Vol , Issue Date of Publication: January 01, 2014
DOI: https://doi.org/10.20529/IJME.2014.015

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Protection of human research participants: accreditation of programmes in the Indian context

Neelambari Bhosale
Shagoofa Nigar
Soma Das
Uma Divate
Pathik Divate
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.


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©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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