Research Ethics Review

Policy

Category: General – Agency
Subject: Research Ethics Review
Division: Information Systems
Policy Number: CA.50.01.106
Effective Date: January 10, 2018

POLICY STATEMENT

Wellington-Dufferin-Guelph Public Health (WDGPH) will ensure that research involving humans meets high scientific and ethical standards that respect and protect participants. WDGPH is committed to the advancement of knowledge through honest and thoughtful inquiry, rigorous analysis, dissemination of research results, and adherence to the use of professional standards.

WDGPH will determine the ethical acceptability of research projects through consideration of the foreseeable risks, the potential benefits and the ethical implications of the project as described by the Tri-Council Policy Statement (TCPS2).  An underlying value of ethical research is respect for human dignity. In the Tri-Council Policy Statement, respect for human dignity is expressed through three core principles:

  • Respect for Persons
  • Concern for Welfare
  • Justice 

SCOPE

This policy applies to all WDGPH research and program evaluation/quality improvement projects involving human participants will be reviewed before any recruitment or data collection begins, to ensure that high ethical standards are met. This includes research and evaluation projects that WDGPH undertakes as part of a partnership or collaborative effort.

DEFINITIONS

Research – is an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation.

Program evaluation – is the assessment of the performance of a program, organization, or employee.

REFERENCES AND RELATED FORMS, POLICIES AND PROCEDURES

Corresponding Procedure: CA.50.02.106 Research Ethics Review

CONTACT FOR INQUIRIES

Manager, Health Analytics

APPROVED BY

Director, Information Systems 


Procedure

Category: General – Agency
Subject: Research Ethics Review
Division: Information Systems
Procedure Number: CA.50.02.106
Effective Date: January 10, 2018

PROCEDURE

It is the responsibility of Wellington-Dufferin-Guelph Public Health (WDGPH) to ensure that research involving humans meets high scientific and ethical standards that respect and protect the participants. All WDGPH research and program evaluation/quality improvement projects involving human participants will be reviewed before any recruitment or data collection begins, to ensure that high ethical standards are met. This includes research and evaluation projects that WDGPH undertakes as part of a partnership or collaborative effort.

WDGPH Categories of Ethics Review:

  1. Public health activities requiring internal ethics review ONLY: An activity that uses a research technique(s) (e.g., focus groups, interviews, surveys) for the purpose of quality improvement/program evaluation, as opposed to pure research.
  1. Research requiring external Research Ethics Board (REB) review AND internal ethics review: The purpose of the project is research (i.e., intended to extend knowledge through a disciplined inquiry or systematic investigation, to contribute to a body of knowledge).  Examples of this type of research include collaborative research projects with academic institutions, and/or research projects funded by one of the three national funding agencies (Canadian Institutes of Health Research, Social Sciences and Humanities Research Council of Canada, Natural Sciences and Engineering Research Council of Canada).

WDGPH Ethics Review Process:

  1. The manager undertaking the research will assess the need for ethics review of a research/program evaluation activity using the CA.30.01.957 Ethics Flowchart.
  1. The manager and assigned project lead (if applicable) will complete the WDGPH online research ethics training module.
  1. The project lead will discuss the research methods with a WDGPH epidemiologist.
  1. The manager will complete a CA.30.01.953 Ethics Review Application Form. If the manager assigns this task to project staff the manager will review and approve the completed form.
  1. The completed Ethics Review Application Form, copies of data collection instruments/ measures/ tools, and project plans will be sent electronically to the Manager, Health Analytics who will keep an electronic record of all submissions.
  1. The Manager, Health Analytics will review the Ethics Review Application Form using the Public Health Ontario Risk Screening Tool to determine whether a delegated review or a full review is appropriate. 
  • A delegated review will be deemed appropriate for projects with a Risk Screening Tool score of 0-1 or that have been previously reviewed by a research ethics committee at another organization.
  • A full review will be deemed appropriate for projects that score 2-3 on the Public Health Ontario Risk Screening Tool.
  1. If  a delegated review is deemed appropriate, the process will proceed as follows:
  • The Manager, Health Analytics will appoint a core member of the Research Ethics Committee (the reviewer) to review the completed Ethics Review Application Form.
  • The Manager, Health Analytics will send the completed Ethics Review Application Form, data collection instruments/measures/tools and project plans (the submission) electronically to the reviewer and the epidemiologist who provided guidance on the research methods. 
  • Within two weeks of receiving the submission, the reviewer will assess it using the CA.30.01.956 Ethics Review Checklist.
  • Within two weeks of receiving the submission, the epidemiologist will assess the research methods using the CA.30.01.959 Research Methods Checklist.
  • The epidemiologist will send research methods comments to the reviewer for inclusion in the CA.30.01.955 Ethics Decision Appeal Form (Decision Form).
  • The reviewer will document the decision, any suggestions for revisions and the epidemiologist’s comments on the Decision Form. The reviewer will send the Decision Form to the applicant(s) and the Manager, Health Analytics.
    • If minor revisions are suggested that do not affect the approval of a submission the applicant(s) will make the revisions and then move ahead with the research project.
    • If a submission is not approved by the reviewer the applicant(s) will submit revised submissions to the reviewer for re-assessment. 
  • Within one week of receiving the revised submission, the reviewer will send the revised Decision Form to the applicant(s) and the Manager, Health Analytics. 
  1. If a full review is deemed appropriate, the process will proceed as follows:
  • The Manager, Health Analytics will determine participants for a Research Ethics Committee (the committee), and the committee will set a meeting date to occur within two weeks of receiving the completed submission. The composition and membership of the committee is described in WDGPH’s Research Ethics Committee’s Terms of Reference.
  • The Manager, Health Analytics will distribute electronic copies of the completed submission to the committee members at least one week prior to the committee meeting. The Manager, Health Analytics will also send an electronic copy to the epidemiologist who provided guidance on the research methods.
  • The committee members will assess the application using the CA.30.01.956 Ethics Review Checklist.
  • The applicant(s) will attend the committee meeting to give a brief presentation of the proposed project to committee members and to answer any questions committee members might have regarding the project.
  • The epidemiologist will assess the research methods using the Research Methods Checklist.
  • The epidemiologist will send research methods comments to the reviewer for inclusion in the Decision Form.
  • The core committee member will document the committee’s decision, any suggestions for revisions and the epidemiologist’s comments on the Decision Form.  The Decision Form will be sent to the applicant(s) and the Manager, Health Analytics. 
    • If minor revisions are suggested that do not affect the approval of a submission the applicant(s) will make the revisions and then move ahead with the research project.
    • If a submission is not approved by the committee, the applicant(s) will submit revised submissions to the core reviewer for re-assessment. 
    • Within one week of receiving the revised submission, the core reviewer will send the revised Decision Form to the applicant(s) and the Manager, Health Analytics. 
  • If consensus on the approval decision cannot be reached, the committee will seek external ethics support from Public Health Ontario or Homewood Health Centre’s Regional Centre for Excellence in Ethics (RCEE).
  1. The Manager, Health Analytics will provide a list of research projects that have received ethics approval, quarterly, to the Director, Information Systems. The Director, Information Systems will inform all directors of research projects that have received ethics approval.

WDGPH Ethics Review Closure Report

Upon completion of the research project, and before sharing any findings, the manager and/or project lead will complete the CA.30.01.960 Ethics Review Closure Report and submit it to the Manager, Health Analytics. The Manager, Health Analytics will send the Ethics Review Closure Report to the core reviewer. 

  • If the Ethics Review Closure Report identifies that the project was completed according to the approved ethics review and any approved amendments, the core reviewer will approve the project closure and send the form to the manager and/or project lead within two weeks.
  • If the Ethics Review Closure Report identifies that the project was NOT completed according to the approved ethics review and any approved amendments, the core reviewer and the Manager, Health Analytics will meet with the project lead and project manager within two weeks.  They will discuss the ethics concerns and steps for mitigation.
    • If mitigation steps are identified and agreed on, the core reviewer will document the steps on the Ethics Review Closure Report and will send the report to the project lead.
    • If the core reviewer and the Manager, Health Analytics decide that ethical concerns cannot be sufficiently mitigated they will instruct the project manager not to share the results of the project. If there is disagreement about this decision the information will be given to the WDGPH directors for a final decision.

WDGPH Process for an Ethics Consult

If an employee at WDGPH plans to collect personal information from someone in their professional capacity they will contact a core member of the Research Ethics Committee to discuss potential risks and benefits of the project.  An example of this type of project is key informant interviews for an environmental scan or needs assessment that are conducted with professionals about their work.

WDGPH Ethics Review Process for Amendments to Previously-Approved Projects

If amendments are made to a previously approved project, a CA.30.01.954 Ethics Amendment Request will be completed and submitted electronically to the core reviewer.  A process parallel to the delegated internal review process (see process above) will ensue.

The following types of amendments warrant completion of an Amendment Request. Changes to:

  • Project sample (e.g., size, target population);
  • Participant recruitment procedures;
  • Information letters and/or consent forms;
  • Study tools (e.g., survey questions);
  • Study methodology; and
  • Privacy/confidentiality measures.

Prior to completing the Amendment Request the applicant(s) are encouraged to consult with the reviewer.

REFERENCES AND RELATED FORMS, POLICIES AND PROCEDURES

Corresponding Policy CA.50.01.106 Research Ethics Review
CA.30.01.953 Ethics Review Application Form
CA.30.01.954 Ethics Amendment Request
CA.30.01.955 Ethics Decision Appeal Form
CA.30.01.956 Ethics Review Checklist 
CA.30.01.957 Ethics Flowchart – Does my project require ethics review?
CA.30.01.959 Research Methods Checklist
CA.30.01.960 Ethics Review Closure Report
CA.31.01.800 Privacy Guidance Document 
CA.58.01.100 and CA.58.02.100 Privacy Governance 
CA.58.02.104 Access and Release of Information
Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans, 2nd edition 2014 (TCPS 2 -2014) http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2… 
Risk Screening Tool (RST) of Public Health Ontario

CONTACT FOR INQUIRIES

Manager, Health Analytics

APPROVED BY

Director, Information Systems