Ethics considerations in outbreak investigations conducted in india, 2015-2025: a systematic review
1
Community and Family Medicine, All Institute of Medical Science, Mangalagiri, Vijayawada, India
2
Department of Community Medicine, Navodaya Medical College Hospital and Research Center, Raichur, India
Popul. Med. 2026;8(Supplement Supplement 1):
ABSTRACT
BACKGROUND:
Formal ethics review is bypassed in outbreak investigation frequently due to urgency, despite guidance from WHO stating that ethical committee review is to be taken even in emergency and ICMR 2017 guidelines that expedited review mechanisms are to be implemented in emergency situations, 1-2. We conducted systematic review on ethics consideration in infectious disease outbreak investigation in India from 2015 to 2025, to comprehensively address this shortcoming.
OBJECTIVES:
To estimate the proportion of outbreaks conducted in India during 2015 to 2025 that reported ethics statements, obtained ethics approval and participant informed consent.
METHODS:
We searched in data bases viz., Embase, PubMed, Scopus, and Web of Science for outbreak investigation reports involving human participants in India, published from January 2015 to September 2025. The review was registered in PROSPERO(CRD420251140176). Analysis was conducted using R software.
RESULTS:
A total of 76 outbreak investigations were included. Overall, 82% reported an ethics statement, whereas 45% obtained formal ethics committee approval, 54% not obtaining consent, 12% documenting verbal consent, and 34% reporting written consent. Investigations conducted in later years were more inclined to report ethical approval. Community-based investigations more commonly lacked ethics statements, whereas hospital-based studies demonstrated more compliance with ethical review.
DISCUSSION:
Ethical reporting in outbreak investigations in India from 2015 to 2025 reveals significant deficiencies, especially regarding ethics approval and informed consent. Despite ICMR’s 2017 guidelines for faster review in emergencies, there is a lack of ethics oversight in several studies 2. Strengthening routine ethics preparedness, assuring IEC readiness for speedy review, and standardizing ethics reporting within Integrated Disease Surveillance Programme(IDSP) are crucial to increase responsibility and participant protection during outbreaks.
Formal ethics review is bypassed in outbreak investigation frequently due to urgency, despite guidance from WHO stating that ethical committee review is to be taken even in emergency and ICMR 2017 guidelines that expedited review mechanisms are to be implemented in emergency situations, 1-2. We conducted systematic review on ethics consideration in infectious disease outbreak investigation in India from 2015 to 2025, to comprehensively address this shortcoming.
OBJECTIVES:
To estimate the proportion of outbreaks conducted in India during 2015 to 2025 that reported ethics statements, obtained ethics approval and participant informed consent.
METHODS:
We searched in data bases viz., Embase, PubMed, Scopus, and Web of Science for outbreak investigation reports involving human participants in India, published from January 2015 to September 2025. The review was registered in PROSPERO(CRD420251140176). Analysis was conducted using R software.
RESULTS:
A total of 76 outbreak investigations were included. Overall, 82% reported an ethics statement, whereas 45% obtained formal ethics committee approval, 54% not obtaining consent, 12% documenting verbal consent, and 34% reporting written consent. Investigations conducted in later years were more inclined to report ethical approval. Community-based investigations more commonly lacked ethics statements, whereas hospital-based studies demonstrated more compliance with ethical review.
DISCUSSION:
Ethical reporting in outbreak investigations in India from 2015 to 2025 reveals significant deficiencies, especially regarding ethics approval and informed consent. Despite ICMR’s 2017 guidelines for faster review in emergencies, there is a lack of ethics oversight in several studies 2. Strengthening routine ethics preparedness, assuring IEC readiness for speedy review, and standardizing ethics reporting within Integrated Disease Surveillance Programme(IDSP) are crucial to increase responsibility and participant protection during outbreaks.
| eISSN: | 2654-1459 |
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