Is India ready for controlled human infection studies? A narrative review of stakeholders' perceptions & regulatory...

Controlled Human Infection Studies (CHIS) involve the introduction of standardized, attenuated or wild type microorganisms into healthy volunteers to further advance understanding of disease pathophysiology, response to treatment and accelerate the development of vaccines and therapeutics. Although CHIS are established in many countries, India has only begun to explore their possibility. This study aims to examine the prevailing stakeholder perceptions and regulatory preparedness for CHIS in India.

A structured literature search was conducted in PubMed, Scopus, and Embase using terms related to CHIS and India. Qualitative studies, surveys, viewpoints, and review articles addressing stakeholder perspectives and regulatory issues were screened. Three empirical studies met the inclusion criteria.

Available evidence indicates that Indian stakeholders acknowledge the potential of CHIS for accelerating vaccine development, particularly for endemic diseases and public health emergencies whilst trying to address different research questions such as concerns regarding participant safety, informed consent, public trust, regulatory oversight, biosafety infrastructure, compensation, and protection against exploitation of vulnerable populations. Public awareness of CHIS was mostly marginal with focus on the time it would take for benefits to reach the public, while ethics committee members emphasized the need for more development in the technical and legal aspects. The 2023 Indian Council of Medical Research policy statement for CHIS provides an important ethical framework, but certain operational and regulatory challenges persist.

India demonstrates conceptual readiness however sustained public awareness, ethics committee training, and comprehensive participant safeguards are essential to ensure that CHIS are conducted responsibly, while upholding the principles of beneficence, non-maleficence, and participant autonomy.