New non-validated practice: an enhanced definition of innovative practice for medicine

Autores
Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia
Año de publicación
2020
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term ‘innovation’ with the more literal ‘new non-validated practice’. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonisation of regulation and legislation (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
Fil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Facultad Latinoamericana de Ciencias Sociales; Argentina. Universidad de Buenos Aires; Argentina. Sorbonne University; Francia
Materia
DISTINCTION BETWEEN RESEARCH AND PRACTICE
INNOVATION IN MEDICINE
INNOVATIVE CARE
INNOVATIVE PRACTICE
RIGHT TO TRY
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/132936
Acceder
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spelling New non-validated practice: an enhanced definition of innovative practice for medicineMastroleo, Ignacio DamianHolzer, Felicitas SofiaDISTINCTION BETWEEN RESEARCH AND PRACTICEINNOVATION IN MEDICINEINNOVATIVE CAREINNOVATIVE PRACTICERIGHT TO TRYhttps://purl.org/becyt/ford/6.3https://purl.org/becyt/ford/6A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term ‘innovation’ with the more literal ‘new non-validated practice’. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonisation of regulation and legislation (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; ArgentinaFil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Facultad Latinoamericana de Ciencias Sociales; Argentina. Universidad de Buenos Aires; Argentina. Sorbonne University; FranciaTaylor & Francis2020-09info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/132936Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; New non-validated practice: an enhanced definition of innovative practice for medicine; Taylor & Francis; Law, Innovation and Technology; 12; 2; 9-2020; 318-3461757-997x1757-997XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://www.tandfonline.com/doi/full/10.1080/17579961.2020.1815405info:eu-repo/semantics/altIdentifier/doi/10.1080/17579961.2020.1815405info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-22T11:36:59Zoai:ri.conicet.gov.ar:11336/132936instacron: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 11:36:59.974CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv New non-validated practice: an enhanced definition of innovative practice for medicine
title New non-validated practice: an enhanced definition of innovative practice for medicine
spellingShingle New non-validated practice: an enhanced definition of innovative practice for medicine
Mastroleo, Ignacio Damian
DISTINCTION BETWEEN RESEARCH AND PRACTICE
INNOVATION IN MEDICINE
INNOVATIVE CARE
INNOVATIVE PRACTICE
RIGHT TO TRY
title_short New non-validated practice: an enhanced definition of innovative practice for medicine
title_full New non-validated practice: an enhanced definition of innovative practice for medicine
title_fullStr New non-validated practice: an enhanced definition of innovative practice for medicine
title_full_unstemmed New non-validated practice: an enhanced definition of innovative practice for medicine
title_sort New non-validated practice: an enhanced definition of innovative practice for medicine
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 DISTINCTION BETWEEN RESEARCH AND PRACTICE
INNOVATION IN MEDICINE
INNOVATIVE CARE
INNOVATIVE PRACTICE
RIGHT TO TRY
topic DISTINCTION BETWEEN RESEARCH AND PRACTICE
INNOVATION IN MEDICINE
INNOVATIVE CARE
INNOVATIVE PRACTICE
RIGHT TO TRY
purl_subject.fl_str_mv https://purl.org/becyt/ford/6.3
https://purl.org/becyt/ford/6
dc.description.none.fl_txt_mv A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term ‘innovation’ with the more literal ‘new non-validated practice’. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonisation of regulation and legislation (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
Fil: Holzer, Felicitas Sofia. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Facultad Latinoamericana de Ciencias Sociales; Argentina. Universidad de Buenos Aires; Argentina. Sorbonne University; Francia
description A significant part of the literature on innovative practice in medicine relates to seizing opportunities and curbing harms for patients in desperate situations. Unfortunately, the term innovation has multiple meanings and a rich rhetorical flourish that adds confusion and misunderstanding to an already difficult debate. This paper aims to enhance the current definition of innovative practice for medicine. First, we replace the term ‘innovation’ with the more literal ‘new non-validated practice’. To identify this meaning, we analyse the traditional research ethics’ distinction between research, validated practice, and innovation in the Belmont Report. Second, we propose the following explicit definition of new non-validated practice: the first or recent use of diagnostic, therapeutic or preventive interventions that introduce a significant change, with an insufficient level of evidence of safety or efficacy for regular healthcare, and with the main aim to benefit individual patients. This definition is a promising conceptual tool to inform empirical research, ethicists, and the harmonisation of regulation and legislation (e.g. right-to-try laws).
publishDate 2020
dc.date.none.fl_str_mv 2020-09
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/11336/132936
Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; New non-validated practice: an enhanced definition of innovative practice for medicine; Taylor & Francis; Law, Innovation and Technology; 12; 2; 9-2020; 318-346
1757-997x
1757-997X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/132936
identifier_str_mv Mastroleo, Ignacio Damian; Holzer, Felicitas Sofia; New non-validated practice: an enhanced definition of innovative practice for medicine; Taylor & Francis; Law, Innovation and Technology; 12; 2; 9-2020; 318-346
1757-997x
1757-997X
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.tandfonline.com/doi/full/10.1080/17579961.2020.1815405
info:eu-repo/semantics/altIdentifier/doi/10.1080/17579961.2020.1815405
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-nc-sa/2.5/ar/
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application/pdf
application/pdf
dc.publisher.none.fl_str_mv Taylor & Francis
publisher.none.fl_str_mv Taylor & Francis
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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