Why in news? India has taken its first step to introduce controlled human infection studies (CHIS) that is used in many countries for vaccine and treatment development.

Highlights:

• Outside India, this relatively new research model involves intentionally exposing healthy volunteers to pathogens in a controlled environment.it has been used to study malaria, typhoid, dengue, and so on.
• Aim of the study: to address a variety of ethical issues so that research can be conducted in India without compromising on ethical principles while ensuring the protection of human participants.

Concerns about the study: 

• Ethically sensitive: regardless of the potential scientific benefits, these 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 the study and research with vulnerable participants.
• The deterrents include technical, clinical, ethical and legal contentions, amid unique socio-cultural context.
• High burden: 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 imperative to reduce this burden.
• CHIS is a highly complex area and may require collaborations at different levels between researchers, institutions, organizations and/or between different countries.

Advantages of the study:

• Helps 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.

Way forward:

• Collaborations should be encouraged to get the right expertise which may not be available with one centre/research team.
• Finding novel, efficient, and cost-effective alternatives to existing methods of research in these diseases and their prevention is imperative to reduce the burden of the diseases.