Public Health Research Ethics: A Research Agenda

One plausible way to structure a narrative about the origin and development of medical ethics is to see much of it as a commentary on the ethical issues that have arisen in biomedical research with human subjects over the last 75 years. Whilst it is obvious that for medical progress to occur scientific studies involving human subjects are necessary, research ethics tends to focus on the examples in which vulnerable persons were harmed, or other moral problems arose. It is important to see that controversial studies are not limited to the work of malevolent ‘scientists’ like Josef Mengele, but are often carried out by researchers and groups that assumed at the time that they were contributing to improvements in the health and well-being of the public. Much discussed examples of controversial studies include Tuskegee (Jones, 1993), Willowbrook (Murphy, 2004), the Kennedy Krieger Institute Lead Paint Study (Mastroianni and Kahn, 2002), and some of the AZT preventive studies in developing countries (Hawkins and Emanuel, 2008). Clearly, research with human beings can create many moral issues that require ethical reflection and analysis: on what ground can it be justified to use individuals as research subjects? What is the meaning and scope of informed consent? How should risks be evaluated vis-à-vis the importance of the study objectives and the proposed methodology? When (if ever) can placebos or otherwise substandard medical interventions be used? However, while we believe that the discussion of such issues needs to continue, we suggest that there are a number of problems with the way that contemporary research ethics is framed. We will focus on just two issues in this brief editorial. First, the dominant approach to research ethics has focused on producing numerous regulations. This is potentially problematic for a number of reasons. Second, research ethics is dominated by a very particular paradigm of research, namely the clinical drug trial. This results in limitations in the range of ethical issues discussed and problems in applying this model to other perfectly legitimate types of research. We will illustrate both points by making reference to the recently issued revised CIOMS International Ethical Guidelines for Epidemiological Research (1991, 2008).