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VCOM Carolinas Campus

Charge, Policy and Procedures

The function of the VCOM Institutional Review Board is the prospective and continuing review and approval of all VCOM research involving human participants.  The committee’s purpose is to ensure that the rights and welfare of research participants are adequately protected, and that all activities involving human subjects are in compliance with federal regulations and VCOM policy.

The committee is charged with the authority for reviewing all research involving human subjects that are conducted at VCOM facilities or by VCOM faculty, staff or students at any location. All research that involves human subjects are reviewed at intervals appropriate to the degree of risk. The committee may approve research with or without modifications, or may withhold approval of all or any portion of a research protocol.

The VCOM IRB is empowered to review suspected violations of federal regulations or VCOM policy, complaints from participants, protocol violations as well as other non-compliance issues that may potential involve risks to participants or others.  The committee also has the authority to suspend or terminate a project should review find violations or non-compliance.  This authority is vested by the Provost, Dean and Executive Vice President of the college.

While the IRB is authorized to review, approve and disapprove research involving human subjects, the protection of research subjects from unnecessary or unacceptable risks is a responsibility of the entire college. The primary responsibility falls upon the investigators who are conducting the research. Nonetheless, other persons not directly involved (faculty colleagues, reviewers, division heads, etc.) share in the responsibility to establish and maintain an atmosphere where respect for the rights of individuals and compliance with applicable regulations is the standard.

IRB Policy and Procedures

Policy and guidance governing human subject research, the protection of participants and the organization and conduct of the IRB is developed and maintained by IRB administration under the guidance of federal requirements (45.CFR.4621.CFR.50, and 21.CFR.56).

Policies are updated on a regular basis to ensure compliance with current requirements. Please make sure you are using the latest versions, which are available in the VCOM Institutional Policy and Procedure Handbook.  Below is a list of the IRB policies and procedures.  The research-related policies are grouped together and are searchable via the interactive table of contents.

VCOM Institutional Policy and Procedure Handbook (PDF)

Policy Number Policy Description


VCOM Institutional Review Board Policies and Procedures


Institutional Review Board Self-Assessment


Emergency Use of a Test Article


IRB Member Conflict of Interest


IRB Administrative Fees for Protocol Review


VCOM Policy on Compliance Auditing


IRB Guidance on Research Limited to Retrospective Medical Records Review


Procedure on Conducting and Documenting Continuing Review


Procedure on Central Institutional Review Board (CIRB) Facilitated Review


Procedure on IRB Review of Applications for HHS Support


Procedure for Obtaining Informed Consent


Procedure on Reporting of Compliance Audit Review Standard Operating Procedure


Procedure on Review of Investigational Device Protocols

R016 VCOM Policy on Case Reports and Case Series