This page will provide answers regarding who should obtain research ethics approval, how to obtain approval, and how to maintain that approval over the course of the project.
Do I need ethics approval?
Your project may need to be reviewed by the Research Ethics Board (REB) if it involves contacting humans, their tissue, and/or data about them. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans defines in Chapter 2 (TCPS2) when REB review is required
Article 2.1 The following requires ethics review and approval by an REB before the research commences:
- research involving living human participants;
- research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.
How long will it take to obtain approval?
The process will take four to six weeks, depending on the complexity and quality of the submission. This flow diagram outlines the review process.
Who can apply for ethics approval?
The “Principal Investigator” named on an REB Application must be a faculty member at the University of Guelph.
- Post-doctoral fellows and sessional lecturers must have a regular faculty member act as the Principal Investigator.
- Applicants from outside the university community must have a regular faculty member act as the Principal Investigator (or someone eligible to submit an ethics application at the University of Guelph).
There are exceptions to this rule, including:
- Senior staff members can be Principal Investigators. They should be the most senior individual in their department/area.
- Adjunct Professors or Emeritus Professors can be Principal Investigators.
- A course instructor can be the Principal Investigator for an REB Application covering student work for that course. The instructor must complete a training program and submit a copy of the certificate(s) with their submission.
When will your project need review at a full board meeting of the REB?
Full board review is required when the project poses greater than minimal risk to the research participants. Minimal risk is defined as “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research.” For a full discussion of risks, consult the TCPS2, Chapter 2 B.
When should you submit for full board review?
- Please submit your application as soon as you can
- Minimal risk studies can be submitted anytime
Studies requiring full board review (higher than minimal risk) MUST be submitted at least two weeks prior to the meeting date. Submitting by this deadline does not guarantee that your project will be reviewed on that specific meeting date. If your submission requires pre-review clarification it will be reviewed at the next full board meeting once the pre-review clarification process is complete and your REB Application is ready for review. Give yourself time.
What is pre-review for clarification?
Ethics office staff will review your submission for anything which requires clarification BEFORE the submission is reviewed by the REB. This process helps the researcher to prepare a clear and complete package ready for REB review, and speeds the review process.
How do I obtain approval to engage humans in a research project?
Submit a new REB Application for the REB to review
- Complete your Human Ethics submission using the REB Application found under the Forms section. See that section for a discussion of which forms you need, including which supplemental forms may be required.
- Email your submission to email@example.com.
- Attach the REB Application as a Word document
- Also attach any other documents (as separate Word documents where possible) such as Consent Forms, Recruitment documents, Questionnaires, etc.
- Attach a training certificate for every student involved in the project. Training is mandatory for students, and recommended for everyone involved in research involving humans.
- The full team will receive a notice of receipt of your new REB application.
- All other communications will occur by email between the Ethics Office and the Principal Investigator.
Note: If your project has already received REB approval based on the TCPS2 or equivalent from another institution?
- submit the main REB Application, filling out only Section A, B, C, D, N, and O. Fill out Sections L and M ONLY IF data is being stored at the University of Guelph.
- Submit along with all documents which received approval at the other institution and a copy of the approval certificate.
I received feedback from the REB. How do I make these revisions and how long will it take?
- After each point in your feedback document, indicate how and/or where you have made the modification in response to the comment.
- For every document which requires modifications, open the document, ensure there are no tracked or highlighted sections, then turn on Word’s track changes. Make your modifications. Save it with filename_tracked.
- Save a copy of the document you just modified, and accept all the changes. Now you have a clean copy of the modified document – save it with the same filename_clean.
- Submit the clean and tracked version of all documents along with your feedback document to firstname.lastname@example.org
- The ethics office can review and clear many of these modifications. Sometimes, modified documents must be sent back to reviewers, and some are reviewed again at a full board meeting.
I have approval, but something has changed. How can I change my ethics protocol after approval?
- Please submit the Amendment form
- NOTE: If your original application was made in ResearchLink, the Ethics Office can supply you with copies of the ResearchLink eForm, and any other documents you wish to amend.
- Amend all documents using track changes and submit ‘clean’ and ‘tracked’ versions (see above) for review to email@example.com
- The ethics office can review and clear many of these amendments. Sometimes, amended documents must be sent to reviewers, and some are reviewed at a full board meeting.
- You will receive a new certificate indicating that the Amendment has been reviewed.
I have finished my project. How do I indicate this?
- Please submit the Annual Renewal form
- For question 5, choose “Please close this submission”
- Submit by email to firstname.lastname@example.org
I need to renew my project. How do I do this?
- Please submit the Annual Renewal form.
- For question 5, choose “Please renew the approval for this submission for another calendar year”
- Submit by email to email@example.com
- You will receive a new certificate indicating another year of clearance.
- Projects can be renewed for UP TO 5 years. Please note that renewal will only be granted up to six weeks prior to the current expiry date.