Public Health Practice v. Research: Making Distinctions for Public Health Practitioners
The Council of State and Territorial Epidemiologists (CSTE)
released its comprehensive assessment, Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Distinctions. The
culmination of months of research and consensus-building through an
expert, advisory body led by John Middaugh, MD, the report was drafted
by James G. Hodge, Jr., J.D., LL.M., Professor, Johns Hopkins
Bloomberg School of Public Health, with Lawrence O. Gostin, J.D., LL.D.
(Hon), Professor of Law, Georgetown University Law Center, and members
of the CSTE Advisory Committee. The report provides guidance on the
distinctions between public health practice and human subjects research
for public health officials, researchers, institutional review board
(IRB) members, and their staffs.
Drawing distinctions between public health practice and human subjects
research is complicated by numerous approaches based in law, ethics,
and policy used in governmental, private sector, and scholarly
settings. Collectively, these approaches muddle distinctions. Clearer
guidance may help ensure IRB reviews are performed only when needed, ,
limit mistreatment of human subjects or privacy infringements, and
reduce burdens on IRBs and public health practitioners.
CSTE’s report draws on existing research, concepts, criteria,
and cases where public health practitioners and IRBs attempt to
distinguish practice and research. Refined conceptual definitions of
human subjects research and public health practice involving
identifiable data are discussed. Legal frameworks for these respective
activities are also examined, including constitutional and other legal
principles authorizing public health practice, human subjects research
requirements under the federal Common Rule, and the HIPAA Privacy Rule.
A host of cases provide examples of the difficulties distinguishing
practice and research in the modern era.
The authors go beyond merely assessing the problem by proposing a
two-stage framework (including a proposed checklist) for public health
practitioners and others to use to classify their activities. The first
stage presents key assumptions and foundations of public health
practice and research to help distinguish these activities in
relatively easy cases. A second stage rejects some existing criteria
often used to draw distinctions, introducing instead enhanced
principles of guidance.
While no set of principles or checklist may completely distinguish
between public health research and practice, these guidelines can help
resolve many cases and provide national uniformity in
decision-making.