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
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/115913
Acceder
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spelling 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 Técnicas2025-10-22T11:48:09Zoai: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:34982025-10-22 11:48:09.931CONICET 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
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eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute
publisher.none.fl_str_mv Multidisciplinary Digital Publishing Institute
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
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reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
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