Research Ethics Board

The Research Ethics Board of Women’s College Hospital is chaired by Dr. Alison Williams, and managed by Marie Steele (REB Manager). The Board meets monthly to review research protocols submitted to the board and to recommend policies and procedures governing the ethical conduct of research at WCH.

Oswa Shafei is the REB Coordinator and is the primary contact for all communication to and from the board.

For questions about ethics and ethical review at Women’s College Hospital, or to submit a proposal for review, please contact the REB Office by email at ethics@wchospital.ca.

Board Membership

Updated November 14th, 2024 | REB Membership List

The WCH Research Ethics Board meets on the second Wednesday of every month.

Applications can be submitted at anytime, however, if an application requires Full-Board review please refer to the 2024 submission deadlines below. The REO makes the final determination of whether a study requires Full-Board review.

The submission deadlines below are the latest dates to be considered for review at the next meeting.

• REB Submissions will be reviewed in order of their delivery.
• All study applications should be sent to ethics@wchospital.ca.
• All submissions will be screened for completeness, and the review of incomplete submissions will be held until all required documentation has been submitted
• All correspondence to the Research Ethics Office (REO) should be sent via email that clearly identifies the PI, REB study number, study title, and the purpose of the correspondence.
• All new study applications: Please submit the REB Submission checklist alongside all study documents and files (TAHSN, Scientific Review Form, Clinical Impact Form, training documentation, etc.).
• Amendment, Change in study personnel, Note to File, Protocol Deviation, SAE, PI Response applications: Please submit all relevant documents and indicate the number associated with the submission (1st amendment for the study file, 2nd amendment, 3rd amendment, etc.)

Please submit all applications via email to ethics@wchospital.ca

Initial Submissions:

• WCH REB Submission Checklist
• WCH TAHSN Application Form
• WCH Retrospective TAHSN Form
• WCH REB Exemption and Administrative Review Form
• NEW Scientific Review must be completed through Project Launch
• NEW Departmental Feasibility must be completed through Project Launch

Ongoing Submissions:

• WCH REB Annual Renewal Form
• WCH REB Study Closure Form
• WCH REB Amendment Form
• WCH REB Change in Study Personnel Form
• Unanticipated Problems Adverse Event Reporting Form
• WCH REB Protocol Deviation Form
• Reportable Events Submission Form

Approval of External REB Oversight for Funding Transfer Submissions:

This application form is meant to facilitate the transfer of research funds from a PI’s originating institution to WCH.  This application form may only be used when the following criteria apply:

• There are no research activities occurring at WCH i.e. the only activity is the transfer of funds
• The PI’s originating institution’s REB is a CTO qualified REB in good standing
• The PI must be the same at both the originating institution and WCH

The PI will be responsible for submitting evidence of continuing review and ongoing review from their originating institution to the WCH REB. The originating REB’s approval letters must be submitted to ethics@wchospital.ca,  in a timely manner, until the study is closed.

If the originating REB is not CTO qualified but is from an institution that administers Tri-Council funding, please consult with Research Operations and the Research Ethics Office to determine whether this application form can be used.

• WCH REB Submission Checklist – Approval External REB Oversight for Funding Transfer
• WCH REB Application – Approval of External REB Oversight for Funding Transfer

Templates:

• WCH Protocol Template Clinical Trials
• WCH Protocol Template Prospective Observational
• WCH Protocol Template Secondary Use or Retrospective Studies
• WCH REB Clinical Trial ICF Template
• WCH REB Observational Study ICF Template
• WCH Research Brochure Template 1
• WCH Research Brochure Template 2

Guidelines:

• Guidelines: Leveraging Communications for Study or Project Recruitment
• Guidelines for Submitting Protocol Deviations
• TAHSN Application Guidelines

The Women’s College Hospital Research Ethics Board (REB) has adopted the N2/CAREB REB Standard operating Procedures (SOPs), effective December 7th, 2022. This national set of SOPs are the collaborative work of the Network of Networks (N2) with the Canadian Association of Research Ethics Board (CAREB), in order to standardize Canadian REB SOPs that are compliant with applicable Canadian and US regulatory. There are also some SOPs that have an addendum associated with them and are to be used in conjunction with the N2/CAREB REB SOP. The adoption of these N2/CAREB REB SOPs do not have a significant effect on our current processes as the content of the previous WCH REB SOPs and the N2/CAREB SOPs were not substantively different.

SOP 101 Authority and Purpose
SOP 102 Research Requiring REB Review
SOP 103 Training and Education
Addendum SOP 103.004 Training and Education
SOP 104 Management of REB Office Personnel
SOP 105A Conflicts of Interest REB Members and REB Office Personnel
Addendum SOP 105A.004 Conflicts of Interest – REB Members and REB Office Personnel
SOP 105B Conflicts of Interest Researcher
SOP 105C Conflicts of Interest Organization
SOP 106 Signatory Authority
SOP 107 Use and Disclosure of Personal Information
SOP 108 Standard Operating Procedures Maintenance
SOP 201 Composition of the REB
Addendum SOP 201.004 Composition of the REB
SOP 202 Management of REB Membership
SOP 203 Duties of REB members
Addendum SOP 203.004 Duties of REB Members
SOP 204 REB Office Personnel Serving as REB Members
SOP 301 REB Submission Requirements and Administrative Review
SOP 302 REB Meeting Administration
SOP 303 Document Management draft
Addendum SOP 303.004 Document Management
SOP 401 Delegated Review
SOP 402 REB Review Decisions
Addendum SOP 402.004 REB Review Decisions
SOP 403 Initial Review Criteria for REB Approval
SOP 404 Ongoing REB Review Activities
Addendum SOP 404.004 Ongoing REB Review Activities
SOP 405 Continuing Review
Addendum SOP 405.004 Continuing Review
SOP 406 Research Completion
Addendum SOP 406.004 Research Completion
SOP 407 Suspension or temination of REB Approval
SOP 501 REB Review During Publicly Declared Emergencies draft
SOP 601 Communication Researcher
SOP 602 Communication Research Participants
SOP 701 Informed Consent Form Requirements and Documentation draft
SOP 801 Researcher Qualifications and Responsibilities
SOP 902 External Inspections or Audits
SOP 903 NonCompliance
REB-SOP-IV-11-001-REB-Administrative-Review-Procedures

Glossary of Terms

REB Terms of Reference

All studies that are industry sponsored or industry supported, regardless of whether or not they are PI initiated, or industry initiated, are charged the following fees for REB review. These fees cover the initial and ongoing costs associated with review of the applications and ongoing monitoring.

Industry sponsored or supported studies are those which are funded by for-profit entities, for example, pharmaceutical companies, medical device companies, or technology companies.

• Initial REB review: $3000 CAD
• Study Renewals: $500 CAD
• Protocol Amendments: $500

All REB fees are charged regardless of the level of review required (full board vs. delegated) or the outcome of the review. Invoicing contact information should be filled out in the WCH REB Submission Checklist, annual renewal form, or amendment application form as applicable.

Questions or concerns related to REB fees and invoicing should be directed to the Manager of the Research Ethics Office at ethics@wchospital.ca

For a full list of frequently asked questions, please visit our FAQ page.

A number of resources are available to support research and related activities across Women’s College Hospital.

Research Grants Office:

• Support and administrative reviews of research proposals, grant and award applications
• Research contract and agreements
• Liaison between grant holders and the WCH finance office
• Post-award research grant administration
• Research cost centres
• Procurement and purchasing

Research Ethics Office: ethics@wchospital.ca

• Primary contact for all communication to and from the Research Ethics Board
• Coordination of research ethics review process at WCH
• Clinical trial registration

Trainee Supports:

• On-boarding of new trainees at WCRI and WCH
• Trainee initiatives and events, including WCRI Summer Student Program and Graduate Student Research Day

Research Hiring:

• Facilitate the recruitment and hiring process of new research support staff
• Liaison with the Department of Human Resources at WCH

RESEARCH RESOURCES: wcri@wchospital.ca

Statistical Support
Statistical support is available for principal investigators and research teams to create databases, implement data analysis plans, carry out statistical analysis and develop appropriate reports.

ICES@UofT Access
WCRI has an ICES Appointed Analyst who works collaboratively with principal investigators and research teams on projects involving ICES data. The analyst contributes to the development of data set creation and analysis plans.

Research Communications
Research dissemination support through the WCRI and WCH websites, the WCRI newsletter (Impact) and annual report

Research Metrics

Infrastructure to track grant and award application success
Database to manage and track publications

WCRI PROFESSIONAL DEVELOPMENT OPPORTUNITIES:

Research Development Rounds
Research Development Rounds cover the full spectrum of WCRI’s research diversity and focus on a wide range of topics. Presenters include WCRI scientists and trainees, WCH physicians and healthcare professionals, local and international guest speakers, and visiting professors. All are welcome to attend.

Research Staff Rounds
Research Staff Rounds focus on various research and administrative processes at WCRI, with the goal of sharing information and best practices, and to add value to research teams. This session is primarily geared to research support staff but all are welcome to attend.

N2 Online Education Program
WCRI is a member of N2, which provides the opportunity to complete certificates in Good Clinical Practice, Responsible Conduct of Research, and Biomedical Research Ethics. Course modules can be completed online and are available to everyone at WCH and WCRI.

WCRI Summer Student Program
May through August

The WCRI Summer Student Program is designed to introduce undergraduate students to the world of scientific and medical research. The program runs for a minimum of 12 weeks up to a maximum of 16 weeks, depending on the length of the students’ project. Research skills sessions are held weekly and each student presents their project at the WCRI Summer Student Research Day. Summer students working in any WCH department are welcome to participate in the WCRI Summer Student Program.

Commercialization of Intellectual Property – WCRI Resources
Contact: Katharine.Schwartz@wchospital.ca

• IP Policy
• Invention Disclosure Form

OTHER RESOURCES:

The Research Clinic
The U.S. Department of Health and Human Services’ Office of Research Integrity and Office for Human Research Protections has released The Research Clinic, a complimentary, online, interactive training video that educates clinical and social researchers about research misconduct, and protecting research subjects.

For questions related to office equipment, space and facilities at WCRI, please contact: Katharine.Schwartz@wchospital.ca.