The VCU IRB provides ethical oversight to all activities that meet the regulatory definitions of "research involving a human subject," meaning that any activity meeting both of the following definitions requires IRB review.

Definition of “research”: 

• A systematic investigation designed to develop or contribute to generalizable knowledge.

Definition of “human subject”: 

• A living individual about whom an investigator conducting research:
  • Obtains information or biospecimens through an intervention or interaction with the individual and uses, studies or analyzes the information or biospecimens
    
    OR
    
    
  • Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens

You can learn more about what these definitions mean and what activities are and are not subject to IRB review by visiting our “How do I know if I need IRB review?” page.

VCU fulfills the federal mandate to ensure all researchers involved in human subjects research are trained by requiring initial and continuing education through the Collaborative IRB Training Initiative. 

In short, all VCU personnel engaged in research must have completed VCU-specific CITI training through their VCU-affiliated CITI accounts. All research staff must complete the VCU-specific basic Human Subjects Protection course in CITI. Refresher courses may be taken after the basic course has been completed, but after three refresher courses, the basic course should be taken again.

Investigators who have completed CITI training at another institution may transfer credits for completed modules that overlap with VCU’s required CITI modules, but if any modules in the VCU-specific CITI training are outstanding after the transfer, these must be completed as well. This is because VCU may require certain CITI modules that other institutions do not require. 

Learn more about required initial training and continuing education requirements on our CITI requirements webpage. This webpage also contains instructions for adding courses to your account and affiliating your account with multiple institutions (which is necessary to transfer credits for completed modules in CITI to count toward the VCU-specific CITI training course). 

In addition to training requirements, your IRB submission will ask you to designate individuals as conflict of interest investigators, and these are the individuals who will need to complete financial interest disclosures and undergo conflict of interest (COI) review.

Prior to submitting expedited or full board projects for IRB review, designated COI investigators must complete any required COI disclosures. The COI review of those disclosures may occur concurrently with IRB review, but IRB approval cannot occur until it is determined that no conflicts exist or any conflicts have been acceptably managed. 

To learn more about COI requirements, COI investigators and financial disclosures, you can visit our COI guidance page and/or the conflict of interest website.

VIRBs (VCU IRB system)

VCU uses an electronic protocol management system to manage IRB review. This system is called VIRBs (VCU IRB system). All information pertaining to VIRBs implementation can be found on the New IRB review system: VIRBs (VCU IRB system) page.

You can access VIRBs by clicking the button below. 

Access VIRBs

It is important to note that if you are off campus (or using hospital network computers), you may need to be connected to the VCU VPN to access VIRBs. You can learn more about the VPN by visiting the Ask IT website for the VPN.

Access our researcher-focused guidance on the VCU HRPP Kaltura channel.

Click on the links below to access resources that will help you learn to navigate VIRBs:

• VIRBs training (single-site): IRB 10.5 single site on Vimeo (Huron)
• Researcher's guide (pdf)
• VIRBs training (multi-site): IRB 10.5 multi-site on Vimeo (Huron)
• Multi-site guide (pdf)
• *All training videos can be found on the HRPP Kaltura channel. Dual authentication sign-on is required for access to videos in Kaltura.

To learn more about what to include in your initial submission to the IRB, visit our Type of reviews webpage. 

Single IRB review/IRB reliance

Investigators who wish to rely on an external IRB, or who are conducting research for which non-VCU sites will be relying on the VCU IRB, should visit our IRB reliance website for more information on single IRB review/IRB reliance.

Templates

Researchers should use the HRP-500 templates developed by the HRPP to build their submission in VIRBs. All updated templates can be found in the VIRBs library feature, on the HRPP policies and guidance web page and on the HRPP/IRB section of OVPRI’s forms page.

Additional templates, including short form consents, can be found in the HRPP/IRB section of OVPRI’s forms page.

Once the IRB submission is completed, the principal investigator or their "PI proxy" should submit the study for IRB review.

The following documents must be uploaded to your application:

• Study protocol
• PI C.V.

Examples of documents that must also be uploaded to if they are applicable to your project are:

• Consent and assent forms
• HIPAA form
• Investigator brochure
• Device manuals
• Recruitment materials
• Study measures (e.g. questionnaires and surveys)

Other documents may be required depending on your projects’ activities.

IRB oversight doesn't end after obtaining approval for an initial submission. There are other submissions to the IRB that happen during the life of a study, such as problem reporting, amendments, continuing reviews and closure requests. The IRB may also request that your study have a monitoring visit to ensure everything is going as planned. Click here to learn more about each type of submission.

You can stay in touch with the IRB by following our blog. Visit the blog to learn about upcoming events, training/education resources and receive emails with other important news and announcements.

When an expedited or full board study meets the criteria for closure, IRB oversight is no longer needed, and a study may be closed with the IRB.

To close a study the following criteria must be met:

• Study is permanently closed to enrollment OR was never open for enrollment
• All subjects have completed all study-related interventions OR not applicable
• Collection of private identifiable information is complete OR not applicable
• Analysis of private information is complete

Closure applications can be submitted via VIRBs using the "continuing review/study closure" function. 

Studies that close with the IRB are still subject to data retention and access policies for VCU. You can learn more by visiting the VCU research data ownership, retention and access policy.

Research materials and data should be maintained and destroyed in accordance with VCU’s records management policies.