Written informed consent to virtual e-consent in clinical research: Changing necessity during COVID times

Abstract

Sir, The informed consent process is an ethical and legal requirement of clinical trials. It is a continuous process between the trial subject and the investigator. This process of obtaining informed consent starts before the commencement of the trial and continues as long as the subject remains enrolled in the study. Intense conversations between the investigator and subject are required to make the subject understand the risk and benefits, his/her rights, and what to do if something goes wrong during the trial period. This helps the subject in taking a voluntary decision regarding his/her participation in the trial. The consenting process has to be in the language which the subject understands and is able to assimilate. The use of audio-visual aids and supporting literature can be used to enhance the process.[1] In this manner, it has to be truly “understood consent.” The New Drugs and Clinical Trials Rules, 2019 provides the provision of audio-visual consenting to ensure this in vulnerable subjects. In 2015, the United States Food and Drug Administration released a guidance document on process of obtaining informed consent through electronic means. The electronic informed consent (e-IC) as it is referred to involves the use of electronic media to obtain and document the informed consent. In this process, the study-related information can be conveyed using text, graphics, audio, video, live chats, interactive websites, etc., to create an effective means of communication with the trial subject. The guidance also gives recommendations on the procedures to help ensure that the rights, safety, and welfare of human subjects are well protected.[2] With the growing use of electronic tablets and devices such as iPads and smartphones, for the e-IC process, it must be ensured that the system that supports e-IC is secure with restricted access and ensure confidentiality of the patient's identity.[3] All subject-related information entered into the e-IC must be encrypted. Appropriate archiving and easy retrieval of the electronic documents along with an audit trail are also a very important aspects of the e-consenting process.[2] An e-IC process often uses an interactive interface, which enhances the subject's ability to understand, retain, and comprehend the study information. This can be done by converting critical information into an easy to understand format using graphics, animations, etc., The system should be easy to use and navigate as well.[4] The most important advantage of e-IC is ability to collect data from a remote location. This can be particularly advantageous during unforeseen circumstances, such as the present COVID times. The COVID-19 situation has posed many challenges for trials related to innovative strategies (repurposing drugs), new molecules, or widespread vaccine trials. The situation is also challenging for other ongoing clinical trials and commencement of new trials. The primary challenge lies in reaching the subject for screening and consenting amidst the current pandemic restrictions, and the risk involved in face-to-face interaction with the subject, while simultaneously ensuring adherence to the ethical consenting process. Keeping in mind the above, most of the multicenter field studies are adopting the e-consenting process. There are innovative technology-savvy companies, ready with customized products, to help in switching over to the e-IC process for clinical trials in India. These, however, need validation. It is time that eminent bodies such as Indian Council for Medical Research and Indian Pharmacological Society conduct training and workshops for investigators, particularly of academic institutions, to quickly learn and adopt the technology. The regulator CDSCO can play an important facilitatory role by providing guidance and clarity to the investigators and sponsors in India, for the process of e-IC.

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