The importance of the training of Ethics committee members

Medicine and Law

Volumn 28, Issue 4, 2009, Pages 649-659

  Ricci, Giovanna ^a   Cannovo, Nunzia ^b  

^a UNIVERSITY OF CAMERINO   (Italy)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

Author keywords

Clinical research; Clinical trials; Decision process; Ethics committee members; Humanizing; Italian situation; Legal medicine expert; Pharmacological research; Responsibility; Training

Indexed keywords

ARTICLE; CONTINUING EDUCATION; EDUCATION; HUMAN; PROFESSIONAL STANDARD; RESEARCH ETHICS;

EDUCATION, CONTINUING; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS;

EID: 74849117569     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (32)

1. Italian Ministerial Decree (1997). Transposition of the EU guidelines relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Ministerial decree of 7/15/1997 published in the Official Gazette of the Italian Republic, n 191,8/18/1997.
2. Italian Legislative Decree (2003). Transposition of the directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Italian Legislative Decree 6/24/2003, no. 211 published in the Official Gazette of the Italian Republic, no. 184, 8/9/2003 - Ordinary Supplement no. 130.
3. Articles 2 and 3, Italian Ministerial Decree of 12 May 2006. Minimum requirements for the setting up, organization and functioning of Ethics Committees for clinical trials on medicinal products, published in the Official Gazette of the Italian Republic no. 194, 8/22/2006.
4. Italian Ministerial Decree (2007). Modality for submission to the Competent Authority, for the communication of substantial amendments and for declaring the conclusion of a clinical trial, and for the request of opinion to the Ethics Committee. Ministerial decree of 21/12/2007 published in the Official Gazette of the Italian Republic, n.53, 3/3/2008.
5. Ministerial Decree supra note 3.
6. Liberati A., I comitati etici nell'era dell'EBM. In: Liberati A, Etica, Conoscenza e Sanità. Milano: Il pensiero Scientifico Editore, 2005; p. 346-380.
7. In order to have a general idea of the regulatory framework in Italy, suffice it to think that there are legislative measures regarding trials in general medicine, Phase I trials, the circular regarding observational studies, transparency rules regarding the compulsoriness of publication for the results of the studies as a condition for their approval by the side of the Ethics Committees, the regulation regarding the evaluation criteria of the drugs before and after the formal approval of their indications etc. A complete collection of the regulatory texts is available from: http://oss-sper-clin.agenziafarmaco. it/normativa.hrm
8. Council for International Organizations of Medical Sciences (CIOMS), International Guidelines for Biomedical Research Involving Human Subjects, guideline 14, (1993), Geneva Available from: www.cioms.ch/frame- guidelines-nov-2002.htm.
9. European Medicines Agency, CPMP/1CH/135/95, art 3.1, July 2002. Available from: http://www.emea.europa.eu/pdfs/human/ich/013595en.pdf
10. Veatch R.M. Hospital Ethics Committees. Is there a Role?. The Hastings Center Repor, 7, 3, 1977: 22-25.
11. Comitato Nazionale per la Bioetica (CNB). I comitati etici in Italia: problematiche recenti, April 1997. Available from: http://www.governo.it/ bioetica/oareri.html.
12. Minacori R. Proceedings of the Giornate di formazione sui Comitati Etici: Gli aspetti assicurativi della sperimentazione clinica; 2000 October 13; Milan. In: Medicina e Morale 6, 2000, p. 1230.
13. Santosuosso A. Proceedings of the Incontro di Studio sulla Biologia, Biotecnologia e legge; 2001 November 8-10; Rome.
14. Davies H. The Role of Ethics Committees. In: Proceedings of the Ethical Aspects of Clinical Research Course, Vienna School of Clinical Research, 2006 14-17 May.
15. Ministerial Decree, supra note 2 and 3.
16. Piana G. Bioetica. Alla ricerca di nuovi modelli. Milan: Garzanti; 2002.
17. Savalescu J. Two deaths and two lessons: is it time to review the structure and function of research ethics committees? J Med Ethics, 28,2002: 1-2.
18. Saunders J. Research ethics committees-time for change? Clin Med, 2, 2002: 534-8.
19. H. Davies, F. Wells, Druml C, How can we provide effective training for research ethics committee members? A European assessment. J Med Ethics, 34, 2008: 301-302.
20. Ministerial Decree, supra note 3.
21. Comitato Nazionale per la Bioetica (CNB), Orientamenti per i Comitati Etici in Italia. 13 July 2001. Available from: http://www.govemo.it/bioetica/ pdf/47.pdf
22. Here mentioned as an example: Master Course in Clinical Bioethics at the University "La Sapienza" in Rome; Master in Bioethics at the Pontifical Lateran University in Rome; Faculty in Bioethics at the Pontifical University Regina Apostolorum; Master in Bioethics at the University of Camerino; International Bioethics Course at the University of Udine; I level Master in Bioethics and Applied Ethics organized by the Faculty of the Humanities of the University of Turin; Training Course on "Bioethics and Experimentation", Center for Bioethics and Biolaw - University of Siena and Ethics Committee - AOU Senese.
23. Cannovo N., et al. The Role of the Legal Medicine Medical Expert within Research Ethical Committees. In: Proceedings of the XX Congress of International Academy of Legal Medicine, 2006, August 23-26, Budapest, Hungary.
24. World Health Organization, Operational Guidelines for Ethics Committees That Review Biomedical Research. TDR/PRD/ETHICS/2000.1, Geneva, 2000. Avaible from: http://apps.who.int/tdr/publications/trainine-guideline- publications/operational-guidelines-ethics-biomedical-research/pdf/ethics.pdf
25. Italian Legislative Decree (1992). Reorganization of the discipline in the health sector under art. 1 of the Law of 23 October 1992, no. 421. Italian Legislative Decree 12/30/1992, no. 502, published in the Official Gazette of the Italian Republic, no. 305, 12/30/1992.
26. Spagnolo A., La protezione dei soggetti di sperimentazione: ruolo e procedure operative dei Comitati di Etica. In: Spagnolo A.G., Sgreccia E. Lineamenti di Etica della Sperimentazione clinica. Milano: Vita e pensiero editore, 1994: p. 300.
27. Information regarding the training of the members of an Ethics Committee in the United Kingdom are available on: www.corec.co.uk.
28. The NOMET project was introduced by Prof. Ruud ter Meulen, director of the Bioethics Institute and professor of Philosophy and Ethics at the University of Maastricht. More information are available on: htro://ec.europa.eu/research/ conferences/2005/recs/cv-en.htm
29. Sarah Edwards, et al, Research ethics committees: differences and moral judgement. Bioethics, Ato, 18, 5,2004, pp. 408-427.
30. Ethics in Medicine; General outline of Bioethics; Purpose and History of Medical research; the History of research ethics; Regulatory references; functioning of the EC and role of the EC members; criteria for evaluating protocols; research methodology: scientific aspects and clinical relevance; informed consent: several models; legal-insurance aspects on the process of ethical decision-making; basic concepts of ethics and ethical decision-making; professional and other role-based obligations; addressing conflicts between alternative bases of obligation; sample cases for discussion; alternative approaches to ethical decision making; value-maximizing and rule- based moral thinking; the role and obligations of the case consultant or case-consulting committee; preserving confidentiality and breaching confidentiality, fraud and misconduct.
31. These are examples of specific topics: trials with products for advanced therapies and gene therapies; processing of personal and genetic information (pharmacogenetic-genomic studies); bio-statistical analysis; insurance implications of clinical trials; test of the local feasibility of a study etc.
32. Chambers T. Centering bioethics. Hastings Center Report, 30, 1,2000:22-29.