CDSCO – DCGI issues draft guideline on AV recording of Informed Consent Process

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The drug controller general of India (DCGI) has issued draft guidelines on audio-visual recording of informed consent process in clinical trials in the country.

As per the guidelines, before requesting an individual’s consent to participate in clinical trial, the investigator must provide the individual with the all the information in a language that is non-technical and understandable by the study subjects and the same shall be recorded through audio-visual means.

If a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability) the information should be provided to the legally acceptable representative (LAR). If the subject or his/her legally acceptable representative is unable to read/write – an impartial witness (IW) should be present during the entire informed consent process.

According to the guidelines, audio visual recording of informed consent process and other related documents should be preserved safely after the completion/termination of the study for at least a period of 5 years if it is not possible to maintain the same permanently.

During the audio-visual recording of informed consent process, the identity and records of the trial subjects are as far as possible kept confidential; and that no details about identity of said subjects, which would result in the disclosure of their identity, are disclosed without valid scientific and legal reasons which may be essential for the purposes of therapeutics or other interventions, without the specific consent in writing of the subject concerned, or someone authorised on their behalf, and after ensuring that the said subject does not suffer from any form of hardship, discrimination or stigmatisation as a consequence of having participated in the trial.

In order to maintain the confidentiality, the videographer should be engaged as part of the study team. Prior to initiation of the study, the Investigator should define and allocate the activities of audio-video recording of informed consent process to the respective identified person as videographer. The Investigator shall maintain the details of the person to whom he has delegated the duties of audio video recording.

Prior consent of the subject should be taken for audio-visual recording of informed consent process and the same should be documented by the Investigator. Such consent may be taken orally. Only those subjects who give the consent for the AV recording shall be included in the clinical trial.

Earlier, acting on the directive from Supreme Court, the DCG1 on November 19, 2013 had issued direction 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 confidentiality. 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.

Download the CDSCO Draft Guideline for AV Recording of Informed Consent Process

Source: PharmaBiz


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