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III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies
Aguilar-Salinas, Carlos A.; Pascual-Ramos, Virginia; Sierra-Madero, Juan G.; Loria-Acereto, Alvar; Zambrano-González, Elena; Kaufer-Horwitz, Martha; González-Duarte, Alejandra.
Afiliação
  • Aguilar-Salinas, Carlos A.; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Research. Mexico City. MX
  • Pascual-Ramos, Virginia; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Research. Mexico City. MX
  • Sierra-Madero, Juan G.; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Research. Mexico City. MX
  • Loria-Acereto, Alvar; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Research. Mexico City. MX
  • Zambrano-González, Elena; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Ethics Committee. Mexico City. MX
  • Kaufer-Horwitz, Martha; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Research. Mexico City. MX
  • González-Duarte, Alejandra; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Ethics Committee. Mexico City. MX
Rev. invest. clín ; Rev. invest. clín;71(5): 297-305, Sep.-Oct. 2019. tab, graf
Article em En | LILACS | ID: biblio-1289699
Biblioteca responsável: BR1.1
ABSTRACT
Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.
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Texto completo: 1 Coleções: 01-internacional Base de dados: LILACS Assunto principal: Ensaios Clínicos como Assunto / Comitês de Ética em Pesquisa / Indústria Farmacêutica Aspecto: Ethics Limite: Humans Idioma: En Revista: Rev. invest. clín Assunto da revista: MEDICINA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: México País de publicação: México
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: LILACS Assunto principal: Ensaios Clínicos como Assunto / Comitês de Ética em Pesquisa / Indústria Farmacêutica Aspecto: Ethics Limite: Humans Idioma: En Revista: Rev. invest. clín Assunto da revista: MEDICINA Ano de publicação: 2019 Tipo de documento: Article País de afiliação: México País de publicação: México