MedZon Healthcare >> Advisory Committee
Human Ethics Committee
MedZon institutional review board (IRB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.Drug Controller General Of India, DCGI regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research.
We performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
To approve a human trial, MedZon IRB needs
- Trial protocol(s)/amendment(s)
- Written informed consent form(s) and consent form updates that the investigator proposes for use in the trial
- Subject recruitment procedures (e.g., advertisements)
- Written information to be provided to subjects
- Investigator's Brochure (IB)
- Available safety information
- Information about payments and compensation available to subjects
- The investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its responsibilities.