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Distinctive Characteristics of Health Services Research There are similarities between the conflicts of interest that arise in health services and other social science research and those that arise in clinical research. The essential values guiding conflict of interest policies—integrity in research, public trust, and ethical conduct of research—are shared among health services research, the social sciences, and clinical and basic science research. In addition, threats to the integrity of researchers’ judgment occur predominantly at similar junctures in the research process: research design, data analysis, and reporting of results. What distinguishes the conflicts of interest in health services research from those in other fields are differences more in degree than in kind. In considering ethical issues in health services research, there are at least five important characteristics of the field that necessarily inform the structure and emphasis of these conflict of interest guidelines for health services research. First, there can be significant conflicts of interest that occur as a result of personal financial interests, such as consulting arrangements with industry, speaking for companies, licensing research instruments, and royalties. In these cases there may be a conflict, or perceived conflict, between financial interests and the goals of research. Such conflicts of interest are common in clinical and biomedical research. While they can and do exist in health services research, it appears that the predominant financial conflict in health services research is less likely to be the result of the personal financial interests of the researcher and more likely to be related to the financial viability of future research possibilities, both for the researcher and the organization in which he or she works. Hints by a company or government agency that future grant funding or contract awards may be withheld if the researcher is not compliant with funder requests (or “suggestions”) can create conflicts between maintaining research integrity and ensuring the future financial security of the research initiative and organization. In addition, there can be considerable financial pressure in soft money organizations and academic settings to secure grants for future research; these pressures from within organizations can also present similar conflicts between upholding the integrity of the research and meeting the financial needs of the organization. Second, health services research findings are frequently relevant to political, legal, and regulatory proceedings. Researchers and sponsors may themselves occupy the role of advocates in such public arenas, making it important but difficult to distinguish between research and advocacy roles. Thus, even if the individual scrupulously adheres to all the appropriate guidelines in undertaking and publishing his or her research, those guidelines, however desirable, may not be mandatory when the individual is involved in advocacy. Consequently, perceptions about potential conflicts of interest may arise. For example, a researcher who gains recognition for advocating particular positions in the policy arena could find the validity of his or her research challenged even when it adheres to the scientific standards of the field. Analogously, researchers who constrain their advocacy may lessen their ability to translate research to practice. One’s balance of the various roles will be guided by personal priorities. Nevertheless, however they balance their various roles, health services researchers must be attuned to what role they are assuming at any particular time and must avoid misleading others about being a dispassionate researcher when, in fact, they are assuming the role of an advocate. Because perceptions by reasonable observers are the essential ethical problem in conflicts of interest, researchers must make clear to others about what “hat” they are wearing in order to be explicit about how the results of the research should be interpreted. In addition to being attentive to the existence of these various roles, identifying means to reduce the influences created by these roles can help to diminish the possibility of conflicts occurring in the first place. Third, all research requires judgments about defining the objectives of the study, designing the study, what data sources to utilize, interpreting the data, and how to disseminate it. Because of the limited feasibility of double-blind, randomized controlled trials in health services research, such research often relies on study designs and data sources that are less straightforward and more complex than basic and clinical research studies with hard endpoints. Well-executed health services research often involves numerous decisions that rely on judgments that cannot be specified in advance and for which objective criteria may be difficult to define. The measurement of endpoints, as well as the endpoints themselves, may be controversial, as this often depends on judgments (e.g., cost per year of life or patient measures of acceptability rather than just mortality). Much of the data used by health services researchers have been collected primarily for other purposes and are being adapted for the research. Finally, the interest in moving from the results of a particular study to implications for generic policy issues requires assessments of generalizabilty. The need for complex judgments about design, data quality, particular analyses, and applicability of findings in health services research is more pervasive and harder to prospectively delineate in a formal protocol. Thus, there is an even greater necessity to rely on the integrity of the researcher and on his or her organization. Fourth, the balance of funding for health services research between sponsors focused purely on supporting the research enterprise and those concerned with the particular programmatic implications of the research findings is likely to differ between health services research and clinical and basic science research. Basic science research is primarily financed through publicly funded investigator-initiated (often know as R-01) funding in which the research objectives are typically specified by the researcher and where the sponsor does not have a direct interest in outcomes. Much clinical
research is supported in a similar manner, by investigator-initiated grants
for public or foundation funding in which the sponsor In health services research, on the other hand, a substantial share of research funding comes from corporate, foundation, or public sponsors with direct financial, programmatic, or institutional interests in the research outcomes. Frequently, funding support is explicitly directed toward evaluation of the sponsor’s programs or to further a preferred policy. In these contexts, it is not uncommon for particular research findings to be viewed as objectionable by a sponsor; perhaps the findings run counter to a preferred policy or the research results speak to the ineffectiveness of highly visible programs. This type of objection may create a conflict over the reporting of those results no less problematic than unfavorable results of a drug trial. Finally, health services researchers are employed by many types of institutions—academic, non-academic, consulting, advocacy, government, and private/commercial. Each entity has distinct characteristics, interests, standard operating procedures, and perceptions of what constitutes a conflict of interest both within the organization and with outside sponsors. Each research and working environment has its own set of expected behaviors, and this is likely to influence both the researcher and how his or her work is perceived by others. In determining how to apply these general guiding values of research to the health services research field, the particular characteristics of health services research need to be considered. While the guiding values may be the same for all types of research, the particular attributes of health services research necessitate management strategies specific to health services research; in other words, management of conflicts of interest in the health services research field is best determined by tailoring such strategies to the issues and settings in which conflicts are most likely to arise. Indeed, when the Committee reviewed conflict of interest guidelines that focused predominantly on clinical research, these guiding principles tended to emphasize the personal financial interests of researchers, and thus did not seem to address the most pressing conflicts confronting health services researchers. ___________________________________________
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