摘要：Ethical issues that can arise in distinguishing public health research from practice are highlighted in 2 case studies—an investigation of a tuberculosis outbreak in a prison and an evaluation of a program for improving HIV prevention services. Regardless of whether such public health investigations represent research or practice, we see a need for ethics oversight procedures that reflect actual risks and enable timely responses to crises. Such oversight should accommodate the perspectives of persons and communities affected by public health threats and by governmental responses to those threats; it should further recognize that public health ethics is a distinct field combining bioethics, political philosophy, human rights, and law. DEFINING THE BOUNDARY between public health research and practice remains a critical challenge within the evolving field of public health ethics. 1 To achieve their mission and meet their responsibilities, public health practitioners in government agencies systematically collect data for surveillance, disease control and prevention, and program development and evaluation. The objectives and methods of these practice-based activities often overlap with those of researchers. As a result, it is sometimes difficult to determine which public health investigations constitute research, as defined and governed by federal human subjects regulations, and which represent public health practice, as authorized and governed primarily by state public health laws. In January 2002, the National Center for HIV, STD, and TB Prevention (NCHSTP) at the Centers for Disease Control and Prevention (CDC) convened a 2-day workshop to examine a series of questions in public health ethics, drawing on case studies from NCHSTP projects and the expertise of a diverse group of invited participants (listed in our Acknowledgments). The workshop was aimed at informing efforts to ensure the ethical conduct of NCHSTP projects and more broadly at contributing to ongoing national discussions concerning the ethical conduct of public health practice. In this article, we present 2 case studies discussed at the workshop that illustrate the ethical dilemmas inherent in distinguishing public health practice from research, and we consider their ethical implications for future efforts to redefine or clarify the research–practice boundary. Within public health, the prevention and treatment of what are sometimes described as “social diseases” present special challenges. For example, people at highest risk for HIV infection, sexually transmitted diseases, and tuberculosis (TB) are often socially, economically, or politically vulnerable. Stigma, poverty, and discrimination are interwoven with the conditions that affect both the transmission and the outcome of these infections. These vulnerabilities heighten the importance of ensuring that public health investigations and interventions are conducted ethically and that appropriate protections and oversight procedures are followed when public health agencies conduct research, including proper institutional review board oversight. If public health investigations are deemed not to represent research, then institutional review board procedures for protecting research participants do not come into play, and the interests of both directly affected individuals and the communities at large are protected under public health laws. The 2 case studies presented in this article illustrate the importance of carefully distinguishing research from practice. The CDC bases its criteria for distinguishing research from “nonresearch” on federal human subjects regulations that include the intent of investigators as an essential part of the definition of research (see 45 CFR §46.102[d]). 2 Under these regulations, if the primary intent is to contribute to “generalizable” knowledge, then the project is deemed to represent research. For example, when investigators seek to address a public health question and conduct an investigation to generalize the findings to other settings, then the project would be considered research and institutional review board oversight would be required. In contrast, if a project is done in the context of a public health agency’s role in preventing or controlling disease or promoting health and is aimed at a specific public health problem, then it is deemed to represent nonresearch or public health practice. Thus, it would not be considered within the purview of an institutional review board. For example, outbreak investigations, public health surveillance, or program evaluations conducted by public health agencies as part of their legally authorized mandate are usually considered nonresearch. In such nonresearch investigations, there may be secondary benefits when investigations yield insights of generalizable value that merit dissemination, but the research versus nonresearch determination would be unchanged because it is based on the primary intent. 3 As noted by the National Bioethics Advisory Commission, drawing the boundary between these 2 activities, research versus practice, can be difficult. 4
