ICMR argues for controlled human infection studies

Source: The post is based on the article “ICMR argues for controlled human infection studies”  published in The Hindu on 25th July 2023.

What is the News?

Indian Council of Medical Research’s (ICMR) Bioethics Unit has released a statement arguing for introducing controlled human infection studies (CHIS) in India.

What are Controlled human infection studies (CHIS)?

In controlled human infection studies (CHIS), healthy volunteers are intentionally exposed to pathogens in a controlled environment in order to promote understanding of the pathogenesis, transmission, prevention and treatment of infectious diseases in humans.

Such studies may be conducted to gain insights into how pathogens infect human hosts and cause disease, to better understand immune responses to infection or to evaluate the efficacy of vaccines and drugs designed to prevent and treat infectious diseases. 

CHIS have a long history and have made important contributions to the treatment and prevention of many infectious diseases of global health importance.

What are the concerns related to Controlled human infection studies (CHIS)?

There are ethical and other concerns such as: 1) deliberate harm 2) possible disproportionate payment and hence inducements 3) third-party risk 4) withdrawal from the study and 4) research with vulnerable participants.

Why is ICMR Bioethics Unit arguing for Controlled human infection studies (CHIS)?

India carries a high burden of morbidity and mortality from infectious diseases. They contribute about 30% of the disease burden in the country. 

Finding novel, efficient, and cost-effective alternatives to existing methods of research in these diseases and their prevention is important to reduce this burden.

In this context, CHIS model can help provide unique insights into disease pathogenesis and can accelerate the development of novel medical interventions.

It offers accelerated, cost-effective and efficient outcomes using smaller sample sizes in comparison to large clinical trials. 

Its social value includes potential contributions to public health response to diseases of concern, healthcare decision-making, policies and economic benefits, improved pandemic preparedness, and community empowerment.

However, ICMR has also cautioned that CHIS is a highly complex area and may require collaborations at different levels between researchers, institutions, organizations and/or between different countries as right expertise may not be available with one centre/research team.