TCPS 2 (2022) – Chapter 7: Conflicts of Interest

Introduction

This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict of interest may arise when activities or situations place an individual or institution in a real, potential or perceived conflict between the duties or responsibilities related to research, and personal, institutional or other interests. These interests include, but are not limited to, business, commercial or financial interests pertaining to the institution and/or the individual, their family members, friends, or their former, current or prospective professional associates.

Conflicts of interest must be assessed when conducting research, as they may jeopardize the integrity of the research and the protection offered to participants. Conflicts that create divided loyalties may distract researchers, research ethics boards (REBs), and institutions from concern for the welfare of participants and are contrary to the core principles on which this Policy is based. Failure to disclose and manage conflicts may impede the informed and autonomous choices of individuals to participate in research. Prospective participants need to know about real, potential or perceived conflicts of interest in order to make an informed decision about whether to participate (Article 3.2[e]). Conflicts of interest may also undermine the respect for participants that is fundamental to the principle of Justice.

It is preferable to avoid or prevent being in a position of conflict of interest. When it is not possible to avoid a conflict of interest, then it shall be disclosed to the appropriate people and steps shall be taken to minimize or manage the conflict. Researchers, their institutions and REBs should identify and address conflicts of interest – real, potential or perceived – to discharge professional and institutional obligations, maintain public confidence and trust, and ensure accountability. In some cases, the conflict cannot be managed and the institutions, the researcher or the REB member may need to abandon one of the interests in conflict. When necessary, researchers may have to manage a conflict of interest either by disclosing it to participants or by removing themselves from the research.

A. Key Concepts

Institutional Conflict of Interest

Institutions involved in research hold trust relationships with participants, research sponsors, researchers, and society. These institutions may have financial or reputational interests including, but not limited to, the provision of education and the promotion of research that conflict with the institution's obligations to protect and respect human dignity as characterized by the core principles of this Policy. For example, institutions may experience pressures to attract particular research funding or certain types of research activities that are self-sustaining, which may compromise their independence and public trust. Institutions have an obligation to ensure that the ethical conduct of research is not compromised by real, potential or perceived conflicts of interest.

An institutional conflict of interest involves a conflict between at least two substantial institutional obligations that cannot be adequately fulfilled without compromising one or both obligations. Conflicts may occur when pursuing particular goals, for instance, the pursuit of two different "goods," such as an effort to obtain general infrastructure funding from a donor that conflicts with an effort to promote research that the donor does not wish to support.

Institutional conflicts of interest may compromise duties of loyalty and lead to biased judgments. Conflicts may also undermine public trust in the ability of the institution to carry out its missions, operations, and ethical responsibilities in research.

Institutions may be in conflict of interest, for example, when they (a) sponsor a research project; (b) manage the intellectual property that forms the basis of a research project or stand to benefit from intellectual property resulting from the research; (c) hold equity in companies and/or receive major donations; or (d) have conflicting roles carried out by one institutional official (e.g., a vice-president who is responsible for the promotion of research activity and funding and also for oversight of research).

Acting in a professional role within the institution, individuals (e.g., institution president, vice-president, dean of a faculty or department head) are in a conflict of interest when they are subject to competing incentives or functions. These may significantly interfere with the impartial exercise of duties, including legal and ethical obligations within the institutional structure. The conflict may be chronic, relating to recurring situations resulting from the institutional structure, or it may be triggered by a unique situation that is not likely to recur.

Research Ethics Board Member Conflict of Interest

The individual REB members, and the REB as a whole, maintain relationships of trust with participants, research sponsors, researchers, and society. REB members must therefore be aware of their own potential for real or perceived conflicts of interest.

For example, REB members are in a conflict of interest when their own research projects are under review by their REB, when they are a co-investigator, or when they are in a supervisory or mentoring relationship with a graduate student applicant. REB members may also be in a conflict of interest situation when they have interpersonal or financial relationships with the researchers, or personal or financial interests in a company, labour union or not-for-profit organization that may be the sponsor of the research project, or that may be substantially affected by the research.

Conflicts of interest based on collaborations or disputes with colleagues, students or others may be ongoing or of limited duration. REBs have an obligation to ensure that the fairness and transparency of research ethics review are not compromised by real, potential or perceived conflicts of interest.

Researcher Conflict of Interest

Researchers and research students hold trust relationships, either directly or indirectly, with participants, research sponsors, institutions, their professional bodies, and society. These trust relationships can be put at risk by conflicts of interest that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers (e.g., to delay or withhold dissemination of research outcomes or to use inappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethical behaviour.

Researchers' conflicts of interest may arise from interpersonal relationships (e.g., family or community relationships), financial partnerships, other economic interests (e.g., spin-off companies in which researchers have stakes or private contract research outside of the academic realm), academic interests or any other incentives that may compromise integrity or respect for the core principles of this Policy. Conflicts may arise from an individual's involvement in dual and multiple roles within or outside an institution. While it may not be possible to eliminate all conflicts of interest, researchers are expected to identify, minimize or otherwise manage their individual conflicts in a manner that is satisfactory to the REB.

B. Institutions and Conflicts of Interest

Article 7.1

Institutions shall develop and implement conflict of interest policies, including procedures to identify, eliminate, minimize or otherwise manage conflicts of interest that may affect research. All parties (e.g., researchers, administrators, REB members) should act in a transparent manner in identifying and addressing conflicts of interest. Institutions should make their written conflict of interest policies and procedures publicly available to all members of the research enterprise, including participants, REBs, researchers, administrators, and research sponsors.

Application

To meet obligations to protect participants, institutional policies should address the roles, responsibilities, and process for identifying, eliminating, minimizing or otherwise managing institutional conflicts of interest relevant to research, including disclosure to REBs. Management of conflicts of interest includes, but is not limited to, prevention, evaluation, disclosure, and the application of appropriate remedies as defined by the institution.

When developing institutional policies and procedures on conflicts of interest, institutions should clarify roles and the distribution of responsibilities, and clarify associated potential for conflicts. This clarity should reduce or eliminate the possibility for confusion of roles that may ultimately lead to conflicting obligations. Ideally, institutional policies will organize roles, responsibilities, reporting lines and accountabilities to eliminate, minimize or otherwise manage conflicts of interest (Articles 6.1, 6.2 and 7.2).

Measures to manage conflicts of interest should reflect the inherent threat of conflicts of interest to participants, as well as to the scientific and scholarly integrity and credibility of research. These measures should also be commensurate with the risks. Institutions should consider the following measures to address conflicts of interest at the institutional level that are germane to research involving humans:

Conflict of interest policies and procedures should be developed in a transparent manner. The goal of these policies is to eliminate conflict of interest where possible or, alternatively, to identify and disclose real, potential or perceived institutional conflicts of interest, to make them transparent and open to scrutiny, and to provide mechanisms to minimize or otherwise manage them.

Article 7.2

Institutions should ensure that real, potential or perceived institutional conflicts of interest that may affect research are reported to the REB through established conflict of interest mechanisms. The REB shall consider whether the institutional conflict of interest should be disclosed to prospective participants as part of the consent process.

Application

Any member of an institution, a senior administrator, researcher, REB member or any other individual who is aware of potential sources of institutional conflicts of interest that may affect research should refer to the institutional policy for the appropriate steps to inform the REB. Institutional policies shall address when disclosure of conflicts of interest to the REB is required and how these conflicts should be evaluated and managed.

Likewise, when a real, potential or perceived institutional conflict of interest is disclosed and brought to its attention, the REB may be guided by the prescribed institutional mechanisms for managing the conflict. However, it is the REB that is responsible for deciding how these conflicts shall be managed. This includes requiring that researchers disclose institutional conflicts of interest that are relevant to participant consent. These decisions must be documented in accordance with Article 6.17.

Community-based research involving small communities or community-based organizations with scarce human resources may present particular issues related to multiple roles of some individuals. In some cases, securing informed advice on cultural or other aspects of research rests with the researcher or the sponsoring institution, and requires engagement with a community advisor who may assume various roles in the research process. The same individual may be involved in providing preliminary information as well as reviewing the ethics of a research proposal at the community level and/or possibly co-managing the approved research. As outlined in Article 7.1, an approach relative to the level of risks, such as disclosure to the participants of the possible conflicts between multiple roles, may be sufficient to manage the conflict (see also Articles 9.6, 9.8, and 9.12).

C. Research Ethics Board Members and Conflicts of Interest

Article 7.3

When reviewing research proposals, REB members shall disclose real, potential or perceived conflicts of interest to the REB. When necessary, the REB may decide that some of its members must withdraw from REB deliberations and decisions.

Application

To maintain the independence and integrity of research ethics review, members of the REB must identify, eliminate, minimize or otherwise manage real, potential or perceived conflicts of interest. If an REB is reviewing a research project in which a member of the REB has a personal or financial conflict of interest (Section A of this chapter), the member must disclose the nature of the conflict and absent themselves from any discussion or decision regarding that research project. In the event that a member's conflict of interest and necessary withdrawal from the meeting will threaten the maintenance of quorum, the REB can ensure that a substitute member be in attendance to maintain quorum.

Conflict of interest policies should determine a reasonable time period during which an REB member is not allowed to review a proposal involving a recent collaborator, supervisor, student or other colleague (as defined by the institution). The purpose of these policies on time limits is to ensure adequate and continued access to competent expertise. In some cases, the scientific expertise of the REB member may still be sought when no other individuals with the scientific expertise relevant to the proposal under review are available to the REB. In such instances, the REB will record this explicitly in the minutes. The member should not be present when the REB makes its decision.

Research Ethics Boards and Senior Administrators

Institutional senior administrators (e.g., a vice-president of research or business development) should not serve on an REB, or directly or indirectly influence the REB decision-making process. The mere presence of an institutional senior administrator at REB meetings may undermine the independence of the REB by unduly influencing REB deliberations and decisions.

REBs and senior administrators should consider other venues to discuss policy issues, general issues arising from the REB's activities, or training and educational needs, to the benefit of the overall operation and mandate of the REB. In the discharge of their interdependent roles and duties to participants, effective communications processes should be established between REBs and the relevant officers of institutions. In cases where senior administrators interfere with the REB decision-making process, REBs should invoke the institution's conflict of interest policies.

Compensation for Research Ethics Board Members

Reasonable compensation by institutions for work done by REB members is appropriate. However, in some instances, individual members of the REB may have a conflict of interest in accepting undue or excessive honoraria for their participation in the REB. Institutions should define appropriate levels of compensation.

D. Researchers and Conflicts of Interest

Article 7.4

Researchers shall disclose in research proposals they submit to the REB any real, potential or perceived individual conflicts of interest, as well as any institutional conflicts of interest or community conflicts of interest of which they are aware that may have an impact on their research. Upon discussion with the researcher, the REB shall determine the appropriate steps to manage the conflict of interest.

Application

Managing conflict of interest is a process that begins with identification and is followed by disclosure. Upon disclosure of a conflict by a researcher to the REB, the steps taken by the REB to manage the conflict should be context-based and commensurate with the risks. In some cases, the REB might conclude that the identified conflict of interest does not warrant further action. REBs and researchers should be mindful of the fact that conflict of interest may also exist within a community where research is taking place (e.g., between the community leadership and its members), between a community and a researcher, or between the community and institutions.

The REB should require, consistent with Article 3.2(e), that the researcher disclose any real, potential or perceived conflict of interest to the participant. When disclosure to the REB is not enough to manage the conflict of interest, the REB, guided by established institutional policies, may require that the researcher withdraw from the research, or that others on the research team, who are not in conflict of interest, make research-related decisions. Where appropriate, disclosure to the sponsor, the institution, the community, and any relevant professional body may also be necessary. In exceptional cases, the REB has the discretion to refuse approval of a research project where the REB decides that the conflict of interest has not been avoided or cannot be appropriately managed.

If there is a need for a researcher with a conflict of interest in a research project to be involved in some aspect of the project, the extent of the involvement should be reviewed and explicitly endorsed by the REB in its minutes. Participants should also be informed during the consent process of the conflict and the extent of the researcher's involvement. In line with the proportionate approach to REB review, and through the continued research ethics review process, REBs may impose additional control mechanisms if necessary.

Dual Roles

Dual roles of researchers and their associated obligations (e.g., acting as both a researcher and a therapist, health care provider, caregiver, teacher, advisor, consultant, supervisor, student or employer) may create conflicts, undue influences, power imbalances or coercion that could affect relationships with others and affect decision-making procedures (e.g., consent of participants). Article 3.2(e) reminds researchers of relevant ethical duties that govern real, potential or perceived conflicts of interest as they relate to the consent of participants.

To preserve and not abuse the trust on which many professional relationships rest, researchers should be fully cognizant of conflicts of interest that may arise from their dual or multiple roles, their rights, and responsibilities, and how they can manage the conflict. When acting in dual or multiple roles, the researcher shall disclose the nature of the conflict to the participant in the consent process.

Financial Conflicts of Interest

Real, potential or perceived financial conflicts of interest may affect any type of research. Institutions, researchers and REBs should be aware of, and consider, the possibility of financial conflicts of interest. They should seek to ensure that financial considerations do not serve to diminish respect for the principles of this Policy or the scientific validity and transparency of research procedures.

Financial incentives have the potential to distort researchers' judgment in ensuring that the design and conduct of research is ethical. When researchers partner with organizations whose primary motive is profit, they must be aware of the potential for conflicts of interest. Consideration for the profitability of the research may threaten the ethical integrity of research design and conduct. Not all research sponsored by for-profit organizations gives rise to financial conflicts of interest. However, institutions should consider the potential for this type of conflict because its ability to undermine the ethical conduct of research has been empirically established.

As part of a research project submitted for institutional review of conflict of interest, researchers shall disclose all kinds and amounts of payment (financial or in-kind) to the researchers by sponsors, commercial interests, and consultative or other relationships, as well as any other relevant information that may affect the project (e.g., donation to an institution by a research sponsor). Researchers shall also supply all relevant documentation and identify strategies to prevent, disclose, minimize or otherwise manage conflicts.

Institutions should ensure that relevant documents, such as budgets and contracts, are reviewed in order to identify conflicts of interest and develop strategies for minimizing and managing them. Reviewers should look for issues such as inappropriate payments or other unexplained expenses that may raise questions about conflict of interest. Payment provisions should be scrutinized to ensure they do not create ethically inappropriate incentives to recruit quickly, at the expense of a careful review of the suitability of prospective participants. Unreasonable payments or undue inducements may place the researcher, and sometimes the institution, in a conflict between maximizing financial remuneration on the one hand and protecting participants and meeting the scientific requirements of the project on the other. Disclosure of the kinds and amounts of payments and other budgetary details encourages the researcher to identify and appropriately manage potential conflicts of interest and helps the institution to assess them. Management by institutions may include prohibiting certain forms of payment.

The perception of a conflict of interest may, in many cases, be as damaging as a real conflict. The REB and institution should assess the likelihood that the researcher's judgment may be inappropriately influenced, or perceived to be influenced, by private or personal interests. It should then determine the magnitude of harm that is likely to result from such influence or from the perception of undue influence. Institutions should make relevant documents available to the REB upon request.

In addressing conflicts of interest, disagreements between the REB or institution and the researcher may arise about the scope and reach of disclosure, including disclosure of new information to participants, or other aspects of managing the conflict. Resolution of disagreements should be guided by the paramount principles of Respect for Persons and Concern for Welfare of participants.

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