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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
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.
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.
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