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What are the regulatory requirements for conducting a human study?

Regulatory approvals are not required in the US and most other countries for the conduct of a clinical study on a nutraceutical/herbal product if it is not intended for the treatment or cure of a disease. All the studies have to be reviewed and approved by the Institutional Review Board (IRB) or an Independent Ethics Committee (IEC). Also, any clinical study has to be conducted in conformance with the ICH-GCP guidelines which is the Gold Standard for clinical studies and improves the chances of approval by most agencies including the tough EFSA. It is also recommended that the study be registered with a clinical study registry such as Clinicaltrials.gov or Clinical Trial Registry of India (CTRI) with all essential information and timely updates. Such a registry provides a unique registration confirmation number by which the non confidential details of the study and its results can be viewed.

IRB approvals and registration on a clinical trial registry lend credibility to the study and the data emerging finally and greatly enhance the possibility of approvals of papers submitted to high impact factor journals.