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Insitiute Ethics Committee (IEC)

Institute Ethics Committee

 

The Ethics Committee (EC) is responsible for scientific and ethical review of research proposals. Although ECs may obtain documentation from a prior scientific review, they must determine that the research methods are scientifically sound and should examine the ethical implications of the chosen research design or strategy.
 
Biomedical and health research

 

A large number of biomedical and health research studies are being conducted across the country at various research centres/medical institutions/ universities etc. 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. These Ethics committee reviewing biomedical and health research shall be constituted and are required to function in accordance with the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.
 
Our Institutional Ethics Committee has been registered under Both Central Drug Standards and Control Organisation (CDSCO) and National Ethics Committee Registry for Biomedical and Health Research (NECRBHR), Department of Health Research (DHR),  Ministry of Health & Family Welfare, Govt. of India 
 
I. CDSCO Approval:  For Clinical trial interventions of drugs, vaccines, biosimilars, biologics, phytopharmaceuticals, radiopharmaceuticals, diagnostic agents, public health or socio behavioural interventions, technologies, devices, surgical techniques or traditional systems of medicine, etc.
 
SOP of CDSCO and approval Certifcate:
 
SL No Subject Download
1 CDSCO IEC Sop INU View/Download
2 CDSCO INU Regn View/Download
3 Prov Reg Certificate DHR View/Download
4 SOP IEC DHR View/Download
5 DHR IEC Protocol Submission Application Word Document View/Download
6 DHR IEC Protocol Submission Application PDF Document View/Download
7 New Drug CT Rules 2019 View/Download
8 ICMR_National_Ethical_Guidelines2017 View/Download
9 INFORMED CONSENT View/Download
10 UNDERTAKING BY THE INVESTIGATOR View/Download

 
II.  National Ethics Committee Registry for Biomedical and Health Research (NECRBHR), Department of Health Research (DHR),  Ministry of Health & Family Welfare, Govt. of India 
All other study proposals other than the ones mentioned under CDSCO for Academic purposes will be reviewed as per these rules.
 
The Functioning of the ethics committee will be in accordance with the New Drugs and Clinical Trials Rules,2019 and ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

Last Updated: 23-08-2022 12:38 PM Updated By: Admin


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