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

On April 1, 2013, the Midwest Health System 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.

• Assurance
• 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 Midwest Health System 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 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
Login In
User Information
Continue
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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** 
• *To view the Midwest Health System 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) 

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