Regulating international clinical research: An ethical framework for policy-makers

Bernardo Aguilera, David Degrazia, Annette Rid*

*Autor correspondiente de este trabajo

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

9 Citas (Scopus)

Resumen

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

Idioma originalInglés
Número de artículoe002287
PublicaciónBMJ Global Health
Volumen5
N.º5
DOI
EstadoPublicada - 2020
Publicado de forma externa

Nota bibliográfica

Publisher Copyright:
© © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Áreas temáticas de ASJC Scopus

  • Políticas sanitarias
  • Salud pública, medioambiental y laboral

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