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 is accordingly being 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 will be 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 is carefully managed by the EC.

COI is managed in the following distinct ways:

  • Executive Committee: All award investment decisions are made at the EC level. To hold a seat on the EC, it is therefore a requirement, to preserve neutrality, that EC members cannot have applied for or held CITF funds in the past and cannot intend to apply for or hold CITF funds in the future.
  • COI declarations: All non-ex officio members of the EC, LG, and WPs, as well as all executive members of the Secretariat must proactively complete a COI declaration form on an annual basis that is publicly available on the CITF website (see below). At each EC, LG and WP meeting, the designated Chair will ask members to provide updates to their forms.
  • External reviewers: At the level of proposal review, potential external reviewers of studies submitted to the CITF for funding are asked to declare any COI. The CITF has adopted COI definitions for the review process drawn from Federal Research Funding Organizations Alternative reviewers are selected when a COI is identified. Reviewers use a standard form that includes 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 invites individual members to disclose COIs (direct or indirect) at the start of the session and again before each proposed study is discussed or evaluated. The COIs disclosed are recorded by the CITF Secretariat in formal minutes. Declarations are assessed and addressed by the meeting Chair. As meetings occur virtually, participants with direct conflicts are recused to an electronic waiting room or must abstain from participation until the project’s evaluation, discussion, and award recommendations have concluded. Participants with indirect COIs may be instructed to abstain from participation at the discretion of the Chair. In some cases, members may choose to formally abstain or recuse themselves. Direct COIs raised for each funding decision made by the EC are published below.

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

To ensure that the CITF’s work proceeds apace, the Task Force Executive Committee (EC), Leadership Group (LG), and Working Parties (WP or WPs) include not only representatives from federal sponsors and provincial partners, but a range of researchers from across Canada who have distinguished themselves in relevant fields of inquiry. The inevitable result is that many LG and WP members are themselves involved with key research teams that are potential candidates for financial support from the CITF. The Task Force co-chairs and federal sponsors are aware of this structural anomaly. They are fully committed to processes that manage the potential conflicts of interest (COI) it creates. At the same time, this unusual situation means that all those involved with the work of the Task Force must 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 Decisions and Actions to Manage Direct COIs – 2021

Decision Actions to Manage COI
Executive Committee Meeting #7 – February 4, 2021
EC approved support for a vaccine surveillance study:

  • Canadian Immunization Research Network (CIRN) Provincial Collaborative Network (PCN) COVID-19 Vaccine Post-Market Studies (PI: Jeff Kwong)
No members declared a direct COI.
Executive Committee Meeting #8 – February 24, 2021
EC approved support for four vaccine surveillance studies:

  • Canadian National Vaccine Safety Network (CANVAS): COVID-19 Vaccine Active Safety Surveillance (PI: Julie Bettinger)
  • Suivi de la réponse immunitaire dans le contexte de la vaccination contre la COVID-19 – Mise en place d’une cohorte longitudinale de donneurs de plasma (PI: Marc Germain)
  • British Columbia COVID Vaccine Immunity Evaluation (PI: Manish Sadarangani)
  • REinfection in COVID-19 Estimation of Risk (RECOVER) Phase 2-Vaccine (PI: Caroline Quach)
No members declared a direct COI.
Executive Committee Meeting #9 – March 25, 2021
EC approved funding for:
Two vaccine surveillance studies

  • Active surveillance for COVID-19 vaccine safety and effectiveness among Canadian children: A Canadian Immunization Monitoring Program ACTive (IMPACT) Project (PI: Karina Top)
  • Immunogenicity and adverse events following immunization (AEFI) with alternate schedules of authorized COVID-19 vaccines in Canada: is “mix and match” of the second dose safe and immunogenic? (PI: Joanne Langley)
No members declared a direct COI.
Executive Committee Meeting #10 – April 8, 2021
EC approved funding for three vaccine surveillance studies:

  • Canadian COVID-19 Emergency Department Rapid Response Network: Real-World Effectiveness and Duration of Protection in Special Populations (PI: Corrine Hohl)
  • Evaluating the safety and immunogenicity of SARS-CoV-2 vaccines among underserved urban populations with intersecting risk factors for COVID-19 morbidity and mortality: a pooled analysis of three prospective cohort studies in Vancouver (PI: M-J Milloy)
  • Vaccines in a Time of Dual Pandemic: COVID 19 Vaccine in People with HIV (PI: Mario Ostrowski)
  • Best Practices for Distributed-Network Studies of Vaccine Safety and Efficacy (PI: Robert Platt)
T. Evans and C. Hankins declared  direct conflicts with the Best Practices for Distributed-Network Studies of Vaccine Safety and Efficacy project and abstained.

C. Kaushic declared a direct conflict with the Vaccines in a Time of Dual Pandemic : COVID 19 Vaccine in People with HIV project and was recused.

Co-Chairs Decision
Funding was awarded for a Héma-Québec and Canadian Blood Services cross-validation study. No members declared a direct COI.
Executive Committee Meeting #11 – April 22, 2021
EC approved funding for:
One vaccine surveillance study

  • Optimizing COVID-19 immunization in patients with adverse events following immunization and patients with immunosuppression in the Special Immunization Clinic (SIC) Network (PI: Karina Top)

Nine vaccine surveillance studies

  • Toward Enhancing COVID-19 Vaccine Confidence among African Canadians: Sustainability of Immune Responses and Safety Profiles (PI: Upton Allen)
  • Investigating Vaccine Access, Immunogenicity, Effectiveness, and Safety among South Asians in Ontario and British Columbia (PI: Sonia Anand)
  • Vaccine Access, Uptake, Effectiveness and Safety in First Nations Communities (PI: Sonia Anand)
  • A prospective multi-site observational study of SARS-CoV-2 vaccination immunogenicity in patients with hematologic malignancies (PI: Arianne Buchan)
  • Characterization of COVID-19 vaccine safety epidemiology and safety signal detection for adverse events following immunization in Alberta (PI: Alexander Doroshenko)
  • COVID-19 vaccination in pregnancy: A province-wide epidemiological assessment of safety and effectiveness using the BORN Ontario Registry (PI: Deschayne Fell)
  • PRospective Evaluation of COVID-19 Vaccine in Transplant Recipients (PREVenT-COVID) (PI: Deepali Kumar)
  • Canadian COVID-19 Vaccine Registry for Pregnant and Lactating Individuals (COVERED): An Evaluation of Safety, Effectiveness, and Acceptability (PI: Deborah Money)

One Hot Spot study

  • COVID-19 Risk and Immunity in Montreal North: A Population-based Study (PI: Jack Jedwab)
No members declared a direct COI.
Executive Committee Meeting #12 – May 4, 2021
EC approved five vaccine surveillance studies for funding:

  • Safety immUnogenicity of Covid-19 vaCcines in systEmic immunE mediated inflammatory Diseases (SUCCEED) (PI: Sasha Bernatsky)
  • Prospective Cohort Study to Examine Immunogenicity of SARS-CoV-2 Vaccination in Cancer Patients with Solid and Hematological Malignancies (PI: Glenwood Goss)
  • Determining the safety and effectiveness of COVID-19 vaccination in the chronic kidney disease population (PI: Matthew Oliver)
  • Assessing the impact of the current SARS-CoV-2 vaccine in Indigenous populations in Arctic Canada (PI: Sangita Sharma)
  • Immunogenicity of current SARS-CoV-2 vaccine schedules in Canada (PI: Pascal Lavoie)
No members declared a direct COI.
Executive Committee Meeting #13 – May 6, 2021
EC approved four vaccine surveillance studies for funding:

  • COVID-19 Vaccine Immunogenicity and Safety in ImmunoDeficient patients (PI: Juthaporn Cowan)
  • Fine analysis of longitudinal immune responses to SARS-CoV-2 in vaccination: Harnessing the power of ‘Stop The Spread Ottawa’ to understand immune protection in COVID-19 (PI: Angela Crawley)
  • COVID-19 Vaccination among People Living with HIV: Immunogenicity, Effectiveness, and Safety (PI: Aslam Anis)
  • Are there post-vaccination antibody levels that correlate with protection against COVID-19? (AB-Protect) (PI: Allison McGeer)

EC also approved support for two provincial serosurveys:

  • Manitoba COVID Sero-prevalence Study (MCS Study) (PI: Derek Stein)
  • Saskatchewan SARS-CoV-2 Seroprevalence Protocol (PI: Maureen Anderson)
No members declared a direct COI.
EC review and approval by email – May 13, 2021
EC approved two vaccine surveillance RFA studies:

  • The PREVENT-COVID in Seniors Study: PRospEctiVe EvaluatioN of immunity after COVID-19 vaccines in Seniors (Co-PI: Agatha Jassem, Manish Sadarangani)
  • Safety and Efficacy of Protective COVID-19 Vaccines (PI: Sharon Walmsley)
No members declared a direct COI.
Executive Committee Meeting #14 – May 27, 2021
EC approved funding for a Hot Spots vaccine surveillance study:

  • COVID-19 in the Orthodox Jewish Community of Montreal: A mixed-methods study of immunity integrating anthropology, epidemiology and immunology (PI: Peter Nugus)
No members declared a direct COI.
Executive Committee Meeting #15 – June 17, 2021
EC approved funding for two vaccine surveillance studies:

  • Sentinel surveillance for serious adverse events following immunization (AEFI) and assessment of COVID-19 vaccine effectiveness for the prevention of serious outcomes among hospitalized Canadian adults: A study of the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN) (PI: Shelly McNeil)
  • Determinants of Community COVID-19 Transmission: Learning from the Hutterites (PI: Mark Loeb)
No members declared a direct COI.
Executive Committee Meeting #16 – July 8, 2021
EC approved funding for one Post-RFA vaccine surveillance study:

  • Nuu-chah-nulth Tribal Council COVID-19 Vaccine Study into Immune Response, Effectiveness, Safety (PI: Lynette Lucas)

Heather Hannah was introduced as replacing Vivek Goel on EC.

No members declared a direct COI.
Executive Committee Meeting #17 – July 15, 2021
EC approved an updated protocol with additional laboratory analysis for:

  • Saskatchewan SARS-CoV-2 Seroprevalence study (PI: Maureen Anderson; this study replaces the project approved on May 6, 2021)
No members declared a direct COI.

List of all CITF Decisions and Actions to Manage Direct COIs – 2020

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 cannot apply to hold CITF funds or be co-investigators on CITF-sponsored studies. Indirect conflicts can occur through other professional and personal relationships between the member and the applicants or the entities they belong 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.