Welcome to the Cape Fear Valley Health Institutional System Human Research Protection Program (HRPP) is to protect the rights, welfare, and privacy of all individuals participating in research conduct at all Cape Fear Valley Health System entities. The Institutional Review Board (IRB) is responsible for the determination, approval, and continued oversight of human subject research protocols.
CFVH employees can locate further information on the HRPP/IRB website found on Cape Fear Valley Health System infoweb. IRB Regulatory Information
Policies & Procedures
- Human Research Protection Program Plan
- Financial Conflict of Interest in Research
- Human Research Protection Program Compliance
Research Subjects & Participants at CFVH
Cape Fear Valley Health System respects your decision to participate or not to participate in a research project. Research participation is voluntary, and you may choose to not participate or stop participation at any time. Your decision will not affect your current or future relations with Cape Fear Valley Health System.
Participant/Patient Rights
All members of the surrounding Cumberland County area and the surrounding rural communities in North Carolina may have the opportunity to participate in research currently taking place at Cape Fear Valley Health System. Research includes both National and Regional participants. Participation usually involves survey completion, interviews, clinic visits or may be a component in the treatment plan for your disease or condition.
The risk involved in a project depends upon its design, subject matter, methodology, and interactions or intervention with participants. It is important to consider the level of risks and compare the risks to any benefits when choosing to participate or not participate in human subjects research. If you have any questions regarding research participant rights, please contact the Research Subject Advocate.
The investigator conducting the research project should provide you with answers to specific questions about the project. You may contact the Investigator or their research team with questions at any time before, during or after the research project.
If you would like to obtain information about a research project, or if you have questions, concerns, or complaints or which to discuss problems or your tights as a research subject with someone unaffiliated with the research project, please contact the IRB Office directly or you may use the HRPP/IRB Form: Research Concerns or Complaints.
Contacts
Shawn Leming, BA, CIP
Research Subject Advocate
910-615-5839
sleming@capefearvally.com
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
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
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