Controlled Human Infection Studies (CHIS), a technique utilised by many nations to produce vaccines and treatments, have been introduced in India for the first time. Although CHIS has long been fraught with ethical problems, the Indian Council of Medical Research’s (ICMR) Bioethics Unit hopes to remedy this.
This more recent research methodology, which involves deliberately exposing healthy volunteers to pathogens in a controlled environment, has been utilised outside of India to study diseases like malaria, typhoid, dengue, etc.
The Bioethics Unit of ICMR has presented a consensus policy statement that is currently up for discussion and makes the case for implementing CHIS. The document discusses the necessity, advantages, and difficulties of CHIS.
In order to conduct research in India without sacrificing ethical standards and to ensure the protection of human participants, this article is intended to address a number of ethical challenges, according to ICMR.
Despite the potential scientific benefits, ICMR notes that India has so far refrained from participating in CHIS because these studies are ethically delicate and raise issues with contentious research ethics, including deliberate harm, potential disproportionate payment and hence inducements, third-party risk, withdrawal from the study, and research with vulnerable participants.
Therefore, the report states, “These studies require an expedited ethics review process with additional ethical oversight and safeguards to protect the study participants.”
A distinct sociocultural environment is mentioned as one of the deterrents in addition to technical, clinical, ethical, and legal disputes.
Infectious disease-related morbidity and mortality are quite prevalent in India. They are responsible for 30% of the nation’s disease burden. To lessen this burden, it is crucial to identify new, effective, and affordable alternatives to the current approaches to studying these diseases and their prevention. According to ICMR, CHIS is a relatively recent research model that contributes to the development of novel medical interventions and offers special insights into the pathophysiology of disease.
Furthermore, it claims that when compared to lengthy clinical studies, CHIS provides quicker, more cost-effective, and efficient results with smaller sample sizes. Its potential benefits for public health responses to diseases of concern, healthcare policy, economic gains, enhanced pandemic preparedness, and community empowerment are just a few examples of its social worth.
The ICMR has also issued a warning that CHIS is a highly complicated field and may call for multi-level collaborations across researchers, institutions, organisations, and/or nations. To obtain the necessary skills, which might not be present with a single institute or research team, collaborations should be promoted.
“The ICMR Bioethics Unit has created a consensus policy statement to address the ethical concerns connected to the conduct of CHIS. This statement was developed after a process of rigorous interaction with experts over the past few months. The scientific understanding of infectious diseases may be improved significantly as a result of these studies, hastening the creation of effective treatment plans. These studies, which purposely expose healthy volunteers to a particular pathogen under controlled circumstances, present a number of ethical hurdles, and an effort has been made to address these problems in this text. The document is available for public comment through August 16 on the ICMR website, according to ICMR.
