Interests, dualities of interest and conflicts of interest
All medical and other decisions that refer to values or ethical contexts invoke interests of one kind or another. In the fields in which health professionals work – clinical practice, research, education, and policy development and implementation, there are always multiple interests at play. From an ethical point of view, decisions are rarely unambiguous, and usually require careful analysis of values and negotiation and compromise among conflicting positions. The process is made more complex as a result of the variety of roles individual practitioners play and of the moral obligations they thereby incur. In other words, as will be explained below, the process of decision-making in healthcare invariably involves a careful balancing of interests, values, ethical perspectives and personal and other preferences.
For the most part, in the normal course of decision-making the proliferation of interests is managed in a routine and non-antagonistic manner. It is part of the skill of the professional to navigate his or her way through the complex manifold of values, purposes, commitments and obligations which are presented. On occasions however, the complexity can be so great that the optimum course of action is uncertain. The various interests may suggest contending or confusing possibilities leading to conflicting demands.
These cases, known as a conflicts of interest (COI), need to be identified and managed appropriately. It is important to define the concept of a COI carefully and to clarify strategies available to address and resolve such conflicts. It is emphasised however, that the absence of COIs does not imply that residual decisions relating to the play of interests are not complex and difficult. Accordingly, although COIs are important, it is essential not to exaggerate their role or to use them to obscure the importance of the interest-laden decisions that are made routinely.
To clarify these ideas it is first necessary to define the concepts:
- An 'interest' is a commitment, goal, obligation or value associated with a social relationship or practice.
- Where two or more distinct interests coexist in a particular decision-making setting, a 'duality' of interests is said to exist.
- When a particular relationship or practice gives rise to two or more conflicting interests, a 'conflict of interest' exists.
These definitions emphasise certain important points:
- All choices and decisions raise issues related to values. We occupy multiple roles, incur various ethical obligations and enter into multiple commitments. This reflects the diversity of societies and the plurality of our individual roles. Inevitably, different roles lead to varying obligations, so conflicts may arise.
- The negotiation of value pathways through dense manifolds of interests is usually required, since decision-making involves judgments about such interests.
- In decision-making settings, opposing and contradictory interests often coexist. Whereas in common usage, the expression ‘conflict of interest’ is often taken to imply the existence of ignominious or unethical behaviour, in reality, conflicts usually arise in the absence of personal errors or faults. COIs arise from the facts and settings and not from malign motivations. Furthermore, neither dualities nor COIs in themselves inevitably cause harm, it is the ambiguity about goals and values and the possibility for harm that arouses concern.
- It is sometimes difficult for individual participants in a given decision-making setting to recognise that a conflict exists. That is why systematic processes are needed to identify the play of interests that are at stake and to assess their significance.
As explained below, the decision about whether a duality constitutes a conflict should not rest with the individual concerned but with the affected community. If a conflict is judged to exist, actions need to be taken to separate the conflicting elements. There are different levels at which change can occur, including at the individual and institutional levels.
Pecuniary and non-pecuniary interests
Interests can be pecuniary or non-pecuniary and both can lead to conflicts and dualities. A pecuniary interest refers to the possibility of financial or other material gain arising in connection with professional decision-making. Examples of pecuniary interests include:
- shareholdings or board memberships
- paid employment, including consultancies, commissioned fee-paid work, speaker fees, fees provided in return for an expert opinion and performance bonuses tied to particular outcomes
- fellowships, research and education grants
- travel grants, conference expenses, gifts and hospitality
Non-pecuniary interests refer to goals, benefits, commitments or obligations not directly linked with material gain. These encompass personal goals and relationships, including family or other commitments, enhancement of career and the possibility of acquiring professional recognition, status or fame. They also include individual belief systems that may influence decision-making, membership of religious and political groups, and adherence to ideologies that guide the operations of institutions.
Neither pecuniary nor non-pecuniary interests are in themselves good or bad, ethical or unethical. They are part of the dynamic of any decision-making process. The key issue is how these interests interact with each other and their implications for the various practices of clinical care, research, education and health policy, within which they are embedded. Although most attention is given to pecuniary interests in health care settings, on many occasions non-pecuniary interests are the most potent and troublesome drivers of action.
Examples of interests, dualities and conflicts
Dualities of interests exist whenever health professionals find themselves having to decide between two contending interests in a given decision-making context. Dualities may or may not constitute conflicts, depending on the circumstances.
Examples of settings in which dualities of interest exist, some of which could also be characterised as conflicts of interest, are as follows:
- Health practitioners or their family members hold shares in a pharmaceutical company, the products of which the practitioner may prescribe.
- A department head faces demands to cut budgets in spite of expanding clinical or other needs.
- A healthcare practitioner undertakes paid employment, with commissioned or non-commissioned fees for working as a speaker, author or expert adviser on behalf of a pharmaceutical company.
- An officer of a professional society is also a member of a political or social organisation which requires loyalty to a policy platform.
- A clinician, researcher or a professional organisation employee holds a fellowship or position supported by a pharmaceutical company, directly or indirectly.
- A professional society accepts payments from commercial sources to support its activities such as continuing education.
- A physician, who is also a researcher, is approached by a current patient considering participating in a clinical trial with which the physician is involved.
- A researcher receives support from a pharmaceutical company for carrying out research.
- A clinician is involved in the research and development of a new device which, if successful, could greatly enhance his or her reputation and professional stature.
- A clinician accepts gifts or hospitality, even of minimal value, from a company whose products he or she prescribes.
- A clinician or researcher receives support from industry for travel and conference expenses.
- A physician is paid to report on a diagnostic test undertaken by a for-profit company with a view to that company selling the devices to the patient.
- A trainee organising an educational event for his or her peers accepts financial support from an industry source.
The effective management of dualities and COIs lies in identifying them, making clear declarations, maintaining openness and transparency, and developing appropriate processes to deal with specific issues. While it is essential that dualities and conflicts are dealt with in an open and transparent manner, it is important to recognise that, in many cases, mere disclosure is not in itself sufficient. Specific action will often need to be taken to separate the activities or roles that are in conflict. The whole process will commonly include the following sequence of steps:
- Individuals reflect on the pecuniary and non-pecuniary interests associated with their various social roles and relationships.
- Individuals declare all pecuniary and non-pecuniary interests that might generate or suggest interests.
- All pecuniary and non-pecuniary interests are considered by a deliberative body that is appropriate to the circumstances, for example an ethics or departmental committee, an independent advisory group or a council of community members directly affected.
- An assessment is made concerning whether the dualities constitute actual conflicts.
- If a conflict of interest is considered to be likely, practical strategies are devised to separate the pursuit of the conflicting interests. In some cases, this will entail withdrawal from or curtailing a particular activity, while in others it will be sufficient to delegate functions or roles to another individual or group of individuals or committee.
- The circumstances, decisions and practical outcomes are communicated openly to affected individuals and organisations.
The details of the process will obviously vary according to circumstances and contexts. For example, in the case of presentations at meetings, organising committees should develop policies that ensure open and complete disclosure in a manner that permits audience members to interpret the content of presentations appropriately. Where there is overlap between the roles of researcher and clinician, the elements deemed conflicting should be separated by delegating one of them to a colleague or assistant. Individuals with political or religious commitments that limit free debate or decision-making may need to recuse themselves when decisions are being made.
- It is important to identify both pecuniary and non-pecuniary interests and to consider their potential for influencing decision-making.
- It is important to identify dualities, which include conflicting interests, in relation to actual circumstances.
- Disclosure alone does not resolve conflicts of interest but is the first step in identifying and managing actual conflicts of interest.
- Dualities should be disclosed to a relevant party for example, a committee, or council or patient, which then considers whether further action needs to be taken
The need for processes to guide responses to issues concerning values and interests
Manifold of interests can be very complex and the issues raised can refer to a wide variety of clinical, research and institutional contexts. In addition, the settings themselves can be diverse and may change and evolve over time. As a result, guidance must be formulated at a high level of generality that permits application in changing settings. Detailed analysis of the circumstances of individual cases and interpretation of the needs of the relevant affected communities are usually required. This necessitates reflection and debate within such communities.
For individual health professionals, recommendations in these Guidelines are proposed as advisory only and are not linked to a prescribed, formal method of enforcement. This is appropriate for ethical decision-making in general because it requires constant scrutiny of issues and principles that cannot be replaced by legislative imperatives. Indeed, clinical practice requires that ethical decisions are taken in a setting of dynamic negotiation and compromise among participants with differing values.
This means that when dilemmas or problems arise, there is a need to access processes that can indeed respond to the details of individual circumstances and contexts. It is therefore recommended that in each relevant organisational setting, a process is established to ensure adequate responses to issues relating to dualities and conflicts of interests. Considerations that may be taken into account during this process include:
- identification of the main issues regarding relations with industry relating to that setting
- establishment of procedures for assessing and managing dualities and conflicts of interest within the given context
- development of measures to ensure adequate transparency and communication with the relevant communities
- maintenance of records of declared dualities and identified conflicts and how they are managed
- development of methods for reviewing the impact and appropriateness of procedures and recommendations
In many cases organisations will delegate these tasks to bodies with appropriate skills and experience such as an ethics committee, or they may establish committees specifically for such purposes, which will often include community representatives. Details of how an organisation deals with dualities and conflicts of interests should be publicly available. In many cases, responsibility for the various functions is likely already to be spread among a number of existing bodies.
In every organisational or practice setting, a process should be established to ensure adequate responses to dualities and actual conflicts of interest.
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