The Protection of the Person is Central in CIOMS International Ethical Guidelines
Keywords:International Ethical Guidelines, Biomedical Research Involving Human Subjects, Epidemiological Studies, Clinical Trials, Evidence-based Medicine, Meta-analysis
AbstractIn this brief article the authors report on the objectives of this nongovernmental organization and, most particularly, on the protection of the person in its International Ethical Guidelines for the fields of clinical trials and epidemiological studies. They emphasize the terminology used to describe the subjects or the populations involved in these studies. They discuss the possibility and nature of harm to persons involved in such studies, and justify the requirement for informed consent also for the persons involved in epidemiological studies. Finally, they consider the roles of such trials and studies as the basis for evidence-based medicine, including cases when their results are pooled in meta-analysis. This methodology is the subject of examination by a CIOMS Working Group of problems concerning identification and selection criteria, analysis and interpretation of results (including unpublished results), and storage of data.
International Ethical Guidelines for Biomedical Research Involving Human Subjects. CIOMS, Geneva, 2002. (http://www.cioms.ch/)
International Ethical Guidelines for Epidemiological Studies. CIOMS, Geneva, 2009. (http://www.cioms.ch/).