SYSTEMATIC FRAMEWORK FOR EVALUATING THE ETHICS IN EPIDEMIOLOGY

Abstract

Rational Ethical research requirements aim to minimize the possibility of exploitation by ensuring that research subjects are not merely used but are treated with adequate respect. Much of modern bioethics is founded on the main ethical principles of respect for autonomy, nonmaleficence, justice, and beneficence. Although these principles provide a useful framework for applying normative ethics to specific problems, they do not provide a full ethical justification. Many of previous ethical documents used as the guidance on the ethical conduct were written in response to specific historical events. Therefore, by focusing on the instigating issues, these guidelines tend to emphasize certain ethical requirements while eliding others. While informed consent is necessary for most epidemiological studies, in no case is it sufficient for ethical conduct. Some of contemporary controversies such as epidemiological studies in developing countries, involvement of children, and protection for communities have raised questions not of informed consent, but of the ethics of subject selection, appropriate risk-benefit analysis, and the value of research to science and society. Since obtaining informed consent does not ensure ethical research, it is imperative to have a systematic and coherent framework that incorporates all relevant ethical considerations. Methods Based on the major ethical codes, declarations, and other documents relevant to epidemiological studies involving human subjects, we developed a systematic and coherent framework to ascertain whether epidemiological research is ethical. Proposed ethical requirements for determining whether an epidemiological study is ethical justify core ethical values and principles of respect for autonomy, nonmaleficence, justice, and beneficence. All ethical requirements were grouped in three major categories according to its specific function in the coherent framework. Proposed ethical conduct categories and subcategories represented an ethical conduct formula for determining the ethics of epidemiological research. Results Proposed nine ethical requirements represent fundamental (scientific and society value, scientific validity, and favorable risk-benefit ratio), procedural (fair subject selection, informed consent, and independent review), and professional (respect for potential and enrolled subjects, intellectual honesty and responsibility, and necessary expertise and training) categories. The 3x3 ethical conduct formula elucidates a coherent and systematic framework for evaluating the ethics of epidemiological study. Although the proposed ethical requirements must be adopted to the specific cultural, social, economical and technological conditions in which study is conducted, the requirements are not limited to a specific study or country and are universal. Conclusions The systematic and coherent framework will not necessarily generate unanimous agreement on ethical conduct for every epidemiological study. Presented categories and subcategories of ethical requirements could be reinterpreted and revised with changes in science. However, all of these ethical requirements are intended to guide the ethical development, implementation, and review of epidemiological study and must be met to ensure the ethical conduct. The fulfillment of each of these requirements also ensures that epidemiological study is socially and scientifically valuable. The proposed systematic framework should help guide the ethical development, implementation and evaluation of epidemiology studies for both investigators and institutional review board members.