IRB Application

1. Review the training requirements
   • All individuals listed on the study protocol must complete CITI training and provide CVs.
2. Review the submission instructions and checklist
3. Complete the AHS-IRB application form. Submit a signed copy and appropriate attachments to the IRB office. In order to process the application, the IRB must receive signatures from all Investigators listed on the study.

If the researcher is a student, the faculty advisor must be identified as the Principal Investigator and must also sign the application forms.

• Depending on the type of research, approvals by other UMKC compliance committees, such as IBC or RSC, may be required before research can be initiated.

• If you believe your activity is not research involving human subjects complete the Human Subjects Research Determination Form.
• If you believe your activity is Human Subjects Research but is likely to be classified as "exempt", complete the Application for Exemption. 

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Supporting Documentation

You may also need the following documents to prepare your IRB application.

• Additional Research Team Members Form
• Additional Study Location Agreement
• Adult Health Consent Form Template
• AHS Genetic Consent Form Template with guidance
• Amendment Submission Form
• Event Reporting Form
• Financial Disclosure Form
• Genomic Consent Form Template
• Progress Report Form (non-exempt research)
• Protocol Violation Form

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Reference Documents

• Algorithm to determine whether an 'event' is a reportable 'Severe Adverse Event'
• SAE Guidance from the Office of Human Research Compliance (OHRP)
• Glossary of Medical-to-Lay Terms
• Commonly Used IRB Terms and Definitions
• Agreement Form for Research Involving Coded Private Information or Biological Specimens with OHRP guidance
• IRB Funding Update Form

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Fees for IRB Proposal Review

There are no fees for the review of the following research conducted by UMKC, Truman Medical Center (TMC), and Children’s Mercy Hospital (CMH) staff:

• Unfunded research
• Federally funded research
• Foundation funded research