Research Ethics Board (REB) Annual Report 2020-21

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 the Agency.

The REB provides support and independent ethics review for all proposed and ongoing research involving humans carried out under the auspices of Health Canada and PHAC, to help ensure that the highest ethical standards are being met and the greatest protection is provided to participants.

The 2020-21 fiscal year was defined by the COVID-19 pandemic, which impacted the REB's work in a number of ways. First, there were no in-person REB meetings in 2020-21; instead, all meetings (12 full board and 58 delegated review) were held by teleconference or videoconference. Second, many applications were considered urgent and required that the REB be available on short notice to conduct expedited reviews. This resulted in a significant number of ad hoc meetings outside of the regularly-scheduled monthly full board meetings and weekly delegated review meetings. And finally, the REB saw an increase in amendment requests as many researchers had to modify their protocols in response to public health restrictions and laboratory closures.

The REB received 44 new applications in 2020-21, of which 19 were from Health Canada and 25 from PHAC. Reflecting the impact of the COVID-19 pandemic on research, 19 applications were related to COVID-19 and 11 applications were from the PHAC National Microbiology Laboratory. The majority of initial applications (34) were deemed to be minimal risk and therefore reviewed at delegated review meetings, which represented a significant change from the previous year in which only 13 out of 43 applications were considered minimal risk. The time from application submission to approval was an average of 32 calendar days for non-expedited protocols (21 days with the REB and 11 days with the applicant), while for expedited reviews the average was only 15 days (6 days with the REB and 9 days with the applicant). The REB also reviewed 112 annual progress reports, 73 amendment requests and 2 adverse event reports in 2020-21, and 25 protocols were closed.

In addition to conducting ethics reviews, the REB received a number of education and information sessions in 2020-21. While there were fewer sessions than in previous years because of the pandemic, the shift to videoconference meetings increased participation by making the sessions more easily accessible to the entire membership. In terms of membership, the REB said farewell to four long-time members whose terms ended in 2020-21 and welcomed six new members to the board.

The REB Secretariat continued its outreach efforts among Health Canada and PHAC staff, including training sessions, targeted consultations and participation in the Health Canada Science Forum. The Secretariat implemented additional operational improvements in 2020-21, including a redesigned REB website, new fillable PDF forms for continuing ethics review, and a Microsoft Access database to better track protocols and workflow. While the COVID-19 pandemic clearly created significant challenges, the REB and the Secretariat were able to quickly adapt and successfully deliver on their mandate. The learnings and operational improvements from 2020-21 have ensured that the REB is well-positioned for the coming year.

Message from the Chair

Chair, Health Canada-PHAC Research Ethics Board

On behalf of the Health Canada (HC) and Public Health Agency of Canada (PHAC) Research Ethics Board (REB), I am pleased to present this report on our REB's activities for the 2020-21 fiscal year.

This report supports the Department's and Agency's commitment to transparency and accountability, with respect to the REB's work.

The REB helps ensure that human participants in research receive the protections they deserve, and that decision-makers have access to ethically sound research when developing policies and regulations. The REB's work in this regard was particularly important over the past year due to the challenges associated with the COVID-19 global pandemic.

It goes without saying that 2020-21 was an exceptional year as Health Canada and PHAC scientists and researchers, and Canadians nationwide, stepped up to support Canada's efforts to curb the pandemic.

The National Microbiology Laboratory played a key role, reorienting its considerable resources and expertise, almost overnight, to focus on pandemic response.

At the same time, staff carried out other essential research to deliver on Department and Agency mandates and to help inform policy and regulatory decisions, all while dealing with limited access to labs and offices, remote working and other disruptions.

The urgency created by the pandemic meant many research protocols required expedited ethics reviews and the REB responded in kind.

I would like to express my gratitude to our REB members for delivering on short notice, adapting quickly to working virtually, and providing expert reviews of urgent studies in the pandemic context. In addition, the REB Secretariat provided exceptional support to the Board in administering the ethics review process.

This year, we also welcomed new members of the REB, and said farewell to valued members whose terms ended. I am grateful to the past and current members who have ensured we have maintained our momentum.

On a personal note, I was honoured that my term as Chair was extended for an additional year, to provide continuity during the pandemic. It is a great privilege to serve in this capacity.

During my time at the REB, it is clear that Health Canada and PHAC are committed to the highest standards of research ethics. This is especially evident through ongoing Department and Agency support, and the REB's wide-ranging collaborative relationships that continue to expand and flourish.

Thank you to past and new members, and our partners for your commitment to supporting and delivering on the REB's mandate.

Barbara McGillivray, MD, FRCP, FCCMG
Chair, Health Canada-PHAC Research Ethics Board

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 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 Canada and the President of PHAC, who jointly appoint REB members, approve REB procedures and authorize research to be initiated or terminated. 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 the Department or Agency grants and contributions.

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 Strategic Policy Branch (Science Policy 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 full Research Ethics Board (REB) typically meets monthly, either remotely or face-to-face in Ottawa. 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 (bi-weekly in July and August) and are attended by the Chair (or Deputy Chair) and one other REB member.

Applications for initial review of research involving humans are generally reviewed at the monthly meetings of the full REB, while delegated review meetings typically evaluate submissions for continuing ethics review (i.e., annual progress reports, amendment requests, adverse event reports and completion/termination reports). Initial applications that represent minimal risk to participants may also be sent to delegated review. For the review of initial applications, the applicant is invited to the REB meeting to give a brief presentation of their proposal and to answer any questions from the REB members.

Types and number of REB meetings in 2020-21:

The number of open protocols varies throughout the year as the REB approves new applications and closes old protocols. There were 153 open protocols on March 31, 2021, and 25 protocols were closed in 2020-21.

Figure 1. Submissions reviewed by the REB in 2020-21Footnote 1

figure 1
Figure 1: Text description

This figure is a bar chart with 12 bars showing the number of submissions reviewed by the REB in the 2020-2021 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 Amendments Adverse events
April 5 11 6 0
May 0 3 8 0
June 4 9 10 0
July 4 10 2 0
August 4 2 3 0
September 5 10 5 0
October 4 11 6 1
November 2 9 5 1
December 8 4 6 0
January 0 15 8 0
February 3 11 6 0
March 2 17 8 0
Total 41 112 73 2

Profile of applications received in 2020-21

The Research Ethic Board (REB) received 44 applications in 2020-21, 19 from Health Canada (HC) and 25 from the Public Health Agency of Canada (PHAC). By comparison, 43 applications were received in 2019-20, and 31 in 2018-19. External protocols were led by researchers outside of the Department and Agency, either in collaboration with Health Canada or PHAC researchers or funded by the Department or Agency.

Figure 2. Affiliation of the principal investigator for REB applications

figure 2
Figure 2: Text description

This pie chart illustrates the affiliation of the lead investigator for the REB applications received during the 2020-2021 fiscal year. The data are as follows:

  • Among the 19 applications received from Health Canada:
    • 2 were from the Controlled Substances and Cannabis branch
    • 2 were from the Health Products and Food Branch
    • 2 were from the Healthy Environments and Consumer Safety Branch
    • 13 were external.
  • Among the 25 applications received from PHAC:
    • 1 was from the Health Promotion and Chronic Disease Prevention Branch
    • 10 were external
    • 14 were from the Infectious Disease Prevention and Control Branch (11 of which were from the National Microbiology Laboratory).

The protocols received spanned a broad range of research areas. One study focused on Indigenous populations, and 19 were related to COVID-19.

Figure 3. Subject areas of the protocols received by the REB

figure 3
Figure 3: Text description

This pie chart illustrates the subject areas of the protocols received by the REB for the 2020-2021 fiscal year. The data are as follows:

  • 10 were about disease investigation and surveillance (8 of which were related to COVID)
  • 9 were about assay development and regulatory testing (6 of which were related to COVID)
  • 2 were about food and nutrition
  • 3 were about machine learning
  • 2 were about chemical exposure (1 of which was focused on Indigenous populations)
  • 8 were about alcohol and drugs
  • 4 were environmental studies
  • 6 were social science research (5 of which were about COVID)

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:

Figure 4. Level of review for initial applications

figure 4
Figure 4: Text description

This pie chart illustrates the level of review that initial applications received by the REB. 34 applications were sent to delegated review and 10 applications received full board review.

Figure 5. Outcome of REB review for initial applications

figure 5
Figure 5: Text description

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

  • 12 applications were approved as submitted
  • 22 applications were approved after 1 round of review
  • 6 applications were approved after 2 rounds of review
  • 4 applications were unresolved, pending a response from the Principal Investigator

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 in 2020-21Footnote 2
  Non-expedited (n = 25) Expedited (n = 15)
  Average (± SD) Median Average (± SD) Median
Days with REB 21 (± 11) 22 6 (± 5) 5
Days with applicant 11 (± 17) 5 9 (± 7) 8
Total 32 (± 22) 26 15 (± 10) 13

Figure 6. Time distribution for each of the 40 applications that were approved by March 31, 2021

figure 6
Figure 6: Text description

This bar graph contains 40 bars, 1 bar for each application that was approved by March 31, 2021. The bars are further divided into 2 sections: number of days with the REB and number of days with the applicant. The 40 bars are ordered from the shortest to longest amount of time by calendar days.

Application number Days with REB Days with applicant Total
1 1 1 2
2 0 3 3
3 3 1 4
4 4 3 7
5 6 1 7
6 2 8 10
7 6 4 10
8 11 0 11
9 6 5 11
10 9 2 11
11 6 7 13
12 6 7 13
13 13 2 15
14 15 0 15
15 10 5 15
16 8 8 16
17 3 13 16
18 10 9 19
19 5 17 22
20 22 0 22
21 23 0 23
22 11 13 24
23 4 20 24
24 9 16 25
25 13 12 25
26 22 4 26
27 26 3 29
28 30 0 30
29 20 10 30
30 29 2 31
31 12 19 31
32 21 11 32
33 26 9 35
34 30 7 37
35 27 11 38
36 36 8 44
37 12 46 58
38 47 15 62
39 26 42 68
40 34 68 102

REB education and information sessions

As noted in 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.

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 2020-21 included the following:

Outreach

Operations

Membership

The REB consists of nine regular and nine 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. The terms for four long-time REB members ended in 2020-21:

Health Canada and PHAC are especially grateful for their expert contributions to the REB over the years, and they are very much missed by the REB members and Secretariat.

The REB welcomed the following individuals who joined the REB in 2020-21 to fill various vacancies:

Finally, Charles Dupras, Ph.D., an Academic Associate with the McGill Centre of Genomics and Policy, joined the REB in July 2020 as an alternate member with expertise in ethics. Dr. Dupras was a valued contributor to the REB who brought a wealth of ethics knowledge and research experience. Unfortunately for the REB, Dr. Dupras was unable to continue on the board following a change in employment and resigned in January 2021. He is certainly missed by the REB and we wish him all the best in his new endeavours.

REB membership as of March 31, 2021

REB Secretariat

PHAC liaison to the REB Secretariat

References

Footnote 1

Note that this chart summarizes the submissions reviewed in 2020-21, and not submissions received. For example, 41 applications were reviewed in 2020-21, which includes 40 of the 44 applications received between April 1, 2020 and March 31, 2021, plus one application received at the end of the 2019-20 fiscal year.

Return to footnote 1 referrer

Footnote 2

"Days with REB" includes time with both the REB Secretariat and the REB. All times are measured in calendar days. 44 applications were received in 2020-21, but four remained outstanding as of March 31, 2021 and were therefore excluded from this analysis. In certain cases, additional time was required following REB review for the Privacy Management Division to complete its assessment; this additional time was excluded from these calculations.

Return to footnote 2 referrer

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