Human Challenge Studies: Future and Prospects

Abstract

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug or device in treating, preventing and diagnosing a disease or a medical condition‟ (Kandi et. al., 2023). Human clinical studies refer to testing of medicine and clinical trials on human beings to scientifically establish the efficacy of drugs on humans. Growth of medical research in India has
taken place under the guidance of ICMR (Indian Council of Medical Research). On July 17, 2023 the ICMR Bioethics Unit came out with a consensus policy statement which sets the pace for the establishment of Human Challenge Studies (also known as Controlled Human Infection Studies-CHIS) in India. Several ethical and regulatory issues are involved in Human Challenge Studies. The question is does India possess a robust system which can deal with such challenges? The challenge of misuse and exploitation can‟t be underestimated. Under the scenario it becomes imperative to understand the challenges involved in such studies and prospective gains accruing from it. This research paper emphasizes the issues and impact of clinical trials on human beings. The research also analyzes the bioethics principles involved in such studies. The principle of bioethics considers misuse of human rights and its impact on the environment. The study also evaluates the existing legal framework regulating use of human beings for clinical studies in India in comparison to the legal framework prevalent in Europe and America. Further the study has found the loopholes existing in the present legal framework of India with the intention of suggesting the corrective measures to meet the gap. 

Keywords- Clinical Trials, Human Clinical trials, Bioethics, National Regulatory Authorities, Human Challenge Studies

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