BHOSALE, NEELAMBARINIGAR, SHAGOOFADAS, SOMADIVATE, UMADIVATE, PATHIK2014-08-052014-08-052014-01BHOSALE NEELAMBARI, NIGAR SHAGOOFA, DAS SOMA, DIVATE UMA, DIVATE PATHIK. Protection of human research participants: accreditation of programmes in the Indian context. Indian Journal of Medical Ethics. 2014 Jan-Mar; 11(1): 55-59.http://imsear.searo.who.int/handle/123456789/153527The 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.enAccreditationBiomedical Research --ethicsEthical ReviewEthics Committees, ResearchHuman ExperimentationHumansIndiaPatient RightsRegistriesSafetyProtection of human research participants: accreditation of programmes in the Indian context.Article