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Ethics Services

We provide ethics review and support services within Public Health Ontario (PHO) and to Ontario’s public health units (PHUs) across the life-cycle of evidence-generating projects that involve human participants, their data, or their biological materials. Projects may include research, evaluation, enhanced surveillance and quality improvement.

Ethics Review and Oversight Services

  • TCPS 2-compliant delegated or full board ethics review of public health evidence-generating projects
  • a single, centralized ethics review board for projects involving multiple PHUs

Capacity Building and Support Services

  • ethics consultations on project related issues
  • a forum for PHUs to share and learn from each other
  • support to develop capacity in the assessment of ethical risks and review of low risk projects
  • ongoing education and training
  

image of a risk monitor

Risk Screening Tool

This 20-item, self-scoring questionnaire facilitates risk assessment for public health evidence-generating initiatives.

 
 

image of a framework model

Framework for Ethical Conduct

This report provides a framework to guide the ethical review of evidence-generating public health initiatives.

 

 

Tri-council Policy Statement (TCPS 2)

The TCPS 2 is the official research ethics policy of Canada’s three federal research agencies: the National Sciences and Engineering Research Council (NSERC), the Social Sciences and Humanities Research Council (SSHRC) and the Canadian Institutes of Health Research (CIHR).​

 

Ethics application process

How to prepare and submit a new ethics review board application

 
1. Confirm that your public health unit (PHU) has an existing board of record agreement with Public
Health Ontario (PHO)

PHUs must have an existing board of record agreement (BOR) with PHO before accessing ethics review services. If your PHU does not have a BOR agreement with us contact ethics@oahpp.ca.

Multi-jurisdictional PHU Projects

A multi-jurisdictional project involving more than one PHU may be eligible to use PHO as a single, centralized ethics review board. For more information, please see PHO's Centralized Ethics Review FAQs or contact ethics@oahpp.ca for assistance.

 

2. Determine whether your project is an evidence-generating activity involving humans, their information
or biological materials

PHO’s approach to ethics review applies to research as well other types of evidence-generating projects involving humans (e.g., evaluation, quality improvement and enhanced surveillance). Applicants should refer to their existing internal policies and procedures to determine whether a project is an evidence-generating activity that warrants ethics review. Contact your PHU’s ethics designate for additional information.

3. Complete the TCPS 2 CORE on-line tutorial

Completion of TCPS 2: CORE (Course on Research Ethics) online tutorial is mandatory for the lead applicant. This document is not required if it has previously been submitted to PHO Ethics Services. The online tutorial is an introduction to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) and provides fundamental guidance on the ethics of research involving human participants.

4. Complete the Risk Screening Tool (RST) Questionnaire

A completed RST questionnaire is required for all project submissions to assess the appropriate level of ethics review. PHO’s Ethics Services will validate the RST score and determine the final level of review.

Our ethics review service applies to projects with a validated RST score of 2 (delegated review) or 3 (full board review). For low risk projects, Levels 0 and 1, we provide consultation services to support capacity development in the review and assessment of ethical risks. Please contact ethics@oahpp.ca to book a consultation.

For more information on how to complete the RST questionnaire, please refer to the Risk Screening Tool Guidelines and FAQs or contact your PHU’s ethics designate.

5. Complete the ERB application form

PHO’s ERB Application Form is the key source of information used by the Board to assess the ethical acceptability of a project. The form was developed in consultation with PHUs to ensure local applicability.

If you require assistance completing your ERB application and supporting material, contact your PHU’s ethics designate.

6. How to prepare and submit your application

The following documents must be included in your application:

  • completed Risk Screening Tool questionnaire
  • completed Ethics Review Board Application form
  • additional supporting material, such as consent forms, questionnaires, recruitment material, data collection tools, privacy assessments, etc. For assistance with consent forms, please refer to PHO’s ERB Consent Form Guidelines and ERB Information Letter and Consent Form Template.

Scan and email your completed applications to ethics@oahpp.ca

If you require assistance preparing your application, contact your PHU’s ethics designate.

What happens after an application is submitted?

RST score validation

PHO’s Ethics Services will validate the RST score and determine the final level of review. Projects with level 2 or 3 RST scores will be considered for review.

For low risk projects, Levels 1 and 0, we provide consultation services to support capacity development in the review and assessment of ethical risks. Please contact ethics@oahpp.ca to book a consultation.

Pre-screening of application package

Applications will not be accepted for review until all relevant information is provided. To ensure the clarity and completeness of a submission, our Ethics Services will pre-screen each submission. Applicants may be asked to re-submit their application if relevant material is missing or if information in the ERB application form is incomplete.

For more information about submission deadlines, please go to Submission Deadlines and ERB Meetings.

Confirmation of successful submission

Ethics Services will send the lead applicant an email acknowledging the successful submission of their application. If you have any questions contact ethics@oahpp.ca.

 

Continuing Review

 
Continuing review

Projects approved by our Ethics Review Board are subject to continuing ethics review throughout the life-cycle of the project. Continuing review may involve project renewals, review and approval of changes to the originally approved application, and project completion or termination.

For additional information refer to the Forms, Guidelines and Tools section

​Renewal Form For projects lasting more than one year, lead applicants are required to submit an annual report using the ERB Renewal Form. Ethics Services will send the lead applicant a reminder email two months prior to the approval expiration date.​
Amendment Form ​To be used when there are substantive changes to the protocol that affect the scientific objectives, study design or risk to human participants or others impacted by the project.
Unanticipated Event or Issue To be used when there are unanticipated issues or events involving participants or that may affect participants’ welfare. This includes unexpected negative consequences of participation (e.g. mental or physical health events), occurrences that might have implications for participants (e.g. confidentiality breach), or unexpected deviations from the approved protocol.
Change in Personnel Form ​To be used when adding or removing a project team member
Completion or Termination Form​ ​To be used when completing or terminating a project
 

Submission deadlines and Ethics Review Board meetings

The ethics review process begins once a project is successfully submitted. Ethics Services will send the lead applicant an email acknowledging the successful submission of their application. For information on submission deadlines, refer to the level of review below.

Level 2 Delegated Review

Level 2 delegated review applies to minimal risk projects and is conducted by one or two members of the ERB. There is no deadline for submitting a level 2 delegated review project.

Level 3 Full Board Review

Level 3 full board review applies to projects with greater than minimal risk and is completed at a scheduled ERB meeting.

The deadline for submission is four weeks prior to the full board meeting date. For more information contact ethics@oahpp.ca.

Due Date for Submission of Completed,
Fully Signed ERB Application
(three weeks prior to ERB meeting date)
ERB Full Board Meeting Dates
​November 15, 2018 ​December 13, 2018
​December 13, 2018 ​January 10, 2019
​January 17, 2019 ​February 14, 2019
​February 14, 2019 ​March 14, 2019
​March 14, 2019 ​April 11, 2019
​April 11, 2019 ​May 9, 2019
​May 16, 2019 ​June 13, 2019
​June 13, 2019 ​July 11, 2019
​July 11, 2019 ​August 8, 2019
​August 15, 2019 ​September 12, 2019
​September 12, 2019 ​October 10, 2019
​October 17, 2019 ​November 14, 2019
​November 14, 2019 ​December 12, 2019

 

 


Forms, Guidelines and Tools

Forms, Guidelines and Tools

Training and Education

Training and Education

Our Ethics Services team provides:

  • training on using the Risk Screening Tool
  • ethics designate forums
  • education on emerging ethics topics

The TCPS 2 CORE on-line tutorial introduces researchers to TCPS2 and focuses on the guidance that is applicable to all research regardless of discipline or methodology.

For more information contact ethics@oahpp.ca or search PHO’s event calendar for listings


External Resources

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Page last updated: 2018-11-20 1:40 PM
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