Ethics and Epidemiology
Third Edition
Edited by STEVEN S. COUGHLIN AND ANGUS DAWSON
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Library of Congress Cataloging-in-Publication Data
Names: Coughlin, Steven S. (Steven Scott), 1957– editor. | Dawson, Angus, editor.
Title: Ethics and epidemiology / edited by Steven S. Coughlin and Angus Dawson. Description: Third edition. | New York, NY : Oxford University Press, [2021] | Includes bibliographical references and index.
Identifiers: LCCN 2021002991 (print) | LCCN 2021002992 (ebook) | ISBN 9780197587058 (hardback) | ISBN 9780197587072 (epub) | ISBN 9780197587089
Subjects: MESH: Epidemiology—ethics | Ethics, Medical | Codes of Ethics | Epidemiologic Methods | Health Services Research—ethics | Social Medicine—ethics Classification: LCC RA652 (print) | LCC RA652 (ebook) | NLM WA 105 | DDC 174.2/944—dc23
LC record available at https://lccn.loc.gov/2021002991
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DOI: 10.1093/oso/9780197587058.001.0001
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PART I FOUNDATIONS
1. Historical Foundations
Steven S. Coughlin
2. Epidemiology and Informed Consent 27
Anna C. Mastroianni and Jeffrey P. Kahn
3. Solidarity and the Common Good: Social Epidemiology and Relational Ethics in Public Health 44 Bruce Jennings
4. Understanding the Ethics of Risk as Used in Epidemiology 66 Diego S. Silva
5. Risk and Precaution: The Ethical Challenges of Translating Epidemiology into Action 85
Stephen D. John
PART III METHODS
6. Ethical Issues in the Design and Conduct of Community-Based Intervention Studies 105
Michelle C. Kegler, Steven S. Coughlin, and Karen Glanz
PART IV ISSUES
7. Ethics in Public Health Practice 137
Robert E. McKeown
8. Ethical Issues in Genetic Epidemiology 175
Laura M. Beskow, Stephanie M. Fullerton, and Wylie Burke
9. Ethics, Epidemiology, and Changing Perspectives on AIDS
Carol Levine
10. Ethics Curricula in Epidemiology
Kenneth W. Goodman and Ronald J. Prineas
11. Conflicts of Interest
Walter Ricciardi and Carlo Petrini
Index
Preface
In the ten years since the second edition of Ethics and Epidemiology was published, there have been many important ethical developments in epidemiology and related fields in public health and medicine. These developments include the rise of public health ethics and the complex interrelations between professional ethics in epidemiology, public health ethics, and research ethics. Most of the chapters in previous editions tended to assume legal and regulatory structures that exist in the United States are the norm across the world, when this is not the case. In the third edition, chapters were written for a truly international, global audience and include the perspectives of additional scholars from across the world.
This book will be of interest to practicing public health professionals from various public health disciplines (epidemiology, behavioral science, genomics, health disparities, and global health), bioethicists, legal scholars, and members of nonprofit organizations, government agencies, and health advocacy organizations. Public health ethics is increasingly a standard part of master of public health (MPH) degrees. This book will be an invaluable resource for the thousands of MPH students across the world.
This revised edition of the book includes selected chapters from the first edition, which have been substantially updated and revised, along with several new chapters. The chapters are organized topically and divided into four parts. The first part is titled “Foundations” because the chapter introduces basic and recurring concepts and principles. The subsequent parts deal with “Key Values and Principles,” “Methods,” and “Issues.”
The objective of this work is to make students, epidemiologists, and health professionals aware of situations that require moral reflection, judgment, or decision, while pointing to ways in which justified moral conclusions can be reached. We hope the book will also be of use to persons interested more broadly in bioethics and health policy.
S.S.C.
A.D.
Contributors
Laura M. Beskow, MPH, PhD Center for Biomedical Ethics and Society
Vanderbilt University Medical Center Nashville, TN, USA
Wylie Burke, MD, PhD Department of Bioethics and Humanities University of Washington Mercer Island, WA, USA
Steven S. Coughlin, PhD, MPH Department of Population Health Sciences
Medical College of Georgia Augusta University Augusta, GA, USA
Angus Dawson, PhD
Sydney Health Ethics University of Sydney Sydney, NSW, Australia
Stephanie M. Fullerton, DPhil Department of Bioethics and Humanities University of Washington School of Medicine Seattle, WA, USA
Karen Glanz, PhD, MPH Department of Biobehavioral Health Sciences
University of Pennsylvania Philadelphia, PA, USA
Kenneth W. Goodman, PhD
Institute for Bioethics and Health Policy University of Miami Miller School of Medicine Miami, FL, USA
Bruce Jennings, MA Department of Health Policy Vanderbilt University Brentwood, TN, USA
Stephen D. John, PhD Department of History and Philosophy of Science
University of Cambridge Cambridge, UK
Jeffrey P. Kahn, PhD, MPH
Berman Institute of Bioethics
Johns Hopkins University Baltimore, MD, USA
Michelle C. Kegler, DrPH, MPH Department of Behavioral, Social and Health Education Sciences
Rollins School of Public Health, Emory University Atlanta, GA, USA
Carol Levine, MA Families and Health Care Project United Hospital Fund New York, NY, USA
Anna C. Mastroianni, JD, MPH School of Law University of Washington Seattle, WA, USA
Robert E. McKeown, PhD Department of Epidemiology and Biostatistics
Arnold School of Public Health, University of South Carolina Columbia, SC, USA
x Contributors
Carlo Petrini, PhD
Bioethics Unit
Italian National Institute of Health (istituto Superiore di Sanità) Rome, Italy
Ronald J. Prineas, MB, BS, PhD, FRCP
Division of Public Health Sciences
Wake Forest University Winston-Salem, NC, USA
Walter Ricciardi, MD, PhD
Dipartimento di Scienze della vita e sanità pubblica
Università Cattolica del Sacro Cuore Rome, Italy
Diego S. Silva, PhD
Sydney Health Ethics, School of Public Health
University of Sydney Camperdown, NSW, Australia
1 Historical Foundations
Steven S. Coughlin
This chapter considers the history of the rise of ethical concerns in the public health movement and epidemiology, which is the study of the distribution and determinants of disease in human populations. Epidemiology is a basic science in public health. This chapter provides an overview of early developments in public health and ethics. More recent developments are also discussed, including the origins of bioethics, regulatory safeguards for human subjects research, public health ethics, and contemporary epidemiologic ethics.
Early Developments in Public Health and Ethics
Until the end of the Middle Ages, few advances were made in public health except for the control of a very limited number of communicable diseases achieved through the segregation and quarantine of persons thought to be infectious.1,2 Around the sixteenth century in Europe, hypotheses began to emerge regarding the social genesis of disease and some proposals were advanced concerning the role of government in public health. At the onset, these ideas had little practical impact, but they ultimately contributed to the emerging realization that government has an obligation to improve unsanitary conditions that threatened the health of rich and poor alike.1
The early writings relied on speculative hypotheses and were based more in the humanities than the sciences. For example, Thomas More (1478–1535) wrote a fictitious story set in the land of Utopia (1516) in which hygiene protected health and insurance was provided against sickness and unemployment. JeanJacques Rousseau (1712–1778) also speculated in Discourse on the Origins and Foundations of Inequality Among Men (1775)2–4 that in the context of a prolonged criticism of “civil society,” disease developed from social circumstances and ill health resulted from many factors, most of which were beyond the power of medicine to heal:
With regard to illnesses, [I note] the extreme inequality in our lifestyle: excessive idleness among some, excessive labor among others; the ease with which
Steven S. Coughlin, Historical Foundations In: Ethics and Epidemiology. Third edition. Edited by: Steven S. Coughlin and Angus Dawson, Oxford University Press. © Oxford University Press 2021. DOI: 10.1093/oso/9780197587058.003.0001
we arouse and satisfy our appetites and our sensuality; the overly refined foods of the wealthy, which nourish them with irritating juices and overwhelm them with indigestion; the bad food of the poor, who most of the time do not have even that, and who, for want of food, are inclined to stuff their stomachs greedily whenever possible; staying up until all hours, excesses of all kinds, immoderate outbursts of every passion, bouts of fatigue and mental exhaustion; countless sorrows and afflictions which are felt in all levels of society and which perpetually gnaw away at souls; these are the fatal proofs that most of our ills are of our own making, and that we could have avoided nearly all of them by preserving the simple, regular and solitary lifestyle prescribed to us by nature.4
Rousseau subsequently influenced writers in ethical theory during the Enlightenment. Rousseau’s theories also had an impact on later public health writers, such as the influential German physician Johann Peter Frank (1745–1821), who held high positions in both government and academia in Germany, Austria, Italy, and Russia and was an early proponent of social medicine controlled by the state. Frank promoted the idea of “medical police,” or physicians with a public health role of sufficient authority to protect people against the health consequences of squalid urban living conditions. He argued that the physician’s primary obligations were not owed merely to patients or the local community, but to the state and the monarch. Public health responsibilities were thereby reconceived as physicians’ primary responsibilities.1,5
Pathogenic microorganisms were still unknown during the Enlightenment. With the exception of a few diseases such as smallpox, disease was regarded as the result of unhealthy lifestyles and environments rather than of contagion. Poor air, water, and living conditions were thought to foster miasmas (poisonous vapors) that caused illness. Hence, many Enlightenment physicians undertook public health campaigns emphasizing both personal and environmental hygiene. They understood that prevention methods were more effective than curative techniques and believed that people were responsible for maintaining their own health. The success of their efforts was not surprising because standard therapies at that time such as laxatives, bloodletting, and induced vomiting yielded less impressive results than did public health efforts.6,7
A small number of Enlightenment figures, including American physician Benjamin Rush (1745–1813) and Scottish physician John Gregory (1724–1773), focused on professional medical ethics. They were among the first writers to lecture and publish extensively on this subject. Both Rush and Gregory believed that physicians had a moral obligation to educate the public and disclose relevant information to patients. However, neither believed that physicians had a moral obligation to obtain informed consent from patients for the care they provided. Rush and Gregory only wanted patients and the general public to be
sufficiently educated to understand physicians’ recommendations and be motivated to comply.
Rush and Gregory doubted that nonphysicians could intelligently form their own opinions about medical issues and make appropriate choices about care. For example, Rush advised physicians to “yield to [patients] in matters of little consequence, but maintain an inflexible authority over them in matters that are essential to life.” Gregory was quick to underscore that the physician must be keenly aware of the harms that untimely disclosures might cause to patients or to the public. Rush, Gregory, and other Enlightenment figures did not discuss the need to respect the patient’s right to self-determination or to obtain consent for any purpose other than a medically successful outcome. Gregory and Rush appreciated the value of providing information, but ideas of informed consent in health care did not originate in their writings. The language of “informed consent” was not used during the Enlightenment, and indeed not until the 1950s.8,9
An organized system to protect public health was not developed until the nineteenth century in England.10 England was the first country to experience the social costs of the Industrial Revolution.2 Due to the efforts of Edwin Chadwick (1800–1890) and other English reformers, laws were enacted that provided relief to the poor, made it illegal to employ children under the age of nine in factories, and promoted the health and welfare of industrial workers.1,10 Chadwick was largely responsible for the passage of the Public Health Act of 1848, which created a board of health to oversee sanitary improvements at about the time that British physician John Snow began his classic series of investigations on cholera in London.1,3,10 A royal commission headed by Chadwick recommended improvements in drainage systems in large towns, where a lack of sanitation had resulted in the spread of typhoid, cholera, and other diseases.1 Legislation of this type quickly spread to other countries and had a major impact on public health and life expectancy.
The primary motivation for reform was the realization that poverty and unsanitary conditions had adverse economic and social consequencies.1,10 Chadwick maintained an association with English philosopher Jeremy Bentham (1748–1832), whose progressive social reforms for children employed in the factories, the poor, and women had a major impact in Victorian England and caused repercussions throughout Europe and India. As a young man, Chadwick was Bentham’s assistant and later applied Bentham’s utilitarian theories11 to practical public health problems. Chadwick came to see poverty as a major cause of ill health through increased exposures to toxic substances, poor diet, and so forth. Chadwick was a contemporary of John Stuart Mill (1806–1873), a Benthamite and the foremost utilitarian writer of the nineteenth century. Mill was elected to the British Parliament in 1865 and supported such unpopular measures as increased protection for the more vulnerable members of society, especially
women, the poor, and persons condemned to capital punishment. Mill described his views on how to control disease in the following passage from his book Utilitarianism, which is still the most widely read account of utilitarian ethics:
Even that most intractable of enemies, disease, may be indefinitely reduced in dimensions by good physical and moral education, and proper control of noxious influences; while the progress of science holds out a promise for the future of still more direct conquests over this detestable foe. And every advance in that direction relieves us from some, not only of the chances which cut short out own lives, but, what concerns us still more, which deprive us of those in whom our happiness is wrapt up.12
Many of the founders of the public health movement in nineteenth-century England were guided by the utilitarian moral philosophy of Benham, Mill, and other philosophers. The leaders of the sanitary movement attempted to use epidemiological methods of observation to prevent or control diseases that afflicted those who were the worse off in society. For example, Chadwick led an inquiry into the diseases and unsanitary living conditions that were prevalent among England’s impoverished working-class population. The resulting General Report on the Sanitary Conditions of the Labouring Population of Great Britain (1842) was a powerful indictment of the appalling living conditions of industrial workers and their families.1,10,13 A similar sanitary survey was undertaken subsequently by legislator Lemuel Shattuck (1793–1859) in Massachusetts. Shattuck’s influential Report of the Sanitary Commission of Massachusetts 1850 outlined the basis for an organized system of public health.14
By the end of the nineteenth century, the germ theory of disease causation gained widespread acceptance because of influential bacteriological discoveries by German physician and Nobel Prize winner Robert Koch, French chemist and biologist Louis Pasteur, and others.15,16 Microbiology and bacteriology became the most important medical sciences of both the United States and Europe, while epidemiology focused on the prevention of infectious diseases.16,17 With major breakthroughs in bacteriology and immunology, disease prevention in the individual moved to the forefront.10
Twentieth-Century Developments in Epidemiology and Ethics
Since the start of the public health movement in the mid-1800s—roughly the period in which epidemiology originated—the goal of epidemiology and public health has been to prevent premature death and disease by applying scientific
and technical knowledge.18 However, as events in the twentieth century attest, the rights of individuals have not always been respected in pursuing these important societal and scientific objectives.
At the beginning of the twentieth century, epidemiology in the United States was developed primarily in federal, state, and local health departments. In 1891, the Marine Hospital Service, later the U.S. Public Health Service, was a major center for epidemiological research in the United States. It was organized by the Hygienic Laboratory. Investigators at the Hygienic Laboratory, renamed the National Institute of Health in 1930, studied both infectious and nutritional deficiency diseases, such as pellagra. Joseph Goldberger, Wade Hampton Frost, and other prominent epidemiologists received their training at the Hygienic Laboratory.17
Epidemiology developed separately in England, where leading epidemiologists in the 1930s, such as Major Greenwood of the London School of Hygiene, were concerned about both infectious and noninfectious epidemiology.16,17 Greenwood was an active member of the Socialist Medical Association and an early advocate of socialized medicine. Like other British epidemiologists of the era, he was concerned about the social causes of disease and the health of all groups in society.10,16
The leading epidemiologists during this period rarely mentioned ethical issues in their publications. Experts in medicine, public health, and moral philosophy showed little interest in the major issues of biomedical ethics that we focus closely on today. A noteworthy exception was U.S. Army surgeon Walter Reed, who developed formal procedures for obtaining the consent of potential subjects in his yellow fever experiments using a written contract that set forth Reed’s understanding of the ethical duties of medical researchers.19 Although deficient by contemporary standards of disclosure and consent, these procedures recognized the right of patients to refuse or agree to participate in research.
By the mid-twentieth century, the focus in epidemiology had shifted in both Europe and the United States in response to the increasing spread of chronic diseases such as cardiovascular disease, cancer, and diabetes. These diseases were believed to have multiple environmental and genetic etiologies. The later part of the 1940s was notable for both the founding of the World Health Organization (WHO) and the initiation of the Framingham Study, a well-known cohort study of heart disease that has been ongoing since 1949.20 The Nuremberg Code and the Declaration of Geneva were also developed during this period. In 1956, Sir Richard Doll and Sir Austin Bradford Hill released the results of their cohort study of cigarette smoking and lung cancer among British doctors.21 A few years later, in 1960, Brian MacMahon and his colleagues published Epidemiological Methods, the first text to provide a clear description of case–control and cohort study designs.20,22
In the years immediately following World War II, references to ethical issues in the epidemiological literature were limited to narrowly focused discussions of the ethics of randomized controlled trials.23,24 Epidemiological researchers, primarily physicians, undertook studies with little or no public scrutiny of their methods or professional obligations. In addition, they were unencumbered by what would later become regulatory safeguards for the protection of human subjects such as the shift to review by institutional review boards (IRBs) or research ethics committees.
Since that time, major regulatory changes have been made in the United States and many other countries. These changes have substantially improved the safeguards for the welfare and rights of human research subjects. These improvements have largely been driven by the widespread belief that people possess fundamental rights that should not be violated in the pursuit of scientific and medical progress.25–27
The Origins of Regulatory Safeguards for Human Subjects Research
In 1908, Sir William Osler, a physician who revolutionized the U.S. medical school curriculum, appeared before the British Royal Commission on Vivisection. He used the occasion to discuss Reed’s research on yellow fever. When asked by the commission whether risky research on humans is morally permissible, a view Osler attributed to Reed, Osler answered: “It is always immoral without a definite, specific statement from the individual himself, with a full knowledge of the circumstances. Under these circumstances, any man, I think is at liberty to submit himself to experiments” (emphasis added). When then asked if “voluntary consent . . . entirely changes the question of morality,” Osler replied, “Entirely.”28
Some writers on the history of this period describe Osler’s testimony as reflecting the usual and customary ethics of research at the turn of the century,29 but this sweeping historical claim has little supporting evidence. The extent to which any principle of research obligation scrutiny and any consent requirement was then ingrained in the ethics of research, or would become ingrained in the next half century, is still a matter of historical controversy.
One reason for the relatively late emergence of interest in research ethics is that scientifically rigorous research involving human subjects did not become common in the United States or Europe until the middle of the twentieth century. Only shortly before the outbreak of World War II had research evolved into an established and thriving concern.30–32 Research ethics prior to World War II had approximately the same influence on research practices as medical ethics had on clinical practices.33
The major events that pushed research ethics to the forefront occurred at the Nuremberg trials, when prominent leaders of Nazi Germany were prosecuted for crimes committed during the Holocaust. The Nuremberg military tribunal developed the Nuremberg Code of 1947, which was a set of ten principles for human experimentation. According to the famous Principle 1, the primary consideration in research is the subject’s voluntary consent, which is “absolutely essential.”34 The Nuremberg Code was not an attempt to formulate new rules of professional conduct.35 Rather, it delineated principles of medical and research ethics in the context of a trial for war crimes. Although it had little immediate impact on the conduct of biomedical research, the Nuremberg Code served as a model for many professional and governmental codes formulated in the 1950s and 1960s, and its provision requiring voluntary consent was a forerunner of informed consent practices in biomedical research.33,36
The General Assembly of the World Medical Association (WMA), an international organization of physicians founded in 1946, drafted the Declaration of Geneva in 1948. Subsequently, the WMA began to formulate a more comprehensive code to distinguish ethical from unethical clinical research. A draft was produced in 1961, but the WMA did not adopt the code until its 1964 meeting in Helsinki.37 This three-year delay was not caused by vacillation or indifference, but rather by international political processes and a determination to produce a universally applicable and useful document.38
The Declaration of Helsinki made consent a central requirement of ethical research and introduced an important distinction between therapeutic and nontherapeutic research. The former is defined in the declaration as research “combined with patient care” and is permitted as a means of acquiring new medical knowledge only insofar as it “is justified as purely scientific research without therapeutic value or purpose for the specific subjects studied.” The declaration requires consent for all instances of nontherapeutic research, unless a subject is incompetent, in which case guardian consent is necessary. According to paragraph I.9 of the declaration, “In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail [and] that he is at liberty to abstain . . . The doctor should then obtain the subject’s freely given informed consent.”25,35
The American Medical Association, the American Society for Clinical Investigation, the American Federation for Clinical Research, and many other medical groups either endorsed the Declaration of Helsinki or established their own ethical requirements consistent with the declaration’s provisions.39 Officials at federal agencies in the United States also developed provisions based on the declaration, some of which were almost verbatim reformulations of the declaration. Regardless of its shortcomings, the Helsinki Code is a foundational
document in the history of research ethics and the first significant attempt at self-regulation by the medical research community. The Nuremberg Code was the first code of medical research developed externally by a court system, and the Declaration of Helsinki was the first code of medical research developed internally by a professional medical body.
More comprehensive guidelines formulated in 1982 by the WHO and the Council of International Organizations of Medical Sciences (CIOMS) used the Declaration of Helsinki (1975) as a starting point.25,35 According to these guidelines, all human subjects research should be reviewed by an independent committee.35 However, the WHO/CIOMS guidelines also contain special provisions for protecting vulnerable persons in medical experiments, such as pregnant women, children, people who are mentally ill, and people in developing countries.35 In the United States, Congress passed the Drug Amendments of 1962 to make fundamental changes in federal regulation of the drug industry.40 These amendments were passed in response to large numbers of prescriptions of the drug thalidomide, which had not been adequately tested for use of pregnant women. Thalidomide caused severe birth defects in many children of such pregnant women. The amendments required researchers to inform research subjects of a drug’s experimental nature and receive their consent before starting an investigation, except when the researchers “deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings.”41
On January 17, 1966, James Lee Goddard, a former assistant surgeon general, became commissioner of the U.S. Food and Drug Administration (FDA). Beset by numerous reports of medical experimentation without consent of subjects as well as the swirl of controversy caused by the injection of live human cancer cells into twenty-two chronically ill patients without their consent at the Jewish Chronic Disease Hospital, Goddard was determined to resolve the ambiguities surrounding informed consent. He appointed several FDA officials to study the issue and make recommendations. In August 1966, the FDA published new provisions in its “Consent for Use of Investigational New Drugs on Humans: Statement of Policy.”42,43
This publication took place two months after the appearance of an influential article in the New England Journal of Medicine by Henry Beecher, MD, an anesthesiologist credited with establishing the peer-review system for experimental protocols in medicine. In his article,44 Beecher charged that many patients involved in clinical research experiments had never had the risks of participating satisfactorily explained to them or were unaware that they were the subjects. This issue was noticed by leaders of the National Institutes of Health (NIH). In late 1963, James Shannon, NIH director from 1955 to 1968, asked the NIH division that supported research centers to investigate these problems and make recommendations.45 An associate chief for program development, Robert
B. Livingston, led this study.46 His report, in November 1964, noted the absence of an applicable code of conduct for research, as well as an uncertain legal context.47
According to Livingston’s report, it would be difficult for NIH to assume responsibility for ethics and research practices without striking an unduly authoritarian posture on requirements for research. The authors also noted that ethical problems were raised by policies “inhibiting the pursuit of research on man” and added that “NIH is not in a position to shape the educational foundations of medical ethics, or even the clinical indoctrination of young investigators.”45 NIH Director Shannon was disappointed with this part of the report because he believed that NIH should command a position of increased responsibility. However, he accepted the report and regarded some of its recommendations as urgent. In early 1965, Shannon asked the U.S. Surgeon General to give “highest priority” to “rapid accomplishment of the objectives” of the basic recommendations. He suggested more consultation with members of the legal profession and clergy as well as the medical profession and endorsed the idea of “review [of research protections] by the investigator’s peers.”48
Shannon and Surgeon General Luther Terry jointly decided to present the problems discussed in the report to the National Advisory Health Council (NAHC) in September 1965. At this decisive meeting, Shannon argued that NIH should assume responsibility for placing formal controls on the independent judgment of investigators to remove conflicts of interest and biases. Specifically, he argued in favor of subjecting research protocols to impartial peer review of the research risks and the adequacy of protections of subjects’ rights.49 Shannon knew that “consent” could easily be manipulated by physicians using their authority to persuade otherwise-unwilling patients to participate and prompted a discussion of how the consent process could also become impartial. The NAHC members agreed that all of these concerns were valid, but they did not believe that the many fields involved in government-supported research, including epidemiology and the social sciences, could be governed by a single set of procedures or regulations. Nevertheless, within three months, NAHC supported a resolution at its December 3, 1965, meeting that followed the broad outlines of Shannon’s recommendations and proposed guidelines for federal research ethics.50
The resolution was accepted by newly installed Surgeon General William H. Stewart, who issued a policy statement in February 1966 that became a landmark in the history of research ethics in the United States. This policy statement on “Clinical Investigations Using Human Subjects” compelled institutions receiving grant support from the Public Health Service to provide prior review by a committee for proposed research with human subjects. The new IRBs would be responsible for reviewing (1) the rights and welfare of subjects, (2) the appropriateness of methods used to obtain informed consent, and (3) the balance
of risks and benefits for research subjects.51 The subjective judgment by a principal investigator or program director that human subjects’ rights would be adequately protected in a proposed study was no longer sufficient for federal funding eligibility.
These developments, along with parallel developments in other countries such as Australia and Great Britain, began the “movement to ethics committees.”52 Peer review served as the basis for several federal policies governing research ethics. The federal initiatives were endorsed by much of the biomedical community53 and were adopted in modified form by the Association of American Medical Colleges as “a requirement” for medical school accreditation.54 Over the next decade, they served as a crude model that was gradually refined and finally became accepted in institutional practices for the protection of human research subjects throughout the United States.
Shortly after these developments, the U.S. Department of Health, Education, and Welfare (now the Department of Health and Human Services) issued a series of guidebooks and regulations for the protection of human research subjects. The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which made a number of important recommendations by 1978, many having the effect of federal law.25,33,55 Subsequent federal regulations for the protection of human research subjects in the United States, including those of the FDA and the Department of Health and Human Services, have resulted in a complex IRB system (to ensure the rights and welfare of research subjects as well as justice in the selection of subjects) and other regulatory safeguards.25,26,33
The Origins of Contemporary Epidemiological Ethics
Ethics in contemporary epidemiology have their origin in the historical developments that led to regulatory safeguards for human subjects research and in parallel developments in the history of bioethics that are beyond the scope of this chapter. Nevertheless, the foundational concepts and principles of bioethics are an important part of ethics in epidemiology.
The 1970s
By the early 1970s, the Tuskegee Syphilis Study (an observational study of four hundred Black men with syphilis who were not given curative treatment), the Jewish Chronic Disease Hospital case, and Beecher’s article had fostered a growing awareness of the potential for ethical problems and dilemmas in epidemiology and clinical research.25,33,56–58 Some ethical issues in epidemiological research and practice drew widespread attention in the 1970s when
U.S. legislators responded to public concern and began drafting stringent laws, including the Privacy Act of 1974 to protect the privacy and confidentiality of medical records.59 Similar data protection legislation was enacted in the Federal Republic of Germany in 1970, and Great Britain followed suit in 1984. Because of this legislative trend, some forms of epidemiological research and routine surveillance activities, including study designs that had provided important insights into the environmental causes of disease, were at risk of becoming unjustifiably restricted. Leading epidemiologists responded to the threat of growing limitations on the use of routinely collected medical records by explaining the usefulness of the endangered research to society and future patients and by outlining the confidentiality safeguards that should be employed by epidemiologists.60 An influential article by Leon Gordis, Ellen Gold, and Raymond Seltser on privacy protection in epidemiological research appeared in the American Journal of Epidemiology in 1977, the same year that the Privacy Protection Study Commission report was released in the United States.60,61 Mervyn Susser, Zena Stein, and Jennie Kline published a far-ranging paper on ethical issues in epidemiology in 1978.62
In the late 1970s, epidemiologists had no ethics guidelines or professional codes of conduct specific to their field. Unlike many other professional groups, they had no acknowledged means of self-regulation.59 As a result of the growth of epidemiology graduate programs for nonphysicians, epidemiologists were being trained without direct exposure to the ethical traditions of medicine.20,60
The 1980s
New public health problems, such as the global spread of AIDS, brought new ethical questions, as discussed by Carol Levine in Chapter 9. In the mid-1980s, Colin Soskolne and others proposed the development of ethics guidelines for epidemiologists.63,64 In “Epidemiology: Questions of Science, Ethics, Morality, and Law,” published in the American Journal of Epidemiology in 1989, Soskolne argued that ethics guidelines could be useful for teaching purposes and as a framework for the debate of ethical issues.59
By 1987, the Society for Epidemiologic Research had formed committees to examine the ethical problems of conflict of interest and access to data by third parties. Also in 1987, the International Epidemiological Association held a major session on ethics at its annual conference in Helsinki, Finland. The Industrial Epidemiology Forum organized a conference on ethics in epidemiology in Birmingham, Alabama, in 1989, in conjunction with the annual meeting of the Society for Epidemiologic Research. The papers presented at this conference were published in 1991 with proposed ethics guidelines for epidemiologists.65,66
The 1990s
In 1990, the International Epidemiological Association circulated draft ethics guidelines for epidemiologists at an ethics workshop in Los Angeles,67 and the International Society of Pharmacoepidemiology established an ethics committee. The next year, the American College of Epidemiology established its Committee on Ethics and Standards of Practice and CIOMS published the CIOMS International Guidelines for Ethical Review of Epidemiological Studies.59,68
By this time, most major groups of epidemiologists had seen the importance of a number of ethical issues. Epidemiologists in Italy, Canada, the United States, and many other countries had discussed the development of ethics guidelines for epidemiologists. A symposium on Ethics and Law in Environmental Epidemiology was held in Mexico City in 1992 in conjunction with the annual meeting of the International Society for Environmental Epidemiology (ISEE),69 and the WHO and the ISEE jointly convened an International Workshop on Ethical and Philosophical Issues in Environmental Epidemiology in North Carolina in 1994, where findings of an international ethics survey were presented.70,71 The International Clinical Epidemiology Network Ethics Group also met during 1994 to discuss the recently published CIOMS ethics guidelines and to determine which participating clinical epidemiology units around the world were adequately protecting human subjects.
In the mid-1990s, many epidemiology graduate programs began incorporating an ethics curriculum (see Kenneth Goodman and Ronald Prineas in Chapter 10).72 During this period, the Society for Epidemiologic Research, the American College of Epidemiology, and other international professional organizations for epidemiologists began including ethics workshops in their annual meetings. By July 1994, membership in the American Public Health Association (APHA) Forum on Bioethics, which organizes sessions on bioethics and public health during the APHA annual meeting, had risen to 145 bioethicists, legal experts, epidemiologists, and other public health professionals. These developments in professional ethics in epidemiology occurred against a background of social and political movements in the early 1990s that included vigorous efforts to ensure that women and minorities were adequately represented in research projects funded by NIH.73,74 NIH launched the Women’s Health Initiative in 1991, and other epidemiological investigations of understudied women’s health problems began during this period.75 Women’s health advocates testified on Capitol Hill in support of increased federal spending for breast cancer research and improved procedures for recruiting and obtaining the informed consent of patients in breast cancer chemoprevention trials. Other important developments during this period included increased public concern about the integrity of scientific research.69,76
Another development in Europe and North America was renewed concern among legislators, data protection advocates, and members of the general public about the privacy and confidentiality of information in health information systems. In light of pending legislation in the European Community that would severely restrict the use of routinely collected medical data for epidemiological research,7 both the International Society for Pharmacoepidemiology Ethics Committee and the joint WHO–ISEE International Workshop on Ethical and Philosophical Issues in Environmental Epidemiology have made recommendations to policymakers and legislative bodies that underscore the societal value of epidemiological research (for example, the contribution of epidemiological studies to scientific knowledge about the etiologies of birth defects and cancer).70
From 1995 to the present, there has been an increased recognition of the societal importance of epidemiological research and practice. The ethical duties of epidemiologists have also been clarified.78 In addition, the number of publications on ethical issues in epidemiology has continued to increase.78–90 Many of these articles have dealt with professional responsibilities of epidemiologists.88,90 Ethical issues in public health practice have also increasingly been addressed,84,91 as discussed by Robert McKeown in Chapter 7. Interest in ethical issues in epidemiology has extended beyond North America and Europe to include researchers in many other parts of the world, including developing countries.
One sign of the increased attention to ethics in epidemiology in recent years is the development of refined guidelines for epidemiologists and policy statements on data sharing, privacy and confidentiality protection, DNA testing for disease susceptibility, and other issues.86,87,92–94 Ethical issues in genetic epidemiology are discussed by Laura Beskow, Stephanie Malia Fullerton, and Wylie Burke in Chapter 8. The ISEE adopted ethics guidelines for environmental epidemiologists in 1999.95 The American College of Epidemiology adopted a set of ethics guidelines for epidemiologists in North America in 1999.96
Ethics surveys of epidemiologists and other public health professionals, public health students, and institutions that train epidemiologists and other public health professionals have provided information about the ethical interests and concerns of epidemiologists.97–101 Several institutions that train public health professionals have created new courses on ethics in epidemiology and public health.99,102 Other institutions have created curricula on public health ethics for epidemiology graduate students, and the Association of Schools of Public Health has developed model curricula in public health ethics, as discussed by Kenneth Goodman and Ronald Prineas in Chapter 10. In the United States, these efforts have been strengthened by training on ethical principles and IRB procedures recommended by the Office for Human Research Protections of the U.S. Department of Health and Human Services.103
