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ICMR Bioethics Unit

Ethics Committee Tools

Common Forms for Ethics Committee Review View Forms

Background

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.

Procedure Adopted

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.

Expected Advantage to ECs and Researchers

  • The form is intended to simplify process of submission to Ethics Committee.
  • The form is available freely for download in Word and Pdf formats from ICMR and ICMR Bioethics Unit web pages.
    (http://ethics.ncdirindia.org/Tools_and_Instruments.aspx)
    (https://www.icmr.nic.in/sites/default/files/guidelines)
  • The forms in word format provide the freedom to Institutions to modify, include the institutional name, logo and make changes as per other additional Institutional/ ECs requirements.
  • The forms will be very useful for multi centric review where the researchers/ PI may have to submit the same proposal to multiple ECs. This will greatly reduce the effort and streamline the ethical review process

Who should use the forms and how

  • The member secretary of ethics committees, member of EC’s can download the form and customize them.
  • Any member from an institution can download and provide a copy to the member secretary, EC to take it up.
  • Hard copy of form is also available and can be requested from ICMR Bioethics Unit, NCDIR Bangalore.

Feedback

  • A feedback form to share user suggestions and inputs is provided in the download link page. The Institutes using the forms may share their comments/ feedback and suggestions to ICMR. The Common forms for Ethics Committee review are dynamic and will be updated based on these feedbacks received.
  • The institutions/ members secretaries may also inform ICMR in the feedback form if they have switched on to Common forms for Ethics Committee Review for our records.



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