Suchergebnisse

The emergence of international principles concerning research ethics requires an independent multidisciplinary committee to evaluate research protocols involving the human person. In France, compliance with these international principles depends, in part, on the "Committees for the Protection of Persons" (CPP). Currently, the regulation of research involving the human person constitutes in France the framework of CPPs but also the keystone on which their role is based. It requires that they ensure that the "conditions of validity" of the research are respected. It does not appear neither in their title nor in legislation that they are compelled to give an "ethical" opinion about research protocols. In this context, what is the meaning of the CPPs in research? Are they research ethics boards? How do members perceive it and invest their roles in carrying out the missions under the CPP? This research was carried out on a qualitative approach through semi-directional interviews. Nine members of the CPP from Île-de-France were interviewed, including two doctors, two presidents, a hospital pharmacist, three lawyers, two user representatives and a psychologist. All those interviewed made it possible to represent five out of ten CPPs in Île-de-France. The results showed that despite a "bureaucratization of ethics", CPPs members are working to maintain their independence throught their volunteerism. This resistance is the cause of the refusal of the members to limit their mission to the acceptability of the research from a legal point of view. Their "ethical" thinking cannot be limited to criteria guaranteeing legal research or even a normative application of the principles of research ethics, under the guise of ethic. ; L'émergence des principes internationaux, concernant l'éthique de la recherche, impose de passer par un comité pluridisciplinaire indépendant pour évaluer les protocoles de recherche impliquant la personne humaine. En France, le respect de ces principes internationaux dépend, en partie, des « Comités de ...

The emergence of international principles concerning research ethics requires an independent multidisciplinary committee to evaluate research protocols involving the human person. In France, compliance with these international principles depends, in part, on the "Committees for the Protection of Persons" (CPP). Currently, the regulation of research involving the human person constitutes in France the framework of CPPs but also the keystone on which their role is based. It requires that they ensure that the "conditions of validity" of the research are respected. It does not appear neither in their title nor in legislation that they are compelled to give an "ethical" opinion about research protocols. In this context, what is the meaning of the CPPs in research? Are they research ethics boards? How do members perceive it and invest their roles in carrying out the missions under the CPP? This research was carried out on a qualitative approach through semi-directional interviews. Nine members of the CPP from Île-de-France were interviewed, including two doctors, two presidents, a hospital pharmacist, three lawyers, two user representatives and a psychologist. All those interviewed made it possible to represent five out of ten CPPs in Île-de-France. The results showed that despite a "bureaucratization of ethics", CPPs members are working to maintain their independence throught their volunteerism. This resistance is the cause of the refusal of the members to limit their mission to the acceptability of the research from a legal point of view. Their "ethical" thinking cannot be limited to criteria guaranteeing legal research or even a normative application of the principles of research ethics, under the guise of ethic. ; L'émergence des principes internationaux, concernant l'éthique de la recherche, impose de passer par un comité pluridisciplinaire indépendant pour évaluer les protocoles de recherche impliquant la personne humaine. En France, le respect de ces principes internationaux dépend, en partie, des « Comités de Protection des Personnes » (CPP). Actuellement en France, la réglementation de la recherche impliquant la personne humaine constitue l'encadrement des CPP mais aussi la base sur laquelle repose leur rôle. Elle prévoit qu'ils s'assurent du respect des « conditions de validité » de la recherche. Il n'apparaît ni dans leur titre, ni dans les textes de loi, qu'ils doivent rendre un avis « éthique » au sujet des protocoles de recherche. Dans ce contexte, quel sens donner au CPP dans la recherche ? Sont-ils des comités d'éthique de la recherche ? Comment les membres le perçoivent-ils et investissent-ils leurs rôles dans l'exercice des missions qui relèvent des CPP ? Cette recherche s'est faite sur une approche qualitative par l'intermédiaire d'entretiens semi-directifs. Neuf membres de CPP d'Île-de-France ont été interrogés, notamment deux médecins dont deux présidents, un pharmacien hospitalier, trois juristes, deux représentants d'usagers et un psychologue. L'ensemble des personnes interrogées a permis de représenter cinq CPP d'Île-de-France sur dix. Les résultats ont montré que malgré une « bureaucratisation de l'éthique », les membres des CPP oeuvrent pour un maintien de leur indépendance à travers leur bénévolat. Cette résistance est l'origine du refus des membres de résumer leur mission à l'acceptabilité de la recherche d'un point de vue de la loi. Leur réflexion « éthique » ne peut se résumer à des critères garantissant la recherche au regard de la loi ou même à une application normative des principes de l'éthique de la recherche, sous couvert de l'éthique.

The emergence of international principles concerning research ethics requires an independent multidisciplinary committee to evaluate research protocols involving the human person. In France, compliance with these international principles depends, in part, on the "Committees for the Protection of Persons" (CPP). Currently, the regulation of research involving the human person constitutes in France the framework of CPPs but also the keystone on which their role is based. It requires that they ensure that the "conditions of validity" of the research are respected. It does not appear neither in their title nor in legislation that they are compelled to give an "ethical" opinion about research protocols. In this context, what is the meaning of the CPPs in research? Are they research ethics boards? How do members perceive it and invest their roles in carrying out the missions under the CPP? This research was carried out on a qualitative approach through semi-directional interviews. Nine members of the CPP from Île-de-France were interviewed, including two doctors, two presidents, a hospital pharmacist, three lawyers, two user representatives and a psychologist. All those interviewed made it possible to represent five out of ten CPPs in Île-de-France. The results showed that despite a "bureaucratization of ethics", CPPs members are working to maintain their independence throught their volunteerism. This resistance is the cause of the refusal of the members to limit their mission to the acceptability of the research from a legal point of view. Their "ethical" thinking cannot be limited to criteria guaranteeing legal research or even a normative application of the principles of research ethics, under the guise of ethic. ; L'émergence des principes internationaux, concernant l'éthique de la recherche, impose de passer par un comité pluridisciplinaire indépendant pour évaluer les protocoles de recherche impliquant la personne humaine. En France, le respect de ces principes internationaux dépend, en partie, des « Comités de Protection des Personnes » (CPP). Actuellement en France, la réglementation de la recherche impliquant la personne humaine constitue l'encadrement des CPP mais aussi la base sur laquelle repose leur rôle. Elle prévoit qu'ils s'assurent du respect des « conditions de validité » de la recherche. Il n'apparaît ni dans leur titre, ni dans les textes de loi, qu'ils doivent rendre un avis « éthique » au sujet des protocoles de recherche. Dans ce contexte, quel sens donner au CPP dans la recherche ? Sont-ils des comités d'éthique de la recherche ? Comment les membres le perçoivent-ils et investissent-ils leurs rôles dans l'exercice des missions qui relèvent des CPP ? Cette recherche s'est faite sur une approche qualitative par l'intermédiaire d'entretiens semi-directifs. Neuf membres de CPP d'Île-de-France ont été interrogés, notamment deux médecins dont deux présidents, un pharmacien hospitalier, trois juristes, deux représentants d'usagers et un psychologue. L'ensemble des personnes interrogées a permis de représenter cinq CPP d'Île-de-France sur dix. Les résultats ont montré que malgré une « bureaucratisation de l'éthique », les membres des CPP oeuvrent pour un maintien de leur indépendance à travers leur bénévolat. Cette résistance est l'origine du refus des membres de résumer leur mission à l'acceptabilité de la recherche d'un point de vue de la loi. Leur réflexion « éthique » ne peut se résumer à des critères garantissant la recherche au regard de la loi ou même à une application normative des principes de l'éthique de la recherche, sous couvert de l'éthique.

Our objective is to examine how certain ethics committees in Europe and in Canada make their reports on the controversial issues of genetically modified crops. Different sorts of criticism have been addressed, either directly or indirectly, to the work of these committees by specialists of moral and political philosophy, social and political science. We aim at questioning the relevance of the different aspects that are subject to criticism; we also question the way these committees function and the kind of ethics that results from institutionalised ethics. To do so, we have completed the analysis of the documents collected by interviewing members sitting on these committees to determine how they perceive their activity. Our study identifies certain characteristics of the way applied ethics is being practiced. The criticisms concerning these committees are confirmed at least partly and for a few of them. But some committees also give original contributions, which are likely to light up public debate on transgenic crops. The analysis of the shortcomings of some of them together with the original contributions from the others lead us to elaborate a critical typology of the arguments which have been put forward on this issue. We then provide some methodological elements for the ethical evaluation of transgenic crops. Finally, our research tends to reconsider the sole resort to this kind of committees and we wonder if another type of functioning which would be complementary may be relevant. ; Notre objectif est d'examiner comment certains comités d'éthique en Europe et au Canada élaborent leurs avis sur la question très controversée des cultures de plantes génétiquement modifiées. Plusieurs critiques ont été adressées directement ou indirectement au travail de tels comités par des spécialistes de philosophie morale et politique, des sociologues et des politologues. Nous proposons de nous interroger sur la pertinence de ces critiques, mais aussi sur la manière dont ces comités fonctionnent et sur l'espèce d'éthique ...

Our objective is to examine how certain ethics committees in Europe and in Canada make their reports on the controversial issues of genetically modified crops. Different sorts of criticism have been addressed, either directly or indirectly, to the work of these committees by specialists of moral and political philosophy, social and political science. We aim at questioning the relevance of the different aspects that are subject to criticism; we also question the way these committees function and the kind of ethics that results from institutionalised ethics. To do so, we have completed the analysis of the documents collected by interviewing members sitting on these committees to determine how they perceive their activity. Our study identifies certain characteristics of the way applied ethics is being practiced. The criticisms concerning these committees are confirmed at least partly and for a few of them. But some committees also give original contributions, which are likely to light up public debate on transgenic crops. The analysis of the shortcomings of some of them together with the original contributions from the others lead us to elaborate a critical typology of the arguments which have been put forward on this issue. We then provide some methodological elements for the ethical evaluation of transgenic crops. Finally, our research tends to reconsider the sole resort to this kind of committees and we wonder if another type of functioning which would be complementary may be relevant. ; Notre objectif est d'examiner comment certains comités d'éthique en Europe et au Canada élaborent leurs avis sur la question très controversée des cultures de plantes génétiquement modifiées. Plusieurs critiques ont été adressées directement ou indirectement au travail de tels comités par des spécialistes de philosophie morale et politique, des sociologues et des politologues. Nous proposons de nous interroger sur la pertinence de ces critiques, mais aussi sur la manière dont ces comités fonctionnent et sur l'espèce d'éthique qui dérive de cette institutionnalisation de l'éthique. Pour ce faire, nous avons complété par une enquête de terrain l'examen des documents produits, afin de préciser comment les membres de ces comités perçoivent leur activité. Notre étude permet de dégager des caractéristiques concernant la façon dont l'on y pratique l'éthique appliquée. Les critiques formulées envers ces comités se trouvent confirmées au moins en partie et pour quelques uns d'entre eux. Néanmoins, certains fournissent aussi des apports originaux, susceptibles d'éclairer le débat public concernant les plantes transgéniques. L'analyse des insuffisances des uns et des propositions originales des autres nous a conduit à élaborer une typologie critique des arguments mobilisés. De là, nous avons dégagé des éléments de méthodologie pour l'évaluation éthique des plantes transgéniques. Notre analyse tend finalement à remettre en cause l'unique recours à de tels comités et à se demander si un autre type de fonctionnement complémentaire serait envisageable.

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 (Comit?onsultatif de protection des personnes dans la recherche biom?cale (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.

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 (Comit?onsultatif de protection des personnes dans la recherche biom?cale (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.

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 (Comit?onsultatif de protection des personnes dans la recherche biom?cale (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.

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 (Comit?onsultatif de protection des personnes dans la recherche biom?cale (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.

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 (Comit?onsultatif de protection des personnes dans la recherche biom?cale (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.

Creative work: theatre/Creative Work: Play The Quebec Budget Act 2010-2011 made the compensation of volunteers participating in bioequivalence studies on medicines taxable. This ethical theatre reflects the debate that this point of the law has provoked in a fictitious research ethics committee. ; The Quebec Budget Act of 2010-2011 has made taxable compensation for volunteers who participate in drug bioequivalence studies. This piece of theatre reflects the ethical debate that this point of law raised in a fictional research ethics committee. ; Creative work: theatre/Creative Work: Play The Quebec Budget Act 2010-2011 made the compensation of volunteers participating in bioequivalence studies on medicines taxable. This ethical theatre reflects the debate that this point of the law has provoked in a fictitious research ethics committee. ; Travail créatif: pièce de théâtre / Creative Work: Play La loi sur le budget du Québec 2010-2011 a rendu imposable l'indemnité des volontaires qui participent à des études de bioéquivalence sur les médicaments. Cette pièce de théâtre éthique rend compte du débat que ce point de la loi a suscité au sein d'un comité d'éthique de la recherche fictif.

Introduction: Pediatricians of the World (PDM) is a french medical association with pediatric specificity. His goal is to work with health professionals of the child and his mother. The main objective of this work is to transcribe the history of PDM. The secondary objective is to open the discussion on humanitarian ethics. Material and Methods: This work was conducted from the PDM archives, supplemented by interviews with members of the association and participation at PDM programs. The part on ethics and humanitarianism starts with an interview with Professor Mattei, has been enriched by meetings within PDM and a bibliographic work. Results: The association was founded in 1995 in AFPA by liberal pediatricians under the name of AFPA-humanitarian and became PDM in 2003. Its action began in Moldova, before developing in Sri Lanka, Nepal, Cambodia, Morocco, Democratic Republic of Congo and France. The programs are based on short relay missions. Ethical deliberation is a collegial questioning, aiming to find the least bad solution possible to a specific problem. It seems legitimate to develop it in humanitarian, recalling that the beneficiaries must be at the center of decisions concerning themselves. Conclusion: PDM has shown that short missions could be the source of long-term projects. His history and experience led him to the creation of an ethics committee in 2018. ; Introduction : Pédiatres du monde (PDM) est une association française médicale à spécificité pédiatrique. Son objectif est de collaborer avec des professionnels de la santé de l'enfant et de sa mère. L'objectif principal de ce travail est de retranscrire l'histoire de PDM. L'objectif secondaire est d'ouvrir la discussion sur l'éthique en humanitaire. Matériel et méthode : Ce travail a été mené à partir des archives de PDM, complété par des entretiens avec les membres de l'association et par la participation aux programmes de PDM. La partie sur l'éthique et l'humanitaire a pour point de départ un entretien avec le Professeur Mattei, a été enrichie par les rencontres au sein de PDM et un travail bibliographique. Résultats : L'association a été fondée en 1995 au sein de l'AFPA par des pédiatres libéraux sous le nom d'AFPA-humanitaire et est devenue PDM en 2003. Son action a débuté en Moldavie, avant se développer au Sri Lanka, au Népal, au Cambodge, au Maroc, en République Démocratique du Congo et en France. Les programmes sont basés sur des missions relais courtes. La délibération éthique est un questionnement collégial, ayant pour objectif de trouver la solution la moins mauvaise possible à une problématique ponctuelle. Il semble légitime de la développer en humanitaire, rappelant que le bénéficiaire doit être au centre des décisions le concernant. Conclusion : PDM a su montrer que des missions courtes pouvaient être à l'origine de projets pérennes. Son histoire et son expérience l'ont mené vers la création d'un comité d'éthique en 2018.