Animal ethics approval
Mandatory/key compliance obligations | Ensure an application (AUPP) is submitted and ACC approval obtained for any research involving animals as described in the Waterloo statement on animal research |
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Waterloo policy, procedure or guideline |
Waterloo statement on animal researchHow to apply for ACC approval |
External policy/requirements |
Failing to meet agency policy requirements or, to comply with relevant policies, laws or regulations, for the conduct of certain types of research activities; failing to obtain appropriate approvals, permits or certifications before conducting these activities. Tri-agency Framework: RCR Research facility required to be registered 4. (1) No person shall commence or continue to operate a research facility unless the research facility is registered under this Act. R.S.O. 1990, c. A.22, s. 4 (1). The Institution agrees to participate in the CCAC's Program, which includes regular assessments, and hold a valid Certificate of GAP – Good Animal Practice confirming that it is in compliance with the CCAC's guidelines and policies. |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Ensure all members of the research team have completed required training and submit proof of this with the AUPP |
Waterloo policy, procedure or guideline | Training Schedule |
External policy/requirements | CCAC Training Guidelines |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Ensure annual renewals are submitted and reviewed by the ACC |
Waterloo policy, procedure or guideline | |
External policy/requirements |
CCAC Terms of Reference for Animal Care Committees Review all protocols annually (i.e., within a year of commencement of the project) |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Seek approval for any minor or major changes which need to be made to the approved protocol |
Waterloo policy, procedure or guideline | |
External policy/requirements | |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Report any problems that occur during the execution of the research which involve the animals or protocol deviations |
Waterloo policy, procedure or guideline | Problem reporting |
External policy/requirements | CCAC Terms of Reference for ACC |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | File a report to close the study once the research has ended |
Waterloo policy, procedure or guideline | Close a study |
External policy/requirements | CCAC Terms of Reference for ACC |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Specifically reference ACC approved SOPs to be used in the protocol |
Waterloo policy, procedure or guideline | Description of procedures: All methods and procedures to be used on the animals must be clearly and sequentially described in detail. These include surgical procedures in addition to behavioural and physiological testing. Any potential adverse effects should be indicated. ACC approved SOPs for techniques and manipulations to be conducted on the animals must be referenced. For reasons of confidentiality, security and IP, all ACC approved Standard Operating Procedures (SOPs) are located on a secure Sharepoint site. To gain access to the Sharepoint page, contact the Office of Research Ethics |
External policy/requirements |
CCAC Terms of Reference for ACC Standard operating procedures and institutional animal care and use policies; SOP review may be delegated to ACC members with the appropriate expertise, but SOPs should be accessible to all ACC members, and the full ACC should review all SOPs that involve procedures that may result in deleterious effects to animal health or welfare. |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Inform Pre-award of any emerging requirements for ACC approval during term of grant/award/contract |
Who can help? | OR Pre-Awards |
Best practices | Perform a quality control check on the AUPP before submitting to ensure all required items have been included and the most common issues addressed |
Waterloo policy, procedure or guideline | Researcher checklist |
Who can help? | ORE Staff |
Best practices | Read the researcher guidelines before starting the initial application |
Waterloo policy, procedure or guideline | Guidelines for initial application |
Who can help? | ORE Staff |
Human ethics approval
Mandatory/key compliance obligations | Ensure all research involving human participants receives ethics clearance prior to starting any interactions with participants |
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Waterloo policy, procedure or guideline |
Waterloo Statement on Human Participant Research Under the auspices of Waterloo Who needs to complete an application |
External policy/requirements |
Article 2.1 The following requires ethics review and approval by an REB before the research commences:
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Who can help? | ORE Staff |
Mandatory/key compliance obligations | Do not file an ethics application for data collection that does not require ethics review |
Waterloo policy, procedure or guideline | |
External policy/requirements |
Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:
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Who can help? | ORE Staff |
Mandatory/key compliance obligations | Complete required training |
Waterloo policy, procedure or guideline | CORE tutorial |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | File annual reports prior to the annual renewal date of the certificate in order to maintain the active status of the clearance |
Waterloo policy, procedure or guideline | Renewal process |
External policy/requirements |
Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life of the project in accordance with Article 6.14 TCPS2 (2018) |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Familiarize the research team with relevant guidelines prior to starting the research |
Waterloo policy, procedure or guideline | Repository containing alphabetical listing of Waterloo guidelines relevant to various types of research and issues |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Notify the ORE if an adverse event or protocol deviation occurs |
Waterloo policy, procedure or guideline | Requirements for handling problems |
External policy/requirements | Article 2.8 Following initial REB review and approval, research ethics review shall continue throughout the life of the project in accordance with Article 6.14 TCPS2 (2018) |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Ensure ongoing consent is obtained from participants if new information is obtained which might have a bearing on the original decision to participate/changes the risk level or benefits for participants |
Waterloo policy, procedure or guideline | |
External policy/requirements |
Article 3.3 Consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research. Article 3.4Researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research. TCPS2 (2018) |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Notify the ORE once the study has been completed |
Waterloo policy, procedure or guideline | Close a study |
Who can help? | ORE Staff |
Mandatory/key compliance obligations | Inform Pre-award of any emerging requirement for ACC approval during the term of grant/award/contract |
Who can help? | OR Pre-Awards |
Best practices | Use sample information and consent letters, other sample wording, and supporting material |
Waterloo policy, procedure or guideline | Sample information, consent letters, and other supporting materials |
Who can help? | ORE Staff |
Best practices | Get help with your research ethics application |
Waterloo policy, procedure or guideline | Overview of the research ethics process |
Who can help? | ORE Staff |
Best practices | Avoid the “Top 10” problems which can lead to delays |
Waterloo policy, procedure or guideline | Top 10 problems and solutions |
Who can help? | ORE Staff |
Best practices | Take advantage of coordinated ethics reviews for multi-jurisdictional research involving some institutional partners |
Waterloo policy, procedure or guideline | |
External policy/requirements | Application Process - Step #2 |
Who can help? | ORE Staff |
Best practices | As an instructor, file a single course application for all students where applicable |
Waterloo policy, procedure or guideline | Course based research application form and process |