Common Forms for Ethics Committee Review

Currently in India, Ethics Committees are prescribing different application formats to investigators for proposal submissions. While some of the ECs have developed formats of their own, others lack such application formats.

To address this issue and ensure a smooth EC review process, ICMR in collaboration with THSTI took an initiative to harmonize different formats being used in the country and prepare common forms and checklists. Forms from more than 25 premiere institutions/ hospitals were received, compiled and pilot tested at five institutions to evaluate the structural and functional ease of use.

The final common forms for EC review are easy to use, adaptable and can be customized as per requirements of ECs across the country.

The forms are available freely for download in PDF and word formats. Comments/suggestions to improvise the form are welcome in the following format.

Click here to download the format for providing comments/suggestions.

Download PDF (Initial Review Form & Annexure) Download WORD (Initial Review Form & Annexure)
General instructions  Instruction to fill the word form
Index Download
Initial Review    
Expedited Review    
Exemption from Review    
Continuing Review / Annual report format    
Application/Notification form for Amendments    
Protocol Violation/Deviation Reporting form (Reporting by case)    
Serious Adverse Event Reporting Format (Biomedical Health Research)    
Premature Termination/Suspension/ Discontinuation Report Format    
Clinical Trials    
Serious Adverse Event Reporting Format (Clinical trials)    
Human Genetics Testing Research    
Socio-Behavioural and Public Health Research    
Study completion/Final report format    
Format for Curriculum Vitae for Investigators