EVALUATION OF ERRORS AND COMPLETENESS OF RESEARCH APPLICATION FORMS SUBMITTED TO THE INSTITUTIONAL ETHICS COMMITTEE (IEC) OF A TERTIARY CARE INSTITUTION: AN OBSERVATIONAL STUDY

Introduction: IECs seek a duly filled application form to provide the overview of the study as per ICMR guidelines in the process of review and to maintain study related records. Aim and Objectives: To evaluate the errors and completeness of research application forms submitted to IEC. Materials and Methods: The present study was undertaken after obtaining approval from IEC, GMC, Kathua. Application forms from January 2023 to December 2024 were analysed regarding: Type of studies, study duration and design, title, detail and signature of investigators, informed consent process, involvement of the vulnerable population, declaration of conflict of interest. Results: Total43 application forms were analysed in which details of principal & co-investigators were incomplete in 19 (44.18%), duration of study was not mentioned in 18 (41.18%), consent forms were missing in 17 (39.5%) forms. The signatures of the head of department and investigators were missing in 14 (32.5%) and 11 (25.58%) forms respectively. All forms mentioned complete title, aims & objectives, background and specified about DCGI permission. Conclusion: Current study underlines that majority of application forms (52%) were incomplete and had one or more errors. This underscores the need of periodic meetings of IEC and awareness among researchers.