The institutional Ethics Committee, IEC, is registered with the Central Drugs Standard Control Organisation (CDSCO) Registration number ECR/1639/Inst/MH/2021
The committee is also provisionally registered with the Department of Health Research [DHR], MOHFW, GOI (EC/NEW/INST/2024/4555)
The Institutional Ethics Committee (IEC) of the institute reviews extramurally funded research studies and Clinical Trials.
General Information:
Clinical studies help to bridge research and patient care by evaluating therapies, drugs and diagnostic tools to give way to discoveries that might be of benefit to human patients in future.
Clinical trials are used to test the safety and effectiveness of drugs and devices. Usually, they are sponsored by pharmaceutical companies and are conducted by research teams that include doctors and other medical professionals. Clinical trials are typically conducted in four phases:
– Phase I is when generally healthy people are given the medication to test if the ingestion of the pill or treatment will have no adverse and/or toxicological effect, and that it is absolutely safe to be used in human patients.
– Phases II and III involve deeper evaluation regarding the safety, effectiveness, and dosage of the medication. It’s after these stages that the country’s drug regulator would approve the drug or device.
– Phase IV examines and conducts to collect more information for previously approved treatments.
All of the phases in clinical trials are governed by strict protocols and are overseen by many regulatory bodies, from the Drug Controller General of India to the Institutional Ethics Committee (IEC). IECs are a group of independent medical experts, ethicists, and lay persons. Researchers periodically report to the IEC regarding the entire conduct of the study, which includes the tests involved in the study, the results recorded, and even the side effects reported.