Protection of human research participants: accreditation of programmes in the Indian context.
Indian J Med Ethics
;
2014 Jan-Mar; 11(1): 55-59
Article
in English
| 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.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Safety
/
Humans
/
Registries
/
Patient Rights
/
Ethical Review
/
Ethics Committees, Research
/
Human Experimentation
/
Accreditation
/
India
Type of study:
Controlled clinical trial
Country/Region as subject:
Asia
Language:
English
Journal:
Indian J Med Ethics
Journal subject:
Ethics
Year:
2014
Type:
Article
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