Chapter 4 - Competence and role of ethics committees in clinical trials

Article type: Research Article

Authors: Buratin, Michele

Affiliations: Alma Mater Studiorum, Università di Bologna, Bologna, Italy. E-mail: michele.buratin@unibo.it

Abstract: Ethics committees are created as a response to requests coming from some sections of public opinion, especially from those who experience a disconnect between the evolution of medical science and technological progress and the development of a corresponding ethical maturity on the part of health professionals. Ethics committees tend to develop in areas as different from those of traditional end-of-life decisions, playing roles that appear distant from the original one. New fields of activity are ethics committees identified in North American clinical practice, for example, to ensure that women who want to give their child up for adoption are adequately informed about the adoption alternatives, or to express opinions to assess the lawfulness by parents, Jehovah's witnesses, to refer their children exclusively to surgical treatments that do not involve the use of blood transfusions. In this work we tried to examine the role and experiences of U.S. Ethics Committees in the field of clinical trials, comparing these organisms with the Italian reality, in order to highlight differences, but also similarities. The work ends by focusing on a few issues that are still unresolved, such as the profile concerning the composition of the ethical committees and the anticipation of establishment of a single national Ethics Committee.

Keywords: Ethics committees, clinical trial, health system, scientific research, ``vulnerable'' subjects

DOI: 10.3233/PPL-160420

Journal: Pharmaceuticals Policy and Law, vol. 17, no. 3-4, pp. 351-370, 2015