AV俱乐部

All use of animals at AV俱乐部 requires the submission of a protocol application. Principal applicants and Principal investigators will normally be AV俱乐部 Faculty members. Directors and Managers of AV俱乐部 animal facilities (Carleton, Aquatron, Farm, Boulden, etc.) may also serve as PI on animal protocols. In circumstances where animal research or testing is undertaken by outside parties who do not hold a AV俱乐部 faculty appointment, a contract will be established between the principal investigator and the Office of the Vice President Research.

Faculty and Directors/Managers whose home department is in Halifax or St. John should submit UCLA protocols to the UCLA. Faculty and Managers whose home department is on the Agricultural Campus should submit ACUC protocols to the ACUC. In the case where the protocol forms of the other campus are much more applicable to the specific research being planned, investigators should consult with the Chair of the local animal ethics committee regarding the most appropriate form and committee to direct their protocol application to.

Animal-based research in two or more institutions: In these situations animal ethics approval may be required by both AV俱乐部 and the host institution () before the animal research can begin. Please contact the Chair of the UCLA/ACUC or the University Veterinarian to discuss the specific requirements.

All members of the Committee are responsible for reviewing each protocol before the UCLA OR ACUC meeting.

Detailed committee review of protocols may vary depending upon the history of the committee and nature of proposals. At least two Committee members are assigned to scrutinize the protocol in particular detail, and they may ask the UCLA or ACUC coordinator to contact the principal investigator prior to the meeting to request more information. At the protocol review meeting, the assigned reviewer(s) point out any problems or omissions that he/she has identified. The remaining members of the committee are then asked for their opinions and comments.

In many cases the protocol cannot be given full approval during the meeting because certain details are missing, or a question has been raised. Where necessary, the Committee will request additional information or supporting evidence from the investigator to justify or explain the proposed protocol. If the missing details are minor, the authority to grant full approval may be delegated to one or a few members (normally the primary reviewer, veterinarian &/or Chair) once the additional information has been received and reviewed. If there are many questions, or if there are remaining ethical concerns, the response must be received and approved by the full committee at the next meeting.

An investigator may be invited to a UCLA OR ACUC meeting to further explain his/her protocols if the committee feels this will facilitate the review process. The Committee will then decide whether to approve the protocol after the investigator has left the room. In some circumstances the Committee may decide to approve only certain portions of the protocol. The approved and non-approved sections of the protocol must be clearly delineated in a letter to the principal investigator.

The Committee will attempt to reach decisions by consensus. The protocol is not approved if there is more than one dissenter. In this case the dissenters may elect to be 鈥渙n the record鈥� (minuted) as objecting to the protocol, and the protocol may then be approved. Otherwise the protocol remains unapproved and the principal investigator may proceed to appeal the decision.

On the Halifax campuses, after a protocol is approved or conditionally approved, the UCLA Coordinator will send a letter to the Principal Applicant with any conditions of the approval outlined. In the Faculty of Agriculture, the Chair of the ACUC signs off on the first page of the protocol once it has been approved and all conditions of the approval met. The signed letter/protocol may be used as evidence of Animal Ethics approval and should be posted where the animals are located.

Animal protocols are approved for one year. At the end of that period, the approval can be extended for one additional year by the submission of a renewal form (Event form on Romeo), provided there are no major changes in experimental procedures. Investigators must complete a progress report as part of the renewal form, including refinements and any unexpected complications. We will accept two renewals on each protocol, giving the reseacher 3 years before a new Form A is due.

The requirement for additional animals must be justified, and submitted on an amendment form. Renewal forms are reviewed by the full Committee. UCLA/ACUC protocols are allowed two renewals. After the completion of the renewal period the investigator must submit a full protocol application as if it were a new project.

As stated in the TOR, the UCLA OR ACUC requires that protocols must be updated and approved prior to any modifications. Investigators must submit an amendment form to modify an existing protocol. The modifications requested should be relatively minor and must remain consistent and within the objectives of the original protocol which is being amended. Examples of modifications suitable for an amendment would include changes in personnel, addition of a small number of animals (usually 20% or less), change in animal strain or breed, or refinement of a technique. The investigator will be required to submit a full new protocol application if the modifications appear to be major, or if they will result in an increase in the level of invasiveness. Please include relative attachments (e.g., A for surgery, F for breeding, H for biohazards).

For more details regarding Minor vs. Major amendments please review the following definitions. 

Minor amendment, a modification to the protocol or Form B amendment that:

• involves a change in personnel or training status 
• involves a change in animal number of not more than 20% of the protocol
• can involve a strain change in mammal model but not a species change
• adds treatments or procedures of similar invasiveness to the level and category previously approved without increase in harms
• does not involve an increase in harms done to an animal during study
• flows naturally from the scientific peer review basis of previous studies

Major amendment, which triggers the requirement for a new Form A:

• increase of more than 20% of previously approved animal numbers
• mammal Species change
• increased category of invasiveness
• increased potential harms to animal, i.e., multiple surgeries/IP injections/compound toxicity
• represents a new research direction that does not naturally flow from previous approved studies, i.e., requires new peer review

Where protocol approval is urgently required, the investigator may request pro tem approval from the UCLA OR ACUC coordinator. In such cases the protocol will be distributed to a minimum of the committee chair or university veterinarian, one animal using faculty member and a community member for review. This subcommittee may request additional information from the investigator if necessary. Pro tem approval will not be granted if the subcommittee feels the application raises ethical concerns which should be addressed by the full committee. In any case, protocols which have been granted pro tem approval are reviewed by the full committee at the next regularly scheduled UCLA OR ACUC meeting.

The UCLA OR ACUC encourages the use of small numbers of animals when new approaches, methods or products are being tried. If deemed necessary, the Committee will require that the new procedure and/or subsequent recovery of the initial animals be monitored by one of the veterinarians, and that these findings be reported back to the Committee.

The committees encourage the development and use of SOPs for all activities and procedures that involve animals. These may be collaboratively written by animal care staff, investigators and consulting veterinarians as appropriate for the procedure and the animal unit. Normally the lead applicant for the submission is the animal unit manager or director. SOPs are to be submitted to the UCLA OR ACUC for review and approval at least every three years. Investigators are encouraged to include approved SOPs in their protocol applications, as well as work in consultation with animal care staff and veterinarians to develop new appropriate SOPs for their specific procedures.

In accordance with CCAC guidelines, the AV俱乐部 Animal Ethics review committees must ensure that scientific merit has been demonstrated through independent peer review before animal research projects can be given ethical approval. Normally, funding of a project by a peer reviewed funding agency is taken as adequate evidence of scientific merit. The UCLA and ACUC reserve the right to ask for additional or more rigorous scientific peer review for a specific use of animals, particularly when the ethical cost to the animals is high. When the funding source does not provide scientific peer review, AV俱乐部 Research Services will either:

1. Arrange for scientific merit review as described in the Scientific Merit Policy document. (see appendix)

OR

2. In the case of Corporate Partners scientific merit review is to be arranged according to the AV俱乐部

Guidelines on Scientific Peer Review of Animal Research Proposals from Corporate Partners and submitted to the Office of the Associate Vice President of Research. (See appendix 2) see form K and L.

In either case, the Animal Ethics review committees will not give full ethical approval to any animal protocol until confirmation of scientific merit has been received from AV俱乐部 Research Services or the Office of the AVPR.

Post-approval monitoring of protocol compliance is achieved by:

1. interactions on a daily basis between Committee members (particularly the veterinary and technical staff) and research personnel

2. meetings between Committee members and field researchers at the conclusion of the field season

3. formal, recorded site visits by Committee members to laboratories and other animal units where animals are used

The formal site visits are arranged at a mutually convenient time for the animal care staff and animal care committee members. A checklist is completed by committee members to assist in evaluating and recording their findings. A report outlining recommendations and commendations is sent electronically to the investigator after the PAM visit, and a copy of the checklist and the report are retained in the office of the University Director of Animal Care. The report is discussed at the next ACUC or UCLA meeting for follow-up action if required. The committees may require additional site visits to follow up on any protocols or site visits that have raised concerns.

In accordance with CCAC guidelines, the AV俱乐部 Animal Ethics review committees are responsible for the review of the pedagogical merit of animal-based teaching/training. Protocol applications for student participation in activities of level 鈥淐鈥� of invasiveness or higher will be subject to review by at least two independent referees. Approval of protocols that involve student observation (as opposed to participation in) of level 鈥淐鈥� management procedures inherent to livestock production or the veterinary technician profession will not require external review but do require (in addition to the teaching protocol application) that the procedure be described in a detailed SOP reflecting current knowledge and expertise. The merit of all animal-based teaching/training protocols of level 鈥淏鈥� will be reviewed by the UCLA or ACUC with consideration of the key aspects outlined in the CCAC policy .

Undergraduate Student research projects are expected to meet the guidelines outlined in the document 鈥淎V俱乐部 Animal Ethics Guidance for Best Practices for Undergraduate Student Research with Animals鈥�, which includes direction for appropriate scientific merit and/or pedagogical merit review.

The committee ensures that all UCLA OR ACUC members, animal users, and animal care staff have the opportunity to become familiar with CCAC guidelines and policy statements, as well as AV俱乐部 requirements. New members to the Committee receive an orientation package which outlines duties/responsibilities and provides supplementary information and links to other resources such as the CCAC website. Each new committee member is encouraged to ask questions during their initial UCLA OR ACUC meetings.

Additional background information is supplied by the chair and/or university veterinarians. Researchers and their staff must attend an initial mandatory orientation session where CCAC and institutional policies are explained. New policies and guidelines are brought to the attention of investigators through electronic distribution lists and newsletters.

Animal care staff must also participate in mandatory training sessions. The committee encourages continuing education of animal care staff through short courses, workshops, seminars and selfinstructive electronic media in order to increase knowledge of new or updated procedures and ethical issues.

All discussions and decisions are documented in the Committee minutes. Necessary corrections are made at the following meeting for a final record of the Committee鈥檚 activities. Copies of the minutes are forwarded to the Vice President鈥檚 office. All correspondence between the Committee and investigators is attached to the relevant protocol forms. Committee minutes, protocol applications, correspondence and other documentation is retained in the office of the University Director of Animal Care.

In addition to regular meetings, the committee holds a Policy Meeting at least once per year, where issues related to AV俱乐部鈥檚 animal care and use program are discussed. At these meetings the committee discusses topics such as: required changes or additions to UCLA and/or ACUC policies; review and approval of SOPs; improvements to UCLA OR ACUC protocol forms; updates on CCAC guidelines/policies; interpretation of ethical issues.

The Committees conducts a tour of each animal facility they are responsible for at least once per year. During this visit committee members assess the facilities for deficiencies, and meet with investigators and staff to gain a better understanding of the animal work being conducted. The facility visits are summarized in a written report, which is forwarded to the chair of the relevant animal user鈥檚 committee, the facility manager, and the Vice President. The University Director of Animal Care works with the Committee to represent and prioritize any deficiencies, and provides guidance to the University administration to ensure that facilities are suitable to undertake research/teaching protocols involving the use of animals.