Research Ethics Board (REB) annual report 2023 to 2024

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:

Carried out by HC or PHAC
Performed by the Department or Agency in collaboration with external researchers
Carried out on Department or Agency premises
Conducted under contract to the Department or Agency

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:

4 full board meetings:
- Two remote (virtual) meetings for the review of an initial application and a major amendment request
- Two in-person meetings with the entire membership for educational sessions and informational presentations
61 delegated review meetings:
- 41 regular weekly meetings
- 20 ad hoc meetings, 15 of which were to review minimal risk initial applications.

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.

see text description below — **Figure 1. Submissions reviewed by the REB in 2023-24 ^{Reference 1}**

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.

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

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.

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:

The application deadline is 3 weeks before each pre-scheduled full board meeting. If an application is deemed to represent minimal risk to participants and is sent to delegated review rather than the full board, the time between submission and review is often reduced.
The REB Secretariat's service standard is to communicate the REB's recommendations to the applicant within one week of the REB meeting. In fact, in many cases this is done within 24 hours.
The REB will conduct expedited reviews for time-sensitive research projects where the urgency is due to public health emergencies or other circumstances beyond the researchers' control.

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

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

Collection and Use of Disaggregated Data – Jessica Roberts, Healthy Environments and Consumer Safety Branch, Health Canada (May 2023)
Research Using Crowdsourcing: Ethical Considerations – Janice Moseley, Manager Research Ethics, and Jessica Castillo, Research Ethics Coordinator, Ontario Tech University; Ruth Milman, past Chair, Ontario Tech University REB (May 2023)
Guide on the Use of Generative AI – Dawn Hall, Privacy and Data Protection Division, Treasury Board of Canada Secretariat (November 2023)
Broad Consent and Other Updates to TCPS 2 – Jean-Frédéric Ménard, Health Canada-PHAC REB Deputy Chair and Law Member; Erika Kleiderman, Tri-Council Secretariat on Responsible Conduct of Research (November 2023)
Métis Research Considerations – Reagan Bartel, Health Director, Métis Nation of Alberta (November 2023)

Sessions on HC and PHAC programs and priorities

Anti-Racism in Science: Mireille Lacroix and Apondi Odhiambo, Office of the Chief Science Officer, PHAC (May 2023)
Health Canada-PHAC Open Science Action Plan: Ethical Implications of Open Data – Lisa Hansen, Office of the Chief Science Officer, PHAC; Denzil Bailey, Digital Transformation Branch, Health Canada (May 2023)
Citizen Science and Participatory Research at Health Canada – Tara Bower and Achla Joshi, Healthy Environments and Consumer Safety Branch, Health Canada (May 2023)
Advancing Uptake of Participatory Research and Citizen Science at Health Canada – Tara Bower, Achla Joshi and Robert Stainforth, Healthy Environments and Consumer Safety Branch, Health Canada; Tierry Laforce, Tri-Council Secretariat on Responsible Conduct of Research (November 2023)
Assessing Privacy Risks in Health Canada-PHAC Research: Role of the Health Canada-PHAC Privacy Management Division – Prosper Béral, Emma Strachan and Claudia Mongrain, Health Canada-PHAC Privacy Management Division (November 2023)

Research presentations

Update on Statistics Canada Canadian Health Measures Survey (CHMS): Cycle 7 – Ron Gravel and Jason Deguire, Statistics Canada (May 2023)
Overview of Tracks Surveys for Bio-Behavioural Surveillance: Plans for Phase 5 of I-Track – Kathryn Zhang, Elsie Wong and Marene Gatali, Infectious Disease Prevention and Control Branch, PHAC (May 2023)
Overview of Health Canada MIREC Study (Maternal-Infant Research on Environmental Chemicals) – Jillian Ashley-Martin and Robin Shutt, Healthy Environments and Consumer Safety Branch, Health Canada (May 2023)
Serosurveillance Platform for Emerging Diseases and Vaccine Coverage – Michael Drebot, National Microbiology Laboratory, PHAC (November 2023)
Rapid Deployment Protocol: An Agile Solution for Typical and Atypical Exposure Scenarios – Christie Cole and Morgan MacNeil, Healthy Environments and Consumer Safety Branch, Health Canada (November 2023)
Biodosimetry Research at Health Canada: Emergency Response and Space Radiation – Ruth Wilkins, Healthy Environments and Consumer Safety Branch, Health Canada (November 2023)

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:

The REB Secretariat and the PHAC Office of the Chief Science Officer delivered one general REB learning session for employees and operated a booth at the annual Health Canada Science Forum.
The REB Secretariat participated in a government-wide community of practice in research ethics that was established to help share best practices for conducting research involving humans at federal government departments.
The REB Secretariat provided ethics advice and support to researchers at other departments including Indigenous Services Canada (ISC) and Immigration, Refugees and Citizenship Canada (IRCC).
The REB Secretariat continued discussions with ISC about expanding the REB's Indigenous research ethics capacity and extending ethics review services to ISC.
The REB Secretariat served on the steering committee for an Indigenous research ethics workshop led by the interdepartmental Indigenous Science, Technology, Engineering, and Mathematics (I-STEM) Cluster, which featured a presentation by a member of the Health Canada-PHAC REB.
The REB Secretariat served on a task group to develop a framework to better support participatory research/citizen science projects at Health Canada.
The REB Secretariat participated in the annual conferences of the Canadian Association of Research Ethics Boards (CAREB) and Clinical Trials Ontario.

Membership

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

Two members with knowledge and expertise in research ethics
Two members with knowledge and expertise in law
One member from Health Canada (HC) with knowledge and expertise in HC research
One member from the Public Health Agency of Canada (PHAC) with knowledge and expertise in PHAC research
One member external to HC and PHAC with broad knowledge and expertise in both HC and PHAC research
One member with broad expertise in public health
One member recruited from the community (general population) served by HC and PHAC
One member from the Indigenous community

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:

Marie-Ève Couture Ménard – Law member
Meredith Curren – Health Canada researcher
Stuart Nicholls – Researcher external to HC and PHAC
Lehana Thabane – Researcher external to HC and PHAC

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:

Charles Batrouny, J.D., LL.L. – Law Member: Mr. Charles Batrouny is currently a senior associate at the law firm Cozen O'Connor LLP. He represents clients across all Canadian provinces, and has been called to the Bar in Ontario, Alberta, British Columbia, and has a temporary call to the Quebec Bar under Rule 42.1 of the Professional Code. Mr. Batrouny is a Qualified Arbitrator (Q. Arb.) under the ADR Institute of Canada, has completed the Toronto Commercial Arbitration Society's Gold Standard Course in Commercial Arbitration, regularly volunteers as arbitrator for the world's largest advocacy competition (the Willem C. Vis International Commercial Arbitration Moot [Hong Kong and Vienna]), is involved in various local arbitration and ADR societies, was a teaching assistant for the ADR and Professionalism class in his law school, graduated with a distinction in ADR, and is further refining his skills as he pursues his Master of Laws (LLM) through the LLM in Dispute Resolution program with Osgoode Hall Law School. Mr. Batrouny earned his degrees in biomedical sciences (B.Sc. Hons.), common law (J.D. with a focus on dispute resolution), and civil law (LL.L.) from the University of Ottawa. Mr. Batrouny is fluent and practices in French and English, and can converse in Arabic.
John Frank, M.D., CCFP, M.Sc., FRCP – External Researcher: Dr. John Frank has held the following major positions: Professor (now Emeritus) at the University of Toronto, at the Dalla Lana School of Public Health, since 1983; founding Director of Research at the Institute for Work & Health in Toronto (1991-1997); and inaugural Scientific Director of the Canadian Institutes of Health Research – Institute of Population and Public Health (2000-2008). From 2008 to 2018, he was the founding Director of an Edinburgh-based Unit, funded by the Medical Research Council and the Scottish Chief Scientist Office: The Scottish Collaboration for Public Health Research and Policy. The Collaboration has sought to develop and robustly test novel public health policies and programs to equitably improve health status in Scotland, through the convening and ongoing support of researcher/research-user consortia. Dr. Frank has held a Personal Chair in Public Health Research and Policy in the Usher Institute at the University of Edinburgh, where he was also Director of Knowledge Exchange and Research Impact from 2017 to 2021, at which time he retired, and currently holds the post of Professorial Fellow. Dr. Frank trained in Medicine and Community Medicine at the University of Toronto, in Family Medicine at McMaster University, and in Epidemiology at the London School of Hygiene and Tropical Medicine.
Jane Ingman Baker, Ph.D., LL.B. – Law Member: Dr. Jane Ingman Baker is a lawyer practicing in British Columbia with a national law firm that has offices in Vancouver and Toronto. She was a law clerk in the British Columbia Supreme Court and is a member of the Law Society of British Columbia. Her law practice focuses on complex litigation matters with a specialty in construction, environmental and insurance coverage matters. She has represented clients in many different parts of Canada. Dr. Ingman Baker was trained as a biochemist, first as an undergraduate at the University of Sussex, England, and then as a post graduate student at the University of British Columbia. After completing her Ph.D., she completed two Medical Research Council Post Doctoral Fellowships in the departments of Physiology and Microbiology at UBC, before becoming a lawyer. Dr. Ingman Baker has taught in both the Faculties of Law and Medicine at the University of British Columbia and is a member of the UBC Clinical Research Ethics Board and the Children's and Women's Research Ethics Board.
Tyler Peikes, M.D. – External Researcher: Dr. Tyler Peikes is a practicing Medical Geneticist and Healthcare Ethics Consultant at the Health Sciences Centre in Winnipeg, Manitoba. He is the director of the Clinical Ethics service for the largest tertiary hospital in the province. He has conducted research in prenatal whole genome sequencing and advanced fetal diagnostic imaging. Dr. Peikes is a member of the Ethics, Education and Public Policy committee for the Canadian College of Medical Geneticists (CCMG) and a co-author of the Joint Statement on Involvement of Human Participants in Genetic Research, soon to be released. He also serves as the Choosing Wisely Canada (CWC) representative for CCMG and chaired a working group to publish new Medical Genetics recommendations. Dr. Peikes also enjoys teaching Medical Genetics and Ethics as an Assistant Professor at the University of Manitoba and has won several teaching awards. He also serves on several committees as ethics representative, including Differences in Sex Development committee, Child Health Program Tracheostomy committee, Perinatal Screening Committee and Child Health Quality Improvement team. Dr. Peikes previously served on the University of Manitoba Health REB and co-authored a report on Genetic Testing in Research including new informed consent templates and educational materials. Dr. Peikes has a B.A. (honours) with distinction in Philosophy (Queen's University), M.A. Bioethics & Health Policy (Loyola University, Chicago), M.D. (University of Manitoba) and HealthCare Ethics Consultant-Certified (ASBH).
Thea Rawn, Ph.D. – HC Researcher: Dr. Thea Rawn is a senior research scientist and Head of the Chemical Contaminants Section of the Food Research Division, Bureau of Chemical Safety, Health Canada. Her area of specialization is method development and analysis of environmental organic contaminants in food and biological tissues. She is currently an adjunct professor at Trent University. In addition to her work to determine dietary exposure to the chemicals of interest (e.g., polychlorinated dibenzo-p-dioxins, polychlorinated biphenyls, halogenated flame retardants, perfluoroalkyl substances, historical pesticides), Dr. Rawn has participated in studies to determine chemical concentrations in human tissues. She participated in the early work to measure chemicals in Canadian serum as part of the Canadian Health Measures Survey (CHMS). Dr. Rawn also participated in the pan-Canadian Maternal-Infant Research on Environmental Chemicals (MIREC) study, focusing on human milk analyses. She has collaborated with researchers in other groups within Health Canada in addition to those from academia (e.g., McGill University, Université du Québec à Montréal [UQAM]) to examine the linkage between chemical exposure and biological impacts. Dr. Rawn is currently the Head of the Canadian Delegation to the Committee on Methods of Analysis and Sampling under the WHO/FAO food standards programme Codex Alimentarius and has contributed to the WHO/FAO Joint Expert Committee on Food Additives and Contaminants (JECFA). Dr. Rawn has a B.Sc. in Chemistry from the University of Winnipeg, an M.Sc. and Ph.D. from the University of Manitoba in Environmental Organic Chemistry.
Elizabeth Rolland Harris, Ph.D. – PHAC Researcher: Dr. Elizabeth Rolland-Harris has nearly 25 years of experience in public health and epidemiology, across multiple levels of government. She joined the Public Health Agency of Canada in 2019 where she oversaw the Guidelines and Global Health Division's Scientific Team, responsible for supporting the Canadian Task Force on Preventive Health Care. Subsequent to this, she joined the Testing Directorate in 2021 as Scientific Director. Prior to joining the Agency, Dr. Rolland-Harris worked for the Department of National Defence where she was Co-PI and Project Lead for the Canadian Forces Cancer and Mortality Study II, which created a nearly 40-year census of Regular Force personnel to study all-cause mortality and cancer morbidity outcomes during and following military service. Dr. Rolland-Harris' areas of expertise include public health surveillance, outbreak and pandemic response, evidence-based guideline development, health outcomes research, respiratory infectious disease epidemiology and occupational epidemiology. She holds a MSc in Epidemiology from the University of Toronto and a PhD in Infectious Disease Epidemiology from the London School of Hygiene and Tropical Medicine (UK).

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

Sandra Romain – Community Member, General Population, effective July 1, 2023 (formerly PHAC researcher)

REB membership as of March 31, 2024

Stéphane Ahern, M.D., Ph.D. – Ethics
Charles Batrouny, J.D., LL.L. – Law
Stephanie Booth, D.Phil. – PHAC Researcher
Michael Wray Clarke, Ph.D. – Public Health Community Member
Louis Forti, Ph.D. – HC Researcher
John Frank, M.D., CCFP, M.Sc., FRCP – Researcher External to HC and PHAC
Glenn Griener, Ph.D. – REB Chair; Ethics
Jane Ingman Baker, Ph.D, LL.B. – Law
Janaki Jayanthan, MPH – Community Member, General Population
Madzouka Kokolo, M.A. – Community Member, General Population
Diane Lu, MD, Ph.D., MPH, FRCPC – Public Health Community Member
Jean Levasseur-Moreau, Ph.D. – Community Member, Indigenous Population
Kathleen Makela, B.A., LL.B. – Community Member, Indigenous Population
Melanie McPhail, J.D. – Law
Jean-Frédéric Ménard, LL.B., B.C.L., Ph.D. – Deputy Chair; Law
Tyler Peikes, M.D. – Researcher External to HC and PHAC
Thea Rawn, Ph.D. – HC Researcher
Elizabeth Rolland Harris, Ph.D. – PHAC Researcher
Sandra Romain, Ph.D. – Community Member, General Population
Julie Toole, RM, MHSc – Ethics
Nancy Walton, Ph.D. – Deputy Chair; Ethics

REB Secretariat

Gregory Huyer, Ph.D. – Manager
Melinda Lee Choon – Senior Research Ethics Coordinator (April – August 2023)
Maria Pereira – Senior Research Ethics Coordinator (September – December 2023)
Hussein Houseini – Senior Research Ethics Coordinator (effective February 2024)
Marissa Livius – Program Officer (effective August 2023)
William Liu –co-op student (May – August 2023)

PHAC liaison to the REB Secretariat

Trista Takacs, Ph.D. – Policy Analyst, Office of the Chief Science Officer

References

Reference 1

Note that this chart summarizes the submissions reviewed in 2023-24, and not submissions received. For example, 52 initial applications were reviewed in 2023-24, which includes 50 of the 53 received between April 1, 2023, and March 31, 2024, plus 2 applications received at the end of the 2022-23 fiscal year.

Return to reference 1 referrer

Footnote 2

Not approved: upon review, the REB determined that this study was largely complete and therefore could not be approved, since the REB cannot retroactively review research involving humans.

Return to reference 2 referrer

Footnote 3

"Days with REB" includes time with both the REB Secretariat and the REB. All times are measured in calendar days. In certain cases, additional time was required following REB review for the Privacy Management Division to complete its assessment and for the finalization of contracts or agreements; this additional time was excluded from these calculations.

Return to reference 3 referrer

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