Published on: July 27, 2023
Controlled human infection studies
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.
- 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.
- 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.