MACQUEEN AND BUEHLER RESPOND

Abstract

In our article we addressed a number of questions regarding the boundary between human subjects research, as defined by federal regulations, and public health practice, as defined by state and federal public health policy and law. The vast majority of work done by public health agencies is not research, and this boundary is usually clear. For example, a randomized controlled trial to evaluate an experimental tuberculosis therapy is human subjects research, despite the public health mission driving the work, and should be reviewed by an institutional review board (IRB). Conversely, a state mandate that physicians report cases of tuberculosis to public health authorities represents public health practice, despite the potential richness of the resulting data for research, and allows health departments to monitor tuberculosis trends and direct prevention and care services. Mechanisms exist to protect the confidentiality of those reported to public health surveillance systems or receiving public health services. There are, however, areas of practice where oversight may be inadequate or lacking. In contemplating new approaches to ensuring ethical public health practice, oversight by a group familiar with public health law and human rights would be more meaningful than review by an IRB familiar mainly with research ethics and procedures. We share Wedeen’s interest in ethical public health. We made no arguments justifying ends over means, and Wedeen’s assertion that we have taken such a position represents a serious misreading of our article. We explicitly argued for the creation of oversight or guidance mechanisms that are meaningful and appropriate for public health. Our intent was to promote thoughtful discussion and informed action in resolving the challenges faced by public health practitioners and researchers who strive to meet their obligations ethically. The National Bioethics Advisory Commission called for innovative solutions to correct the limitations of current procedures for distinguishing research from practice and for ensuring the ethical conduct of investigations in which the risks primarily involve stigmatization or potential threats to privacy and confidentiality.1 The engagement of community advisory boards by public health agencies is one approach to addressing these concerns,2,3 reflecting parallel interest in such boards for research projects.4 Another approach would be to more clearly inform and engage the public concerning the objectives, methods, and procedures of public health practice, in turn improving the oversight of public health agencies already provided by the political process of governance.5