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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.