Skip to content

Research Ethics Board

Frequently Asked Questions

Submission
TAHSC/TAHSN application questions
Review Process
Approval Process
Continuing Review
Protocol Amendments
Serious Adverse Events

Submission

1. I have never submitted an application for review to the St. Michael's Hospital (SMH) Research Ethics Board (REB), or I have questions about the application. Who do I talk to?

If you have any questions about the process, the application form, or any other REB submission questions, you are welcome to call the REB office for assistance. If you require assistance in completing a submission (e.g. TAHSC application form), the REB is available for consultations. Please contact the Research Ethics Office in advance, to schedule an individual consultation.

2. What information must we include in our packages for submission?

  • TAHSC Human Subjects Research Application (294 KB doc file) with all sections completed.
  • All signatures already obtained for:
    • The Principal Investigator (PI)
    • Any Co-Investigator(s)
    • Division/Department/Program (must NOT be one of the Investigators)
  • PHIPA Appendix (125 KB doc file)
  • Research protocol (mandatory)
  • Patient information (Note: if participants are under 16 years of age, assent form must be included)
  • Consent Forms
  • Questionnaire, Data collection and/or Study instrument
  • Investigator's brochure(s) / Product Monograph(s)(if applicable)
  • Advertisement/poster (if recruiting participants by advertisement: Note – must use SMH letterhead)
  • Copy of peer review or any other REB approvals (Note: if the study has been approved elsewhere, a copy of the approval letter is required)

3. How many package copies are required?

  • In terms of the number of packages that you need to submit to the REB, for a full board review submission:
    • You need six sets of the entire package (that would include all the documents mentioned above)
  • 24 sets of a condensed package, which include:
    • The TAHSC application form
    • The PHIPA addendum
    • The consent form
    • Other applicable documents (e.g. posters, telephone scripts, etc.)
  • In terms of the number of packages that you need to submit to the REB, for an expedited/delegated review submission:
    • You need four sets of the entire package (that would include all the documents described in the full board review listing)
  • Note: The REB reserves the right to request additional copies if a study should be determined to require Full Board review.

4. What are the submission deadlines?

  • The REB has no specific deadlines for submission. Both expedited/delegated review and full board review studies are reviewed on a first-come, first-served basis.

TAHSC/TAHSN application questions

1. Who needs to sign the TAHSC application form?

  • The TAHSC application needs to have signatures for the Principal Investigator (PI), any Co-Investigators (Co-Is), and the Department/Division/Program Head. Please note that the Department/Division/Program Head signature must not be of someone involved in the study in any way (i.e. not listed as a Co-Investigator).

2. Who can be a Principal Investigator (PI)?

  • The role of Principal Investigator must be compliant with institutional requirements (i.e. St. Michael's Hospital and/or the University of Toronto) and meet regulatory standards if needed. This means the PI must be an employee or have an appointment at SMH. Also, for any student study, the PI must be the student's Supervisor at SMH. The student can act as the Co-I.

3. I am not from St. Michael's Hospital. How do I submit a study to the SMH REB?

  • To do so, you need to have a Principal Investigator at SMH (i.e. someone who is an employee of or has an appointment at SMH) who will be solely responsible for the scientific and ethical conduct of the study at SMH.

4. I am a student, and want to conduct research at St. Michael's Hospital. What do I need to do?

  • All student research needs a Supervisor at SMH. This Supervisor will act as the Principal Investigator. In addition, if you are a student from the University of Toronto (U of T), you will need to comply with U of T policies and guidelines.

5. Do I need to get Co-Investigator signatures?

Review Process

1. What requires REB review?

  • Any study involving human participants or human related information requires review and/or approval by the SMH REB. There are some exceptions to this. Please contact the Research Ethics Office for further information.

2. What happens to a submitted protocol?

  • Pre-screening by the Administrative Assistant
  • Assigned to a Research Ethics Coordinator
  • Determination of whether or not a protocol qualifies for expedited/delegated review
  • Reviewed and questions/comments are sent to the Principal Investigator
  • Research Ethics Coordinator is the contact person

3. What does "expedited/delegated" really mean?

  • The protocol is reviewed by a subset of the Board and is deemed to be of minimal risk over standard procedures. Studies that qualify for expedited/delegated review include:
    • Research with no direct patient contact (i.e. retrospective chart review)
    • Database development
    • Questionnaire
    • Surveys

4. What is a full board review?

  • Full Board review refers to a study that qualifies as greater than minimal risk, and is subsequently reviewed by the entire Research Ethics Board. Full Board review studies (those studies that are greater than minimal risk) include studies such as:
    • Clinical trials of drugs, devices, or natural health products.
    • Those collecting significant personal health information.
    • Those studies where the participant/patient population is particularly vulnerable.

5. How often does the Board meet?

  • The Board meets bi-monthly and reviews over 350 new protocols per year.

6. How does the REB assess risk?

7. Who do I contact with my questions?

Approval Process

1. How long does approval take? Is it different for a full board review study or an expedited/delegated review study?

  • The length of time for a study to be approved varies according to a number of factors. The study classification (as full board or expedited/delegated) is a primary determinant. Additional factors can include the complexity of the study, the risks involved, availability of expert reviewers, and the time taken by investigators to respond to the REB all impact the length of time to approval, amongst others.

Continuing Review

1. What do I need to do to ensure that my study continues to remain approved by the REB?

  • The REB approves studies for a maximum of one (1) year. It is the responsibility of the Principal Investigator (PI) to keep their REB approval current. The annual/interval review form (147 KB doc file) must be completed and submitted to the REB prior to the expiration date for approved projects. The form must be submitted in hard copy with original signatures.

2. My study is complete. How do I close a study?

  • The REB considers a study to be complete (i.e. ready to be closed) when the following criteria have all been met:
    • All recruitment is completed for all sites.
    • All active treatment and follow-up is completed for all sites.
    • All analyses are completed from this site.
    • There is no further involvement of the principal investigator at this site in any aspect of the study.

If your study meets all these criteria, please complete the annual/interval review form (147 KB doc file), mentioning that you wish to close the study. The form must be submitted in hard copy with original signatures.

Protocol Amendments

1. How do I report a change to my study to the REB?

Any changes to the study, such as changes to

  • study personnel
  • the way the study is being conducted
  • the types of information being collected
  • the analysis being conducted

must be reported to the REB on a cover letter. Each change must be accompanied by a relevant explanation, as well as updated copies of all relevant documents, with the changes from the previously approved documents highlighted.

2. How long will it take for a protocol amendment to be reviewed?

Protocol amendments are reviewed on a first-come, first served basis. The same factors that affect the length of time for initial study approval also impact protocol amendment review and approval.

Serious Adverse Events

1. What is a serious adverse event? How do I report it?

A serious adverse event (SAE) is any adverse occurrence or response to a drug/intervention, whether expected or not, that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity that is life threatening or that results in death.

  • Any SAE must be reported to the SMH REB using the adverse event notification form (123 KB doc file).
  • The reporting of SAEs may not be deferred to the Annual Progress Report.
  • In addition, local SAEs must be reported by the Locally Responsible Investigator to the study Sponsor and/or if the Investigator is the Study Sponsor, then the Investigator must report to the appropriate federal government agencies (e.g. Health Canada).

2. How soon do I need to report a SAE to the SMH REB?

For local serious adverse events, the Principal Investigator must:

  • Use the adverse event notification form (123 KB doc file).
  • Promptly report all local serious adverse events, whether expected or not, to the Research Ethics Board.
  • The expectation for reporting all locally occurring serious adverse events, drug-related or other is as follows:
    • If it is neither fatal nor life threatening, within seven business days after becoming aware of the information.
    • If it is fatal or life threatening, within 72 hours after becoming aware of the information.

For non-local serious adverse events:

  • If the local site is part of a multi-centre study, the Locally Responsible Investigator is responsible for providing regular (two to three times per year) Data Safety Monitoring Board (DSMB) or Sponsor-generated Safety Reports to the REB Office, as described below, along with an appropriately completed adverse event notification form (123 KB doc file).

Data Safety Monitoring Board (DSMB) and Sponsor-generated Safety Reports:

  • All DSMB Reports must be forwarded as soon as they are available and must be accompanied by a letter from the Locally Responsible Investigator indicating that he/she accepts the findings and recommendations of the DSMB.
  • Any sponsor-generated safety reports must be accompanied by a complete adverse event notification form (123 KB doc file) from the Locally Responsible Investigator indicating his/her assessment of the seriousness and causality of the side effects and whether in his/her opinion they alter the risk/benefit ratio and/or require changes to the Information/Consent documents, Protocol, or other study documents.

3. How many copies of serious adverse events do I need?

  • For any local serious adverse event, the REB requires that three copies of the completed adverse event notification form (123 KB doc file) (along with relevant documentation) be submitted to the Research Ethics Office.
    • One copy will be stamped, and returned to you at the time of submission – this will serve as your proof of submission of the adverse event notification form to the REB.
    • A reviewing member of the REB will sign and date the remaining two copies of this Adverse Event REB Notification Form. One copy will be retained for our files and the other copy will be returned to you for your files.
  • For any non-local serious adverse event, the REB requires that two copies of the completed adverse event notification form (123 KB doc file) (along with relevant documentation) be submitted to the Research Ethics Office.
    • One copy will be returned to you for your files; this copy will be stamped, and returned to you at the time of submission, and will serve as your proof of submission of the adverse event notification form to the REB.
    • A reviewing member of the REB will sign and date the remaining copy, which will be retained for our files.