An Enhanced Approach to Distinguishing Public Health Practice and Human Subjects Research

Abstract

What are the Differences between Public Health Practice and Research? This perplexing 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 analyze 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 requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), 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 resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects (or their identifiable, private data).