants from an approved project. If the participant has been listed under B7 or F4, they will first need to be removed from these sections via an application modification before complete removal via a personnel modification.

Requests for project extensions are discouraged by UNSW ACEC. A minor extension (via "Application Modification") for an approved project may considered on an individual basis. Shorter extensions (approximately 6 weeks) may be requested under the following circumstances: (1) to allow the researcher sufficient time to submit a new application to the next ACEC meeting for continuation of the project; or (2) in the situation where the researcher does not plan to submit a new application to continue the project, to allow the completion of an ongoing animal experiment where no additional animals will be recruited into the study.