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Help for Completing an Animal Use Protocol Form


Sections: 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11| 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 |20 | 22 | 23 | 24 | 25 | 26 | 2728 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | Error Verification and Submission | Annual Review

(Note that there is no section 21 anymore)

This is best used with an internet browser such as Google Chrome and Firefox, certain versions of Internet Explorer do not bring the hyperlink of the Darwin form to the exact section here. 

We regret the situation and encourage you to use the section numbers above to bring you to the exact spot. 


Section 1 - PI Contact Record

Section 1 - PI Contact Record

"PI" stands for "Principal Investigator". A PI must be an appointed faculty member or, if a service protocol, a Veterinarian or Animal Facility Manager. Note that an additional section, similar to this one, will appear if you are not the Principal Investigator but a person in his research/teaching group authorized to do protocol management.


Section 2 - Protocol Title

Section 2- Protocol Title

The title of a research project does not have to match the grant's title anymore since there is a section dedicated to the funding sources later on in the protocol form. 

Section 2- Protocol Title - part 2

Many protocol sections have an attachment feature. This permits you to attach some of your files. The files can be in many different format such as Word, Excel, images... Exceptionally, section "2- Protocol Title" is also used by the administration to attach the Animal Certificate for every year the protocol is active in Darwin. If animals are brought to the researcher's laboratory, there will also be attachment of the ALPHA Certificate to certify that this lab was assessed by the FACC and is approved for the purpose. 


Section 3 - Goals

Section 3- Goals

It is very important that this section is simple enought that any adult, with or without scientific knowledge, can understand it. In very general terms, explain why are you doing this project, what you are doing, what can be the benefits and why this is important.


Section 4 - Specific Objectives

Section 4- Specific Objectives

This is where the goals are to be very specific, preferably in a list, so that we know what to expect in the following sections.


Section 5 - Keywords of Procedures

Section 5- Keywords of Procedures

This section is for the information requested by the Canadian Council on Animal Care (CCAC). It is to be included in the annual report to give readers an idea of the procedures involved. Only those directly related to the animals are to be listed.

For suggested keywords, see Appendix C of the CCAC Interpertation Bulletin for the Animal Use Data Form (AUDF) 


Section 6 - Funding Sources

Section 6- Funding Sources - main page

There can be more than one funding source. Checking a box will launch a new section related to the type of funding in which you will be supplying details for each of the grants.

Section 6- Funding Sources - bottom of the main page

Before any project is approved, it needs to be peer reviewed for scientific merit. Most agencies perform this as a normal part of their selection process (CIHR, NSERC, NIH...) so the answer would be 'Yes'. If the funds are from a source that did not peer review for scientific merit, the answer will have to be 'No' and you will need to request internal peer review from your Faculty/Institute.

Section 6 - Funding Agency List

Section 6 - Funding Agency List

Section 6- Funding Sources - Agency but under OSR

If you checked the box "Agency Funding" and answered 'Yes' to the question "Administered by McGill's Office of Sponsored Research (OSR)...", you will be presented with the section above. Select the grant related to this protocol from the drop down list. The list if fed by McGill OSR's database which displays all active grants under the animal protocol's PI name. If for some reason, you cannot find it or the grant is under another PI's name, go back, uncheck the box and use "Dept., Start up or Other funding...". The information here helps Grants Officers to link the animal protocol to the grant. Funds are only released when there is a valid protocol, also called an Animal Certificate, for all animal research.

Section 6- Funding Sources - Agency but not under OSR

If you checked the box "Agency Funding" and answered 'No' to the question "Administered by McGill's Office of Sponsored Research (OSR)...", clicking the button "Add Grant" will present you with the section above. Supply the source of funding, exact title of the grant and name of the grant's PI if different from this protocol's PI and the grant number if known. The information here helps Grants Officers to link the animal protocol to the grant. Funds are only released when a valid protocol, also called an Animal Certificate, is obtained.

Section 6 - Private/Commercial Funding

Section 6- Funding Sources - Private Commercial

This includes companies that are owned by the protocol's PI. Most private and commercial funding do not perform peer review for scientific merit. No animal research can be done without a strong potential for benefits to animals and/or humans. If the funding sources does not perform peer review, the PI needs to request internal peer review to be performed on this project from your Associate Dean/Director. The protocol will continue being reviewed but will remain pending approval until favourable peer reviews have been supplied. Mske sure to attach the peer review letter to the protocol in the appropriate funding section.

Section 6 - Department, Startup and Other

Section 6- Funding Sources - Dept Startup or Other Funding

To use for any source of funding not fitting any of the previous types. If this is for a McGill OSR administered grant that you could not find in the drop down list of the Agency/OSR section, please specify this.


Section 7 - Animal Use Location

Section 7- Animal Use Location

Information is centrally accessible for all sites under the McGill & Affiliated Research Institutes Animal Care Program. For sites outside the program, more information is needed. Answering 'Yes' to either of the questions will launch a new section to complete.

Section 7 - Animal Use Location

Section 7- Animal Use Location - Offsite, Field Study

Examples for animals located elsewhere include equipment or expertise found at another institution.

Section 7 - Field Study Information

Section 7- Field Study Form - top part

Section 7- Field Study Form - bottom part

This section replaces the discontinued "Field Study Form". All information pertinent to wild animals is to be included here.


Section 8 - Collaboration

 

Section 8 - Collaboration

A collaborator is another researcher working on the same project. They can be on the same grant; sometimes the other person is the PI on the grant. This is not for cases where the source of some animals is another researcher; it needs to be more than being a supplier of animals. Collaboration can be with or without having animals at the collaborator's institution. Answering 'Yes' to either of the two questions, inside or outside collaboration, will launch a related new section to complete. 

Section 8 - Outside Institution Collaboration

Section 8 - Outside Institution Collaboration

Outside the institution means other than McGill, the MUHC (MGH, RVH and MCH), JGH, Douglas and the Shriners.

Section 8- Inside Collaboration

Section 8 - Inside Institution Collaboration


Section 9 - Changes in Project's Goals

Section 9 - Changes in Project's Goals

This is for renewals only; if a new project, just answer 'No'. If answering 'Yes', a new section will open.

Section 9 - Changes in Project's Goals - details

The changes should be related to the animal procedures mostly.


Section 10 - Non -Standard Animal Husbandry and Care

Section 10 - Animal Husbandry and Care

This is very important to the Animal Facility Staff. The animals are all treated as per standard operating procedures unless you have flagged that your animals have special conditions. It can be such things as avoiding corn cob bedding because (the animals could eat it), special low fat diet, a treatment drug in the drinking water...

Section 10 - Animal Husbandry and Care - details

All non-standard care should be detailed including who will be responsible for them and that cages will be labelled.


Section 11 - Potential Hazards to Personnel and Animals

Section 11- Potential Hazards to Personnel and Animals - General Intro

This section looks at flagging the types of hazardous agents that are involved. Answering 'Yes' will launch the identification of the hazard type.


Section 12 - Species Use Instructions

Section 11- Potential Hazards to Personnel and Animals - General Intro 2nd page

When applicable, attach the Biohazard Certificate, Radiation Certificate and/or cell line testing.


Section 13 - Purpose of Animal Use

Section 13- Purpose of Animal Use

Section 13- Purpose of Animal Use - Teaching and Training Questions

The Purpose of Animal Use is a label requested by the CCAC and is included in our annual report. If the Purpose is 1, 2 3 or 4, skip the orange questions. If the Purpose is "5. Teaching and Training", all the orange questions must be answered. Note that if you completed the orange questions by mistake and attempt to delete the answers, this will not work on the Yes/No answers; just leave them in. 


Section 14 - Transportation of Animals

Section 14- Transportation of Animals


Section 15 - Housing Outside Animal Facility

Section 15- Housing Outside Animal Facility


Section 16 - Use of Human Clinical Areas

Section 16- Use of Human Clinical Areas

Section 16- Use of Human Clinical Areas - Details


Section 17 - Species List

When a section is a list, the PI can add or remove the item (in this case a species) but cannot edit the other column (in this case the total number). The # requested column is auto-completed from the section(s) "18- Species Information" further on.

Section 17- Species List


Section 18 - Species Information (individual section)

Section 18- Species Information

This section is very important. The grand total number for this species will be the number appearing in section "30- Categories of Invasiveness". This total must match the grand total you arrive in section "19- Justificatin for Numbers Requested" and section "30- Categories of Invasiveness". 

The questions under "Species Activities", will launch a new section if answered 'Yes'. For example, if answering 'Yes' to the question about doing surgeries, a section "26- Surgery Type" will appear for you to complete. All the items in each individual 'Activities' will be copied into the Personnel section for you to select for each person dependant on what they will do and use. 


Section 19 - Justification For Number Requested

Section 19- Justification of Number Requested

This section is often problematic with confusing, too much or not enough information. The committee basically wants to have the arithmetic you used to arrive at the grand total you stated in section "18- Species Information". It should be very clear and include all animals.

Investigators should clearly justify the number of animals per strain needed for the experiments described in this protocol for the coming year.

Based on these experimental numbers, the investigator is to list separately the number of animals generated by breeding to obtain the experimental numbers. They should take into consideration the standard number for animals generated through breeding for the specific strain: for example, a single breeding couple of mice can generate on average 72 pups per year (1 female x 12 litters x 6 pups/litter).

The investigator is responsible for estimating how many breeding couples will be necessary to obtain the experimental animals carrying the right genotype, while taking into account the complexity of the breeding scheme necessary to achieve the genotype needed.

Example:

Experimental: Analysis of 10 different axonal projections in 6 wild type and 6 mutant mice to perform statistical analysis on results (10 projections x 2 strains x 6 mice =120 mice needed for analysis).

Breeding:

Wild type mice: One breeding pair will be maintained for this strain. Each breeding couple will generate 72 pups per year. (1 breeding pair x 72 pups + 2 breeding mice = 74 mice)

Mutant mice: Two breeding pairs will be maintained for this line. Only 1 in 4 pups will have the desired genotype. They are poor breeders; each breeding couple will generate 40 pups only per year. (2 breeding pairs x 40 pups x 4 of different genotypes + 4 breeding mice =  324 mice)

Total number of mice requested is 398.


Section 20 - Justification For Choice of Species

Section 20- Justification For Choice of Species


Section 22 - Species Strains List

When a section is a list, the PI can add or remove the item (in this case a strain) but cannot edit the other columns (in this case Age and Weight). These last columns are auto-completed by other section(s) further.

Section 22- Species Strains List

Section 22 - Strain Information (individual section)

Section 22- Strain Information - Individual Details


Section 23 -  Housing Location List

Section 23- Housing Location List

Housing is a location where the animals will be kept overnight or longer.

You should know that if you plan to use a location outside the animal facility, this needs to be justified in section '32- Description of Procedure" to the satisfaction of the FACC. It will also have to be inspected by the FACC before its use and every year after that to obtain and retain its ALPHA certification.

Section 23 - Housing Location Information (individual section)

Section 23- Housing Location - Individual Details


Section 24 - Procedures Location List

When a section is a list, the PI can add or remove the item (in this case a procedure location) but cannot edit the other column (in this case Room no.). The last column is auto-completed by the other section(s) further.

Section 24- Procedures Location List

A procedure location is every place you will be bringing live animals regarless of what will be done. This includes animal facility rooms, reseach laboratories and other sites.

You should know that if you plan to use a location outside the animal facility, this needs to be justified in section '32- Description of Procedure" to the satisfaction of the FACC. It will also have to be inspected by the FACC before its use and every year after that to obtain and retain its ALPHA certification.

Section 24 - Procedures Location Information (individual section)

Section 24- Procedures Location - Individual Details


Section 25 - Non-Surgical Procedures List

Section 25- Non-Surgical Procedures List

Section 25- Non-Surgical Procedures - If item not found in list


Section 26 - Surgery Procedures List

When a section is a list, the PI can add or remove an item (in this case a surgery) but cannot edit the other column (in this case if recovery or not). The last column is auto-completed by the other section(s) further.

Section 26- Surgical Procedures List

Section 26 - Surgical Type (Individual section)

Section 26- Surgical Type

Section 26- Surgical Type - location of surgery

Do not forget to choose the location where the surgery will take place. If you cannot find the location, save this section, go to section 24 and add the new procedure location there, return to this section and select.


Section 27 - Hazardous Material List 

When a section is a list, the PI can add or remove an item (in this case a hazardous agent) but cannot edit the other columns (in this case Type and if brought into the facility). The last columns are auto-completed by the other section(s) further.

Section 27- Hazardous Material List

Section 27 - Hazardous Material Information (individual section) 

Section 27- Hazardous Material Information - Individual details

Section 27- Hazardous Material Information (individual section) - risks

If you are not certain about the risks, Material Ssfety Data Sheets (MSDSs) are available on myLab and on the internet. Please download and attach to this section when possible.

Section 27- Hazardous Material Information (individual section) -  precautions

Check first if an SOP already exists for the agent you intend to use by visiting the UACC site SOP section. If an SOP exists, you only need to refer to it but please specify the room(s) where the agent and treated animals will be located.

Information about precautions can also be obtained from an MSDS from myLab and the internet.

Section 27- Select Agent 

Section 27 - Select Agent

Click one of the agents from the list and click "Select Agent"  - OR -

Section 27- If agent is not in the list

if the agent you want is not in the list above, enter a new one using the question in the bottom of the page and click "Save Other Agent".


Section 28 - Drugs and Other Substances List

When a section is a list, the PI can add or remove an item (in this case a drug agent) but cannot edit the other columns (in this case type, dosage, volume, route and frequency/duration). The last columns are auto-completed by the other section(s) further.

FYI: for controlled drugs, requests for an exemption on the use of a controlled drugs to use in research is by applying to Health Canada; application forms are available at:http://www.hc-sc.gc.ca/hc-ps/substancontrol/exemptions/index-eng.php  For more information, see http://www.hc-sc.gc.ca/contact/dhp-mps/hecs-dgsesc/ocs-bsc-eng.php. Also, we have an institutional Standard Operating Procedure SOP #401 on Controlled drugs .

Section 28- Drugs and Other Substances List

Section 28 - Select Drug 

Section 28- Select Drug

Section 28 - Select Drug - if item is not in the list

Section 28 - Select Drug - If not in the list

Note that the question "Is this a Controlled Substance?" is automatically filled by the software as per veterinary pre-settings. If a controlled substance, you need to have an exemption to use controlled drugs in research; apply for it from Health Canada

You are expected to follow Health Canada requirements. Be aware that Health Canada has started inspecting research laboratories without prior warning.

Section 28 - Drug Information (individual section)

Section 28- Drug Information - Individual details


Section 29 -  Euthanasia Methods List

Section 29- Euthanasia Methods List

Section 29 - Euthanasia Method Information (individual section)

Section 29 - Euthanasia Method Information - Select method


Section 30 - Categories of Invasiveness

Section 30- Categories of Invasiveness


Section 31 - Adverse Effects and Humane Intervention Points (also known as clinical endpoints)

Section 31- Adverse Effects and Humane Intervention Points (clinical endpoints)


Section 32 - Description of Procedures

Section 32- Description of Procedures


Section 33 - SOP Deviations

Section 33- SOP Deviations


Section 34 - Environmental Enrichment

Section 34- Environmental Enrichment

It is mandatory to allow the aninmal facility staff to include environmental enrichment in the cages for the animals' wellbeing. If you do not want certain types of enrichment or none at all, this must be justified and accepted by the FACC.


Section 35 - Personnel List 

When a section is a list, the PI can add or remove an item (in this case the name of a person) but cannot edit the other columns (in this case Phone + ext., email, cell phone, temp contacts, emergency contact and if monitoring). These last columns are auto-completed by the other section(s) further.

Section 35- Personnel List

Section 35- Add Person - Name Search

 

35- Personnel - Add Person - Name Search

This list is what the software found in its database that matches the name or partial name you supplied. The database is fed from McGill's Human Resources database and is supported by the Animal Compliance Office.

Section 35- Personnel - Selecting a name from the search list

Click the radio button to select the person you want and click the button "Select". If the name is not there, Click "Return to Name Search Filters".

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Section 35 - Personnel Information (individual section)

Section 35- Personnel Information - Individual details top part of page 1

Don't foget to identify if this person is an emergency contact (which will require 2 phone numbers) and if this person will be responsible for monitoring the animals.

Section 35- Personnel Information - Individual details bottom part of page 1

The answer to each question and the selection of the species will determine what lists of Activities you will be presented on the next page. These answers as well as the Activities selected on the next page is needed to enable the Training Coordinator to evaluate if theory and practical training is appropriate for each person. Everyone must satisfy training requirements before the protocol or amendment can be approved.

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Section 35 - Activities Page

Section 35- Personnel Protocol Related Activities


Section 36 - The 3Rs: Replacement, Reduction and Refinement

 Replacement, Reduction and Refinement

The 3Rs are important to consider when designing a project involving animals and to revisit on a yearly basis. If this is a renewal, you must look at possibilities in replacing and reducing and refining your project; it may not be possible but you should make the effort to find oppurtunities to make changes beneficial to the animals.

Replacement: Any part that can be replaced by non-animal equipment and methods must be. If you cannot replace, you need to justify why you need live animals. 

Reduction: The least number of animals must be involved while remaining valid for statistical validity. Do not mention cost, it is not a valid argument for the ethical and compliance review here.

Refinement: Have you designed or made changes that have contributed to the alleviating distress in the animals? Do not state that you are following Standard Operating Procedures (SOPs) because you must follow them. This is about doing more to make things better.


Error Verification and Submission 

Error Verification

You can save and finish later or you can ask for an error verification of your completed protocol. It looks at required sections and fields (identified by a red asterisk *).

Found error

If it finds an error, it will suggest an action/solution at the top of the page and then copy the section that generated the error. You only need to correct right there and save. It will present you with messages one by one.

Electronic signature

Once it is finished with the error verification, you will have the electronic signature page. If you are certain you want to submit, enter your password (the same McGill password you used to log into Darwin) and click 'Continue'. 

Important: never give your McGill password to someone else. The integrity of the electornic signature is maintained by have only one person using it. In the event of an audit due to non-compliance or research misconduct, the password used states who has done which action. If someone else is using your password, you are responsible for all actions performed by that person. You should also be aware that this password may give the person access to your work emails and personnal information via other McGill software including your details of your paycheck deposits into your bank account. 

Submitting to the FACC

The final step is submitting to the FACC (Facility Animal Care Committee). Note that if you are not the PI, you will be submitting to your PI. An email will be sent to the PI to alert him that a protocol or amendment is waiting for his review and submission. Only the Principal Investigator can submit to the committee.

Once submitted, you can view it but cannot edit anymore. If you realize that it needs changes, you can contact the FACC Coordinator to request that it be sent back to you however, if it has already be sent to FACC Members for review, this will have to wait until the review is finished.


ANNUAL REVIEW - Short renewal form

The cycle of an animal protocol is 3 years. The 1st year requires the full form with the detailed sections you see above. The next 2 years only requires the short Annual Review. There are 5 questions to answer.

Annual Review - questions 1 and 2

Question 1: This is about the clinical endpoints. It is understood that the humane endpoints SOPs are to be followed. In addition, what potential adverse effects can the procedures and drugs have on the animals specifically (if surgery then infection of the site or locomotor difficulties...)? What should be done if the adverse clinical signs are present (treat, stop the procedure/drug or euthanize...)? Did you encounter unexpected pain or distress and had to change the clinical endpoints or certain procedures in your project?

Question 2: Every year, the 3Rs have to be considered. Can what you do be replace, entirely or in part, by other non-animal equipment or subjects? Can the total number of animals be reduced without sacrificing the validity of your results? Has then been changes to alleviate pain and distress even further? Note that following Standard Operating Procedures (SOPs) is not a refinement but an obligation unless you have justified it to the satisfaction of the FACC. 

Annual Review - 3R question

Annual Review - question 3

First, the objectives for the coming year must be stated and then the justificaiton of the number of animals requested is to be explained.

The grand total in this section must match the grand total per species in the last column of the table under question 5 (see below).

Annual Review - bottom of the page

Note that if you are not renewing, "Research withdrawn" needs to be checked and the fate of the disposition of the animals stated. The protoocol will be taken out of circulation as soon as no animals are cage carded under this protocol number.

If you have animals that are not Darwin-barcode-cage-carded and you are not renewing, in addition to selecting "Research withdrawn", you must supply the number of animals used last year per species in answer to question 4.

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Note that approval of an animal protocol does not garantee availability of space, equipment and staff services. Every effort is given to support research and teaching projects but resources may be in high demand or temporarily unavailable.