Determination of IRB Review

In general, any human subjects 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 five key decision steps:

Step 1: Is the project considered research?

Step 2: Does the project involve human subjects?

Step 3: Does the project qualify for exemption review?

Step 4: Does the project qualify for expedited review?

Step 5: May informed consent and/or its documentation be waived or altered?

The following is a link to the 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 under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46:

There is frequently a gray area between public health practice and research. Although consensus has not yet been reached on this issue, the following report on public health practice vs. research by the Council of State and Territorial Epidemiologists (CSTE) is a good source for guidance: