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Charge, Policy & 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, but not less than once per year. 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 humans subject research, the protection of participants and the organization and conduct of the IRB are developed and maintained by IRB administration under the guidance of federal requirements (45.CFR.4621.CFR.50,and21.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.

R004

VCOM Institutional Review Board Policies and Procedures

R004A1

Institutional Review Board Self-Assessment

R004A2

Emergency Use of a Test Article

R004A3

IRB Member Conflict of Interest

R004A4

IRB Administrative Fees for Protocol Review

R004A5

VCOM Policy on Compliance Auditing

R004A6

IRB Guidance on Research Limited to Retrospective Medical Records Review

R004A7

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 on Obtaining Informed Consent

 

Procedure on Reporting of Compliance Audit Review Standard Operating Procedure

 

Procedure on Review of Investigational Device Protocols