Institutional Review Board (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.
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. IRB0004558
Expiration date: 12/15/2017 under IRB Registration No.
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:
- Pediatric Emergency Medicine Doctor
- Radiation Oncologist
- Orthopedic Surgeon
- Pediatric Oncologist
- Family Practitioner
- PhD-level Nurses
- Community Members
A current IRB roster may be obtained by contacting the IRB Administrative Office at (303) 584-2300.
The following IRB’s are listed on the HCA-HealthONE LLC Federal Wide Assurance (FWA) as an IRB that may provide IRB oversight for human subject research conducted at a HCA-HealthONE facilities.
- HCA-HealthONE IRB
- Western Institutional Review Board (WIRB)
- National Cancer Institute Central IRB #2
- Colorado Cancer Research Program IRB #1 -Colorado Community IRB
- National Jewish Health IRB
- U.S. Oncology IRB #1
- U.S. Oncology IRB #2
- Colorado Multiple Institutional Review Board (COMIRB) - transplant studies only
PLEASE NOTE: If an investigator conducts research at one of the HCA-HealthONE facilities and utilizes the services of an IRB not listed on the HCA-HealthONE LLC FWA, the IRB approval for this research is not accepted or approved. Contact the IRB Administrative Office at (303) 584-2300 for additional information.
The HCA-HealthONE IRB has been designated as an IRB for the following organizations who have obtained their own Federal Wide Assurance (FWA) and have completed an IRB Authorization Agreement:
- Colorado Neurological Institute (CNI)
- Craig Hospital
- Rocky Mountain Cancer Centers
- Colorado Multiple Institutional Review Board (COMIRB)
- National Jewish Health
- Lincoln Surgery Center
- Rocky Mountain Surgery Center
- Outpatient Surgery Center of Lakewood, L.P.
- Denver Cyberknife
- Fertility Laboratories of Colorado
- The Urology Center of Colorado
The HCA-HealthONE LLC holds a Federal Wide Assurance from the Office for Human Subject Protection (OHRP) in the Department of Health and Human Services (HHS). An FWA is required for any institution that is engaged in human subjects research that is not otherwise exempt, which is conducted or supported by any agency of the U.S. Department of Health and Human Services (HHS).
A FWA is an assurance of compliance with HHS regulation pertaining to the protection of human subjects.
Assurance Identification No. FWA00002864
Expiration date 12/15/2019
To view the HCA-HealthONE FWA information, go to the OHRP website. Select the Assurance (FWAs) radio button for document type. Enter FWA Number: 00002864.
The HCA-HealthONE IRB is responsible for research conducted in the following HCA-HealthONE facilities:
- Presbyterian/St. Luke’s Medical Center
- Rose Medical Center
- Swedish Medical Center
- Sky Ridge Medical Center
- The Medical Center of Aurora
- North Suburban Medical Center
- Spalding Rehabilitation Hospital
- Swedish Southwest ER
- HealthONE Clinic Services