Ethics
and
Public Health:
Model
Curriculum
Editors:
Bruce Jennings, MA
The Hastings Center
Jeffrey Kahn, PhD, MPH
University of Minnesota
Anna Mastroianni, JD, MPH
University of Washington
Lisa S. Parker, PhD
University of Pittsburgh
Ethics and Public Health:
Model Curriculum
Editors:
Bruce Jennings, MA
The Hastings Center
Jeffrey Kahn, PhD, MPH
University of Minnesota
Anna Mastroianni, JD, MPH
University of Washington
Lisa S. Parker, PhD
University of Pittsburgh
This project was supported under a cooperative agreement from the Health Resources and Services
Administration (HRSA) through the Association of Schools of Public Health (ASPH). Grant Number 1D38AH10001-05. The contents of this report are solely the responsibility of the authors and do not
necessarily represent the official views of HRSA or ASPH.
Preface
There is a growing interest in the ethical, legal, and social aspects of public health policy and practice.
This interest no doubt has been fueled by the threat of bioterrorism after 9/11. But it had been growing
for some time before that in the wake of various infectious disease outbreaks and with the growing
recognition that public health issues are inseparable from issues of human rights and social justice,
problems of cultural and behavioral change, and environmental issues on a global scale. With this
growing interest in ethics in public health comes a demand for the teaching of ethics and for resource
materials to support it. Ethics education is needed both in pre-professional degree and certificate
programs, and in settings of continuing professional education. This model curriculum for Ethics in
Public Health is intended as a resource to enhance and encourage thoughtful, well informed, and
critical discussions of ethical issues in the field.
Ethics in Public Health: A Model Curriculum grew out of a series of meetings and discussions by
leading researchers and educators in public health beginning with a meeting convened in Washington
DC in May 2000. This meeting was sponsored by the Association of Schools of Public Health (ASPH)
and the Health Resources and Service Administration (HRSA). It brought together teachers of ethics
from nearly every school of public health, other experts in ethics and public health, and representatives
of the government and public health practice communities. One of the clearest recommendations to
come out of that meeting was that educational materials and resources should be developed to enhance
curricular and continuing professional education offerings. HRSA generously agreed to fund the
development of a collection of modules, through their Cooperative Agreement with ASPH.
In June 2001 a special advisory group was formed and met in Washington to plan the new curriculum.
During this period The Hastings Center was working on a project funded by the Robert Wood Johnson
Foundation to promote the discussion of ethical issues within public health. This effort converged so
well with the HRSA/ASPH effort that the two groups joined forces and their collaboration began with
the advisory meeting. At that meeting it was agreed that the curriculum would take the form of several
self-contained units or modules, each written by a leading expert on the topic in question, and each
containing the same types of resources for classroom use—an analysis of the ethical question, several
case studies with commentary for discussion, resources for further study and research, and the like.
Shortly after the June 2001 advisory group meeting experts in ethics and public health were recruited to
write the modules, with the understanding that they would work closely with local members of the
public health practice community to be sure that concerns and issues from the practice community were
well represented. The input of the practice community was critical to the quality and credibility of the
modules, and we thank these consultants for their generous participation.
During the period in which the modules were being developed, meetings and workshops continued the
discussion begun in Washington. These included a working group on ethics and public health at The
Hastings Center, a summer workshop on ethics and public health co-sponsored by the University of
Minnesota Center for Bioethics and The Hastings Center, and conference workshops on teaching ethics
in public health at annual meetings of both the American Public Health Association and the American
Society for Bioethics and Humanities.
We trust that this collection will serve as the springboard for many discussions of public health ethics in
classrooms and workshops, and we hope that the curriculum development discussion continues as well.
v
Since the modules exist in electronic form, we see them as continuing works in progress. To that end,
we hope that those who use these materials will provide us with feedback about what works, what needs
improvement, and what additional information and topics might be added to future editions of this
curriculum. You can e-mail your comments to either Jeff Kahn at kahnx009@umn.edu, or Bruce
Jennings at publichealthcurriculum@thehastingscenter.org and please type “public health ethics
modules” in the subject line.
The development of this curriculum was made possible by the support of HRSA and the Robert Wood
Johnson Foundation, and through the cooperation of ASPH, the University of Minnesota Center for
Bioethics, and The Hastings Center.
Finally, the entire project could not have been completed without the staff at ASPH, who included
Wendy Katz, Sandra Maldague, and Monica Stadtler. We thank them, along with all those who
participated in the many workshops and conferences for their input and insights. Lastly, we offer our
sincere thanks to the modules’ authors who enthusiastically undertook the task of creating this valuable
resource for the public health community.
Bruce Jennings
Jeffrey Kahn
Anna Mastroianni
Lisa Parker
July 2003
vi
LIST OF CONTRIBUTORS
Hilary K. Alvarez
Dartmouth College
Ronald Bayer, PhD
Joseph L. Mailman School of Public Health, Columbia University
Ruth Gaare Bernheim, PhD
Institute for Practical Ethics, University of Virginia
Richard Bonnie, LLB
School of Law, University of Virginia
Michael Garland, D.Sc.Rel.
Department of Public Health and Preventive Medicine, Oregon Health & Science University
Lawrence O. Gostin, J.D., LL.D (Hon.)
Georgetown University Law Center
Elizabeth Heitman, PhD
University of Mississippi Medical Center, Jackson, Mississippi and
University of Texas School of Public Health, Houston, Texas
Bruce Jennings, MA
The Hastings Center
Jeffrey Kahn, PhD, MPH
Center for Bioethics, University of Minnesota
Patricia A. Marshall, PhD
Department of Bioethics, Case Western Reserve University
Anna C. Mastroianni, JD, MPH
University of Washington School of Law and Institute for Public Health Genetics
Laura C. McKieran, DrPH
El Centro del Barrio, San Antonio, Texas
vii
Phillip Nieburg, MD, MPH
Center for Biomedical Ethics, University of Virginia
Lisa S. Parker, PhD
Center for Bioethics and Health Law, University of Pittsburgh
Kristin Shrader-Frechette, PhD
Department of Biological Sciences and Department of Philosophy, University of Notre Dame
John Stull, MD, MPH
Department of Public Health and Preventive Medicine, Oregon Health & Science University
James Thomas, MPH, PhD
School of Public Health, University of North Carolina at Chapel Hill
Stephen Thomas, PhD
School of Public Health, University of Pittsburgh
viii
TABLE OF CONTENTS
Module 1:
Tradition, Profession, and Values in Public Health
Lawrence O. Gostin, J.D., LL.D (Hon.) ……………………………………………………………..Page 13
Module 2:
The Legacy of the Tuskegee Syphilis Study
Lisa S. Parker, PhD; Hilary K. Alvarez; Stephen Thomas, PhD ………………………………..Page 37
Introduction to Modules 3 and 4:
Research Ethics in Public Health
James Thomas, MPH, PhD …………………………………………………………………………….Page 75
Module 3:
Public Health Research and Practice in International Settings: Special
Ethical Concerns
Patricia A. Marshall, PhD………………………………………………………………………………Page 85
Module 4:
Community-Based Practice and Research: Collaboration and Sharing Power
Elizabeth Heitman, PhD; Laura C. McKieran, DrPH ……………………………………………..Page 103
Module 5:
Ethics and Infectious Disease Control: STDs, HIV, TB
Ronald Bayer, PhD ………………………………………………………………………………………Page 133
Module 6:
Ethics of Health Promotion and Disease Prevention
Ronald Bayer, PhD ………………………………………………………………………………………Page 147
Module 7:
Ethical Issues in Environmental and Occupational Health
Kristin Shrader-Frechette, PhD ……………………………………………………………………….Page 159
Module 8:
Public Health Genetics: Screening Programs and Individual Testing/Counseling
Ruth Gaare Bernheim, PhD; Richard Bonnie, LLB; Phillip Nieburg, MD, MPH……………Page 193
Module 9:
Public Health and Health System Reform: Access, Priority Setting, and
Allocation of Resources
Michael Garland, D.Sc.Rel.; John Stull, MD, MPH ………………………………………………Page 241
ix
INTRODUCTION:
A Strategy for Discussing Ethical Issues in Public Health
Bruce Jennings, M.A.
The Hastings Center
Yale School of Public Health
This is a general introduction and orientation to the ethics and public health curriculum. It explains the
goals and strategy for ethics education and training and provides guidance about the skills of facilitating
an ethics discussion with adult learners.
Why This Curriculum Was Created
Public health policy and interventions are always the product of controversy, and often remain
surrounded by controversy as they are implemented. Routinely in public health, scientific considerations
blend with political and ethical conflicts, and questions of autonomy, individual rights, coercion,
justice, community, the common good, the norms of research, and multi-cultural values are central. In
public health today several different types of political and moral theory overlap, converge, and contend
with one another, including libertarian liberalism, egalitarian liberalism, utilitarianism, human rights
frameworks, and communitarianism. This curriculum will explore the “application” of ethics to a broad
range of contemporary public health issues. It is intended for use both in pre-service educational
programs at the undergraduate and graduate level, and for in-service continuing professional education
settings in public health agencies and related organizations.
This curriculum and facilitator’s guide offers a planned approach to the discussion of ethical and values
issues in public health. It is designed to help you identify appropriate topics and issues for discussion—
issues that are pertinent to the public health practitioner and policymaker, and issues that lend
themselves to an in-depth discussion of the often-conflicting values and ethical dilemmas raised by
current public health knowledge and its applications.
Ethical issues are rarely neat, tidy, or cut-and dried. The questions of genetics, international and
community based research, the control of infectious disease, and others that have been selected for this
program are particularly difficult. They pose ethical “dilemmas” rather than black and white moral
questions. They involve quandaries about which well-informed persons of good will can reasonably
disagree.
For this reason, these materials will not offer clear-cut answers to many of the ethical issues raised. The
best and most responsible thing an educational program can do in the face of these moral and social
dilemmas is to provide public health practitioners with many perspectives on the issues, and to guide
their own reasoning processes toward conclusions with which not everyone will necessarily agree, but
which can stand up under close scrutiny and open dialogue with others.
Introduction
1
What is Ethics?
Terms like “ethics,” “morals,” “morality,” and “values” will occur frequently in this curriculum. It would
be helpful to define them clearly and succinctly at the outset. Unfortunately, however, this is not easy or
even possible to do.
Ethics and morals are most often used interchangeably, so that the sentence “He acted ethically,” and
the sentence “He acted morally,” mean the same thing. Sometimes, though, morality (or morals) is
defined as the beliefs and standards of good and bad, right and wrong, that people actually do and
should follow in a society, while ethics is defined as the systematic study of morality. Ethics, in other
words, is the theory and morality is the practice; morality is what people do and believe, ethics gives a
philosophical account of justified behavior and belief.
Moral values are those things that people should prize and promote. Values are names for states of
affairs that conform to what is ethically right and that further the human good (or the good of all
beings).
Understood as the systematic study of morality, ethics is often divided into two subfields, metaethics
and normative ethics. The relationship between them may be compared to the relationship between the
philosophy of science, on the one hand, and science itself, on the other. Metaethics tries to clarify the
rational standards and methods for the study of ethics, much as philosophy of science tries to clarify the
nature and method of scientific inquiry. Normative ethics is where the substance of ethics resides. It
develops ethical principles, rules, and ideals that spell out standards of good and bad, right and wrong.
Normative ethics tries to offer a substantive, albeit general answer to the questions, What should I do?
And How ought I to live? And it tries to spell out reasons why a rational person ought to accept the
answer it gives.
Bioethics is normative ethics applied to decisionmaking and public policy in the domains of biology,
medicine, and health care. It is concerned with matters of basic scientific research and with the social
applications of biological knowledge and biomedical technology. Medical ethics, the ethics of the
physician’s role, is as old as medicine itself. But bioethics is a newer, broader field of study that has
arisen largely during the past twenty to thirty years as new powers, new choices, and new dilemmas have
been opened up by the biological revolution.
Public health ethics, in turn, has arisen along side bioethics and the two fields of applied ethics have
many strong affinities and connections. Just as the perspective and focus of public health often differs
from that of clinical medicine, however, so too are there important differences between bioethics and
medical ethics, on the one hand, and public health ethics on the other. In a nutshell, the difference can
be characterized by the individualistic orientation of clinical medicine and the social or population
based perspective of public health. Public health deals with patterns of disease, the social determinants
of disease, and collective and institutional solutions to alleviate the risk or burden of disease in a
population and to affect the distribution of health benefit and disease burden in a society, or globally.
Nonetheless, public health should not overlook the rights, interests, and freedom of the individual.
Whenever possible, public health goals should be reconciled with the promotion of human rights and
the protection of civil liberties. If there is an inevitable clash between public health and civil liberties,
then the situation must be open to public debate, the elements of the conflict should be made explicit,
Introduction
2
and rigorous, critical reasoning should be brought to bear on the relative benefits and burdens of a
particular policy or intervention.
A Strategy for Ethics Education
Many teachers or facilitators find group discussions of ethics and values frustrating and difficult because
such discussions tend to jump all over the place. They may seem to have no rhyme or reason, no logical
order or sequence of information to discover and points to consider. Ethics discussions seem to have
no starting point, no sense of progress and forward movement, and, worst of all, no satisfying
resolution or conclusion.
Ethics discussions need not be like this; they need not be an educator’s nightmare. They can—and
should—follow an orderly progression of steps. And they can end, if not always with firm, agreed-upon
conclusions, then at least with the feeling that something has been clarified—people have been led to
think.
As with any education program, regardless of the subject matter, achieving these results when
discussing public health ethics requires careful planning and some background preparation by the
discussion leader or facilitator. If you have a good grasp of the issues on all sides of a question (which
is not the same thing as having strong personal convictions on one side or another), then you will be in
a position to guide the class discussion so that the participants are led to discover and express these
issues themselves and to think thoroughly about the pros and cons. Much of the material in this
instructor’s guide is designed to provide the background information and ideas that will assist
facilitators in this way.
Moreover, to keep the participant’s thinking about ethical questions focused and moving forward, you
need to devise a strategy for analyzing ethical questions in concrete cases or situations. A strategy for
guiding discussion and learning gives you an overview of what a good ethics discussion should contain
and where it should lead.
The strategy we recommend for use with these educational materials and case studies consists of the
following six steps or tasks to complete during each module. Completing these tasks is one way to
provide a structure for discussion and to keep it focused. Completing these tasks is also one way to
ensure that the participants are given a thorough exposure to the ethical issues in each unit.
Identify the ethical problem(s) germane to the decision. What has to be decided, by whom, and
what ethical problem(s) does this decision seem to raise? In complex cases this problem identification
step will actually be only a “first cut”; the identification of the problem will be refined and revised as the
situation is understood more deeply and as the ethical values and concepts that explain why the
problem is a problem are articulated.
Assess the factual information available to the decisionmaker(s). Of all the facts that are known
now, which are relevant to the ethical problem, and which are not relevant? For example, the fact that a
pregnant woman has brown hair is not relevant to the ethical question of genetic screening, while the
fact that she has a history of cystic fibrosis in her family is. Equally important, what is not known that
should be known before a decision is made, and how can that information be obtained? Finally, how
Introduction
3
reliable is the information we have, and what type of information is it? How can we separate fact from
hearsay or opinion? How can we assess probabilistic information in making ethical decisions?
Identify the “stakeholders” in the decision. Who will be affected by the decision, and in what ways?
How directly will they be affected—if they will be harmed is the harm justified by greater benefit to
others? Is the harm intended by the decision-maker or is it merely foreseeable? Have they placed
themselves in a position to be harmed voluntarily and with appropriate information and understanding
of the risks involved? Or are they “innocent bystanders”? How do all these factors affect the weighing of
benefits and harms involved in the decision?
Identify the values at stake in the decision. Values are those things that have significance or worth
relative to some state of affairs, such as human well-being, respect for persons, or fairness that is taken
to be good or desirable in itself. In this step the values that seem relevant to the situation should be
identified and discussed. Here the instructor can provide a kind of common vocabulary of concepts to
assist with the discussion, for participants will often grasp the concept without having the commonly
used word or label to express it. Freedom, truth telling, protecting another from harm, fairness, respect
for other people, empathy, altruism, the growth of scientific knowledge—these are a few of the values
that are typically presented by cases in public health ethics.
Identify the options available to the decisionmaker. At first glance, many ethical cases seem to pose
very stark moral choices, even tragic choices where no outcome is without significant human cost. There
are tragic choices in life, it is true, and it is important for participants to be able to face that fact and
consider how they will learn to live with the decision they had to make. But it is equally important not to
give the impression that all moral choices are tragic choices. Part of the skill of thinking analytically
about moral decisionmaking is to see beyond artificially narrow options and forced choices. Insightful
moral reasoning is often a process of resisting forced choice, and wiggling out of a moral dead end in
order to find some more acceptable alternative. Would more information enable us to see more options
here? Can we wait until that information is available? Is some compromise or middle way possible that
will respect a broader range of values and more stakeholders’ interests than any other option? Ethical
decisionmaking is akin to creative problem solving, and seeking the Yes-Yes or Win-Win solution.
Consider the process for making the decision and the values that pertain to the process. A few
such values would be authority, legitimacy, participation, and due process rights to be heard and to
appeal. These topics may appear legalistic, but they apply in virtually any decisionmaking situation to
some extent, in families no less than in bureaucratic or legal settings. Should I be the one making this
decision? To what extent and in what ways should I involve others in the decision? Will the outcome of
my decision be shaped by the cooperation of others with the decision I have made, and will their
willingness to cooperate be shaped by whether or not they view my decision as fair and legitimate? If the
ethical justification of my decision hinges on a good outcome I expect, but if that good outcome
assumes the cooperation of others, then ethically I also have to take steps to assure that cooperation
beforehand. So what I decide is only half of the ethical equation. How I decide is also important.
What Should You Try To Accomplish?: Learning Objectives
The goals of ethics education at various developmental levels remains a subject of considerable
controversy. Our program does not assume that the teaching of ethics will automatically produce
professionals who are more ethical in their personal choices and behavior than they would be without
Introduction
4
the instruction proposed by the program. That goal demands too much—clearly there are many more
important sources of moral belief and motivation in their lives than a few hours of discussion in a
classroom or a conference room. But, in another way, that goal also demands too little—for the
teaching of ethics is concerned not only with how people behave but also with the reasons they have for
behaving as they do.
There are five general goals of ethics education that have guided the development of these materials
and that facilitators should bear in mind when using them.
1. Stimulating the Moral Imagination. Ethics education should produce a blend of cognitive and
affective components. Ethical thinking, judgment, and sensibility are neither matters of pure, abstract
intellect nor of unreflective “gut feelings” and prejudices. Regardless of the specific subject matter
under discussion, guiding your participants or colleagues through the components of ethical reasoning
can help them gain a better appreciation of the fact that human beings live their lives in a web of moral
relationships. It will also show them that moral conflicts, which are frequently inevitable and difficult,
involve high stakes in the lives of real people. Stimulating the moral imagination involves the ability to
gain a feel for the lives of others, some sense of the motions and the feelings that are provoked by
difficult ethical choices, and some insight into how moral viewpoints influence the way individuals live
their lives. And the goal is not simply to stimulate but also to broaden the moral imagination—to begin
with what people at first feel to be right or good, but then to deepen and sometimes to challenge and
change those feelings by transforming them into more reflective judgments and more sophisticated and
well-informed convictions.
2. Recognizing Ethical Issues. Ethics education is not unlike scientific education in one respect: it
involves a certain structuring of perception, a certain kind of “seeing as.” To see a certain state of affairs
or decision as a moral issue is to see that it raises considerations of human value, and that it has
significant implications for harms or benefits human beings experience. To see something as a moral
issue is also to see that it involves questions of human freedom and choice, that it could be different
from what it is, and that the way the choice it permits is made significantly affects the rights and wellbeing of individuals involved in or affected by the choice.
3. Developing Analytical Skills. Ethical analysis involves the use of a certain set of prescriptive and
evaluative categories, such as rights, duties, virtue, justice, responsibility, freedom, respect, dignity, and
well being. These categories comprise the basic moral vocabulary of our society. However, they are
difficult to define and their meaning is never determined once and for all, but is worked out instead in a
process of dialogue, moral disagreement and debate. Participants need to acquire the ability to use
these concepts in constructing arguments that are logical, consistent, and defensible in the face of
reasoned disagreement and challenge. Analytical skills also involve the ability to make conceptual
distinctions so that ethical claims are not unduly broad and undiscriminating. Finally, the ability to
detach oneself from personal interests and parochial perspectives is an analytical ability that must be
practiced and learned. During the course of discussion it is a good idea to check for the presence of
this detachment from time to time. If a participant states or agrees with a moral rule that would limit the
freedom of others, ask if he or she would be willing to have the rule applied to his or her behavior too.
4. Eliciting a Sense of Moral Obligation and Responsibility. Ethics discussions usually start with
simple assumptions and beliefs, challenge them, and replace them with more nuanced thinking. In this
way, ethical analysis sometimes makes moral choice more, not less, difficult and complex. And properly
Introduction
5
so. On the other hand, in ethics teaching you should be careful not to paralyze or intimidate the
participant with such hard cases or dilemmas that ethics seems hopeless. The point is to enable them to
make better, more thoughtful choices, not to make choices seem impossible or simply arbitrary, like a
coin toss. The goal is to enable participants to see when and how their own actions and choices do
make a difference in the lives of others as well as in their own life. It is to motivate them to take action
in accordance with ethical commitments and to assume a sense of responsibility for their own conduct,
as well as for the effects of their conduct on others.
5. Coping with Moral Ambiguity. It is simply a fact of life that we must learn to tolerate
disagreements and to accept the inevitable ambiguities that arise when examining ethical problems.
Many ethical issues admit of no final, clear resolution. Reasonable persons of good will may disagree on
the course of action that ethical considerations require. Yet while we must tolerate disagreement and
ambiguity, we must also attempt to locate and clarify the sources of disagreement, to resolve
ambiguities as far as possible, and to see if ways can be found to overcome differences of moral
viewpoint and belief. Group discussion built around the ethics modules in this curriculum can model
these goals. Through directed group discussion you can demonstrate that progress can be made in
reducing disagreement, and in gaining a narrower, and perhaps more manageable, area of
disagreement. It is important not to simply assert this but to show how it can happen. Participants
should be led to understand that there are general standards by which to judge the quality of ethical
arguments, that disagreements are inevitable but can be reduced, and that ethical perspectives can be
detached from pure subjectivity or self-interest. Questions of right and wrong, good and bad may finally
admit of no single or final answer, but this does not mean that the answers we do and must give are
simply matters of taste.
Leading Ethics Discussions
It is perfectly natural to feel uncomfortable with the subject matter of public health ethics and with the
special challenges of “teaching ethics.” Most public health professionals who will be using these
materials will not have any formal training in philosophy or ethics.
Make no mistake: the key to any successful group discussion of ethical questions lies in the skill of the
facilitator who guides the discussion and in the curiosity and engagement of the participants. They must
open their minds to unfamiliar ideas and learn to see connections between decision, actions, and their
consequences for the person, for others, and for society as whole. Curriculum materials can’t do the
work of good teaching. Drawing on the strengths that public health professionals can bring to the
task—maturity of judgment, logical reasoning and analytic skills, and mastery of the scientific subject
matter—we believe that these materials will provide you with the tools you need to handle ethical and
value questions in a constructive, thoughtful fashion with your participants.
You won’t be preaching to them. You won’t be giving them the definitive answers or imposing your own
personal moral beliefs on them. Nor will you be presiding over a session in which everyone simply
makes personal statements of their “values” without engaging in genuine dialogue or without being
called on to give reasons in support of their beliefs.
You will be helping participants and colleagues think more consistently and completely through
problems that they will have to face soon—or are facing now—in their own careers in public health.
Introduction
6
Each of the ethical topics in the program raises questions of choice—understanding the options one
has—and questions of responsibility—what values are at stake in one’s choices and what moral
principles, rights, and obligations should guide those choices. Eliciting a sense of responsibility on the
part of the participant is one important objective of all ethics teaching, and especially in health care,
where so many of the issues do in fact involve decisions that individuals will probably have to make
sometime in their lives, be it reproduction, medical care for a child or a loved one, or choices as
consumers and as citizens that affect the environment.
Before a discussion of ethics can get off the ground, two pervasive feelings, which are probably
widespread even among advanced students and public health professionals, must be overcome. The first
is a sense of powerlessness and alienation–the feeling that nothing one does as an individual really
makes any difference. When you feel helpless you are not prone to accept the idea that you have
responsibility for what happens to you or for what goes on in society. Of course, this perception is not
simply to be dismissed; there is a large kernel of truth in it. But it should not be allowed to lead to
apathy and the denial of the participant’s own moral agency and responsibility. The trick is to make
connections between the “big issues” and more tangible, controllable aspects of personal life, and to
lead the discussion beyond the classroom by considering ways participants can get involved in
community activities that address some of the problems discussed in class. These materials have been
organized in a way that will help make those connections and provide some type of follow up.
The second obstacle to overcome is the feeling of invulnerability—the belief that these issues affect the
interests and lives of others, but won’t touch my family or me. Here too eliciting a sense of
responsibility is coupled with good factual information and with the connection-making capacity that is
inherent in what we have called the moral imagination. However comforting it may be, the notion of
personal invulnerability is an illusion in contemporary society. The bad choices others make with the
knowledge and technologies made available by the life sciences do affect us all.
A large part of ethical analysis involves tracing the chain of consequences that follow from a given
action as they ripple through the lives of other people. It involves estimating the probability or
likelihood of various possible outcomes that are foreseeable at the time of the action, and evaluating
those possible consequences as beneficial or harmful, good or bad, right or wrong, in terms of some
background ideas of ethical principles, duties, and ideals of human freedom and well-being. Examining
these consequences of action is one part of the process of giving reasons for or against the action, and
it also has the side effect of enabling participants to perceive—perhaps for the first time—the
interconnections between what they do and the lives of other people, as well as what other people do
and their own lives. Blindness, not maliciousness, is often the source of harmful, irresponsible conduct.
Ethics education may or may not be able to overcome bad character, but it can mitigate ethical and
social misperception.
To elicit a sense of responsibility and to chip away at feelings of powerlessness and invulnerability, the
materials in this program have been set up to focus oftentimes on an analysis of ethical decisionmaking.
This is only one approach to ethics, to be sure, since it is also important to look at large patterns of
conduct, the shape and functioning of institutions, and broad social and historical forces that serve to
limit the actions of individuals. To handle those issues that are in fact matters of collective choice and
public policy rather than private, individual choices, the discussion can be framed as the
decisionmaking of government policymakers (or corporate officials), or indeed as a question for society
as a whole. The question: “How should I decide what to do morally in this situation?” is parallel to the
Introduction
7
question “How should society (or decisionmakers acting on behalf of society) decide what to do morally
in this situation?” The considerations that factor into each of these questions may be different and the
answers may not be the same: at times it may be ethically appropriate for an individual to decide one
thing and for society to decide another. But in this case you still have good food for thought in an
ethics discussion because after the class has come to the conclusion that society’s answer should be
different from the individual’s, you can go on to ask: What then should be done about this conflict or
tension? How should the rights, freedom, and privacy of the individual be protected, and how should
the interests of the individual be balanced against the interests of others and of society as a whole?
One of the biggest single hurdles to overcome in leading an ethics discussion is to become willing to
tolerate disagreement and ambiguity yourself. So much education today assumes that participants are
containers into which the teacher pours facts, information, and authoritative opinion. And in science
especially perhaps, the participants come to expect that there are right answers that they must learn to
come to, and which the teacher possesses to give them if necessary. In public health ethics the right
answers are not in the back of the book; and you won’t have them all either, because there are
sometimes no definitive right answers, only answers that are more or less reasonable, more or less
defensible and justifiable in the light of reflection, analysis, and dialogue. So an ethics session will take
some adjustment of expectations on your part and on the part of your participants. Perhaps it is best to
raise this very point with the participants right at the outset.
In ethics things become clearer as you talk about them in group discussion. Initial ideas and feelings
(philosophers call them moral intuitions) are not supposed to be flawless or complete at the beginning.
Make the point that an ethics discussion is not a competition. (That is another habit of our schooling
that ethics pedagogy must resist.) There is nothing wrong with expressing an idea that others will
disagree with, and that the participant will modify as he or she goes along. Initial ideas and opinions
must be put out on the table so the whole thing can get started. If you can create a non-threatening
environment, most participants will present ideas on these ethical questions because they do have ideas
and because it is gratifying for all of us to be in a situation where others want to hear our ideas and take
them seriously, even if they disagree with them.
Note, however, that a non-threatening environment does not mean a value-neutral or non-judgmental
environment. This is one mistake that has been made by the so-called values clarification approach to
ethics education. The ethics discussion should be open to many different ethical or value
perspectives—indeed one key part of the exercise is to inventory the various and often conflicting
values at stake. But openness is not value-neutrality or indifference. The teaching approach we
recommend in these materials is very definitely and strongly affirming of several substantive educational
values (which are also ethical values): namely, the values of clear and logical reasoning, empathetic
imagination, tolerance and respect for others, decisionmaking on the basis of solid information, and a
careful assessment of the consequences of the action on others.
Gently, but firmly, the ideas, reasons, and arguments offered by the participants should be guided and
redirected in accordance with those standards. False factual or scientific assumptions should be
corrected, inconsistent beliefs and ideas should be exposed, faulty reasoning and logic should be
pointed out and avoided, and the hidden assumptions and implications of ideas should be clarified and
made explicit so that participants will more fully and deeply understand the nature and implications of
the moral arguments they are making. A greater degree of self-consciousness about one’s moral beliefs
is usually a more effective means of getting participants to rethink and refashion those beliefs than is
Introduction
8
the authoritative imposition of the facilitator’s moral beliefs on the participant. This is the kind of moral
learning that will last.
As much as possible try to allow the give and take of class discussion to discover these standards of
argument and analysis spontaneously. Be patient if things don’t move forward quickly; the discussion
should be exploratory as well as task oriented. Try not to lecture or to do the analysis for the
participants; instead, you can accomplish more when you play traffic cop and let participants express
themselves for awhile and then intervene to summarize and clarify from time to time, fitting what has
just been said into a framework: “Now, let’s pause for a minute to think about what John just said and
how it relates to Nancy’s position. John is basically saying that Nancy can’t have it both ways,” and so
on.
This will have the added benefit of helping to deal with another common obstacle to a productive ethics
discussion: the widespread ethical subjectivism and relativism of American culture. In a nutshell, ethical
subjectivism is the idea that moral beliefs have no rational or interpersonal basis, they are only outward
projections of subjective preference that may (and probably will) differ from one person to the next.
Relativism, a closely related notion, is the view that there are no universal standards of right and wrong;
what is right for one person, or society, is not necessarily right for another person or society. For both
subjectivism and relativism the entire enterprise of having a reasoned discussion about ethics is suspect
inasmuch as rational dialogue, persuasion, and agreement about ethics and values are impossible.
Few people will articulate these positions in any elaborate way, but many will feel an uneasiness about
having an ethics discussion. This uneasiness comes from relativism and subjectivism. Many may also
associate ethics with the imposition of rules and restrictions by authority figures whom they consider
arbitrary and illegitimate. Relativism and subjectivism tend to see all of ethics in this way and feed off of
rebellion against such authority.
In keeping with the goal of developing a sense of personal responsibility and empowerment, it is
important to stress that “ethics” as it will be discussed in these sessions does not have primarily to do
with the imposition of rules from above; it has to do instead with the creation of rules and standards
from within each of us; it has to do with being a responsibly self-directing adult in a free society where
individuals are allowed a fairly wide range of moral discretion and choice. But that freedom is possible
only because reason and clear thinking do make a difference in ethics. We may often not know exactly
what is right, but we can attempt to justify and give reasons for what we do, and we can be guided in
our choices by what seem to be the best justifications and reasons we can come up with from our own
thinking and with the help of others.
The best response to ethical subjectivism and relativism as they are vaguely felt by participants is simply
to plunge in and “do ethics.” To say, “It’s all right to be skeptical, but just put your doubts on hold for a
while and let’s try this and see what happens.” Much of their wariness and skepticism will fade as they
experience a sustained ethics discussion and discover what it is like to think hard and carefully about
ethical and value questions in the company of a facilitator and fellow participants who are also trying to
be serious and thoughtful.
At the other extreme, some participants or colleagues may be ethical absolutists, who also do not see
the point of an ethics discussion because they already know the right answer and do not wish to defend
their beliefs by giving reasons or to make themselves open to other views. Obviously, it is important to
Introduction
9
respect participant beliefs that are strongly held or are based in a religious perspective. In this case it is
probably best to depersonalize the meaning of the exercise somewhat by pointing out that however
secure a person may be in his or her own religious faith and belief, we still must live with others in a
secular and pluralistic society where it is important to at least understand other people’s point of view,
even if we don’t share it. And we must all learn to find some common ground and some shared ideas so
that we can communicate with one another about matters of ethics and values. Just as an educated
person must understand something about science and biology to cope with information and decisions in
today’s society, so too must one comprehend a way of talking about ethics that is not directly tied to any
particular faith tradition. You can reassure such participants or colleagues that the ethics sessions will
not attack their faith or put it down, but will simply explore whether reason and dialogue will lead to the
same conclusions or not.
How To Use the Curriculum
Nine modules are included in this program: (1) Tradition, Profession and Values in Public Health; (2)
The Legacy of the Tuskegee Syphilis Study; (3) Public Health Research and Practice in International
Settings; (4) Community Based Practice and Research; (5) Ethics and Infectious Disease Control; (6)
Ethical Issues in Health Promotion and Disease Prevention; (7) Ethical Issues in Environmental and
Occupational Health; (8) Public Health Genetics; (9) Public Health and Health System Reform.
Each module addresses a particular area of public health where practices and policy are in a state of
flux, where new knowledge is changing the way we understand what these practices can and should be,
and where there are active ethical, social, and political debates taking place in society. Hence most
participants will have some background exposure to these topics from the media and elsewhere. Thus
you may find some pre-existing interest in these topics in your class, or else that interest can readily be
stimulated by presenting a basic amount of factual information—for example, that it may soon be
possible to test people for a genetic predisposition to alcoholism—and posing some questions for
discussion.
Clearly these units are interrelated in various ways, and the themes of choice, responsibility, taking
risks, individual rights, and social welfare serve as connecting threads woven throughout the program.
Nonetheless each unit has been designed so that it may stand alone and the material within it is selfcontained. The order in which the units are presented in this guide is arbitrary; the units are not
sequential, and later units do not presuppose familiarity with earlier units. Therefore you have the
flexibility to use any or all of these materials in many different ways and at many different times.
We would make only one recommendation in this respect: do not attempt to cover the material in a
module in less than one hour. Ideally, 90 minutes to two hours per unit would be better. If time is very
limited, it would be advisable to cover one or two units in more depth than to skim over all of them.
Most units have a common format and features:
1. Issue essay
This is designed to provide background information on the history, social and cultural context, and
factual elements of the issue(s) addressed by the module. It also provides a “state of the debate”
discussion, summarizing the leading arguments surrounding the topic and proposed actions or policy
initiatives germane to it.
Introduction
10
2. Fact Sheets
A quick reference to significant study findings, health statistics or epidemiological data pertinent to the
module issue, as well as key concepts. Suitable for use as a handout. Provides a common factual and
terminological frame for the session. It notes areas of significant factual controversy. It may also note
methodological problems in studying this topic.
3. Cases
Each case is designed to be realistic and relevant, and to serve as a discussion vehicle for raising and
discussing salient ethical or value issues. The events, actions, and decisions narrated by the case place
ethics in a suitably complex context (in terms of either internal organizational structures, or external
socio-political context). Suitable for use as handouts, these cases often reflect “real time” decision
making in the presence of limited information. Some case studies reflect actual historical and current
cases.
4. Analytic discussion of the cases
Following each case there is an analysis that provides a framework or approach designed to assist the
facilitator in leading a session on the case. While the participants themselves should bring up most of
the important questions and issues on their own, if they do not, the facilitator may utilize discussion
questions to initiate discussion. The case analyses are frequently organized around the key steps in a
model ethical decision-making process and emphasize key questions, concepts, or issues introduced in
the issue essay.
In the case discussions, participants are encouraged to:
(a) identify the ethical problem(s);
(c) identify the information needed before a responsible decision can be made—what is this
information and from whom should it come?
(d) identify the stakeholders involved in the decision;
(b) articulate the values relevant to this problem;
(e) identify the available options and assess them in light of values served and in light of feasibility
(e.g., financial, political, organizational constraints); and
(f) discuss the process by which the decision should be made and who should be involved in
making it.
5. Tools for best practice and policy assessment
Having discussed cases, the next activity of the training module may be to apply the ideas generated by
this discussion to actual agency policy and practice. The participants are asked to identify real issues
that would lend themselves to such analysis, effectively creating a case study of their own. The product
of the exercise would be to agree on action steps that could be taken by the agency, and to identify who
should be part of the process.
For Further Reading:
M. Aroskar, Exploring Ethical Terrain in Public Health. 1999. Journal of Public Health Administration
Management and Practice. 1(3):16-22.
Introduction
11
M. Aroskar, Teaching ethics in health care administration: a course profile. 1993. Journal of Health
Administration Education. Fall; 11(4): 601-608.
M. Aroskar, Stuart D. Yoak, Ethics teaching in health administration programs: A report. 1996. Journal
of Health Administration Education. Summer; 14(3): 355-363.
D. Beauchamp and B. Steinbock, Eds. New Ethics for the Public’s Health
New York: Oxford Press, 1999.
P. Bradley and A. Burls, Ethics in Public and Community Health. New York: Routledge, 2000.
Daniel Callahan and Sissela Bok, eds., Ethics Teaching in Higher Education. New York: Plenum Press,
1980.
Daniel Callahan and Bruce Jennings, “Ethics and Public Health: Forging a Strong Relationship,”
American Journal of Public Health 92: 2 (February 2002), 169-176
S. S. Coughlin, T. L. Beauchamp, eds., Ethics and Epidemiology, NY: Oxford University Press, 1996.
C. Roland Christensen, Teaching and the Case Method. Boston: Harvard Business School Publishing
Division, 1987.
Howard B. Radest, Can We Teach Ethics? New York: Praeger Publishers, 1989.
N. Stevens and T. McCormick, What are students thinking when we present ethics cases?: An example
focusing on confidentiality and substance abuse. 1994. Journal of Medical Ethics. 20:112-117.
The Teaching of Ethics in Higher Education: A Report by The Hastings Center. Hastings-on-Hudson,
N.Y.: The Hastings Center, 1980.
Introduction
12
MODULE 1
Tradition, Profession, and Values in Public Health
Lawrence O. Gostin, J.D., LL.D (Hon.)
Georgetown University Law Center
Issue Essay
This module asks the difficult questions—what is public health? and what is public health ethics? The
module also recognizes that even though public health and biomedical ethics overlap, they have distinct
aspects. The module examines the unique population-based perspective of public health and how it can be
distinguished from patient-centered biomedical ethics. Additionally, scholars and practitioners often use
ethical analyses with other forms of reasoning, particularly law and human rights. The module, therefore,
explores the relationship among public health ethics, public health law (notably the exercise of the state’s
police power), and human rights. The various meanings of each form of reasoning are discussed, as well as
the similarities and differences among them.
What Is Public Health?
In thinking about the application of ethical thought to problems in public health, it is important first to
understand what we mean by public health. How is the field defined and what is its content—mission,
functions, and services? Who engages in the practice of public health—government, the private sector,
charities, community-based organizations? What are the principal methods or techniques of public health
practitioners? In truth, finding answers to these fundamental questions is not easy because the field of
public health is highly eclectic and conflicted.
Definitions of public health vary widely, ranging from the utopian conception of the World Health
Organization of an ideal state of physical and mental health to a more concrete listing of public health
practices. The Institute of Medicine, in its seminal report on the Future of Public Health in 1988, proposed
one of the most influential contemporary definitions: “Public health is what we, as a society, do collectively
to assure the conditions for people to be healthy.” The IOM’s definition emphasizes the cooperative and
mutually shared obligation (“we, as a society”). It reinforces the fact that collective entities such as
governments and communities take responsibility for health. The goal of public health is the health of
populations—rather than the health of individuals—and this goal is reached by a generally high level of
health throughout society, rather than the best possible health for a few. The field of public health is
concerned with health promotion and disease prevention throughout society. Consequently, public health is
less interested in clinical interactions between health care professionals and patients, and more interested in
devising broad strategies to prevent, or ameliorate, injury and disease.
The State of Debate: Scholars and practitioners are conflicted about the “reach” or domain of public
health. Some prefer a narrow focus on the proximal risk factors for injury and disease. The role of public
health agencies, according to this perspective, is to identify risks or harms and intervene to prevent or
ameliorate them. Others prefer a broad focus on the socio-cultural-economic foundations of health. Those
Module 1: Tradition, Profession, and Values in Public Health
13
favoring this position see public health as interested in a more equitable distribution of social and economic
resources because social status, race, and wealth are important influences on the health of populations.
What are Public Health Ethics?
If public health is what society does collectively to assure the conditions for healthy people, then what are
public health ethics? Public health ethics may be defined as the principles and values that help guide actions
designed to promote health and prevent injury and disease in the population. In thinking about this problem
it will be helpful to distinguish public health ethics from biomedical ethics.
The field of biomedical ethics has richly informed practice and policy in medicine and health care.
Biomedical ethics has often stressed the importance of individual interests of patients, notably the right to
autonomy, privacy, and liberty. Ethicists, however, at least until recently, have given insufficient attention to
the equally strong values of partnership, citizenship, and community. As members of a society in which we
all share a common bond, we also have an obligation to protect and defend the community against threats
to health, safety, and security. There remains much work to do in public health ethics. Is the populationbased perspective of public health different from the patient-centered perspective of medicine? Is a public
health ethic merely the aggregation of individual interests in a population? What is the moral standing that
should be attached to the common good? Under what circumstances should individual interests yield to
achieve a collective benefit for the population?
Some scholars have thought about public health ethics in three overlapping ways: professional ethics (the
values that help public health professionals to act in virtuous ways); applied ethics (the values that help to
illuminate hard problems in public health policy and practice); and advocacy ethics (the overarching value of
population health and social justice).
Professional ethics are concerned with the ethical dimensions of professionalism and the moral trust that
society bestows on public health professionals to act for the common welfare. This form of ethical discourse
stresses the distinct history and traditions of the profession, seeking to create a culture of professionalism
among public health students and practitioners. It instills in professionals a sense of public duty and trust.
Professional ethics are role oriented, helping practitioners to act in virtuous ways as they undertake their
functions. Currently, the Public Health Leadership Society is developing a Code of Public Health Ethics
(available at www.publichealthlaw.net/reader).
Applied public health ethics are concerned not so much with the character of professionals as with the
ethical dimensions of the public health enterprise itself. Here, scholars study the philosophical knowledge
and analytic reasoning necessary for careful thinking and decision making in creating and implementing
public health policy. This kind of applied ethics is situation or case-oriented, seeking to understand morally
appropriate decisions in concrete cases. Scholars can helpfully apply general ethical theory and detached
analytical reasoning to the societal debates common in public health.
In addition to “professional” and “applied” ethics, it is possible to think of an “advocacy” ethic informed by
the single overriding value of a healthy community. Under this rationale, public health authorities think they
know what is ethically appropriate, and their function is to advocate for that social goal. This populist ethic
serves the interests of populations, particularly the powerless and oppressed, and its methods are
principally pragmatic and political. Public health professionals strive to convince the public and its
Module 1: Tradition, Profession, and Values in Public Health
14
representative political bodies that healthy populations, reduced inequalities, and social justice are the
preferred societal responses.
The State of Debate: Scholars and practitioners disagree on each of the three forms of public health
ethics. First, many believe that a code of ethics, or at least a well-articulated values statement, could
increase the status of the field and help clarify the distinctive ethical dilemmas faced by public health
professionals. Others, however, point to the fact that no single public health profession exists, but rather a
variety of different disciplines—e.g., epidemiologists, nurses, sanitary engineers, and public health
educators. It would be difficult to find a single set of values that is relevant to each of these distinct groups.
Second, many believe that the value of population health and safety should be salient. However, others
criticize the public health model because it assumes that the appropriate mode of evaluating options is
some form of cost-benefit calculation that appears to permit, or even require, that the most fundamental
interests of individuals be sacrificed in order to produce the best overall outcome. Applied public health
ethics draws from the traditions of utilitarianism, which is not always favored in modern philosophical
scholarship. Third, many believe that the central role of public health is to advocate for community health
and social justice. Public health advocates are supported by a body of literature demonstrating a
relationship between socio-economic status and healthy populations. However, others believe that it is not
self-evident that health and justice should always be the prevailing value. They also point to the fact that the
redistributive agenda of public health is best reserved to the political branches of government.
What is Public Health Law?
Public health law differs from ethics in that it is concerned with a body of rules of action prescribed by
controlling authority and having binding legal force. Law is found in constitutions, which empower
governments to act and set limits on their power; statutes, which are enacted by legislative bodies and
control the actions of individuals and businesses; regulations, which have similar effects as statutes but are
usually promulgated by the executive branch; and court cases, which interpret the constitution, statutes and
regulations, often setting binding precedent.
Law is a primary means with which government creates the conditions for people to lead healthier and safer
lives. Law creates a mission for public health authorities, assigns their functions, and specifies the manner
in which they may exercise their authority. Law is a tool in public health work which is used to influence
norms for healthy behavior, identify and respond to health threats, and set and enforce health and safety
standards. The most important social debates about public health take place in legal fora—legislatures,
courts, and administrative agencies—and in the law’s language of rights, duties, and justice.
The police power is the most famous expression of the natural authority of sovereign governments to
regulate private interests for the public good. The police power is the inherent authority of a state to
protect, preserve and promote the health, safety, morals, and general welfare of the people. To achieve
these communal benefits, the state retains the power to restrict, within constitutional limits, private
interests–personal interests in autonomy, privacy, association, and liberty as well as economic interests in
freedom to contract and use property.
Law can be an effective tool to achieve the goal of improved health for the population. Statutes, regulations,
and litigation, like other public health prevention strategies, intervene at a variety of levels, each designed
to secure safer and healthier populations. First, government interventions are aimed at individual behavior
Module 1: Tradition, Profession, and Values in Public Health
15
through education (e.g., health communication campaigns), incentives (e.g., taxing and spending powers),
or deterrence (e.g., civil and criminal penalties for risky behaviors). Second, law regulates the agents of
behavioral change by requiring safer product design (e.g., safety standards and indirect regulation through
the tort system). Finally, law alters the informational (e.g., advertising restraints), physical (e.g., city
planning and housing codes), or business (e.g., inspections and licenses) environment.
The State of Debate: Not everyone believes that law is an appropriate way to protect and promote the
community’s health, and when law is used in any of its manifestations it is bound to create controversy.
Coercive interventions aimed at changing individual behavior are perhaps most contentious, such as
infectious disease powers. Many people believe that government should rarely exercise coercive powers
either because they are ineffective (e.g., it will “drive the epidemic underground”) or overly intrusive (e.g., it
will undermine autonomy, privacy, or liberty). Regulation of products through the tort system is also
controversial. Here, people argue that tort law often offers the wrong kind of incentives (e.g., deterring
innovation for vaccines or pharmaceuticals) and is inefficient (e.g., devoting too many resources to lawyers).
Finally, regulation of the informational or economic environment is controversial. Think about the disputes
that arise from regulation of advertising of cigarettes (public health versus free speech) or the regulation of
businesses through licenses and inspections (public health versus property rights).
What is the Role of Human Rights in Public Health?
The language of human rights is used in different, but overlapping, ways. Some use human rights language
to mean a set of entitlements under international law, while others use human rights for its aspirational, or
rhetorical, qualities. Depending on the way in which human rights is used, the field can have features that
are quite similar to law or ethics.
Legal scholars use human rights to refer to a body of international law that originated in response to the
egregious affronts to peace and human dignity committed during World War II. The main source of human
rights law within the United Nations system is the International Bill of Human Rights comprising the United
Nations Charter, the Universal Declaration of Human Rights, and two International Covenants of Human
Rights. Human rights are also protected under regional systems, including those in American, European,
and African countries.
Human rights are often divided between those that protect civil and political rights on the one hand and
economic, social, and cultural rights on the other. Civil and political entitlements include the right to life,
liberty, and security of person; the prohibition of slavery, torture, and cruel, inhuman, or degrading
treatment; freedom from arbitrary interference with privacy, family, or home; and freedom of conscience,
religion, expression, and association. Economic, social and cultural rights include the right to social
security, education, and work, as well as the right to share in scientific advancement and its benefits.
Notably, human rights instruments recognize the right of everyone to the highest attainable standard of
physical and mental health, “including the right to a standard of living adequate for the health and wellbeing of himself and his family, including food, clothing, housing and medical care and necessary social
services.”(Universal Declaration of Human Rights, Art. 25).
The language of human rights is often used for its aspirational, or rhetorical, qualities. When “rights”
language is invoked, it is intended to convey the fundamental importance of the claim. It expresses the idea
that government should adhere to certain standards, or provide certain services, because it is right and just
Module 1: Tradition, Profession, and Values in Public Health
16
to do so. Human rights as a symbol commands reverence and respect. Used in this aspirational sense,
human rights need not be supported by text, precedent, or reasoning; they are self-evident and
government’s responsibility simply is to conform.
The State of Debate: Although human rights are supported by a body of international law and express an
inspiring idea about personal dignity, they are often criticized for imprecision and lack of enforceability.
Civil and political rights are perhaps the most precisely defined and carefully studied, but international
agencies often fail to rigorously defend these rights in the real world. Economic, social and cultural rights
are thought to be vague and unenforceable. For example, the conceptualization of health as a human right,
and not simply a moral claim, suggests that states possess binding obligations to respect, defend, and
promote that entitlement. Considerable disagreement, however, exists as to whether “health” is a
meaningful, identifiable, operational, and enforceable right, or whether it is merely aspirational or
rhetorical. To achieve the goal of greater clarity and enforceability, the United Nations Committee on
Economic, Social, and Cultural Rights issued General Comment No. 14: The Right to the Highest Attainable
Standard of Health (2000). This General Comment seeks to define the right to health and suggest ways in
which it can be enforced.
Tradeoffs Between the Collective Good and Individual Rights
Public health law and ethics often require careful balancing between individual interests in personal (e.g.,
autonomy, privacy, and liberty) and economic (e.g., contracts and property) freedoms on the one hand and
collective interests in health safety and security on the other. Certainly, freedom and security can be
mutually reinforcing. Affording individuals their rights can result in greater overall wellbeing by empowering
people to safeguard their own health and safety. For example, if people do not fear loss of privacy or liberty,
they are more likely to seek medical and public health services. Coercive powers can literally “drive
epidemics underground.”
Sometimes policy makers must make hard tradeoffs between individual and collective interests and, in these
circumstances, they need to be guided by ethical values and attentive to legal procedures and norms. Public
health laws and our courts have traditionally balanced the common good with individual civil liberties. As
Justice John Marshall Harlan wrote in the seminal United States Supreme Court case of Jacobson v.
Massachusetts, 197 U.S. 11 (1905), “the whole people covenants with each citizen, and each citizen with the
whole people, that all shall be governed by certain laws for the ‘common good.’” Jacobson was a case that
concerned compulsory vaccination, but the difficult tradeoffs between public and private interests can
extend to many areas of public health concern ranging from infectious disease control powers (e.g., testing
and screening, partner notification, and quarantine) to control of businesses (e.g., inspections and nuisance
abatements) and the professions (e.g., licensing).
How should society determine whether to intervene to protect the public’s health and safety when doing so
will diminish a personal or economic interest? There is no sure way to know when interventions are
necessary and appropriate, but here are some of the factors that need to be taken into consideration:
Step One: Demonstrate Risk. Risk is a complex idea that involves several dimensions. First, what is the
nature of the risk? Risks arise from numerous sources including physical, chemical, organic, environmental,
and behavioral. Second, what is the duration of the risk? Risks may be imminent, distant, acute or chronic.
Third, what is the probability that the risk will actually occur? Risks may be either highly likely or remote.
Module 1: Tradition, Profession, and Values in Public Health
17
Finally, what is the severity of harm should the risk materialize? Harms can be catastrophic or relatively
trivial if they do occur. They may affect individuals or populations, current or future generations, or people
or the things that people value (e.g., plants, animals, or the environment).
Step Two: Demonstrate the Intervention’s Effectiveness. The intervention should be reasonable likely to
reduce the risk. Public health is primarily about prevention so one important measure is whether the
intervention is reasonably like to work. This is a “means-ends” inquiry, which seeks to understand if the
public health intervention will lead to effective risk reduction.
Step Three: Assess the Economic Cost. The intervention should not only be capable of reducing the risk,
but it should do so at a reasonable cost. Policy makers, therefore, should discover the costs to the
regulatory agency and the subject of the regulation. Wherever possible, policy makers should prefer
strategies that are least expensive and most effective. The reason is that government only has limited
resources. If it spends money wastefully on an intervention, it will not have those resources available for
another, potentially more effective, intervention. Thus, cost-ineffective measures have “lost opportunity”
costs.
The criterion to prefer cost-effective measures does not mean that society must wait until there is
unassailable scientific evidence before it can intervene. Some advocates have argued for the adoption of a
“precautionary principle.” The precautionary principle is not consistently defined but it means that public
health authorities may act to prevent future harms to people and the environment even in the absence of
conclusive proof that the harm is real or that the intervention will be effective.
Step Four: Assess the Burdens on Human Rights. Sometimes even cost-effective policies should not be
undertaken if they disproportionately burden human rights. Policy makers, therefore, should think about the
invasiveness of the intervention, the frequency and scope of the infringement, and the duration of the
infringement. Human rights do not always trump public health, but they certainly need to be weighed
carefully.
Step Five: Assess the Fairness of the Intervention. Policies should be formed and implemented in just ways.
Thus, there should be a fair distribution of benefits and burdens. Ethicists examine fairness in a variety of
different ways, but they often focus on need and risk. Benefits or public health services should often be
distributed based on need. That is, those who have the greatest need should have some claim to the benefit
or service. On the other hand, regulatory burdens should often be distributed on the basis of risks posed.
That is, those who pose the greatest risks to the public or the environment should bear the costs and
burdens of regulation. There are certainly other ways to evaluate the just allocation of benefits and burdens
(e.g., principles of the most efficient distribution), but need and risk are two likely criteria.
In summary, a public health intervention can be evaluated using several criteria: (i) the nature, probability,
and severity of the risk; (ii) the likelihood that it will be effective in meeting its objectives; (iii) the economic
costs entailed, including opportunity costs; (iv) the burdens on human rights, and (v) the fairness, including
a just allocation of benefits and burdens.
Module 1: Tradition, Profession, and Values in Public Health
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Conclusion
The field of public health is highly complex. What is the meaning of pivotally important abstract concepts
that are common in public health: population, community, risk, harm, and benefit? How should society
decide when it is necessary and appropriate to intervene to protect the public’s health? Are factors such as
risk, effectiveness, cost, burdens, and fairness the best ways to evaluate public health interventions? How
does the population perspective differ from the individual perspective? To what extent should social justice
be an animating value in public health? Scholars and practitioners use various forms of reasoning in
analyzing these problems, notably ethics, law, and human rights. Each form of reasoning has its own
benefits and disadvantages. While each form of reasoning is distinct, all the forms overlap in important
ways. One thing is certainly clear, there are no “correct” answers in public health. However, careful
examination of principles and values taken from each of these fields can clarify thinking and, ultimately, lead
to more effective and just policies and practices in public health.
Further Readings in Public Health Law and Ethics
Books
Beauchamp DE, Steinbock B (eds.), New Ethics for the Public’s Health, New York: Oxford University Press,
1999.
Gostin LO (ed.), Public Health Law and Ethics: A Reader, Berkeley and New York: University of California
Press and Milbank Memorial Fund, 2002.
Gostin LO, Public Health Law: Power, Duty, Restraint, Berkeley and New York: University of California
Press and Milbank Memorial Fund, 2000.
Articles
Callahan D, Jennings B, Ethics and Public Health: Forging a Strong Relationship, Am J Pub Health (2002):
92:169-176.
Childress JF, Faden, RR, Gaare RD, et al., Public Health Ethics: Mapping the Terrain, J Law, Med & Ethics
(2002) 30:170-178.
Gostin LO, Sapsin JW, Teret SP, et al., The Model State Emergency Health Powers Act: Planning and
Response to Bioterrorism and Naturally Occurring Infectious Diseases, JAMA (2002) 288:622-628.
Gostin LO, Public Health, Ethics, and Human Rights: A Tribute to the Late Jonathan Mann, J Law, Med &
Ethics (2001) 29: 121-130.
Kass NE, An Ethics Framework for Public Health, Am J Pub Health (2001): 91:1776-1782.
Roberts MJ, Reich MR, Ethical Analysis in Public Health, Lancet (2002) 359:1055-1059.
Thomas JC, Sage M, Dillenberg J, Guillory VJ, A Code of Ethics for Public Health, Am J Pub Health (2002):
92:1057-59.
Internet Resources
Web site of the Center for Law and the Public’s Health at Georgetown and Johns Hopkins University (CDC
Collaborating Center Promoting Health Through Law): http://www.publichealthlaw.net
Module 1: Tradition, Profession, and Values in Public Health
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Web site accompanying the book, Gostin LO (ed.), Public Health Law and Ethics: A Reader, Berkeley
and New York: University of California Press and Milbank Memorial Fund, 2002:
Module 1: Tradition, Profession, and Values in Public Health
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Fact Sheet: Tradition, Profession, and Values in Public Health
This module explores the relationship between public health ethics, public health law (notably the exercise
of the state’s police power), and human rights. The various meanings of each form of reasoning are
discussed, as well as the similarities and differences among them.
I. What Is Public Health?
Definitions of public health vary widely; however, a unifying theme is that public health is a mutuallyshared, societal obligation. Collective entities such as governments and communities must take
responsibility for promoting the health of the public.
The Institute of Medicine defines public health as “what we, as a society, do collectively to assure the
conditions for people to be healthy.” (Future of Public Health,1988)
The focus of public health is the health of populations, rather than the health of individuals.
Public health is more concerned with broad strategies to prevent or ameliorate injury and disease than
with clinical interactions between professionals and patients.
Scholars and practitioners are conflicted about the “reach” or domain of public health between 2 major
foci:
– Narrow focus on the proximal risk factors for injury and disease; or
– Broad focus on the socio-cultural-economic foundations of health.
II. What are Public Health Ethics?
Public health ethics are principles and values that guide actions to promote health and prevent injury
and disease among the population.
Public health ethics should be distinguished from biomedical ethics.
– Biomedical ethics often stress the importance of individual interests of patients.
– Public health ethics emphasize partnership, citizenship, and community.
Some scholars have structured public health ethics in three overlapping ways:
– Professional ethics are concerned with ethical dimensions of professionalism.
– Applied ethics relate to dynamics of the public health enterprise itself.
– Advocacy ethics are informed by the single overriding value of a healthy community.
Scholars and practitioners disagree on each of the three forms of public health ethics.
– A code of ethics could clarify the field and provide guidance regarding ethical dilemmas.
– Some suggest that no single public health profession exists. It is difficult to find a single set of
values that relates to all public health professionals.
Module 1: Tradition, Profession, and Values in Public Health
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III. What is Public Health Law?
Public health law refers to rules of action prescribed by controlling authority and having binding legal
force. Law is found in constitutions, statutes, regulations, and court cases.
Law creates a mission for public health authorities, assigns their functions, and specifies the manner in
which they may exercise their authority.
The most important public health debates occur in legal fora—legislatures, courts, and administrative
agencies—and in the law’s language of rights, duties, and justice.
Police power is the inherent authority of a state to protect, preserve and promote the health, safety,
morals, and general welfare of the people. The state may restrict individual interests within limits to
achieve these communal benefits.
Law regulates behavior and alters the informational, physical, and business environment. However, the
appropriate role of law in public health is controversial (e.g., coercive interventions aimed at changing
individual behavior may unduly restrict liberty and foster resentment).
IV. What is the Role of Human Rights in Public Health?
The language of human rights is used in different, but overlapping, ways in public health.
Human rights may refer to a set of entitlements under international law, or may be invoked for
aspirational, or rhetorical, purposes.
Considerable disagreement exists as to whether “health” is a meaningful, identifiable, operational, and
enforceable right, or whether it is merely aspirational or rhetorical.
Although human rights are supported by international law and express an inspiring idea about personal
dignity, they are often criticized for imprecision and lack of enforceability.
V. How to Evaluate Public Health Interventions
Policy makers should subject public health interventions to systematic evaluation.
– Demonstrate risk.
– Demonstrate effectiveness.
– Assess economic cost.
– Assess human rights burdens.
– Assess fairness.
Module 1: Tradition, Profession, and Values in Public Health
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Case Study 1: Legal and Ethical Implications of a Public Health Approach
1
to Disability
Malik Johnson has been the Human Resources Manager of MedCentre, a hospital in West Virginia, for two
years. Monday morning, Juanita Carlson, the Benefits Coordinator at MedCentre, informed Malik of the
hospital’s plan to implement screening procedures to detect hepatitis B among prospective and incumbent
employees.
Viral hepatitis B can be transmitted when blood or bodily fluids from an infected individual enter the body
of an individual who is not immune to the virus; e.g., from mother to unborn child or from partner to
partner via unprotected sexual intercourse, blood transfusion, or sharing needles. Symptoms of hepatitis B
include jaundice, fatigue, abdominal and/or joint pain, loss of appetite, and nausea. These symptoms are
more common in adults than in children, yet approximately 30% of infected individuals will not experience
any symptoms. In the absence of vaccination or treatment, death from chronic liver disease occurs among
15-25% of hepatitis B infected individuals The hepatitis B vaccine, available since 1982, is the best
protection against contracting the virus; however, other precautions are also advisable, such as condom use
and/or refraining from injection drug use.
Juanita stated that screening MedCentre employees for hepatitis B was necessary to (1) alert MedCentre’s
HMO to potential elevated costs in its medical coverage, (2) notify the hospital’s administration that special
accommodations may be needed (e.g., infection control and/or leaves of absence for seropositive
individuals), and (3) protect the hospital’s patients and employees from the transmission of this contagious
disease. Malik suspected that the screening plan was also influenced by the recent hepatitis B diagnosis of
MedCentre’s chief cardiac surgeon, Michele Kim.
MedCentre provided notification of the screening plan in a brief memorandum to current employees and to
individuals who received an offer of employment from the hospital as of Monday afternoon. The plan was to
become effective the following Friday, at which point all prospective and current employees were instructed
to report to the hospital’s laboratory for screening.
Malik is responsible for responding to employees’ questions about MedCentre’s screening plan. Juanita also
assigned Malik the task of evaluating the plan in light of employees’ concerns in a confidential memorandum
to MedCentre’s Board of Directors.
Prospective Employees
Paula Smith, a prospective employee in MedCentre’s maintenance department, called Malik on the
telephone immediately after she read MedCentre’s notification memo on Tuesday morning. Ms. Smith was
concerned that MedCentre would rescind its recent offer of employment once her seropositive status was
discovered.
Ms. Smith questioned why MedCentre needs to screen maintenance staff members at all. Ms. Smith does
not understand how screening for hepatitis B status relates to the responsibilities or performance of her job.
1
I thank James G. Hodge, Jr., and research students at the Georgetown University Law Center, for help in researching and
drafting these case studies.
Module 1: Tradition, Profession, and Values in Public Health
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Because maintenance staff members have limited contact with patients and/or other MedCentre employees,
Ms. Smith argued that the threat posed by infected maintenance staff members at the hospital is minimal.
Although Ms. Smith agrees that the effects of hepatitis B may be debilitating and the costs of treatment may
be considerable, she does not see why hepatitis B should be singled out from other diseases that impose a
similar burden, such as syphilis.
Malik thanked Ms. Smith for expressing her concerns, promised to research the answers to her questions,
and told her he would return her telephone call in a couple of days.
Current Employees
After Malik ended his conversation with Ms. Smith, he received a second urgent telephone call. This time,
the voice on the other side of the line belonged to Robert Jones, a loyal employee and respected orthopedic
surgeon at MedCentre for fifteen years. Dr. Jones suspected that he contracted hepatitis B from a recent,
unprotected homosexual encounter. Dr. Jones told Malik that he was keenly aware of the case of Dr. Kim,
whose hepatitis B diagnosis last month prompted her leave of absence, contributed to the temporary
rescission of her surgical privileges, and generated relentless gossip around the hospital.
The prospect of sharing Dr. Kim’s fate terrified Dr. Jones. He is troubled that his homosexual orientation
and his seropositive status could both be exposed to the detriment of his career at the conservative
hospital. Dr. Jones is afraid that a hepatitis B diagnosis will quickly become a stigma, and that people will
perceive him as incapable of performing his responsibilities as a surgeon. Dr. Jones needs assurance that he
will not be discriminated against by MedCentre staff or patients on the basis of his serological status.
Malik sympathized with Dr. Jones’ predicament and promised to address his concerns in a confidential
meeting with him on Thursday morning.
Disability Discrimination
Tonya Perez, MedCentre’s general legal counsel, outlined the relevant disability law pertaining to the
hospital’s screening plan. Ms. Perez told Malik that the Americans with Disabilities Act of 1990 (ADA)
places certain limitations on employer-mandated medical examinations, including the screening of
employees. Under the ADA, an employer can require the screening of prospective employees after an offer
of employment has been made but before a prospective employee commences work. All prospective
employees must be subjected to the same examination and the information collected must be maintained in
a separate, confidential medical record. Furthermore, an employer can require the screening of current
employees if such medical examinations are shown to be “job-related” or “consistent with business
necessity.” Again, the results must be kept in a separate, confidential medical record. Prospective or current
employees may not be discriminated against on the basis of their disabilities. Thus, qualified persons with a
disability may not be terminated or adversely treated because of their disabilities. A “qualified” person with
a disability must meet all the essential criteria for performing the job and must not pose a significant risk to
himself or others.
Ms. Perez noted that even if MedCentre’s screening plan is otherwise legally permissible, MedCentre must
also avoid unlawful discrimination in violation of the ADA. Modern jurisprudence indicates that hepatitis B
meets the criteria for a “disability” under the ADA since its taxing physiological manifestations may
“substantially limit” the “major life activity” of working. For example, symptoms such as extreme nausea or
Module 1: Tradition, Profession, and Values in Public Health
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fatigue may constrain Paula Smith’s ability to perform the physical tasks associated with her position as a
hospital maintenance staff member. Furthermore, the ADA protects individuals such as Robert Jones who
are “regarded as” disabled, or who have a record of disability. However, the courts have been divided as to
whether a person infected, but not yet symptomatic, is covered under the ADA as a person with a disability.
Therefore, the question arises, from a perspective of law and ethics, can MedCentre use the information
acquired from the screening to discriminate against seropositive individuals on the basis of their serological
status? If we assume that seropositive individuals do have a disability, then MedCentre must neither
manifest nor tolerate adverse treatment of an individual diagnosed with hepatitis B who is “otherwise
qualified” for a hospital position, if “reasonable accommodations” or “modifications” can be made on his or
her behalf (e.g., leaves of absence).
A Public Health Approach
You are Malik’s first choice for consultation regarding his assignment from MedCentre’s Board of Directors.
Malik wants to adopt a public health perspective that addresses the human rights and ethical issues
implicated in MedCentre’s screening plan. Malik’s memorandum must offer recommendations that are
legally and ethically sound. Due to Malik’s time constraints, he has asked that you e-mail him responses to
the following questions by tomorrow evening:
Should MedCentre screen all employees, or should it “target” or limit screening to employees
whose jobs involve regular contact with hospital patients and employees, as Paula Smith suggested?
Assuming that certain jobs are less likely to transmit infection via interpersonal contact, will general
screening be perceived as paternalistic?
Should MedCentre obtain employees’ consent to the screening? If so, how can MedCentre ensure
that the employees are sufficiently informed?
How should MedCentre document and store the records of screening results?
How should MedCentre notify employees of their serological status? Should or must MedCentre
provide counseling?
What “reasonable accommodations” can or should MedCentre make for seropositive individuals? Is
vaccination legally, ethically, or economically feasible?
What preventative procedures and/or programs can MedCentre implement to ensure that
seropositive individuals are not discriminated against on the basis of their serological status?
Module 1: Tradition, Profession, and Values in Public Health
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Case Study 1: Discussion
Ethical Problems
This case study presents two sets of ethical dilemmas.
Paula Smith, a prospective employee at MedCentre, raises concerns regarding the ethical implications of
general versus targeted screening procedures. Assuming that certain jobs at MedCentre are less conducive
to transmission of hepatitis B than others, is general screening of all employees unnecessary, inefficient,
and/or paternalistic? Conversely, would targeted screening exclude seropositive individuals and/or alienate
already marginalized individuals or groups? Also, how should MedCentre decide which employees to
“target” for screening; e.g., by the level of risk associated with their employment positions (e.g., extent of
interpersonal contact) or by the level of risk associated with their personal habits (e.g., intravenous drug
use or promiscuous sexual behavior)? As Human Resources Manager of MedCentre, Malik Johnson must
evaluate the costs and benefits, both economic and philosophical, of these two screening alternatives before
writing his memorandum of recommendations to the Board of Directors.
Second, Malik must address the concerns of Robert Jones, a current employee at MedCentre, regarding
discrimination. What safeguards (e.g., educational or training programs) should MedCentre implement to
ensure that seropositive individuals will not be discriminated against on the basis of their serological status?
Malik must be attentive to the privacy and bodily integrity concerns of individuals who will be screened, yet
he must also ensure effective screening procedures that will protect MedCentre’s patients and staff from
transmission of hepatitis B.
Relevant Values
As the liaison between MedCentre’s staff and administration, Malik is aware that different values are
motivating the perspectives of each “side.” For example, MedCentre employees subject to screening, such
as Paula Smith and Robert Jones, have prioritized the values of bodily integrity, autonomy, liberty, and
privacy; whereas MedCentre’s Board of Directors will likely prioritize the values of efficacy and efficiency,
and MedCentre’s investors/patrons may prioritize the value of conservatism. Malik’s recommendations must
be informed by each of these values, yet Malik must also acknowledge the value of compromise.
Necessary Information
An integral step in resolving these ethical dilemmas is for Malik to gather all information pertaining to
MedCentre’s screening plan and to the individuals whom it will involve. For example, Malik should consult
with other MedCentre officials to determine the source and extent of funding allocated for the screening
procedure. This information may determine which type of screening is more feasible and/or appropriate
(e.g., are sufficient funds available for general screening of all employees?) as well as which preventative
measures or safeguards can be implemented to prevent discrimination subsequent to the screening (e.g.,
are sufficient funds available for educational/training programs and/or for counseling?).
Malik should also have several informal discussions with MedCentre’s administrators and employees about
the screening plan. These talks will help Malik identify where sensitivities may lie and where compromises
Module 1: Tradition, Profession, and Values in Public Health
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may be made. They will also reinforce the values mentioned above and ensure that Malik’s recommendations
to the Board of Directors are ethically sound.
Finally, Malik should schedule another meeting with Tonya Perez, MedCentre’s general legal counsel, to
ensure that his recommendations are legally valid. Malik will want to discover and avoid legal issues that
surfaced in comparable screening programs in other medical centers. He will also want to ensure that Tonya
is prepared to defend MedCentre’s screening plan against potential lawsuits.
Stakeholders to the Decision
Throughout the decision-making process, Malik must be respectful of and attentive to the many
stakeholders to this decision. Malik’s recommendations to the Board of Directors must be informed by the
interests, concerns, and values of MedCentre’s prospective employees, current employees, patients,
administrators, and investors/patrons. As was noted in the above sections, each of these parties and entities
has values and needs that may conflict with those of the others.
Available Options
Malik must carefully assess the values that each recommendation serves, as well as its financial, political,
and organizational feasibility. A sample of the many potential recommendations that Malik can offer in his
memorandum to MedCentre’s Board of Directors includes the following:
General screening of all employees to minimize stigma and/or alienation associated with targeted
screening and to convey the message that everyone should be cognizant of the risks associated with
hepatitis B
Confidential and professional screening procedures conducted by authorized medical personnel
who are respectful and discreet
Notification of serological status via contact information provided directly by the employee who was
subject to the screening, with provision of referrals and a free counseling session for seropositive
individuals
Access to and disclosure of medical records limited to those with a legitimate need to know; e.g.,
to medically treat the employee
Implementation of educational and training initiatives to prevent discrimination
Decision Process
Although the foregoing analysis is essential for Malik’s own decision process regarding recommendations to
MedCentre’s Board of Directors, the “official” decision process that determines the fate of the screening
plan will begin (or will recommence) when the Board receives Malik’s memorandum. It is hoped that the
Board’s final decision on the plan will be influenced by the input of each of the stakeholders discussed
above. However, to ensure that the plan continues to be responsive to the interests, needs, and values of
these diverse stakeholders, perhaps Malik can suggest the formation of an Oversight Committee that
contains a representative from each “side.”
Module 1: Tradition, Profession, and Values in Public Health
27
Case Study 2: Protecting Health Information Privacy
Dr. Sharon Smart is a senior genetics researcher for Genomatic, Inc., an emerging pharmaceutical company
that researches and develops pharmacogenomic products. Dr. Smart was the lead researcher in a recent
large-scale clinical study designed to test the efficacy of Alive, a new pharmaceutical. Alive is designed to
successfully treat a terminal form of ovarian cancer that has common genetic links in a sizable portion of the
general public. The study amassed considerable, longitudinal health data on thousands of research subjects.
Genomatic’s shares recently soared on the NASDAQ stock exchange in expectation of potential approval of
Alive through the Food and Drug Administration (FDA). Genomatic had sought final FDA approval after
completing its clinical drug trials.
Seeking FDA Approval
As part of the approval process, the FDA requested copies of relevant medical records of individuals
involved in the clinical drug trials for Alive. In its correspondence, the FDA said that it needed the data for
review and examination pursuant to the approval process for Alive. In her laboratory in Rockville, Maryland,
Dr. Smart assembled the personally identifiable data, including research subjects’ informed consent forms.
Each of the research subjects had previously executed a general waiver for the release of his or her medical
records to “federal authorities, including the FDA, for the purposes of conveying study results.”
In the same letter, the FDA also asked for additional medical data about whether the research subjects
involved in the Alive clinical trials had participated in other clinical trials at Genomatic. The FDA suggested
that it wanted this data to confirm that Genomatic had not improperly recruited its research subjects for
multiple trials, or provided incentives for their long-term participation in the company’s clinical trials
programs. Another pharmaceutical company had recently engaged in a practice of soliciting clinical trial
research subjects from community homeless shelters. These individuals became “career” research subjects,
participating in dozens of trials and reaping sizeable financial incentives.
Dr. Smart contacted an FDA official about the second request for information. She inquired as to whether
the approval process for Alive was contingent upon forwarding the res…
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