Ethical Problems in Research and Practice of Environmental Epidemiology

Eubios Journal of Asian and International Bioethics 6 (1996), 128-130.

This is a resume of a Special Issue of Science and the Total Environment , edited by Colin L. Soskolne and Roberto Bertollini on "Ethical and Philosophical Issues in Environmental Epidemiology" Volume 184,1-147, 17 May 1996, Published on behalf of the World Health Organization, Regional Office for Europe. The Special Issue constitutes the proceedings of a Workshop held 16-18 September, 1994 at Research Triangle Park, N.C., USA in conjunction with the meeting of the International Society for Environmental Epidemiology. The resume was prepared by John R. Goldsmith, Colin L. Soskolne, and Roberto Bertollini who take full responsibility for its representativeness. Comments to John Goldsmith, M.D., Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, ISRAEL.

The workshop on "Ethical and Philosophical Issues in Environmental Epidemiology" provided an exceptional opportunity to listen to a broad range of environmental health scientists identify and grapple with a selection of problems they considered to reflect on ethical issues of current concern. The organizers of the Workshop, Prof. Colin L. Soskolne, of the University of Alberta, Edmonton, Canada and Dr. Roberto Bertollini of the World Health Organization's European Center for Environment and Health in Rome had broad objectives for the Workshop and sought thoughtful guidance for those professionals engaged in research and practice of environmental epidemiology. They have brought together the presentations of many of the participants in published form, facilitating a broader review of the workshop experience, and enabling further examination of the questions the participants brought to one another.

This precis of some of these questions is not intended to substitute for the published proceedings and the rich sources of reference materials cited therein, but rather to illustrate the types of questions being asked and the patterns used for obtaining answers. The latter was facilitated by including several moral philosophers in the workshop, whose sound advice and broad experience helped those more familiar with scientific issues to focus on new approaches to understanding ethical discourse associated with environmental health concerns.

An excellent background document was presented at the outset of the Workshop (pp. 5-11). This was a survey concerning environmental epidemiology among three groups, members of the International Society for Environmental Epidemiology, (55 respondents out of 184), the Italian Epidemiology Association (35 responses out of 120), and the WHO Global Epidemiology Network (253 responses out of 1340). Nearly 1/3 of the 346 respondents provided a case-study, 37% of which involved standards of practice and 15% dealt with problems of confidentiality/disclosure.

Case studies were based on nine topics: 1. Scientific Misconduct; 2. Standards of Practice; 3. Publishing Issues; 4. Financial conflicts; 5. Confidentiality/disclosure issues; 6. Compromise of personal or scientific values; 7. Conflicts of Interest; 8. Personal or cultural value conflicts; 9. Interpersonal or intercollegial conflicts

A source of constructive tension during the workshop was the differences of opinion as to the need and usefulness of " Ethics Guidelines for Environmental Epidemiology." A majority seemed to favor such guidelines. Mark Frankel, American Association for the Advancement of Science, Washington, D.C. (pp. 13-16) felt that such guidelines could be an "essential part of building a professional community with shared values". He felt that a central task was the articulation of the profession's core values which define the goals and virtues of professional practice.

Craig Summers, Department of Psychology, Laurentian University, Sudbury, Ontario, (pp. 17-23) emphasized the importance of psychological factors affecting risk perception and ethical decision-making. He noted the difficulty of measurement using questionnaires on matters of value and ethics. He characterized the development and implementation of guidelines as a political process, and referred to the literature on evaluation of such guidelines in various professional groups. He writes that "In order for codes to be effective, therefore, it would seem that more than the existence of guidelines is necessary. Implementation needs to be assured and consistently administered."

Robert James, Univ. of Manitoba (pp. 25-32) discussed data protection issues as they are involved in epidemiological research. This discussion was given urgency by the pending adoption by the European Community of rigid restrictions on data access which were generally agreed to be unnecessarily harmful for the future of epidemiological research. The workshop authorized formal communication on this issue. It was suggested that a meeting of experienced epidemiologists and those concerned with general privacy of data files would be useful.

A specific and authorized Act on Cancer Registration in Germany was discussed by Barbel Bellach and Dieter Schon from the Robert Koch Institute , Berlin (pp. 33-36). This act was felt needed to overcome the inconsistent registration and disclosure practices by the several German Lander.

Phillipe Grandjean and Marja Sorso from Odense University, Denmark and the Finnish Institute of Occupational Health presented he problems of genetic predisposition to environmentally related disease (pp. 37-43). They note that the most important tensions relate to autonomy, and the right to privacy, fairness and equality, which often can be seen to oppose paternalistic approaches to public interest. Scientists are warned that open discussion is often needed and should involve non-scientific inputs. Honest presentation of scientific uncertainties is essential to constructive resolution of these tensions.

Nicholas Ashford, Massachusetts Institute of Technology reported (pp. 45-49) on the legal and ethical considerations of worker and community monitoring in the USA. Genetic monitoring is one of the most prominent sources of tension. Ashford identifies three classes of conflicts: (1) those arising from differences in legitimate interests of the various actors/institutions (2) conflicts in moral and legal duties of each actor/institution, and (3) conflicts among actors/institutions arising from different perceptions of what is right or wrong, fair or unfair. In the workplace, for example, the worker would rather be safe and keep his or her job, while the employer wants to limit his/her legal and economic liability. Ashford lays down some wise guidelines for tension reduction in monitoring activities in the workplace and the community.

Holmes Rolston, the Department of Philosophy, Colorado State University, (pp. 51-56) pointed out that human health and the health of natural systems have entwined destinies. In light of this and the undercurrent of advocacy in mission-oriented medical and public health research, he urges the greater involvement of ecological sciences, and puts forward the view that "Sustained Development" derived as it is on commodity based managed systems, is too narrow a goal. He proposes priority for sustainability of natural ecosystems.

Laura Westra, Department of Philosophy, University of Windsor, Ontario, Canada, (pp. 57-66) also notes the close relationship of protection of ecosystem integrity and wilderness and protection of human health. Focusing on climate change and global warming, food production and global equity , she emphasizes the principle of integrity as a source for strengthening current regulations , focused now mostly on human health. Two cases were cited, wells near Woburn, Mass. and the development of a waste-transfer facility near Titusville Alabama, a black community. The latter was cited as an example of environmental racism.

Steven Coughlin of Tulane University School of Public Health and Tropical Medicine, (pp. 67-76) speaks to the development of the environmental justice movement in the US as an analogy of the civil rights movement. He starts with a citation of the location of landfills and incinerators in predominantly black portions of Houston, Texas, and goes on to cite a number of administrative and public issues. He urges greater involvement of environmental epidemiologists in the movement. The international nature of the movement is noted as multinational firms tend to transfer the most objectionable operations to countries with lower standards for regulation.

Vladimir Bencko, from the Institute of Hygiene, Prague, Czech Republic (pp. 77-81) characterizes the monolithic practices of informed consent based on the Soviet model of health care services, which prevailed in most of Central and Eastern Europe. Decades of pragmatism encouraged the atrophy of the capacity to identify and act effectively in problem areas. Now that conformity is no longer to be assumed, the task of the ethical epidemiologist is more complex. In response an institute of medical ethics was established at Charles University, and a textbook prepared. Sharing of experience from other countries and especially those undergoing changes can also play a constructive role.

John Goldsmith (Ben Gurion University of the Negev) Beer Sheva, Israel) (pp. 83-89) analyzed the experience of US embassy employees in Eastern Europe, during the cold war, who were exposed to microwave radiation by the Soviets. At first workers were not informed, but abnormalities in blood counts and white cell mutations were found, but not followed up. A large scale epidemiological study was undertaken, but critical information was withheld from the investigators and the contract officer had the investigators play down their concerns and interpretations. Legal action led to the documentation of these cover-up activities under the Freedom of Information Act.

Benedeto Terracini, University of Turin, Italy reviewed (pp. 91-95) ethical aspects for the identification of cancer hazards. While epidemiological findings have been responsible for the identification of most known human environmental carcinogens, an even greater number of agents are "reasonably anticipated to be carcinogenic", usually on he basis of animal experimentation. Expert committees are often used to provide guidance to governmental and intergovernmental agencies on environmental cancer risks. Such committees have the problem of choosing what evidence to consider, preparation of summary reports and the ultimate assignment of the risk associated with exposure to the material. The process of evaluation can either err in the direction of excess caution or can allow potential risk to continue while additional evidence is accumulated. Terracinni recommends the creation of ad hoc groups under the auspices of ISEE and WHO to survey ethical behavior or subjectivity of participants carcinogen risk assessment, possibly based on a survey by the Society for Risk Analysis.

Caterina Botti, Pietro Combaa, Francesco Forastiere, and Laura Settimi , European University Institute, Florence, Instituto Superiore di Santa, Rome and Epidemiological Unit, Latium Regional Health Authority, Rome, Italy, (pp. 97-101) raise the matter of subjective judgment in production and evaluation of epidemiological studies. They use two case studies, one of carcinogenic risk of exposure to non-arsenic pesticides and the second of urban air pollution mortality and asthma. The first case-study is based on data used by the International Agency for Research on Cancer, including 34 epidemiological studies in four countries. Sometimes only the exposure was specified; at other times not.

The review (IARC monograph No.53) finds the epidemiological evidence inconclusive, but strong enough to suggest caution. The conclusion was "limited evidence of carcinogenicity". However taking also into account, adverse reproductive outcomes and cytogenetic damage, the conclusion was "Probably carcinogenic to humans". The dispute over the decision is described. In the second case-study, the authors note the general agreement that sudden elevations in levels of air pollution had led to increased mortality, but that recent studies appear to find that commonly occurring levels of particulate pollution are associated with small increases in daily mortality, increases in hospital admissions, exacerbation of asthma and other chronic pulmonary conditions as well as lung function decrements. The arguments about what action is justified are cited. The authors conclude that the lack of a reasonable biological mechanism for these effects is the real problem. Toxicological studies have shown (1) no evidence for pathological effects at such levels of exposure, (2) the assumption that pollutant exposures precipitate deaths in terminally ill patients has no support from clinical studies, and (3) the specific constituents of particulate matter which might be responsible are not known. In a balanced discussion of these two cases, the authors conclude that the conflicts are not between two scientific positions, but are conflicts based on differences in judgment.

Dale Jamison from the Center for Values and Social Policy in Boulder Colorado, (pp. 103-107) asks when to communicate research findings to the public in the face of scientific uncertainty. He recognizes that many want a rule such as "Communicate research findings if and only if condition C obtains". Condition C is thought to reflect some function of the probability of harm, the seriousness of the harm , the reliability of the data concerning harm, and the potential for its remediation. He argues that no such rule is possible. First it is necessary to distinguish uncertainty from ignorance or indeterminism. Uncertainty is said to be a social construct based on context, rhetorical role, assumption of purposes, and the acceptance of knowledge claims. Appreciating how the uncertainties have been constructed is the first step in deciding to communicate research findings. Only then can ethical issues become relevant to such communications.

Daniel Wartenburg of the Robert Wood Johnson Medical School, Piscataway, New Jersey gives (pp. 109-112) two examples of community environmental health problems. The first one concerns ground water pollution with a toxic pesticide in a rural area. The local government with Federal assistance undertook a limited well-sampling program. Tension developed on the question of to whom the results of the sampling could be released. Seven years previously an agricultural extension agent had noted the potential risk and asked for information provided to the Federal Government when the material was registered. His request was refused. But the manufacturer, Union Carbide had made an published erroneous predictions of the persistence and distribution of the material. A combination of corporate aggression and timid local government blocked an adequate evaluation and, consequently, similar problems arose in many other states. The second issue is of how to respond constructively to the occurrence of a disease cluster. He concludes that more effort is needed to educate the public as to the limitation of science, but notes the common interest of scientists and the public for open information.

Earle R. Winkler of the Philosophy Department, University of British Columbia, reviewed the history of bioethics and the relevance of what is called the Georgetown paradigm.(pp. 113-120) This includes the three principles of autonomy, beneficence (including non-maleficence) and justice as the core values in bioethics. Winkler notes first that the principles derive largely from medical practice. He also notes that moral theories are usually oriented to two functions, one intellectual (systematic understanding of the moral domain), and one practical (guidance of moral practice by grounding moral decisions in fundamental principles). Alternatively to the Georgetown paradigm, he discusses an instrumental conception, attributing to various domains of social life a set of socially recognized goals or purposes providing support for certain moral standards relative to that domain. He includes the family, economic institutions, the educational system, the scientific community, and various professions such as law, medicine and journalism. He asks "What social and economic forces and other changing pressures are creating the sense of ethical concern within environmental epidemiology?" He urges continued effort to separate the two main functions of ethical theory, the intellectual and the practical, and extensive recourse to case study and analogy.

Michael Greenberg, Rutgers University, New Brunswick, N.J. (p.121) recounts a series of conferences and surveys dealing with risk analysis and potential misconduct related to it. His citations of the reports are a valuable resource.

Tore Nilstun, Department of Medical Ethics, Lund University, Sweden and Hazel Inskip from the MRC Environmental Epidemiology Unit, Southampton, UK evaluated (pp. 123-127) the possible role conflict of the epidemiologist who gives testimony in a trial. The example was a suit brought by two families whose children had developed leukemia and Hodgkin's disease after their fathers had been exposed to radiation at Sellafield, UK. The background was a widely cited and discussed epidemiological study by Gardner et al. showing that excess childhood leukemia in the area could largely be accounted for by the exposure of the fathers to radiation at the plant. The ethical question Nilstun and Inskip pose is whether an epidemiologist asked to testify should agree to be an expert witness for the plaintiffs or maintain independence. In their systematic evaluation, they note that written confidentiality has been assured the participants in the Gardner study, but at the request of the defendants, the court ordered that all the data be made available. To some extent this allowed challenges to the position of the epidemiologists, which could not be answered if the epidemiologists remained independent. The final position was that the epidemiologists, weighing all the ethical costs and benefits, decided to remain independent because the Plaintiffs were not speaking for a class of employees, but only for themselves.

Moyses Szklo from Johns Hopkins University, Baltimore, Maryland (pp. 129-130) discussed four types of ethical issues related to the publication of research findings. They are publication bias, timing of publication, conflict of interest and fraud. The problem of publication bias is obvious, but the timing of publication involves the need for adequate time for peer review prior to use of new research in policy changes. Conflicting interests can be evaluated against guidelines recently issued by the Society for Epidemiological Research. They imply that epidemiological research should not be conducted secretly, and its results published openly and promptly. Sponsorship should be acknowledged and whether or not the results are favorable to a sponsor's interest shouldn't affect their release and publication.

The Special Issue concludes with the WHO Summary report (pp. 131-136) including a definition of the mission of environmental epidemiology.

Reflecting the substance of the discussion at the Workshop, Colin Soskolne and Andrew Light (Philosophy Department, Univ. of Alberta) present "Toward Ethics Guidelines for Environmental Epidemiologists" (pp. 137-147). This attempts to integrate the ideas presented into a draft of guidelines, which are also consistent with the broader field of epidemiology. The result is a coherent set of ethics guidelines which should prove useful for environmental epidemiologists in their training and educational programs, in their research and in their practice.

The work represented here advanced not only bioethics, but is important to the development of environmental epidemiology.

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