ABSTRACT
OBJECTIVE: The aim of this study was to analyze the functioning of the French committees for the protection of people in biomedical research (CCPPRB). DESIGN: An independent evaluator visited all of the committees and analyzed their functioning by assessing the annual activity reports, filling data grids and observing the committees in session. RESULTS: We observed that the representation of a range of professions, which is required by law, was not always respected. This was partly because the administrative authority had accumulated delays in nominating members. Another explanation could be the absence of remuneration for the work and attendance of the members. There was considerable inter-committee variation concerning the way documents were distributed to the members during sessions and the extent of investigator and promoter involvement. Finally, large differences in the number of dossiers handled between committees led us to investigate the fairness of dossier distribution, as the number of dossiers dealt with has consequences, particularly for the finality of the opinions of the committees. CONCLUSIONS: This evaluation of the committees playing a crucial role in protecting participants in research trials provides new information that could be helpful for improving the way in which these committees function in the context of the European Directive.
Subject(s)
Ethics Committees, Research/standards , Research Subjects , Research/standards , Clinical Protocols , Committee Membership , Data Collection , Documentation , FranceABSTRACT
UNLABELLED: Fetal ultrasounds examinations allow identification of brain malformations; announce of diagnosis and information about prognosis may be difficult when malformation is rare and prognosis uncertain. OBJECTIVES: In this study we tried to analyze how fetal imaging for prenatal screening was organized and how couples were managed and supported. METHODS: We focused on the procedures used to inform couples: content, method of delivery and consequences. A referent physician in each large multidisciplinary center for prenatal diagnosis in Paris area was questioned by semi-directed interview. RESULTS: Our study showed that it is difficult to standardize the way in which information is supplied before and after fetal ultrasounds examination; uncertainty about prognosis led more often to abortion. CONCLUSION: Thus, couples should have clear and complete information provided by a multidisciplinary team including specialists particularly concerned by the malformation (neuropediatrician and/or neurosurgeon)--moreover when prognosis is uncertain, in order to support them, and to accompany their decision concerning pregnancy.
Subject(s)
Brain/abnormalities , Patient Education as Topic , Adult , Brain/embryology , Decision Making , Female , Health Care Surveys , Humans , Middle Aged , Physician-Patient Relations , Practice Patterns, Physicians'/statistics & numerical data , Pregnancy , Prognosis , Ultrasonography, PrenatalABSTRACT
OBJECTIVE: Since 1988, any human biomedical research protocol in France must be submitted to a committee for the protection of persons participating in biomedical research programs (Comité consultatif de protection des personnes dans la recherche biomédicale (CCPPRB). This study is one of the first to analyse the functioning of the French CCPPRB at the onset of the application in 2004 of a European ruling on drug research, so as to study the pertinence of the opinions and the necessity or not of homogenising committee habits. METHOD: Ten CCPPRB participated in the study. An external observer visited all the centres. Three methodological instruments were used: semi-directive interviews with categories representative of the committee, analysis of the observer's documents and analysis of the discussions during dossier sessions. RESULTS: The habits are heterogenic regarding the crucial definitions represented by biomedical research and the limits of the latter. In half of the committees, the decision to investigate a protocol is taken by the president alone. All the dossiers are studied by one or several reporters, but not always within discussion sessions, hence underlining the need to respect the multidisciplinarity within a CCPPRB. CONCLUSION: These results show the importance of developing training courses for the members of a CCPPRB and the need to consecrate means for these CCPPRB, representing the democratic authority for the analysis of the protocols.
