Ethical Guidelines for Managing Conflicts of Interest in Health Services Research

Transcription

1 Ethical Guidelines for Managing Conflicts of Interest in Health Services Research December 2004

2 Table of Contents Executive Summary Introduction AcademyHealth Ethical Guidelines Committee and Its Objectives Conflicts of Interest What is a Conflict of Interest? Conducting Research versus Using Research Distinctive Characteristics of Health Services Research Guiding Values Ethical Guidelines Initiation of Research Conducting Research Reporting Research Analyzing a Potential Conflict of Interest Implementation and Enactment of the Guidelines Appendix A AcademyHealth Ethical Guidelines Committee Appendix B Committee Actions Appendix C Conflict of Interest Resources

3 Executive Summary The primary interest of health services researchers is to generate and disseminate valid and reliable research that informs policy and practice and to ensure integrity in the process. A conflict of interest occurs when secondary interests such as teaching, administration, political advocacy, or financial or avocational pursuits distort the integrity of judgments regarding the primary interest. AcademyHealth convened an Ethical Guidelines Committee comprising individuals reflecting a range of organizations and disciplines to provide practical guidance to individuals and organizations who struggle with the potential for conflicts of interest in health services research and health policy analysis. The Committee identified five characteristics that distinguish conflicts of interest confronted by health services researchers from those faced by other fields: 1. The predominant financial conflict is less likely to be related to personal financial interests (as in clinical research) than to the financial viability of future research possibilities. 2. Findings are frequently relevant to political, legal, and regulatory proceedings which may make it difficult to distinguish between research and advocacy roles. 3. Because of the limited feasibility of randomized controlled trials in health services research, such research often relies on study designs and data sources that are less straightforward than those in basic and clinical research studies. 4. A substantial share of research funding comes from corporate, foundation, or public sponsors with direct financial, programmatic, or institutional interests in the outcomes. 5. Researchers are employed by many types of institutions (academic, private, government, etc.), each of which has its own interests, procedures, and perceptions of what constitutes a conflict. The Committee focused on three values to guide development of the guidelines: preserving and enhancing the integrity of health services research; maintaining consistency with other ethical values of health-related research; and adhering to ethical guidelines of other intersecting fields. Keeping these values in mind, the Committee developed the guidelines summarized on page 2 of this report. In developing these guidelines, it has been the Committee s intent to assist individuals and organizations in managing conflicts of interest and preserving the ethical values described above. We hope this is a helpful first step in creating a shared understanding of best practice strategies in order to ensure that conflicts of interest do not arise in the initiation, design, conducting, or dissemination of health services research. We look forward to receiving feedback and to future discussions of this critical issue. 1

4 Ethical Guidelines for Health Services Research Status of Research Initiation of Research Pursue research maintaining openness to unanticipated results: do not pursue research intended to reach a pre-determined conclusion. Many methods and techniques used in research may be appropriately used to clarify or justify pre-determined positions, but that is not research. Researchers and sponsors should come to a mutual agreement on the research objectives and data sources at the outset. Make any sponsor-imposed limitations on the research explicit in the contract prospectively; do not pursue research if the limitations are not acceptable to the researcher. Sponsors should assume responsibility to promote ethical research standards by setting reasonable objectives and deliverables as well as giving the researcher freedom to analyze the data and report conclusions as the researcher sees fit. Conducting Research There should be no fraud or fabrication in research, regardless of the purposes for which the research will be used. Maintain objectivity in conducting research and analysis; whenever possible, use measures and methods that are widely-accepted and reproducible. Record the methods and measures of research and analysis, making this information available to legitimate requests, such as confirming or replicating the reported results. Reporting Research Authors should be free to report data and results within 2 months (but no longer than 6 months) after the research has concluded; any restrictions on this timing must be disclosed. Any sponsor-imposed changes in the reporting of results that distort or misrepresent the research findings are unethical and should not be accepted by the researcher. Differences in opinion between the researcher and the sponsor about the interpretation of data should be appropriately managed; if differences remain after the researcher and sponsor endeavor to agree upon conclusions, differences should be disclosed whenever the data are reported. Further disagreements should be resolved through a peer review-like mechanism consisting of appointments by both parties of people with relevant expertise. Researchers should endeavor to make their methods transparent and available to peers for replication or confirmation of results. All reporting of research results should specify who sponsored and financed the research, as well as their role and involvement in the research at any point. Work originally intended for advocacy or similar purposes (rather than as research) should be identifiable as such. Researchers must be explicit about their other roles and interests when reporting results and must not conceal the possible limitations of the research. 2

5 Introduction As in all professions, conflicts of interest are inevitable in health services research and health policy analysis. Conflicts can arise when initiating projects, designing study methods, analyzing data, and disseminating research findings. Conflicts can involve individuals or organizations. The purpose of this report is to provide guidance to researchers, sponsors, and others to help them anticipate and manage the inevitable conflicts that will arise in the conducting of health services research and policy analysis. AcademyHealth Ethical Guidelines Committee and Its Objectives At the request of its Board of Directors, AcademyHealth convened the Ethical Guidelines Committee ( Committee ) composed of individuals from a variety of organizations and reflecting a wide range of disciplines. The overall objective of the Committee was to provide practical guidance to individuals and organizations who struggle with the potential for conflicts of interest in the conducting of health services research and health policy analysis. Understanding that conflicts of interest vary widely both across disciplines and with circumstances, the Committee worked to develop best practice strategies for navigating various situations, including ones in which some parties may not always act in an ethically appropriate manner. According to the Institute of Medicine and the Association for Health Services Research, a predecessor to AcademyHealth, health services research is: a multidisciplinary field of inquiry using both quantitative and qualitative methodologies that examines the use, costs, quality, accessibility, delivery, organization, financing, management, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations. Based on this understanding, health services research encompasses activities ranging from basic research intended to uncover knowledge about health and health care, to applied research assessing current policies, activities, and organizations, to policy analysis intended to inform new policies and decisions. Because of the diverse aims and objectives of the health services field, there are many manifestations of how this work is carried out that fall along a broad spectrum, encompassing activities ranging from advocacy to research and policy analysis. While all of the endeavors that fall along this spectrum are integral and vital to the health services field, this AcademyHealth report will maintain a focus primarily on research and policy analysis and will seek to establish ethical guidelines and management policies for these central activities. In fact, this report will focus on some vital differences between research and advocacy in an attempt to extricate the primary objectives and ethical conduct related to health services research. Because some important features of health services research, such as methodology, funding, venue, and oversight, often differ from those of clinical and biomedical research, the types of conflicts that confront health services researchers are also likely to vary. For this reason, the Committee maintained a focus on the situations and guidelines that are particularly important in the context of health services research, and supplemented such guidelines with those that should be adhered to in other fields relevant to the work being done. Ethical guidelines cannot be mathematical formulae or computer algorithms; rather they require judgment in order to balance competing values and to take into consideration the wide range of possible facts and circumstances. The guidelines proposed by the Committee should serve to generate dialogue and as a resource for preventing and resolving conflicts of interest in an ethical manner while sustaining viable research programs in diverse organizational environments ranging from academic centers to commercial enterprises. We urge that individual health services researchers and their home organizations, as well as journals that publish health services research, adopt these guidelines and use them as a starting point for developing their own policies and practices to manage conflicts of interest. Ultimately, we aim to ensure the integrity of health services research findings and the public s trust in these findings. 3

6 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. A conflict of interest can occur when a secondary interest of any type affects a judgment about a primary interest. Researchers could have a conflict between their research goals and spending time with their families, advocating for political beliefs, or volunteering in the community. This report will concentrate on financial conflicts of interest; that is, those secondary interests related to the financial interests. This focus is not to suggest that nonfinancial conflicts of interest are any less dangerous; rather, we maintain a focus here on financial conflicts of interest because they are more objective and easier to regulate. 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 intraorganizational conflicts of interest. Recent attention in clinical medicine has focused on this issue. For example, the Association of 4

7 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. 5

8 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.

9 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. 7

10 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 has a direct interest in the completion of the project but not in the findings themselves. Nevertheless, a substantial proportion of clinical research funding comes from corporate sponsors, who typically have a financial interest in specific outcomes for example, in the positive outcome of a drug trial that would promote the use of the drug they manufacture. 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, nonacademic, 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. 8

11 Guiding Values In developing a set of guidelines for the field, the Committee focused on three underlying values. We began with a belief that health services research can lead to improved clinical and public policies, but only if such research and analyses are conducted to yield valid and reliable results and are considered credible by the public. Therefore, the first and most crucial value is preserving and enhancing integrity in health services research by identifying and minimizing potential bias and appearances of such bias and by providing effective oversight for individual and institutional decisions. Such a commitment to integrity includes not only professional integrity as a health services researcher, but also personal integrity to act in an ethically responsible way, especially when faced with difficult or complicated decisions and situations. At the very least, integrity in research requires not knowingly making false, inaccurate, or misleading statements or withholding relevant information. Furthermore, while researchers can have and probably need conjectures and passionate commitments, integrity requires fairness and openness to finding the truth. Integrity in research requires not pursuing a pre-determined conclusion, but pursuing a hypothesis and accepting whatever conclusions are revealed through the research, particularly if they contradict one s initial preconceptions. Integrity requires thoroughness and transparency in regard to the multitude of decisions made, conclusions drawn, and the consequent limitations in the analysis. Fundamental to the notion of integrity, then, is the realization that perceptions of conflicts of interest, particularly those that are perceived as concealed, can be damaging not only to the organization or individual researchers, but to the entire discipline. In this sense, health services researchers must recognize that their actions are both individual and communal they not only ensure personal integrity, but also the integrity of the field. The second value is maintaining consistency with other ethical values of health-related research. Conflicts of interest are not the sole relevant ethical consideration in health services research; these guidelines must be consistent with other ethical principles such as respect for research subjects and confidentiality of information that guide health services researchers in their related fields. Basic ethical principles apply across all arenas; thus, it is important for health services researchers to be clear and transparent about the role they have assumed and to maintain their ethical principles at all times. A third guiding value is adhering to the ethical guidelines of other intersecting fields. As noted by the IOM, health services research is inherently a multidisciplinary field of inquiry and health services researchers frequently associate with other disciplines. For instance, health services researchers findings may be used to improve service delivery, shape policies in the political arena, or researchers may be called as expert witnesses in a court of law or regulatory hearing. In each of these cases, health services researchers must not only recognize the ethical expectations of these other fields, but also recognize how these expectations may conflict with the ethical imperatives related to their research role. For example, health services research should be open, transparent, and available to the public when possible. However, if health services research is introduced into a legal proceeding, such research may be required to adhere to the special norms of the law, such as having testimony sealed and therefore not available to the public. Health services researchers should adhere to the ethical guidelines related to health services research and, when ethical expectations and guidelines differ from those in health services research, there must be compelling reasons to deviate, such as the requirements of law or national defense. Lacking such compelling reasons, they should choose not to undertake activities because of the possibility of such conflicts. 9

12 Guiding Values of Health Services Research Guiding Issues Principals Actions Preserving and enhancing integrity in health services research Integrity Ensure the personal integrity of individual researchers. Ensure the credibility of the health services research field. Minimize possible bias in conduct and reporting of results. Be fair and open to pursing the truth rather than predetermined conclusions. Maintain transparency in research judgments. Maintaining consistency with other ethical values of health-related research Consistency of Research Ethics Ensure conflicts of interest are balanced within all basic ethical principles relevant to health services research: Respecting research subjects; Maintaining confidentiality of personal information; Endeavoring to pursue meaningful research; Minimizing risks or negative effects of research; Maintaining justice and equality in research; and Avoiding coercion or undue inducement. Adhering to the ethical guidelines of other intersecting fields Inter-Disciplinary Ethics Recognize the ethical expectations of other arenas engaged with health services research, such as legal procedures. Be aware of conflicts between the ethical expectations of the health services research field and other related fields. Avoid conflicts by not undertaking research that could pose such inconsistencies in ethical expectations. 10

13 Ethical Guidelines To be practical, these values must be specified in ethical guidelines delineated according to the temporal sequence of initiating, conducting, and reporting research. As all of these stages are tightly interconnected, safeguards introduced at earlier stages can influence and frequently pre-empt potential ethical dilemmas at subsequent stages in the sequence. Initiation of Research It is unethical to label an activity or project as research if it is designed to reach a predetermined result. Research requires the real possibility of finding potentially unanticipated results. When a contract either explicitly or implicitly (by specification of the research process) is intended to reach a pre-determined or biased conclusion, it should be rejected as unethical if it is to be presented as research. Just because a research question is specified does not mean that the activity is not research; rather, it is the preset definition of an endpoint or conclusion that should be viewed as unethical. will be involved or have constrained the specification of outcome measures, data sources, methods of analysis, or the timing of the release of results. When sponsors seek to impose restriction and constraints that are likely or intended to affect the major elements of study design, methods, and analysis in ways that may produce biased results, researchers should avoid conducting such research. Sponsors themselves should assume responsibility toward adhering to ethical standards and conducting of research when entering into professional relationships in the health services field. Sponsors should seek to implement fair and ethical contracts and agreements with health services researchers. This entails setting reasonable objectives and, if necessary, specifying any constraints on outcome measures or data sources at the outset and allowing researchers the freedom to analyze the data and draw conclusions based on the researcher s professional judgment. Researchers and sponsors should mutually agree upon the objectives of the research and the data sources at the outset. From the perspective of research, the ideal is to leave the researchers free to analyze the data, draw their own conclusions, and report the results consistent with their professional training and judgment. While this is the ideal, we also acknowledge that sometimes limitations and constraints on contracts cannot be avoided; such restrictions, if reasonable, can be ethical as long as they are properly disclosed. Researchers should also be vigilant about disclosing any alterations to such contracts. Because much valuable health services research is sponsored under contract or through organizational-financed research that entails restrictions or constraints on the nature of the research, it is important that such limitations be made explicit in the contract prospectively. This includes, for example, any ways in which sponsors Conducting Research There should be no fraud or fabrication in research, whether carried out for publication, legal proceedings, public advocacy, or another form of dissemination. Research and analysis should be conducted with a fair and objective assessment using, whenever possible, measures and methods that are widely accepted and could be reproduced by peers. The use of data sources, variables, coding, outcome measures, and methods of analysis should be recorded and made available in response to legitimate requests. Details that would enable independent researchers to reproduce and evaluate the research should be kept and made available for the purpose of confirmation and/or replication of reported results. The various disciplines involved in health services research, however, vary in the degree to which they expect detailed lab notes to be kept. 11

14 Reporting Research All data and research results should be available for reporting by the authors after a short time, preferably within two months but no longer than six months. Any restrictions on the researchers ability to publish any and all findings they feel worthy of submission should be specified in the contract. Contract or even verbal and/or implicit restrictions on the reporting of results should be disclosed to journals and other publication sources, with the expectations that such restrictions will be disclosed to readers, included in final reports whenever the data are reported, and made publicly accessible if the findings are not reported. Changes sought to be imposed by the sponsor in the reporting of the research findings or implications that threaten the integrity of the research, the research results, or the research report are unethical and unacceptable. Differences in opinion between sponsors and researchers in interpreting data and findings are not unusual; many differences are resolved in discussions of the relative merits of alternative conclusions. When differences of opinion remain, they are most effectively addressed by publicly presenting both sides. Differences should be disclosed to journals and other publication sources, which should endeavor to publicly provide coverage of both sides of the argument. More complicated disagreements over the quality of research and the interpretation of results between researchers and sponsors should be resolved through a peer review-like mechanism that draws upon people with the relevant expertise who might be named by each party. Researchers, analysts, and their funders should strive to make the reporting of methods transparent. Researchers should make the study databases, variables, computer programs, and related materials available to peers in order that others can replicate the study if desired. To the extent that there are legitimate limitations on this peer accessibility to databases and related material, such as confidentiality of patient records, researchers should attempt to create transparency through other vehicles. The purpose of peer accessibility, however, is to ensure the integrity and validity of research, not to facilitate the undertaking of new research where conflicts may exist among competing researchers for access to unique data sets. All reporting of research results should specify who sponsored and financed the research, the role including no role of the sponsor, any involvement of the sponsor in defining the study objectives, measures, endpoints, data sources, and other methodological considerations, and any restrictions imposed in these areas whether specified in the contract or done verbally. All journals and other publications should contain a table, note, or other mechanism that clearly and explicitly specifies this sponsorship information. When publishing research in journals or other publications, researchers cannot disclose relevant information unless the journals themselves have disclosure procedures in place. To this end, journals and other publications should work to implement policies that ensure appropriate and sufficient disclosure. Researchers and policy advocates should always be sensitive to and aware of the various roles in which they may be acting, or perceived to be acting, especially with respect to the distinction between research and advocacy. In reporting research results, it is unethical not to clearly and explicitly distinguish research from advocacy roles, and it is the responsibility of the researchers and policy analysts to properly specify the role in which they are acting. There cannot be any deliberate concealment or dissemblance of the limitations of the research and there must be explicit disclosures of: political, legal, or other interests; payments for research or advocacy work; or advocacy role as distinct from researcher role. 12

15 Analyzing a Potential Conflict of Interest In discussing conflicts of interest, it is important to specify what types of conflicts of interest are impermissible and what types may be permissible with proper management. There are some conflicts that are always impermissible and should be prohibited. For example, a conflict could arise when a sponsor makes it clear that an agreed upon endpoint not be used because it is potentially detrimental to the position of that sponsor. The contract language may preclude the sponsor from prohibiting the use of the endpoint, but if the sponsor pressures the researcher to voluntarily decide to change his or her mind, perhaps because of the fear of losing future work, such influence can be unethical and constitutes a serious conflict of interest. Similarly, if a sponsor insists on not being disclosed as the source of financial support or if the sponsor specifies certain data sources, outcome measures, or methods of analysis and refuses to include that specification in the contract and disclose it to the appropriate reporting sources, this would remove the work from the realm of research and it would be unethical for the researcher to lead others to believe that it was research. Other types of conflicts require careful discussion and may be permissible with appropriate management, such as disclosure and oversight. For example: A dispute arises over contract parameters. Disputes may arise for any number of reasons, the vast majority of which do not necessarily imply ethical problems. A sponsor threatens to withhold future funding unless project design is revised. However, the nature of health services research often makes difficult or inappropriate the a priori specification of a rigid study design and may require discretion in implementing a protocol. Thus, rigid adherence to an initial design when new data suggest a change is neither good science nor ethical. A researcher also serves in an advocacy role on the subject of his or her research. Constitutional rights to freedom of speech protect a wide variety of advocacy roles that are not necessarily in conflict with good, dispassionate research. Deciding just how to present one s activities in each realm, however, may require careful thought and negotiation. It is the responsibility of the researcher or advocate to ensure the reasonable observer is informed about the actual role of the presenter

16 Implementation and Enactment of the Guidelines AcademyHealth is a professional organization lacking formal enforcement authority. At best, it can use its suasion to identify ethical practices that act as moral standards for others. Nevertheless, AcademyHealth s guidelines can serve as a backdrop against which individuals and institutions can evaluate their own behavior and educate their trainees, as well as a resource when managing difficult ethical situations. The Committee believes that a set of ethical guidelines outlining accepted behavior will serve health services researchers well. To implement the spirit of this policy, AcademyHealth urges the following substantive changes. Organizations entering into grant and contract agreements for research and analysis with sponsors should require that the agreement contains explicit statements allowing researchers to be free to analyze the data, draw their own conclusions, and disseminate the results. The agreement should specify the outcome measures, data sources, methods of analysis, and mode/timing of the release of results required by the sponsor and agreed to by the researcher; if not specified, these items must be at the sole discretion of the researcher. Contracts should also specify that all restrictive requirements necessitated by the sponsor may be publicly disclosed by the researcher. In addition, contracts should contain information regarding the amount of time that the sponsor has for review of the results prior to reporting; this time is preferably two months, but should not exceed six months, except in extraordinary circumstances. Journals that publish health services research should adopt policies that require disclosure of sponsors involvement in the research, especially in identifying the objectives, measures, data sources, methods of analysis, and interpretation. These disclosures should accompany the reporting of the research results. AcademyHealth and other supporters of research should increase awareness of these guidelines in the field and among research sponsors, taking whatever actions are feasible collectively to encourage research sponsors to employ practices consistent with these guidelines. Researchers and policy analysts should adhere to these guidelines in the conducting of their research and whenever they are engaged in advocacy. They should clearly and consistently distinguish their researcher and advocacy roles when they might be confused by observers, disclose the sponsorship of their work, any personnel payments for research and advocacy work their have received, and any political, legal, or other interests in their research. Institutions that train or sponsor training of health services researchers should include instruction in conflict of interest and these guidelines as part of that training. 14

17 Appendix A AcademyHealth Ethical Guidelines Committee Robert A. Berenson, M.D. Senior Fellow The Urban Institute 2100 M Street, NW Washington, DC (tel) (fax) rberenson@ui.urban.org M. Gregg Bloche, M.D., J.D. Professor of Law Georgetown University Law Center 600 Jersey Avenue, NW Washington, DC (tel) (fax) bloche@law.georgetown.edu Norman Daniels, Ph.D. Professor of Ethics and Population Health Dept. of Population and International Health Harvard School of Public Health 665 Huntington Avenue Building 1, Room 1104C Boston, MA (tel) (fax) ndaniels@hsph.harvard.edu Ezekiel J. Emanuel, M.D., Ph.D. Director, Dept. of Clinical Bioethics National Institutes of Health Warren G. Magnuson Clinical Center Building 10, Room 1C118 Bethesda, MD (tel) (fax) eemanuel@nih.gov Marsha R. Gold, Sc.D. Senior Fellow Department of Research Mathematica Policy Research, Inc. 600 Maryland Avenue, SW Suite 550 Washington, DC (tel) (fax) mgold@mathematica-mpr.com W. David Helms, Ph.D. President and CEO AcademyHealth 1801 K Street, NW Suite 701-L Washington, DC (tel) (fax) david.helms@academyhealth.org Harold S. Luft, Ph.D. Caldwell B. Esselstyn Professor of Health Policy & Economics Director, Institute for Health Policy Studies University of California, San Francisco 3333 California Street, Suite 265 San Francisco, CA (tel) (fax) hluft@itsa.ucsf.edu Nicole Lurie, M.D. Senior Scientist and Paul O Neill Alcoa Professor RAND Corporation 1200 South Hayes Street Arlington, VA x 5127 (tel) (fax) lurie@rand.org William D. Marder, Ph.D. Senior Vice President and General Manager Medstat 125 Cambridge Park Drive Cambridge, MA (tel) (fax) bill.marder@thomson.com David Mechanic, Ph.D. Director Institute for Health Care Policy Rutgers University 30 College Avenue New Brunswick, NJ (tel) (fax) mechanic@rci.rutgers.edu 15

18 Deborah Prothrow-Stith, M.D. Associate Dean for Faculty Development Director, Division of Public Health Practice Harvard School of Public Health 1552 Tremont Street Boston, MA (tel) (fax) Elliot M. Stone Executive Director & CEO Massachusetts Health Data Consortium, Inc. 460 Totten Pond Road, Suite 385 Waltham, MA (tel) (fax) Dennis F. Thompson, Ph.D. Alfred North Whitehead Professor of Political Philosophy Director, The Center for Ethics and the Professions Harvard University 79 John F. Kennedy Street Taubman Building Cambridge, MA (tel) (fax) AcademyHealth Staff Anne K. Gauthier Vice President AcademyHealth 1801 K Street, NW Suite 701-L Washington, DC (tel) (fax) anne.gauthier@academyhealth.org Bonnie J. Austin, J.D. Senior Manager AcademyHealth 1801 K Street, NW Suite 701-L Washington, DC (tel) (fax) bonnie.austin@academyhealth.org Research Fellows Lindsay A. Hampson Department of Clinical Bioethics National Institutes of Health 10 Center Drive, MSC 1156 Bethesda, MD (tel) (fax) lhampson@cc.nih.gov Naomi K. Seiler, J.D. Greenwall Fellow in Bioethics and Health Policy Johns Hopkins School of Public Health 1865 California Street, NW, #4 Washington, DC (tel) naomi_seiler@post.harvard.edu 16

19 Appendix B Committee Actions Background In 2002, AcademyHealth s Board of Directors approved the formation of an advisory committee to assess how we might assist our members as they confront ethical issues in the conducting of health services research and health policy analysis. The Ethical Guidelines Committee s charge was to explore/affirm the need for AcademyHealth to develop a set of ethical guidelines, make recommendations on the scope of such guidelines, and prepare a draft report for the full Board approval and broad dissemination. November 2002: The Committee agreed on the scope of the project financial and non-financial conflicts of interest, rather than a broader range of ethical issues. They identified dimensions that influence potential conflicts of interest and discussed examples of conflicts of interest that could be used to help inform the guidelines. February 2003: The Committee refined the sources and character of conflict in health services research, which are influenced by types of research organizations, types of research sponsors, types of research financing, and types of dissemination strategies. May 2003: The Committee reviewed an outline of the report and refined the guiding values and examples of conflicts. June 2003: Members of the Committee conducted a special session at AcademyHealth s Annual Research Meeting. They sought input from the membership on how best to respond to specific ethical dilemmas and examples of real-world cases that individuals or institutions have confronted. Committee Members made presentations at AcademyHealth s Center Directors Meeting and Meeting of AcademyHealth Members on progress to date. July 2003: A call for information was sent out to AcademyHealth s Center Directors for insights into the ethical dilemmas that they face or about which they may be aware. September 2003: Drawing on suggestions by Committee members and insights from AcademyHealth s members, Chairman Zeke Emanuel prepared an initial draft report. The report was distributed to Committee members for critical review. October 2003: The Committee reviewed the draft report, with emphasis on a list of ethical guidelines. November 2003: The report drafting and review process continued among Committee members. December 2003: Chairman Zeke Emanuel presented the draft report to AcademyHealth s Board of Directors for its review. Winter 2003: Board members offered substantive comments on the draft report for consideration by the Committee. April 2004: Draft report was distributed to AcademyHealth members for comment. The Committee reviewed comments and provided final edits on the draft report. June 2004: At a June 7 meeting of AcademyHealth members during the Annual Research Meeting in San Diego, a summary of comments to date was provided and additional comments invited. A final report was presented to the Board for its approval at its June 8 meeting. In addition to the Board s review and approval of the final report, they provided guidance on a dissemination strategy for the ethical guidelines. 17

20 Appendix C Conflict of Interest Resources Federal NIH Guide Objectivity in Research Miscellaneous CoI Information from the NIH Office of Extramural Research Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy NIH Site Visit Mock Interview Questions NIHSITEVISITMOCKINTERVQUESTIONS.doc NIH Guide Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards, June 5, NSF COI Policy FDA Guidance: Financial Disclosure by Clinical Investigators (March 20, 2001) GAO Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest (November 2001) Department of Veterans Affairs Conflict of Interest in Research Handbook OHRP Draft Interim Guidance Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing with Issues of Financial Interests and Human Subject Protection Associations/Societies AAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research AAMC Task Force on Financial Conflicts of Interest in Clinical Research Individual and Institutional Guidance Washington Fax Article: AAMC conflict of interest proposal puts rebuttal burden on financially interested researchers (12/20/01) a.html Association of American Universities Conflict of Interest Resources International Society for Pharmacoeconomics and Outcomes Research Code of Ethics for Researchers TFCodeEthics.pdf American Society of Clinical Oncology Oversight of Research and Conflict of Interest Policies American Anthropological Association Ethics American Political Science Association A Guide to Professional Ethics in Political Science American Sociological Association Code of Ethics Ethical issues in CME, Clinical Research From the May 2001 ACP-ASIM Observer, ethicalprobs.htm Medical Professionalism Project