CONFLICT OF INTEREST GUIDELINES
The COVID-19 Immunity Task Force, (hereafter, the Task Force) has been launched in response to a public health emergency of global proportions. The work of the Task Force accordingly will be conducted at a rapid pace and built around partnerships with provinces and territories, communities, agencies, institutions, and researchers 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 intends to stand down many of the conventions of independent investigator-initiated research to expedite Canada’s response to the COVID-19 pandemic. For field work, the majority of funding will flow from Health Canada as contracts, not as research grants. For laboratory work, CIHR grants will be made with very specific provisions. Reasonable efforts will be made to protect the academic interests of participating researchers, but rapid publication of results and wide sharing of data will be essential.
To ensure that the Task Force’s work can proceed apace, the Task Force Leadership Group includes not only representation 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 Leadership Group members are themselves involved with key research teams that are potential candidates for financial support from the Task Force. The Task Force co-chairs and federal sponsors are fully aware of this structural anomaly. They are fully committed to processes that manage the potential conflicts of interest 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.
Read the full COI Guidelines text.
APPLICABILITY AND PURPOSE
These guidelines apply to all those directly engaged with the work of the Task Force and the decisions it will make. As such, they apply to Leadership Group [LG] members, all members of the Secretariat, and Task Force participants, including those working on a distributed basis at designated hubs for large-scale project execution, as those who support the work of the Task Force through engagement as resources persons to Task Force working groups or who may serve on ad hoc committees of the Task Force. The purpose of the guidelines is to bring to light, minimize, and appropriately manage conflicts of interest on the part of those individuals.
CONFLICT OF INTEREST
The Task Force will work with a modified version of the CIHR definition: Conflict of interest (COI) is defined as “a situation in which external interests or engagements of [the Task Force members] compete or conflict with their official responsibilities to [the Task Force and the public interest], and
could be seen as furthering their interests or the interests of others, or giving an unfair advantage to others in their dealings with [the Task Force] or with [Task Force sponsors and partners].”
“A conflict in this context should be interpreted broadly to include any circumstances that could reasonably be perceived as giving rise to COI situations and can be actual, potential or perceived in nature.”
Disclosure is the key to minimizing and managing the risk of COI. All those involved with the work of the Task Force, especially LG and Secretariat members, should proactively disclose their relevant external interests and influences. COI arise from, inter alia, direct or indirect financial benefits, personal relationships (both positive and negative), undue institutional/regional loyalties, and any other influence that might cloud an objective assessment of plans or projects to be pursued under the aegis of the Task Force. Consistent with the policy of other organizations engaged in knowledge generation, members should seek advice of the Co-Chairs of the Task Force or Executive Director of the Secretariat if they are in doubt about their own COI.
It is impossible to over-emphasize the importance of open declaration of any and all COI during discussions that bear on pivotal decisions. To facilitate this process, all LG and Secretariat members will be asked to submit an initial report in writing on actual and perceived/potential COI arising from their participation in the Task Force. A template for this purpose will be circulated by April 27th. However, the onus is on all members to disclose any new COI, and that, in the course of LG/Secretariat deliberations, they identify any relevant COI that bears on matters under discussion as and when they believe an actual COI exists or a COI could be perceived. Individuals who are co-opted to participate in working groups, ad hoc committees, advisory panels, and scientific review committees will be ask to declare all COI.
MANAGING CONFLICT OF INTEREST FOR THE TASK FORCE LEADERSHIP GROUP
The operations of the Task Force will be structured so as to minimize COI for LG members in the following ways:
a) LG members will be involved in setting strategic directions and recommending lines of inquiry, but all final decisions about priorities will be made by the Group as a whole. Members should declare their conflicts at relevant points in LG discussions. Where a member perceives that an LG decision could directly advantage her/him or others with whom s/he has close collaborative relationships, abstention or recusal is recommended.
b) Elaborating on the general point above, in any instance where the LG members are themselves intending to be part of a team that is pursuing or likely to pursue a contract or submit a proposal in response to a Task Force call, they must recuse themselves from the all granular deliberations on that process – including framing of the call, decisions on reviewers, and decisions about awarding the contract or directed grant.
c) Likewise, in any instance where the LG members have no intent to be direct participants but are close collaboratorsj with those who are likely to pursue a contract or submit a proposal in response to a Task Force call, they should declare those relationships, and offer to recuse themselves from all granular deliberations on the relevant decision-making process – including framing of the call, decisions on reviewers, and decisions about awarding the contract or directed grant.
d) As noted above, persons involved with the secretariat are encouraged to bring any COI issues to Dr Evans for discussion and resolution. All others involved with the Task Force should be in touch with one or the other of the co-Chairs.
To mitigate reputational risk, records will be kept of all disclosures, abstentions, and recusals in the course of LG deliberations. As a general rule, contracts and grants will be awarded only after obtaining external opinions. Where rare exceptions are made, the co-Chairs will arrange review by LG members and/or through the Executive Director and the Secretariat, only after satisfying themselves that there is no conceivable COI on the part of those referees.
The proceedings and deliberations of the LG and Secretariat may give members access to novel processes/ideas as well as confidential information about applicants and/or their proposals for contracts or grants. In some cases, this information may have a bearing on major commercial contracts regarding laboratory reagents and technologies. Members are accordingly expected to treat deliberations and decisions as confidential until announced. In particular, there should be no advance notice given of competitions/RFPs, early reports of funding/contracting decisions, or disclosure of strategic deliberations by the LG/Secretariat.
*The definition of close collaborator is modified from CIHR. For our purposes, it refers to currently shared institutional affiliations ( including provincial agencies, research hospitals and research institutes) or recently shared affiliations (last three years) or a close professional affiliation with an applicant, as a result of having in the last five years:
- 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.
COI Declaration Form
Governance Structures to Address COI
Download the Memo on the formation of an Executive Committee to improve management of conflicts of interest and enhance financial oversight.
Declarations of Conflict of Interest
The CITF’s Management of Potential Conflict of Interest
The Task Force manages potential conflict of interest in its review process as well as in its decision-making process.
In its review process of possible studies to fund, the Task Force follows Canada’s Tri-Agency (The Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council (NSERC), and Social Sciences and Humanities Research Council (SSHRC)) guidelines of Conflict of Interest.
In regard to decisions pertaining to the recommendation of studies for CITF financing, the CITF has established an Executive Committee. The Executive Committee was formed to strengthen CITF governance and accountability, part of which includes the management of conflict of interest in decision making (see link). A key prerequisite was that Executive Committee members could not seek major project funding from the CITF.
CITF’s Executive Committee Members:
CITF Co-Chairs: Catherine Hankins and David Naylor;
CITF Executive Director: Tim Evans;
CITF Leadership Group Members: Vivek Goel, Charu Kaushic , Mona Nemer, Gina Ogilvie, Jutta Preiksaitis, James Talbot.
List of All CITF Decisions and Actions to Manage COI
|Decision||Actions to Manage COI|
|SeroTracker funding, as under $500,000||Neither Co-Chair declared a COI. Investments under $500,000 do not require Leadership Group or Executive Committee approval, as per criteria outlined in Investment Note Approval Process|
|Leadership Group Meeting #4 – May 19, 2020, (before Executive Committee creation)|
|Two studies approved for funding: Canadian Blood Services and Héma Québec||No members declared a COI.|
|Leadership Group Meeting #6 – June 9, 2020 (before Executive Committee creation)|
|Discussion of investment notes for Antenatal and CLSA studies||No decision taken.|
|Leadership Group Meeting #7 – June 23, 2020|
|Decisions regarding the following studies were on the agenda: Antenatal, CLSA, Indigenous communities and Statistics Canada||Before discussion, it was decided an Executive Committee would be formed (read full decision here). In view of this recommendation, no decisions were taken on the four Investment Notes submitted for approval. Leadership Group members were asked to provide comments on the Investment Notes to the Secretariat. The Secretariat would collate these comments and circulate them without attribution to inform deliberations at the first meeting of the Executive Committee.|
|Executive Committee Meeting #1 – June 29, 2020|
|EC approved support for four studies: Antenatal, CLSA (elderly), Indigenous communities, Statistics Canada (household survey)||No recusals from discussion. ABSTENTION regarding antenatal study: Cate Hankins, due to an indirect conflict of interest because she has worked with one of the investigators within the last three years.|
|Executive Committee Meeting #2 – July 30 2020|
|EC approved funding for 24 studies from the CIHR COVID-19 Rapid Research competition, based on evaluation by the CIHR proposal Assessment Group made up of members of the Secretariat.||No members declared a COI.|
|EC approved support for four pediatric studies, two of which were not already in the CIHR-related proposals above (EnCORE, BC Child)||RECUSAL FROM DISCUSSION & ABSTENTION: Gina Ogilvie, due to ties to UBC and the BC Centre for Disease Control, leading the BC Child study.|
|EC approved support for Phase 1 of CanPath study||RECUSAL FROM DISCUSSION & ABSTENTION: Vivek Goel, given his role as co-chair of the CanPath Advisory Board until June 30, 2020.|
|Executive Committee Meeting #3 – August 27, 2020|
|EC approved support for Correctional Services Investment Note||ABSTENTION: Cate Hankins declared an indirect conflict of interest because she has worked with one of the investigators within the past three years.|
|Executive Committee Meeting #4 – October 28, 2020|
|The EC reviewed the recommendations from an external review panel regarding its recent funding call on COVID-19 “Hot Spots”. Recommendations were unanimously accepted with no changes.||COIs were identified from the EC members listed below. When a COI was identified, the EC member RECUSED themselves from discussion around the decision for the specific proposal.