MRAP Protocol Form Information

MRAP Access

To access the My Research Animal Protocols (MRAP) online system, please go to http://www.research.utoronto.ca/my-research/. A valid UTORid is required.

For technical assistance, the MRAP Help Desk can be reached at 416-946-5000 or raise@utoronto.ca from 9am-5pm, Monday-Friday. The MRAP user guide can also be consulted for detailed system instructions.

General Instructions

  1. Please complete all sections of the protocol. Insert “N/A” where the requested information does not apply. Incomplete protocols will not be reviewed.
  2. Note the meeting dates and submission deadlines for your LACC, as listed here. Late protocol submissions will be held until the next available meeting.
  3. If a proposed project involves more than one (1) animal species, a separate protocol for each species must be completed (the only exception may be for the use of invertebrate species – contact Jennifer Lapierre prior to the preparation and submission of a protocol involving invertebrates).
  4. There must be an approved protocol for all procedures involving the use of vertebrate and higher-form invertebrate animals (e.g. cephalopods, etc.) being used by faculty members, graduate and undergraduate students, research associates, and all other personnel regardless of source of funding. Protocols for non-faculty members must be submitted under the name of the senior faculty member supervising the project.
  5. Any animal research or teaching project administered by the University which is to be conducted in the field or in a facility not owned by the University of Toronto must be covered by an approved protocol.
  6. The protocol must ultimately be submitted by a faculty member.

Protocol Type

If your work will be performed at an on-campus facility or in the field, please submit a U of T protocol application. If the work is being performed in collaboration with researchers from other unaffiliated institutions and the project funding is administered by U of T, approval in principle will be required and a U of T protocol application should be submitted.

In the case of a research or teaching project where the funding is administered by the University and the research is to take place at a hospital or other fully-affiliated institution, approval for use of animals is obtained through the Animal Care Committee connected with the external institution. The Office of Research Ethics requires a complete copy of the currently-valid animal use protocol from the affiliated institution, which can be uploaded directly to the MRAP system.

Approved protocols are eligible for annual renewal up to three times, for a total approval length of up to 4 years before a new protocol is required. The Principal Investigator on the project will receive an automated email 60 days before protocol expiry to notify them of the upcoming expiry. It is recommended that renewals be created and submitted in MRAP at least 45 days prior to expiry to ensure that disruptions to projects do not occur due to lapses in protocol approvals.

Protocol Review Process

Protocols and amendments both require full committee review by the local animal care committee (LACC) prior to approval. In order to allow the committee members sufficient time to adequately review protocols, submission deadlines are set for at least one week prior to the meeting, and usually longer than that to allow additional time for the committee comments to be collated and synthesized before each meeting. Given that committee members must review large volumes of protocols on a monthly basis, late submissions for a given LACC meeting cannot be accommodated for review. Instead, they must either wait until the next scheduled meeting or undergo interim review (only available if urgent).

Note that amendments that only involve administrative changes (additions/removal of research personnel, room changes, etc.) are eligible for expedited review and approval by the Animal Ethics and Compliance Manager. The turnaround time for these minor amendments is normally less than one week.

General information about each review type (full and interim) is given below:

Protocol/amendment submissions (regular full-committee review)

Protocols/amendments will be assigned to the next full committee meeting for review. If a submission deadline has passed the protocol/amendment will be assigned to the following committee meeting.

Based on the comments made at the LACC meeting, the protocol or amendment will be assigned one of the following decisions:

For additional information on the steps involved in each decision, please see the workflow charts.

Protocol/amendment submissions (interim review)

The interim review mechanism was put in place to allow the emergency review of protocols or amendments that cannot wait for review until the next meeting. Any protocol or amendment submission that proposes the interim review mechanism must clearly justify the need for interim review, and the LACC will determine if interim review will actually be provided, as it requires significant resources from the LACC to perform interim reviews. If an interim review is not explicitly requested and justified, the submission will be assigned to the next available LACC meeting for review.

A submission that is reviewed on an interim basis is sent to either the full committee or a subset of members for review, with a normal review period of up to one week. Within approximately 48 hours after the review period is complete, the committee comments are collated by the AECP Manager and a final decision (as described above) is assigned to the protocol based on the committee’s recommendation. Once all comments have been addressed to the satisfaction of the committee, the protocol is then sent to the LACC Chair for interim approval.

Please note that all submissions that undergo interim review and approval are subject to full committee review at the next available LACC meeting and should only be considered provisionally approved until they have received that full approval. Failure to respond to LACC comments on an interim-approved protocol following a full committee meeting may result in the interim approval being rescinded.

For additional information on the steps involved in each decision, please see the workflow charts.

Detailed instructions for filling out the My Research Animal Protocols online form

Identification

The title should be concise and succinct; it serves to identify the project for administrative purposes and need not be overly descriptive. The same title should not be used for separate protocol submissions.

Funding

Please indicate the source of funding from the provided list of your grants that are taken from the MRA database. Sources can be external (e.g. NSERC, CIHR, Canadian Diabetes Association) or internal (e.g. faculty/departmental funding, start-up funding).

University of Toronto and CCAC regulations stipulate that all research must be peer-reviewed for scientific merit. Please click here for more information on peer-review requirements.

3Rs

Consideration of the 3Rs (replacement, reduction and refinement) should be undertaken before a study using animals is proposed.

Replacement refers to methods which avoid or replace the use of animals in an area where animals would otherwise have been used. This includes both absolute replacements (i.e., replacing animals with inanimate systems, such as a computer program) and relative replacements (i.e., replacing more sentient animals such as vertebrates, with animals that current scientific evidence indicates have a significantly lower potential for pain perception, such as some invertebrates). Examples of replacement include:

Reduction refers to any strategy that will result in fewer animals being used to obtain sufficient data to answer the research question, or in maximizing the information obtained per animal and thus potentially limiting or avoiding subsequent use of additional animals, without compromising animal welfare. Examples of reduction include:

Refinement refers to the modification of husbandry or experimental procedures to minimize pain and distress, and to enhance the welfare of the animal used in science from the time it is born until its death. Examples of refinement include:

The CCAC publishes an excellent online resource dedicated to the 3Rs, which has many helpful links to alternatives that can remove or reduce the need to use animals. For assistance in performing a 3Rs search, see the CCAC’s 3Rs Search Guide. An online tutorial on implementing the 3Rs can be found here.

Completion of all three parts of this section is mandatory.

History of Protocols

The past history section is intended to indicate that scientific progress was made on similar of the protocol. If this protocol is closely linked to a protocol that was valid within the last 2 years, please select “Yes”. You will then be prompted to select the expired protocol, which will then import the information from the expired protocol’s Protocol Completion Report (PCR) into the current submission.

If this is a new study that is not closely related to a recently expired protocol, then please indicate “No”.

Project Description

The primary objectives and expected benefits of the research must be described in non-scientific language that must be understandable to someone without a science background (a high-school level of writing is suggested).  Many protocols are sent back to the researcher for revisions owing to technical language used in this section, as the content must be understandable to the non-scientist community representatives that sit on the LACC.

Keywords are used as part of the annual reporting to regulatory agencies. Please select up to six keywords that apply to the proposed project.

If this protocol is a new submission, please indicate the proposed start date of the research. Please note that the start date cannot be prior to the date of submission to the LACC, and the research may not commence until the protocol has been approved in full. If this protocol is a renewal of a currently-approved protocol, then please indicate “ongoing” for the start date. The expected completion date should be provided if the project is anticipated to last less than a year; “ongoing” should be checked if will not.

The category of invasiveness is used to determine the degree of invasiveness of a procedure on an animal. The scale ranges from A-E (see below), with Category A being minimally invasive and Category E causing severe pain or discomfort. If animals are undergoing multiple procedures within the protocol, the category that describes the most invasive portion of the project should be selected. The categories are delineated as follows:

Category A: Experiments on most invertebrates or on live isolates

Possible examples: the use of tissue culture and tissues obtained at necropsy or from the slaughterhouse; the use of eggs, protozoa or other single-celled organisms; experiments involving containment, incision or other invasive procedures on metazoa.

Category B: Experiments which cause little or no discomfort or stress

Possible examples: domestic flocks or herds being maintained in simulated or actual commercial production management systems; the short-term and skillful restraint of animals for purposes of observation or physical examination; blood sampling; injection of material in amounts that will not cause adverse reactions by the following routes: intravenous, subcutaneous, intramuscular, intraperitoneal, or oral, but not intrathoracic or intracardiac (Category C); acute non-survival studies in which the animals are completely anesthetized and do not regain consciousness; approved methods of euthanasia following rapid unconsciousness, such as anesthetic overdose, or decapitation preceded by sedation or light anesthesia; short periods of food and/or water deprivation equivalent to periods of abstinence in nature.

Category C: Experiments which cause minor stress or pain of short duration

Possible examples: cannulation or catheterization of blood vessels or body cavities under anesthesia; minor surgical procedures under anesthesia, such as biopsies, laparoscopy; short periods of restraint beyond that for simple observation or examination, but consistent with minimal distress; short periods of food and/or water deprivation which exceed periods of abstinence in nature; behavioral experiments on conscious animals that involve short-term, stressful restraint; exposure to non-lethal levels of drugs or chemicals. Such procedures should not cause significant changes in the animal’s appearance, in physiological parameters such as respiratory or cardiac rate, or fecal or urinary output, or in social responses.

Note: During or after Category C studies, animals must not show self-mutilation, anorexia, dehydration, hyperactivity, increased recumbency or dormancy, increased vocalization, aggressive-defensive behavior or demonstrate social withdrawal and self-isolation.

Category D: Experiments which cause moderate to severe distress or discomfort

Possible examples: major surgical procedures conducted under general anesthesia, with subsequent recovery; prolonged (several hours or more) periods of physical restraint; induction of behavioral stresses such as maternal deprivation, aggression, predator-prey interactions; procedures which cause severe, persistent or irreversible disruption of sensorimotor organization; the use of Freund’s Complete Adjuvant.

Other examples include induction of anatomical and physiological abnormalities that will result in pain or distress; the exposure of an animal to noxious stimuli from which escape is impossible; the production of radiation sickness; exposure to drugs or chemicals at levels that impair physiological systems.

Note: Procedures used in Category D studies should not cause prolonged or severe clinical distress as may be exhibited by a wide range of clinical signs, such as marked abnormalities in behavioral patterns or attitudes, the absence of grooming, dehydration, abnormal vocalization, prolonged anorexia, circulatory collapse, extreme lethargy or disinclination to move, and clinical signs of severe or advanced local or systemic infection, etc.

Category E: Procedures which cause severe pain near, at, or above the pain tolerance threshold of unanaesthetized conscious animals

This Category of Invasiveness is not necessarily confined to surgical procedures, but may include exposure to noxious stimuli or agents whose effects are unknown; exposure to drugs or chemicals at levels that (may) markedly impair physiological systems and which cause death, severe pain, or extreme distress; completely new biomedical experiments which have a high degree of invasiveness; behavioral studies about which the effects of the degree of distress are not known; use of muscle relaxants or paralytic drugs without anesthetics; burn or trauma infliction on unanaesthetized animals; a euthanasia method not approved by the CCAC; any procedures (e.g., the injection of noxious agents or the induction of severe stress or shock) that will result in pain which approaches the pain tolerance threshold and cannot be relieved by analgesia (e.g., when toxicity testing and experimentally-induced infectious disease studies have death as the endpoint).

The Canadian Council on Animal Care requires that the purpose of the study be provided for regulatory reporting purposes. The blue help icon provides a detailed definition for each of the various options.

If a project involves surgery, then please indicate whether it’s acute or non-acute. Likewise, for projects that do not involve surgery, indicate if the study is acute or non-acute. More than one descriptor may apply.

In part 2 of the Project section, a detailed project description must be provided, with procedural timelines for each experimental group of animals from the time of birth/receipt until final disposition clearly indicated. Diagrams, flowcharts and tables should be included if appropriate, and may be uploaded using the document upload functionality at the bottom of the page (all standard MS Office filetypes are accepted, along with PDF files). Examples of helpful flowcharts can be viewed here. Copies of complete grant applications will not be accepted.  Clear and concise descriptions which are easily understandable to those with a general science background are desirable. If the members of the LACC cannot understand a procedure or experimental protocol, it may require additional submissions to the committee which may delay the review process.

If the project includes a breeding component, please describe the breeding method (e.g. harem, pair, use of studs, etc.), age when genotyped, method of genotyping and method of euthanasia for excess animals.

The University publishes a list of Standard Operating Procedures (SOPs) that govern the performance of many tasks and procedures. All procedures must be performed in accordance with an approved SOP. Please indicate the SOPs that will be used in conjunction with the protocol; if the SOP you are using is not listed, please choose “other” from the dropdown list and upload a copy using the document upload functionality.

Part 3 of the Project section will only need to be completed if the protocol submission is for teaching purposes. Please answer all questions fully, and upload a copy of the approval letter from the pedagogical merit review committee, as pedagogical merit review is mandatory prior to ethics review for all teaching protocols.

Animals

The animals to be used for the research project should be listed in this section. A different protocol must be filled out for each species used (i.e. rats, mice, etc). Different breeds or strains of a single species can be covered by a single protocol, provided they are used for the same study. Information must be provided regarding the source(s) of the animals (e.g. the number of animals that are obtained from specific suppliers, the number that are to be bred in-house and the number that are obtained through other means). If multiple breeds or strains of animals are being used, then total numbers should be indicated for each of the three sourcing options. Please note that if breeding and experimental protocols are separated, animals that are to be used experimentally must be transferred from the breeding protocol as they are used using MRAP. 

If mice are being used, please ensure that the strain information chart is completed and uploaded to the MRAP system. This form must be completed for all mouse strains in use, including commonly-used strains. If multiple strains are being used, please put the information for each strain on a separate row of the spreadsheet.

The locations where the animals will be held must be specified, as well as the locations for any surgical work or field work (as appropriate). The use and/or housing of animals outside the vivarium must be clearly justified and must conform to the Guidelines for Animal Holding and Use Outside Central Vivaria.

The justification section requires that the type of animal and the numbers requested be justified for scientific merit. The choice of species for the study and the rationale for the number of animals requested should be fully explained. Cost is never an acceptable justification for using a given species. When justifying the number of animals to be used, it can be helpful to include statistical calculations or power analyses. A helpful publication that provides some basic information on calculating appropriate sample sizes can be found here.

Environmental enrichment and/or social housing must be provided for all research animals unless experimentally contraindicated and strongly justified.

Studies that involve field work or trapping of wild animals require that the Field Research Appendix be filled out. Permit information for the collection of wild animals should be indicated, along with the name of the relevant authority that granted the permit and the permit expiry date. Detailed information regarding the method of capture, containment methods and transportation of animals from the field, potential capture of secondary/non-target species and any potential injuries that may arise during the capture process should be provided in the relevant sections. Upon completion of the study, the provision for disposal or release of the animals should be described.

Drugs and Hazardous Agents

All drugs used for anaesthesia and analgesia should be indicated. The name of the drugs used, their dosages (expressed in mg/kg as appropriate) and the route of administration (e.g. intraperitoneally, IP; intramuscularly, IM; subcutaneously, SC; inhalation) should be provided. Please consult veterinary staff if you are unsure of the proper dosages. Appropriate procedures for monitoring the animals while under anaesthesia and during recovery should be followed, as well as proper intra-operative and post-operative care. Please note that the frequency (number of doses per day) and duration (number of days) of analgesia administration must be indicated.

The use of any hazardous agents in the study requires that they be detailed in this section. Any biological agents (e.g. viruses), chemical agents, carcinogens  or radioisotopes must be listed. If radioisotopes are to be used, then the radiation permit number and its expiry date must be provided. For the hazardous agents listed, specific details regarding the amounts, routes and half-life must be provided in the relevant sections. Any necessary precautions to be taken to prevent harm to humans and/or animals outside the study subjects must be provided.

Endpoints and Final Disposition

The endpoints section should describe the necessary measures that will be taken in the event of an experimentally-induced negative impact on the health or welfare of the animal (i.e. a disease or life-threatening condition). Appropriate measures include careful ongoing monitoring and consultation with veterinary staff for appropriate treatment or euthanasia should there be any negative impact on animal health.

Animals should be monitored by trained laboratory staff, generally on a daily basis. This monitoring should be in addition to any monitoring that is done by vivarium staff. Laboratory staff responsible for monitoring should be specifically named, and contact phone numbers should be provided. Please ensure that all staff listed in this section are also listed in the next section (Handlers and Emergency Contacts).

The final disposition of the animals upon termination of the study must be described. If animals are to be euthanized, the method of euthanasia should be described, and all applicable SOPs relating to that method must be strictly followed. Strong justification should be given in the event that a physical method of euthanasia will be performed without the prior use of a general anaesthetic. In the event that the animals are not euthanized, the disposition of the animals should be provided (i.e. released back to the wild for certain field studies).

Handlers and Emergency Contacts

At least one emergency contact must be provided. This individual may be called upon to make decisions regarding animals covered by the protocol in the event of an emergency where the principal investigator cannot be reached. A secondary alternate contact may also be listed.

All research staff who are working with the live animals should be listed, along with their academic rank or designation. All staff are required to take the University’s Short Course on Animal Care. Future additions of research staff will require the protocol to be amended and approved by the LACC before those staff may work with animals.

Undertaking

Please note that while a principal investigator may delegate the completion of the online MRAP protocol form to others, the protocol cannot be ultimately submitted by anyone else. Before submitting the document, please ensure that all fields are complete and the information provided is accurate.

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