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1. Title Title of document Protection of human research participants: accreditation of programmes in the Indian context
 
2. Creator Author's name, affiliation, country Neelambari Bhosale; Jehangir Clinical Development Centre, Jehangir Hospital Premises, 32, Sassoon Road, Pune 411 001, Maharashtra; IN
 
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4. Description 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.
 
5. Publisher Organizing agency, location Forum for Medical Ethics Society
 
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7. Date (YYYY-MM-DD) 2016-11-30
 
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9. Format File format HTML , PDF
 
10. Identifier Uniform Resource Identifier https://ijme.in/articles/protection-of-human-research-participants-accreditation-of-programmes-in-the-indian-context/
 
11. Source Title; vol., no. (year) Indian Journal of Medical Ethics;: Ringing out the old!
 
12. Language English=en en
 
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