The HCA Midwest Health's Institutional Review Board (IRB) was established in 2008 for the purpose of reviewing studies for institutional (HCA-Midwest) affiliated researchers. The IRB is owned and operated by HCA Midwest Health.
The research reviewed by the HCA Midwest Health IRB is guided by the ethical principles for all research involving humans as subjects and abides by:
- The Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, and
- The Common Rules 45 CFR 46 and 21 CFR 56
The HCA Midwest Health IRB approval and registration was completed by OHRP on June 10, 2008. The assigned registration number by The Office of Human Research Protection is IRB00006581.
Julie Iseman, Director IRB Program
HCA Midwest Health IRB
600 NW Murray Road, Ste. 201
Lee’s Summit, MO 64081
Phone: (816) 246-3921
Fax: (816) 246-5013
On April 1, 2013, the HCA Midwest Health IRB Office will use the following fee structure for protocols that are industry sponsored and submitted on or after this date. Studies approved prior to April 1, 2013 will not be subject to the new fees.
Initial Review of the Research Fee: Initial review encompasses the review of the research protocol, qualifications of the investigator, associated consent forms, protocol-related advertisements, questionnaires, screening scripts, and other submitted materials: $2,500
Continuing Review Fee: IRBs must review ongoing research at least annually. The protocol is reviewed on an annual basis, or more frequently as directed by the Board: $1,000
Changes to Research Fee: Modifications to research such as protocol amendments, revised protocols, updates to consent forms, and new recruitment or retention materials, change of Principal Investigator or Sub-Investigator incur a Changes to Research fee. The change in research fee applies each time Board review and preparation of regulatory documentation is required for a research site: $250
There is no charge for administrative modifications (i.e., study personnel changes, or site additions) or submission of reportable events (i.e., unanticipated problems, adverse event/serious adverse event, protocol deviation)
If your study does not have a funding source, the Board will consider waiving the review fee on a case by case basis.
- Elements of a Research Protocol
- Financial Disclosure
- HIPAA Consent Elements
- Informed Consent Guidance Document
- Informed Consent Guidance Document (Sample)
- Manager Access Form
- PI Agreement
- PI Submission Check-off List IRB Manager
- Regulatory Binder
- Sample - Assent Form
- Sample - Consent HIV Antibody Testing
Study Submission Process
The HCA Midwest Health IRB meetings are held the third (3rd) Wednesday of every month. Submission deadlines are the first (1st) day of the month prior to the meeting. This will ensure our staff and IRB members have enough time to thoroughly review each study.
Each study submission will be reviewed by the IRB staff for required documentation. You will receive an email indicating that your study is either ready to be presented to the IRB members or that additional specific information is required.
New Study Submission
Submit new studies utilizing the HCA Midwest Health electronic submission process, which can be accessed here. The instructions manual for entering new a study into IRB Manager can be found here.
Existing Study Submission
Continuing reviews, amendments/addendums, serious adverse events/unanticipated problems, and safety reports/DSMB reports will all be submitted electronically here. A complete list of all applicable submission documents can be found by accessing the PI checklist.
Larry Cordell, MD, is the Chairman of the HCA Midwest Health IRB. Dr. Cordell is a long standing member of the medical community. His medical expertise is held in high esteem.
The IRB Membership consists of the following disciplines:
- Orthopedic Surgeon
- Radiation Oncologist
- OB/GYN High Risk Maternal Fetal Medicine
- Family Practice
- Chief Nursing Officer
- Social Worker
- Community Members
IRB rosters may be obtained by contacting the IRB office.
- Board Member Training
- Research Admin Training
The Midwest Health System requires that every Principal Investigator, Sub/Co-Investigator, and Research Coordinator receive online training in human research protections every two years.
The IRB utilizes the OHRP and the NIH training modules to administer and track the online training.
Basic Learner Instructions
Table of Contents - click on the first module
- HHS Regulation and Institutional Responsibilities
- Investigators Responsibilities & Informed Consent
- Human Research Protection Program
Educational Materials (left side of page)
Protecting Human Research Participants
Protecting Human Research Participants (PHRP)
New Registration (enter your information and create password
HCA Midwest Health IRB Materials:
- Federal Wide Assurance*
- Food and Drug Administration
- National Institute of Health
- Office for Human Research Protections**
- *To view the HCA Midwest Health FWA information, go to the OHRP website. Select the Assurances (FWAs) radio button for document type. Enter FWA Number: 00013422
- **Formerly the Office for Protection from Research Risks (OPRR). OHRP has primary responsibility for developing, monitoring and overseeing compliance with Health and Human Services (HHS) regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services, including the National Institutes of Health (NIH).
Office of Human Research Protection (OHRP)
- 45 CFR Part 46 (aka “The Common Rule”)
- DHHS Regulations
- 45 CFR Part 46 (aka “The Common Rule”)
- Guidance Documents
Food and Drug Administration (FDA)
- 21 CFR Part 50 Human Subjects Protections (Informed Consent) and Additional Safeguards for Children in Clinical Investigations
- 21CFR Part 56 Institutional Review Boards
- 21 CFR Part 312 Investigational New Drug Application (INDs)
- 21CFR Part 812 Investigational Device Exemptions (IDE)