[2] Once the Ministry makes the necessary amendments in this regard, the AV recording of informed consent will become mandatory in India. A video tape recording of the consent interview is also recommended by United States Food and Drug Administration www.selleckchem.com/products/AZD2281(Olaparib).html in case of illiterate participants who can understand and comprehend spoken English but are physically unable to talk or write.[3] As per Indian Council of Medical Research Ethical Guidelines, in case of sensitive nature of the project or when participants cannot sign or give thumb impression AV methods could be adopted with prior consent and adequate precaution to ensure confidentiality. In addition, Ethics committee (EC) approval is required for such procedures.[4] This article enlists the anticipated advantages and foreseeable challenges in the process of implementing AV recording of informed consent process.

ANTICIPATED ADVANTAGES Safeguarding the stakeholders Though the intention of the DTAB is safeguarding the rights, safety, and well-being of the participants enrolled in clinical trials. AV recording will actually play a major role in safeguarding all stakeholders involved in a clinical trial, not just the patients. The investigator will be able to demonstrate that all relevant information was provided to the potential participant before he/she understood and voluntarily agreed to take part in the clinical study. The EC can use this as a tool to oversee the consent process at the site and direct the investigator in case of any shortcomings in the process.

In case of any dispute/litigation, the sponsor will have some solid evidence to support that adequate measures were taken to obtain consent appropriately rather than simply rely on the signed informed consent form (ICF) and the documented narrative. Simplification of the consent process In the absence of AV recording of the consent process, the monitors rely on the documentation Brefeldin_A of informed consent narrative to reconstruct informed consent process. The sites are often advised and trained to write a detailed informed consent narrative, which can run into pages. The expectation of documentation from the site has grown over time and will continue to increase. The emphasis needs to be shifted from laborious documentation of mechanical aspects of research process to assuring true comprehension and voluntary participation. The efforts will be worth the time and cost involved, as it will strengthen the research effort through recruitment and retention thorough of participants who better understand their roles and responsibilities in the study and thus can adhere to protocol.