Ethics in Epidemiologic Research
Dr. Javier Lopez-Zetina
Department of Health Science
California State University, Long Beach
Supporting Materials
Significance
The practice of public health and epidemiologic research is uniquely challenged by
fundamental ethical concerns. With its emphasis on population and community work,
public health practitioners are routinely presented with activities that may affect the wellbeing and liberties of individuals. Broadly speaking, the public health mission
encompasses two major activities: health surveillance and community intervention for
preventing disease and reducing disparities in the impact of impairment and mortality.
Epidemiologic research provides the tools to effectively implement the public health
mission. In both disciplines, ethical dilemmas constantly arise; and they often challenge
current notions of what “ethical” means in the context of a changing world.
In the U.S., there is a rich history of efforts, dating back several decades, that provides an
ethical framework for public health and medical and epidemiologic research. Driven in
part by highly reprehensible abuses in experimental medical research during the mid1900s1, this ethical framework has given rise to a unique component of current
epidemiologic/medical research: the Institutional Review Board (IRB). An integral
component of federally-funded research with human subjects, the IRB prescribes specific
ethical requirements and compliance in research. These ethical requirements have been
enacted to ensure that research with human subjects meets current principles of
beneficence, justice and respect for persons. Given the importance of these principles in
guiding federally-funded research, students trained in ethics should be familiar with these
principles and the tensions that arise when applications of these principles and the
principles themselves are applied in epidemiologic research. Briefly, the first principle
refers to beneficence or the prescriptive principle of acting for the benefit of others 2.
The principle of justice obligates researchers to ensure that in their scientific activities,
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For example, in what it was later known as the Tuskegee experiment; beginning in 1932 and well into the
early 1970s, 400 black men affected by syphilis were left with no treatment for four decades. Despite
knowledge of effective treatment for syphilis by the researchers involved in the study, government doctors
continued with the experiment so they could learn more about the natural history of syphilis.
2
The CSULB IRB policy document defines Beneficence as follows. “Persons are treated in an ethical
manner not only by respecting their decisions and protecting them from harm, but also by making efforts to
secure their well being. Such treatment falls under the principle of beneficence. The term "beneficence" is
often understood to cover acts of kindness or charity that go beyond strict obligation. In this document,
beneficence is understood in a stronger sense as an obligation. Two general rules have been formulated as
complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible
benefits and minimize possible harms”.
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benefits outweigh the risks, and that a shared decision-making process accompanies all
activities involving human subject participation in the research protocol 3.
Finally, the principle of respect for persons states that the dignity and autonomy of
individuals should always be respected. Moreover, individuals with diminished autonomy
(e.g. children, persons under correctional supervision or medically incapacitated) should
be afforded the same level of respect 4. These basic ethical principles have been, in turn,
translated into specific applications, for example, obtaining informed consent, assessment
and disclosure of risks and benefits, voluntariness, disclosure of conflict of interest, and
other applications.
Despite this ethical framework, public health practitioners are constantly faced with new
challenges arising from the evolving and extended nature of what constitutes “research”.
For example, few or no regulations for the protection of human subjects are followed by
private companies conducting research with their employees and with their own funds
(McDaniel, Solomon et al. 2006). Another gray area posing unique ethical challenges is
international research (Miller 1988; Kelley 2002; Hyder, Wali et al. 2004). Domestically,
the growing tension between the IRB prescriptive translations of ethical principles and
the specific need of community participatory research is generating ethical issues that are
as yet, unresolved (Malone, Yerger et al. 2006). Next, but not last or least, examination
of genetic variation in large communities and populations has often been met with heated
controversy over whether such screening and testing, even under IRB protection, is
bound to cast upon entire communities the stigma of being branded “genetically
defective” (Sterling, Henderson et al. 2006).
Curriculum Development Proposal
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CSULB IRB policy definition. Justice. “Who ought to receive the benefits of research and bear its
burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An
injustice occurs when some benefit to which a person is entitled is denied without good reason or when
some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to
be treated equally. It is necessary, then, to explain in what respects people should be treated equally. There
are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation
mentions some relevant property on the basis of which burdens and benefits should be distributed. These
formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to
each person according to individual effort, (4) to each person according to societal contribution, and (5) to
each person according to merit”.
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CSULB IRB policy definition. Respect for Persons. “Respect for persons incorporates at least two ethical
convictions; first, that individuals should be treated as autonomous agents, and second, that persons with
diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two
separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect
those with diminished autonomy”.
2
The proposed 3-hour ethics module will be integrated into the course HSC500 Principles
of Epidemiology. Dr. Lopez-Zetina has taught this course since 2000 to graduate students
of the Master’s of Public Health in the Department of Health Science. Ethical issues in
epidemiologic research are covered in various lectures and assignments but there is
currently no stand-alone module solely dedicated to examining ethical principles,
dilemmas, and controversies. As former member of the CSULB IRB, Dr. Lopez-Zetina is
uniquely qualified to provide a comprehensive training on ethics and research
compliance.
Overall Objective I: The proposed module will provide students with the intellectual and
academic tools to recognize currently accepted institutional mechanisms for the
protection of human subjects when conducting epidemiologic research. In particular, the
prescriptive and oversight role of the local CSULB IRB will be examined.
Overall Objective II: The proposed curriculum will provide students with an overview of
current ethics controversies and dilemmas impacting implementation of public health,
biomedical and epidemiologic research, both domestically and internationally.
The module will be comprised of the following sections:
1. Overview of the IRB Principles of Beneficence, Justice and Respect for Persons
2. Overview of specific applications of IRB Principles
 Informed Consent
 Confidentiality
 Disclosure of risks and benefits
 Disclosure of conflict of interest
3. Current ethical dilemmas and controversies
 Shared clinical decision-making
 Genetic screening
 International ethics and IRB review of international collaboration
 Participant observation and community-based participatory research
 Non federally-funded research: ethical framework
Each section of this module will be structured as follows:
Learning Objectives
Presentation of invited speakers (if scheduled)
Overview
Case Study/Discussion Questions
Overview of Collective Answers
Suggested Reading
Other online resources
Work Cited and Suggested Preliminary Module Bibliography (Appended)
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Hyder, A. A., S. A. Wali, et al. (2004). "Ethical review of health research: a
perspective from developing country researchers." J Med Ethics 30(1): 6872.
Kelley, S. D. (2002). "The forum. A contextualized approach to IRB review for
collaborative international research." Ethics Behav 12(4): 371-6.
Malone, R. E., V. B. Yerger, et al. (2006). ""It's Like Tuskegee in Reverse": A Case
Study of Ethical Tensions in Institutional Review Board Review of
Community-Based Participatory Research." Am J Public Health 96(11):
1914-1919.
McDaniel, P. A., G. Solomon, et al. (2006). "The ethics of industry experimentation
using employees: the case of taste-testing pesticide-treated tobacco." Am J
Public Health 96(1): 37-46.
Miller, J. (1988). "Towards an international ethic for research with human beings."
Irb 10(6): 9-11.
Sterling, R., G. E. Henderson, et al. (2006). "Public Willingness to Participate in and
Public Opinions About Genetic Variation Research: A Review of the
Literature." Am J Public Health 96(11): 1971-1978.
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