ReviewDialogues in health2026
Is India ready for controlled human infection studies? A narrative review of stakeholders' perceptions & regulatory preparedness.
Review in Dialogues in health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.