Patient’s lived experience with DBS between medical research and care: some legal implications
Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scienti...
Ausführliche Beschreibung
Autor*in: |
Desmoulin-Canselier, Sonia [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2018 |
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Schlagwörter: |
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Übergeordnetes Werk: |
Enthalten in: Medicine, health care and philosophy - Getzville, NY : HeinOnline, 1998, 22(2018), 3 vom: 03. Aug., Seite 375-386 |
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Übergeordnetes Werk: |
volume:22 ; year:2018 ; number:3 ; day:03 ; month:08 ; pages:375-386 |
Links: |
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DOI / URN: |
10.1007/s11019-018-9859-5 |
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Katalog-ID: |
SPR015787184 |
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520 | |a Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. | ||
650 | 4 | |a Deep brain stimulation |7 (dpeaa)DE-He213 | |
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650 | 4 | |a Legal regimes |7 (dpeaa)DE-He213 | |
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10.1007/s11019-018-9859-5 doi (DE-627)SPR015787184 (SPR)s11019-018-9859-5-e DE-627 ger DE-627 rakwb eng 610 ASE 44.02 bkl Desmoulin-Canselier, Sonia verfasserin aut Patient’s lived experience with DBS between medical research and care: some legal implications 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. Deep brain stimulation (dpeaa)DE-He213 Clinical research (dpeaa)DE-He213 Care (dpeaa)DE-He213 Legal regimes (dpeaa)DE-He213 Enthalten in Medicine, health care and philosophy Getzville, NY : HeinOnline, 1998 22(2018), 3 vom: 03. Aug., Seite 375-386 (DE-627)320430421 (DE-600)2003695-4 1572-8633 nnns volume:22 year:2018 number:3 day:03 month:08 pages:375-386 https://dx.doi.org/10.1007/s11019-018-9859-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_184 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.02 ASE AR 22 2018 3 03 08 375-386 |
spelling |
10.1007/s11019-018-9859-5 doi (DE-627)SPR015787184 (SPR)s11019-018-9859-5-e DE-627 ger DE-627 rakwb eng 610 ASE 44.02 bkl Desmoulin-Canselier, Sonia verfasserin aut Patient’s lived experience with DBS between medical research and care: some legal implications 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. Deep brain stimulation (dpeaa)DE-He213 Clinical research (dpeaa)DE-He213 Care (dpeaa)DE-He213 Legal regimes (dpeaa)DE-He213 Enthalten in Medicine, health care and philosophy Getzville, NY : HeinOnline, 1998 22(2018), 3 vom: 03. Aug., Seite 375-386 (DE-627)320430421 (DE-600)2003695-4 1572-8633 nnns volume:22 year:2018 number:3 day:03 month:08 pages:375-386 https://dx.doi.org/10.1007/s11019-018-9859-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_184 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.02 ASE AR 22 2018 3 03 08 375-386 |
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10.1007/s11019-018-9859-5 doi (DE-627)SPR015787184 (SPR)s11019-018-9859-5-e DE-627 ger DE-627 rakwb eng 610 ASE 44.02 bkl Desmoulin-Canselier, Sonia verfasserin aut Patient’s lived experience with DBS between medical research and care: some legal implications 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. Deep brain stimulation (dpeaa)DE-He213 Clinical research (dpeaa)DE-He213 Care (dpeaa)DE-He213 Legal regimes (dpeaa)DE-He213 Enthalten in Medicine, health care and philosophy Getzville, NY : HeinOnline, 1998 22(2018), 3 vom: 03. Aug., Seite 375-386 (DE-627)320430421 (DE-600)2003695-4 1572-8633 nnns volume:22 year:2018 number:3 day:03 month:08 pages:375-386 https://dx.doi.org/10.1007/s11019-018-9859-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_184 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.02 ASE AR 22 2018 3 03 08 375-386 |
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10.1007/s11019-018-9859-5 doi (DE-627)SPR015787184 (SPR)s11019-018-9859-5-e DE-627 ger DE-627 rakwb eng 610 ASE 44.02 bkl Desmoulin-Canselier, Sonia verfasserin aut Patient’s lived experience with DBS between medical research and care: some legal implications 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. Deep brain stimulation (dpeaa)DE-He213 Clinical research (dpeaa)DE-He213 Care (dpeaa)DE-He213 Legal regimes (dpeaa)DE-He213 Enthalten in Medicine, health care and philosophy Getzville, NY : HeinOnline, 1998 22(2018), 3 vom: 03. Aug., Seite 375-386 (DE-627)320430421 (DE-600)2003695-4 1572-8633 nnns volume:22 year:2018 number:3 day:03 month:08 pages:375-386 https://dx.doi.org/10.1007/s11019-018-9859-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_184 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.02 ASE AR 22 2018 3 03 08 375-386 |
allfieldsSound |
10.1007/s11019-018-9859-5 doi (DE-627)SPR015787184 (SPR)s11019-018-9859-5-e DE-627 ger DE-627 rakwb eng 610 ASE 44.02 bkl Desmoulin-Canselier, Sonia verfasserin aut Patient’s lived experience with DBS between medical research and care: some legal implications 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. Deep brain stimulation (dpeaa)DE-He213 Clinical research (dpeaa)DE-He213 Care (dpeaa)DE-He213 Legal regimes (dpeaa)DE-He213 Enthalten in Medicine, health care and philosophy Getzville, NY : HeinOnline, 1998 22(2018), 3 vom: 03. Aug., Seite 375-386 (DE-627)320430421 (DE-600)2003695-4 1572-8633 nnns volume:22 year:2018 number:3 day:03 month:08 pages:375-386 https://dx.doi.org/10.1007/s11019-018-9859-5 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_184 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.02 ASE AR 22 2018 3 03 08 375-386 |
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Enthalten in Medicine, health care and philosophy 22(2018), 3 vom: 03. Aug., Seite 375-386 volume:22 year:2018 number:3 day:03 month:08 pages:375-386 |
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Desmoulin-Canselier, Sonia @@aut@@ |
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It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Deep brain stimulation</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Clinical research</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Care</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Legal regimes</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Medicine, health care and philosophy</subfield><subfield code="d">Getzville, NY : HeinOnline, 1998</subfield><subfield code="g">22(2018), 3 vom: 03. 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patient’s lived experience with dbs between medical research and care: some legal implications |
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Patient’s lived experience with DBS between medical research and care: some legal implications |
abstract |
Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. |
abstractGer |
Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. |
abstract_unstemmed |
Abstract In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient’s experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient’s lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation. |
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container_issue |
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title_short |
Patient’s lived experience with DBS between medical research and care: some legal implications |
url |
https://dx.doi.org/10.1007/s11019-018-9859-5 |
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up_date |
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score |
7.3996363 |