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• W4231483375 abstract "The debate on the bioethical aspects of medical research has been always very lively [1.Slowther A. Clinical ethics committees.Br Med J. 2000; 321: 649-650Crossref PubMed Scopus (37) Google Scholar] as medical progress is based on research, which ultimately must rest on experimentations involving human subjects (i.e. clinical research). All recommendations and/or normative and legislative bills regarding experimental interventions require the preparation of a formal protocol, must obtain approval from the appropriate ethical committee (EC), and seek written informed consent from potential participants. In Italy, new guidelines on the aims, structure, composition and accountability of ECs were published in 1998, together with standards for the accreditation of the institutions where research is conducted and new rules for examining the quality and safety of the drugs under evaluation [2.Ministeriale Decreto 18 Marzo. 1998. Linee guida di riferimento per l’istituzione e il funzionamento dei Comitati Etici.Gazzetta Ufficiale. May 1998; 122: 28Google Scholar]. One year later, there was widespread agreement that the immediate impact of these new rules (i.e. decentralization and emphasis on the pharmacological aspects of studies) was negative. A two-step prospective study was launched to produce reliable data and information on the impact of these new rules on the functioning of ECs. A questionnaire previously developed and tested on an independent sample of 50 physicians was administered twice (March 1999 and September 2000) to 110 oncologists involved in two multicentre trials involving colorectal cancer patients [3.Mosconi P. Andreoni B. Confalonieri C. et al.A randomized trial of intensive versus minimalist follow-up of patients with resected Dukes B2-C colorectal carcinoma. The pilot phase.Proc Am Soc Clin Oncol. 1998; 17 (Abstr 1063): 276aGoogle Scholar, 4.Wils J. The establishment of a large collaborative trial program the adjuvant treatment of colon cancer.Br J Cancer. 1998; 77: 23-28Crossref PubMed Scopus (24) Google Scholar]. Most physicians worked in large specialised or teaching hospitals, located in northern Italy. The questionnaire explored nine aspects of ECs, including the presence of an EC at hospital level, personal experience with an EC, average time taken to receive feedback, and, using a five-point Likert scale, the level of satisfaction with the important functions of the EC. Overall, 84% and 74% of physicians contacted gave valid answers at the first and second survey, respectively, pertaining to 57 and 48 ECs. When the first survey was carried out 112 ECs were in operation; however, by September 2000 when the second survey was launched, the figure had nearly doubled to 207. In Table 1, the respondent characteristics and principal results of both surveys are reported. In both surveys, clinicians reported being satisfied with scientific (survey 1: 85%; survey 2: 89%) and ethical (survey 1: 96%; survey 2: 98%) feedback, and unsatisfied with educational and formative activities(survey 1: 40%; survey 2: 33%), and bureaucratic and clerical requirements (survey 1: 62%; survey 2: 59%). At the second survey, the mean time required for feedback after the submission of a study protocol was ∼2.4 months. The analysis of the change in the level of satisfaction between the two surveys documented small changes in all aspects evaluated.Table 1Description of the two cross-sectional study samples and relevant findingsFirst surveySecond surveyNo. of cases11093No. of responders9369No. of hospitals7256No. of cities5241No. of ethics committees5748Years of EC activity (mean, range)5.1, 0–165.2, 1–17Change in the EC composition during last 6 months? (%)4216Have you contacted an EC for review during last 6 months? (%)6847If yes, how much time elapsed from submission to feedback?(months) (mean, median, range)2.7, 2, 1–82.4, 2, 1–8Satisfaction (%) withaProportion of satisfied and very satisfied/total.:Bureaucratic and clerical aspects6259Ethical aspects9698Scientific and methodological aspects8589Education and formative aspects4033a Proportion of satisfied and very satisfied/total. Open table in a new tab In Italy, with the implementation of the new rules, emphasis was placed upon optimising the evaluation and review of research protocols in which pharmaceutical products are tested on human subjects. Two main observations were made: first, a change occurred in the composition of the EC, with greater involvement of pharmacologists and statisticians to keep up to date with the new standards and duties; and secondly, most of the time spent during EC meetings was actually related to legislative and pharmacological issues, while less attention was paid to the ethical and moral aspects of the protocols. According to the results presented here, the level of satisfaction with critical EC functions, such as ethical and scientific feedback to clinical researchers, was high. On the other hand, the level of clinician satisfaction with their EC regarding implementation of educational and formative initiatives and the bureaucratic and clerical requirements for submission was very low. The analysis of change over time documented a moderate increase in satisfaction with all aspects of ECs, with the exception of bureaucratic and clerical functioning. Despite the limitations of the present study, namely the small sample size and the peculiarity of the Italian setting, these findings provide empirical evidence on the functioning of local ECs and on the opinions of clinical researchers [5.Macneill P.M. Walters J. Webster I.W. Ethics decision making in Australian hospitals.Med J Aust. 1994; 160: 63-65Crossref Scopus (14) Google Scholar, 6.Dal-Rè R. Espada J. Ortega R. Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.J Med Ethics. 1999; 25: 268-273Crossref PubMed Scopus (39) Google Scholar]. In addition, our experience confirms that empirical studies of medical ethics are feasible and may produce important information to help facilitate the implementation of ECs in the medical and lay community [7.Hope T. Empirical medical ethics.J Med Ethics. 1999; 25: 219-220Crossref PubMed Scopus (45) Google Scholar]." @default.
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• W4231483375 date "2002-07-01" @default.
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• W4231483375 title "Oncologists’ opinion of ethics committees functioning in Italy" @default.
• W4231483375 doi "https://doi.org/10.1093/annonc/mdf193" @default.
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