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The Medical IRB reviews all biomedical research involving human subjects (including VAMC and FDA-regulated research). IRB members include individuals with a broad range of expertise. The Medical IRB members are appointed by the director of the Office of Research Integrity.

All research involving the use of human subjects subject to the Marshall University Human Research Protection Program MUST be submitted to an IRB designated by Marshall University for review and approval PRIOR to initiation of the project.

Applications for medical/biological research should be submitted to IRB #1. Applications for studies that have been approved under the National Cancer Institutes Central IRB should be submitted to the MU CIRB (under IRB#1).

Forms for Investigators

Initial Protocol Application Package
Protocol Flow Chart
Meeting Dates/Deadlines
Huntington VA Medical Center Protocol Submission Forms
Conflict of Interest Checklist (WordPDF)
Expedited Categories 1-9
Closure Request Form
Adverse Event & Other Problem Report Form
Consent Templates/Waivers
Continuing Review Instructions
Continuing Review Request Form
Continuing Review Protocol Assessment Form
Modification Protocol Assessment Form
Emergency Use Letter Template

Forms for IRB Members

IRB#1 Member List
Meeting Dates
Education Requirements
Conflict of Interest Checklist (Word, PDF)
IRB Guest Non-Disclosure Agreement

Ethics Reports

The Belmont Report
Declaration of Helsinki
Nuremberg Code (Directives for Human Experimentation)

Standard Operating Procedures

Regulations

Health Insurance Portability and Accountability Act (HIPAA)
Code of Federal Regulations (45 CFR 46)

Additional Guidance

Guide For Determining When Protocols Involving Coded Private Information or Biological Specimens Meet the Federal Definition of “Human Research”

Links

VHA Handbook 1200.05