Assessing completion reports for compliance with institutional ethics committee-approved protocols: An observational
Snehalata V Gajbhiye1, Sharmila V Jalgaonkar2, Sarita G Dabba3
1Assistant Professor, Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012 INDIA.
Indian Journal of Medical Ethics
|May 13, 2020
Summary
Clinical research protocol non-compliance is frequent, impacting patient safety and data integrity. Investigator training is crucial for improving adherence and ensuring ethical, scientific standards in studies.
Area of Science:
- Clinical Research
- Medical Ethics
- Data Integrity
Background:
- Protocol non-compliance is a common issue in clinical research, potentially compromising patient safety and data integrity.
- Existing literature lacks studies specifically investigating the prevalence and nature of protocol non-compliance.
- This study addresses this gap by assessing non-compliance rates and identifying specific areas of deviation within research protocols.
Purpose of the Study:
- To determine the proportion of protocol non-compliance in clinical research studies.
- To identify specific aspects of research protocols where non-compliance occurs.
- To evaluate the extent of deviations from approved study plans.
Main Methods:
- A retrospective analysis of study completion reports submitted to an institutional ethics committee between January 2017 and December 2017.
- Development and validation of a 12-point checklist to systematically record protocol non-compliance.
- Comparison of submitted reports against approved study protocols to identify deviations.
Main Results:
- Out of 193 studies reviewed, significant protocol deviations were identified in multiple areas, including modified objectives (9.32%), failure to collect data (3.10%), and unmet sample sizes (30.05%).
- A substantial number of studies (40.41%) exceeded their stipulated study duration.
- A significant discrepancy exists between the 180 protocol deviations found and the 14 reported by principal investigators, highlighting underreporting.
Conclusions:
- Adherence to research protocols is not consistently maintained across all aspects of clinical studies.
- Implementing adequate training for investigators is essential to mitigate non-compliance.
- Enhanced investigator training can improve ethical conduct and scientific integrity in clinical research.
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