Determination of IRB Review

Human Subject Research

Not all research requires IRB review. However, any human subject research is usually subject to review and approval by the VDH IRB. This includes:

• Research conducted by VDH
• Research conducted by outside investigators in collaboration with VDH
• Research conducted by outside investigators using VDH data.

Decision-Making Process

In brief, the decision-making process is divided into five key decision steps:

1. Is the project considered research?
2. Does the project involve human subjects?
3. Does the project qualify for exemption review?
4. Does the project qualify for expedited review?
5. May informed consent and/or its documentation be waived or altered?

IRB Decision Charts & Guidance

• Office for Human Research Protections (OHRP) Decision Charts – developed to provide guidance for institutional review boards (IRBs), investigators and others on whether an activity is research involving human subjects that must be reviewed by an IRB.
• Council of State and Territorial Epidemiologists (CSTE) Public Health Practice versus Research – There is frequently a gray area between public health practice and research. Although consensus has not yet been reached on this issue, this report provides helpful guidance.