Office of Research Integriy

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.

Investigators

Initial Protocol Application Package

Protocol Flow Chart

Meeting Dates/Deadlines

Huntington VA Medical Center
Protocol Submission Forms

Conflict of Interest Checklist (Word PDF)

Expedited Categories 1-9

AE/SAE/Problem Report Form (Word PDF)

Consent Templates/Waivers

Continuing Review Instructions

Continuing Review Protocol
Assessment Checklist (Word PDF)

Modification Protocol
Assessment Checklist (Word PDF )

Members

IRB#1 Member List

Meeting Dates

Forms for Members

Education Requirements

Conflict of Interest Checklist (Word PDF)

Ethics Reports

The Belmont Report

Declaration of Helsinki

Nuremberg Code
(Directives for Human Experimentation)

Standard Operating Procedures

Behavioral and Social Science

Budget

Central Institutional Review Board (CIRB/PCIRB)

Complaints, Non-Compliance and Regulatory Improprieties

Confidentiality

Conflict of Interest (Investigators/Staff)

Conflict of Interest (IRB Members)

Definition of Principal Investigators and
Co-Investigators

Education and Training

Ensuring Prompt Reporting of Unanticipated Problems Involving Risks to Participants or Others

Informed Consent

Investigational Drugs/Devices

Investigator Responsibilities for Submitting IRB Documents

IRB Administration

IRB Documentation and
Record Retention

IRB Membership

Non-Member Attendance at MU IRB Meetings

Primary and Secondary Reviewer system

Quality Assurance/Quality Improvement

Recruitment and Selection of Human Subjects

Reporting Policy

Risk and Benefits

Types of Research and Types of Reviews Conducted by the IRB

Vulnerable Subjects

Regulations

HIPAA

Code of Federal Regulations

(45 CFR 46)

Links

VHA Handbook 1200.5

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