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Draft 2nd Edition of the TCPS (December 2008)

Chapter 7

CONFLICT OF INTEREST

Researchers and research ethics boards (REBs) hold trust relationships with research 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 to commercialize research or suspend dissemination of research outcomes heighten concerns.

Research institutions, too, hold trust relationships with research participants, research sponsors, researchers and society. Research institutions may have financial or reputational interests that conflict with the institution’s obligations to protect and respect human dignity as characterized by the core principles of this Policy. Institutions have an interest in ensuring that the conduct of research is not compromised by real, potential or perceived conflicts of interest.

Conflicts of interest that jeopardize the integrity of research and the protection of potential research participants are contrary to the core principles on which this Policy is based. Conflicts that create divided loyalties may distract researchers, REBs and institutions from the welfare and well-being of participants. Failures to disclose and manage conflicts may impede the informed and autonomous choices of individuals to participate in research. Conflicts of interest may also undermine the respect for participants that is fundamental to the principle of equal moral status. Researchers, their institutions and REBs should identify and address conflicts of interest - real, potential or perceived - to maintain public confidence and trust, discharge professional and institutional obligations, and ensure accountability.

A. Institutions and Conflicts of Interest

Article 7.1 Institutions should develop conflict of interest policies and procedures to identify, prevent, disclose and manage conflicts of interest that may affect research involving humans. Institutions should act in a transparent manner in addressing conflicts of interest and should make their written conflict of interest policies and procedures publicly available.

Application When developing institutional policies and procedures on conflicts of interest, institutions should clarify the 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 minimize, manage or avoid conflicts of interest. (See Articles 6.1 and 6.2 in Chapter 6 [“Governance of Research Ethics Review”] and Article 7.2.) Institutions must respect the autonomy of the REB and ensure the REB has the appropriate financial and administrative independence to fulfil its duties. (See Articles 6.1 and 6.2 in Chapter 6 [“Governance of Research Ethics Review”].)

Measures to manage conflicts of interest should be proportionate to potential harms and should be founded on an assessment of relevant institutional operations. Institutions should consider the following measures to address conflict of interest at the institutional level:

  • Apply firewalls to insulate potentially conflicting roles and duties;
  • Refine or redesign roles and responsibilities to minimize or avoid the potential for conflicts;
  • Prevent or minimize conflict of interest in institutional design and structuring when creating new roles, responsibilities or relationships;
  • Withdraw from, or not participate in, roles or functions unduly compromised or disabled by perceived or real conflict; and
  • Create central institutional mechanisms such as a conflict of interest committee or other delegated body within the institution to help identify and manage conflicts of interest.

Conflict of interest policies and procedures should be developed in a transparent manner and should be publicly available to all members of the research enterprise, including research participants, REBs, researchers, administrators, research sponsors and others.

The goal of such policies is to identify and disclose potential, perceived or real institutional conflicts of interest to make them transparent and open to scrutiny.

Article 7.2 Institutions should ensure that the research ethics board is informed of real, potential or perceived institutional conflicts of interest that may affect research involving humans.

Application 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 be real, potential or perceived. 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 involving humans.

An individual acting in a professional role with the institution is in a conflict of interest when he or she is subject to competing incentives or functions that significantly interfere with the impartial exercise of duties, including legal and ethical obligations within the institutional structure. An institutional conflict of interest may thus directly divide one’s professional duties and loyalties when the incentive structure of the institution places individuals acting in institutional roles in conflicts of loyalty and function. The conflict may be chronic, relating to recurring situations occasioned by the institutional structure, or it may be triggered by a unique situation that is not likely to recur.

To meet obligations to protect research participants, institutional policies should address the roles, responsibilities and process for disclosing and managing institutional conflicts of interests relevant to research involving humans, including disclosure to REBs. Institutions may consider establishing relevant structures such as a competent institutional authority, a delegated body, or conflict of interest committee within the institution (see Article 7.1).

A senior administrator, researcher, REB member or other individual who is aware of potential sources of institutional conflicts of interest that may affect research involving humans should refer to the institutional policy to inform the REB of such conflicts. Likewise, when a significant real, potential or perceived institutional conflict of interest is disclosed and brought to its attention, the REB should be guided by the central institutional mechanisms for consulting with the relevant body to manage the conflict.

B. REB Members and Conflicts of Interest

Article 7.3 Research ethics board (REB) members must disclose real, potential or perceived conflicts of interest to the REB, and, where necessary, members must withdraw from REB deliberations and decisions.

Application To maintain the independence and integrity of ethics review, members of the REB must avoid and disclose real, potential 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 REB members are or have been in direct conflict with researchers on academic or scientific issues, or when they have collaborated with the researcher whose proposal is under review, REB members should disclose and fully explain to the REB the conflict of interest to prevent bias or undue influence in the outcome of the review process. In such cases, the researcher should be able to raise with the REB any concerns with respect to conflict of interest. To manage such conflicts, REB members should withdraw from the committee when such projects are under consideration.

While the presence of administrative staff may be relevant and appropriate to support REB procedures, an institutional senior administrator should not serve on an REB, attend meetings, or influence the REB decision-making process. (See Articles 6.2, 6.4 and 6.10 in Chapter 6 [“Governance of Research Ethics Review”].) The presence of a non-voting institutional senior administrator at REB meetings may undermine the independence of the REB by unduly influencing REB deliberations and decisions.

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 even co-managing the approved research. As outlined in Article 7.1, an approach proportionate to the level of harms, such as disclosure of the possible conflicts between multiple roles, may be sufficient to manage the conflict.

Institutional conflicts of interest may give rise to professional conflicts or divided loyalties for individuals working in affected institutions. Reasonable compensation by institutions for REB members is appropriate. However, in some instances, individual members of the REB may have a conflict of interest in accepting undue or inappropriate honoraria for their participation in the REB. The REB must avoid or manage such conflicts of interest.

C. Researchers and Conflicts of Interest

Article 7.4 Researchers should disclose to the research ethics board real, perceived or potential individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware that may have an impact on their research.

Application Individual conflicts of interest may arise from interpersonal relationships (for example, family or community relationships), financial partnerships, other economic interests or any other incentives that may compromise integrity, confidence of the research participant, 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 generally it is impossible to eliminate all conflicts of interest, researchers are expected to recognize, disclose, limit and manage their individual conflicts in a manner that is satisfactory to the REB.

Managing conflict of interest is a process, of which the first step is disclosure. Upon disclosure to the REB, the steps taken by the REB to manage the conflict should be context-based and proportionate to potential harms. For example, in some cases, the REB might conclude that the identified conflict of interest does not warrant specific actions. In other cases, 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 abandon one of the interests in conflict by withdrawing from the research or allowing others to make research-related decisions.

Dual roles of researchers (for example, acting as both a researcher and a therapist, 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 (for example, free and informed consent of participants). Article 3.2(e) reminds researchers of relevant ethical duties that govern potential, perceived or real conflicts of interest as they relate to the free and informed 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, and they should attempt to manage the conflict.

Care should also be exercised in developing relationships between researchers and authorities, so as not to compromise the free and informed consent and privacy of participants and the confidentiality obligations of researchers, and to maintain public confidence and trust.

As part of the research plan for REB review, researchers should provide details on the research project, budgets, commercial interests, consultative relationships and other relevant information and documentation, and identify strategies to prevent, disclose and manage conflicts properly. Disclosure of the kinds and amounts of payments, and other budgetary details, especially if the researcher also holds a therapeutic, clinical or other fiduciary relationship with research participants, will assist the REB, or other delegated body within the institution, to assess potential conflicts of interest and will help the researcher in resolving them. (See Articles 11.8 and 11.9 in Chapter 11 [“Clinical Trials”].)

The appearance of a conflict may in many cases be as damaging as a real conflict. The REB should assess the likelihood that the researcher’s judgment may be influenced or appear to be influenced by private or personal interests, and it should assess the level of harm that is likely to result from such influence or from the perception of undue influence.

In addressing conflicts of interest, disagreements 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 a paramount principle of respecting the autonomy and welfare of participants and by relevant institutional policies. If disagreement cannot be resolved by the researcher and REB, recourse to the appeals process should be considered. (See Articles 6.19 and 6.20 in Chapter 6 [“Governance of Research Ethics Review”].)