Frequently Asked Questions

Frequently Asked Questions

I want to conduct research at The Michener 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.

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.

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.

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.

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.

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.

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.

What happens to my application once it is submitted for an REB review?

Once you submit your application you will receive an acknowledgement email to let you know your application has been received. 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).

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.

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.

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.

How do I report a change to my study?

The REB Amendment(s) Form should 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.

Useful Links                                                                                           

Applied Educational Research (AER) Proposal Writers Guide

Alberta Research Ethics Community Consensus Initiative (ARECCI) Ethics Screening Tool

WHO Guide for writing a Research Protocol for research involving human participation

WHO International Clinical Trials Registry Platform (ICTRP) -Frequently asked questions

The Canadian Association of Research Ethics Boards (CAREB)

The Belmont Report

The Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects

The Nuremberg Code

Canadian Institutes of Health Research (CIHR)

The National Council on Ethics and Human Research (NCEHR)

Council for International Organizations of Medical Sciences (CIOMS)

45 Code of Federal Regulations (CFR) 46 (US)

21 CFR 56 (US)

21 CFR 50 (US)

National Institutes of Health (NIH) (US)

Office for Human Research Protections (OHRP) (US)

Tri-Council Policy Statement 2 (Course on Research Ethics) Online Tutorial

Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards (MOU)

ClinicalTrials.gov

ICMJE-Uniform Requirements for Manuscripts Submitted to Biomedical Journals

Index Medicus-abbreviation of journal titles

Good Clinical Practices – Compliance and Enforcement – Drugs and Health Products – Health Canada

UofT Research Ethics

UofT Principles to Determine Exemptions from Research Ethics Review

UofT Principles to Distinguish between Research and Field-based Professional Inquiry

Toronto East General Hospital-Does this project require REB review?

Fraser Health Authority Department of Evaluation and Research Services-Differentiation of Research, Quality Improvement and Program Evaluation

Guidance and Regulations                                                                        

Tri-Council Policy Statement (TCPS 2).  Ethical Conduct for Research Involving Humans 2011

International Conference on Harmonisation ( ICH) Harmonized Tripartite Guideline.  Good Clinical Practice: Consolidated Guideline (E6)1996

Health Canada (Division 5, Part C) Food and Drug Act 2001

Part 4 of the Natural Health Products Regulations 2003

Part 3 of the Medical Devices Regulations 1998

Ontario Personal Health Information Protection Act (PHIPA) 2004

Personal Information Protection and Electronic Documents Act (PIPEDA) 2000

The Health Care Consent Act, S.O. 1996, c.2.

The University of Toronto Guidelines and Practices Manual for Research Involving Human Subjects

CIHR Best Practices for Protecting Privacy in Health Research 2005

The Regulated Health Professions Act 1991

Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004)

We Can Help

For general inquiries or assistance please contact research@michener.ca.