Chitkara University defines anINTO Institutional Human Ethical Committee (CU.IHEC ) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup.
An IHEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research.
- Reviews all study-related materials before and during the trial
- Must operate in accordance with national and/or local regulations of Indian Council of Medical Research
IHEC Responsibilities Before, During and After a Research Study
Before any research is allowed to start enrolling human subjects, the IHEC must review all study-related materials in an initial review. The IHEC also performs periodic reviews – called continuing reviews – throughout the study. Continuing reviews may take place at least once a year and include the entire study, not just changes.
The IHEC may also ask for additional information regarding payments and compensation to study participants, as well as the informed consent process.
Investigator Responsibilities for Ensuring Compliance
The principal investigator (PI) or Supervisors are responsible for ensuring compliance with any IHEC procedures or requirements. He or she may deviate from the study protocol without prior IHEC approval only to eliminate immediate safety hazard to a study participant. In addition, the PI must notify the IHEC of any departures from the protocol as soon as possible.