Abbreviations: AIDS, CDC, DNA

Address for correspondence: Steven S. Coughlin, Ph.D., Epidemiology and Health Services Research Branch, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, 4770 Buford Highway, NE (K-55), Atlanta, GA 30341. E-mail sic9@cdc.gov

Running head: Ethics and Values in Epidemiology

Important advances have occurred in ethics and epidemiology in the closing decades of the twentieth century (1, 2). These advances include explications of the societal importance of epidemiologic research and practice, clarifications of the ethical duties of epidemiologists, and the increasing integration of ethics into the professional life of epidemiologists (3-12). These developments in ethics are not isolated events. Rather, they have occurred in conjunction with historical events--improvements in institutional and regulatory safeguards for protecting human subjects, rising public concern over the privacy and confidentiality of medical records, the onset of the acquired immunodeficiency syndrome (AIDS) epidemic, and the emergence of molecular epidemiology, to name a few.

One sign of the increased attention to ethics and values in epidemiology in recent years is the development of ethics guidelines for epidemiologists and policy statements on data sharing, privacy and confidentiality protection, deoxyribonucleic acid (DNA) testing for disease susceptibility, and other issues (6-10, 13-15). Courses on ethics in epidemiology and public health have also been initiated at several institutions that train public health professionals (16-19). In addition, the number of publications on ethical issues in epidemiology have increased (20-23). Indeed, all these developments have likely contributed to the increasing recognition of epidemiology as a distinct profession (2, 12).

The focus of these developments (ethics guidelines, curricula, and publications) has often been on identifying and communicating ethical rules and duties and on controversial or still-evolving ethical precepts (for example, the extent to which epidemiologists should engage in public health advocacy) (24-26). Ethical problems, such as conflicts of interest and scientific misconduct, have also been dealt with (27-33). Less attention has been given to core values in epidemiology, even though an examination of core values may help clarify ethical precepts in epidemiology while highlighting positive aspects of professional ethics.

To identify and clarify basic scientific values in the field, I examine core values in epidemiology and public health as reflected in mission statements for public health institutions, preambles to ethics guidelines for epidemiologists, and results obtained from ethics surveys. Professional values are discussed in relation to an important controversy in contemporary epidemiology: whether epidemiology has failed to sustain its commitment to public health. Finally, I discuss future directions of ethics and values in epidemiology.

Core Values in Epidemiology

Core values are fundamental ethical and scientific precepts (i.e., basic scientific values) that are consistent with and provide support for the mission and purpose of the profession. In the case of epidemiology, the mission is to acquire new scientific information that can be used to maintain, enhance, and promote the public's health (9, 34-36). Widely held and accepted core values exist within the profession of epidemiology. Nevertheless, individual epidemiologists may hold different opinions about core values and the values in the profession may gradually change or evolve over time (36). Core values in epidemiology are closely related to core values in the broader field of public health. As Barry Levy explained in his American Public Health Association presidential address in November 1997, "Values define us as a group of public health professionals; values drew many of us into public health in the first place" (37).

Published accounts suggest that, like other scientists, epidemiologists accept ideals of free inquiry and the pursuit of knowledge and that they uphold values of improving the public's health by applying scientific knowledge (5, 22). The way in which these core values guide epidemiologic research and practice is shaped by societal values and by the personal values of individual epidemiologists. As Susser and colleagues noted, an examination of ethics in epidemiology is an examination of the way in which the values of science and its potential benefits to public health are balanced against the values of individuals and communities (5). Other values within the profession that may be less fundamental but nevertheless important (for example, the value of establishing partnerships between academic and public health practice institutions) and epidemiologic duties and virtues (for example, the obligation that epidemiologists have to respect the autonomy of persons) further shape the influence of core values.

Core values can be distinguished from duties and ethical rules, which are more specific and tied to specific contexts (for example, the rule that research protocols involving human subjects should be submitted for ethical review by an institutional review board) (11, 38). Duties are those obligations epidemiologists hold to various parties, such as subjects, society, funding sources, employers, and colleagues (7, 11). Core values can also be distinguished from epidemiologic virtues that are often aspirational and grounded in professional character (for example, truth-telling, objectivity, and scientific excellence) (11, 39). Whereas epidemiologic values are not based in any particular moral theory, virtues are an important aspect of virtue ethics, a moral theory that emphasizes the character and moral motivation of the agent (person) rather than the actions taken by the person (39, 40).

Our understanding of core values and specific ethical rules and duties in epidemiology is shaped by contemporary discussions about ethical issues arising in biomedical research, such as issues arising in genetics research, how best to protect participants in placebo-controlled trials, and guidelines for conducting studies in developing countries (15, 41-43).

Epidemiologic values reflected in mission statements

Core values and other values in the profession are reflected in mission statements that have been drafted by an increasing number of epidemiology professional societies. For example, the mission statement of the American College of Epidemiology states that it is a professional organization that serves the interests of its members (i.e., epidemiologists) through sponsorship of scientific meetings, publications, and educational activities; it recognizes outstanding contributions to the field and advocates for issues pertinent to epidemiology (44). Thus, the college highlights the value of disseminating and sharing scientific information, providing continuing professional education, promoting scientific excellence, and advancing the profession. The mission statement of the International Society for Environmental Epidemiology states that the society provides a forum for discussing problems unique to the study of health and the environment. With membership open to environmental epidemiologists and other scientists worldwide, the society provides a variety of forums for discussions, critical reviews, collaborations, and education on issues of environmental exposures and their human health effects (45). These activities include annual meetings; newsletters; workshops; and liaisons with academic, governmental, inter-governmental, non-profit, and business institutions. Thus, in addition to the dissemination of scientific information and continuing professional education, the society upholds the value of international and interdisciplinary scientific collaboration and links with stakeholders outside the profession.

Epidemiology values are also reflected in statements drafted for public health institutions. For example, the U.S. Centers for Disease Control and Prevention (CDC) statement of core values emphasizes the need for CDC employees to act decisively and compassionately in service to people’s health and to ensure that CDC research and services are based on sound science and meet genuine public needs (46). Respect for persons, cultural diversity, honesty, scientific integrity, and professional excellence are also emphasized in the statement. The CDC has employees from many disciplines, including epidemiology, the basic sciences, and other public health professions. The National Institutes of Health, a federal biomedical research institution in the United States, also has a multidisciplinary workforce. Its mission statement emphasizes science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability (47). The goals include creative discoveries and innovative research strategies; their application to protect and improve health; and scientific integrity, public accountability, and social responsibility in the conduct of science.

Many schools of public health (which include epidemiology training programs) have developed mission statements. The goals of the University of Texas at Houston School of Public Health, for example, emphasize education, research, community service, and the importance of public health values (table 1) (48). Public health practice, public health research, and service to local, state, national, and international agencies and communities are highlighted in the mission statement as well.

A number of sets of ethics guidelines for epidemiologists have been proposed (6-9). Guidelines drafted by the International Epidemiological Association include a preamble defining the purpose of epidemiology; a statement of core values in epidemiology; a summary of basic principles of biomedical ethics; and various sections outlining the obligations of epidemiologists to individuals, communities, colleagues, employers and funding agencies, and the profession (6). The guidelines state that "We who practice epidemiology are concerned with the health of all population groups. Our role is to identify interventions likely to restore, maintain and improve health... As public health professionals, we have an obligation to communities..." (6). Other values are implicit in the discussion of professional obligations of epidemiologists. For example, the association’s draft guidelines indicate that epidemiology is primarily concerned with providing service to communities and that epidemiologists are frequently drawn to the problems of disempowered communities. Cultural variations in values are also discussed in the guidelines.

Ethics guidelines proposed by the Industrial Epidemiology Forum provide an account of the obligations of epidemiologists to research subjects, society, employers and funding agencies, and colleagues (7). Although the guidelines are written in the form of professional obligations or duties, they do provide some information about core values in the field. For example, the accompanying commentary states that "The principles in these guidelines presume that there is no absolute right to scientific investigation even if scientific knowledge stands to be advanced appreciably. The advancement of knowledge is a worthy pursuit, but it is not so valuable as to provide a sufficient justification in all cases for overriding competing values such as privacy, confidentiality, and protection against risk" (7). Thus, the guidelines highlight the value that epidemiologists and society place on general ethical principles (e.g., avoiding harm, providing benefits, balancing benefits against risks, respecting personal autonomy, and protecting privacy and confidentiality).

The Council for International Organizations for Medical Sciences International Guidelines for Ethical Review of Epidemiological Studies address similar issues (8). They draw a distinction between epidemiologic research and routine practice and consider the problems associated with obtaining informed consent and respecting cultural differences in ethics and values in some epidemiologic studies. The guidelines note that "Ethical issues often arise as a result of conflict among competing sets of values, such as in the field of public health, the conflict between the rights of individuals, and the needs of communities" (8).

Ethics guidelines for environmental epidemiologists drafted by Soskolne and Light summarize the mission and core values of environmental epidemiology. They note that the mission of environmental epidemiology is to maintain, enhance, and promote health in communities worldwide by identifying or evaluating environmental hazards (9). Soskolne and Light also note that environmental epidemiologists contribute to scientific knowledge about environmental risks and environmentally induced diseases and that they protect public health at the local, regional, national, and global levels.

The Italian Epidemiological Association and the American College of Epidemiology are refining and updating ethics guidelines for epidemiologists. These documents are likely to further contribute to our understanding of ethics and values in epidemiology (17, 49).

Ethics guidelines for epidemiologists can be considered within the broader context of regional and international guidelines for biomedical researchers, which have also been periodically revised and updated (50, 51).

Epidemiologic values reflected in results from ethics surveys

Ethics surveys have provided information about the ethical interests and concerns of epidemiologists and about core values in the field. Surveys to date have targeted epidemiologists and other public health professionals, public health students, and institutions that train public health professionals (19, 52-55).

Soskolne and colleagues conducted an international ethics survey in 1994 among environmental epidemiologists (52). The participants were reached through mailings from the International Society for Environmental Epidemiology, the Italian Epidemiological Association, and the Global Environmental Epidemiology Network (managed by the Office of Global and Integrated Environmental Health of the World Health Organization, Geneva). The response rate was about 30 percent for the International Society for Environmental Epidemiology and the Italian Epidemiological Association and 19 percent for the Global Environmental Epidemiology Network. A total of 346 returned questionnaires were available for analysis. The survey focused on statements of ethical values and principles which were grouped into nine major areas. The greatest disagreement concerned the role of the environmental epidemiologist as a "dispassionate scientist" or a "passionate advocate"; other disagreement revolved around whether environmental epidemiology is an applied science or a basic science and whether environmental epidemiologists should be committed to influencing society in ways that maximize the likelihood of "health for all". Thus, the results suggest that different opinions among environmental epidemiologists exist about certain ethical precepts and professional obligations. The differences may reflect a lack of consensus about the mission of environmental epidemiology and core values in the field or, alternatively, a measurement problem (e.g., ambiguity in the wording of the questionnaire).

To obtain input from practicing epidemiologists on ethics guidelines, the American College of Epidemiology's Ethics and Standards of Practice Committee developed a questionnaire (53). The survey was conducted among a random sample of 300 North American members of the American College of Epidemiology, the Society for Epidemiologic Research, and the American Heart Association Council on Epidemiology and Prevention. The response rate was 88 percent (265 respondents). The majority of respondents agreed that any new ethics guidelines should address the goals and purposes of epidemiologic research which (according to questionnaire items for which there was good agreement) include "providing a rational basis for improving public health," "increasing scientific knowledge," and "establishing, guiding, changing public policy." There was less agreement among the respondents about the need for guidelines to address the "use of study results to advocate change in values or customs."

Professional Values and Epidemiology's Commitment to Public Health

The 1988 report The Future of Public Health by the Institute of Medicine observed that "public health professionals rely on expert knowledge derived from such areas as epidemiology and biostatistics to identify and deal with the health needs of whole populations. A central tenet of their professional ethic is commitment to use this knowledge to fulfill the public interest in reducing human suffering and enhancing the quality of life" (56). The report also noted that knowledge and values remain decisive elements in the shaping of public health practice. Similar sentiments were expressed by Krieger and Zierler who, as epidemiologists, share a vision of reducing human suffering by generating beneficial knowledge (57).

In the past decade, there has been extensive debate about whether epidemiology has lost its commitment to public health (58-62). Terris argued that as a result of a shift of epidemiologic research from health departments to schools of public health, epidemiology has withdrawn from the community (for example, fewer field studies and more secondary analyses of existing data) and concern with the methodology of data manipulation--rather than with the solution of disease problems--has grown (59). He noted "an orientation geared more to the goal of ‘publish or perish’ than to the goal of preventing disease and death" (59).

Some leading epidemiologists have criticized epidemiology subspecialties, such as clinical epidemiology and molecular epidemiology, because of a perceived lack of a population perspective and public health orientation. For example, Last argued against the uncritical enthusiasm with which clinical epidemiology has been embraced by many medical schools (63). He was concerned about a particular definition of epidemiology: the use of clinical experience to inform and guide decisions about the care of individual patients. Last argued that "such a narrow view of epidemiology would sadden the founders of the Epidemiological Society of London, most of whom were public health workers and saw epidemiology as a discipline that existed primarily to protect and promote the public health" (63). Of course, many clinical epidemiologists and epidemiologists in other subspecialties may uphold public health values (36).

Susser and Susser called for a return to public health values and for a paradigm shift from the current emphasis on individual risk factors for disease to a new ecological approach ("eco-epidemiology") that encompasses many levels of organization, including molecular, individual, and societal (61, 62). Gori observed that the two approaches (eco-epidemiology and the present paradigm, which emphasizes individual risk factors for disease) are complementary rather than opposed (64). In a commentary about "black box epidemiology," Weed argued that epidemiologists need a common set of values and that they lack consensus about their obligation to public health (65). He concluded that epidemiologists should embrace a systems theory approach.

Although epidemiologists remain divided about the need for a new scientific paradigm in their field, the debate has drawn attention to the need for a sustained epidemiologic commitment to public health. To some commentators, present efforts in epidemiology to address public health problems are insufficient. Echoing concerns by others (57-62), Pearce and McKinlay recently argued that epidemiologists should pay more attention to the real determinants of health at the upstream population level (including socioeconomic, cultural, and political factors), address the most important public health questions, and use appropriate methods to address these questions (66). Such scientific arguments are founded in social concerns and in core values in epidemiology and public health.

Ethics, Values, and Future Directions in Epidemiology

One future direction in epidemiology is likely to be the further development of curricula on public health ethics for epidemiology graduate students, including coursework on the ethics of epidemiologic research and practice (16-19, 55, 67). The Council on Education for Public Health criteria for graduate schools of public health in the United States emphasize public health values, concepts, and ethics, but do not currently require ethics instruction. Courses on public health ethics provide students with the conceptual abilities and decision-making skills they need to deal successfully with ethical issues in their own research and practice (18). The cognitive aspects of ethics that can be taught include the identification of the ethical commitments of epidemiologic research and practice, the application of concepts and methods for ethical decision-making to actual cases, and critical reflection about personal values and obligations as a public health professional (18, 39). Small group discussion of ethics cases, including important historical cases such as the Tuskegee Syphilis Study, is an important part of such coursework (54). Core values in epidemiology and public health are often transmitted informally through informal teaching and mentoring of students and fellows. Schools of public health and academic departments of epidemiology can be seen as communities with their own culture and subculture; students and fellows are taught what is valued in that culture and are provided opportunities to internalize the core values (68).

Future directions in epidemiology are also likely to include the development of mission statements, statements of core values, and ethics guidelines for epidemiology specialties, such as molecular epidemiology, reproductive and perinatal epidemiology, and public health practice (2). Such efforts contribute to the further recognition of epidemiology subspecialties as distinct subdisciplines while reinforcing their commitment to public health. Mission statements and statements of core values may also contribute to efforts to educate the public and stakeholders about the societal importance of epidemiology.

Another possible direction is the further incorporation of epidemiologic perspectives into policy statements and regulations that deal with the protection of human subjects, the privacy and confidentiality of medical records, and genetic testing (14, 15). For example, distinctions have not always been drawn between highly penetrant disease susceptibility genes and more common genetic polymorphisms in developing ethical rules for genetic testing carried out as part of research protocols (69).

Substantial attention has been given to issues surrounding the privacy and confidentiality of medical records, data sharing, and linkage of large databases for the purposes of health research (13, 14, 70). In view of recent legal and regulatory developments in these areas, and technological refinements such as increased use of health information systems and of the Internet (71, 72), epidemiologists are likely to continue to face professional challenges related to these important topics for the foreseeable future.

Finally, more attention will likely be given to ethics and values in public health practice and to ways to resolve conflicts between professional values and community values (73-75). The ethics of public health practice have often been neglected in the literature on ethics and epidemiology compared with issues that arise in epidemiologic research, but recent articles and presentations at scientific meetings suggest that increasing attention is being devoted to these important issues.

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Table 1. University of Texas at Houston School of Public Health Mission and Goals1

The mission of the school is to improve and sustain the health of people by providing the highest quality graduate education, research, and community service for Texas, the nation, and internationally.

The school provides the citizens of Texas the opportunity for quality graduate education in the basic disciplines and practices of public health, extends knowledge of these disciplines, and assists public health practitioners. The mission emphasizes:

Education - The school’s first responsibility is to provide present and future practitioners, teachers, and scientists the highest quality graduate education in the theory and practice of public health. Its educational philosophy is based on the premise that education is a lifelong process and that, while the school offers resources and guidance, the fundamental responsibility for each person’s education resides with the individual, with guidance and support of the faculty. The school teaches public health values and a diversity of skills in the physical, biological, behavioral, and analytic sciences needed by public health practitioners today. The school is committed to maintaining a broad perspective of health, disease, and the health care system.

Research - The school is committed to the pursuit of knowledge which enhances both the theory and practice of public health. Faculty support and engage in research directed toward such activities as health promotion, environmental health, disease control, and health care delivery.

Community Service - The faculty seek to provide service to local, state, national and international health agencies that is consistent with the school’s instructional and research commitments. The school develops public policy, contributes to the activities of these agencies, and enhances the well-being of the public.

1UT-Houston School of Public Health statement of mission