research and patient care at The Neuro

The Neuro Animal Care Committee

Mission Statement

The Neuro Animal Care Committee (ACC) is set up to ensure that all animals used in research, teaching or testing within its jurisdiction, are used and cared for in accordance with the Canadian Council on Animal Care (CCAC), the University Animal Care Committee (UACC), and The Neuro Animal Care and Use Program guidelines and policies and all other applicable requirements.

The ACC also serves as a resource to faculty, investigators, technicians, students, staff, and administrators and provides guidance for conducting all animal use procedures with the highest scientific, humane, and ethical principles.

The ACC is composed of a Chair, Administrator, Compliance Officer, Veterinarian, Community Representative, Student Representative, Researchers, Animal Facility staff, and Director of the McGill Animal Compliance Office or representative. It meets at least 10 times per year.

Terms of Reference

Facility Animal Care Committees (FACCs) are established for each major McGill University campus and affiliated institutions, including the MNI, using animals in research, teaching or testing, in accordance with the Policies and Guidelines of the Canadian Council on Animal Care (CCAC). The purpose of each FACC is to ensure that all animals used in research, teaching or testing within its jurisdiction, are used and cared for in accordance with all applicable requirements. The MNI ACC’s operation is governed by the following Terms of Reference. The MNI ACC reports to the Director of the MNI. In addition, the MNI ACC is part of the McGill University Animal Care and Use program and has representation on the University Animal Care Committee (UACC).

 

1. Membership

The MNI ACC members are appointed for terms of no less than two years and renewable, usually up to a maximum of eight consecutive years of service. This does not apply to ACC members who must be part of the ACC because of their role within the MNI (ex officio members): the ACC Administrator, the MNI Compliance Officer, the Clinical Veterinarian(s), the Centre for Neurological Disease Models (CNDM) Director (animal facility), the CNDM Operations Manager, and the Colony Manager. At the MNI, the membership of the ACC consists of:

1.a. A minimum of two scientists experienced in animal care and use, who may or may not be actively using animals during their term on the ACC; representation of the diverse animal-using units of the MNI must be ensured; 

1.b. An institutional member whose normal activities do not depend on or involve animal use for research, teaching or testing; 

1.c. One or two graduate student(s) and/or research trainee representatives;   

1.d. Full-time clinical veterinarian(s) experienced in laboratory animal medicine;  

1.e. The animal facility director, operations manager, and colony manager; 

1.f. Technical staff representation (either an animal health or an animal care technician );  

1.g. At least one, and preferably two person(s), representing community interests and concerns, who has (have) had no affiliation with the MNI or McGill, and who has (have) not been involved in animal use for research, teaching or testing for at least one year; community representation must be ensured for all ACC activities throughout the year;

1.h. The Director of the McGill Animal Compliance Office or delegate and

1.i. The MNI full-time ACC administrator and MNI compliance officer.

In order to avoid potential conflicts of interests, the MNI ACC Chair must not be directly involved in the management of the institutional animal facilities, nor be the facility clinical veterinarian(s), and should not be involved in the preparation of a significant number of the protocols to be reviewed by the committee.

The MNI ACC administrator supports the ACC by ensuring that animal use protocols are well managed in the electronic protocol management system, Darwin, that committee minutes and reports are promptly produced and distributed, that all exchanges between the ACC and animal users are well documented and filed in a timely manner, and that animal users and ACC members are provided with necessary information. The MNI compliance officer is responsible for the MNI Post-Approval Monitoring Program (PAM) and all other MNI compliance functions.

2. Authority

The MNI ACC must have access at all times to all areas where animals are or may be held or used.
The ACC has the authority, on behalf of the Director of the MNI, who is responsible for animal care and use at the MNI, to:

2.a. Stop any procedure if it considers that unnecessary distress or pain is being experienced by an animal.

2.b. Stop immediately any use of animals which deviates from the approved use, any non-approved procedure, or any procedure causing unforeseen pain or distress to animals.

2.c. Have an animal euthanized humanely if pain or distress caused to the animal is not part of the approved protocol and cannot be alleviated.

2.d. Have an animal(s) placed on Holding Protocol in the following circumstances:

2.d.i. When an Animal Use Protocol (AUP) approval is pending.

2.d.ii. When an AUP is terminated and there are remaining housed animals.

2.d.iii. In all other circumstances deemed appropriate by the MNI ACC, such as:

2.d.iii.1. If animals are received prior to approval of a new AUP.

2.d.iii.2. If the AUP has expired and is still pending renewal submission to MNI ACC.

2.e. Order the withholding of research funds and/or animal ordering privileges for programs in non-compliance with the applicable requirements.

2.f. Supervise the Post-Approval-Monitoring (PAM) process and ensure that recommendations of the MNI Compliance Officer are implemented.

2.g. Monitor Breaches of Compliance:

The MNI ACC is the body responsible for determining and working to correct breaches of compliance with approved animal use protocols and Standard Operating Procedures (SOPs). Breaches of compliance that cannot be resolved by negotiation of the MNI ACC with the involved PI must be referred to the MNI Director. This also applies when the work already completed is done without an approved protocol, as this cannot be corrected by negotiation. The ACC working with the concerned animal users and veterinary/animal care staff must be referred to the MNI Director. All members of the animal care and use program will be informed about sanctions that will be taken by the MNI senior administration in the event of serious breaches of compliance.

The MNI ACC collaborates with the MNI Compliance Officer, the MNI veterinarian(s), the MNI facility animal care staff, and the McGill Animal Compliance Office, to ensure compliance with its decisions and with the conditions set out in approved protocols. The Compliance Officer, veterinarian(s), and animal care staff must work in a collegial manner with animal users and attempt to correct deficiencies collaboratively. Where there are persistent breaches of compliance or threats to the health and safety of personnel or animals, these must be reported back to the Chair of the MNI ACC, and the ACC must promptly address these issues, through communications with the animal user (s), meetings and site visits, and eventually communications with the Director of the MNI, as necessary. Furthermore, if deemed necessary, the veterinarian reports major animal welfare compliance issues directly to the MNI Director.

The MNI ACC also delegates to the MNI veterinarian(s) the authority to treat, remove from a study or euthanize, if necessary, an animal according to the veterinarian(s)'s professional judgment. The veterinarian(s) involved must attempt to contact the animal user whose animal is in poor condition before beginning any treatment that has not previously been agreed upon, and must also attempt to contact the MNI ACC Chair, but the veterinarian(s) has the authority to proceed with any necessary emergency measures, whether or not the animal user and ACC Chair are available. For life threatening emergencies where immediate action is needed, the veterinarian(s) may proceed with emergency procedures based on his/her professional judgment prior to contacting the animal user and MNI ACC Chair. In such case, the veterinarian(s) will inform the animal user and MNI ACC Chair of the actions that were taken as soon as practical. A written report should be sent by the veterinarian(s) to the animal user and to the MNI ACC following any such event.

3. Responsibility of Higher Administration

The Director of the MNI appoints the Chair, ACC Administrator, and Compliance Officer. The MNI ACC Chair appoints the other committee members. For specifics on appointment of community representatives refer to UACC Policy on Community Representatives.

The MNI must also ensure that ACC members are provided with training opportunities to understand their work and role: these must include at least a formal orientation session, to introduce new ACC members to the MNI`s animal care and use program and its members, policies and procedures, as well as to the animal facilities and to CCAC guidelines and policies. Ongoing opportunities to better understand animal care and use in science should also be provided.

4. Responsibility of ACC

It is the responsibility of the ACC to:

4.a. Ensure that no procedures involving animals be commenced without prior ACC approval of a written animal use protocol; further to this, that no animals be acquired or used before such approval. This includes internally funded projects.

4.b. Ensure that no animals be held for breeding purposes, or for eventual use in research, teaching or testing projects, without prior ACC approval of a written animal use protocol, except where current CCAC guidelines provide for exemptions. The ACC should also be aware of other animal-based activities, such as commercial or recreational activities, within the institution, and should work with the persons responsible for these activities to ensure that animal care and use is undertaken according to appropriate procedures.

4.c. Require all animal users to complete an electronic animal use protocol form in its entirety and ensure that the information therein includes the following points, clearly presented in a form that all members of the ACC can readily understand.

4.c.i. Project title and descriptive procedural keywords and brief description of the procedures to be conducted on animals.

4.c.ii. List of principal investigators/teachers, and all personnel (post-doctoral fellows, research staff, graduate and undergraduate students) who will handle animals, along with their training and qualifications with respect to animal handling.

4.c.iii. The PI’s departmental affiliation.

4.c.iv. If the study is to take place over more than one year, the work and numbers of animals for the first year only should be provided, and further work can then be approved in annual review(s), full review(s), or new protocol(s).

4.c.v. For research or testing projects, funding source(s) and status of funding approval.

4.c.vi. For research projects, an indication of whether the project has received peer review for scientific merit.

4.c.vii. For teaching programs, a course number and an indication of whether the course has been reviewed with respect to the pedagogical merit of using live animals.

4.c.viii. For testing projects, an indication that the testing has been planned according to the most current regulatory requirements, using guidelines acceptable to the regulatory agency(ies) and which meet the requirements of the CCAC policy statement on: ethics of animal investigation; that the planned animal use not exceed the requirements of the regulatory authorities - if it does, justification for the additional animal use must be provided.

4.c.ix. Lay summary.

4.c.x. An indication of the use of biohazardous, hazardous chemical or radioactive agents in animal-based projects; and, if so, an indication of institutional approval of this use.

4.c.xi. category(ies) of invasiveness as defined in the CCAC policy statement on: categories of invasiveness in animal experiments, and Purpose of Animal Use (PAU) as defined in the CCAC Animal Use Data Form.

4.c.xii. Proof of awareness of the Three Rs (replacement, reduction and refinement alternatives) of animal use, to include:

4.c.xii.1. Awareness of why sentient animals must be used for the project, of how the applicant arrived at this conclusion (e.g., searches of databases on alternatives), and of possible replacement alternatives (non-animal methods, cell/tissue culture, computer simulations, audio-visual teaching methods, the replacement of sentient animals with animals of lower sentiency, etc.) and justification if these are not to be employed.

4.c.xii.2. Justification of the species and numbers of animals to be used over the course of the year, to emphasize minimization (reduction) of animal use within an appropriate experimental design, while ensuring that sufficient numbers of animals will be used to fulfill requirements for statistical significance/scientific validity in the case of research projects, or for acceptance of regulatory tests.

4.c.xii.3. Awareness of all of the refinements to be employed to protect and enhance animal health and welfare, which may include:

4.c.xii.3.1. Anesthesia and analgesia, including dosages and methods of use, for all invasive protocols.

4.c.xii.3.2. Other medical treatments as appropriate, as indicated through veterinary consultations.

4.c.xii.3.3. Housing and husbandry methods, and environmental enrichment as a means to refine animal care; any limitations on environmental enrichment from that normally offered to animals in the institution, based on CCAC guidance, must be justified to the ACC.

4.c.xii.3.4. Refinements to the procedures to be employed on the animals.

4.c.xii.3.5. Refinements to the length of time that animals will be held/used.

4.c.xii.3.6. Any other possible refinements.

4.c.xiii. A clear description detailing the procedures that are carried out on the animals (referring to appropriate SOPs as much as possible).

4.c.xiv. A description of the endpoint(s) of the experimentation, selected according to the CCAC guidelines on: choosing an appropriate endpoint in experiments using animals for research, teaching and testing, (refer to MNI/McGill SOPs, if available and relevant); the person(s) responsible for monitoring the animals and applying endpoints should be identified, and the schedule for monitoring animals and any relevant checklists of signs and symptoms to be used when evaluating the animals should be included; all protocols, even non-invasive ones, must identify endpoints, to ensure that any animals requiring treatment are treated and that animals are not simply kept indefinitely; relevant information for identifying and applying endpoints must be readily available, preferably posted, in the area where the animal-based work is taking place.

4.c.xv. The method of euthanasia, if used; justification for any physical euthanasia methods, or for any methods that deviate from those described in the most recent CCAC guidelines on euthanasia.

4.c.xvi. A description of the fate of the animals if they are not to be euthanized, including the length of time that they are to be held.

4.c.xvii. Any other information considered important or necessary and pertinent, including information or results derived from any relevant previous protocols; the description and use of previous relevant results is particularly important to ensure that methodologies are not simply re-used without learning from any animal welfare problems that were encountered in the past, that the protocol continues to have relevant goals and methodology, and that appropriate refinements to protect and enhance animal welfare are sought and implemented.

4.d. Ensure that each research project has been found to have scientific merit through independent peer review before approving the project; if such review is not carried out during the grant application review process it must be obtained according to the CCAC policy statement on: the importance of independent peer review of the scientific merit of animal based research projects. At the MNI, in the case of protocols not so reviewed, the Principle Investigator (PI) is required to contact the MNI Associate Director, Scientific Affairs, and request that an ad-hoc committee be set up according to the CCAC guidelines, to review his/her project for scientific merit.

4.e. Review and assess all animal use protocols and amendments, with particular emphasis on the CCAC policy statement on: ethics of animal investigation and CCAC guidelines on: animal use protocol review as well as on all other relevant CCAC guidelines and policy statements and, where necessary, require further supportive information from the investigator/teacher or meet with the investigator/teacher to ensure that all members of the committee understand the procedures to be used on the animal. Information exchanges and ACC discussions with protocol authors can be very useful, but protocol authors and members of their teams must always clearly remove themselves from the final ACC decision-making on their own protocols.

The committee must also ensure that all procedures comply with CCAC guidelines, and, if at variance with those guidelines, require justification for the variance on scientific grounds. ACC should discuss protocols and make decisions on them during full committee meetings, rather than through individual reviews, and should attempt to reach decisions by consensus.

4.e.i. New protocols and third year renewals are reviewed by the full committee.

4.e.ii. Short reviews (first and second year) are also reviewed by the full committee.

4.e.iii. Amendments:

4.e.iii.1. For any major changes, a review by the full committee is required. Major changes are defined as: change in the fundamental objective, an increase of 15% or more in the number of animals required, a change of species, use of more invasive or more frequent procedures.

4.e.iii.2. For minor modifications, a review by the Chair of the FACC or a delegate is required. Minor modifications are defined as: changing contact information, changing funding source, addition or removal of personnel, an increase of less than 15% in animal numbers, addition of a new strain, changing housing or procedure location, switching to less invasive, distressful or painful procedures, switching to a non-physical euthanasia method covered by an approved SOP. Minor modifications approved by the Chair (or delegate) are documented in the minutes of the following FACC meeting, with exceptions to changes to the AUP title, funding, personnel contact information or additional personnel.

4.f. Ensure that animal users update their protocols with any modifications they intend to make, and approve any amendments to a protocol before they are implemented.

4.g. Ensure that animal users report any unanticipated problems or complications using the form entitled, Animal Incident Report, as well as on the steps they have taken to address the problem(s), to the ACC.

4.h. Review all protocol short reviews annually and all protocol full reviews every third year;

4.i. Document ACC discussions and decisions in the committee minutes.

4.j. Ensure that appropriate care of animals in all stages of their life and in all experimental situations is provided by the MNI CNDM Veterinary services.

4.k. Establish procedures, commensurate with current veterinary standards, to ensure that;

4.k.i. Unnecessary pain or animal stress and injuries are avoided, whether during transfers of animals or in their normal quarters.

4.k.ii. Anesthesia and analgesia are properly and effectively used; the only exception to this may be when agents must be withheld as a scientifically justified requirement of the study, and that this has been approved by the ACC.

Painful studies requiring exemption from the use of either anesthetics or analgesia must be subject to particular scrutiny, not only prior to approval, but also during the experiment.

4.k.iii. Appropriate post-operative care is provided and documented.

4.k.iv. All due consideration is given to animal welfare, including environmental enrichment.

4.l. Ensure that animal users report on the results of any pilot studies, no matter whether they wish to pursue the study immediately or not, in order to preserve important data on various approaches to animal-based studies, whether they work well or not.

4.m. In the case of projects involving proprietary or patentable research or testing, ensure that as much information as possible is provided to the ACC in terms of what effects to expect on animal health and welfare, and insist on close monitoring of animals.

4.n. In the case of projects involving collaboration with investigators from other institutions, ensure that appropriate MNI committees have access to the approved Animal Use Protocol from the other institution, if only technological services are provided and animals never enter the MNI CNDM. When other procedures and/or housing of animals at the ACF are also to be carried out at the MNI, the host investigator has to provide an amendment to his/her approved protocol where available or submit a new AUP for review and also attach an approved protocol from the collaborator’s home ACC.

4.o. In the case of MNI PIs who have animals housed and/or perform survival procedures in areas outside of the facility, the ACC applies the McGill UACC approved, Policy on permission to use animals in laboratories outside of the animal facility, by:

4.o.i. A subcommittee that is composed of the Chair or delegate, Veterinarian(s), and Compliance Officer inspecting the area in question.

4.o.ii. All comments from the inspection are summarized in a report by the MNI Compliance Officer and the report is reviewed and approved by all sub-committee members before sending it to the PI.

4.o.iii. The PI responds to the recommendations(s) of the report and is then issued an Alternate Laboratory Animal Procedure, Housing or Holding (A.L.P.H.A.) certificate to be posted in the area inspected, and the area is reinspected annually.

5. Meetings

MNI ACC meets at least ten times per year and as often as necessary to fulfill their Terms of Reference and be satisfied that all animal use within their jurisdiction is in compliance with institutional and CCAC guidelines. Minutes detailing ACC discussions are forwarded to the MNI Director.

Quorum is the majority of the members, but under most circumstances it must include a Community Representative, one researcher, and a Veterinarian. Meetings should be scheduled at times that are convenient for all members, including Community Representatives. If the Community Representative cannot be present due to an unforeseen last minute event, the meeting may proceed but her/his review provided in Darwin should be discussed by the committee. Unavoidably absent members are nevertheless encouraged to review all documents in Darwin by the previously set due date.

Visits by the ACC members to the MNI animal facility must be conducted at least once a year, and must be documented in the ACC minutes. Those responsible for the animal facility should respond to any ACC recommendations in writing, and visit reports should always be followed up on jointly by the MNI senior administration and the ACC.

In addition, the ACC is encouraged to visit the animal care facility in order to better understand the work being conducted within the institution, to meet with those working in the animal facilities and discuss their needs, to assess any weaknesses in the facilities (ageing facilities, overcrowding, insufficient staffing, appropriate management of controlled substances and documentation of use, and any other concerns) and to forward any recommendations or commendations to the person(s) responsible for the facilities and for animal use.

More frequent visits by the ACC should be made as necessary to follow up on any protocols that have raised significant concern during the protocol review and/ or PAM process or with some aspect of animal facility operation. These visits may be carried out by the Chair of the ACC or delegate, accompanied or not by other members or animal care staff.

6. General

The MNI Animal Care Committee:

6. a. Must submit the Animal Use Data form for the past year (CCAC report) to the UACC prior to March 31 of every year.

6. b. Should submit an annual PAM Report every year to the MNI Director of the Institution and is a member of the Quality Assistance Subcommittee and participates in refining the PAM program at an institution-wide level. and at regular intervals to the University Animal Care Committee (UACC).

6.c. Must ensure that a crisis management program is in place for the animal facilities and for the animal care and use program, in conjunction with the MNI/McGill/MUHC crisis management plan(s). This program must detail plans in the event of power outages (short and prolonged), work stoppages, fires, natural disasters, large chemical spills and other similar crises, and must include a communications plan for addressing public and media inquiries on concerns related to animal use.

6.d. May, from time to time, sponsor seminars or workshops on the use of animals in science and the ethics of animal experimentation, and encourage as many animal users, animal caregivers, students, ACC members and other interested parties to attend as possible.

 

MNI ACC Revised June 7, 2019

MNI ACC Approved June 19, 2019

AUP Submissions

To The Neuro Animal Users,

All Neuro Animal Use Protocols (AUPs) and amendments should be submitted using the Darwin software. To submit, please log onto the Darwin Website.

The AUP or amendment submission process is the following:

  1. Please log onto the Darwin Website and prepare and submit the AUP to the FACC. 
  2. For AUPs, the ACC administrator will send it to the Committee for review.
  3. For amendments, the ACC administrator will pre-screen for omissions and send back, if necessary, through Darwin to the PI. The PI or a member of his group will make the necessary changes. The PI will send it back to the FACC. 
  4. The AUP/amendment will be reviewed at the ACC meeting.  
     

Please note: Even if a designated member of the PI's team prepared the document, only the PI can submit it to the FACC. The electronic signature is like written signature.

All information resources for the Darwin software can be found on the McGill UACC website at Darwin Software.

ACC Submission Deadlines

The Darwin software can expedite submissions very quickly. In order to submit an AUP in a timely manner, please refer to the list below .

New Protocols: New protocols need to be submitted at least 3 weeks before any meeting of the Committee.

Annual Renewals: Two months before the expiry date of an approved protocol, Darwin will automatically send a notification to the PI and post the AUP on the PI's Home Page in Darwin. The PI will have 4 weeks from the Darwin notification to prepare and submit the protocol to the FACC for review.

3rd Year Renewals: An approved protocol that will be renewed in its 3rd year will require a full review. It needs to be submitted at least 3 weeks before the next ACC meeting.

Expiry dates will be strictly enforced. It is important to submit renewals in a timely manner (preferably as soon as the AUP has been posted on Darwin), considering the time needed for review, for implementation of any recommended changes, and verification and updating of training issues, all in the space of 2 months.

ACC Meeting Dates

January 16, 2019

February 20, 2019

March 20, 2019

April 10, 2019

May 15, 2019

June 19, 2019

July - no meeting

August 21, 2019

September 18, 2019

October 16, 2019

November 20, 2019

December - no meeting

Forms

Forms for Animal Use Protocol Submission

To submit a protocol or an amendment, please log onto the Darwin Website.

Standard Operating Procedures(SOPs)

Standard Operating Procedures (SOPs) for AUP Submission can be found on the McGill Animal Compliance Office Website.

ACC Meeting information

For ACC Members.

Login here.

Post-Approval Monitoring

The Neuro Animal Care Committee (ACC) is set up to ensure that all animals used in research, teaching or testing within its jurisdiction, are used and cared for in accordance with the Canadian Council on Animal Care (CCAC), the University Animal Care Committee (UACC), and The Neuro Animal Care and Use Program guidelines and policies and all other applicable requirements.

The ACC also serves as a resource to faculty, investigators, technicians, students, staff, and administrators and provides guidance for conducting all animal use procedures with the highest scientific, humane, and ethical principles.

The ACC is composed of a Chair, Administrator, Compliance Officer, Veterinarian, Community Representative, Student Representative, Researchers, Animal Facility staff, and Director of the McGill Animal Compliance Office or representative. It meets at least 10 times per year.

FAQs

1. What is the purpose of the Ethical review by the ACC?

The Neuro follows the guidelines established by the Canadian Council on Animal Care (CCAC). According to the Canadian Council on Animal Care (CCAC) Guide to the Care and Use of Experimental Animals Volume 1 - Chapter I , “it is the responsibility of the institutional ACC to ensure that no research or testing project or teaching program, (including field studies), involving animals be commenced without prior ACC approval of a written animal use protocol; further to this, that no animals be acquired before such approval. This includes internally funded projects."

The review process is to ensure that animals are humanely cared for and that the "3R" tenet is respected: replacing the use of animals by alternative methods if possible, reducing the number of animals used and refining the techniques so that pain and discomfort are minimized.

2. When do I have to submit an Animal Use Protocol (AUP)?

Submission deadlines for AUP submission are listed here

3. What approval do I need for a grant application?

3. Information on grant applications can be found at the Office of Sponsored Research. If you intend to use animals in your research, you must submit an animal certificate (an approved AUP) before your funds can be released.

4. What is peer review?

4. The McGill University UACC Policy on Peer Review for Scientific Merit outlines peer review. As well, the Neuro Animal Care Committee (ACC) Terms of Reference in Section 4d, states that the ACC has the responsibility to “ensure that each research project has been found to have scientific merit through independent peer review before approving the project.”

If a study is not peer reviewed during the grant application review process, Section 4d states, “...the Principle Investigator (PI) is required to contact the Neuro Associate Director, Scientific Affairs, and request that an ad-hoc committee be set up according to the CCAC guidelines, to review The Neuro projects for their scientific merit.” The PI must request this prior to submitting the AUP for ACC review.

5. How do I submit an AUP for animal ethics review?

5. Please log onto to Darwin to submit the AUP to The Neuro ACC Administrator, who will pre-screen the AUP to ensure that administrative errors and omissions are corrected before the ethical and scientific review by the Committee. The address for Darwin is: https://darwin.research.mcgill.ca/eSirius2011D/

6. What is involved in the approval of an AUP?

6. The Neuro ACC meets 10 times per year to review AUPs.

At The Neuro ACC meeting the committee members review all AUPs and provide comments. All AUPs are approved, or approved pending modifications, through consensus. The AUPs that require modifications will be returned to the PI through Darwin explaining which sections need to be corrected. The PI will submit the corrected AUP through Darwin to the FACC for final review and to obtain the ACC Chair's approval. Please note: only the PI can submit the AUP to the FACC.

All AUPs reviewed and approved at The Neuro ACC meeting are sent via Darwin to McGill’s Animal Compliance Office, for final approval.

Level D AUPs and all pertaining to research on Non Human Primates (NHPs) may be reviewed by McGill’s Ethics Subcommittee and if additional information and/or corrections are requested from the PI, The Neuro ACC Administrator forwards a letter to the PI detailing what modifications are requested.

The ACC has the option of requesting an Ethical review to the McGill Ethics Subcommittee of any protocol submitted to it.

7. What do I have to do, if I want to add animals, and/or change procedures to my approved AUP?

7. Any changes to an approved AUP must be added to the protocol by submitting an amendment through Darwin to the FACC, before being implemented.

These amendments are submitted for review and approval at the next ACC meeting.

8. What do I have to do, if I want to add new personnel, change funding source or title of my approved AUP?

8. These changes are considered minor. An amendment with the changes to the approved AUP should be submitted through Darwin to the FACC.

The Neuro ACC Chair approves these amendments and the Administrator forwards them through Darwin to the McGill Animal Compliance Office. Once approved, the changes will be incorporated automatically by Darwin into the protocol.

9. What do I have to do, if I want to house animal(s) and /or perform animal proecdure(s) outside of the MNI ACF?

9. According to CCAC guidelines all animal housing and procedures should be in the Animal Care Faclity. However, if the investigator requires, because of special circumstances, animal(s) to be housed and/or procedures perfomed outside the ACF, The Neuro ACC must be informed.

For animal housing, the investigator must provide a written request to The Neuro ACC explaining in detail why the animal(s) cannot be housed in the ACF and the location of the housing area must be listed under "Housing Outside Animal Facility" section of the AUP in Darwin or an amendment to an approved AUP must be submitted.

For animal procedures, the location of the procedure area must be listed in the AUP by species in the "Procedures Location" section in Darwin or an amendment to an approved AUP must be submitted.

All housing and procedure areas oustide the ACF within The Neuro must be inspected by a sub-committtee of The Neuro ACC. Only after the investigator receives approval from the sub-committee that the area conforms to CCAC guidelines can the area be used.

Please contact The Neuro ACC Compliance Officer for information on these types of requests. Also, you can consult the McGill UACC "Policy on Permision to use Animals Outside the Animal facility".

10. Why does the AUP section "Goals" in Darwin have to be written in simple terminology?

10. One member of the ACC is the Community Representative and his/her role is to represent the public's interest with respect to animal care and use. The Community Representative is unlikely to have a scientific background, therefore it is imperative to provide a summary of the project in a language that can be understood by a layperson.

11. What is required in the Species List of the AUP in Darwin?

11. This section is based on the CCAC guidelines on Animal Protocol Review.

Species List: Complete all columns in the table for each species that will be required for one year.

Species Information: The PI must give details on the species chosen for the AUP: the type, age, weight, and sex. The PI must give the number of animals needed for the AUP and how many come from vendor(s), in-house breeding and/or other. The total must be the sum of these three sources. The PI must answer to questions on Species Activities: drug usage, euthanasia, surgeries, etc.

Ensure that the number to be purchased + number produced by in-house breeding correctly add up to the total per year.

Justification of Animal Numbers: In this section, the PI must explain in detail the number of animals required for one year. A clear outline of the experimental design and the statistical rationale for the size of the control and test group(s) must be given. The information should include numbers regarding control groups, failure rates, breeding and progeny and the various strains. The justification must be in strictly scientific terms.

A clear summary of the total number of animals per species must be given. The summary can be structured as an arithmetic equation. For example: # of Strain A + # of Strain B= Total # of species per year.

If breeding animals, ensure that the number of animals listed in the table includes all animals produced by breeding, whether they are going to be used for experimental purposes or not. In order to estimate the amount of animal numbers produced by breeding, please consult the following link at: http://www.nap.edu/openbook.php?record_id=10732&page=181

Please Note: If using and/or breeding genetically modified animals, please refer to the “Guidelines for Reporting Numbers of Genetically Modified Animals Used”. N.B.: according to Section 1 of the Guidelines, as an explanation to the community at large, every protocol has to have a statement to explain the high numbers required for producing genetically modified animals.

Justification for Choice of Species: The PI must provide a brief statement justifying the use of live and more sentient animals. If the scientific objectives of the study can be achieved by using available non-animal models (e.g., mathematical, computer, tissue culture) or animals of low sentience (e.g., lower vertebrates) the investigator must consider the use of an alternative to live and/or more sentient animals or provide justification for its rejection. The absence of specific alternatives to animal use should be stated and explained.

The characteristics of the animal model that make the species/strain appropriate for the study should be described. This might include structural, behavioural, physiological, biochemical or other features or considerations (e.g., data from previous studies) which make the model compatible with the research objectives.

Please review the new microsite of CCAC: Three Rs Search Guide to find the most up to date information on the 3Rs.

Species Strain: Complete all columns in the table for each strain that will be required.

Strain Information: Complete applicable rows detailing the species strain requested for one year, including information on phenotype if pertinent. Indicate animal numbers that were purchased earlier and remain in use from the previous year(s). This will ensure a more accurate count of animal numbers provided to the CCAC every year, since animals will only be counted once.

12. What are the categories of invasiveness?

12. The category of invasiveness of an AUP is based on the degree of pain and distress that the procedures will, or can, produce in the animal.

A detailed description of each category can be found at CCAC Website.

13. How long is the AUP valid?

13. The AUP is valid for one year and has to be renewed annually in Darwin with a short renewal.

Darwin will send an email alerting the PI that the AUP is due for review two months before it expires.

14. Do I have to notify someone if I do not renew my AUP?

14. Yes. In Darwin, under the section "Continuation Action", there is a box marked "Research Withdrawn". Click on the radial button. In the box, "If research is withdrawn, please indicate the animal disposition", select the appropriate response from the drop-down menu.

15. How long will it take to have my AUP or amendment approved?

15. With Darwin the final approval process is fast. Protocols approved by The Neuro ACC at the monthly meeting will have McGill Compliance Approval within 24 to 48 hours (2 working days). Protocols requiring corrections will have final approval within 24 to 48 hours of the date of return of corrected protocols to The Neuro ACC.

Amendments receive final approval from the McGill Animal Compliance Office within 24 to 48 hours (2 working days) following approval from The Neuro ACC. Amendments for additional personnel may be delayed due to verification and updating of training issues.

Darwin will send an email notification to the PI when a protocol or an amendment receives final approval.

16. Who has to sign the AUP?

16. The Principle Investigator is responsible for submitting AUPs in Darwin, even if the document was prepared by a designated member of the PI's team. The PI's electronic signature is like a written signature.

17. What kind of animal training is required?

17. Everyone listed in an AUP must successfully pass the on-line course located at https://mcgill.ca/research/research/compliance/animals/training/general-information and all personnel who will be handling live animals must also successfully pass an MNI hands on workshop appropriate for the species he/she will be working with.

Information on animal workshops offered at The Neuro can be found at Neuro Animal Care Facility Website.

18. Where can I get a copy of an AUP, amendment, and SOP forms?

18. All AUP and amendment requests are made through Darwin. SOP forms can be found at: McGill University Animal Care Committee Website.

19. What do I have to do if I am using hazardous materials in a study?

19. Indicate which hazardous materials are used in the sections "Potential Hazards to Personnel and Animals" and "Hazardous Use Info" listed in the AUP in Darwin. Attach Biohazard and/or Radiation safety permits to the AUP that is submitted for review.

Application forms for use of hazardous materials can be found at: McGill Environmental Health and Safety Website.

20. What do I have to do if I am using controlled substances in a study?

20. All researchers wishing to use controlled drugs must submit to the Office of Controlled Substances a completed Application Form for an Exemption to use a Controlled Substance for Scientific Purposes. For more information and to download the form, please visit: 

https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/exemptions/application-form-exemption-use-controlled-substance-scientific-purposes.html

It is required that controlled drugs be stored in locked cabinets and a written log be maintained with the date and amount used and the purpose of use.

21. Where can I find information on the McGill Occupational Health and Safety Program?

22. What do I have to do if I am collaborating on a project with a researcher from another institution?

22. This depends on the type of collaboration. If the collaborative project only involves providing technological services and no animals enter the MNI Animal Care Facility (ACF), you must ensure that you have access to the approved AUP from the other institution.

If the project involves procedures and/ or housing of animals at The Neuro ACF, then The Neuro PI has to provide an amendment to his/her approved protocol where available, or submit a new AUP for review to the home ACC.

For both types you must ensure that The Neuro ACC is provided with a copy of the approved AUP from the other institution.

If you have a question that is not on the list or require more information, please contact the ACC Administrator at acc.mni [at] mcgill.ca.

Useful links

The following are links to websites that you may find useful. If you know of another link that should be included in this list, please e-mail the website address to acc.mni [at] mcgill.ca.

MNI/McGill

Information Session Registration form

The Neuro Student Information Package

Animal Compliance Office

Animal Resource Center

McGill Theory Training course

Research Grants Office

Occupational Health Program

The Neuro Animal Care Facility

Douglas Neurophenotyping Center

Small Animal Imaging Lab

 

Canadian and US Guidelines/Regulatory

Canadian Council on Animal Care (CCAC)

Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)

NSERC-Memorandum of Understanding: Schedule 3

United States Department of Agriculture (USDA)

Office of Laboratory Animal Welfare (OLAW)

Laboratory Biosafety Guidelines

 

Alternatives

CCAC-3Rs

AltWeb

Norwegian School of Veterinary Science

Netherlands Center Alternatives

John Hopkins University-Center for Alternatives to Animal Testing

 

Animal Welfare

Animal Welfare Information Center (AWIC)

Animal Welfare Institute

Scientists Center for Animal Welfare

Campbell Centre for the Study of Animal Welfare

 

Laboratory Animal and Research

Society for Neuroscience

National Center for Research Resources (NCRR)

Canadian Association for Laboratory Animal Science (CALAS)

The American College of Laboratory Animal Medicine (ACLAM)

American Association for Laboratory Animal Science (AALAS)

AALAS Whyville

LabAnimal

Institute for Laboratory Animal Research (ILAR)

International Council for Laboratory Animal Science (ICLAS)

Institutional Animal Care and Use Committee (IACUC)

The Whole Mouse Catalogue

Primate Enrichment Database

Animal Research Questions and Answers-American Physiological Society

Foundation for Biomedical Research

CCAC-Reference Database

Contact

For all administrative questions, please acc.mni [at] mcgill.ca (email the ACC Administrator).

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The Neuro is a McGill research and teaching institute; delivering the highest quality patient care, as part of the Neuroscience Mission of the McGill University Health Centre. We are proud to be a Killam Institution, supported by the Killam Trusts.