The Protection of the Person is Central in CIOMS International Ethical Guidelines

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Published: May 12, 2014
DOI: https://doi.org/10.5750/ijpcm.v3i4.449
Keywords:
International Ethical Guidelines Biomedical Research Involving Human Subjects Epidemiological Studies Clinical Trials Evidence-based Medicine Meta-analysis

Main Article Content

Michel Vallotton
Council of International Organisations of Medical Sciences (CIOMS)
Sian Fluss
Gian Sjolin Forsberg

Abstract

In 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Group of  problems concerning identification and selection criteria, analysis and interpretation of results (including unpublished results), and storage of data.

Article Details

Issue
Vol. 3 No. 4 (2013)
Section
Regular Articles
Author Biography

Michel Vallotton, Council of International Organisations of Medical Sciences (CIOMS)

Born March 1933 in Lausanne, Switzerland.Public school and College in Lausanne: bachelor Greek-Latin. Medical Faculty at the University de Lausanne. Federal diploma of Medicine, 1957. Doctor in Medicine, University of Geneva, 1961. ECFMG certificate, 1962. First-lieutenant in medical corps of alpine troops.Postgraduate training in internal medicine at the University Hospital of Geneva (1958-60) and of Zurich (1960-62). Research assistant at the Institute of  Biochemistry, University of Zurich (1962-64). Clinical and research Fellow at the Endocrine Unit and at the Thyroid Unit, Massachusetts General Hospital, Boston (1964-66). Research Fellow, Cardiac Unit and Hypertension Unit, Massachusetts General Hospital, Boston and Harvard Medical School (1966-67). Assistant Resident, Department of Medicine, Massachusetts General Hospital.Academic and clinical positions: Acting chief of the Laboratories for Clinical Investigation, University Hospital, Geneva (1968-98). Chief of the Division of Endocrinology and Diabetes, Department of Internal Medicine, Faculty of Medicine (1974-98). Full Professor of Medicine and Endocrinology (1974-1998). Member of the Council of the National Swiss Science Foundation (1979-89) and of the selection committee of other private research foundations attributing research grants, academic positions, prizes or awards. Over 300 scientific publications in international journals and author of review articles and chapters of book in the field of endocrinology, nephrology and hypertension. Past reviewer of many international scientific journals and member of many national and international societies in the field of clinical investigation, endocrinology, nephrology, cardiology and hypertension.Distinctions: Fellow of The Royal College of Physicians, London. Foreign Corresponding Member of the Royal Academy of Medicine of Belgium. Member of the Swiss Academy of Medical Sciences. Honorary Professor of the Faculty of Medicine of Geneva. Honorary Member of the Swiss Society of Endocrinology and Diabetology.Activities in the fields of medical ethics in research: President of the Central Ethical Committee in Research of the Department of Medicine examining research projects involving human beings (1989-1998). President of the Central Ethical Committee of the Swiss Academy of Medical Sciences (1998-2006). President of Council of International Organisations of Medical Sciences (CIOMS) (2003-2006), re-elected President in 2007-2010. Many publications and editorials in the field of medical ethics.

References

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/).