Research Ethics Board (REB) annual report 2023 to 2024

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Executive summary

The Health Canada (HC) and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) is a joint board for both the Department and Agency. The REB provides support and independent ethics review for all proposed and ongoing research involving humans carried out under the auspices of HC and PHAC, to help ensure that the highest ethical standards are being met and the greatest protection is provided to participants.

The REB held 65 meetings in 2023-24 (61 delegated review and 4 full board meetings). All meetings were held by videoconference, except for two full board meetings that were held in person in Ottawa in May and November (with an option for virtual participation for members unable to travel).

The REB received 53 new applications in 2023-24, of which 26 were from HC and 27 from PHAC. Only one study was considered to be greater than minimal risk and therefore required full board review; all other studies were referred to delegated review. The time from application submission to approval was an average of 40 calendar days (25 days with the REB and 16 with the applicant). The REB also reviewed 146 annual progress reports, 40 amendment requests and 3 adverse event reports in 2023-24 and closed 41 protocols.

In addition to conducting ethics review, the REB members received several educational and informational sessions in 2023-24. These sessions were delivered at the REB meetings in May and November to which the entire membership was invited. There was a high level of participation at both meetings, ensuring that almost all the members were able to benefit from these presentations. The REB Secretariat also continued its outreach efforts, supporting and collaborating with stakeholders from HC, PHAC and other federal departments.

Overall, the REB effectively delivered on its mandate in 2023-24 in continuing to provide expert research ethics support to HC and PHAC.

About the Health Canada-PHAC REB

The Health Canada (HC) and Public Health Agency of Canada (PHAC) Research Ethics Board (REB) provides support and independent ethics review for all proposed and ongoing research involving humans conducted under the auspices of the Department or Agency, to help ensure the highest ethical standards are being met, and that the greatest protection is provided to participants. The REB reviews applications in accordance with the considerations set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) as the minimum standard. The REB is also guided by relevant federal laws and regulations, such as the Privacy Act and clinical trial regulations, where applicable.

The REB reports to the Deputy Minister of Health and the President of PHAC, who jointly appoint REB members and approve REB procedures. The REB makes recommendations to the Deputy Minister and President (through their delegated Decisional Authorities) as to whether research projects should be approved, rejected, modified, or terminated. The REB also provides ethical oversight of all approved research throughout the duration of the project. Finally, the REB serves various educational functions for Department and Agency managers and researchers.

The REB is responsible for the ethics review of all research involving humans that is:

The REB may also review research involving humans that is funded through grants and contributions from the Department or Agency.

The REB is supported by a Secretariat that manages its operations and administers the REB review process. The Secretariat works closely with REB members and applicants to ensure a quality and timely review of all research proposals received for ethics review. The Secretariat is based at Health Canada within the Healthy Environments and Consumer Safety Branch (Environmental and Radiation Health Sciences Directorate).

In the case of applications from PHAC researchers, the REB Secretariat collaborates with the PHAC Office of the Chief Science Officer which administers its approval process and provides additional advice to applicants. The REB Secretariat and the PHAC Office of the Chief Science Officer also work closely together on policies, procedures and guidance related to the REB.

REB meetings and reviews

The Research Ethics Board (REB) meets as required to conduct full board reviews by videoconference. A minimum of five members is required for quorum (one member each with expertise in ethics and in law, one community member, and two researcher members). All REB members also attend delegated review meetings on a rotating basis. Delegated review meetings are held weekly by videoconference with additional meetings as required, and are attended by the Chair (or Deputy Chair) and one other REB member.

Full board meetings are primarily to evaluate initial applications and major amendment requests that represent greater than minimal risk to research participants. By contrast, minimal risk applications are generally sent to delegated review, along with submissions for continuing ethics review (i.e., annual progress reports, amendment requests and adverse event reports). For the review of initial applications, the applicant is normally invited to the REB meeting (whether full board or delegated review) to give a brief presentation about the proposal and to answer any questions from the REB members.

The entire REB also meets up to twice a year in person, and remotely as required, for educational sessions and informational presentations from researchers.

Types and number of REB meetings in 2023-24:

The number of open protocols varies throughout the year as the REB approves new applications and closes old protocols. There were 201 open protocols on March 31, 2024 (103 from HC and 98 from PHAC), and 41 protocols were closed in 2023-24.

Figure 1. Submissions reviewed by the REB in 2023-24 Reference 1
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Figure 1: Text description

This figure is a bar chart with 12 bars showing the number of submissions reviewed by the REB in the 2023-2024 fiscal year. Each bar corresponds to a month of the year, starting with April and ending with March. Each bar is further subdivided into 4 sections corresponding to the type of submission that was reviewed (initial application, annual progress report, amendment request and adverse event report). The data are as follows:

Month Initial applications Annual progress reports Amendment requests Adverse event reports
April 4 11 4 1
May 5 12 7 1
June 2 6 3 0
July 4 9 5 0
August 6 8 3 0
September 4 20 5 0
October 6 17 2 0
November 3 10 1 0
December 3 14 2 0
January 8 18 3 1
February 4 10 1 0
March 3 11 4 0
Total 52 146 40 3

Profile of applications received in 2023-24

The Research Ethics Board (REB) received 53 applications in 2023-24: 26 from Health Canada (HC) and 27 from the Public Health Agency of Canada (PHAC). By comparison, 45 applications were received in 2022-23, and 54 in 2021-22. External protocols were led by researchers outside of the Department and Agency, either in collaboration with HC or PHAC researchers or funded by the Department or Agency.

Figure 2. Affiliation of the principal investigator for applications submitted to the REB
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Figure 2: Text description

This pie chart illustrates the affiliation of the lead investigator for the REB applications received during the 2023-2024 fiscal year. The data are as follows:

  • Among the 26 applications received from Health Canada:
    • 3 were from the Controlled Substances and Cannabis branch
    • 10 were from the Healthy Environments and Consumer Safety Branch
    • 7 were from the Health Products and Food Branch
    • 6 were external
  • Among the 27 applications received from PHAC:
    • 8 were from the National Microbiology Laboratory Branch
    • 2 were from the Health Promotion and Chronic Disease Prevention Branch
    • 6 were from the Infectious Diseases and Vaccination Programs Branch
    • 3 were from the Corporate Data and Surveillance Branch
    • 8 were external

The protocols received spanned a broad range of research areas. Two studies focused on Indigenous populations.

Figure 3. Subject areas of the applications submitted to the REB
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Figure 3: Text description

This pie chart illustrates the subject areas of the protocols received by the REB for the 2023-2024 fiscal year. The data are as follows:

  • 9 were about disease investigation and surveillance
  • 4 were about diagnostic testing
  • 6 were about assay/methods development
  • 5 were about food and nutrition
  • 7 were about chemical and radiation exposure
  • 3 were about alcohol and drugs
  • 7 were environmental studies (1 Indigenous)
  • 9 were social science research (1 Indigenous)
  • 3 were about genomics and genetic studies

Application review process and outcomes

The Research Ethics Board (REB) applies a proportionate approach to research ethics review; that is, the level of risk to participants determines the level of scrutiny by the REB. Thus, at the discretion of the REB chair, applications deemed to be minimal risk can be sent to delegated review (and if the risk is determined to be greater than initially thought, subsequently referred to the full board for further review).

Following the review of an application, the REB makes one of the following recommendations:

A. Approved as submitted: The application meets ethics requirements for research involving humans and is recommended for approval.

B. Approved with modifications/clarifications: The application meets ethics requirements for research involving humans, but the REB members require modification of the application or clarification or further information to secure approval. The revised material may be reviewed via delegated review or a subset of the members as directed by the REB Chair.

C. Deferral: The application does not meet ethics requirements for research involving humans and is not approved as conditions need to be met. The revised material must be reviewed by the full board via videoconference, or by email circulation to all REB members.

D. Disapproval: The application fails to meet the ethical standards for approval and revision is unlikely to enable the REB to reach a positive determination.

Figure 4. Level of REB review for initial applications
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Figure 4: Text description

This pie chart illustrates the level of review that initial applications received by the REB. 52 applications were sent to delegated review and 1 application received full board review.

Figure 5. Outcome of REB review for initial applications Reference 2
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Figure 5: Text description

This pie chart illustrates the outcome of the REB review for initial applications. The data are as follows:

  • 25 applications were approved as submitted
  • 21 applications were approved after 1 round of review
  • 5 applications were approved after 2 rounds of review
  • 1 application was withdrawn post initial REB review
  • 1 application was not approved

Approval times: The time from application submission to approval is a function of the REB Secretariat, the REB and the applicant. The time taken by the applicant to respond to the REB's recommendations and other requests from the Secretariat is beyond the REB's control; thus, the approval time is broken down into days with the REB and days with the applicant. In terms of time with the REB:

Time from submission to approval for the applications received and approved in 2023-24 Reference 3

Time period Average (± SD) Median
Days with REB 25 ± 13 21
Days with applicant 16 ± 29 4
Total 40 ± 36 30
Figure 6. Time distribution for the 51 applications received and approved in 2023-24
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Figure 6: Text description

This bar graph contains 51 bars, 1 bar for each application that was received and approved in the 2023-2024 fiscal year. The bars are further divided into 2 sections: number of days with the REB and number of days with the applicant. The 51 bars are ordered from the shortest to longest amount of time by calendar days.

Application number Days with REB Days with applicant Total
1 11 0 11
2 10 1 11
3 12 0 12
4 13 0 13
5 14 0 14
6 14 0 14
7 10 5 15
8 13 3 16
9 16 0 16
10 17 0 17
11 17 0 17
12 10 8 18
13 6 13 19
14 18 2 20
15 20 0 20
16 18 2 20
17 16 4 20
18 19 2 21
19 21 0 21
20 21 0 21
21 8 15 23
22 24 0 24
23 24 1 25
24 16 12 28
25 19 9 28
26 21 9 30
27 31 0 31
28 18 13 31
29 13 19 32
30 33 1 34
31 27 8 35
32 34 1 35
33 33 2 35
34 32 4 36
35 37 2 39
36 40 0 40
37 25 18 43
38 40 4 44
39 41 3 44
40 13 33 46
41 31 16 47
42 22 26 48
43 30 37 67
44 52 15 67
45 53 16 69
46 57 15 72
47 18 65 83
48 33 68 101
49 28 78 106
50 53 100 153
51 50 151 201

REB education and information sessions

As noted in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), an important component of Research Ethics Board (REB) meetings is the inclusion of educational opportunities that may benefit the overall operation of the REB. To this end, a broad range of educational sessions were organized over the course of the year, as described below. The list also includes presentations from researchers about their programs of research. These interactions served not only to educate board members about emerging research areas, but also to strengthen the relationships between the REB and researchers. The REB would like to thank all the presenters for generously giving their time to enlighten the board.

Sessions on ethics issues

Sessions on HC and PHAC programs and priorities

Research presentations

Secretariat activities

The Research Ethics Board (REB) Secretariat administers the REB review process and supports the board in fulfilling its mandate. Important elements of the Secretariat's work are to build partnerships and increase awareness about the REB, and to continually improve the board's processes. Key Secretariat activities for 2023-24 included the following:

Membership

The REB consists of ten regular and ten alternate members with expertise in the following areas:

Members are appointed by the Deputy Minister of Health and the President of PHAC for a term of three years, renewable once.

Four members left the board in 2023-24:

Health Canada and PHAC are especially grateful for their expert contributions to the REB. The REB and Secretariat will miss them and wish them all the best in their future endeavours.

The REB welcomed six new members to the REB in 2023-24:

The following REB member assumed a new role in 2023-24:

REB membership as of March 31, 2024

REB Secretariat

PHAC liaison to the REB Secretariat

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2026-06-12