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Institutional Review Board

Learn more about how to create and submit a research protocol for studies involving human subjects.

About the Institutional Review Board (IRB)

What is the IRB?

An 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.

IRB Registration

The HCA-HealthONE LLC IRB is registered with the Office for Human Subject Protection (OHRP) and the Food and Drug Administration (FDA) through the IRB Registration site with the Department of Health and Human Services (DHHS).

IRB Registration No. IRB00005427
Expiration date: 08/17/2024

IRB Roster

The Institutional Review Board (IRB) is comprised of a diverse membership while maintaining the expertise needed to fulfill its functions. The Board meets on a monthly basis, the third Wednesday of each month at the HCA-HealthONE Division Building in Denver.

The IRB member roster consists of the following disciplines:

  • Neurologist/Neuro-Oncologist
  • Radiation Oncologist
  • Orthopedic Surgeon
  • Cardiologists
  • Pediatric Oncologist
  • Family Practitioner
  • Attorneys
  • Pharmacists
  • PhD-level Nurses
  • Community Members
  • Actuary

A current IRB roster may be obtained by contacting the IRB Administrative Office at (303) 584-2300.

Utilizing an External IRB (e.g. WIRB, NIH)

Please contact the IRB administrative office at (303) 584-2300 for information regarding use of an external IRB.