A Desk Review of Standard Operating Procedures of Ethics Committees in the Philippines on the Review of Clinical Trial Protocol Deviations
Abstract:
The review of
post-approval submissions such as clinical trial protocol deviations (PDs) is a
key function of Ethics Committees (ECs) to ensure data integrity and
participant safety. However, the quality of PD management by ECs depends on the
SOPs that are anchored in national and international guidelines. This desk
review aimed to analyze the SOPs of Level III-accredited ECs in the Philippines
in terms of protocol deviation management. From July to September 2025, SOPs of
ECs were obtained from institutional websites and through web searches. The
SOPs were then compared with recommendations by the Philippine Health Research
Board SOP workbook for the presence or absence of the following: (a) policy
statement; (b) objectives; (c) scope; and (d) work flow; (e) definition of
protocol deviation (PD) or protocol violation (PV); and determine the (f)
required timeline for submission to EC; (g) EC processing time; and (h) type of
review for the noncompliance. A total of 28 SOPs were reviewed. The results
revealed that while most institutional SOPs follow PHREB recommendations, ECs
operationalize PD review differently. Key SOP provisions, such as the definition
of PD/PV, timelines for reporting, processing time, and the type of review, can
affect the quality of EC review and resolution of clinical trial noncompliance.
Future research should extend beyond document analysis to investigate the
practical implementation of SOP provisions regarding protocol deviation
management.
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