We have changed the name of our Research Ethics Board (REB) to Oak Valley Health Research Ethics Board. Research teams can refer to the following guideline for guidance on how the new name change will impact existing studies at Oak Valley Health.
The primary and clear purpose of the Oak Valley Health Research Ethics Board (REB) is to protect the rights, safety, and well-being of patients involved in studies at Markham Stouffville Hospital and Uxbridge Hospital. The Oak Valley Health REB operates in compliance with the following:
- the Tri-Council Policy Statement 2 (TCPS2): Ethical Conduct for Research Involving Humans (2010);
- the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines;
- Part C, Division 5 of the Food and Drug Regulations of Health Canada; and
- the Personal Health Information Protection Act (PHIPA-Ontario 1998, updated through November 2005)
All applications to conduct research at Oak Valley Health must be submitted to the REB for review and approval before starting research activities.
To apply for review, you must:
- Identity a principal investigator (PI) at Oak Valley Health
- Ensure all individuals conducting research activities have completed the necessary training (e.g. TCPS2, GCP, Health Canada Division 5), based on the study type
- Obtain approval from the head of the department the research study will impact, and
- Provide an REB approval letter from the lead REB site, if the research study is initiated elsewhere
Initial Review Forms
- REB submission checklist
- Confidentiality agreement
- Conflict of interest declaration
- Privacy and security fundamentals training
- Privacy and security fundamentals training – attestation of completion
- Initial application form for human subjects
- Initial application form for retrospective studies
Ongoing Review Forms
- Amendment application form
- Protocol deviation form
- Study closure form
- Study renewal form
- Personnel change form
- Internal SAE reporting form
- External SAE reporting form
The REB meets on the second Thursday of each month and submissions are due on the last calendar day of each month for review at the next month’s meeting.
- Please view our list of meeting dates and deadlines.
- You can also view a list of current REB members.
Minimal risk studies for delegated REB review and approval can be submitted at any time.
A study of “minimal risk” research is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research (Article 6.2, TCPS2).
Please see below documents that are useful when preparing a research application to the REB.
- Protocol template
- Minimal risk informed consent form
- Clinical trials informed consent form
- Verbal consent checklist
- Invitation letter from Circle of Care
- Informed consent checklist
- Informed consent requirements and documentation
- Reporting SAEs and Unanticipated problems
- Reporting protocol deviations
- Signing authority guidelines
- Determining if a project is research or quality improvement
- Health Canada REB attestation (REBA) form
- Recruitment material guidelines
The REB offers one-on-one or group ethics consultations for staff, investigators, coordinators, and students prior to and throughout the ethics review process. In a consultation, the REB can provide advice on:
- developing an ethically sound human research protocol during the design phase of a study (including multisite or complex projects);
- resolving ethical dilemmas that may arise through study planning and execution;
- navigating the REB review process, including guidance for researchers new to the REB review
- process who would like additional information before submitting their first application;
- making changes to REB-approved studies; and
- other human research ethics questions.
Please contact ResearchAdmin@oakvalleyhealth.ca to arrange an individual or group consultation.
The following fees apply to industry-sponsored studies:
- Initial REB submission/review: $3,000
- Amendments: $500
- Annual/continued renewals: $500