Research Ethics

Policy

Category: General – Agency
Subject: Research Ethics
Division: Family Health and Health Analytics
Policy Number: CA.50.01.106
Effective Date: February 22, 2016

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

CONTACT FOR INQUIRIES

Manager, Health Analytics & Health Promotion

APPROVED BY

Director, Family Health and Health Analytics 


Procedure

Category: General – Agency
Subject: Research Ethics
Division: Family Health and Health Analytics
Procedure Number: CA.50.02.106
Effective Date: February 22, 2016

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.
  2. 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 recognizes the need for ethics review of a research/program evaluation activity (see WDGPH categories of Ethics Review above).

2. The Manager and assigned lead project staff (if applicable) complete the WDGPH online research ethics training module.

3. The Manager completes 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.

4. The completed Ethics Review Application Form, copies of data collection instruments/ measures/ tools, and project plans are sent electronically to the Manager of Health Analytics (HA & HP Manager) who will keep an electronic record of all submissions. 

5. The HA & HP Manager will review the Ethics Review Application Form using the Public Health Ontario Risk Screening Tool to determine whether an expedited  review or a full  review is appropriate. 

  • An expedited 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.

6. If  an expedited  review is deemed appropriate, the process will proceed as follows:

  • The HA & HP Manager will appoint a core member of the Research Ethics Committee (the reviewer) to review the completed Ethics Review Application Form.
  • The HA & HP Manager will send the completed Ethics Review Application Form, data collection instruments/measures/tools and project plans (the submission) electronically to the reviewer. 
  • Within one week of receiving the submission, the reviewer will assess it using the CA.30.01.954 Ethics Review Checklist.
  • The reviewer will send the completed Ethics Review Checklist (hard copy or scanned) to the HA & HP Manager for record-keeping.
  • The reviewer’s decision and any suggestions for revisions will be documented on the CA.30.01.955 Ethics Review Decision Form (Decision Form). The Decision Form will be sent to the HA & HP Manager.  The HA & HP Manager will review the form and forward it to the applicant(s) and the Manager of the applicant(s).​
    a) ​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.
    b) 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 HA & HP Manager.  The HA & HP Manager will review the form and forward it to the applicant(s) and the Manager of the applicant(s).
  • The HA & HP Manager will submit all approved submissions and Decision Forms electronically to the Director of Family Health and Health Analytics. The Director of Family Health and Health Analytics will inform all Directors of research projects that have received ethics approval.

7. If a full review is deemed appropriate, the process will proceed as follows:

  • The HA & HP Manager will determine participants for a Research Ethics Committee (the committee), and 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 HA & HP Manager will distribute electronic copies of the completed submission to the committee members at least one week prior to the committee meeting. 
  • The committee members will assess the application using the 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 HA & HP Manager will maintain copies of the committee members’ completed Ethics Review Checklists.
  • 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).
  • ​The core committee member will document the committee’s decision and any suggestions for revisions on the Decision Form.  The Decision Form will be sent to the HA & HP Manager for review.  The HA & HP Manager will forward the Decision Form to the applicant(s) and the Manager of the applicant(s).
    a) 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.
    b) If a submission is not approved by the committee the applicant(s) will submit revised submissions to the core committee member for re-assessment.
    c) Within one week of receiving the revised submission, the core committee member will send the revised Decision Form to the HA & HP Manager for review.  The HA & HP Manager will forward the revised Decision Form to the applicant(s) and the Manager of the applicant(s).
  • The HA & HP Manager will submit all approved submissions and Decision Forms electronically to the Director of Family Health and Health Analytics. The Director of Family Health and Health Analytics will inform all Directors of research projects that have received ethics approval.

If an employee at WDGPH plans to collect personal information from someone in their professional capacity they will contact a core member of the 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 previously approved projects, a CA.30.01.956 Amendment to an Ongoing Research or Program Evaluation Project Form (Amendment Form) will be completed and submitted electronically to the HA & HP Manager.  A process parallel to expedited internal review (see process above) will ensue.

The following types of amendments warrant completion of an Amendment Form. 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 Form, the applicant(s) are encouraged to consult with the HA & HP Manager.

REFERENCES AND RELATED FORMS, POLICIES AND PROCEDURES

Corresponding Policy CA.50.01.106 Research Ethics
CA.30.01.953 Ethics Review Application Form
CA.30.01.954 Ethics Review Checklist
CA.30.01.955 Ethics Review Decision Form
CA.30.01.956 Amendment to an Ongoing Research or Program Evaluation Project Form
CA.31.01.800 Privacy Guidance Document
CA.58.01/02.100 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
http://www.publichealthontario.ca/en/ServicesAndTools/ResearchAndEducati…         

CONTACT FOR INQUIRIES

Manager, Health Analytics & Health Promotion

APPROVED BY

Director, Family Health and Health Analytics