Julie Iseman, Director IRB Program

Midwest Health System IRB
600 NW Murray Road, Ste. 201
Lee’s Summit, MO 64081
Phone: (816) 246-3921
Fax: (816) 246-5013

The Midwest Health System IRB review fee is $2500 for the Life of the Study*. The review fee is due at the time of submission.

*Life of the study is from Initial Review until enrollment stops, all active and follow-up participants have completed and review data analysis is finished.

Note: If your study does not have a funding source, all fees will be waived.

• Assurance
• Financial Disclosure
• Manager Access Form
• PI Agreement
• PI Submission Check-off List IRB Manager
• Sample - Assent Form
• Sample - Consent HIV Antibody Testing

Study Submission Process
The Midwest Health System IRB meetings are held the third (3rd) Tuesday 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 Midwest Health System 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 Midwest Health System 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
• Oncologist/Hematologist
• Radiation Oncologist
• Cardiologist
• Neurologist
• OB/GYN High Risk Maternal Fetal Medicine
• Pediatrics/Neonatology
• Family Practice
• Chief Nursing Officer
• Attorney
• Pharmacists
• 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
OHRP training

Educational Resources/QI
Online Training
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Table of Contents - click on the first module

• HHS Regulation and Institutional Responsibilities
• Investigators Responsibilities & Informed Consent
• Human Research Protection Program

NIH training

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 IRB Materials:

• IRB Manager
• PI Procedure Manual
• PRIM&R
• SOPs

Federal Regulations:

• Federal Wide Assurance
• Food and Drug Administration
• National Institute of Health
• Office for Human Research Protections 

Office of Human Research Protection (OHRP)

• 45 CFR Part 46 (aka “The Common Rule”)
• 45 CFR Part 160 and 164 (164.512) 

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) 

Ethical Guidelines:

• Nuremberg Code
• Declaration of Helsinki
• Belmont Report
• Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research