Research Ethics at Michener │ About the REB │What REB Applicants Need to Know│ Forms │ Templates│ Checklist │ Policies & Procedures│ Research Study Submission Process│ Related Resources │ Contact Us│ Frequently Asked Questions │ Useful Links│ Guidance & Regulations
The Michener Institute has policies and procedures in place to ensure that research involving human subjects conducted under its auspices meet the highest ethical standards. This includes research conducted independently or collaboratively by Michener faculty, staff and students, as well as research conducted by individuals or groups external to the Michener Institute.
The Research Ethics Board (REB) is responsible for assuring that all research carried out or in collaboration with the Michener Institute meets current scientific, regulatory and ethical standards for the protection of human research participants. The REB has two main functions:
- Review proposed study submissions for science and ethics;
Promote education pertaining to research ethics
- Individuals carrying out research at or in collaboration with the Michener Institute must be appropriately qualified in terms of their education, training and experience to assume the responsibilities associated with the role. Investigators will carry out research at the Michener Institute in such a way that the research meets current scientific, regulatory and ethical standards while maintaining alignment with Michener’s corporate policies, vision, mission and values. For a complete list of Investigator responsibilites, please refer to Michener's REB Policy on Investigator Qualifications and Responsibilities.
- Any research studies carried out at The Michener Institute, or in collaboration with Michener faculty, staff or students, which involve human participants, must be reviewed and approved by The Michener Institute's REB. Research studies may not commence until it meets institutional requirements and REB approval have been obtained.
- All REB applicants must complete the Tri-Council Policy (TCPS) 2: Course on Research Ethics (CORE) online tutorial before their study commences. The TCPS describes standards and procedures to be used by REBs for governing research involving human subjects.
- The Michener Institute REB Submission Form can be obtained here. An REB Submission Checklist should also be obtained and submitted with your REB Submission Form. The REB Submission Checklist is used as a guide to ensure that all required elements are included in your submission to be considered for REB review.
- REB submissions should be completed and submitted to the Applied Educational Research (AER) Office at email@example.com.
- The Michener Instutite REB Submission Form
The REB Submission Form is used for social sciences/humanities projects/studies.
* The Michener Institute REB Submission Form is aligned and harmonized with The Toronto Academic Health Science Network (TAHSN) Human Subjects Research Application Form. The TAHSN form is designed and used to facilitate inter-institutional research studies.
- REB Delegated Review Report Form (for REB Committee members only).
The REB Delegated Review Report Form is used to assist REB Committee members with recommendations and decisions about REB submissions.
- REB Research Project Continuation and Renewal Form
The REB Research Project Continuation and Renewal Form is used to obtain REB approval to continue with research studies beyond the original completion date of REB approved projects.
- REB Adverse Event Reporting Form
The REB Adverse Event Reporting Form is used to report to the REB, any unanticipated issues that arise from the research study. As per TCPS 2, Article 6.15 "Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants, or has other ethical implications that may affect participants’ welfare."
- REB Amendment(s) Form
The REB Amendment Form is used to report to the REB any amendment(s)/change(s) to a previously approved research project.
- REB Protocol Deviation Form
The REB Protocol Deviation Form is used to report to the REB any major protocol deviations that profoundly affect the integrity of the study and/or have the potential to be hazardous to participant safety.
- REB End of Study Report Form
The REB End of Study Report Form is used to report to the REB when a study has completed. Study completion refers to the point when there is no further participant involvement and/or data collection, access to data is no longer needed, clarification, and transfer of data is complete.
- Collaboration Agreement Form
The Collaboration Agreement is a form used when a Michener staff, faculty, and/or student(s) has agreed to collaborate on a research project with a Principal Investigator(s) from another institution/organization. By completing this form, the Principal Investigator has agreed to adhere to the conditions outlined in the agreement form.
- Informed Consent Form Template
This template is provided to assist applicants with development of an Informed Consent Form. Applicants should customize this template according to their particular research project.
- Focus Group Consent Form Template
The Focus Group Consent Form Template is used to recruit participants in a focus group to obtain feedback about a particular topic. It is also used to explain to the potential participant what the focus group process entails. Applicants may use this template as a reference document to help create a customize Focus Group Consent Form for their project/research studies.
- REB Submission Checklist
The REB Submission Checklist outlines all required elements for submission of a complete application for ethical review.
- Informed Consent Form Checklist
The Informed Consent Form Checklist outlines all required elements that should be addressed in an Informed Consent Form.
- Activities Requiring REB Review
- REB Amendments, Changes, Notifications
- Investigator Qualifications and Responsibilities
- REB Delegated Review
- Tri-Council Policy Statement (TCPS 2). Ethical Conduct for Research Involving Humans 2011
- The Ontario Personal Health Information Protection Act (2004)
To see the full list of REB policies please visit the Policies section of My Michener.
- Research Study Process Map (for Internal Applicant)
- Research Study Process Map (for External Applicant)
For more information or assistance regarding the REB process, contact us:
Applied Educational Research Office
The Michener Institute for Applied Health Sciences
222 St. Patrick's Street
Toronto ON M5T 1V4
Carlo Mandarino, Research Manager
Tel: (416) 596-3101 ext 3477
Fax: (416) 596-3105
Room 1332, 13th Floor
Monday - Friday, 9:00am - 5:00pm
1. I want to conduct research at The Michene Institute. What do I need to do?
Please refer to section above on “What REB applicants need to know and do prior to submission” for a complete list of requirements for REB submissions.
2. How do I know if my project requires Research Ethics Review?
You can get a preliminary assessment for your project by reviewing the Toronto East General Hospital (TEGH) chart* "Does this project require REB review?". Alternatively, you can contact the Research Office for a project consultation.
* The Michener Institute would like to acknowledge Toronto East General Hospital (TEGH) for its permission to use their REB review chart.
3.What types of projects are NOT subject to ethical review?
Research activities of the following nature do not require REB review:
Quality assurance/improvement studies, program evaluation, performance reviews-Studies to directly assess the performance of an organization, its employees or students;
Research regarding individuals living in the public arena or artists-based on information that is publically accessible including creative practice activities where an artist makes or interprets a work or works of art;
Naturalistic observation of people in public places not associated with any specific participant or group of individuals where there is no expectation of privacy and the dissemination of findings does not allow for the specific identification of any individual;
Information already publicly available or legally accessible to the public where there is no expectation of privacy;
Research that involves the secondary use of anonymous information or anonymous human biological material which cannot be traced to the original research participant(s).
The REB should be contacted for any research activities where there is doubt regarding the necessity of review. For more information, please refer to Michener's REB policy on Activities Requiring REB Review.
4. I'm working with a Principal Investigator at another institution where they already obtained an Ethics Approval there. Do I need to get an approval from the Michener as well?
Yes, you still have to submit an application for ethical review and get approval from the Michener Institute’s REB before any research study begins. Submitting your exisiting application may expedite the review and approval process.
5. How do I submit a complete Michener REB application for ethical review?
Before submitting your application, ensure all forms contain appropriate signatures. You may submit your completed application to the REB for review by email, mail, or fax. Please see the Contact Us section to obtain the contact information.
6. What other information do I include with my submission to be considered for an REB review?
The REB Submission Checklist will give you a full list of all the required elements to include with your submission in order to obtain an ethical review.
7. When can I submit my application for an REB review?
You may submit your REB application for review only when you have followed and/or completed section 3.0 of Investigator Qualifications and Responsibilities Policy. The REB Terms of Reference (section VI) stipulates that meetings are scheduled on an as needed basis, however, it does not stipulate deadline for REB submissions.
8. What happens to my application once it is submitted for an REB review?
Once you submit your application you will recieve an acknowledgement email to let you know your application has been recieved. The REB Chair receives all incoming submissions and will determine whether expedited review or full review is required (section X of Michener's REB Terms of Reference).
9. When can I expect to hear from the REB about my submission?
You can expect to hear from the REB about your submission usually within five weeks from the date of submission, if the following three conditions have been met:
1) all required information pertaining to the project has been submitted;
2) no further information or clarification is required by the Principal Investigator(s);
3) the project meets current scientific, regulatory and ethical standards for the protection of human research participants.
The REB may delay final approval pending clarification or other information to be provided by Principal Investigator(s). Submissions may also need to be revised and resubmitted to the REB for an ethical review.
10. How do I know if my submission requires delegated or full review? What is the difference?
TCPS 2, Article 6.12, states the two levels of research ethics review that may apply:
1) Full REB review is the default requirement for research involving humans;
2) Delegated REB review of minimal risk research.
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.” TCPS 2, Chapter 2 Section B.
The Michener Institute provides proportionate review for all research protocols and as such all research submissions will be stratified by the Chair of the REB into those studies requiring full board review and those studies that may be delegated. Please refer to the policy on REB Delegated Review.
11. For how long is my ethics approval valid?
Approval will be valid for twelve (12) months unless otherwise stipulated. It is the responsibility of the Principal Investigator (PI) to keep their REB approval current. The investigator must seek a renewal approval for another 12 months prior to current approval expiration by completing an REB Research Project Continuation and Renewal Form and submitting it to the Michener Institute REB.
12. How do I report a change to my study?
The REB Amendment(s) Form shoub be obtained and completed to report any amendment(s)/change(s) to a previously approved research project to the REB for review.
The REB will place greater importance on the ethical implications of the amendment(s), change(s) or notification(s), rather than the size of the amendment(s), change(s), or notification(s) in determining the degree of scrutiny required for review. For more information on this policy please refer to Michener's REB Amendments, Changes, Notifications.
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