Ethical research includes independent ethics review before a study is begun. All research involving Toronto Rehab patients, staff and/or facilities must be submitted to a Research Ethics Board (REB) for review. The Toronto Rehab Research Ethics Board is now the Rehabilitation Medicine and Science Board of the University Health Network (UHN), also referred to as UHN Board D.
The REB assesses the ethical implications of proposed research and assists researchers to maximize potential benefits and minimize potential harms related to individual projects. Research may not commence before institutional authorization is granted; REB approval must be maintained for the length of the project by submitting new information as it arises and annual status reports for ethical review.
Manager Research Ethics Education and CAPCR
+1 (416) 597-3422 ext. 7611
Associate Director, Bioethics
REB Co-Chair (Board D)
+1 (416) 597-3422 ext. 3972
Dr. Paul Oh
REB Vice Chair (Board D)
+1 (416) 597-3422 ext. 5263
The REB membership includes scientists, ethicists, members of the lay public, the privacy officer, a lawyer, etc. The decision-making of the REB is independent of the researchers and independent of the institution. Members with a conflict of interest regarding a particular project do not take part in the approval decision.
The REB uses a proportionate approach to ethics review: the greater the risk, the greater the scrutiny of the ethical implications. Minimal risk studies may qualify for a delegated review process; studies of more than minimal risk will be reviewed by the full board at an REB meeting. The REB appreciates the researchers’ input on the risk level however the REB has the final decision about risk level and related review process.
Ethics consultations help researchers to design their studies to incorporate the highest ethical standards. Ethics consultations can also help researchers with ethical dilemmas during the conduct of research. (For ethics consultations in clinical or organizational issues, please contact Ann Heesters, Ethics and Spiritual Care pillar.)
Questions to determine whether an Ethics Consultation is recommended:
(There should be at least one ‘Yes’ or ‘Potentially Yes’ response.)
1a. Is there uncertainty, disagreement or conflict between people involved, about what should be done?
1b. Does it centre around values, obligations, principles, responsibilities?
2. Is clarification needed around research ethics-related policy or legislation?
3. Is someone being treated unfairly or are someone’s rights being violated or affected?
4. Is this decision or course of action making you uncomfortable?
5. Are you concerned about whether something is consistent with your professional values / standards / code of ethics?
6. Is the research subject (or family member) struggling with a difficult decision?
For more information about submitting to the UHN REB, please visit:
http://www.uhnresearch.ca/reb/rebhome.htm (External website)
http://intranet.uhnresearch.ca/departments/research-ethics-board (UHN Intranet)
All new proposals must now be submitted using the Coordinated Approval Process for Clinical Research (CAPCR).
For information about using CAPCR, please visit:
http://www.uhnresearch.ca/programs/CAPCR/index.html (External website)
http://capcr.uhnresearch.ca/ (UHN Intranet)
The REB is responsible for overseeing all aspects of the study, once it is approved. Any new information (such as adverse events, amendments to the Protocol or Informed Consent documents, protocol deviations or violations, annual status updates must be submitted to the REB for ethics review, on a timely basis.
All UHN REB forms can be found at: http://www.uhnresearch.ca/reb/rebforms.htm
Pages which include signatures can be scanned and sent electronically in PDF format or mailed by inter-departmental mail.
Toronto Rehab researchers conduct their research according to the relevant legislation, guidelines and institutional policies.
Toronto Rehab, as a recipient of Canadian federal research grants, must follow the Memorandum of Understanding which includes the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans.
.. and the Tri-Council Policy Statement: Integrity in Research and Scholarship.
Research involving personal health information complies with Ontario Personal Health Information Protection Act (PHIPA).
Clinical trials of drugs or natural health products are conducted in accordance with Health Canada’s Food & Drug Regulations (Division 5)
Natural Health Products Regulations
... and also ICH Good Clinical Practice Guidelines
Medical Device Regulations
University of Toronto Office of Research Ethics
Declaration of Helsinki
For US-funded studies, see:
21 CFR 50 - Protection of Human Subjects
21 CFR 56 - Institutional Review Boards (equivalent to Canadian REBs)
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 812 - Investigational Device Exemptions
45 CFR 46 – Protection of Human Subjects