J Clh Epldembl Vol. 44, Suppl. I, pp. 9S-13s. 1991 Printed in Great Britain. All rights rewvcd
0895-4356/91 $3.00 + 0.00 Copyright &$ 1991 Pergamon Press plc
ETHICAL AND PROFESSIONAL ISSUES IN THE CHANGING PRACTICE OF EPIDEMIOLOGY LEON GORDIS The Center for Epidemiology and Public Policy, Department of Epidemiology, Johns Hopkins School of Hygiene and Public Health, 615 North Wolfe Street, Baltimore, MD 21205, U.S.A.
Abstract-New ethical and professional issues are affecting epidemiology today as a result of the changing social and scientific context in which epidemiology is practiced. These issues arise in interpreting the findings of epidemiologic studies, dealing with potential conflicts of interest, fulfilling obligations to the people studied, publishing study results and providing others access to the data after studies have been completed. The epidemiologist is also faced with new challenges including the need to communicate new information on health risks to non-epidemiologists, and to apply her epidemiologic expertise and study findings to the development of public policy.
actions or to identify them and respond to them. This paper will focus on some questions and actions which may involve more elements of judgement, philosophy, attitude and opinion on which epidemiologists may differ considerably. Perhaps the first question to ask is whether epidemiology in fact differs from other scientific disciplines in regard to ethical issues. Although epidemiology shares many problems with other scientific disciplines, epidemiology has certain unusual if not unique characteristics. It is a discipline which grew out of medicine and even in its earliest years it had immediate policy implications for clinical care or public health action. John Snow’s studies of cholera in London, and his removal of the handle of the Broad Street pump, whether actually done before or after the crest of the outbreak, reflected the clear policy implications of his work. The ultimate objective of epidemiology is to improve human health. Throughout these discussions we must keep in mind that epidemiology serves as the basic science of disease prevention. Hence, the relation of epidemiology to development of public policy is integral to the discipline. As a result, the ethical and professional issues go beyond those that might apply to a scientific discipline such as biophysics or physiology and must be viewed in a broader
INTRODUCTION
The changing social and scientific context in which epidemiologic research is being conducted today has led to new challenges to those working in this field. This paper will present an overview of several of these issues, some of which are ethical or moral in character and others which relate to professionalism and appropriateness of actions for practicing epidemiologists. As the title indicates, epidemiology is viewed not only as the conduct of research studies but as a constellation of activities, responsibilities and obligations which constitute the professional practice of epidemiology; epidemiology cannot be an isolated intellectual enterprise. This is more than a semantic issue. If the epidemiologist is viewed only as a researcher, the scope of ethical issues applying might be more limited than if epidemiology is viewed also as a professional practice and I shall return to this issue later on. This paper will not address issues of fraud, deceit, or misrepresentation. These issues would generate broad consensus among epidemiologists and there would be little disagreement regarding the unacceptability of such actions although opinions might differ regarding the specific steps to be taken either to prevent such 9s
LEONG~RDIS
10s
context: first, our findings have direct societal relevance. Second, we are often funded from public resources. Third, our research involves human subjects in one way or another, and finally, in general, the subjects who participate in our studies derive no benefit personally from the results of the study. In this paper, the issues to be discussed will be divided into two groups: first, those which relate to the actual conduct of studies we ourselves are carrying out and second, those relating to other broader societal roles of the epidemiologist that go beyond our own research itself. CONDUCTING OUR OWN STUDIES
Interpreting the findings
Many of the most critical issues in our conduct of research studies arise in connection with the appropriateness of the study design and the interpretation and reporting of findings. Epidemiologists have been accused of seemingly endless reporting of new risks, many of which are not confirmed in subsequent studies. Results of many epidemiologic studies do not agree and some policy makers have opted for using toxicologic data to the point of the complete disregard of epidemiologic data since they find the toxicologic data more consistent. The result is often a loss of credibility not only with the public but with scientific colleagues in other disciplines as well. We must therefore ask at what point does a reported trivial increase in risk ratio, even if statistically significant, become a biologically significant risk which merits public concern? A major problem is how do we interpret the data when there was no a priori hypothesis relating to the finding. Will we interpret the finding differently if it resulted from a so-called “fishing expedition” than when the data were obtained in an attempt to specifically confirm or refute the hypothesis? What if a new hypothesis was added after the beginning of the study based on reports which appeared in the literature after the study had started? In this situation, the findings relating to the hypothesis do not represent a “fishing expedition” but relate to a hypothesis for which there is presumably biologic and epidemiologic support albeit support which first appeared after the study was initiated. Epidemiologists are often inconsistent in how they use the standard of statistical significance. If they do not find an increase in risk the finding may be reported as “no statistically significant
association.” However, at times if our findings go against our preconceptions and we remain unconvinced despite the data, we may see the identical data described in the words “there was a suggestion of an association but it did not achieve statistical significance.” Of course, judgement does in fact enter into science in interpreting findings, and consistency was said by Emerson to be “the hobgoblin of little minds,” but I believe that in this situation, inconsistency in approach is not consistent with credible investigations. The starting point for research is often some preconception on the part of the investigator. Even if the study hypotheses are articulated as null hypotheses, the usual objective of the investigator is to put to the test one or more of his preconceptions. However, preconception can lead to conscious or subconscious biases so that there is a need to shield the research process including interpretation of the results, from any biases that may result from any preconceptions of the investigator. Conflict of interest
Other biases may arise from conflict of interest which can be both actual and perceived. Conflict can arise at each stage of a study from the initial decision as to whether a study should be undertaken in the first place, through the analysis and interpretation of the data. When a study is undertaken under corporate auspices and addresses for example the possible health effects of a manufacturing process or commercial or industrial product, we must ask what is the investigator’s responsibility to the corporation and how can it be reconciled with his ethical and professional obligations. Obligations to study subjects
What are the investigator’s obligations to the subjects in the study? I am not referring to clinical trials of therapeutic or preventive modalities but wish to comment only on the observational studies with which most epidemiologists generally deal. Can a truly informed consent be obtained from a subject? If we believe that a full description of the study’s objectives will introduce a response or other bias, clearly the consent will not be a fully “informed” one. Another issue in consent relates to privacy and confidentiality. For many years we had, in good conscience, assured subjects that their data would be kept
Ethical
and Professional
confidential, and that our commitment was unqualified. However, we became aware that research data would be subject to subpoena with few exceptions such as drug abuse history. We have therefore qualified our informed consent statement to allow for breaks in confidentiality that may be legally mandated and which would therefore be beyond control of the investigator. In a study of men at high risk for HIV infection, confidentiality was promised. In the interview subsequently administered, subjects were asked whether they had donated blood during the past 2 years. Several subjects who were found to be HIV positive reported having given blood within the 2 years prior to the HIV testing. Although the blood may have been discarded by the Red Cross, there was no way to check without breaching confidentiality and violating the original commitment to the subjects. One could argue that it was the responsibility of the investigators to have anticipated such a problem if the content of the interview had been well thought out prior to obtaining the informed consent. However, such problems will arise: in this case how do we balance the original commitment to the subjects, with a need to determine whether anyone had received these donors’ bloods so that further transmission of HIV might be prevented? A third obligation to the subjects relates to communicating the study findings to them. The approach may differ depending on whether the subject has been found to have a health problem or has been found to be at increased risk. One can also argue that as a study participant, the subject is entitled to receive the findings of the study even if they have no direct bearing on his health. Our policy is to offer all subjects the option of requesting a report on the study when it has been completed. Publication of the study results
The issue of publication of the results has many facets. While we are concerned with protecting the right of the investigator to publish we must also be concerned that the investigator live up to his obligation to publish. This is a particular problem when no exciting findings have been obtained. Journals are unenthusiastic about socalled “negative” findings, and indeed investigators themselves are reluctant to submit such findings for publication. Investigators, particularly younger and non-tenured ones, are also reluctant to go against accepted dogma. Perhaps
Issues in Epidemiology
11s
when the findings go against a large body of existing evidence, we might be more demanding in regard to the strength of the evidence we are willing to accept. However, failure to publish such findings results in a publication bias that is a serious matter, and consequently the issue of both internal and external constraints on an investigator’s publishing his results must be addressed. Access to the data
Finally, when a study has been completed, who should have access to the data-either “raw” or partially cooked, and under what conditions? We live in a new era in which we can be confident that any data we generate dealing with a controversial issue will be reanalyzed by experts who support a different position. Some of the relevant questions regarding sharing of data include: (1) Should the policy on sharing research data differ depending on who has paid for the study? (2) When is a study truly completed? (3) Should the policy depend on who is requesting the data and that person’s possible motivations in making the request? (4) Under what conditions should identifiers be included with the data? (5) How can the investigator’s interests be protected? (6) Who will pay for the expenses involved? We are faced with the problem of striking a proper balance between the interests of the investigator on the one hand and those of society on the other. They do not necessarily invariably coincide. SOCIETAL
ROLES
OF THE
EPIDEMIOLOGIST
I should like to turn briefly to the societal roles of the epidemiologist-i.e. roles that go beyond her own research. The first question which may be asked is whether the epidemiologist does in fact have a societal role, or in other words should the epidemiologist be seen as a researcher only or as a researcher and practitioner combined. I believe that most epidemiologists have a dual obligation. Since, as I said earlier, epidemiology is an essential foundation of pubic policy, the epidemiologist has crucial roles in this process. Not all epidemiologists need do all things related to the discipline. However, although there is room for different roles, our basic view of the discipline must include the relevance of epidemiology for public health and the practical application of the results of epidemiologic studies to the improvement of human health.
12s
LEON
Communicating health risks
The epidemiologist has a major function in communicating health risks and in interpreting epidemiologic data for non-epidemiologists. If we do not accept this responsibility, others with less training and expertise will do it, and will do it poorly. This is an essential part of the policymaking process. Epidemiologists have generally honed their critical skills and can identify every deficiency in a study, sometimes giving the problem excessive emphasis. However, the difficulty is that human studies often disagree. The epidemiologist will hesitate to draw a conclusion on the basis of existing data, and will decide that “further studies are needed.” This sentence should be stricken from the epidemiologic vocabulary and excluded from journals. Policy-makers working at the front lines do not have the luxury of delay available to them but must make a decision, and that decision should ideally capitalize on epidemiologic information. Policy makers cannot act in a rational fashion by waiting for future studies to direct their actions in response to current health issues. Epidemiologists must therefore learn to derive the best conclusions possible on the basis of currently available data, fully realizing that tomorrow a better or even a perfect study may appear which may undermine today’s conclusions. If further studies are indeed needed, the proponent of these studies should describe the type of study needed or the changes in methodology that should be included to overcome the methodological limitations of the currently available reports. Role in policy-making
The second societal role I see for the epidemiologist is in policy-making. The epidemiologist can have several roles in the policy-making process which may include producing the data and its interpretations, presenting specific policy options and projecting the impact of each, developing specific policy proposals and evaluating the effect of policies after they have been implemented. An important question which arises, is can an epidemiologist be both a researcher and an advocate for a specific policy? I believe this question urgently needs to be addressed. Is our scientific credibility adversely affected by our taking a strong advocacy position regarding specific public policies? Even if we believe the answer is “yes” we should also ask whether it is ethical not to advocate.
~ltDL¶
Nevertheless, regardless of our answers to these questions, we have an educational and interpretive function that need not compromise our credibility and indeed will only enhance it. An additional consideration is that since our data have important societal implications, if we want society to continue to support our efforts we will have to demonstrate the value of our research for the health of the public. This can only be done if we broaden our responsibility from the research only role to that of policyrelated functions. Thus, the epidemiologist must also serve as an educator. Her efforts are directed at many target populations including other scientists, other health professionals, legislators, policy makers, lawyers and judges, and the public. Each must be dealt with differently depending on the specific needs of that population and the objectives towards which the educational effort is directed. At times, epidemiologists have also raised unrealistic expectations among the public regarding what epidemiology can do. It is our ethical obligation to examine the limits of epidemiology, such as problems as measuring exposures which occurred in the remote past and detecting minimal increases in risk; we must not overstate our potential contributions to environmental issues and other health concerns. Epidemiologists as expert witnesses
Increasingly, epidemiologists are being called upon to serve as expert witnesses. The large number of toxic tort cases require consideration of epidemiologic evidence on environmental issues. Many are uncomfortable in this role, partially as a result of a basic difference in the modus operandi of the lawyer and the scientist. The lawyer’s objective is to do what he can to advance his client’s interests; the scientist is interested in pursuing truth, a pursuit that may be remote from the lawyer’s actions on behalf of his client. Although we are all accustomed to having our methodology and findings questioned on scientific grounds by colleagues and by study sections, we are not accustomed to having our motivation questioned or to the techniques of witness impeachment that characterize courts of law. The danger is that as a result, epidemiologists will refuse to participate in this process. A dialogue is needed that will identify the problems in more detail and develop a plan for dealing with them that will facilitate the participation of epidemiologists in
Ethical and Professional Issues in Epidemiology
the legal process. Such a dialogue is already in process.
13s
objectivity and rigor of our scientific work in the process.
Epidemiologists as members of the community Finally, above and beyond each of these considerations, the epidemiologist must keep in mind that he or she is a citizen of the community in which we live and work. As issues affect the health of the community, locally, regionally or nationally, or issues of international concern arise, we should not hide under the mantle of scientific objectivity and detach ourselves from critical decision making in public health. Ideally, we will also bring to bear on the problem our epidemiologic expertise coupled with our humanitarian concern, but not losing the
CONCLUSION
We cannot enforce integrity, but we can build in certain safeguards and raise consciousness levels both among the members of the research staffs we employ and among our students. We need to identify the most effective means for enhancing the awareness of ethical issues among them. We should also examine graduate degree curriculum in epidemiology to determine whether these vital issues are receiving sufficient emphasis in our training programs.
0895-4356/91 $3.00 + 0.00 Copyright &$ 1991 Pergamon Press plc
ETHICAL AND PROFESSIONAL ISSUES IN THE CHANGING PRACTICE OF EPIDEMIOLOGY LEON GORDIS The Center for Epidemiology and Public Policy, Department of Epidemiology, Johns Hopkins School of Hygiene and Public Health, 615 North Wolfe Street, Baltimore, MD 21205, U.S.A.
Abstract-New ethical and professional issues are affecting epidemiology today as a result of the changing social and scientific context in which epidemiology is practiced. These issues arise in interpreting the findings of epidemiologic studies, dealing with potential conflicts of interest, fulfilling obligations to the people studied, publishing study results and providing others access to the data after studies have been completed. The epidemiologist is also faced with new challenges including the need to communicate new information on health risks to non-epidemiologists, and to apply her epidemiologic expertise and study findings to the development of public policy.
actions or to identify them and respond to them. This paper will focus on some questions and actions which may involve more elements of judgement, philosophy, attitude and opinion on which epidemiologists may differ considerably. Perhaps the first question to ask is whether epidemiology in fact differs from other scientific disciplines in regard to ethical issues. Although epidemiology shares many problems with other scientific disciplines, epidemiology has certain unusual if not unique characteristics. It is a discipline which grew out of medicine and even in its earliest years it had immediate policy implications for clinical care or public health action. John Snow’s studies of cholera in London, and his removal of the handle of the Broad Street pump, whether actually done before or after the crest of the outbreak, reflected the clear policy implications of his work. The ultimate objective of epidemiology is to improve human health. Throughout these discussions we must keep in mind that epidemiology serves as the basic science of disease prevention. Hence, the relation of epidemiology to development of public policy is integral to the discipline. As a result, the ethical and professional issues go beyond those that might apply to a scientific discipline such as biophysics or physiology and must be viewed in a broader
INTRODUCTION
The changing social and scientific context in which epidemiologic research is being conducted today has led to new challenges to those working in this field. This paper will present an overview of several of these issues, some of which are ethical or moral in character and others which relate to professionalism and appropriateness of actions for practicing epidemiologists. As the title indicates, epidemiology is viewed not only as the conduct of research studies but as a constellation of activities, responsibilities and obligations which constitute the professional practice of epidemiology; epidemiology cannot be an isolated intellectual enterprise. This is more than a semantic issue. If the epidemiologist is viewed only as a researcher, the scope of ethical issues applying might be more limited than if epidemiology is viewed also as a professional practice and I shall return to this issue later on. This paper will not address issues of fraud, deceit, or misrepresentation. These issues would generate broad consensus among epidemiologists and there would be little disagreement regarding the unacceptability of such actions although opinions might differ regarding the specific steps to be taken either to prevent such 9s
LEONG~RDIS
10s
context: first, our findings have direct societal relevance. Second, we are often funded from public resources. Third, our research involves human subjects in one way or another, and finally, in general, the subjects who participate in our studies derive no benefit personally from the results of the study. In this paper, the issues to be discussed will be divided into two groups: first, those which relate to the actual conduct of studies we ourselves are carrying out and second, those relating to other broader societal roles of the epidemiologist that go beyond our own research itself. CONDUCTING OUR OWN STUDIES
Interpreting the findings
Many of the most critical issues in our conduct of research studies arise in connection with the appropriateness of the study design and the interpretation and reporting of findings. Epidemiologists have been accused of seemingly endless reporting of new risks, many of which are not confirmed in subsequent studies. Results of many epidemiologic studies do not agree and some policy makers have opted for using toxicologic data to the point of the complete disregard of epidemiologic data since they find the toxicologic data more consistent. The result is often a loss of credibility not only with the public but with scientific colleagues in other disciplines as well. We must therefore ask at what point does a reported trivial increase in risk ratio, even if statistically significant, become a biologically significant risk which merits public concern? A major problem is how do we interpret the data when there was no a priori hypothesis relating to the finding. Will we interpret the finding differently if it resulted from a so-called “fishing expedition” than when the data were obtained in an attempt to specifically confirm or refute the hypothesis? What if a new hypothesis was added after the beginning of the study based on reports which appeared in the literature after the study had started? In this situation, the findings relating to the hypothesis do not represent a “fishing expedition” but relate to a hypothesis for which there is presumably biologic and epidemiologic support albeit support which first appeared after the study was initiated. Epidemiologists are often inconsistent in how they use the standard of statistical significance. If they do not find an increase in risk the finding may be reported as “no statistically significant
association.” However, at times if our findings go against our preconceptions and we remain unconvinced despite the data, we may see the identical data described in the words “there was a suggestion of an association but it did not achieve statistical significance.” Of course, judgement does in fact enter into science in interpreting findings, and consistency was said by Emerson to be “the hobgoblin of little minds,” but I believe that in this situation, inconsistency in approach is not consistent with credible investigations. The starting point for research is often some preconception on the part of the investigator. Even if the study hypotheses are articulated as null hypotheses, the usual objective of the investigator is to put to the test one or more of his preconceptions. However, preconception can lead to conscious or subconscious biases so that there is a need to shield the research process including interpretation of the results, from any biases that may result from any preconceptions of the investigator. Conflict of interest
Other biases may arise from conflict of interest which can be both actual and perceived. Conflict can arise at each stage of a study from the initial decision as to whether a study should be undertaken in the first place, through the analysis and interpretation of the data. When a study is undertaken under corporate auspices and addresses for example the possible health effects of a manufacturing process or commercial or industrial product, we must ask what is the investigator’s responsibility to the corporation and how can it be reconciled with his ethical and professional obligations. Obligations to study subjects
What are the investigator’s obligations to the subjects in the study? I am not referring to clinical trials of therapeutic or preventive modalities but wish to comment only on the observational studies with which most epidemiologists generally deal. Can a truly informed consent be obtained from a subject? If we believe that a full description of the study’s objectives will introduce a response or other bias, clearly the consent will not be a fully “informed” one. Another issue in consent relates to privacy and confidentiality. For many years we had, in good conscience, assured subjects that their data would be kept
Ethical
and Professional
confidential, and that our commitment was unqualified. However, we became aware that research data would be subject to subpoena with few exceptions such as drug abuse history. We have therefore qualified our informed consent statement to allow for breaks in confidentiality that may be legally mandated and which would therefore be beyond control of the investigator. In a study of men at high risk for HIV infection, confidentiality was promised. In the interview subsequently administered, subjects were asked whether they had donated blood during the past 2 years. Several subjects who were found to be HIV positive reported having given blood within the 2 years prior to the HIV testing. Although the blood may have been discarded by the Red Cross, there was no way to check without breaching confidentiality and violating the original commitment to the subjects. One could argue that it was the responsibility of the investigators to have anticipated such a problem if the content of the interview had been well thought out prior to obtaining the informed consent. However, such problems will arise: in this case how do we balance the original commitment to the subjects, with a need to determine whether anyone had received these donors’ bloods so that further transmission of HIV might be prevented? A third obligation to the subjects relates to communicating the study findings to them. The approach may differ depending on whether the subject has been found to have a health problem or has been found to be at increased risk. One can also argue that as a study participant, the subject is entitled to receive the findings of the study even if they have no direct bearing on his health. Our policy is to offer all subjects the option of requesting a report on the study when it has been completed. Publication of the study results
The issue of publication of the results has many facets. While we are concerned with protecting the right of the investigator to publish we must also be concerned that the investigator live up to his obligation to publish. This is a particular problem when no exciting findings have been obtained. Journals are unenthusiastic about socalled “negative” findings, and indeed investigators themselves are reluctant to submit such findings for publication. Investigators, particularly younger and non-tenured ones, are also reluctant to go against accepted dogma. Perhaps
Issues in Epidemiology
11s
when the findings go against a large body of existing evidence, we might be more demanding in regard to the strength of the evidence we are willing to accept. However, failure to publish such findings results in a publication bias that is a serious matter, and consequently the issue of both internal and external constraints on an investigator’s publishing his results must be addressed. Access to the data
Finally, when a study has been completed, who should have access to the data-either “raw” or partially cooked, and under what conditions? We live in a new era in which we can be confident that any data we generate dealing with a controversial issue will be reanalyzed by experts who support a different position. Some of the relevant questions regarding sharing of data include: (1) Should the policy on sharing research data differ depending on who has paid for the study? (2) When is a study truly completed? (3) Should the policy depend on who is requesting the data and that person’s possible motivations in making the request? (4) Under what conditions should identifiers be included with the data? (5) How can the investigator’s interests be protected? (6) Who will pay for the expenses involved? We are faced with the problem of striking a proper balance between the interests of the investigator on the one hand and those of society on the other. They do not necessarily invariably coincide. SOCIETAL
ROLES
OF THE
EPIDEMIOLOGIST
I should like to turn briefly to the societal roles of the epidemiologist-i.e. roles that go beyond her own research. The first question which may be asked is whether the epidemiologist does in fact have a societal role, or in other words should the epidemiologist be seen as a researcher only or as a researcher and practitioner combined. I believe that most epidemiologists have a dual obligation. Since, as I said earlier, epidemiology is an essential foundation of pubic policy, the epidemiologist has crucial roles in this process. Not all epidemiologists need do all things related to the discipline. However, although there is room for different roles, our basic view of the discipline must include the relevance of epidemiology for public health and the practical application of the results of epidemiologic studies to the improvement of human health.
12s
LEON
Communicating health risks
The epidemiologist has a major function in communicating health risks and in interpreting epidemiologic data for non-epidemiologists. If we do not accept this responsibility, others with less training and expertise will do it, and will do it poorly. This is an essential part of the policymaking process. Epidemiologists have generally honed their critical skills and can identify every deficiency in a study, sometimes giving the problem excessive emphasis. However, the difficulty is that human studies often disagree. The epidemiologist will hesitate to draw a conclusion on the basis of existing data, and will decide that “further studies are needed.” This sentence should be stricken from the epidemiologic vocabulary and excluded from journals. Policy-makers working at the front lines do not have the luxury of delay available to them but must make a decision, and that decision should ideally capitalize on epidemiologic information. Policy makers cannot act in a rational fashion by waiting for future studies to direct their actions in response to current health issues. Epidemiologists must therefore learn to derive the best conclusions possible on the basis of currently available data, fully realizing that tomorrow a better or even a perfect study may appear which may undermine today’s conclusions. If further studies are indeed needed, the proponent of these studies should describe the type of study needed or the changes in methodology that should be included to overcome the methodological limitations of the currently available reports. Role in policy-making
The second societal role I see for the epidemiologist is in policy-making. The epidemiologist can have several roles in the policy-making process which may include producing the data and its interpretations, presenting specific policy options and projecting the impact of each, developing specific policy proposals and evaluating the effect of policies after they have been implemented. An important question which arises, is can an epidemiologist be both a researcher and an advocate for a specific policy? I believe this question urgently needs to be addressed. Is our scientific credibility adversely affected by our taking a strong advocacy position regarding specific public policies? Even if we believe the answer is “yes” we should also ask whether it is ethical not to advocate.
~ltDL¶
Nevertheless, regardless of our answers to these questions, we have an educational and interpretive function that need not compromise our credibility and indeed will only enhance it. An additional consideration is that since our data have important societal implications, if we want society to continue to support our efforts we will have to demonstrate the value of our research for the health of the public. This can only be done if we broaden our responsibility from the research only role to that of policyrelated functions. Thus, the epidemiologist must also serve as an educator. Her efforts are directed at many target populations including other scientists, other health professionals, legislators, policy makers, lawyers and judges, and the public. Each must be dealt with differently depending on the specific needs of that population and the objectives towards which the educational effort is directed. At times, epidemiologists have also raised unrealistic expectations among the public regarding what epidemiology can do. It is our ethical obligation to examine the limits of epidemiology, such as problems as measuring exposures which occurred in the remote past and detecting minimal increases in risk; we must not overstate our potential contributions to environmental issues and other health concerns. Epidemiologists as expert witnesses
Increasingly, epidemiologists are being called upon to serve as expert witnesses. The large number of toxic tort cases require consideration of epidemiologic evidence on environmental issues. Many are uncomfortable in this role, partially as a result of a basic difference in the modus operandi of the lawyer and the scientist. The lawyer’s objective is to do what he can to advance his client’s interests; the scientist is interested in pursuing truth, a pursuit that may be remote from the lawyer’s actions on behalf of his client. Although we are all accustomed to having our methodology and findings questioned on scientific grounds by colleagues and by study sections, we are not accustomed to having our motivation questioned or to the techniques of witness impeachment that characterize courts of law. The danger is that as a result, epidemiologists will refuse to participate in this process. A dialogue is needed that will identify the problems in more detail and develop a plan for dealing with them that will facilitate the participation of epidemiologists in
Ethical and Professional Issues in Epidemiology
the legal process. Such a dialogue is already in process.
13s
objectivity and rigor of our scientific work in the process.
Epidemiologists as members of the community Finally, above and beyond each of these considerations, the epidemiologist must keep in mind that he or she is a citizen of the community in which we live and work. As issues affect the health of the community, locally, regionally or nationally, or issues of international concern arise, we should not hide under the mantle of scientific objectivity and detach ourselves from critical decision making in public health. Ideally, we will also bring to bear on the problem our epidemiologic expertise coupled with our humanitarian concern, but not losing the
CONCLUSION
We cannot enforce integrity, but we can build in certain safeguards and raise consciousness levels both among the members of the research staffs we employ and among our students. We need to identify the most effective means for enhancing the awareness of ethical issues among them. We should also examine graduate degree curriculum in epidemiology to determine whether these vital issues are receiving sufficient emphasis in our training programs.
