Apply for Human Ethics

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
  
• If you are a UW graduate student: there is one additional step: You must include a completed and signed PDF of the Graduate Student Supervisor Ethics Review Form with your Human Ethics Application (Section 20). This ensures that the supervisor has reviewed and supports the student’s application.
• If you are not from UW but want to do research using UW staff, faculty, or students as participants, see Institutional Permission below.
• The PI and any staff working on the project must complete Tri-Council Policy Statement CORE training. Training certificates must be attached to the Human Ethics Application (Section 20).
• Check the research memos to ensure you’re considering COVID-19 as needed.

Step 1: Ensure you have a WebGrants account. If you don’t have a WebGrants account, contact ethics@uwinnipeg.ca so an account can be created for you.

Step 2: Log into WebGrants, select “Funding Opportunities”, and select “Human Ethics Application”.

Step 3: Select either “Copy Existing Application” or “Start a New Application”. The following steps assume “Start a New Application” was selected.

Step 4: Enter the Primary Investigator (you) and the Project Title, then select “Save”.

Step 5: Select “Go to Application Forms”. This opens the remaining sections of the Human Ethics Application. Select each section, then select “Edit” to start working on the section. Complete each section fully, selecting “Save” then “Mark as Complete” for each section. Once every section is complete, select “Submit”. The sections are listed below with some general tips:

1. Project Information
   • Write in plain lay language
   • COVID-19 is no longer considered a publically declared emergency under TCPS2 requirements, so make sure to answer “No” to “Is this study being conducted under a publicly declared emergency?”    
2. Conflict of Interest
3. Participant Information
   • Only complete 3.6, 3.7, and 3.8 if the answer for 3.5 is “Yes.”
4. Research Involving the First Nations, Inuit, and Métis Peoples of Canada
   • If your research may impact Indigenous peoples, you must complete this section.
   • If you are unsure whether you need to complete this section, please use the Indigenous Research Ethics Self-Assessment Tool. For a version accessible for screen readers, choose Accessible Indigenous Research Ethics Self-Assessment Tool.
   • If you’ve selected "No" for Section 4.0, you are still strongly encouraged to provide justification as to why your research does not fit the criteria for this section, and if you choose not to provide justification, UHREB may request it.     
5. Other Communities
6. Risk/Benefit Analysis
   • COVID-19 no longer needs to be acknowledged as a risk in this section and in any consent/assent forms. In cases where the investigator or UHREB determines the likelihood or magnitude of COVID-19 risk is elevated, or that participants may be more vulnerable to COVID-19 infection or adverse outcomes, investigators should include more detailed risk mitigation and UHREB may require additional information.             
7. Recruitment
8. Secondary Use of Data
9. Informed Consent Determination
10. Deception or Partial Disclosure
11. Reimbursements and Incentives
12. Anonymity and Confidentiality
13. Interviews, Focus Groups, and Surveys
14. Use or Production of Creative Works
15. Internet-based Interaction
16. Safeguarding Information
17. Data Storage
18. Human Biological Material
19. Biohazard Safety
20. Application Attachments
    • Include any document referenced in the application (example: consent/assent forms, interview questions, recruitment materials, etc.)
    • Include TCPS 2: CORE certificates for each member of the research team.
    • A separate COVID-19 safety plan, face-to-face checklist, or note in consent forms are not required for projects where the risk of COVID is deemed no greater than participants or researchers encounter in their normal daily activities. If the risk of contracting COVID-19 is elevated for particular research subjects, researchers may include a safety plan and/or face-to-face checklist, available in Resources, under Forms.
    • Graduate Students: include a completed and signed PDF of the Graduate Student Supervisor Ethics Review Form.
21. Declaration

Step 6: Submitting your Human Ethics Application sends it to the Ethics Program Officer for their completeness review (ensuring all sections are complete, all sections are cohesive, all attachments are included, etc.). If revisions are required after the completeness review, the Ethics Program Officer will communicate with you via email and reopen the relevant sections of the Human Ethics Application in WebGrants. This allows you to revise those sections.

Step 7: Once your revisions are submitted, the Human Ethics Application is then sent to UHREB for their risk review, then to delegated or full board review as per the risk review. UHREB may also request revisions, which the Ethics Program Officer will communicate to you via email.

Step 8: Delegated or full board review by UHREB may result in additional requests for revision or clarification. Once revisions are provided and reviewed to the satisfaction of UHREB, the Human Ethics Application will be approved. An approval letter will be attached to your Human Ethics Application in WebGrants and emailed to you.

After approval:

• Any changes to the approved Human Ethics Application require an amendment.
• Any adverse events, deviations, privacy breaches, and premature suspensions or termination of the research must be reported to UHREB promptly.
• Each year your project is active, you’re required to renew your UHREB approval.
• When your project is finished, you’re required to submit a Human Ethics Final Report.

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• As per Federal regulations, the University cannot provide access to research funding for projects with activities that require ethics review at any point of the award term prior to ethics approval; however, researchers seeking access to any of the award funds for research-related activities not subject to ethics review are able to request partial fund access by providing the Research Office with a completed RPA form.
• When completing the RPA form, researchers usually use the budget they've prepared for their grant for expenses that aren't ethics-related (equipment, RA salaries, etc.).
• When the Research Office receives your RPA form, we double check that the funds requested do not require ethical approval, then it is approved and sent along to Research Accounting to release the partial funds.

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• Any change to the project requires UHREB approval. To get this approval, submit an amendment via WebGrants.
• Note: You can submit a renewal and an amendment at the same time.

Step 1: Log into WebGrants, select “My Grants”, select the title of the project, then select the title of the project.

Step 2: Select “Post-Approval Activity”, select “Add”, then “Human Ethics Amendment/Renewal” and provide a title. Select “Save”.

Step 3: Return to components and complete each section, selecting “Save” then “Mark as Complete” for each section. Below are some tips:

• A Human Ethics Amendment submitted for an approved study needs to be comprehensive and clear within the form, and provide all supporting documentation. A Human Ethics Amendment that asks reviewers to refer to attachments for explanations is not acceptable.

• Justification – needs to have a clear rationale for the amendment that briefly describes the original study, and the specific need for the current amendment to that study. Full sentences are required.
• Description – needs to fully describe the nature of the change to the study that is being proposed. Documents can be attached such as a work plan that provides greater detail, but the essential information should be in the Human Ethics Amendment. The description requires full sentences and clear language.
• Documents to be included where relevant: Partnership agreements that clarify new roles or responsibilities; revised consent documents; revised research instruments; revised protocols for research methods; any communication from an organization or funder that informs the changes. Currently, one PDF of all documents is able to be submitted to WebGrants under the Human Ethics Amendment.

Step 4: Once every section is complete, select “Submit”.

Step 5: Submitting your Human Ethics Amendment sends it to the Ethics Program Officer for their completeness review (ensuring all sections are complete, all sections are cohesive, all attachments are included, etc.). If revisions are required after the completeness review, the Ethics Program Officer will communicate with you via email and reopen the relevant sections of the Human Ethics Amendment in WebGrants. This allows you to revise those sections.

Step 6: Once your revisions are submitted, the Human Ethics Amendment is then sent to UHREB for their review and approval. If revisions are required, the Ethics Program Officer will communicate them to you via email. UHREB may also determine that there is an increase in the level of risk, which would result in a Full Review.

Step 7: An approval letter will be attached to your Human Ethics Application in WebGrants and emailed to you.

After approval:

• Any further changes to the approved Human Ethics Application require an amendment.
• Any adverse events, deviations, privacy breaches, and premature suspensions or termination of the research must be reported to UHREB promptly.
• Each year your project is active, you’re required to renew your UHREB approval.
• When your project is finished, you’re required to submit a Human Ethics Final Report.

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• Ethics approval is normally granted for a period of one year. If any project extends beyond one year, the PI must apply for a renewal of the project before the original approval has lapsed. This is also the case for projects that are approved for a multi-year study.
• Renewal Approval Length: Normally, a renewal will be granted by UHREB for one year, except in the case of substantive change to the research method, adverse participant responses, or major changes to the University's ethics policy.
• Renewing a Lapsed Protocol: There may be situations when a protocol is not renewed as no human participatory research was occurring at the time of renewal. Should a researcher wish to conduct further human participatory research within the same protocol after initial approval has expired, they must go through the renewal process and have approval in place before resuming the research. The approval will be granted from the time of renewal approval to two years from the initial approval, not for an additional year from the date of renewal approval.
• Note: You can submit a renewal and an amendment at the same time.

Step 1: Log into WebGrants, select “My Grants”, select the title of the project, then select “Post-Approval Activity”.

Step 2: Select “Add”, then “Human Ethics Amendment/Renewal” and provide a title. Select “Save”.

Step 3: Return to components and complete each section, selecting “Save” then “Mark as Complete” for each section.

Step 4: Once every section is complete, select “Submit”.

Step 5: Submitting your Human Ethics Renewal sends it to the Ethics Program Officer for their completeness review (ensuring all sections are complete, all sections are cohesive, all attachments are included, etc.). If revisions are required after the completeness review, the Ethics Program Officer will communicate with you via email and reopen the relevant sections of the Human Ethics Amendment/Renewal in WebGrants. This allows you to revise those sections.

Step 6: Once your revisions are submitted, the Human Ethics Renewal is sent to UHREB for their approval.

Step 7: An approval letter will be attached to your Human Ethics Application in WebGrants and emailed to you.

After approval:

• Any changes to the approved Human Ethics Protocol require an amendment.
• Any adverse events, deviations, privacy breaches, and premature suspensions or termination of the research must be reported to UHREB promptly.
• Each year your project is active, you’re required to renew your UHREB approval.
• When your project is finished, you’re required to submit a Human Ethics Final Report.

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• Unanticipated event reporting reporting is required for all research studies whether a study is a clinical or non-clinical trial, or sponsor- or investigator-initiated. Use the Unanticipated Event form in WebGrants.
• Adverse event collection should document unfavourable changes in the current health status of the research participant or any incident, experience or outcome that suggests that the research may place participants or others at a greater risk of harm (including physical, psychological, economic or social harm).
• The PI is responsible for reporting any unanticipated issue or event that may increase the level of risk to participants, or have other ethical implications for participants.
• Any unanticipated issue that may increase the level of risk to participants or may impact participants’ welfare should be reported immediately to the REB.
• The researcher should indicate whether the unanticipated issue was directly related to the research and whether changes to the protocol are necessary to reduce the chance of recurrence.
• If changes are necessary, an amendment request should be submitted in addition to the Unanticipated Event form in WebGrants.
• See SOP 404.003 and 003 for more details.

Step 1: Complete the Unanticipated Event form in WebGrants.

Step 2. The Ethics Program Officer will do a completeness review. If revisions or clarification are required after the completeness review, the Ethics Program Officer will communicate with you via email.

Step 3: Once any revisions or clarification are submitted, the Ethics Program Officer will send the Unanticipated Event form to UHREB for their review. UHREB will determine if any action or follow-up is required.

• If the event does not raise concerns and does not appear to involve risks to research participants or others, UHREB or designee acknowledges the report, and no further action is required;
• If UHREB or designee determines that immediate action is required to protect the safety of research participants, he/she may suspend ethics approval of the research pending review by the Full Board, providing the justification for such action is documented;
• If the event raises concerns or involves risk to research participants such that UHREB action may be required, the item is added to the agenda of the next Full Board meeting after which time the Ethics Program Officer will communicate the next steps to the researcher.

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• When a project is finished, the PI must submit a final report.
• See SOP 406 for more details.

Step 1: Log into WebGrants, select “My Grants”, select the title of the project, then select “Status Reports”, the “Add”.

Step 2: Select “Human Ethics – Final Report” and select dates for the reporting period. Select “Save”.

Step 3: Return to components and complete each section, selecting “Save” then “Mark as Complete” for each section.

Step 4: Once every section is complete, select “Submit”.

Step 5: Once your revisions are submitted, the Final Report is sent to UHREB for their approval.

Before getting started:

• The instructions below are for Principal Investigators (PIs) must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate. Other individuals may be considered on a case-by-case basis. Trainees, research staff, and community research partners should normally be listed as co-investigators, co-primary investigator, or staff as applicable.
• If the project involves the secondary use of date and no contact with human participants, the PI may complete the UHREB Waiver Request – Secondary Use of Data and, if granted, will not have to complete a full New Human Ethics Application

Step 1: Complete the UHREB Waiver Request – Secondary Use of Data and send it to ethics@uwinnipeg.ca.

Step 2: The Ethics Program Officer will do a completeness review. If revisions or clarification are required after the completeness review, the Ethics Program Officer will communicate with you via email.

Step 3: Once any revisions or clarification are submitted, the Ethics Officer will send the UHREB Waiver Request – Secondary Use of Data to UHREB for their review. UHREB will approve as appropriate.

Before getting started:

• The instructions below are for Principal Investigators (PIs) who must have a UWinnipeg affiliation, specifically one of: professoriate, instructor, librarian, professor emeritus, adjunct, graduate student, postdoctoral fellow, or senior research associate who are NOT the lead PI on the project, but are co-investigators or collaborators on a project that is led at a different institution. The protocol must be minimal risk and have prior approval by another TCPS2 institution.
• In circumstances where the UHREB is not “the REB of record” (i.e., a UW researcher is co-investigator or collaborator, not the principal investigator) and the research involves minimal risk, the submission to “the REB of record” will be reviewed by the UHREB Chair alone.

Step 1: Ensure you have a WebGrants account. If you don’t have a WebGrants account, contact ethics@uwinnipeg.ca so an account can be created for you.

Step 2: Log into WebGrants, select “Funding Opportunities”, and select “Multi-Jurisdictional Human Ethics Application (Protocols previously approved by other TCPS2 institution).”

Step 3: Fill out sections 1-22 and submit application.

After approval:

• Any changes to the approved Multi-Jurisdictional Human Ethics Application require an amendment.
• Any adverse events, deviations, privacy breaches, and premature suspensions or termination of the research must be reported to UHREB promptly.
• Each year your project is active, you’re required to renew your UHREB approval.
• When your project is finished, you’re required to submit a Human Ethics Final Report.

Before getting started:

• The instructions below are for any researchers external to UW who hope to access UW faculty, staff, students, or any other UW party to be research participants. You must seek Institutional Permission to contact UW faculty or students for recruitment into the study.

Step 1: Please submit the following to ethics@uwinnipeg.ca:

• Cover letter requesting access to students/faculty of UW
• Lead site’s human ethics application, ethics approval certificate, and all associated documents

Step 2: The Ethics Program Officer will do a completeness review. If revisions or clarification are required after the completeness review, the Ethics Program Officer will communicate with you via email.

Step 3: Once any revisions or clarification are submitted, the Ethics Program Officer will send everything to UHREB for their review. UHREB will approve the request for Institutional Permission and confirm that the study is acceptable with UW’s Vice-President, Research and Innovation (VPRI).

Step 4: The VPRI will determine the next steps for proceeding with your project at UW and will confirm the approval in a letter to the individual requesting Institutional Permission.

• Course-Based and Senior Undergraduate Independent Student Research projects that are minimal risk are reviewed and approved by Department Ethics Committees (DECs).
• Please see Guidance Document 4 – Procedures Related to Course-Based and Independent Undergraduate Student Research for more specific information.
• Depending on the nature of the project, The Course-Based and Senior Independent Undergraduate Ethics Application can be completed by either the course instructor or the student.
• Contact your department to learn more about the relevant DEC.