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Background <p>While 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.</p> Methods <p>A 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.</p> Results <p>Of 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.</p> Conclusion <p>While 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.</p> Clinical trial number <p>Not applicable.</p>

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Ethics review of multi-centre trials in India: a survey of researchers and ethics committee members on perspectives, challenges, and opportunities

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月23日

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  • Nikhil Benroy Noronha,
  • Jerin Jose Cherian,
  • Gunjan Kumar,
  • Tanu Anand,
  • Sudipto Roy,
  • Alka Turuk,
  • Mayank Gangwar,
  • Elna Paul Chalisserry,
  • Sujata Sinha,
  • Aruvi Poomali,
  • Roli Mathur,
  • Taruna Madan Gupta,
  • Aparna Mukherjee

摘要

Background

While 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.

Methods

A 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.

Results

Of 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.

Conclusion

While 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.