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Draft Guidelines on Audio-Visual Recording by Health Ministry

Draft Guidelines on Audio-Visual Recording by Health Ministry

Union health ministry in order to strengthen clinical research in India has released new draft clinical trial guidelines on audio-visual recording during a clinical trial for all the parties involved in clinical trials. The guidelines are aimed at seeking recommendations and improving the process for audio-visual recording of informed consent process during clinical trials in the country.

The guidelines on audio-visual recording of information for prospective study subjects, corroborates principle of privacy and confidentiality, consent of the subjects for recording, process for recording, and storage and archival of audio-visual recording during a clinical trial.

According to Schedule Y, in all trials, a freely given, informed, written consent is to be obtained from each study subject. The lnvestigator must inform subjects regarding the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject.

Consent of the subject must be obtained in writing on Informed Consent Form (ICF). If the subject or its representative is illiterate, then an impartial witness should be present during the entire informed consent process to explain the minute details of the study. The subject should provide a written consent using Informed Consent Form.

“The new set of draft guidelines has been circulated for stakeholders review and 45 days time has been given for the same,”informed Additional Secretary Health Dr R K Vats.

According to international standards, a clinical study should be understood by a lay person and is approved by the ethics committee overseeing the study. If the patient is unable to read or write, the study doctor provides all information verbally and an impartial witness needs to be present during the informed consent discussion and must sign the informed consent form indicating that all necessary information was provided to the patient. The informed consent process is required to be recorded on video under the new guidelines in India.