Continuous review for ethical conduct of clinical trial-are the ethics committees complying?

Ethics committees (ECs) play a crucial role in safeguarding clinical trial participants through ongoing review beyond initial protocol approval. Although regulations require periodic monitoring of study progress, risk, protocol adherence, and informed consent processes, evidence from India indicates significant gaps in implementation.. Challenges such as limited resources, insufficient training, and lack of structured monitoring hinder effective continuous review. Strengthening EC capacity and accountability is essential to ensure ethical conduct and participant safety in ongoing clinical research.

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Publication Details

Journal
Perspectives in Clinical Research
Published
2025-12-09
DOI
https://doi.org/10.4103/picr.picr_184_25
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
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Continuous review for ethical conduct of clinical trial-are the ethics committees complying?

Perspectives in Clinical Research
Ethics in Clinical Research
article

Continuous review for ethical conduct of clinical trial-are the ethics committees complying?

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Abstract

Ethics committees (ECs) play a crucial role in safeguarding clinical trial participants through ongoing review beyond initial protocol approval. Although regulations require periodic monitoring of study progress, risk, protocol adherence, and informed consent processes, evidence from India indicates significant gaps in implementation.. Challenges such as limited resources, insufficient training, and lack of structured monitoring hinder effective continuous review. Strengthening EC capacity and accountability is essential to ensure ethical conduct and participant safety in ongoing clinical research.

Perspectives in Clinical ResearchVol. 17(1)
All India Institute of Medical Sciences Raipur (IN), Government Medical College (IN), All India Institute of Medical Sciences Bhopal (IN), All India Institute of Medical Sciences, Nagpur (IN)
Openalex Percentile: Top 30%
Ethics in Clinical Research
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