Public Health Research

Abstract

Having a scientific basis for the practice of public health is critical. Research leads to insight and innovations that solve health problems and is therefore central to public health worldwide. For example, in the United States research is one of the ten essential public health services (Public Health Functions Steering Committee 1994 ). The Principle s of the Ethical Practice of Public Health , developed by the Public Health Leadership Society ( 2002 ), emphasizes the value of having a scientifi c basis for action. Principle fi ve specifi cally calls on public health to seek the information needed to carry out effective policies and programs that protect and promote health. This chapter pres ents ethical issues that can arise when conducting public health research. Although the literature about research ethics is complex and rich, it has at least two important limitations when applied to public health research. The fi rst is that much of research ethics has focused on clinical or biomedical research in which the primary interaction is between individuals (i.e., patient-physician or research participant- researcher). Since bioethics tends to focus on the individual, the fi eld of research ethics often neglects broader issues pertaining to communities and population s, including ethical issues raised by some public health research methods (e.g., the use of cluster randomized trials to measure population, not just individual, effects). However, if our discussion of public health research ethics begins by examining public health activities, it becomes apparent that the process of gaining consent involves more than individuals. We must consider that communities bear risks and reap benefi ts; that not only individuals but also populations may be vulnerable; and that the social, political , and economic context in which research takes place poses ethical challenges. Public health research, with its focus on intervention at community and population levels, has brought these broader ethical considerations to researchers’ attention, demonstrating how ethics guidance based on biomedical research may limit, if not distort, the ethical perspective required to protect human subjects. The second limitation has to do with how guideline s and regulations are conceived and used. As described in Chaps. 1 and 2 of this casebook, research ethics has mostly evolved out of concern for research abuses. Consequently, the intent of many guidelines and regulations is to strengthen the ethical practice of research with human subjects. These ethical guidance documents include the Nuremberg Code ( 1947); the Universal Declaration of Human Rights (United Nations 1948 ); the Declaration of Helsinki (World Medical Association 1964 , last revised in 2013); and two documents developed by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO) : International Ethical Guidelines for Biomedical Research Involving Human Subjects ( CIOMS 2002 ) and the International Ethical Guidelines for Epidemiological Studies (CIOMS 2009 ). In the United States, the primary ethical guidance for protecting human subjects is Title 45, Part 46, of the Code of Federal Regulations (U.S. Department of Health and Human Services 2009 ). The e thical principles of respect for persons , benefi cence , and justice have oft en framed the discussion on ethical conduct of research with human subjects . These principle s were fi rst articulated by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ( 1979 ) in the Belmont Report and expanded upon by Beauchamp and Childress ( 1979 ) in Principles of Biomedical Ethics .