India's Controlled Human Infection Studies (CHIS)

India has taken the initial step towards implementing Controlled Human Infection Studies (CHIS), a vaccine and therapy development research approach commonly used in other nations.
The Bioethics Unit of the Indian Council of Medical Research (ICMR) has created a consensus policy statement that is accessible for public discussion, addressing the need, benefits, and ethical challenges related with CHIS.

CHIS, also known as human challenge trials, are scientific investigations in which healthy human volunteers are purposely exposed to infectious pathogens under controlled conditions.
The major goal of these studies is to get a better understanding of pathogen behaviour, human immune response, and to evaluate novel vaccines, therapies, or infection prevention strategies.

Informed Consent: Volunteers in CHIS must provide informed consent after fully understanding the risks and benefits of their participation.
Pathogen Types: CHIS can be used to examine a variety of infectious agents, including viruses (e.g., influenza, dengue, Zika), bacteria (e.g., cholera, typhoid), and parasites (e.g., malaria).
Vaccine Development: CHIS plays an important role in vaccine development by providing controlled conditions in which to evaluate the efficacy of candidate vaccines and their ability to elicit protective immune responses.
Controversy: The use of CHIS has raised ethical debates regarding how to balance potential hazards to participants with potential public health benefits.

Delicate Ethical Balance: Because of concerns regarding intentional injury to participants, fair pay, third-party risks, withdrawal from the study, and including vulnerable people, CHIS is deemed ethically sensitive.
ICMR recognises the necessity for a specialised ethics assessment process with enhanced oversight and protections to protect study participants.
Technical, clinical, ethical, and regulatory problems previously hindered India from implementing CHIS, which was impacted in part by the country’s distinct socio-cultural background.

High Disease Burden: Infectious diseases cause a large morbidity and death burden in India, accounting for around 30% of the disease burden.
CHIS provides unique insights into illness pathophysiology and enables quicker and cost-effective outcomes with smaller sample sizes than major clinical studies.
CHIS has the potential to improve public health response, healthcare decision-making, policies, economic rewards, pandemic preparedness, and community empowerment.

The Complex Nature of CHIS: The ICMR emphasises the complexity of CHIS and proposes that cooperation between researchers, institutions, organisations, and countries may be required to ensure adequate knowledge.
Important Contribution to Scientific Understanding: The consensus policy statement of the ICMR Bioethics Unit strives to address ethical concerns about CHIS while also noting its potential significance in enhancing scientific understanding of infectious illnesses and speeding treatment methods.

Open for Public Comment: The ICMR’s consensus policy statement on CHIS is open for public comment through August 16 in order to elicit input from stakeholders and experts.
Striving for Ethical Research: The ICMR emphasises its commitment to conducting CHIS in India while upholding ethical norms and protecting human participants.

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