If your research involves human participants or animals

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
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).

Animals in Research Act

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

Guidelines for annual renewals

Renewal process

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

Modification process

External policy/requirements

CCAC Terms of Reference for ACC

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
Waterloo policy, procedure or guideline

Waterloo Statement on Human Participant Research

Under the auspices of Waterloo

Who needs to complete an application

Definition of research and participant

What requires ethics review

Decision Tree

Research integrity – frequently asked questions

External policy/requirements

TCPS2 (2018)

Article 2.1 The following requires ethics review and approval by an REB before the research commences:

  • research involving living human participants;
  • research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals;
  • a determination that research is the intended purpose of the undertaking is key for differentiating activities that require ethics review by an REB and those that do not (see Article 2.5). Choice of methodology and/or intent or ability to publish findings are not factors that determine whether or not an activity is research requiring ethics review;
  • “human participants” (referred to as “participants”) are those individuals whose data, or responses to interventions, stimuli or questions by the researcher, are relevant to answering the research question
Tri-agency Framework: RCR
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

Human data collection which does NOT require ethics review

External policy/requirements

Article 2.2 Research that relies exclusively on publicly available information does not require REB review when:

  • the information is legally accessible to the public and appropriately protected by law; OR
  • the information is publicly accessible and there is no reasonable expectation of privacy;
  • research involving the observation of people in public places where it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
  • individuals or groups targeted for observation have no reasonable expectation of privacy; and any dissemination of research results does not allow identification of specific individuals;
  • research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information;
  • Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, and do not fall within the scope of REB review;
  • Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review TCPS2 (2018)
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

Modification Process or Incidental Findings Process

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