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Master's Dissertation
DOI
10.11606/D.2.2012.tde-27082013-162359
Document
Author
Full name
Fernando Henrique de Oliveira Biolcati
Institute/School/College
Knowledge Area
Date of Defense
Published
São Paulo, 2012
Supervisor
Committee
Scaff, Fernando Campos (President)
Grassi Neto, Roberto
Nero, Joao Alberto Schutzer Del
Title in Portuguese
Requisitos para a realização de pesquisa clínicas com menores incapazes e a responsabilidade civil no caso de danos
Keywords in Portuguese
Adolescentes
Bioética
Crianças
Direito à saúde
Direitos humanos
Pesquisa Clínica
Responsabilidade civil
Abstract in Portuguese
Este trabalho tem por escopo analisar o procedimento de experimentação de novos tratamentos médicos e farmacêuticos em seres humanos, mais especificamente, crianças e adolescentes. A partir da ideia da condição do menor de pessoa em formação e da proteção especial garantida pela ordem jurídica, busca-se, constatando a necessidade de realização de pesquisas clínicas com este grupo, analisar de que modo a doutrina dos denominados direitos humanos e fundamentais e a regulamentação bioética devem atuar no sentido de estabelecer normativamente os requisitos que garantam o desenvolvimento científico sem o sacrifício das prerrogativas humanas mais comezinhas, como a integridade física e psíquica, bem como a autonomia. Por fim, tendo em vista os conceitos de risco e precaução, são estabelecidos os pressupostos para o nascimento da responsabilidade civil, de pesquisadores, patrocinadores e responsáveis legais pelo menor, inclusive pais, com a abordagem, também, dos reflexos no poder familiar, quando eventuais danos venham a ser produzidos contra as crianças e adolescentes sujeitos de pesquisa.
Title in English
Requirements for performing clinical research with incapable minors and liability in case of damage
Keywords in English
Bioethics
Children and teenagers
Clinical research
Health law
Human and fundamental rights
Liability
Risk and precaution
Abstract in English
This work has as scope the analysis of the procedure regarding new medical and pharmaceutical treatments testing in humans, more specifically children and teenagers. From the idea of the minors status as person under development and the special protection guaranteed by law, it is intended with this work, considering the need of clinical researches involving this group, an examination of how the so-called human and fundamental rights as well as bioethics regulation must act to standardize the requirements that ensure the scientific development without sacrificing the most basic human prerogatives, such as physic and psychological integrity and independence. Finally, in view of risk and precautions concepts, the assumptions are set to the arise of researchers, sponsors and guardians liability, including parents, also regarding the repercussion of such liability on parental authority, in the event of damages occurrence in children and teenagers in the context of clinical trials.
 
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Publishing Date
2013-09-12
 
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