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How ethical is your clinical trial?

Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming...

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Detalles Bibliográficos
Autores principales: Miller, L, Folayan, M, Allman, D, Nkala, B, Kasirye, L M, Mingote, L R, Calazans, G, Mburu, R, Ntombela, F, Ditmore, M
Formato: Texto
Lenguaje:English
Publicado: Blackwell Publishing Ltd 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2916216/
https://www.ncbi.nlm.nih.gov/pubmed/20561091
http://dx.doi.org/10.1111/j.1742-1241.2010.02421.x
Descripción
Sumario:Is Institutional Review Board (IRB) approval and a rigorous informed consent process enough? It is our view that this is no longer the case. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level (1,2).