Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice
- Autores
- Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia
- Año de publicación
- 2019
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics? distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.). In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws).
Fil: Mastroleo, Ignacio Damian. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Instituto de Investigaciones Sociales de América Latina. - Facultad Latinoamericana de Ciencias Sociales. Instituto de Investigaciones Sociales de América Latina; Argentina. Universidad de Buenos Aires; Argentina
Fil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires; Argentina. Facultad Latinoamericana de Ciencias Sociales; Argentina - Materia
-
RIGHT TO TRY
INNOVATION IN MEDICINE
INNOVATIVE CARE
INNOVATIVE PRACTICE
DISTINCTION BETWEEN RESEARCH AND PRACTICE - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- https://creativecommons.org/licenses/by/2.5/ar/
- Repositorio
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/115913
Ver los metadatos del registro completo
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Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative PracticeMastroleo, Ignacio DamianHolzer, Felicitas SofiaRIGHT TO TRYINNOVATION IN MEDICINEINNOVATIVE CAREINNOVATIVE PRACTICEDISTINCTION BETWEEN RESEARCH AND PRACTICEhttps://purl.org/becyt/ford/6.3https://purl.org/becyt/ford/6https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3https://purl.org/becyt/ford/3.4https://purl.org/becyt/ford/3The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics? distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.). In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws).Fil: Mastroleo, Ignacio Damian. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Instituto de Investigaciones Sociales de América Latina. - Facultad Latinoamericana de Ciencias Sociales. Instituto de Investigaciones Sociales de América Latina; Argentina. Universidad de Buenos Aires; ArgentinaFil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires; Argentina. Facultad Latinoamericana de Ciencias Sociales; ArgentinaMultidisciplinary Digital Publishing Institute2019-05info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/115913Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice; Multidisciplinary Digital Publishing Institute; Preprints; 5-2019; 1-442310-287XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.preprints.org/manuscript/201905.0070/v1info:eu-repo/semantics/altIdentifier/doi/10.20944/preprints201905.0070.v1info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:17:48Zoai:ri.conicet.gov.ar:11336/115913instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:17:49.222CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse |
dc.title.none.fl_str_mv |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
title |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
spellingShingle |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice Mastroleo, Ignacio Damian RIGHT TO TRY INNOVATION IN MEDICINE INNOVATIVE CARE INNOVATIVE PRACTICE DISTINCTION BETWEEN RESEARCH AND PRACTICE |
title_short |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
title_full |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
title_fullStr |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
title_full_unstemmed |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
title_sort |
Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice |
dc.creator.none.fl_str_mv |
Mastroleo, Ignacio Damian Holzer, Felicitas Sofia |
author |
Mastroleo, Ignacio Damian |
author_facet |
Mastroleo, Ignacio Damian Holzer, Felicitas Sofia |
author_role |
author |
author2 |
Holzer, Felicitas Sofia |
author2_role |
author |
dc.subject.none.fl_str_mv |
RIGHT TO TRY INNOVATION IN MEDICINE INNOVATIVE CARE INNOVATIVE PRACTICE DISTINCTION BETWEEN RESEARCH AND PRACTICE |
topic |
RIGHT TO TRY INNOVATION IN MEDICINE INNOVATIVE CARE INNOVATIVE PRACTICE DISTINCTION BETWEEN RESEARCH AND PRACTICE |
purl_subject.fl_str_mv |
https://purl.org/becyt/ford/6.3 https://purl.org/becyt/ford/6 https://purl.org/becyt/ford/3.3 https://purl.org/becyt/ford/3 https://purl.org/becyt/ford/3.4 https://purl.org/becyt/ford/3 |
dc.description.none.fl_txt_mv |
The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics? distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.). In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws). Fil: Mastroleo, Ignacio Damian. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Instituto de Investigaciones Sociales de América Latina. - Facultad Latinoamericana de Ciencias Sociales. Instituto de Investigaciones Sociales de América Latina; Argentina. Universidad de Buenos Aires; Argentina Fil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires; Argentina. Facultad Latinoamericana de Ciencias Sociales; Argentina |
description |
The activity of innovative practice relates to seizing opportunities now for patients in desperate situations and the ethical dilemmas around it. Sadly, the term innovation has multiple meanings, adding confusion and misunderstanding to an already difficult debate. This paper aims to enhance the definition of innovative practice in two ways. Fist, we propose to curb ambiguity by replacing the term "innovative practice" with the more precise of "new non-validated practice" and by distinguishing the specific meaning of innovation at stake. To identify this meaning, we analyse the traditional research ethics? distinction between research, validated practice, and innovation. Second, we propose the following unified definition of "new non-validated practice", that is, the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change (new); with an insufficient level of evidence of safety or efficacy for regular healthcare (non-validated); and with the main aim to benefit patients (practice). To avoid objections to our definition, we analyse its three core elements (significant novelty, insufficient validation for, and patients' best interests) and we present a 2D classification of medical practice that follows from our definition. If sound, our enhanced definition of "new non-validated practice" allows comparing exceptional activities in different fields of medicine that previously have been considered unconnected (e.g. compassionate use of investigational drugs, humanitarian uses of devices, novel off-label uses, etc.). In turn, it also provides a promising conceptual tool to inform empirical research, discuss responsible access to innovative care and evaluate the regulation of innovative practice (e.g. right-to-try laws). |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-05 |
dc.type.none.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://purl.org/coar/resource_type/c_6501 info:ar-repo/semantics/articulo |
format |
article |
status_str |
publishedVersion |
dc.identifier.none.fl_str_mv |
http://hdl.handle.net/11336/115913 Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice; Multidisciplinary Digital Publishing Institute; Preprints; 5-2019; 1-44 2310-287X CONICET Digital CONICET |
url |
http://hdl.handle.net/11336/115913 |
identifier_str_mv |
Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; Seizing Opportunity at the Limits of Medicine: An Enhanced Definition of Innovative Practice; Multidisciplinary Digital Publishing Institute; Preprints; 5-2019; 1-44 2310-287X CONICET Digital CONICET |
dc.language.none.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
info:eu-repo/semantics/altIdentifier/url/https://www.preprints.org/manuscript/201905.0070/v1 info:eu-repo/semantics/altIdentifier/doi/10.20944/preprints201905.0070.v1 |
dc.rights.none.fl_str_mv |
info:eu-repo/semantics/openAccess https://creativecommons.org/licenses/by/2.5/ar/ |
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rights_invalid_str_mv |
https://creativecommons.org/licenses/by/2.5/ar/ |
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application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Multidisciplinary Digital Publishing Institute |
publisher.none.fl_str_mv |
Multidisciplinary Digital Publishing Institute |
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reponame:CONICET Digital (CONICET) instname:Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) |
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Consejo Nacional de Investigaciones Científicas y Técnicas |
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CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas |
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13.070432 |