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SickKids

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 November 2020)

Dr. Elizabeth Stephenson (Chair)
  • Specialty: Cardiology
Ms. Arbelle Manicat-Emo (Vice-chair) 
  • Specialty: Neurosurgery
Dr. Kathy Boutis (Vice-chair)  
  • Specialty: Emergency Medicine
Dr. Vijay Ramaswamy 
  • Specialty: Haematology/Oncology 
Mr. Matthew Mokanski
  • Specialty: Bioethics
Dr. Jonathan Wasserman
  • Specialty: Endocrinology
Dr. Jeffrey Traubici
  • Specialty: Radiology
Dr. Brian Feldman
  • Specialty: Rheumatology
Dr. Deborah Levy
  • Specialty: Rheumatology
Dr. Rana Khafagy
  • Specialty: Pharmacist
Mr. Howard Simkevitz
  • Specialty: Legal
Dr. Ian Stedman
  • Specialty: Legal
Mr. Asher Maan
  • Specialty: Community
Dr. Priyanka Rathore
  • Specialty: Community
Mr. John Wunderlich
  • Specialty: Community/Privacy
Ms. Leslie Ordal
  • Specialty: Community

Panel B (as of April 2021)

Dr. Elizabeth Stephenson (Chair) 
  • Specialty: Cardiology
Ms. Rose Gaiteiro (Vice-chair) 
  • Specialty: Critical Care
Dr. Kevin Weingarten (Vice-chair)
  • Specialty: Haematology/Oncology/BMT
Dr. James Anderson
  • Specialty: Bioethics
Dr. Emilie Jean-St-Michel
  • Specialty: Cardiology
Ms. Maria Zak
  • Specialty: Neurology
Dr. Reza Vali
  • Specialty: Diagnostic Imaging
Ms. Regan Klatt
  • Specialty: Genetic Counselling
Dr. Theo Moraes
  • Specialty: Respiratory Medicine
Dr. Dustin De Souza
  • Specialty: Pharmacist
Ms. Sheliza Moledina
  • Specialty: Pharmacist
Ms. Pamela Spencer
  • Specialty: Legal
Ms. Alexandra Wilbee
  • Specialty: Legal
Ms. Liz Phillips
  • Specialty: Community
Ms. Daria Ilkina
  • Specialty: Community/Privacy
Ms. Tania Sleman
  • Specialty: Community

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. 

Email Clinical Research Services

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.

Download 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.

Download 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).

Review the PHIAExternal Link

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.

Download the Research Ethics Handbook

Templates and forms for researchers

A broad overview of research ethics concepts. 

Download the REB Handbook

REB Standard Operating Procedures (SOPs)

Expand the section below to view and download SickKids' REB Standard Operating Procedures (SOPs).

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.

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Clinical Research Services

Clinical Research Services

Clinical Research Services supports study teams and quality clinical research by providing tools, templates, education, facilities and more.

Participate in clinical research

Participate in clinical research

Study participants like you allow us to advance our groundbreaking studies. Learn how you can get involved in the next SickKids discovery.

Research Integrity

Research Integrity

SickKids actively promotes a culture of research integrity, providing integrity education & resources to the organization.

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