Institutional Review Board

One of the many ways the Virginia Department of Health (VDH) serves the public and fulfills its mission is through research. VDH frequently conducts research that involves human subjects, and the protection of human subjects is as important as the methodology, research findings, or any other component of the research project.

VDH has developed policies and procedures to ensure that the rights and welfare of human subjects involved in research are protected and consistent with both State (12 VAC 5-20-10) and Federal (45 CFR Part 46) regulations. The Office for Human Research Protections (OHRP), under the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Health, is responsible for ensuring the safety and welfare of people who participate in HHS-sponsored research. Policies, guidelines, regulations and ethical principles from OHRP provided the framework for the development of the Virginia regulations, and provide the structure for VDH review and approval of human subjects research.

A major component of the process for ensuring the protection of the rights and welfare of human subjects involved in VDH research is the Institutional Review Board (IRB), also known as the research review committee. Research protocols must be either approved or granted an exemption by the IRB before human subjects can begin participation. The IRB also conducts continuing review of each approved protocol at least annually. The IRB may modify, suspend or terminate approval of research that has been associated with serious harm to subjects or is not being conducted in accord with the IRB's decisions, stipulations, and requirements.

Determination of the Need for IRB Review and Types of Review

In general, any research that is conducted by VDH, by outside investigators in collaboration with VDH, or by outside investigators using VDH data, is subject to review and approval by the VDH Institutional Review Board. However, not all studies require IRB review. In brief, the decision-making process is divided into four key decision steps:

Step 1: Does the project involve human subjects?
Step 2: Is the project considered research?
Step 3: Does the project qualify for exemption review?
Step 4: Does the project qualify for expedited review?

Each step is outlined in a flow diagram that can be found in the VDH IRB Guidelines and Procedures Manual.

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All forms and documents should be submitted to:

Office of Minority Health and Public Health Policy/Institutional Review Board,
Virginia Department of Health
109 Governor Street, 10th Floor East
P.O. Box 2448
Richmond, VA 23218-2448

For electronic submissions, questions or additional information, please contact:

Kathy H. Wibberly, Ph.D., Chair of the VDH IRB
Phone: (804) 864-7426
Fax: (804) 864-7440
E-mail: Kathy.Wibberly@vdh.virginia.gov

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