Governance and COI management

The COVID-19 Immunity Task Force (CITF) was launched in response to a global health emergency. The work of the Task Force has been conducted at a rapid pace and is built around partnerships with provinces, territories, communities, agencies, institutions, and research experts from coast to coast.

On one level, the Task Force is engaged in research that must be rigorous and that entails meeting both high ethical standards and modern expectations of engagement with stakeholders. At the same time, the Task Force has been mandated to expedite Canada’s response to the COVID-19 pandemic and therefore rapid publication of results and wide sharing of data has been essential.

The CITF’s management of conflict of interest

The CITF has developed rigorous and transparent processes at all levels of operation, from the identification of priority research topics to the implementation of proposal evaluation and decision-making procedures for applications submitted for funding. The CITF is especially attentive to issues related to COI, particularly regarding the assessment of applications for funding, a process which was carefully managed by the EC.

Prior to January 1, 2023, when deciding on whether to award funding to a researcher and a project, COI was managed in the following distinct ways:

COI is managed in the following distinct ways:

  • Executive Committee: All award investment decisions were made at the EC level. To hold a seat on the EC, it was therefore a requirement, to preserve neutrality, that EC members could not have previously applied for or held CITF funds and could not intend to apply for or hold CITF funds.
  • COI declarations: All non-ex officio members of the EC, Leadership Group (LG), and Working Parties (WPs), as well as all executive members of the Secretariat, had to complete a COI declaration form on an annual basis, found on the CITF website (see below). At each EC, LG and WP meeting, the designated Chair asked members to provide updates to their forms.
  • External reviewers: At the level of proposal review, all candidate external reviewers for studies submitted to the CITF for funding were asked to declare any COI. The CITF adopted COI definitions for the review process drawn from Federal Research Funding Organizations Alternative reviewers were selected when a COI was identified. Reviewers used a standard form that included pre-determined evaluation criteria to guide the assessment of proposals and ensure transparency.
  • Committee meetings/recusals and abstentions: In all formal CITF committee meetings, the meeting Chair invited individual members to disclose COIs (direct or indirect) at the start of the session and again before each proposed study was discussed or evaluated. The COIs disclosed were recorded by the CITF Secretariat in formal minutes. Declarations were assessed and addressed by the meeting Chair. As meetings occurred virtually, participants with direct conflicts were recused to an electronic waiting room or abstained from participation until the project’s evaluation, discussion, and award recommendations concluded. Participants with indirect COIs could be instructed to abstain from participation at the discretion of the Chair. In some cases, members could choose to formally abstain or recuse themselves. Direct COIs raised for each funding decision made by the EC are published below.

Going forward, as of January 1st 2023 under the joint governance structure, the procedure to evaluate and issue decisions on funding will continue to follow similar guidelines.

Confidentiality

Members of CITF advisory and decision-making bodies and the CITF Secretariat may have access to novel processes or ideas as well as confidential information about applicants and their proposals for contracts or grants. Members are accordingly expected to treat deliberations and decisions as confidential until announced publicly. In particular, there should be no advance notice given regarding funding competitions, early reports of funding decisions, or disclosure of strategic deliberations by the EC, CITF advisory bodies, and Secretariat.

Conflict of interest management in the Canadian COVID research reality

The Task Force Executive Committee (EC), Leadership Group (LG), and Working Parties (WP or WPs) included not only representatives from federal sponsors and provincial partners, but a range of researchers from across Canada who had distinguished themselves in relevant fields of inquiry. The inevitable result was that many LG and WP members were themselves involved with key research teams that were potential candidates for financial support from the CITF. The Task Force Co-Chairs and federal sponsors were aware of this structural anomaly. They were fully committed to processes that managed the potential COI it created. At the same time, this unusual situation meant that all those involved with the work of the Task Force had to conduct themselves with careful attention to perceived and actual conflicts of interest.

Conflict of interest is defined as a tension between duties and responsibilities, and private, professional, business, or public interests. There may be a real, perceived, or potential conflict of interest when someone:

  • Receives professional or personal benefit resulting from the funding opportunity or application being reviewed;
  • Has a professional or personal relationship with an applicant or the applicant’s institution; or
  • Has a direct or indirect financial interest in a funding opportunity or application being reviewed.

List of all CITF funding decisions and actions to manage direct COIs

EC Meeting #25 – January 11, 2022
EC approved the extension and additional funds for:

Tracking Seroprevalence beyond January 2022 through Canadian Blood Services (PI: Chantale Pambrun)

The EC approved in principle:

Statistics Canada Canadian COVID-19 Antibody Health Survey 2 (PI: Ron Gravel)

EC approved funding for:

Lab analysis for the CIHR-funded study entitled Ab-C Risk: Action to Beat Coronavirus Sub-study on Population Immunity in High-Risk Groups in Canada (PI: Prabhat Jha)

No members declared a direct COI.
EC Meeting #26 – January 21, 2022
EC reviewed study amendments where no additional funds were requested. No members declared a direct COI.
EC meeting #27 – February 4, 2022
EC approved new funding for:

Immune Response in Young Immuno-Suppressed children to COVID-19 vaccination (IRYIS) (PI: Hélène Decaluwe)

EC approved the extension and additional funds for :

Action to Beat Coronavirus in Canada (Ab-C) – Phases 4 and 5 (PI: Prabhat Jha)

COVID-19 Occupational Risks, Seroprevalence and Immunity Among Paramedics in Canada (PI: Brian Grunau)

Integrating Longitudinal Epidemiologic, Virologic and Immunologic Analyses to Understand COVID-19 Immunity and Infection in Long-Term Care (PI: Marc Romney)

EC reviewed additional study amendments where no additional funds were requested

No members declared a direct COI.
EC Meeting #28 – March 4, 2022
EC approved the extension and additional funds for:

Investigating Vaccine Access, Immunogenicity, Effectiveness, and Safety among South Asians in Ontario and British Columbia (PI: Sonia Anand)

No members declared a direct COI.
EC Meeting #29 – April 1, 2022
The EC approved the extension and additional funds for:
COVID-19 Vaccination in Pregnancy: A Province-wide Epidemiological Assessment of Safety and Effectiveness Using the BORN Ontario Registry (PI: Deshayne Fell)EC approved the extension and additional funds for:
Héma Québec COVID-19 Seroprevalence Study (PI: Marc Germain)The EC approved the operating budget for:
Statistics Canada Canadian COVID-19 Antibody Health Survey 2 (PI: Ron Gravel)

The EC approved additional funds for:
SUrveying Prospective Population cOhorts for COVID19 pRevalence and ouTcomes in Canada (SUPPORT-Canada) (PI: Philip Awadalla)

No members declared a direct COI.
EC Meeting #30 – May 12, 2022
EC approved new funding for:
COVID-19 seroepidemiology among children Using Retrieved POPCORN site Leftover blood Samples (CURNLS) (PI: Soren Gantt)EC reviewed additional study amendments where no additional funds were requested.
No members declared a direct COI.
EC Meeting #31 – June 9, 2022
EC approved the extension of the MOSAIC-2 study to include MOSAIC-3:
Immunogenicity and adverse events following immunization (AEFI) with alternate schedules of COVID-19 vaccines in Canada: is “mix and match” of the second dose (MOSAIC-1; CT24a) and additional doses (MOSAIC-2 and MOSAIC-3; CT24b and CT24c) safe and immunogenic (PI: Joanne Langley)EC approved the extension and additional funds for:
Immunité cellulaire et séroprévalence des anticorps contre SARS-CoV-2 : caractérisation de trois populations de travailleurs de l’alimentation (PI: Denis Boudreau)
EC Meeting #32 – July 21, 2022
EC approved the extension and new funds for:
Canadian Blood Services Federal COVID-19 Immunity Task Force Initiative Project (PI: Chantal Pambrun)EC recommended new funding for 9 hybrid immunity studies:
SUrveying Prospective Population cOhorts for COVID19 pRevalence and ouTcomes in Canada (SUPPORT-Canada) (PI: Philip Awadalla)Caractérisation de la réponse humorale chez des donneurs vaccinés contre le SRAS-CoV-2 puis infectés par des variants préoccupants (PI: Denis Boudreau)

Hybrid Immunity in Residents of Long-term Care Facilities (PIs: Dawn Bowdish and Andrew Costa)

Long-term impact of COVID-19 infection and immunity In education workers (PI: Pascal Lavoie)

How well does vaccination and prior infection protect residents of long term care homes from new COVID-19 variants? (Co-PIs: Sharon Straus and Alison McGeer)

SARS-CoV-2 Immunity in BC Prenatal Women: Variants and Vaccination Interplay (PI: Deborah Money)

Deconstructing hybrid immune responses to SARS-CoV-2 in older adults and people living with HIV (PI: Marc Romney)

Hybrid immunity in participants of the STOPCoV study (PI: Sharon Walmsley)

Characterization of Hybrid Cellular and Humoral Immunity Against SARS-CoV-2 and Evaluation of its Role in Protection from Infection and from Severe Illness (PI: Michael Grant)

EC approved an additional study amendment where no additional funds were requested.

Meeting #33 – EC August 25, 2022
EC approved extensions for five studies with new funds for hybrid immunity objectives:
Safety and immunogenicity of Covid-19 vaCcines in systEmic immune mediated inflammatory Diseases: Infections and Immunity (SUCCEED-II) (PI: S. Bernatsky)A prospective multi-site observational study of SARS-CoV-2 immunity in patients with hematologic malignancies (A continuation of “The VIP Study”) (PI: C. Buchan)

Determining the impact of hybrid immunity on the evolving landscape of host responses to SARS-CoV-2 in the Biobanque Québecoise de la COVID-19 (BQC19) (PI: V. Mooser)

Vaccines in a Time of Dual Pandemic (PI: M. Ostrowski)

Humoral and cellular responses to SARS-CoV-2 vaccination in pediatric acute lymphoblastic leukemia patients (PI: T. Watts)

EC approved new funding for the following provincial serosurvey:
Age-stratified SARS-CoV-2 Serological Prevalence Estimates Using Anonymized Residual Sera Following Delta and Omicron Waves in the Northwest Territories (PI: K. Kandola)

EC approved an extension including new funding for:
Pediatric Longitudinal Cohort of Children Vaccinated and Unvaccinated Against COVID-19: Duration and Evolution of Immunity and Immune Protections in Children 3-11 Years Old (PI: J. Maguire)

No members declared a direct COI
Meeting #34 – EC November 17, 2022
EC approved extensions for four studies with new funds for objectives to study bivalent vaccines:
COVID-19 Infection and Immunity in Residents of Long-term care Facilitites (PIs: A. Costa, D. Bowdish)Vaccine effectiveness against SARS-CoV-2 variants of concern in long-term care populations: a multi-province study (PI: A. Hsu)

Stop the spread Ottawa (correlates of protection) (PI: MA Langlois)

Are there post-vaccination antibody levels that correlated with protection against COVID-19 (AB-Protect) (PI: A. McGeer)

Minutes record the between meeting EC approval via email of the following extensions including new funds:

Active Surveillance for COVID-19 vaccine safety and effectiveness among Canadian children: A Canadian Immunization Monitoring Program ACTive (IMPACT) Project (PI: K. Top)

Hybrid immunity in participants of the STOPCoV study (PI: S. Walmsley)

No members declare a direct COI

List of all CITF decisions and actions to manage direct COIs

2021 Decisions & Actions
2020 Decisions & Actions

Definitions

A direct COI occurs due to current or recent close collaborator status or close personal relationships between applicants and members reviewing study proposals. A declaration of financial interests is considered to be direct a COI, however this scenario is mitigated because EC members could not apply to hold CITF funds or be co-investigators on CITF-sponsored studies. Indirect conflicts could occur through other professional and personal relationships between the member and the applicants or the entities they belonged to.

Close collaborator refers to currently shared institutional affiliations (including provincial agencies, research hospitals and research institutes) or recently shared affiliations or a close professional affiliation with an applicant:

  • Had frequent and regular interactions with an applicant in the course of their duties at their department, institution, organization, or company;
  • Been a supervisor or a trainee of an applicant;
  • Collaborated, published, or shared funding, or have plans to do so in the immediate future.