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dc.contributor.author
Mastroleo, Ignacio Damian  
dc.contributor.author
Holzer, Felicitas Sofia  
dc.date.available
2021-06-01T19:03:27Z  
dc.date.issued
2020-09  
dc.identifier.citation
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  
dc.identifier.issn
1757-997x  
dc.identifier.uri
http://hdl.handle.net/11336/132936  
dc.description.abstract
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).  
dc.format
application/pdf  
dc.language.iso
eng  
dc.publisher
Taylor & Francis  
dc.rights
info:eu-repo/semantics/openAccess  
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/  
dc.subject
DISTINCTION BETWEEN RESEARCH AND PRACTICE  
dc.subject
INNOVATION IN MEDICINE  
dc.subject
INNOVATIVE CARE  
dc.subject
INNOVATIVE PRACTICE  
dc.subject
RIGHT TO TRY  
dc.subject.classification
Ética  
dc.subject.classification
Filosofía, Ética y Religión  
dc.subject.classification
HUMANIDADES  
dc.title
New non-validated practice: an enhanced definition of innovative practice for medicine  
dc.type
info:eu-repo/semantics/article  
dc.type
info:ar-repo/semantics/artículo  
dc.type
info:eu-repo/semantics/publishedVersion  
dc.date.updated
2021-04-28T21:56:31Z  
dc.identifier.eissn
1757-997X  
dc.journal.volume
12  
dc.journal.number
2  
dc.journal.pagination
318-346  
dc.journal.pais
Reino Unido  
dc.description.fil
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  
dc.description.fil
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  
dc.journal.title
Law, Innovation and Technology  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.tandfonline.com/doi/full/10.1080/17579961.2020.1815405  
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1080/17579961.2020.1815405