COMPLETENESS OF INSTITUTIONAL ETHICS APPLICATION FORMS SUBMITTED TO THE ETHICS COMMITTEE IN A RURAL TERTIARY TEACHING HOSPITAL

Abstract

Aim & objective: To evaluate the completeness of ethics application forms submitted for review to institutional ethics committee. Materials & methods: Application forms of year 2011-2013 submitted to our institutional ethics committee were studied. Results: The total numbers of application forms submitted to ethics committee were 100. Of these 67 were dissertation and 33 were research project. The type of studies consists of observational prospective studies (88%), procedure related studies (8%) & interventional studies consist of clinical trial (4%). Title of study was incomplete in 15 forms and place of the study was not mentioned in 11 forms. Time period required was mentioned in 76 forms. Only 37 forms have attached the consent form. Involvement of risk to participating subjects mention in 7 forms, none of form filled information related to compensation, financial burden will be met and conflict of interest and data maintence and storage of application forms. Conclusion: The present study highlights the importance of knowledge and awareness about the filling of the application forms of ethics committee. A uniform well prepared application form of ethics committee required for evaluation and understanding of research project.

Keywords

• Application form
• Institutional Ethics Committee
• Standard Operating Procedure