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Uso de placebos em pesquisas com fins comerciais: limitações jurídicas à luz do ordenamento brasileiro / Placebo use in research with commercial purposes: legal restrictions in the light of the Brazilian legal system
Rivabem, Fernanda Schaefer.
  • Rivabem, Fernanda Schaefer; Pontifícia Universidade Católica do Paraná. Curitiba. BR
Rev. direito sanit ; 17(2): 138-159, jul.-out. 2016.
Article in Portuguese | LILACS | ID: biblio-836093
RESUMO
Muito se discutem as pesquisas em seres humanos com uso de placebos sob o ponto de vista bioético, em especial à luz dos princípios bioéticos da autonomia, justiça e equidade. No entanto, não desconsiderando a importância dessas discussões, o assunto deve ser pensado também sob seu aspecto jurídico, particularmente no que se refere às pesquisas com fins comerciais. O presente artigo, a partir de pesquisa bibliográfica interdisciplinar, tem por objetivo discutir, à luz do ordenamento jurídico brasileiro, como devem ser tratadas as relações jurídicas decorrentes das pesquisas com uso de placebos financiadas por laboratórios e farmacêuticas e como devem ser aferidas as responsabilidades em caso de danos provocados ao pesquisado.
ABSTRACT
There are many ethical discussions about the use of placebo in research with humans. These discussions often occur from a bioethical standpoint, particularly in the light of the bioethical principles of autonomy, justice and equity. However, and without disregarding the importance of these discussions, the legal aspect should also be considered, particularly concerning medical research with commercial purposes. This article, from a literature interdisciplinary review, aims to discuss, in the light of the Brazilian legal system, how research using placebo and financed by laboratories and pharmaceutical companies should be tackled and how to assess the liability arising from this research in case of damage caused to the participants.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Placebos / Pharmaceutical Preparations / Commerce / Ethics, Medical / Right to Health / Human Experimentation Type of study: Controlled clinical trial / Etiology study / Risk factors Limits: Female / Humans / Male Country/Region as subject: South America / Brazil Language: Portuguese Journal: Rev. direito sanit Journal subject: Public Health Year: 2016 Type: Article Affiliation country: Brazil Institution/Affiliation country: Pontifícia Universidade Católica do Paraná/BR

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Full text: Available Index: LILACS (Americas) Main subject: Placebos / Pharmaceutical Preparations / Commerce / Ethics, Medical / Right to Health / Human Experimentation Type of study: Controlled clinical trial / Etiology study / Risk factors Limits: Female / Humans / Male Country/Region as subject: South America / Brazil Language: Portuguese Journal: Rev. direito sanit Journal subject: Public Health Year: 2016 Type: Article Affiliation country: Brazil Institution/Affiliation country: Pontifícia Universidade Católica do Paraná/BR