Ethical Justification for Conducting Public Health Surveillance Without Patient Consent

摘要

Public health surveillance by necessity occurs without explicit patient consent. There is strong legal and scientific support for maintaining name-based reporting of infectious diseases and other types of public health surveillance. We present conditions under which surveillance without explicit patient consent is ethically justifiable using principles of contemporary clinical and public health ethics. Overriding individual autonomy must be justified in terms of the obligation of public health to improve population health, reduce inequities, attend to the health of vulnerable and systematically disadvantaged persons, and prevent harm. In addition, data elements collected without consent must represent the minimal necessary interference, lead to effective public health action, and be maintained securely. Public health surveillance is defined as the ongoing, systematic collection, analysis, and interpretation of health-related data with the a priori purpose of preventing or controlling disease or injury, or of identifying unusual events of public health importance, followed by the dissemination and use of information for public health action. 1 It is distinct from other types of surveillance (e.g., security or intelligence) in that the purpose of public health surveillance is to prevent or control disease or injury and to improve the public's health. 2 Surveillance is a foundational tool of public health, serving as the finger on the pulse of the health of a community. Public health surveillance is used, in some cases uniquely, to quantify the magnitude of health problems, describe the natural history of disease, detect outbreaks and epidemics of known or new pathogens, document the distribution and spread of health events, facilitate epidemiological and laboratory research, generate and test hypotheses, evaluate control and prevention measures, monitor isolation activities and changes in infectious agents, detect changes in health practices, plan public health actions and use of resources, and appropriate and allocate prevention and care funds. 3 Public health surveillance consists of 7 ongoing, systematic activities in 3 basic steps—system development, data collection and analysis, and data use—that provide continuous feedback for system improvement. The first step, system development, involves (1) planning and design. The second step, data collection and analysis, involves (2) data collection, (3) collation, (4) analysis, and (5) interpretation. The third step, data use, involves (6) dissemination and (7) application to public health program. These 7 activities create the infrastructure of a coherent and state-of-the-art system. 4 Findings from such systems are fed directly to public health programs that benefit the populations and communities from which the data are collected 2 ; this feedback into programmatic action distinguishes public health surveillance from other ways of knowing about health. 5 Public health surveillance systems vary according to their purpose, the condition monitored, and the planned uses of the data. Some systems use non–name-based reporting mechanisms; others require names and other personal identifiers for case reporting. We examine the conditions under which it is ethically justifiable to create and maintain a public health surveillance system that, in addition to the disease or health outcome, risk factors, and demographic characteristics, requires that a name or other identifying information be reported to the local or state health official for storage and future use. The first public health surveillance system in the United States was developed in Rhode Island in 1741, when public health law required tavern keepers to report persons with infectious diseases to health officials. 3 Today, public health surveillance is legally authorized and widely implemented; every state requires health care providers to report certain health conditions to the local or state public health authority. 6 Under police powers of the states, these reports are legally required regardless of patient consent or knowledge 7 and are, as they have been for nearly 300 years, justified scientifically. 8–11 Scientific justification stems from the population-based nature of public health surveillance systems, in which all diagnoses or health events have an equal chance of being reported to the system, producing a highly representative set of information to describe a health condition in the populace. In some systems, such as those for tuberculosis and HIV, laboratories and health care providers are required to report all diagnosed cases of a health event; these public health surveillance systems exemplify a reference standard for completeness, representing the accurate number and distribution of cases in the population. 12 In systems such as these in which more than 1 event is reported per case (e.g., a positive HIV antibody test followed by an HIV viral load measure) or persons can be reported in more than