Protection of human research participants: accreditation of programmes in the Indian context.
Indian J Med Ethics
;
2014 Jan-Mar; 11(1): 55-59
Artigo
em Inglês
| IMSEAR
| ID: sea-153527
ABSTRACT
The recent negative media reports on the status of participants in clinical trials in India, together with the concerns expressed by the regulatory bodies, have raised questions regarding India's credibility in the conduct of clinical research. Even though the regulations require the registration of trials with the Clinical Trial Registry – India and despite the recently mandated registration of ethics committees (ECs) with the Drugs Controller General of India, the lack of governmental audit and accreditation procedures and bodies has resulted in inadequate protection of human participants in clinical research. Institutions and research sites would benefit by implementing a human research protection programme, which would safeguard the rights, safety and wellbeing of participants in clinical trials, in addition to improving the processes and procedures for the conduct of the trial.
Texto completo:
DisponíveL
Índice:
IMSEAR (Sudeste Asiático)
Assunto principal:
Segurança
/
Humanos
/
Sistema de Registros
/
Direitos do Paciente
/
Revisão Ética
/
Comitês de Ética em Pesquisa
/
Experimentação Humana
/
Acreditação
/
Índia
Tipo de estudo:
Ensaio Clínico Controlado
País/Região como assunto:
Ásia
Idioma:
Inglês
Revista:
Indian J Med Ethics
Assunto da revista:
Ethics
Ano de publicação:
2014
Tipo de documento:
Artigo
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