Annual Report 2019-2020

Table of Contents

Message from the Chair

Photograph of Dr. Barbara McGillivray, Chair of the Health Canada-PHAC Research Ethics Board.

On behalf of the Health Canada-PHAC REB, I am pleased to present this report on the REB’s activities for the 2019-20 fiscal year. For nearly 20 years the REB has played an essential role for Health Canada and PHAC in providing ethical oversight of research with humans. The fundamental purpose of research ethics review is to ensure the highest level of protection to human participants in research while encouraging that research to occur. This report has been prepared in the spirit of transparency and accountability to underscore Health Canada and PHAC’s commitment to this principle through its REB.

It has been my privilege to chair the REB since 2015, and prior to that to serve as a regular member of the board. I continue to be inspired by the dedication of the REB members who freely volunteer their time to serve on the board. The thoroughness of their reviews and the quality of the discussions are always of the highest standard. I am also grateful for the relationships that we as a board have been able to develop with many of the researchers who apply to the REB. Ensuring the highest standards in research ethics depends on a partnership between the REB and the researchers, and it is clear that Health Canada and PHAC researchers recognize the value that ethics review brings to their work.

The REB is supported by a very capable Secretariat, which has been managed by Dr. Gregory Huyer since March 2019. I would like to express my sincere thanks to Dr. Peter Monette for his excellent work as interim Manager on top of his regular role as Manager of Bioethics and Science Advice. Under Dr. Huyer’s leadership, the REB Secretariat has implemented a number of operational changes that have improved the REB process for the REB members and applicants alike.

The REB continues to evolve itself as members’ terms run out. I have been amazed at the number and high quality of applicants for open positions; I am confident our new members’ solid backgrounds will only enhance the REB’s expertise.

I also want to recognize the exceptional work of the REB and the Secretariat in response to the COVID-19 pandemic. By late January it was apparent that we were facing an extremely serious situation in Canada and around the world, and the urgent need for research on COVID-19 meant a concomitant need for expedited ethics reviews. The REB members responded without hesitation – despite the impact of the pandemic on their own professional and personal lives – and ensured that urgent protocols were reviewed in as little as 24 to 48 hours, without compromising the thoroughness of their evaluations. I would also like to express my enormous respect for the researchers studying COVID-19, particularly at the National Microbiology Laboratory, who have put so much effort into studying the virus: it is truly an honour for the REB to support the work of such selfless and dedicated scientists.

A unique aspect of the research conducted by Health Canada and PHAC is its often direct contribution to the development of Canadian policy and regulations. Because these policies and regulations affect many, if not all Canadians, it is critical that decision-makers base their decisions on ethically-sound research. The REB takes this responsibility seriously, both in terms of initial review and in following the research progress. I thank all the REB members, the REB Secretariat and the scientists and officials at Health Canada and PHAC for their collective commitment in service of the public good.

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

About the Health Canada-PHAC REB

The Health Canada and Public Health Agency of Canada Research Ethics Board (HC-PHAC REB) is a joint REB for both Health Canada and the Public Health Agency of Canada. The REB provides support and independent ethics review for all proposed and ongoing research involving humans, 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 HC-PHAC REB reports to the Deputy Minister of Health 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 Health Canada and PHAC managers and researchers.

The HC-PHAC 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 Health Canada or PHAC grants and contributions.

REB Meetings and Reviews

The full REB meets monthly (except for August), either by teleconference 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 teleconference (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 normally 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).

The REB met as a full board 11 times in fiscal year 2019-20:

In addition, there were 45 delegated review meetings in 2019-20.

Submissions reviewed by the REB in 2019-20
Figure 1 - Text Equivalent

This figure is a bar chart with 12 bars showing the number of submissions reviewed by the REB in the 2019-2020 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 reports Amendments Adverse events Total
April 4 4 4 1 13
May 2 5 2 0 9
June 4 5 8 0 17
July 2 8 2 1 13
August 0 5 4 1 10
September 5 6 4 0 15
October 9 7 8 2 26
November 7 7 6 0 20
December 4 9 1 0 14
January 3 10 2 0 15
February 2 12 5 1 20
March 3 9 4 0 16
Total 45 87 50 6 188

The number of open protocols varies throughout the year as the REB approves new applications and closes old protocols. On March 31, 2020, there were 145 open protocols and 22 protocols were closed in 2019-20.

Profile of Applications Received in 2019-20

The REB received 43 applications in 2019-20, 24 from Health Canada and 19 from PHAC. By comparison, 31 applications were received in 2018-19, and 45 in 2017-18. External protocols were led by researchers outside of Health Canada and PHAC, either in collaboration with Health Canada or PHAC researchers or funded by Health Canada or PHAC.

Affiliation of the principal investigator for REB applications
Figure 2 - Text Equivalent

This pie chart illustrates the affiliation of the lead investigator for the REB applications received during the 2019-2020 fiscal year. The data are as follows:

  • Among the 24 applications received from Health Canada:
    • 3 were from the Controlled Substances and Cannabis branch
    • 6 were from the Health Products and Food Branch
    • 8 were from the Healthy Environments and Consumer Safety Branch
    • 7 were external.
  • Among the 19 applications received from PHAC:
    • 1 was from the Health Promotion and Chronic Disease Prevention Branch
    • 12 were external
    • 6 were from the Infectious Disease Prevention and Control Branch (National Microbiology Laboratory).

The protocols received spanned a broad range of research areas. Three studies involved Indigenous populations, and two were related to COVID-19.

Subject areas of the protocols received by the REB
Figure 3 - Text Equivalent

This part chart illustrates the subject areas of the protocols received by the REB for the 2019-2020 fiscal year. The data are as follows:

  • 10 were about disease investigation and surveillance
  • 3 were about assay development and regulatory testing
  • 6 were about food and nutrition
  • 4 were about air/water quality
  • 4 were about chemical exposure
  • 6 were about alcohol and drugs
  • 2 were genomics and genome studies
  • 3 were about climate change
  • 5 were social science research.

Application Review Process and Outcomes

The 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 approved.

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 teleconference or face to face, 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.

Level of Review for Initial Applications
Figure 4 - Text Equivalent

This pie chart illustrates the level of review that initial applications received by the REB. 13 applications were sent to delegated review and 30 applications received full board review.

Outcome of REB Review for Initial Applications
Figure 5 - Text Equivalent

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

  • 20 applications were approved as submitted
  • 10 applications were approved after 1 round of review
  • 9 applications were approved after 2 rounds of review
  • 3 applications were unresolved, pending a response from the Principal Investigator
  • 1 application was rejected.

Approval times: The time from application submission to approval is a function of the REB Secretariat, the REB and the applicant. To help accelerate the approval time, the REB Secretariat changed the application deadline from approx. one month prior to the REB meeting to three weeks, beginning in January 2020. In the vast majority of cases, the REB Secretariat communicates the REB’s recommendations to the applicant within one week of the REB meeting. The REB also conducted several expedited reviews in March 2020 to ensure the rapid approval of urgent COVID-19 related research.

The time from submission to approval for the applications received in 2019-20 was as follows Footnote 1
- Average Std. Dev. Median
Days with REB 42 18 40
Days with applicant 25 47 5
Total 67 51 51
Table 1 Footnote *

“Days with REB” includes time with both the REB Secretariat and the REB. All times are measured in calendar days. 43 applications were received in 2019-20, but three remained outstanding as of March 31, 2020 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 * referrer

The following graph shows the time distribution for each of the 40 applications that were approved or resolved by March 31, 2020

Time distribution
Figure 6 - Text Equivalent

This bar graph contains 40 bars, 1 bar for each application that was approved or resolved by March 31, 2020. The bars are further divided into 2 sections: number of days with the REB and number of days with the principal investigator (PI). The 40 bars are ordered from the shortest to longest amount of time by calendar days.

Application number Days with REB Days with PI Total
1 4 0 4
2 6 3 9
3 21 0 21
4 23 3 26
5 17 11 28
6 22 6 28
7 34 0 34
8 31 4 35
9 25 10 35
10 31 4 35
11 23 13 36
12 35 2 37
13 35 2 37
14 39 0 39
15 40 3 43
16 40 3 43
17 40 3 43
18 40 3 43
19 42 7 49
20 28 22 50
21 51 0 51
22 51 1 52
23 52 1 53
24 55 0 55
25 49 10 59
26 40 24 64
27 65 2 67
28 47 23 70
29 45 30 75
30 49 29 78
31 80 1 81
32 55 31 86
33 53 34 87
34 78 11 89
35 77 55 132
36 73 66 139
37 60 83 143
38 36 157 193
39 54 156 210
40 19 204 223

REB Education and Information Sessions

As noted in TCPS 2, an important component of 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 a number of presentations from Health Canada and PHAC researchers about their programs of research. These interactions served not only to educate the 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 of their time to enlighten the REB.

Secretariat Activities

The Health Canada-PHAC REB is supported by a Secretariat that administers the REB review process. The REB 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).

Key Secretariat activities for 2019-20 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 three long-time REB members ended in June 2019:

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 2019-20 to fill various vacancies:

Finally, the REB was pleased to welcome back Marie-Ève Couture Ménard who returned to the REB in December 2019 after a maternity leave.

REB Membership as of March 31, 2020:

REB Secretariat:

PHAC liaison to the REB Secretariat:

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