Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia
Bull World Health Organ
;
87(10)2009.
Artigo
em Inglês
| LILACS, BDS
| ID: biblio-875483
ABSTRACT
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of and responsibility for group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Prática de Saúde Pública
/
Ética Médica
/
Pesquisa sobre Serviços de Saúde
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Humanos
País/Região como assunto:
África
/
Ásia
Idioma:
Inglês
Revista:
Bull World Health Organ
Ano de publicação:
2009
Tipo de documento:
Artigo
País de afiliação:
Bangladesh
/
Índia
/
Malauí
/
Nepal
/
Reino Unido
Instituição/País de afiliação:
Department of Paediatrics, Kamuzu Central Hospital/MW
/
Ekjut Project, Chakradharpur/IN
/
Mother and Infant Research Activities (MIRA)/NP
/
Perinatal Care Project/BD
/
Society for Nutrition/IN
/
University College London/GB
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