Suchergebnisse

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely ...

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely ...

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely ...

The principle of precaution, a fundamental, essentially legalistic, rule underpinning health care legislation in France, basically arose from environmental protection policies. This principle became the topic of a good deal of well-publicized debate following the decree concerning HIV contamination rendered in 1993 by the Conseil d'Etat, the supreme jurisdiction on legislative matters in France. This translation of a fundamental principle from one domain to another is not devoid of significance and could have an unexpected impact on the nature and meaning of health care itself. When applied to medicine, the principle of precaution must be confronted with the notion of risk, inherent in all acts of health care. This risk certainly implies patients' rights and informed consent to medical care, but also, in a reasonable search for an acceptable balance between risk and benefit, the freedom of biomedical research from overly-restrictive regulations. Consequently, in accordance with an ethical approach to medical care, legislative and judicial bodies must take into consideration the practical reality of medicine in order to integrate the scientific, economic, social, and psychological aspects of everyday medical practice into health care laws and regulations. Once faced with the reality of health care, the principle of precaution could appear contradictory to the fundamental principles of medicine. Indeed, every physician, every health care worker, makes daily evidence-based decisions that are never devoid of risk. Unrestricted application of the principle of precaution to a growing number of public domains, including medicine, as advocated by a large number of opinion leaders, could lead to an inextricable situation, in total contradiction with the goal of health care itself. In order to develop new truly ethical and adapted health care regulations, we must break down the barriers confining judges and legal representatives to a purely legalistic vision of health care and equally confining physicians to a purely scientific vision of their mission.

La relation soignante se caractérise par deux impératifs : garder la distance nécessaire à la prise de décision et à la réalisation de gestes techniques d'une part, accorder à la personne la reconnaissance et l'empathie dont elle a besoin dans des circonstances difficiles d'autre part. À partir de l'exemple de la gestion de cas, pratique professionnelle qui se développe en France dans le cadre du plan Alzheimer, nous explorerons ici les ambivalences, les risques mais aussi la nécessité d'un engagement des soignants dans cette relation.

La gestion de cas est une pratique professionnelle qui s'implante actuellement en France, en particulier dans le domaine des soins aux personnes âgées en perte d'autonomie, sous l'impulsion du Plan National Alzheimer 2008-2012. Les « gestionnaires de cas » sont des professionnels qui interviennent auprès de personnes âgées vivant à domicile dont la situation est jugée particulièrement complexe sur le plan médical et social. Ils ont une expérience professionnelle comme infirmiers, travailleur social, psychologue ou ergothérapeute, et reçoivent une formation spécifique. Ils évaluent les besoins des personnes suivies et planifient et coordonnent les soins et les aides nécessaires. Ils accompagnent la personne sur le long terme, avec des visites régulières à domicile. L'implantation de ce nouveau service s'accompagne de la mise en place d'outils visant à favoriser le travail en commun des acteurs des secteurs sanitaires et sociaux au niveau d'un territoire pour lutter contre la fragmentation du système et promouvoir l'intégration. Nous discutons ici des spécificités du modèle français de gestion de cas, dit « intensif », et des questions éthiques qu'il soulève. Elles concernent principalement trois domaines : le respect des choix des personnes vulnérables, en particulier en cas de refus de soins ; le respect de leur vie privée alors que des informations personnelles sont recueillies et partagées ; et la place possible du gestionnaire de cas dans le système d'allocation des ressources.

OBJECTIVE: The aim of this study was to evaluate the effects of French law (court rulings in the Perruche decision and its progeny as well as the statute enacted on March 4, 2002 to reverse or moderate this jurisprudence) on physicians' prenatal diagnosis and fetal medicine practices. METHODS: We sent questionnaires to 186 physician-ultrasonographers in two French districts, inquiring about changes in their daily practice and their provision of information to and communication with the future parents, as well as their opinions about the future of their specialization. RESULTS: We received 54 responses (29%): 40% of respondents found it more difficult to tell patients about fetal anomalies. Written and oral information, medical reports and explanations about the limitations of ultrasound have improved substantially in content for 64% and are better used for 42%. Some clinicians (24.1%) report that they take the future parents' emotions into account more often. Some try to be more distant (13%) or more neutral (9.3%). More than half (51.9%) request the opinion of a center for prenatal diagnosis and fetal medicine more often and 20.4% request karyotyping more often. In all, 7.4% believe that their counseling now leads more often towards abortions. CONCLUSION: Although practitioners had an extremely negative perception of the case law and some were also unhappy with the new statute, these did lead to the reorganization and formalization of their practices. We can see that judicial decisions taken in a specific, individual situation can change collective practices and influence--or even overturn--public health strategies. The respondents' intention to take parents' emotions into account suggests they will find a common language to communicate with them. It is nonetheless necessary to organize a nationwide debate about the objectives of fetal ultrasound.

OBJECTIVE: The aim of this study was to evaluate the effects of French law (court rulings in the Perruche decision and its progeny as well as the statute enacted on March 4, 2002 to reverse or moderate this jurisprudence) on physicians' prenatal diagnosis and fetal medicine practices. METHODS: We sent questionnaires to 186 physician-ultrasonographers in two French districts, inquiring about changes in their daily practice and their provision of information to and communication with the future parents, as well as their opinions about the future of their specialization. RESULTS: We received 54 responses (29%): 40% of respondents found it more difficult to tell patients about fetal anomalies. Written and oral information, medical reports and explanations about the limitations of ultrasound have improved substantially in content for 64% and are better used for 42%. Some clinicians (24.1%) report that they take the future parents' emotions into account more often. Some try to be more distant (13%) or more neutral (9.3%). More than half (51.9%) request the opinion of a center for prenatal diagnosis and fetal medicine more often and 20.4% request karyotyping more often. In all, 7.4% believe that their counseling now leads more often towards abortions. CONCLUSION: Although practitioners had an extremely negative perception of the case law and some were also unhappy with the new statute, these did lead to the reorganization and formalization of their practices. We can see that judicial decisions taken in a specific, individual situation can change collective practices and influence--or even overturn--public health strategies. The respondents' intention to take parents' emotions into account suggests they will find a common language to communicate with them. It is nonetheless necessary to organize a nationwide debate about the objectives of fetal ultrasound.

OBJECTIVE: The aim of this study was to evaluate the effects of French law (court rulings in the Perruche decision and its progeny as well as the statute enacted on March 4, 2002 to reverse or moderate this jurisprudence) on physicians' prenatal diagnosis and fetal medicine practices. METHODS: We sent questionnaires to 186 physician-ultrasonographers in two French districts, inquiring about changes in their daily practice and their provision of information to and communication with the future parents, as well as their opinions about the future of their specialization. RESULTS: We received 54 responses (29%): 40% of respondents found it more difficult to tell patients about fetal anomalies. Written and oral information, medical reports and explanations about the limitations of ultrasound have improved substantially in content for 64% and are better used for 42%. Some clinicians (24.1%) report that they take the future parents' emotions into account more often. Some try to be more distant (13%) or more neutral (9.3%). More than half (51.9%) request the opinion of a center for prenatal diagnosis and fetal medicine more often and 20.4% request karyotyping more often. In all, 7.4% believe that their counseling now leads more often towards abortions. CONCLUSION: Although practitioners had an extremely negative perception of the case law and some were also unhappy with the new statute, these did lead to the reorganization and formalization of their practices. We can see that judicial decisions taken in a specific, individual situation can change collective practices and influence--or even overturn--public health strategies. The respondents' intention to take parents' emotions into account suggests they will find a common language to communicate with them. It is nonetheless necessary to organize a nationwide debate about the objectives of fetal ultrasound.

OBJECTIVE: The aim of this study was to evaluate the effects of French law (court rulings in the Perruche decision and its progeny as well as the statute enacted on March 4, 2002 to reverse or moderate this jurisprudence) on physicians' prenatal diagnosis and fetal medicine practices. METHODS: We sent questionnaires to 186 physician-ultrasonographers in two French districts, inquiring about changes in their daily practice and their provision of information to and communication with the future parents, as well as their opinions about the future of their specialization. RESULTS: We received 54 responses (29%): 40% of respondents found it more difficult to tell patients about fetal anomalies. Written and oral information, medical reports and explanations about the limitations of ultrasound have improved substantially in content for 64% and are better used for 42%. Some clinicians (24.1%) report that they take the future parents' emotions into account more often. Some try to be more distant (13%) or more neutral (9.3%). More than half (51.9%) request the opinion of a center for prenatal diagnosis and fetal medicine more often and 20.4% request karyotyping more often. In all, 7.4% believe that their counseling now leads more often towards abortions. CONCLUSION: Although practitioners had an extremely negative perception of the case law and some were also unhappy with the new statute, these did lead to the reorganization and formalization of their practices. We can see that judicial decisions taken in a specific, individual situation can change collective practices and influence--or even overturn--public health strategies. The respondents' intention to take parents' emotions into account suggests they will find a common language to communicate with them. It is nonetheless necessary to organize a nationwide debate about the objectives of fetal ultrasound.

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.