For Physicians & Health Professionals
Research Ethics Board Information
Trillium’s Research Ethics Board is composed of staff, volunteers, Ethics and Privacy Specialists and legal representation. Membership of this team is in line with the REB membership requirements of: (1) the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans; (2) Health Canada’s Food and Drugs Act & Regulations; (3) ICH Guidance E6: Good Clinical Practice: Consolidated guideline; (4) the Office of Human Research Protections; and (5) the prescribed requirements that must be met by a research ethics board according to the Personal Health Information and Protection Act.
The Research Ethics Board maintains active registration with the Office of Human Research Protections.
Frequency of Meetings
- A minimum of 10 (ten) meetings per year
- Meetings occur every 3rd Thursday of the month from 7:30-10:00am
- Members who are directly involved in an application under discussion are non-voting.
- Quorum is 51% of voting membership.
- Minutes will be prepared and maintained by the Chairperson or their delegate and will clearly document all research review activities which led to any recommendations.
- Members will attend regularly, and the Chairperson will address any attendance issues
The team is accountable to the Vice President, Strategic Planning and Business Transformation.
Serious Adverse Events Subcommittee (SAE)
The SAE subcommittee reviews all serious adverse events. This assists with assessing the general safety of a study (study intervention) in our patient population. The subcommittee specifically follows-up on all SAE involving Trillium Health Centre patients to ensure that all of the appropriate measures were followed in their care and follow-up.
Terms of Reference
The Research Ethics Board advises the Chief of Staff with respect to the acceptability of new and ongoing research proposed by researchers affiliated with Trillium Health Centre. This is accomplished by:
- Reviewing and evaluating all research applications against accepted ethical, scientific and organizational standards [Tri-Council Policy Statement, Office of Human Research Protections (OHRP) and Health Canada Regulations, International Conference on Harmonization Good Clinical Practice (ICH GCP) Guidelines and Trillium Health Centre protocols].
- Ensuring affected Health Systems and SBU’s have completed an impact analysis, and any issues or questions have been discussed and resolved with the Principle Investigator.
- Ensuring site agreements have been reviewed and accepted.
- Arranging for a dispute resolution meeting if required.
- Reviewing and evaluating all ongoing ethical, scientific and organizational concerns during the research period, and advising the Chief of Staff of any unanticipated events.
- Reviewing compliance with Trillium Health Centre’s principles and protocols on Research
- Providing annual research reports based on the database of all research activities maintained by the Chairperson.
Research Applications and Information
- Trillium Health Centre site REB Meeting Dates and Submission Deadlines
- Research Application Package A
- Research Application Package B
- Research Application Package C
- Research Application Package D
- Amendment Submission Form
- Study Closure Report
- Research Ethics Board Terms of Reference
- Application for Annual Re-approval