ICMR Argues For Controlled Human Infection Studies

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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

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.

About CHIS

India has taken its first step to introduce Controlled Human Infection Studies (CHIS) that is used in many countries for vaccine and treatment development. 

Outside India, the relatively new research model which involves intentionally exposing healthy volunteers to pathogens in a controlled environment,has been used to study malaria, typhoid,dengue and so on.

It provides insights into disease pathogenesis and can accelerate the development of novel medical interventions. The model 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.

The Issue

The ICMR-Indian Council of Medical Research’s Bioethics Unit aims to change the CHIS due to ethical issues. 

The ICMR’s Bioethics Unit has introduced a consensus policy statement that is open for comment and argues the case for bringing CHIS. 

The paper aims at addressing ethical issues so that research in India is conducted without compromising on ethical principles which ensure protection of human participants.

The ICMR notes that India has so far stayed away from CHIS,because regardless of its potential benefits, the studies are ethically sensitive and raise concerns about contentious research ethics- issues like deliberate harm,possible disproportionate payment and hence inducements,third-party risk, withdrawal from study and research with vulnerable participants.