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Unreported protocol deviations – The tip of the research-berg

1 Professor, Ophthalmology, Yenepoya Medical College, Additional Faculty Centre for Ethics, Mangalore, Karnataka, India
2 Professor, Internal Medicine, Yenepoya Medical College, Additional Faculty, Centre for Ethics, Mangalore, Karnataka, India
3 Associate Professor and Head, Medical Social Work Department, Yenepoya Medical College, Mangalore, Karnataka, India
4 Associate Professor, Pharmacology, Yenepoya Medical College, Mangalore, Karnataka, India
5 Associate Professor, Public Health Dentistry, Yenepoya Dental College, Yenepoya Ethics Committee-1 and affiliated to Yenepoya (Deemed to be University), Mangalore, Karnataka, India

Correspondence Address:
Uma Kulkarni,
Additional Faculty Centre for Ethics, Member-Secretary Yenepoya Ethics Committee-1 Yenepoya (Deemed to be University), Mangalore, Karnataka
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.picr_235_21

Introduction: Failure to stay within an ethics committee (EC)-approved protocol limits is termed protocol deviation or violation (PD/PV), depending on the seriousness of the transgression and its attendant risks and/or harms. PD/PVs arise in the post-approval phase of the research and are often missed. Current guidelines expect ECs to detect, report and recommend suitable actions such that research participants' risks and harms are mitigated, to the extent possible. Objective: Yenepoya Ethics Committee-1 conducted an internal audit of ongoing postgraduate dissertations involving human participants to assess the occurrence of PD/PVs. Materials and Methods: 54 out of 80 postgraduates responded to our request for filling out a self-reported checklist. These responses were followed up with physical verification of the protocol-related documents. Results: Protocol transgressions were classified as non-compliance (administrative issues), protocol deviations (minor transgressions with minimal or less than minimal increase in attendant risk to participants) and protocol violations (serious transgressions with more than minimal increase in attendant risk to participants). The non-compliances included non-reporting for audit and non-reporting of PDs. Protocol deviations included non-conformance to EC validity, sample size, approved methodology, informed consent process and documentation and suboptimal data storage. No protocol violations were observed. Conclusion: We report PD/PVs from these 54 protocols – with our assessment on the negative impact it may have on scientific validity, harm to participants, EC functioning and credibility of the institution – in the hope that our readers appreciate this important aspect of the post-approval process in the functioning of an EC.

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    -  Kulkarni U
    -  Vaswani R
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