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Research Ethics Board (REB) Annual Report 2024 to 2025

Table of contents

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.

In fiscal year 2024 to 2025, an agreement was signed with Indigenous Services Canada (ISC) to extend the REB's services to ISC for an initial period of two years. The agreement also provided for the expansion of Indigenous community representation on the REB from two to four members, and the recruitment of a Deputy Chair for Indigenous research ethics, establishing an "Indigenous-focused arm" of the REB.

The REB held 69 meetings in 2024-25 (61 delegated review and 8 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 who were unable to travel).

The REB received 52 new applications in 2024-25, of which 22 were from HC, 26 from PHAC and 4 from ISC. 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 45 calendar days (31 days with the REB and 14 with the applicant). The REB also reviewed 156 annual progress reports, 47 amendment requests and 5 adverse event reports in 2024-25 and closed 46 protocols.

In addition to conducting ethics review, the REB members received several educational and informational sessions in 2024-25. 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.

Overall, the REB effectively delivered on its mandate in 2024-25 in continuing to provide expert research ethics support to HC, PHAC and ISC.

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.

Under the terms of an agreement between HC, PHAC and Indigenous Services Canada (ISC) that was signed in 2024, the REB also provides ethics review services and advice to ISC.

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. Similarly, the REB Secretariat collaborates with the ISC Office of the Chief Science Officer on applications from ISC. 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 held 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, minor 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.

During the 2024 to 2025 fiscal year, the REB held:

The number of open protocols varies throughout the year as the REB approves new applications and closes old protocols. There were 214 open protocols on March 31, 2025 (115 from HC, 97 from PHAC and 2 from ISC). In addition, 46 protocols were closed in 2024-25.

Figure 1. Submissions reviewed by the REB in 2024-25Footnote 1
Figure 1: Text version below.
Figure 1: Text description

This figure is a bar chart with 12 bars showing the number of submissions reviewed by the REB in the 2024-2025 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 9 4 0
May 2 8 4 0
June 4 5 5 0
July 6 17 3 0
August 2 8 4 1
September 6 11 4 0
October 3 27 5 2
November 6 15 0 0
December 4 11 5 0
January 5 15 7 1
February 5 15 3 1
March 1 15 3 0
Total 48 156 47 5

Profile of applications received in 2024-25

The Research Ethics Board (REB) received 52 applications in fiscal year 2024 to 2025: 22 from Health Canada (HC), 26 from the Public Health Agency of Canada (PHAC) and 4 from Indigenous Services Canada (ISC). By comparison, 53 applications were received in 2023-24, and 45 in 2022-23. 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
Figure 2: Text version below.
Figure 2: Text description

This pie chart illustrates the affiliation of the lead investigator for the REB applications received during the 2024-2025 fiscal year. The data are as follows:

  • Among the 22 applications received from Health Canada:
    • 3 were from the Controlled Substances and Cannabis Branch
    • 12 were from the Healthy Environments and Consumer Safety Branch
    • 2 were from the Health Products and Food Branch
    • 5 were external
  • Among the 26 applications received from PHAC:
    • 8 were from the National Microbiology Laboratory Branch
    • 3 were from the Health Promotion and Chronic Disease Prevention Branch
    • 2 were from the Infectious Diseases and Vaccination Programs Branch
    • 3 were from the Data, Surveillance and Foresight Branch
    • 10 were external
  • 4 applications were received from Indigenous Services Canada.

The protocols received spanned a broad range of research areas. Six studies focused on Indigenous populations (four of which were from ISC).

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

This pie chart illustrates the subject areas of the protocols received by the REB for the 2024-2025 fiscal year. The data are as follows:

  • 8 were about disease investigation and surveillance
  • 2 were about diagnostic testing
  • 3 were about assay/methods development
  • 5 were about food and nutrition
  • 7 were about chemical and radiation exposure
  • 9 were about alcohol and drugs (1 Indigenous)
  • 7 were about environment and health (4 Indigenous)
  • 9 were social science research (1 Indigenous)
  • 2 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:

  1. A. Approved as submitted: The application meets ethics requirements for research involving humans and is recommended for approval.
  2. B. Approved with modifications/clarifications: The application meets ethics requirements for research involving humans, but the REB members require modification of the application, clarification or further information to secure approval. The revised material may be reviewed via delegated review or by a subset of the members as directed by the REB Chair.
  3. 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.
  4. 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
Figure 4: Text version below.
Figure 4: Text description

This pie chart illustrates the level of review that initial applications received by the REB. 51 applications were sent to delegated review and 1 application received full board review.

Figure 5. Outcome of REB review for initial applications
Figure 5: Text version below.
Figure 5: Text description

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

  • 21 applications were approved as submitted
  • 20 applications were approved after 1 round of review
  • 9 applications were approved after 2 rounds of review
  • 2 applications were unresolved (pending REB review or PI response)

Approval times: The time from application submission to approval depends on 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 fiscal year 2024 to 2025Footnote 2
Time period Average (± SD) Median
Days with REB 31 ± 12 30
Days with applicant 14 ± 20 8
Total 45 ± 25 36.5
Figure 6. Time distribution for the 50 applications received and approved in 2024-25Footnote 2
Figure 6: Text version below.
Figure 6: Text description

This bar graph contains 50 bars, 1 bar for each application that was received and approved in the 2024-2025 fiscal year. The bars are further divided into 2 sections: number of days with the REB and number of days with the applicant. The 50 bars are ordered from the shortest to longest amount of time by calendar days.

Application number Days with REB Days with applicant Total
1 14 1 15
2 18 0 18
3 19 0 19
4 20 0 20
5 20 0 20
6 20 0 20
7 21 0 21
8 22 0 22
9 23 0 23
10 24 0 24
11 22 3 25
12 24 2 26
13 14 13 27
14 15 14 29
15 26 5 31
16 18 14 32
17 12 21 33
18 33 0 33
19 32 1 33
20 16 18 34
21 26 8 34
22 35 0 35
23 31 4 35
24 34 1 35
25 27 9 36
26 36 1 37
27 38 0 38
28 21 19 40
29 36 8 44
30 29 16 45
31 45 0 45
32 43 4 47
33 31 18 49
34 44 5 49
35 28 21 49
36 38 12 50
37 29 24 53
38 45 9 54
39 40 15 55
40 43 14 57
41 53 4 57
42 46 18 64
43 33 34 67
44 47 22 69
45 50 27 77
46 57 23 80
47 50 31 81
48 41 56 97
49 47 75 122
50 14 112 126

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. Key elements of the Secretariat's work are to build partnerships and increase awareness about the REB, and to continually improve the board's processes.

An important milestone for 2024-25 was the signing of a Memorandum of Understanding (MOU) between Health Canada (HC), the Public Health Agency of Canada (PHAC) and Indigenous Services Canada (ISC) to extend the REB's services to ISC. The MOU included a commitment to recruit two additional Indigenous community members, bringing the total to four, with at least one member from each distinction (First Nations, Inuit and Métis). It also provided for the recruitment of a Deputy Chair to support the new Indigenous-focused arm of the REB and help implement the MOU. It was anticipated that this additional capacity would better position the REB when reviewing Indigenous research proposals, benefitting the research participants and helping to ensure respect for cultural values and cultural safety. The MOU also presented an opportunity to further enhance the capacity and knowledge across the REB as a whole with respect to Indigenous research ethics. Within a few months of signing the MOU, one Indigenous community member (Chelsey Purdy) and a Deputy Chair (Dr. Barbara McGillivray) were recruited. Efforts to recruit an additional Indigenous community member were ongoing at the end of March 2025.

Other key Secretariat activities for fiscal year 2024 to 2025 included the following:

Membership

As per the Terms of Reference for the REB, the board consists of at least 18 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. In the case of Indigenous community members and the Deputy Chair for Indigenous research ethics, the Chief Science Officer of Indigenous Services Canada also approves the appointment.

Five members left the board in 2024-25:

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 three new members to the REB in 2024-25:

REB membership as of March 31, 2025

REB Secretariat

PHAC liaison to the REB Secretariat

ISC liaisons to the REB Secretariat

References

Page details

2026-06-12