About the IRB

An Institutional Review Board (IRB) is a federally mandated organization of scientific and non-scientific persons, whose charge is to review research studies involving human subjects to ensure subject safety and welfare.  While the responsibility for the conduct of a research study ultimately lies with the Principal Investigator, the HCA-HealthONE IRB ensures that any research study under its jurisdiction is in compliance with federal, state, and institutional regulations.

A research project is reviewed in its proposal phase—even before subjects are recruited.  Each project must be approved by the IRB before it can begin and must be re-evaluated at least annually.  Investigators and the IRB work together to revise projects to ensure adequate protection for a subjects’ welfare and rights are maintained.

The HCA-HealthONE process for protecting human research subjects reflects federal regulations and institutional policies.  The Department of Health and Human Services (DHHS) Office for Human Research protection (OHRP) oversees the operation of the IRB, and the Food and Drug Administration (FDA) enforces regulations for use of experimental drugs and devices.