The Union health ministry will soon amend the Schedule Y of Drugs and Cosmetics Rules to make a provision for audio/video recording of the informed consent in clinical trials and also to ensure that the clinical trial subjects are adequately informed about the failure of investigational products to give therapeutic effect or the lack of effect of placebo in certain trials.

Once the ministry makes the necessary amendments in this regard, the audio/video recording of informed consent will become mandatory in the country. Besides, the audio/video recording of the informed consent process of individual subject, including procedure of providing information to the subject and his understood consent, should be maintained by the investigator for record.

The purpose behind this provision is that it will authenticate that at the time of enrolment, proper care is taken to inform the subject about the pros and cons of the clinical trial and to ensure his participation is voluntary.

The Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, has already given its approval to the proposal of the CDSCO to amend Schedule Y of the D&C Act to insert a clause, “An audio/video recording of the informed consent process of individual subject including procedure of providing information to the subject and his understood consent shall be maintained by the investigator for record.”

Even though it is mandatory under Schedule Y of the Drugs and Cosmetics Rules to obtain a freely given informed, written consent from each study subject before he is enrolled in a clinical trial, in the absence of audio/video proof, there have been complaints of misuse of this provision by the companies who are engaged in clinical trial business. There were reports that many a time the informed consent was taken from the participating subjects without informing them the pros and cons of the trial.

The feeling among the ministry officials is that it is the duty of the investigators to adequately inform the trial subjects about the essential elements of the study and that of the drug to be administered. The trial subjects should be made aware that the drug is a new drug and is first time being administered, its therapeutic efficacy and serious adverse reactions have not yet been well documented. The research subject should also give his consent stating that he has understood the information provided by the investigator in respect of the study and his participation in the trial is voluntary.

The officials feel that the audio and video recording of this procedure of individual subject will act as a proof of a well informed consent.