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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 7

CONFLICT OF INTERESTS

This chapter addresses ethical issues that can arise when research activities and other activities conflict. A conflict of interests may arise when activities or situations place a person or institution in a real, potential or perceived conflict between their duties or responsibilities related to research and their personal, institutional or other interests. Conflict of interests may occur when individuals’ judgments and actions or institutions’ actions in relation to research are, or could be, affected by personal, institutional or other interests, including, but not limited to, business, commercial or financial interests, pertaining to these individuals, their family members, their friends, or their former, current or prospective professional associations – or of the institution itself.

Conflicts of interests must be assessed when conducting research involving humans to ensure protection of the potential participant and integrity of the research. Conflicts of interests that jeopardize these protections are contrary to the core principles on which this policy is based. In light of this, the first step is to avoid or prevent being in a condition of conflict of interests, if possible. When it is not possible to avoid such a condition, then the next step is to disclose the conflict to the appropriate persons which will then result in appropriate efforts to minimize or manage the conflict of interests.

Researchers and students hold trust relationships, either directly or indirectly, with research participants, research sponsors, institutions, their professional bodies and society. These relationships based on trust between parties can be put at risk by conflicts of interests that may compromise independence, objectivity or ethical duties of loyalty. Although the potential for such conflicts has always existed, pressures on researchers, for example, to suspend dissemination of research outcomes or use inappropriate recruitment strategies, heighten concerns regarding ethical behaviour.

Institutions involved in research, too, hold trust relationships with research participants, research sponsors, researchers and society. These institutions may have financial or reputational interests that conflict with the institution’s obligations that may include provision of education, the promotion of research, as well as their obligation 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 interests.

The research ethics board (REB), as an entity, or as the members that make up the board, also hold trust relationships with research participants, research sponsors, researchers and society. The REB can also find itself in a conflict of interests.
Conflicts of interests may jeopardize the integrity of research and the protection offered participants. Conflicts that create divided loyalties may distract researchers, REBs and institutions from concern for the welfare of participants and are contrary to the core principles on which this Policy is based. Failures to disclose and manage conflicts may impede the informed and autonomous choices of individuals to participate in research. Potential participants need to know about real, potential or perceived conflicts of interest in order to consent. (See Article 3.2 [e]). Conflicts of interests may also undermine the respect for participants that is fundamental to the principle of justice.

Researchers, their institutions and REBs should identify and address conflicts of interests – real, potential or perceived – to discharge professional and institutional obligations, maintain public confidence and trust, and ensure accountability. In some cases, the conflict (real, potential or perceived) cannot be managed and the institutions, the researcher or the REB member may need to abandon one of the interests in conflict. Where necessary, the researcher may have to manage the conflict of interests either by disclosing it to participant or removing himself/herself from the research.

This chapter addresses Conflict of Interests for Institutions in Part A, for REB members in Part B, and for Researchers in Part C.

A. Institutions and Conflicts of Interests

Article 7.1 Institutions shall develop and implement conflicts of interests policies including procedures to identify, prevent, disclose and manage conflicts of interests that may affect research involving humans. All parties should act in a transparent manner in identifying and addressing conflicts of interests. Institutions should make their written conflict of interests policies and procedures publicly available to all members of the research enterprise, including research participants, REBs, researchers, administrators, research sponsors and others.

Application  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.

When developing institutional policies and procedures on conflicts of interests, 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 interests. (See Articles 6.1, 6.2 and Article 7.2).

Measures to manage conflicts of interests should reflect the inherent threat of conflict of interests to research participants, as well as to the scientific and scholarly integrity and credibility of research. Measures to manage conflicts of interests should be proportionate to the risks. Institutions should consider the following measures to address conflicts of interests at the institutional level that are germane to research involving human participants:

  • Create central institutional mechanisms, such as a competent institutional authority, a conflict of interests committee, or other delegated bodies within the institution to help identify, evaluate and manage conflicts of interests;

  • Refine or redesign roles, responsibilities and reporting lines to avoid, minimize or manage the potential for conflicts;

  • Prevent or minimize conflict of interests in institutional design and structuring when creating new roles, responsibilities or relationships;

  • Apply barriers to insulate potentially conflicting roles and responsibilities;

  • Institute requirements that individuals involved in the conduct of research withdraw from, or do not participate in, roles or functions unduly compromised or disabled by any real, potential or perceived conflict.

Conflict of interests policies and procedures should be developed in a transparent manner.

The goal of such policies is to avoid conflict of interests where possible, or alternatively, to identify and disclose real, potential or perceived institutional conflicts of interests, to make them transparent and open to scrutiny and to provide mechanisms to evaluate and manage them. Institutions must respect the autonomy of the REB decision making processes and ensure the REB has ongoing and adequate financial and administrative resources to fulfil its duties. (See Articles 6.1 and 6.2).

Article 7.2 Institutions should ensure that real, potential or perceived institutional conflicts of interests that may affect research involving humans are reported to the REB through the established conflict of interest mechanisms. The REB shall consider whether the institutional conflict of interests should be disclosed to potential participants as part of the consent process.

Application An institutional conflict of interests 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.” For example, seeking to expand its donors’ base for the development of the infrastructure of the university may conflict with the conduct of research. Conflicts may be real, potential or perceived. Institutional conflicts of interests 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.

Institutions may be in conflict of interests, for example, when (a) they sponsor a research study; (b) they manage the intellectual property that forms the basis of a study or they stand to benefit from intellectual property resulting from the research; (c) the institutions hold equity holdings in companies and/or receive major donations, or (d) through the roles or responsibilities of the institutional official responsible for research development (e.g. vice-president responsible for fundraising with industry) and for oversight of research involving research participants.

Acting in a professional role within the institution, an individual is in a conflict of interests when this individual (e.g. university president, vice-president, dean of a faculty or department head) is 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. An institutional conflict of interests may, thus, directly divide one’s professional duties and loyalties when the incentive structure of the institution places individuals who have responsibilities for functions or actions that may be in conflict with one another in conflicts of loyalty and function. The conflict may be chronic, relating to recurring situations resulting from by the institutional structure, or it may be triggered by a unique situation that is not likely to recur.

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 interests that may affect research involving humans should refer to the institutional policy for proper steps to inform the REB of such conflicts. Institutional policies shall address when the disclosure of the conflict to the REB is appropriate. The disclosure of the institutional conflict of interests prior to the actual review may jeopardize the independent decision making of the REB. For example, it might be better that an REB not know prior to its review of a research proposal that the sponsor of the research is considering an endowment or major donation to that institution. In other instances, prior disclosure to the REB will be necessary for the REB deliberations and decision making regarding disclosure of such a conflict in the consent process. Identification, disclosure, evaluation and management of the institutional conflict should be resolved in accordance with the institutional conflict of interests policies.

Likewise, when a significant, real, potential or perceived institutional conflict of interests is disclosed and brought to its attention, the REB should be guided by and defer to, the prescribed institutional mechanisms for consulting with the relevant body to manage the conflict. The REB should record the fact that the issue has been forwarded to the appropriate body through relevant institutional mechanisms. To that end, effective communications processes should be established between REBs and institutions they serve.

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 even co-managing the approved research. As outlined in Article 7.1, an approach proportionate to the level of risks, such as disclosure of the possible conflicts between multiple roles, may be sufficient to manage the conflict. (See also Chapter 9).

B. REB Members and Conflicts of Interests

Article 7.3 When reviewing research proposals, REB members shall disclose real or potential conflicts of interests to the REB, and, where 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 ethics review, members of the REB must avoid, disclose and/or manage real, or potential conflicts of interests. For example, REB members are in a conflict of interests when their own research projects are under review by their REB, when they are the 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 interests situation when they have interpersonal relationships or personal or financial interests in a company, labour union or not-for-profit organization that may be the sponsor of the research study, or may be substantially affected by the research.

When REB members are, or have been, in direct conflict with researchers on academic or scientific issues, or when they have engaged in research collaborations and/or commercial transactions with the researcher whose proposal is under review, REB members should disclose and fully explain to the REB the conflict of interests 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 interests. To manage such conflicts, the REB as a whole, first in consultation with the REB member and then in that person’s absence, should discuss and determine whether the REB member should withdraw from the committee when such projects are under consideration.

Conflict of interests policies should determine a reasonable time period during which an REB member is not allowed to review a proposal from a close colleague 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. In exceptional circumstances guaranteeing unbiased, competent and independent decision making by the REB may require reducing the quorum. The REB minutes should record whether with the withdrawal of the REB member, the REB was unable to maintain its quorum for decision making. (See Article 6.9).

While the presence of administrative staff dedicated to research ethics functions (e.g. the research ethics office administrator or director) may be relevant and appropriate to support REB procedures, an institutional senior administrator (e.g. a vice-president research or business development) should not serve on an REB, attend meetings, or influence the REB decision making process. (See Articles 6.2, 6.4 and 6.10). The mere 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.

REBs and non-voting senior administrators should consider other venues to discuss policy issues, general issues arising from the REB’s activities, revisions of policies or training or educational needs, to the benefit of the overall operations and mandate of the REB. In the discharge of their interdependent roles and duties to research participants, effective communications processes should be established between REBs and the relevant officers of institutions they serve.

In cases where senior administrators interfere with the REB decision-making process, REBs should invoke the institutional conflict of interests policies.

Institutional conflicts of interests may give rise to professional conflicts or divided loyalties for individuals working in affected institutions. 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 interests in accepting undue or excessive honoraria for their participation in the REB. Institutions should define appropriate levels of compensation.

C. Researchers and Conflicts of Interests

Article 7.4  Researchers shall disclose to the REB real, potential or perceived individual conflicts of interests, as well as any institutional conflicts of interests 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 interests.

Application Individual conflicts of interests 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 generally it is impossible to eliminate all conflicts of interests, researchers are expected to recognize, disclose, limit and manage their individual conflicts in a manner that is satisfactory to the REB.

Managing conflict of interests is a process, of which the first step is identification followed by disclosure. Upon disclosure to the REB, the steps taken by the REB to manage the conflict should be context-based and proportionate to the risks. For example, in some cases, the REB might conclude that the identified conflict of interests does not warrant specific actions. Generally, the REB should require, consistent with Article 3.2(e), that the researcher disclose any real, potential or perceived conflict of interest to the research participant. When disclosure to the REB is not enough to manage the conflict of interests, the REB, guided by established institutional policies, may require that the researcher withdraw from the research or that others who are not in conflict of interests make research-related decisions. Where appropriate, disclosure to the sponsor, the institution and any relevant professional body may also be necessary. In exceptional cases, the REB has the discretion to refuse approval of a study where the REB decides that the conflict of interests has not been avoided or cannot appropriately be managed.

If there is a need to involve the researcher in some aspect of the research for which this individual is in conflict of interests, such involvement should be justified and disclosed to the research participant by the researcher, and reviewed and endorsed explicitly by the REB in its minutes. In line with the proportionate approach, and through the continued ethics review process, REBs may impose additional control mechanisms in such cases.

Dual roles of researchers and 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. free and informed consent of participants). Article 3.2(e) reminds researchers of relevant ethical duties that govern real, potential or perceived conflicts of interests 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 interests that may arise from their dual or multiple roles, being entirely aware of their rights and responsibilities, and they shall manage the conflict. When acting in dual roles, the researcher shall disclose this fact to the participant.

In some instances, the perceived or real conflict of interest may arise after the research has been conducted. For example, when after the completion of a clinical trial conducted in a clinical practice, the physician is invited to participate in a seminar organized by the sponsor of the trial in an interesting location or when a company offers to ghost-write a scientific article only to be signed by the physician-researcher.

Care should also be exercised in developing relationships between researchers and authorities, so as not to compromise the consent and privacy of participants and the confidentiality obligations of researchers, and to maintain public confidence and trust. Article 3.1 provides additional information on coercive situations and how they may impact on consent.

As part of the research plan for REB review, researchers must provide details on the research project, payments to the researchers by sponsors, commercial interests, consultative relationships and other relevant information (e.g. donation to an institution by a research sponsor) and documentation, and identify strategies to prevent, disclose and manage conflicts properly. Disclosure of the kinds and amounts of payments to researchers, 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 interests and will help the researcher in resolving them. (See Articles 11.9 and 11.10).

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

In addressing conflicts of interests, disagreements between the REB 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 a paramount principle of respect for persons and concern for welfare of participants. If the researcher and the REB cannot resolve their disagreement they should use the institutional conflict of interest mechanisms.

Reference

Memorandum of Understanding (MOU) on the Roles and Responsibilities in the Management of Federal Grants and Awards. www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp