Ethics committees in Italy: A survey on a sample of oncologists

Paola Mosconi, Giovanni Apolone, Giovanna Cattaneo, Livia Pomodoro, Silvio Garattini

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Aims and background: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental Interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. Methods and study design: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Results: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Conclusions: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.

Original languageEnglish
Pages (from-to)189-192
Number of pages4
JournalTumori
Volume89
Issue number2
Publication statusPublished - Mar 2003

Fingerprint

Ethics Committees
Italy
Clinical Ethics Committees
Medical Ethics
Education
Surveys and Questionnaires
Oncologists
Politics
Informed Consent
Sample Size
Multicenter Studies
Emotions
Research Personnel
Prospective Studies
Pharmacology
Guidelines
Physicians

Keywords

  • Ethics committees
  • Italy
  • Medical ethics
  • Oncology
  • Survey

ASJC Scopus subject areas

  • Cancer Research

Cite this

Ethics committees in Italy : A survey on a sample of oncologists. / Mosconi, Paola; Apolone, Giovanni; Cattaneo, Giovanna; Pomodoro, Livia; Garattini, Silvio.

In: Tumori, Vol. 89, No. 2, 03.2003, p. 189-192.

Research output: Contribution to journalArticle

Mosconi, Paola ; Apolone, Giovanni ; Cattaneo, Giovanna ; Pomodoro, Livia ; Garattini, Silvio. / Ethics committees in Italy : A survey on a sample of oncologists. In: Tumori. 2003 ; Vol. 89, No. 2. pp. 189-192.
@article{1bae85996d6c46958d6ad4218bd9c104,
title = "Ethics committees in Italy: A survey on a sample of oncologists",
abstract = "Aims and background: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental Interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. Methods and study design: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Results: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44{\%}) and educational activities and training (64{\%}). Analysis of the change over time documented small differences (from -8{\%} to +7{\%}) in all aspects evaluated. Conclusions: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.",
keywords = "Ethics committees, Italy, Medical ethics, Oncology, Survey",
author = "Paola Mosconi and Giovanni Apolone and Giovanna Cattaneo and Livia Pomodoro and Silvio Garattini",
year = "2003",
month = "3",
language = "English",
volume = "89",
pages = "189--192",
journal = "Tumori",
issn = "0300-8916",
publisher = "SAGE Publications Ltd",
number = "2",

}

TY - JOUR

T1 - Ethics committees in Italy

T2 - A survey on a sample of oncologists

AU - Mosconi, Paola

AU - Apolone, Giovanni

AU - Cattaneo, Giovanna

AU - Pomodoro, Livia

AU - Garattini, Silvio

PY - 2003/3

Y1 - 2003/3

N2 - Aims and background: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental Interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. Methods and study design: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Results: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Conclusions: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.

AB - Aims and background: The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental Interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. Methods and study design: A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Results: Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Conclusions: Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This experience confirms that empirical studies on medical ethics are feasible and may produce useful information to facilitate the implementation of EC in the medical and lay community.

KW - Ethics committees

KW - Italy

KW - Medical ethics

KW - Oncology

KW - Survey

UR - http://www.scopus.com/inward/record.url?scp=0037869464&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037869464&partnerID=8YFLogxK

M3 - Article

C2 - 12841669

AN - SCOPUS:0037869464

VL - 89

SP - 189

EP - 192

JO - Tumori

JF - Tumori

SN - 0300-8916

IS - 2

ER -