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Related Experiment Video

Updated: Jul 26, 2025

Improving IV Insulin Administration in a Community Hospital
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Unreported protocol deviations - The tip of the research-berg.

Uma Kulkarni1, Ravi Vaswani2, Mohammed Guthigar3

  • 1Professor, Ophthalmology, Yenepoya Medical College, Additional Faculty Centre for Ethics, Mangalore, Karnataka, India.

Perspectives in Clinical Research
|June 16, 2023
PubMed
Summary

An internal audit found protocol deviations in postgraduate research, highlighting risks to participants and institutional credibility. Addressing these deviations is crucial for ethical research conduct and maintaining trust in ethics committees.

Keywords:
Auditethics committee functioningpostapproval processprotocol deviationprotocol violation

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Area of Science:

  • Medical Ethics
  • Clinical Research Governance

Background:

  • Protocol deviations and violations (PD/PVs) occur post-approval and can be missed.
  • Ethics committees (ECs) are responsible for detecting and mitigating risks associated with PD/PVs.

Purpose of the Study:

  • To assess the occurrence of PD/PVs in postgraduate dissertations.
  • To evaluate the impact of PD/PVs on research integrity and participant safety.

Main Methods:

  • An internal audit was conducted by Yenepoya Ethics Committee-1.
  • A self-reported checklist was administered to 54 postgraduate students, followed by physical verification of protocol documents.

Main Results:

  • Protocol deviations were observed in 54 out of 80 postgraduate dissertations.
  • Deviations included non-conformance to EC validity, methodology, informed consent, and data storage.
  • No protocol violations (serious transgressions) were identified.

Conclusions:

  • Protocol deviations pose risks to scientific validity and participant harm.
  • Addressing PD/PVs is essential for effective EC functioning and institutional credibility.