SynthesisBMC medical ethics2026
Ethical reporting and oversight in outbreak investigations conducted in India, 2015-2025: a systematic review.
Synthesis in BMC medical ethics, 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.
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Who cites it
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Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOutbreak investigations generate actionable evidence to identify sources of infection and guide effective control measures. In outbreak settings, ethical considerations become even more significant because such investigations often involve vulnerable populations, the collection of identifiable data, and interventions under conditions of uncertainty. The Indian Council of Medical Research states that while there may be a need to undertake research quickly, this should not compromise scientific validity or the need to uphold ethical requirements. However, the extent to which outbreak investigations in India comply with ethics oversight reporting has not been systematically examined. The objective was to evaluate ethical considerations in outbreak investigations conducted in India, published between 2015 and 2025 that reported ethical statements, obtained ethical approval, and participant informed consent.
methodsThe review was registered in PROSPERO 2025 CRD420251140176. Human outbreak investigations conducted in India, published from 1 January 2015 to 25 August 2025, were searched in databases viz., Embase, PubMed, Scopus, and Web of Science. Analysis was conducted using R software.
resultsA total of 76 outbreak investigations were included. Overall, 14 (18%) did not report an ethics statement, while 31 (41%) reported an ethics statement without Institutional Ethics Committee approval, and 31 (41%) reported both an ethics statement and approval. Participant consent was not obtained in 41 (54%) publications, written consent was obtained in 26 (34%), and 9 (12%) reported verbal consent. Investigations published in later years demonstrated significantly higher levels of ethics oversight (p < 0.001), and ethics oversight varied significantly across disease groups (p = 0.04); no association was observed with study setting or methodological completeness. DISCUSSION: Ethics reporting in outbreak investigations in India remains inconsistent. Routine ethics preparedness requires IEC readiness for rapid review and integration with outbreak investigation initiation.
conclusionLess than half documented formal Institutional Ethics Committee approval. The findings highlight the need to strengthen ethical preparedness within outbreak response systems. Strengthening ethical preparedness through rapid review mechanisms, integration of ethics oversight within IDSP-linked investigations, standardised reporting practices, and capacity building of field investigators may help ensure a more ethically robust and transparent outbreak response system.
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