3. Ethics Committee (EC)/Institutional Review Board (IRB)
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3. Ethics Committee (EC)/Institutional Review Board (IRB)
- 6 Mins to read
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As described in section 2.2, in Canada, EC and IRB (Institutional Review Boards) are referred to as Institutional Ethics Committee (IEC) and Research Ethics Boards (REB).
3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.
Canada has a decentralized process for the ethical review of clinical trial applications and requires the sponsor to obtain REB approval for each participating trial site. Canadian provinces may have varying requirements, and, therefore, the sponsor should consult with the applicable province(s) for more information.
Each REB has an application form and clearance requirements and can differ significantly regarding the number of copies to be supplied and application format requirements. However, the following requirements comply with GCP and are generally consistent across all Canadian REBs:
- Clinical protocol
- ICFs and participant information
- Participant recruitment procedures
- Investigator’s Brochure
- Safety information
- Participant payments and compensation
- Investigator(s) current curriculum vitae (CVs) where applicable
- Additional required institutional EC documentation
Qualified Investigators (QIs) are required to include a plan for monitoring safety, efficacy/effectiveness (where feasible), and validity in their proposal for REB review.
3.2 Time required for EC/IRB review and approval process and turnaround time if any query is raised during the review process.
All REB ethics recommendations shall be communicated in writing to the QI within 15 days of the meeting at which the recommendation is made. Positive recommendations include a statement of the QI’s responsibilities, including:
- Confirming the acceptance of any requirements imposed by the REB;
- Submitting an annual progress report;
- Notifying the REB of protocol amendments (other than amendments involving only logistical or administrative aspects of the study);
- Notifying the REB in the case of amendments to the recruitment material, research subject information, or the informed consent process or form;
- Reporting unforeseen circumstances or the termination of the study; and
- Submitting a final summary report upon completion of the study.
It is worth considering that stated timelines should be considered as the average time. As per the usual process, upon receipt of an application, HC REB or local/institutional ethics (sites) where the study is being run will review the application for completeness of outstanding items and once the application is deemed complete, it will be referred to EC for review. Usually, their recommendations are sent within 7-10 business days.
From actual experience dealing with institutional EC (i.e. site EC), the process may take longer.
A negative recommendation from the REB shall be supported with reasons. QIs have the right to request, and the REB has an obligation to provide, a reconsideration of negative recommendations concerning a research project. Any QI who seeks reconsideration of a negative recommendation must provide a clear basis for his or her disagreement and a request for reconsideration by the REB. This is to be sent by letter or email to the REB Secretariat within 10 days of receiving notification from the REB of the negative recommendation. A meeting between the REB and the QI shall be scheduled at the earliest possible REB monthly meeting. At that meeting, the QI shall be invited to further discuss the project with the REB with a view to having the REB reach a decision on the issues that are subject to disagreement and should bring all relevant documentation that will support the case for reconsideration.
The QI will receive notice from the REB within two weeks (may vary based on the EC) of the meeting providing the results of the reconsideration.
3.3 Does EC/IRB have a fast-track or expedited review process?
Decisions regarding expedited review are at the discretion of the REB Chair or Deputy Chair, for those categories of research that are confidently expected to involve minimal risk to research subjects.
Where REB review is urgently required in emergency situations, due to circumstances beyond the researchers’ control, the REB Chair or Deputy Chair may also allow an application to be reviewed on a time-sensitive basis via teleconference in one of the following cases:
- Epidemiological studies where incidences of the study target are limited, such as research conducted in the context of an outbreak of a new disease;
- Studies of time-limited events; or
- Research whereby a delay caused by waiting for the next REB meeting would place individuals at risk.
3.4 Does EC/IRB need to be registered and/or accredited/approved by RA/CA?
No.
The Research Ethics Board is authorized by the Deputy Minister of Health and the Chief Public Health Officer of the Public Health Agency of Canada. The Research Ethics Board is mandated to conduct ethics reviews of the Public Health Agency of Canada research projects involving human subjects.
3.5 How frequently do EC/IRB meet? Please describe their schedule.
For Health Canada, EC meetings are held on a monthly basis except during the summer.
However, for institutional sites or independent ECs, meetings could be more frequent: once a week, once every two weeks, etc.
3.6 Is any additional approval apart from EC/IRB (e.g. scientific committee, subject matter expert committee, etc.) needed?
Please refer to section 3.7 below.
3.7 Please describe the process of EC/IRB submission for clinical trial approval.
REB procedures are detailed in the Foreword, Introduction, and sections 1.24, 1.27, 2.6, 3, and 5.11 of Good Clinical Practice: Integrated Addendum to E6(R1) ICH Topic E6(R2).
3.8 What is the relevant EC/IRB fee in local currency/USD? (e.g., if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)
There are no fees to submit a clinical trial application in Canada.
REBs may independently decide whether to charge fees to conduct protocol reviews, e.g., an REB may require industry sponsors or other for-profit organizations to pay a fee.
The reference that is given below refers to the REB for Alberta province as an example but ethics application follows the provincial laws where it is subject.
3.9 Does EC/IRB accept checks or payment can be made electronically? Please explain. Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?
Details vary by province and territory. Please refer to section 3.8 above.
3.10 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.
Yes, please refer to section 4.9.
3.11 Does EC/IRB require any mock screens/screenshots of participant-facing material on the app? If yes, do these need to be submitted in the local language?
From the research conducted, no specific guidance currently exists regarding the specific regulation of participant-facing material as a feature of DCTs. However, advertising or participant-facing materials are considered part of the informed consent process and must be submitted for approval by the Ethics Committee. This could include photos or videos used in advertisements to promote the trial or connect with participants, pre-screeners, flyers as recruitment tools, etc.
3.12 Does EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?
Yes.
Health Canada’s interpretation of the relevant provisions of the Food and Drug Regulations, regarding the requirements of ICF, is available in sections 5.5, 5.6, 5.8, 5.10, 5.12 of the Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”.
3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirement?
Yes.
Please refer to section 2.20 for a discussion of compensation for injury.
For a discussion of compensation for participation, and for the cost of OTC IP, please refer to sections 5.9 and 5.10.
3.14 Are there any specific local safety reporting requirements on clinical studies?
Yes. Please refer to section 2.15.
3.15 Does EC/IRB require any periodic study reporting?
Yes. Study reporting requirements are set out in section 2.16.
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