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Conflicts of Interest AcademyHealth members will confront and need to resolve a wide variety of ethical dilemmas in the course of their professional lives. At this juncture, the Committee decided to limit its focus by developing guidelines that address financial and non-financial conflicts of interest, leaving other important issues, such as authorship and confidentiality, for attention at a later date. What
Is a Conflict of Interest? AcademyHealth members take on many roles within their professional lives. These roles may have different public and professional expectations and norms about what constitutes ethical behavior. For example, in the role of an advocate, an individual may promote certain health care reforms through political campaigns, which naturally tolerate and even expect zealous promotion. In another role as a health services researcher, the same individual may—perhaps should—restrain his or her passionate commitments in order to conduct the research with honest, reliable, and unbiased methods; this includes an openness to discover and disseminate findings, even if they prove counter to his or her personal commitments. When carrying out a specific activity, it is imperative for an individual to recognize which role he or she occupies and to abide by its ethical norms. Frequently, identifying the appropriate role will be obvious and straightforward; however, in some circumstances it will require reflection, discretion, and judgment. Based on the nature of an individual’s principal professional role, he or she has primary interests that stem from that role. For teachers, it is educating their students; for physicians, it is promoting the well-being of their patients; for judges, it is ensuring that justice be done. For all researchers, including health services researchers in their researcher role, the primary interest is to generate and disseminate valid and reliable research that informs policy and practice and to ensure integrity in the process. Individuals, however, are not typically limited to a single role; in fact, they usually play multiple roles. Thus, in addition to the primary interest, individuals customarily have numerous secondary interests that originate from their other interests, personal commitments, and roles. These secondary interests of researchers include teaching, administration, financing research, political advocacy, obligations to employers, financial, as well as family and other avocational interests. The presence
of secondary interests is not necessarily unethical or otherwise nefarious.
On the contrary, such interests are frequently praiseworthy activities
in their own right; being politically engaged, a devoted teacher, a dedicated
employee, or concerned with one’s family, for example, is admirable.
What makes these interests potential conflicts is their ability to unduly
influence decisions that compromise the health services research role.
Thus, a conflict of interest occurs when secondary interests distort the
integrity of judgments regarding the primary interest. In the case of health services research, not only can individual interests pose a conflict, but since much of the research is conducted within organizations, different actors in the same organization and even on the same research team can have different interests. This reality can easily lead to intra-organizational conflicts of interest. Recent attention in clinical medicine has focused on this issue. For example, the Association of American Medical Colleges recently adopted guidelines to address institutional conflicts of interest, such as the conflicts that could arise when an institution has licensed a patent or obtained an equity interest in a company that might be affected by research undertaken by researchers at that institution, even if the researchers themselves have no personal financial interest in the company. When referring to conflicts of interest, many commentators distinguish between actual and perceived conflicts of interest. An actual conflict of interest occurs when these other, secondary interests objectively distort judgment. It is important to note that individual actors, as well as outsiders observing them, will typically be uncertain about the true motivations for specific decisions and actions. Observers—and even actors themselves—can be unsure about which of myriad considerations and interests ultimately influenced a person’s judgments. The distance of observers, and the inherent limitations on their access to knowledge about decisions, means their perceptions about the influence of interests may well differ from those of the researchers. Uncertainty about what interests a person has and how these interests influence decision-making can cast suspicion on the integrity of the judgments. Thus, a perceived conflict of interest occurs when a reasonable person could perceive that a secondary interest might unduly affect the integrity of a judgment regarding a primary interest. Indeed, since it is impossible to know for sure what considerations influence judgments, conflicts of interest inherently entail how reasonable people will perceive the influences on judgments. Consequently, even perception of a conflict of interest is ethically worrisome and requires prevention, prohibition, or remediation. Health services researchers should endeavor to avoid even perceptions by others of conflicts of interest. Health services researchers must take an active role in ensuring ethical conduct regarding conflicts of interest. It is imperative that not only do researchers adhere to ethical guidelines to manage such conflicts, but that they also maintain a clear personal code of ethics that might prevent such conflicts in the first place and help to manage them when they arise. Researchers should be responsible for acting in an ethical manner while representing professional organizations and conducting health services research—not only because their profession demands it, but also because we would hope that individuals themselves would abide by a personal code of ethics. Such personal ethics will ultimately help to mitigate conflicts of interest and will lead to a more ethical mode of professional conduct in the health services field. Because every person has numerous roles and interests, conflicts of interest are inevitable. While they may not always affect the decisions of the research team, conflicts must be appropriately managed. Left unchecked, these conflicts can threaten the credibility of the research team or the organization. More important, individual or organizational conflicts that are not dealt with can threaten the credibility of the entire field, raising suspicions about research and the integrity of researchers in general. Ensuring the integrity of judgment of individuals and the field requires that these conflicts of interest be properly managed. To be useful, any management strategy must be sensitive both to legitimate competing interests and to the manifold considerations of actual practice, while simultaneously retaining sufficient specificity to guide action in an ethically acceptable manner. Conducting Research versus Using Research There is a growing body of guidelines concerning the ethical issues that arise in the conducting of research—the actual “doing” of the science—that are within the purview of the researcher or analyst; these address issues such as research integrity and independent control over the conduct and publication of research. Recently, this has been an area of special concern in privately funded clinical research. The same concerns, values, and level of control should apply to health services research. The relationship between research teams and sponsors exists along a broad spectrum, from grants in which researchers possess maximum discretion in pursuing an objective to solicitations and contractual relationships in which the sponsor specifies the objectives and outcome measures but leave the research team discretion on the data sources and methods of analysis, to even closer researcher-sponsor partnerships in which the sponsor is involved in each step from conception to analysis to reporting of the results. Nevertheless, the health services researcher or multidisciplinary research team should have primary control over how studies are developed and carried out and how findings are disseminated. In each of these researcher-sponsor relationships, it is essential to recognize that there is a crucial difference between seeking research to address certain questions, to quantify trends, to identify or assess the importance of causal factors, and seeking support for predetermined conclusions. The difference inheres neither in the topics being studied nor in the nature or sophistication of the research methods, data, or findings. Rather, the distinction exists in the intent in conducting the research, the purposes for which the research is being used, and how these objectives affect the topics, methods, data, and reporting of the findings. Generating data merely to substantiate predetermined conclusions is not research. As such, it is vital that whenever the researcher or research team works with the sponsor in a collaborative partnership, all parties must work together to reach decisions that maintain the objectivity and credibility of the research. This is not to say that researchers cannot engage in work with sponsors under more restrictive arrangements—just that such work should not be construed or presented as research. Health services researchers work within a vast range of organizations, from those conducting pure research to those engaged in policy development and advocacy. The expectation of independence assumed for a researcher in a university or nonpartisan research organization may or may not apply in an advocacy or policy context, where such research may be applied. Even within the university-based or independent research setting, there are often legitimate constraints and policies that may limit the independence of an individual researcher. For instance, how research is disseminated, whether in a report to sponsors or peer-reviewed publications, may not be decided by the researcher. Similarly, while university-based researchers may have more discretion to define their research topics and agendas, other researchers may appropriately have their topics partially defined by the research organization or policy group they work for. Clearly then, when evaluating potential ethical dilemmas and management strategies, it is crucial to distinguish these roles and the context in which the researchers are working. ___________________________________________
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