Questions about Animal Use Protocol
1. What is the purpose of the Ethical review by the ACC?
The MNI 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?
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?
The McGill University UACC Policy on Peer Review for Scientific Merit outlines peer review. As well, the MNI 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If a study is not peer reviewed during the grant application review process, Section 4d states, “...the Principle Investigator (PI) is required to contact the MNI Associate Director, Scientific Affairs, and request that an ad-hoc committee be set up according to the CCAC guidelines, to review MNI 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?
Please log onto to Darwin to submit the AUP to the MNI 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/
6. What is involved in the approval of an AUP?
The MNI ACC meets 10 times per year to review AUPs.
At the MNI 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 MNI 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 MNI 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?
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?
These changes are considered minor. An amendment with the changes to the approved AUP should be submitted through Darwin to the FACC.
The MNI 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?
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 MNI ACC must be informed.
For animal housing, the investigator must provide a written request to the MNI 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 MNI must be inspected by a sub-committtee of the MNI 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 MNI 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?
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?
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?
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?
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?
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?
With Darwin the final approval process is fast. Protocols approved by the MNI 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 MNI ACC.
Amendments receive final approval from the McGill Animal Compliance Office within 24 to 48 hours (2 working days) following approval from the MNI 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?
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?
Everyone listed in an AUP must successfully pass the on-line course located at http://www.mcgill.ca/research/researchers/compliance/animal/training/theorycourse 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 MNI can be found at MNI Animal Care Facility Website.
18. Where can I get a copy of an AUP, amendment, and SOP forms?
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?
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?
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: http://www.hc-sc.gc.ca/hc-ps/substancontrol/exemptions/applic-scien-eng.php
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?
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 MNI ACF, then the MNI 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 MNI 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.