The purpose of the IRB review is to assist Radford researchers as they prepare a human subjects research protocol that is compliant with federal, state, and local regulations, Radford University policy, and ethical standards. IRB protocol review is based on federal regulations 45 CFR 46 and Radford IRB Policies & Procedures. Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group and includes a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d).
For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts.
Planning Your IRB Application
One of the questions frequently asked of the Radford University IRB office is, “When will my IRB protocol be reviewed?” or “How long will it take for my IRB protocol to be approved?” Protocols are reviewed on a first-come, first-served basis year-round. While the time for IRB review will vary, it typically takes 4-6 weeks from submission for the initial review of a protocol to occur.
Most protocol applications are not approved on their first submission due to information that is incomplete or needs clarification. It is important to remember to carefully read each question on the IRB application and respond to each question. Many times, an IRB application will be returned by the IRB office to the PI for revisions following IRB review due to an incomplete response(s) to questions in the IRB application or lack of required documents for the project.
In those cases, the Radford University IRB office will return the protocol to the PI for revisions. Once revisions are submitted, the protocol application is again reviewed in the order it was received.
Please note: Until you receive final approval from the Radford University IRB office, you may not begin your research. This includes the recruitment of study participants.
A researcher may contact the Radford University IRB office to request an “expedited” review of their protocol. "Expedited" does not necessarily mean the review is fast. Rather, an expedited study is a technical term in the IRB world which means your study is no more than minimal risk and meets conditions found in 45 CFR 46.110.
Under expedited review, the review may be carried out by the IRB Chair or by one or more experienced IRB reviewers designated by the Chair. This review may exercise all of the authorities of the IRB except this reviewer may not disapprove of the research. What the researcher may mean to say instead is, “Can you rush my protocol to the front of the review queue?” Unless the request will immediately affect a participant’s well-being, the answer is usually no. It is a matter of justice and equity for your fellow Radford University researchers who are also waiting for their protocol to be reviewed.
If Your IRB Application Needs to be Reviewed by the Full Board
If your IRB application needs to be reviewed by the Full Board at a monthly meeting, the PI and student (if applicable) will be notified and sent an invitation to attend the meeting. While it is not mandatory for the PI and student to attend the IRB meeting, the Board has found it helpful to resolve any outstanding points of clarification to provide an adequate review and assist the researcher in the review and approval process.
If the application is related to a student project and there are conflicts related to the ability of the PI/Radford University faculty member to attend the regularly scheduled IRB meeting, the IRB application may be deferred until the following month's IRB meeting to accommodate schedules.