Central Idea

India has taken its first step towards introducing Controlled Human Infection Studies (CHIS), a research model widely used in other countries for vaccine and treatment development.
The Indian Council of Medical Research’s (ICMR) Bioethics Unit has prepared a consensus policy statement open for public comment, addressing the need, benefits, and ethical challenges associated with CHIS.

What is Controlled Human Infection Studies (CHIS)?

CHIS also known as human challenge trials, are scientific studies conducted to deliberately expose healthy human volunteers to infectious agents under controlled conditions.
The primary objective of these studies is to gain a better understanding of the pathogens’ behavior, human immune response, and to test potential vaccines, treatments, or preventive measures against the infection.

Key points about Controlled Human Infection Studies (CHIS) include:

Informed Consent: Volunteers participating in CHIS must provide informed consent, fully understanding the potential risks and benefits associated with their participation.
Types of Pathogens: CHIS can be used to study various infectious agents, such as viruses (e.g., influenza, dengue, Zika), bacteria (e.g., cholera, typhoid), and parasites (e.g., malaria).
Vaccine Development: CHIS plays a crucial role in vaccine development by providing controlled environments to assess the efficacy of candidate vaccines and their ability to induce protective immune responses.
Controversy: The use of CHIS has sparked ethical debates about balancing potential risks to participants against potential benefits to public health.

Delicate Ethical Balance: CHIS is considered ethically sensitive due to concerns about deliberate harm to participants, fair compensation, third-party risks, and withdrawal from the study, and involving vulnerable participants.
Streamlined Ethics Review: ICMR acknowledges the need for a specialized ethics review process with additional oversight and safeguards to protect study participants.
Deterrents and Unique Context: Technical, clinical, ethical, and legal challenges deterred India from adopting CHIS earlier, partly influenced by the nation’s unique socio-cultural context.

High Disease Burden: India faces a significant burden of morbidity and mortality from infectious diseases, contributing about 30% of the disease burden in the country.
Novel Insights and Efficiency: CHIS offers unique insights into disease pathogenesis and enables accelerated and cost-effective outcomes with smaller sample sizes compared to large clinical trials.
Social Value: CHIS can contribute to public health response, healthcare decision-making, policies, economic benefits, improved pandemic preparedness, and community empowerment.

Complex Nature of CHIS: ICMR highlights the complexity of CHIS and suggests that collaborations between researchers, institutions, organizations, and countries may be necessary to ensure the right expertise is available.
Crucial Role in Advancing Scientific Understanding: The ICMR Bioethics Unit’s consensus policy statement aims to address ethical concerns associated with CHIS, acknowledging its potential role in advancing the scientific understanding of infectious diseases and accelerating treatment strategies.

Open for Public Consultation: The ICMR’s consensus policy statement on CHIS is open for public consultation until August 16 to gather input from stakeholders and experts.
Striving for Ethical Research: ICMR emphasizes its commitment to conduct CHIS in India while ensuring ethical principles are upheld and human participants are protected.

The introduction of CHIS in India is a significant step towards advancing medical research and finding cost-effective solutions for infectious diseases.
Public consultation and expert collaborations will help shape the future direction of CHIS research in India and contribute to scientific progress and improved healthcare outcomes.