Apparently browbeaten by the Supreme Court for not maintaining the required level of transparency in clinical trials in the country, the union health ministry has made mandatory the audio-visual recording of informed consent process of each subject who participates in the clinical trials in the country. This is in addition to the requirement of obtaining written informed consent from the participating subjects.
The health ministry's rather belated action in this regard comes after the Supreme Court's recent directive to the government while delivering its order in a writ petition filed by the NGO Swasthya Adhikar Manch, Indore against the ministry of health and family welfare regarding lack of transparency in clinical trials. As per the apex court order dated on 21.10.2013, in respect of five global clinical trials for which approval has been given by the DCGI office from January 1, 2013 to August 31, 2013, before the clinical trials are conducted, appropriate provision should be made or administrative direction should be issued which ensures that audio-visual recording of the informed consent process of the participants is done and the documentation preserved, adhering to the principles of confidentially.
“In view of the above, it has been decided with the approval of the ministry of health and family welfare, that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentially. Such audio-visual recording and related documentation would be preserved. This is applicable to the new subjects to be enrolled in all clinical trials including global clinical trials,” Drugs Controller General of India (DCGI) Dr GN Singh in his order said, and added further that “All the sponsors/investigators/institutes/organisations and other stakeholders involved in conduct of clinical trials in the country are hereby directed to adhere to the above requirement of audio-visual recording of informed consent process of trial subjects with immediate effect.”
Source:Pharmabiz
The health ministry's rather belated action in this regard comes after the Supreme Court's recent directive to the government while delivering its order in a writ petition filed by the NGO Swasthya Adhikar Manch, Indore against the ministry of health and family welfare regarding lack of transparency in clinical trials. As per the apex court order dated on 21.10.2013, in respect of five global clinical trials for which approval has been given by the DCGI office from January 1, 2013 to August 31, 2013, before the clinical trials are conducted, appropriate provision should be made or administrative direction should be issued which ensures that audio-visual recording of the informed consent process of the participants is done and the documentation preserved, adhering to the principles of confidentially.
“In view of the above, it has been decided with the approval of the ministry of health and family welfare, that in all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentially. Such audio-visual recording and related documentation would be preserved. This is applicable to the new subjects to be enrolled in all clinical trials including global clinical trials,” Drugs Controller General of India (DCGI) Dr GN Singh in his order said, and added further that “All the sponsors/investigators/institutes/organisations and other stakeholders involved in conduct of clinical trials in the country are hereby directed to adhere to the above requirement of audio-visual recording of informed consent process of trial subjects with immediate effect.”
Source:Pharmabiz
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