3. Ethics Committee (EC)/Institutional Review Board (IRB)

As described in Section 2.2, in Canada, EC and IRB (Institutional Review Board) are referred to as Institutional Ethics Committee (IEC) and Research Ethics Boards (REB).

There is a central as well as a local REB. QIs should use their local REB. If a QI does not have an allocated local REB, s/he can use a Central REB.

Local and central REBs have the same roles and responsibilities. The local REB is associated with the institution where the study is being run. The central REB manages several sites in various Canadian locations. The same information is submitted to either a local or central REB. For a multicenter study, if a local REB exists, permission from the local REB must be granted before the Central REB may be used. In addition, submission to the Local REB may also be necessary.

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. 

Documentation requirements may vary per REB as well as per different types of products and trials.

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:

1. Signed and dated application form
2. Clinical protocol and protocol synopsis 
3. Protocol summary (non-technical language)
4. Description (usually included within the protocol) of ethical considerations involved in the research
5. ICFs and participant information (French may be required too)
6. Participant recruitment procedures
7. Investigator’s Brochure
8. Safety information
9. Participant payments and compensation
10. Investigator(s) current curriculum vitae (CVs) where applicable
11. Data Collection form (Case report forms, data elements to be collected)- this information can be included within the protocol or as separate documents
12. All significant previous decisions by other REB or regulatory authorities for the proposed study.
13. Description of arrangements for indemnity as well as insurance coverage
14. Additional required institutional EC documentation
15. Some REBs may also require Health Canada's No Objection Letter- NOL-, Investigational Testing Authorization ITA if applicable

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.

Timelines will vary depending on the REB. Some REBs may require the Qualified Investigator or co-investigator to attend the meeting.

3.3 Does EC/IRB have any 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?

For HC, EC meetings are held monthly 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 required apart from the EC/IRB (e.g. scientific committee, subject matter expert committee, etc.)?

It may depend on the type of study and participant population.

For example, research involving exposure of participants 0-17 years of age to any amount of ionizing radiation, regardless of how little, must be approved by the regional Radiation Safety Committee (RSC). 

3.7 Please describe the process of the 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 the 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., is the fee different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, investigator site addition, etc.)?

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 here 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 can payment be made electronically? 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.

Submission procedures may vary depending on the REB/s involved. Please consult each REB for more information.

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, any documentation seen by (or read to) a participant, such as recruitment advertising, information sheets, pamphlets, forms/questionnaires, diaries, and online material must be submitted for approval by the Ethics Committee. Therefore, screenshots or mock screens may be requested if online material is provided. 

3.12 Does the EC/IRB have any template or specific element requirements on ICF and/or other participant-facing materials?

Yes. Health Canada provides various Informed Consent templates applicable for research applying to Health Canada-PHAC-REB.

Additionally, local REBs may have their own Informed Consent templates.

3.13 Is there any guidance tool on participant compensation including clinical study-related injury per local requirements?

Yes. The Canadian regulations do not require compensation for trial participants in the event of trial-related injuries or death. However, the CA-ICH-GCP E6 R2 indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. 

Note that HC Notice-CA-ICH-GCP, from 03 April 2019, indicates that HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

Chapter 3 of the “ The Tri-Council Policy Statement: Ethical Conduct for Research” indicates the following under the “Incentives” section:

“Incentives are anything offered to participants, monetary or otherwise, for participation in research (incentives differ from reimbursements and compensation for injury, which are discussed in Article 3.2[j]). Because incentives are used to encourage participation in a research project, they are an important consideration in assessing voluntariness. Where incentives are offered to participants, they should not be so large or attractive as to encourage reckless disregard of risks. This is a particular consideration in the case of healthy volunteers for the early phases of clinical trials, as discussed in Article 11.2. The offer of incentives in some contexts may be perceived by prospective participants as a way for them to gain favor or improve their situation. This may amount to undue inducement and thus negate the voluntariness of participants’ consent.

This Policy neither recommends nor discourages the use of incentives. The onus is on the researcher to justify to the REB the use of a particular model and the level of incentives. In considering the possibility of undue influence in research involving financial or other incentives, researchers and REBs should be sensitive to issues such as the economic circumstances of those in the pool of prospective participants, the age and decision-making capacity of participants, the customs and practices of the community, and the magnitude and probability of harms (Chapter 4, Section B). Guardians and authorized third parties should not receive incentives for arranging the involvement in research of the individual they represent. However, they may accept reasonable incentives or compensation on behalf of that individual, as long as these are suitable to the circumstances.”

3.14 Are there any specific local safety reporting requirements for clinical studies?

Yes. Please refer to Section 2.15 of this guidebook.

3.15 Does the EC/IRB require any periodic study reporting?

Yes. Investigators and sponsors have the shared responsibility of submitting interim and annual reports on the status of the clinical trial.

The investigator is required to provide annual progress reports to the REB and submit interim progress reports to the REC and HC if there are any significant changes affecting the trial or risk to participants.

Upon completion of the trial, the investigator is required to submit a final report to the REB summarizing the trial’s outcome.