Pruthak C Shah1, Ashwin K Panchasara2, Manish J Barvaliya3, C B Tripathi4. 1. Student, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India . 2. Assistant Professor, Department of Pharmacology, GMERS Medical College , Sola, Ahmedabad, Gujarat, India . 3. Assistant Professor, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India . 4. Professor and Head, Department of Pharmacology, Government Medical College , Bhavnagar, Gujarat, India .
Abstract
INTRODUCTION: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). AIM: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. MATERIALS AND METHODS: The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. RESULTS: Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. CONCLUSION: Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.
INTRODUCTION: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). AIM: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. MATERIALS AND METHODS: The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents. RESULTS: Total 100 application forms were analysed. Among them, 98 were academic and 2 were industrial studies. Majority of academic studies were of basic science type. In 63.26% studies, type of study was not mentioned in title. Age group of subjects was not mentioned in 8.16% application forms. In 34.6% informed consent, benefits of the study were not mentioned. Signature of investigators/co-investigators/Head of the Department was missing in 3.06% cases. CONCLUSION: Our study recommends that the efficiency and speed of review will increase if investigator will increase vigilance regarding filling of application forms. Regular meetings will be helpful to solve the problems related to content of application forms. The uniformity in functioning of EC can be achieved if common application form for all ECs is there.
Authors: Dinesh K Badyal; Chetna Desai; Santanu K Tripathi; S P Dhaneria; Sujith J Chandy; B K Bezbaruah Journal: Indian J Pharmacol Date: 2014 Nov-Dec Impact factor: 1.200
Authors: Simon N Whitney; Kirsten Alcser; Carl Schneider; Laurence B McCullough; Amy L McGuire; Robert J Volk Journal: Int J Med Sci Date: 2008-04-02 Impact factor: 3.738
Authors: Sangeetha Paramasivan; Philippa Davies; Alison Richards; Julia Wade; Leila Rooshenas; Nicola Mills; Alba Realpe; Jeffrey Pradeep Raj; Supriya Subramani; Jonathan Ives; Richard Huxtable; Jane M Blazeby; Jenny L Donovan Journal: BMJ Glob Health Date: 2021-05