FAQs

New study applications must be submitted through SunRISE no later than 4:00 p.m. on the 22nd of the month. This deadline applies to both delegated and full board reviews. In the case that the 22nd falls on a holiday or weekend, the next business day will be considered the deadline date. See this list for all scheduled REB meetings

For queries related to completing an research ethics board (REB) application, contact Research Ethics.

No, residents and fellows cannot be principal investigators. However, they may act as co-investigators on a study being conducted at Sunnybrook.

The following describes what happens to research ethics board (REB) applications after being received by research ethics:

1. All applications, received by the deadline for consideration at the REB meeting held the following month, are screened to ensure that they are complete and include all required appendices and appropriate signatures. Applications received after the deadline are held by research ethics and screened the following month.
2. Applications for delegated review are distributed to a REB member for review.
3. Applications for full board review are distributed to all REB members for review and discussion at the next full board meeting. The REB utilizes the primary and secondary reviewer model for initial review. Primary and secondary reviewers are required to review assigned research projects in detail and lead the discussion at the meeting.
4. After a review, delegated or full board, and if the reviewer(s) require clarification, a comment letter is issued to the principal investigator.
5. The principal investigator responds to the comment letter by way of research ethics.
6. Once all comments have been satisfactorily addressed, an approval letter is issued to the principal investigator.

The length of time from the REB submission deadline to research ethics issuing a comment letter is about three to four weeks.

To reduce the number of unnecessary research ethics board (REB) reviews completed for research proposals that are never initiated due to unsuccessful funding applications, the REB requests that you do not submit for review until confirmation of funding has been received.

The REB will consider the review of applications when funding is pending if it is a requirement of the funding agency or if there is confirmation that the research will proceed even if funding is not awarded. The reason must be clearly documented on the REB application.

Fees for submitting to the Sunnybrook REB apply to all industry-sponsored/supported studies and are invoiced upon receipt of the submission by research ethics.

All funds are in Canadian currency.

The following are the fees currently in place:

• initial REB submission/review: $3,500
• renewals: $500
• amendments: $500

For more information on REB fees, refer to the Sunnybrook Research Institute (SRI) policy “REB – Review, Renewal, and Amendment Fees” on the Sunnybrook intranet.

View the CTO fee schedule (under 1.)

The level of REB review assigned to above minimal risk research projects. Conducted by the full membership of the REB, it is the default requirement for the ethics review of research involving humans. The REB meets at a scheduled monthly meeting to review these studies.

The level of review assigned to minimal risk research projects. Delegated reviewers are selected among the REB membership and the reviews are conducted independently (not at a meeting).

Studies that may qualify for delegated review:

• are considered either minimal risk and noninvasive (e.g., retrospective chart reviews, nonintrusive questionnaires or surveys, noninvasive assessments, use of existing samples); or
• involve only current standards of care; or
• have had prior approval from a TAHSN institution’s REB. These studies are not considered for delegated review, unless the relevant documentation (REB review letter, reply to any REB concerns and approval letter) is provided, and the sponsor accepts this process.

No, REB approval is not required.

Click here for Ethics Centre Resources

For questions about case reports and consent requirements for case reports, please contact Kevin Reel (kevin.reel@sunnybrook.ca) in the Ethics Centre.

View Institution-specific information.

Visit information for staff

Visit the Clinical Trials Ontario website for more information

Any exchange of funds, resources, information, data, equipment, samples etc. require appropriate agreements to be in place. Please contact Legal Services for further guidance.

*UPDATED August 2022

Regulated Drug and Natural Health Product Studies

• Drug or natural health products studies that are regulated by Health Canada require 15-year study-related record retention.

Regulated Medical Device Studies

• Sunnybrook strongly recommends a 15 year retention period for clinical trials regulated under a Medical Device ITA unless otherwise advised in writing by the named sponsor of the ITA. For more information, please see our Note To File_N2SOP 024.

Other Non-Regulated Studies

• There are no defined regulations or standards for other research studies (i.e., non-regulated). The Sunnybrook research ethics board’s recommended standard is ten years for non-regulated studies. However, sponsor, publishing journal or professional affiliation standards for record retention may apply.

Data and/or biological samples collected for a future unspecified research purpose can only be considered for REB approval if the future research will relate to the subject matter of the current study that the data/sample collection is occurring in connection to (e.g. should be related to the specific condition, study intervention, etc.­ currently under study).

Broad consent, as defined in Section E of TCPS2 (2022), must be obtained prior to collection of the data/samples fo­­r future research purposes. Broad consent differs from blanket consent in that it specifies limits on what research can be conducted on the data/samples collected whereas blanket consent is not permitted under TCPS2 (2022).

Please refer to Article 3.13 of the TCPS2 (2022) for guidance on the necessary elements of broad consent.

Sunnybrook REB does not require a copy of this Health Canada authorization as part of its review.

No, the REB approval letter for the study can be provided to Health Canada in lieu of the signature in Part 3 (c) of Appendix 2.

When Sunnybrook REB is the Board of Record:

• Submit the plan to the REB for review and approval.
• The participant must consent to these visits.
• The Informed Consent Form (ICF) or consent addendum should include the following:
  • Identify the name of the company conducting the home visits
  • State that they are not affiliated with Sunnybrook but have been contracted by the sponsor
  • Specify what activities may be conducted
  • State that the PI and research team will be providing the company with information about the participant in order to conduct the necessary research activities
  • Explain how privacy and confidentiality will be maintained
  • Outline any risks related to these visits
  • Detail the measures the company will be taking to protect the participant e.g. wearing PPE
  • Outline any other applicable details

When Sunnybrook REB is NOT the Board of Record, consult with the applicable REB for their requirements.

Contact SRI Safety and Compliance

It is a Sunnybrook Health Sciences Centre (Sunnybrook) policy to have a Research Ethics Board (REB) that ensures all health research activities involving human subjects or human materials, being conducted within or on behalf of Sunnybrook, meet current scientific, regulatory and ethical standards for the protection of human research subjects.

The principal investigator assumes full responsibility for the scientific and ethical conduct of the study as described in the REB application and submitted protocol, and agrees to conduct the study in compliance with the regulations (outlined below). The principal investigator assures that all investigators, researchers and other personnel involved in the study are appropriately qualified and will undergo appropriate training to fulfill their role in the study.

All research studies submitted to the Sunnybrook REB must be conducted in compliance with:

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2); and
• The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004.

All clinical trials filed with Health Canada or the Food and Drug administration (FDA) and phase IV trials (i.e., post-marketing), must also comply with the following, as applicable:

• International Conference on Harmonization (ICH) Guidance E6: Good Clinical Practice (GCP): Consolidated Guideline;
• Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations of Health Canada 2001; 
• Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003;
• Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Device Regulations of Health Canada;
• International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects – Good Clinical Practice 2020 (ISO 14155); and
• United States Code of Federal Regulations Title 21 Part 50 and Part 56, and CFR Title 45 Part 46

*Updated August 2022

Use language that is as non-technical as possible, and understandable to the participant, without compromising the content. An eight-grade reading level is recommended (N2 SOP006).

The Flesch-Kincaid Grade Level score, available in Microsoft Word, may be used to assess the readability of an ICF.

Initial contact with patients about recruitment for a research study should be made by a member of the patient’s circle of care (e.g. the patient’s physician, health professional, medical secretary, etc.). Specifically, the member of the patient’s circle of care can ask them if they would like to hear more about a research study from a member of the research team. If the patient agrees, the study team member will be permitted to speak to them about possible participation in the research study.

In certain scenarios, the REB may consider alternate acceptable methods of initial contact for patient recruitment if adequate justification is provided in the REB application:

• For minimal risk research studies, the REB may consider permitting physicians to delegate authority to research staff to contact all of their patients who are potentially eligible patients under their care.
• For greater than minimal risk research studies, the REB may consider permitting the research staff to obtain permission from the physician prior to contacting each potential participant on a per-patient basis.

In both of the above cases, research staff must ensure patients are aware that they are speaking to them on behalf of their physician and this delegation of authority must be documented in the study files. See N2 SOP 009 Addendum for more information.

A member of the study staff must obtain consent. This may be the principal investigator or designate. Consideration must be given to possible coercion by virtue of pre-existing relationships (i.e., physician-patient, professor-student). When feasible, to minimize any possible coercion, another member of the study staff should obtain consent.

Note: The person obtaining informed consent does not have to be the same person, or only person, that conducts the informed consent discussion.

In cases of online or paper based survey research when minimal risk or harm is anticipated and identification of the individual is not necessary for the study design, the research ethics board (REB) typically accepts the use of implied consent.

Implied consent is accomplished by providing the potential participant with the necessary information at the beginning of the survey to “inform” them of the research project. The information section should include an abbreviated version of all of the relevant material normally included in a consent form, but no signature line for the participant is needed. In the information section, the participant is instructed that participation in the survey is voluntary.

The implied consent process may state something like: “If you return/submit this survey, it will be understood that you have consented to participate.”

View details on the Research Ethics page

Data/results that are generated through research may be included in a patient medical record when:

1. the research data/results are generated through a validated method, AND
2. clinical use of the data/results are supported by a published practice/clinical guideline, AND
3. including the research data/results in a patient’s medical record is supported by the patient’s written informed consent.
4. It is the responsibility of the PI to follow institutional process in adding the documents to the patient chart.

Note: The research and clinical landscape changes over time as more is learned so the decision to report should be based on current evidence and can not be expected to change beyond the duration of the study. The care plan ultimately rests with the clinician and their patient.

• If the project involves research conducted only within/at Sunnybrook, you can apply to the Sunnybrook REB
  • Note that at Sunnybrook, a resident or medical student cannot be the Principal Investigator (PI) on the REB application. The medical student or resident must work with a PI who has an appointment at Sunnybrook
• If the project will be conducted by medical students and/or residents and the project will exclusively enroll medical students, residents, or physicians, that span across the university system, you can apply to UofT REB

Note: For studies reviewed by the UofT REB, faculty approval through submission to the Associate Dean, Post-MD Education (adpgm@utoronto.ca) is required. Further info on this process and its requirements can be found here.

The REB expects that data collection for retrospective studies will only occur within the date range specified in the initial application. The REB will consider one date range extension request if sufficient justification is provided as part of an amendment submission to the REB.

Best practice for all research studies is to obtain consent prior to enrollment of participants in a research study. Generally, due to the possibility of commercializing research findings, the REB does not consider consent waivers for research studies that involve sharing of participant data with an industry partner. In such cases, irrespective of study design, participant informed consent is normally required.

There are rare limited situations (e.g. sending truly anonymous data etc.) where granting a consent waiver may be permissible and would need to be considered on a case-by-case basis. To confirm, please contact the Sunnybrook Research Ethics Office to discuss further prior to study submission.

Review by a research ethics board is required for all research that relies exclusively on secondary use of information or human biological materials, unless the information or materials are anonymous and the process of data linkage or recording or dissemination of results does not generate identifiable information.

Secondary use: The use in research of information or human biological materials originally collected for a purpose other than the current research purpose.

Anonymous: The information or human biological materials never had identifiers associated with it (e.g. anonymous surveys) and risk of identification of individuals is low or very low.

For assistance with determining whether your secondary use of data requires review by the research ethics board, contact Research Ethics.

At Sunnybrook, the REB accepts a study completion form, which triggers clsure of a study with the REB, once all of the following conditions are met: 

1. no participants remain on the study
2. no further data collection or access to data sources are required, and 
3. no further access to patient records are required. 

Sunnybrook Health Sciences Centre has an organizational account with ClinicalTrials.gov. To obtain a user account for registering your clinical study with ClinicalTrials.gov, contact the Research Ethics Coordinator, who is the protocol registration system (PRS) administrator for Sunnybrook.

Note: Once a study is registered, you are responsible to ensure that the information entered is accurate and up to date (i.e. overall recruitment status, study completion date, enrollment). If during the course of the study there is a protocol amendment, the affected data elements (i.e., eligibility criteria) must be updated.

Published in September 2016, the NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.

In regards to your trial, ask yourself these questions:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an intervention?
3. Is the study designed to evaluate the effect of the intervention on the participants?
4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is yes, then we consider your research a clinical trial, and therefore the trial should be registered.

Reference: https://nexus.od.nih.gov/all/2017/08/11/4-questions-for-researchers-and-institutions-involved-in-human-subjects-research/

Yes, this information must be updated in ClinicalTrials.gov to reflect the new record owner and/or responsible party. Please see 7.3 “Changing Record Owner” and 7.4 “Transferring a record to/from a different organization” in the ClinicalTrials.gov FAQ for step-by-step instructions to make this change in your study’s ClinicalTrials.gov record.

For further information and other helpful FAQs, please visit the following site: NIH Clinical Trial FAQs