All clinical trials in India will henceforth have to take subject consent audiovisually and preserve the records. Acting on a directive of the Supreme Court, the drug controller has issued an order making audiovisual recording mandatory for all trials. While industry has raised objections, officials in the Health Ministry say that the order will not be applicable for ongoing clinical trials.
In all clinical trials in addition to the requirement of obtaining written informed consent, audiovisual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding of such consent is required to be done while adhering to the principles of confidentiality. Such audiovisual 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,” reads an order signed by Drug Controller General of India Dr G N Singh. The order was issued last week.
The Indian Society for Clinical Research has expressed concern over the “lack of guidance and direction on operational and logistical issues of managing the audio visual recording process like kind of equipment to be used, where and how information should be stored, etc, which could leave room for ambiguity and inconsistencies in execution”.