Institutional Review Board

Welcome to the Cape Fear Valley Health Institutional Review Board (IRB). The role of the IRB is to provide educational leadership for research activities within the Health System and community while ensuring the protection of human research subjects. GME Research Program provides additional support to our residency and training programs by providing structured review and feedback to new researchers.

Use the Human Subjects Research Determination Worksheet for assistance on whether your project constitutes research involving human subjects, according to the regulatory definition and therefore requires review and determination or approval by the IRB.

Contacts

GME Resident and Trainee Information

The GME Research Program assists residents and students conducting scholarly activities which includes non-research activities and research activities. Please review the information below and contact the Research Program Administrator at sleming@capefearvalley.com for more information.

Training

IRB Guidance HSR Training

Instructions

• GME Resident/Student Scholarly Activities & Research Application Instructions
• GME Human Subjects Research Determination Worksheet
• GME Criteria for QI/QA Projects Checklist
• GME Scholarly Activities & Human Research Protection Training

Forms

• GME: Case Report/Series Form
• GME: Quality Improvement Form
• GME Investigator Agreement

Application Forms

• Non-Human Subjects Research Application
• Exempt Protocol Application
• Exempt Category 4 Application (Medical Records)
• IRB New Protocol Application (contact the IRB to request this)

Supplemental Application Forms

• Research Plan Template
• Attachment A: HIPAA - Use of PHI
• Investigator Agreement
• Research Personnel
• Conflict of Interest Disclosure

Informed Consent Templates

• Case Report Consent Template
• Online Survey Consent Template
• Project Information Sheet Template
• Verbal Consent Template

Guidance Library

• Human Subjects Research Determination Worksheet
• Benign Behavioral Interventions
• Determining Engagement in Research
• Case Report/Series Project
• Quality Improvement Projects
• Exempt Research Categories
• Expedited Research
• Investigator Responsibilities
• Non-Human Subject Research
• Recruitment
• Use of Advertisements
• Characteristics of Research vs Quality Improvement
• HIPAA and Human Subjects Research
• Informed Consent and Waiver/Alterations
• Medical Record/Chart Reviews
• Research Plan Guidance
• Designated Public Data Sets

Research Plan Template

• Exempt Research Plan Template