Research Ethics Board
The Research Ethics Board (REB) is an independent body established by the SickKids Board of Directors to protect the rights and welfare of human research participants. The REB ensures that all research involving humans meets today’s ethical and scientific standards, and complying to national and international regulations, guidelines, and policies, including the Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans (TCPS 2 2018).
The SickKids REB brings perspective and expertise from our interdisciplinary, community-representative group to review, discuss, deliberate and approve research studies. The REB is comprised of two panels (A and B), including physicians, clinical staff, members of the community, lawyers, and individuals knowledgeable in ethics and privacy.
What is research ethics?
Research ethics review is an initial and ongoing process that monitors research involving human participants to ensure ethical standards are considered and met.
Ethical considerations for research require independent evaluation of all proposed research by an independent committee of people with varied backgrounds who use their knowledge and expertise to examine the research study from the perspective of prospective participants.
Ethics in research is guided by respect for human dignity, which encompasses three core principles: Respect for Persons, Concern for Welfare, and Justice.
About SickKids REB
The types of clinical and scientific research that requires the REB’s review and approval before research begins includes:
- Research involving living human participants.
- Research involving human remains, cadavers, tissues, biological fluids, embryos or foetuses.
- Research involving secondary use of data (use of data initially collected for another purpose) - health records, employee records, student records, computer listings, banked tissue - if any form of identifier is involved and/or if private information pertaining to individuals is involved.
- Research about a living individual in the public arena if the person is to be interviewed and/or private papers accessed.
- Quality improvement/assurance studies and program evaluations which address a research question.
- Program Evaluation: REB review is required only if a QI or PE meets the TCPS2 definition of research or serves as a component of a research project.
The following research studies do not require ethics review (TCPS 2 Articles 2.2 to 2.4):
- Research about individuals in the public arena using only publicly available or accessible records without contact with the individual/s.
- Research involving naturalistic observation in public venues.
- Quality assurance studies, program evaluations, performance reviews, and testing within normal educational requirements if there is no research question involved.
- Research based on review of published/publicly reported literature.
- Research involving secondary use of data (Article 5.5) or samples which is provided without any identifiers (completely anonymous) or group of identifiers which would allow attribution of private information to an individual.
- Consulting, unless carried out by SickKids.
Panel A (as of September 2024)
Elizabeth Stephenson (Chair)
- Specialty: Cardiology, Ethics/Privacy
Kathy Boutis (Vice-chair)
- Specialty: Emergency Medicine, Ethics
Arbelle Manicat-Emo (Vice-chair)
- Specialty: Neurosurgery, Ethics
Jeffrey Traubici
- Specialty: Radiology
Vijay Ramaswamy
- Specialty: Haematology/Oncology
Brian Feldman
- Specialty: Rheumatology, Complementary/Alternative Medicine
Rana Khafagy
- Specialty: Emergency Medicine
Matthew Mokanski
- Specialty: Bioethics
Howard Simkevitz
- Specialty: Legal/Privacy
Asher Maan
- Specialty: Community, Bioethics
Priyanka Rathore
- Specialty: Community, Clinical Research and Regulatory Affairs
John Wunderlich
- Speciality: Community, Privacy
Shanice McLeish
- Specialty: Community, Ethics
Panel B (as of September 2024)
Elizabeth Stephenson (Chair)
- Specialty: Cardiology, Ethics/Privacy
Kevin Weingarten (Vice-chair)
- Specialty: Haematology/Oncology/BMT, Ethics
Andrew Helmers
- Specialty: PICU/Bioethics
Reza Vali
- Specialty: Radiology/Nuclear Medicine
Sarah Lord
- Specialty: Complex Care/Palliative Medicine
Regan Klatt
- Specialty: Genetic Counselling
Maria Zak
- Specialty: Neurology, Complementary and Alternative Medicine
Dustin De Souza
- Specialty: Pharmacy
Sheliza (Moledina) Datoo
- Specialty: Pharmacy
James Anderson
- Specialty: Bioethics
Alexandra Wilbee
- Specialty: Legal
Daria Ilkina
- Specialty: Community, Privacy
Tania Sleman
- Specialty: Community
Rose Gaiteiro
- Specialty: Critical Care, Privacy/Ethics
Panel C (as of September 2024)
Elizabeth Stephenson (Chair)
- Specialty: Cardiology, Ethics/Privacy
Kathy Boutis (Vice-chair)
- Specialty: Emergency Medicine, Ethics
Birgit Erti-Wagner
- Specialty: Diagnostic Imaging
Clyde Matava
- Specialty: Anaesthesia
Adam Yan
- Specialty: Haematology/Oncology
Ismail Akrout
- Specialty: Genetics/Genome Biology
Mandy Rickard
- Specialty: Urology
James Anderson
- Specialty: Bioethics
Melissa McCradden
- Specialty: Bioethics
Ian Stedman
- Specialty: Legal/Ethics
Shanice McLeish
- Specialty: Community, Ethics
Rose Gaiteiro
- Specialty: Critical Care, Privacy/Ethics
Panel A (2nd Friday of each month)
- January 8, 2021
- February 12, 2021
- March 12, 2021
- April 9, 2021
- May 14, 2021
- June 11, 2021
- July 9, 2021
- August 13, 2021
- September 10, 2021
- October 8, 2021
- November 12, 2021
- December 10, 2021
Panel B (4th Friday of each month)
- January 22, 2021
- February 26, 2021
- March 26, 2021
- April 23, 2021
- May 28, 2021
- June 25, 2021
- July 23, 2021
- August 27, 2021
- September 24, 2021
- October 22, 2021
- November 26, 2021
- *December 17, 2021
*Rescheduled from usual occurrence.
These fees cover the initial and ongoing review costs of all the applications in industry-funded research studies. Please note that research supported by public funds (i.e., CIHR) is not subject to these fees. All funds are invoiced in the currency of the budget/agreement.
Research Ethics Review Fees
Initial REB Review – $3,000
- For review of new ethics applications funded by a for-profit entity (i.e., pharmaceutical/medical device company).
Study Renewals – $500
- For review of study renewal applications of ongoing research studies (annual or otherwise) funded by a for-profit entity (i.e., pharmaceutical/medical device company).
Protocol Amendments – $500
- For review of amendments involving revisions to the study protocol and/or patient safety changes to the consent documents. Amendments that do not include changes to the study protocol and/or patient safety information will not be subject to this fee.
Invoicing and Payment
All REB fees are charged regardless of the level of review required (full board vs. delegated) or the outcome of the review.
REB invoicing and payments is handled by the SickKids Research Awards and Financial Services (RAFS). Please contact RAFS for more information regarding invoicing, billing of REB fees.
Questions or concerns respecting this notice may be directed to the Manager of the Research Ethics and Regulatory Compliance (RERC) Office at 416-813-7654 ext. 205718, or by email at david.kenney@sickkids.ca
Investigators and study teams should plan to submit a complete application for REB review well in advance of when research begins. The REB recommends that research teams use the following timelines:
- Full Board Studies – Submit at least six months in advance of anticipated start date
- Delegated Studies – Submit at least three months in advance of anticipated start date
- Retrospective Studies – Submit at least one month in advance of anticipated start date
- Amendments – Submit at least six weeks in advance of anticipated start date
Submissions to the REB are processed and reviewed on a first-come, first-served basis. Failure to plan for the REB review process may delay the start of your research. No research activities involving participants or identifiable data, including recruitment, may begin until final REB approval.
If your study requires full board review, remember that a complete submission needs to be received at least three weeks prior to the scheduled meeting date in order to make the meeting agenda. The level of review (full board vs. delegated) is determined by the Research Ethics and Regulatory Compliance Office based on your protocol.
Research Ethics and Regulatory Compliance Office
Working alongside the REB, the Research Ethics and Regulatory Compliance Office (RERC) at SickKids provides support for and administration of all aspects of the ethics review and approval process for research involving human participants.
The REB and RERC quickly respond to evolving best practices in research ethics, and our tools and processes reflect these developments and emerging issues at the local, national and international levels. Our staff are recognized as leading experts in paediatric research ethics, and are committed to promoting ethical research and developing high-quality resources.
eREB
The eREB is SickKids’ electronic filing system that streamlines and simplifies creating, approving, and finding study files for study teams.
The system is exclusive to SickKids staff.
Please contact Clinical Research Services or your SickKids study team members if you require information about the study.
Research ethics resources
Submitting to the SickKids REB
For detailed information on submitting an application to the SickKids REB, including types of REB applications, submitting to Clinical Trials Ontario (CTO), submission requirements, and more, refer to the SickKids Research Ethics Handbook.
Participant Recruitment
Participant recruitment refers to finding individuals, groups or communities that meet the inclusion criteria of a study. It can include identifying potential participants, contacting them and introducing them to the study, and the actual recruitment of participants (e.g. screening and informed consent). More information on participant recruitment, including identifying potential study participants, pre-screening medical records, eligibility screening, study advertisements, and more, can be found in the Research Ethics Handbook.
Privacy and Confidentiality
Collecting and storing Personal Health Information (PHI) about patients must satisfy the Personal Health Information Act (PHIPA). Researchers have an ethical duty and professional code of conduct to treat personal information in a confidential manner to protect the privacy of participants. Privacy risks can arise at all stages of the research life cycle, from initial collection of information, to data analysis, dissemination of findings, storage and retention of information, and disposal of records or devices on which identifiable information is stored. Researchers must develop a plan to ensure confidentiality of all personal information throughout the research life cycle, such as the use of linking logs or proper data storage and destruction, as outlined in both TCPS 2 and the Personal Health Information Act (PHIPA).
Consent and Assent
Age doesn’t determine whether a potential participant can consent to be in the research, and being under the age doesn’t imply that consent must be obtained from parent(s). Patients who lack the capacity to provide consent must still be informed of the research study at a comprehension level they are able to understand. In paediatric research, assent is always accompanied by the parent(s)/legal guardian/substitute decision maker’s consent. Assent is a child's agreement to participate in research. Assent should be obtained when the potential participant understands the significance of the research (TCPS 2 Article 3.10). Like the informed consent process, the assent process is intended to be an ongoing conversation between the research team and the child or adolescent lacking the capacity to give informed consent. For more information on consent and assent, including assessing participant comprehension/understanding, consent discussion and documentation, obtaining written consent, waivers of consent, and more, refer to the Research Ethics Handbook.
Templates and forms for researchers
A broad overview of research ethics concepts.
- SickKids Assent Form Template
- SickKids Biobank Participant Consent Form Template
- SickKids Consent Template - Case Reports and Series
- SickKids Genetic Consent Language
- SickKids Implied Consent
- SickKids Informed Consent Discussion Template
- SickKids Informed Consent Form Checklist (PDF)
- SickKids Consent for Interventional Studies - Parent
- SickKids Consent for Interventional Studies - Participant
- SickKids Consent for Non-Interventional/Observational Studies - Parent
- SickKids Consent for Non-Interventional/Observational Studies - Participant
- SickKids Retrospective Participant Consent
- SickKids Retrospective Parent Consent
- SickKids Verbal Consent Telephone Script Template
REB Standard Operating Procedures (SOPs)
Expand the section below to view and download SickKids' REB Standard Operating Procedures (SOPs).
- Standard Operating Procedures Development and Maintenance (PDF)
- Activities Requiring REB Review (PDF)
- Authorized Signatory-Signing Authority (PDF)
- Training and Education (PDF)
- Management of Research Ethics Office Personnel (PDF)
- Conflict of Interest - REB Members and REO Personnel (PDF)
- Conflict of Interest - Researcher (PDF)
- Conflict of Interest - Organization (PDF)
- Use and Disclosure of Personal Health Information (PDF)
- Use of a Board of Record (PDF)
- Composition of the Research Ethics Board (PDF)
- Management of the Research Ethics Board Membership (PDF)
- Duties of REB Members (PDF)
- REO Personnel Serving as REB Members (PDF)
- REB Submission Requirements and Administrative Review (PDF)
- REB Meeting Administration (PDF)
- Document Management (PDF)
- Health Canada REB Attestation Form (REBA) (PDF)
- REB Review Process (PDF)
- REB Review Decisions (PDF)
- Delegated Review (PDF)
- Initial Criteria for REB Approval (PDF)
- Determination of Study Approval and Expiry Dates (PDF)
- Ongoing Review Activities (PDF)
- Continuing Review - Study Renewal (PDF)
- Unanticipated Problem Reporting (PDF)
- Study Completion (PDF)
- Suspension or Termination of REB Approval (PDF)
- Non-Compliance (PDF)
- Appeals of REB Decision (PDF)
- Audits and Inspections of REB Operations (PDF)
- Scientific Review for Research Ethics Applications (PDF)
- REB Review During Publicly Declared Emergencies (PDF)
- Vulnerable Populations (PDF)
- Communication - Investigators and Research Staff (PDF)
- Communication - Research Participants (PDF)
- Informed Consent Form Requirements (PDF)
- Informed Consent Process (PDF)
- Waiver or Alteration of Consent (PDF)
- Researcher Qualifications and Responsibilities (PDF)
Contact REB
For general inquiries, please email ask.crs@sickkids.ca.
For questions or concerns about REB fees, please call or email David Kenney, Manager of the Research Ethics and Regulatory Compliance Office.
- Email: david.kenney@sickkids.ca
- Phone: 416-813-7654 ext. 205718