Usha Sharma – Mumbai
With the objective of making volunteers on clinical trials more aware of the risks involved, the Drugs Controller General of India (DCGI) plans to make it mandatory to have informed consent forms in regional languages. This rule could be in place by the end of this year.
Talking exclusively with Express Pharma, DCGI GN Singh said, “As it is difficult to make rules without understanding the ground realities, I am making surprise visits to different clinical trial sites. On these visits, I have realised that all subjects enrolled in trials were not fully informed of the possible risks and related side effects of participating in clinical trials. I feel that the language barrier is the key reason for this information gap as most of the subjects enrolled in clinical trials tend to belong to the economically deprived sections of society and enroll themeselves in trials due to lack of money. As a regulator, our primary concern is the health of the human volunteers enrolled in clinical trials. I feel it is my responsibility to address this issue and make them aware of the pros and cons of participating in clinical trials by ensuring that the informed consent form is in languages that they can read.”
He also highlighted that enforcing this rule will ensure that no sponsor or CRO violates this rule, and if they do, the regulator may need to take strict action against them and maybe even stop the trial.
In an effort to ensure that the subject has access to all the information on the trial, the CDCSO has recently defined 14 essential elements that have to be incorporated into informed consent documents.
These include: a statement that the study involves research and explanation of the purpose of the research; expected duration of the subject’s participation; a description of the procedures to be followed, including all invasive procedures; a description of any reasonably foreseeable risks or discomforts to the subject; a description of any benefits to the subject (if no benefits are expected, the subjected should be made aware of this); information on appropriate alternative procedures or therapies available to the subject; a statement describing the extent to which confidentiality about the subject’s records would be maintained; information on the trial’s treatment schedule and the possibility of random assignment of each treatment (in case of randomised trials); information on compensation and/or treatments available to the subject in the event of a trial-related injury; information on whom to contact for trial-related queries and rights of a subject, especially in case of a trial-related injury; information on the payment, if any, to the subject for participating in the trial; and a statement that participation is voluntary and that the subject can withdraw at any time while clarifying that withdrawal from the trial will not involve any penalty or less of benefits to which the subject is otherwise entitled.
DCGI has also requested that all subjects participating in clinical trials go through this information in the informed consent form carefully before enrolling themselves in the trial.
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