Research Ethics Board

Post-Approval FAQ

Please see the Procedures for Completing Requests for Ethics Review‌ guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

Post-approval FAQ Categories:

  • A. General
  • B. Adverse Event
  • C. Modification
  • D. Annual Renewal
  • E. Closure

A. General Questions

  1. Can I submit post approval request documents such as modification, annual renewal/extension or closure requests electronically or do I need to send the original copy  to the Office of Research Ethics and if so, how many copies should I include?
  2. What if I don't have a copy of my Certificate of Ethical Acceptablitly and I need it for my thesis binding?
  3. When do I have to update the REB?

Answers:

1. Can I submit post approval request documents such as modification, annual renewal/extension or closure requests electronically or do I need to send the original copy  to the Office of Research Ethics and if so, how many copies should I include?

Yes. Post-approval request documents may be sent to the Office of Research Ethics at ethics@smu.ca. Only one copy is required.  Please ensure that you submit your relevant documents with your request. (Example: All of your relating revised documents along with a modification request.)

Please see the Procedures for Completing Requests for Ethics Review‌ guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

2. What if I don't have a copy of my Certificate of Ethical Acceptablitly and I need it for my thesis binding?

Certificates of Ethical Acceptability are sent to the supervisor/Principal Investigator of the research project along with copies to all researchers.  You should be receiving your certificate directly from your supervisor.  The first step is to check with your supervisor.  If you are unable to obtain a certificate, please contact the Office of Research Ethics.  The Research Ethics Office has your master file.

3. When do I have to update the REB?

You are to contact the REB with updates when:

  • risk to participants change
  • staff/contact information for researchers of the study changes
  • your funding circumstances change (Example: You received new or additional funding for your research.)

B. Adverse Event Questions

  1. What happens if a participant of my research study experiences an adverse event?
  2. Will I receive a certificate involving the adverse event from the REB?

Answers:

1. What happens if a participant of my research study experiences an adverse event?

All adverse events of all magnitude must be reported to the SMU REB as soon as possible no later than one business day following the event.

Relating Reading: SMU REB Policy on Adverse Events

Please see the Procedures for Completing Requests for Ethics Review‌guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

2. Will I receive a certificate involving the adverse event from the REB?

Once the Adverse Event Report has been reviewed by the Board the Chair will provide written feedback from the REB meeting with any additional actions that need to be taken.  Acknowledgement of the researcher’s response will be sent by the Chair to all researchers but a certificate of any type will not be issued.


C. Modification Questions

  1. What if I need to make changes to an already approved application?
  2. Do I need to submit a modification request when someone new joins the research team?
  3. Do I need to submit a modification request when someone leaves the project?
  4. Do I need to submit a modificaiotn request when the proposed end date of my research study as indicated on my initial submission has changed?
  5. How long does it generally take to get my modification request approved?
  6. Will I receive a certificate involving my modification from the REB?

Answers:

1. What if I need to make changes to an already approved application?

You may make changes to the protocol, informed consent or supporting documents at any time and as many times as needed.  A Modification to Previously Approved Proposals (Form 2), is submitted to the REB and you may employ the new changes in the conduct of your research when it is formally approved by the REB.  At the maximum, it takes a few days for the REB to approve modification requests.  Please inform the Office of Research Ethics of your circumstances upon submission of your request.

Please see the Procedures for Completing Requests for Ethics Review‌ guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

2. Do I need to submit a modification request when someone new joins the research team?

If the new team member is handling the data or is involved in an aspect of the project that involves contact with participants, then yes.  If that person is involved in, for example, library research or activities that are removed from participants, then no.  For instance, the REB should be notified (via Form 2) if a student joins a research project and conducts it as part of his or her thesis.

3. Do I need to submit a modification request when someone leaves the project?

Normally, the REB would not need to be notified if someone leaves the project however, in cases where the supervisor of the student project would no longer hold SMU affiliation by leaving the campus a new supervisor will be required and such change must be reported to the REB.  Ensure that the Office of Research Ethics is always updated on the correct contacts involvint the research until the study is formally closed by the REB.  While there may not be a formal requirement it is always good practise to update the Office of Research Ethics so your file can be up-to-date.

4. Do I need to submit a modification request when the proposed end date of my research study as indicated on my initial submission has changed?

It is not required that you formally amend the end of your study date.  However, if the study date is extended and the date exceeds the period for which you have REB approval (one year at a time, one year from the original approval date) you may need to submit an annual approval request; an Annual Progress Report for Previously Approved Proposals, (Form 3).

5. How long does it generally take to get my modificaiton request approved?

At the maximum, it takes a few days to have your modification request approved by the REB including if revisions are required or if you are requested to submit missing documents that would accompany the modification request form. In some instances, if the proposed changes increase the risk to study participants the request will be reviewed at a meeting of the full Board.

Please see the Procedures for Completing Requests for Ethics Review‌guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

6. Will I receive a certificate involving my modification from the REB?

No.  A certificate will not be issued for amending a protocol, informed consent or supporting documents.  You will receive an email notification from the Office of Research Ethics conveying that the changes you requested have been approved and you may start employing the changes immediately.


D. Annual Renewal Questions

  1. When should I send in my extension request?
  2. Will I receive a certificate involving my renewal/extension from the REB?

Answers:

1. When should I send in my extension request?

If you would like to continue conducting your research beyond the date specified on your Certificate of Ethical Acceptability, you are required to submit a Annual Progress Report for Previously Approved Projects (Form 3) a month prior to the anniversary date of your REB approval stated on your original Certificate of Ethical Acceptability or your most recent Certificate of Continuation.

Please see the Procedures for Completing Requests for Ethics Review‌guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.

2. Will I receive a certificate involving my renewal/extension from the REB?

Yes. As all active projects must have a current REB approval at all times, you will always have a valid certificate to prove that you have ethics approval as it is a requirement of the TCPS 2, SMU Senate, SMU REB and your funder/sponsor if applicable. You will receive an email notification from the Office of Research Ethics that your annual renewal request has been approved and a Certificate of Continuation will be issued to the supervisor/Prinicpal Invesigator of the project along with copies for all researchers involved in the study. It is the researchers resposibility to ensure that there is no lapse in approval for the research study.

Please see the Procedures for Completing Requests for Ethics Review‌guideline under the "Policies and Guidelines" section of the SMU REB website that stipulates the SMU REB's requirements.


E. Closure Questions

  1. When has research ended from the perspective of the REB?
  2. Will I receive a certificate involving my closure from the REB?

Answers:

1. When has research ended from the perspective of the REB?

Since the primary purpose of the REB is to protect human research participants, a project is deemed to be complete when involvement with and risk exposure to participants has ended.  Please consult the Office of Research Ethics if you have any questions.

2. Will I receive a certificate involving my closure from the REB?

No. A certificate is not issued when the REB formally closes your file in the Office of Research Ethics. The Completion of Research form (Form 5) is processed and your master file is closed.