In recent years, there has been considerable debate about the ethics of clinical research practices in developing countries. One of the major issues is the quality of informed consent process.
India's clinical trials process has come under intense scrutiny after a series of scandals involving alleged malpractices which have sparked huge public protests. Owing to this concerns have been raised about the lack of ethical outlook, and there have also been allegations that patients are recruited to clinical trials without any proper informed consent.
With this background, it is not surprising that the Central Government in consultation with Drugs Technical Advisory Board , Central Drug Standard Control Organization proposed to make draft rule that audio-video recording of the informed consent process of individual participant by an investigator including process of providing information to the subject and his understanding on such consent shall be maintained by the investigating person for record while conducting clinical trials in India.
As per proposal the investigator should make audio / video recording of the procedure of obtaining informed consent of the individual subject and maintain it for record. This will make it a practice that at the time of enrollment proper care would be taken to tell the subject about the pros and cons of the clinical trial and that his participation was totally voluntary.
DCGI further mentioned that the clinical trial subject should also be made aware during informed consent process, that there are chances of failure of the trial product to give the intended therapeutic effect and in case of placebo controlled trial, the placebo administered might not have the right effect.
Once the necessary amendments are made by the ministry in this regard, the AV recording of informed consent will become mandatory in India. Besides, the AV recording of the informed consent process of individual patient, including procedure of giving information to the subject and his understood consent, should be maintained by the investigator for record.
The reason behind this provision is that it will authenticate that at the time of enlistment, proper care is taken to inform the trial subject about the pros and cons of the clinical trial and to make sure that his participation is exclusively voluntary.
The Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, has given its approval to the proposal of the CDSCO to make some amendments in Schedule Y of the D&C Act to insert a clause that an AV recording of the informed consent process of individual patient including procedure of giving information to the subject and his understood consent shall be maintained by the investigator for record.”
Even though it is compulsory under Schedule Y of the Drugs and Cosmetics Rules to obtain a freely given informed, written consent from each trial subject before he is enlisted in a clinical trial, in the absence of AV proof, there have been complaints of exploitation of this provision by the companies who are engaged in clinical research business. There were certain reports that many times the informed consent was taken from the participating subjects without telling about them the pros and cons of the trial.
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.
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