Human Ethics Resources

Forms

Please keep in mind that Human Ethics applications, amendments, renewals, and final reports are completed via WebGrants.

Face-to-Face Checklist under COVID-19 for in-person research - no longer mandatory
COVID-19 Research Safety Plan - Example - no longer mandatory
Informed Consent Checklist
UHREB Waiver Request: Secondary Use of Data
Graduate Student Supervisor Ethics Review Form

Guidance Documents for Researchers

Tri-Council Policy Statement and CORE-2022 Training

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) provides ethics guidance that applies to all research involving human participants – including their data and/or biological materials – conducted under the auspices of an institution eligible for funding by the federal Agencies (CIHR, NSERC, SSHRC).

The online tutorial CORE-2022 (Course on Research Ethics) is an introduction to the TCPS 2 for the research community. It focuses on the TCPS 2 ethics guidance that is applicable to all research involving human participants, regardless of discipline or methodology.

The Panel on Research Ethics highly recommends that all researchers who intend to engage in research involving human participants, as well as REB members and administrators, successfully complete the new CORE-2022. Everyone listed on a UW UHREB Human Ethics Application must complete TCPS-CORE training and their training certificates must be attached to the application unless otherwise directed.

Completing CORE-2022 should take approximately 4 hours. The course is self-paced. It is therefore possible to complete the different modules over multiple sessions. All the modules must be completed before taking the knowledge consolidation exercise.

While UHREB recommends that researchers update their training to review the new modules that have been added to the 2022 certificate, it is not mandatory to do so and UHREB will accept certificates completed prior to 2022.

UHREB SOPs and Policies/Procedures

UHREB uses the following documents to guide its form and function:

A Table of Contents which lists all relevant documents
Specific UHREB policies and procedures from Office of the Vice-President, Research and Innovation
SOPs from Network of Networks (N2)/Canadian Association of Research Ethics Board (CAREB)
UW Addendums to N2/CAREB SOPs which provide specific guidance for local interpretation as required.

Specific UHREB Policies and Procedures:

SOP#. Version	UNIVERSITY OF WINNIPEG POLICIES AND PROCEDURES
UW-UHREB 1.001	Composition of the University Human Ethics Research Ethics Board (UHREB)
UW-UHREB 2.001	Reconsideration and Appeal of UHREB Decisions
UW-UHREB 3.001	Departmental Ethics Committees (DEC)
UW-UHREB 4.001	Scholarly Review of Non-Peer Reviewed Research
UW-UHREB 5.001	Responsibilities of Researchers

N2/CAREB SOPs and UW Addendums:

SOP#. Version	N2/CAREB SOP TITLE
100 General Administration (101-108)
101.003	Authority and Purpose
102.003	Research Requiring REB Review
	University of Winnipeg Addendum 102.001
103.003	Training and Education
104.003	Management of REB Office Personnel
105A.003	Conflicts of Interest – REB Members and REB Office Personnel
105B.003	Conflicts of Interest – Researcher
	University of Winnipeg Addendum 105B.001
105C.003	Conflicts of Interest – Organization
106.003	Signatory Authority
107.003	Use and Disclosure of Personal Information
108.003	Standard Operating Procedures Maintenance
200 REB Organization (201-203)
202.003	Management of REB Membership
203.003	Duties of the REB Members
300 Functions and Operations (301-303)
301.003	REB Submission Requirements and Administrative Review
302.003	REB Meeting Administration
303.003	Document Management
400 Reviews of Research (401-407)
401.003	Delegated Review
402.003	REB Review Decisions
403.003	Initial Review - Criteria for REB Approval
	University of Winnipeg Addendum 403.001
404.003	Ongoing REB Review Activities
405.002	Continuing Review
406.003	Research Completion
407.003	Suspension or Termination of REB Approval
500 Reviews Requiring Special Consideration (501)
501.003	REB Review During Publicly Declared Emergencies
600 REB Communication and Notification (601-602)
601.003	Communication – Researcher
602.003	Communication – Research Participants
700 Informed Consent (701)
701.003	Informed Consent Form Requirements and Documentation
800 Researcher Qualifications and Responsibilities (801)
801.000	Researcher Qualifications and Responsibilities
900 Quality Management (901-903)
902.003	Non-Compliance

Consent Templates and Examples

Please note that all informed consent forms must be on UWinnipeg letterhead. Visit the institution's branding page for logos and letterhead.

DEC Applications and Forms

Department Ethics Committees (DEC) are responsible for reviewing undergraduate and course-based ethics proposals (see Guidance Document 4 for more information). See below for forms and relevant information for DECs.

DEC - Course-Based and Senior Independent Undergraduate Ethics Application Form
DEC - Review Form
DEC - Ethics Amendment Application Form
DEC - Ethics Renewal Application Form
DEC - Ethics Final Report Form
DEC - Unanticipated Event Form

Indigenous Research Ethics

Before submitting your human ethics application, consider whether your research will require the completion of Section 4.0 (Research Involving the First Nations, Inuit, and Métis Peoples of Canada) by using this Indigenous Research Ethics Self-Assessment Tool. For a version accessible for screen readers, choose Accessible Indigenous Research Ethics Self-Assessment Tool.

For case studies on the scope of Indigenous research and corresponding levels of community engagement, see Article 9.2 of Chapter 9 of the TCPS 2 (2022).

For examples of ethics applications that demonstrate appropriate and inappropriate levels of responsiveness to Section 4.0 (Research Involving the First Nations, Inuit, and Métis Peoples of Canada) of The University of Winnipeg human ethics application form see:

Responsive
Insufficiently responsive (i.e., insufficient community engagement plan)
Unresponsive (i.e., acknowledgement of Chapter 9 absent)

For additional information and guidance on respectful research with Indigenous communities and participants, including scope of Indigenous research, University of Winnipeg Indigenous resources, and a select bibliography of literature on Indigenous research methods, ethics, evaluation, knowledge mobilization, and data governance see:

Guidance Document 9 - Guidance for Research with Indigenous Communities and Participants - UPDATED November 2022

Minimal risk studies involving Indigenous communities are normally subject to delegated review by UHREB, with a minimum review timeline of 6 weeks. In rare cases, such as where the research is complex or requires substantive clarification, full board review may be considered.

If you are uncertain about the nature of community engagement required for your research, including whether you need to complete Section 4.0 of the human ethics application, please contact ethics@uwinnipeg.ca for advice before submitting your application, or you may face delays in your ethics approval.

Other Related Policies, Approvals, and Permissions

It is the responsibility of the investigator to be aware of and seek out any other approvals, permissions, or agreements that are required to conduct their research activities. These include both University of Winnipeg policies, as well as those imposed by legislation, outside institutions, or stakeholder organizations.

Obtaining UHREB ethics approval is not a substitute for other approvals that apply to research.

UHREB’s default position is that ethical approval is normally not conditional on other policies or permissions. An exception is made where outside policies or permissions directly relate to ethical aspects of the research as guided by TCPS 2 (2022), such as activities related to participant recruitment, study risks, or community engagement.

Examples of University of Winnipeg policies include:

Visit Institutional Analysis's policy page for a complete listing of University of Winnipeg policies.

Examples of non-University of Winnipeg policies and regulations include:

Federalwide Assurance (FWA)

For research conducted using human participants in the United States, please note the Federalwide (FWA) Assurance regulations.

"The Ooffice for Human Research Protections (OHRP) protects the rights, welfare, and well-being of subjects involved in research conducted or supported by the Department of Health and Human Services (HHS) and helps ensure that such research is carried out in accordance with the regulations described at 45 CFR 46.

OHRP provides leadership in the protection of human subjects participating in such research by providing clarification and guidance, developing educational programs and materials, and maintaining regulatory oversight.

To carry out their research mission, nearly 10,000 universities, hospitals, and other research institutions in the U.S. and abroad have formal agreements with OHRP to comply with the regulations pertaining to human subject protections."

For more information, please visit the Office for Human Research Protections (OHRP) website.

The Federalwide Assurance (FWA) number assigned to the UW is: FWA00013649

You will find this approval listed on the Office for Human Research Protections (OHRP) website. Funding agencies use this website to verify that an institution holds an active OHRP-approved FWA.