With a view to further streamline the 'informed consent' aspect in the clinical trials, the Drugs Controller General of India (DCGI) has issued detailed format and exhaustive check-lists to ensure the quality of informed consent being taken from the trial subjects.
For the first time, the Central Drugs Standard Control Organization (CDSCO) has prescribed the "essential elements" of informed consent documents used for enrolling subjects to a drug trial. The sponsors were asked to ensure that all subjects, before signing up for the trials, are given detailed information based on these essential elements.
“In all trials, a freely given, informed, written consent is required to be obtained from each study subject. The investigator must provide information about the study verbally as well as using patient information sheet, in a language that is non-technical and understandable by the study subject. The subject’s consent must be obtained in writing using an informed consent form. Both the patient information sheet as well as the informed consent form should have been approved by the ethics committee and furnished to the Licensing Authority. Any changes in the informed consent documents should be approved by the ethics committee and submitted to the licensing authority before changes are implemented,” said the notice by the DCGI.
The essential elements are designed to ensure that subjects are aware of their rights (e.g. for compensation etc.) and clearly understand that they are agreeing to participate in a research of their free will even though alternate treatment options may be available.
Specifically, the CDCSO has outlined 14 essential elements that will 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.
In addition, the CDSCO put six additional elements that may be required for informed consent documents depending on the trial. These include, among other things, a statement that the subject will be notified if significant new findings are highlighted during the course of the research which may affect the subject's willingness to continue participating in the study.