|Common Forms for Ethics Committee Review
A large number of biomedical /clinical research studies are being conducted across various research centres/medical institutions across the country. Ethics Committees (EC) are entrusted with the responsibility to undertake the ethical review of research proposals prior to initiation, and also have a continuing responsibility to regularly monitor the approved research to ensure ethical compliance during the conduct of research and to ensure that the rights, safety and well-being of research participants is protected.
Currently Ethics Committees at different institution are providing different application formats to investigators for making their submissions. Many institutions do not have proper application formats and checklist of their own. In order to improve the quality of ethics review by the ethics committee it is important to have a comprehensive form that seeks relevant information related to the study.
ICMR Bioethics Unit took the initiative to prepare the Common forms for Ethics Committee review with funding support by Translational Health Science and Technology Institute (THSTI) to harmonize and unify ethics committee submission across the country. The forms would cater to different needs of Ethics Committees and provide a much needed common EC format for improving ethical review of biomedical and health research in the country. The common forms for Ethics Committees review consists of an application form for initial review that collects basic information, research and participant related information, declarations and checklists. In addition, there are 13 annexures which provide formats for other types of EC reviews, adverse events, protocol violations, reporting formats. Additional forms focussing on clinical trials, socio-behavioural, public health research and human genetics testing research are also provided.
Efforts have been made to make comprehensive forms that would be able to collect all relevant information about the study protocol and assist the ethics committees in its process of review. Use of standardized forms in all institutions would also improve collaborative/ multicentric studies that are conducted at several sites in the country.
Ethics Committee proposal submission forms from more than 25 premier institutes were requested and received. Information provided in these forms was collated to identify common as well as unique questions and common forms were drafted. These forms were pilot tested by Sree Chitra Tirunal Institute for Medical Sciences and Technology at five Institutions to evaluate the structural and functional ease in translating a research protocol into ethics committee review format. The form was modified based on suggestions received, finalized and released.