ArticleBMC medical ethics2026
Ethics review of multi-centre trials in India: a survey of researchers and ethics committee members on perspectives, challenges, and opportunities.
Article 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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Authors and funding
13 authors.
Funding
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Abstract
backgroundWhile large multicentre trials (MCTs) helps in timely recruitment of participants and gives generalizable results, fragmented ethics approval processes delay trial initiation. This study explored the perspectives of ethics committee (EC) members and researchers on ethics review processes in MCTs, and approaches to streamline ethics approval.
methodsA cross-sectional survey with semi-structured and open-ended questions gathered perspectives (August-October 2024) from researchers and EC members across India using a non-probability, network-based sampling strategy. Survey items were developed based on study objectives and relevant literature, and organised into key domains on EC functioning, operational challenges, EC communication and alternative ethics review processes: joint, designated, and national/ regional ECs. Participants shared their perspective regarding the current and three hypothetical ethics review processes. Quantitative data were analysed descriptively; and open-ended responses underwent qualitative content analysis.
resultsOf the respondents with MCT experience (106 researchers and 136 EC members), 21% of researchers and 31% of EC members supported the current model of independent EC review at each site. Less than half of respondents viewed the current process as very effective, and only about a quarter considered them efficient in avoiding delays. While researchers perceived designated ECs (30%) to have better efficiency, many EC members (32%) perceived joint reviews would ensure collaborative decision-making. National/ regional models were perceived to have challenges (16% EC members and 22% researchers) due to accountability concerns. Key challenges identified include absence of guidelines for joint review, conflicting decisions, need for training, prolonged timelines, resource constraints, and poor inter-EC communication.
conclusionWhile there was no clear consensus for any of the proposed ethics review processes, consensus emerged regarding the need to optimise and reform the current process. These perspectives regarding operations of ECs could provide exploratory insights, although gathered using a non-probabilistic sample of potentially highly engaged respondents. These insights may inform further empirical research and discourse on contextually appropriate models to improving ethics review efficiency while safeguarding participant welfare. CLINICAL TRIAL NUMBER: Not applicable.
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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.