33 J.L. Med. & Ethics 125 (2005)
An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research

handle is hein.journals/medeth33 and id is 125 raw text is: An Enhanced Approach to
Distinguishing Public Health Practice
and Human Subjects Research
James G. Hodge, Jr.

hat are the Differences between Public
Health Practice and Research? This per-
plexing question constantly arises in the
planning and performance of public health activities
involving the acquisition and use of identifiable health
information. Public health agencies collect and ana-
lyze significant identifiable health data from health
care providers, insurers, other agencies, or individuals
to perform an array of public health activities. These
activities include surveillance (e.g., reporting require-
ments, disease registries, sentinel networks), epidemi-
ological investigations (e.g., to investigate disease out-
breaks), and evaluation and monitoring (e.g., public
health program development and analysis, oversight
functions). Few debate that these essential public
health activities, often specifically authorized by law,
are classifiable as public health practice.
Other public health activities in which identifiable
health data are acquired or used, however, can resem-
ble, include, or constitute human subjects research.
Human subjects research is legally defined as a sys-
tematic investigation, including research develop-
ment, testing, and evaluation, designed to develop or
contribute to generalizable knowledge' that involves
living human subjects (or their identifiable, private
data). A public health agency may, for example, con-
duct a double-blinded, controlled study to assess the
efficacy of a new vaccine among a randomly-selected
group of persons within the affected population. The
study's hypothesis, methods, and underlying intent
substantiate that the activity is research. As a result,
the public health agency must adhere to a series of
James G. Hodge, Jr., J.D., LL.M., is an Associate Professor,
Johns Hopkins Bloomberg School of Public Health; Adjunct
Professor of Law, Georgetown University Law Center; and
Executive Director, Center for Law and the Public's Health.

protections (e.g., individual informed consent absent
a waiver) and procedures (e.g., review by an institu-
tional review board [IRB]) designed to protect the
health and safety of human subjects.
Lost in a legal and ethical gray zone are a host of
public health activities that are not neatly character-
ized as either practice or research.2 Classification of
these types of activities is complicated for many rea-
sons.3 Some suggest that lack of clarification as to
what constitutes legitimate public health functions
causes confusion.4 The scope of public health is
exceedingly broad; its vastness complicates the carv-
ing out of distinct research activities. Others think
that the definition of human subjects research is inap-
plicable to public health activities.5 Still others stress a
need for national reform to include some form of
explicit, systematic review for surveillance or other
public health practices through ethical bodies exter-
nal to public health,6 or the outright exemption of
public health agencies from the federal human
research protections.7 Underlying each of these diver-
gent proposals, however, is the same, persistent ques-
tion: how are public health practice and research dis-
tinct? Until this question is answered, none of these
approaches is wholly satisfying.
Many public agencies and practitioners have recog-
nized the importance of drawing distinctions between
public health practice and research, including the
Department of     Health   and   Human     Services
(DHHS),8 Centers for Disease Control and Prevention
(CDC),9 National Institutes of Health (NIH),10
Department of Energy (DOE), National Bioethics
Advisory Committee (NBAC),12 and the Institute of
Medicine (IOM),13 as well as state and local lawmak-
ers and public health officials. Clearer distinctions are
needed because (1) federal, state, and local laws and


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