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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/132936
Ver los metadatos del registro completo
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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 Técnicas2025-09-29T10:07:05Zoai: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:34982025-09-29 10:07:05.639CONICET 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 |
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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 |
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Taylor & Francis |
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Taylor & Francis |
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