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.

RAMS-IRB

VCU uses an electronic protocol management system to manage IRB review. This system is called RAMS-IRB. 

Each submission within RAMS-IRB consists of a "smartform," which is all the questions used to capture the information necessary to carry out IRB review. We call it a smartform because it uses branching logic to populate questions and pages based on the responses to earlier questions, and it provides the user with an experience similar to filling out an online form. 

You can access RAMS-IRB by clicking the button below. 

Submit to the IRB

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 RAMS-IRB. You can learn more about the VPN by visiting the Ask IT website for the VPN.

Access our researcher-focused RAMS gif guides on the HRPP blog to learn how to navigate RAMS-IRB to create and manage submissions by using the researcher gif guides tag. These guides use a combination of narrative instructions and animated gif images to illustrate common navigation processes in RAMS-IRB.

Click on the links below to access resources that will help you learn to navigate RAMS-IRB and how to complete the smartform:

• RAMS-IRB researcher gif guides
  These guides use a combination of narrative instructions and animated gif images to illustrate common navigation processes in RAMS-IRB
• RAMS-IRB researcher video walkthroughs
  These video walkthroughs illustrate common navigation processes in RAMS-IRB

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

Level of review

In your submission in RAMS-IRB, you will be asked to request one of the three levels of review. You can learn more about each of these levels of review by going to our Types of Review webpage, or by viewing this Detailed comparison chart. 

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 Reliance website for more information on single IRB review/IRB reliance.

Templates

The VCU IRB offers a variety of consent templates for different types of studies and different types of circumstances, as well as templates for other study documents. Our templates can be found in the IRB section of OVPRI’s forms webpage.

A protocol template is not provided by the IRB because the RAMS-IRB smartform takes the place of the protocol. The Wright Center for Clinical and Translational Research offers support with developing research protocols. Visit their protocol support webpage for more information. 

When does the IRB meet?

Full board reviews: The IRB generally meets on a weekly basis. Research submissions are assigned to the next available IRB meeting. Assignment of new submissions to a meeting is dependent on factors that include the nature of the submission, the quality of the submission and the number of submissions already assigned to that meeting for review.

Expedited and exempt reviews: Expedited and exempt research is reviewed on an ongoing basis by a single IRB reviewer. There are no deadlines for initial submissions. Deadlines for review of ongoing studies are communicated via email. If you have specific deadlines for an initial review, communicate this to your IRB coordinator as soon as possible after submitting.

WCG IRB: WCG IRB reviews all industry sponsored research. Please contact WCG IRB for information regarding deadlines and meeting dates.

Other external IRBs: Please contact the reviewing IRB for information regarding deadlines and meeting dates.

Policies and guidance

The VCU IRB is required to have written policies and procedures detailing how we operationalize the regulations. These policies and the additional guidance we have available on special topics (such as vulnerable populations, genetics research, limited English proficiency subjects and so on) will assist you in preparing your IRB submission.

You can access our policies and special guidance on our Policies and Guidance webpage.

Once you have completed your IRB submission, the principal investigator should utilize the “Submit” button in RAMS-IRB to submit the study for IRB review. (Refer to the RAMS-IRB Guide for Researchers above for instructions.) 

Flowchart of the IRB review process - an illustration from the point the PI submits the study through approval. 
Alternative text for the flowchart.

For students/trainees/residents/fellows/postdocs submitting their research projects: At VCU, students/trainees (including residents and postdocs) are not eligible to serve as PIs on their own projects. The student/trainee must designate a qualified PI in the RAMS-IRB submission. To learn more about who is qualified to serve as a PI, refer to VCU WPP IX-1 (see Page 121).

Note: When a study is first submitted to the IRB for review, only the individual listed as the PI in RAMS-IRB will be able to use the “submit” button to submit the study. If the study is sent back for changes, anyone listed as the PI or a protocol editor may use the “submit” button to resubmit changes. It is only the initial submission that must be done by the PI.

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.

The IRB also offers resources for maintaining good study records. See the Study Conduct Toolkit: Regulatory binder resources.

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.

VCU IRB oversight may end (following a request for closure) only when ALL of the following conditions are met:

• The research is permanently closed to enrollment at the site(s) under the VCU IRB approval.
• All interactions/interventions with subjects, or access to a subject’s personally identifiable information (including identifiable biological specimens) for the purpose of research data collection is complete.
• All use, study and/or analysis of identifiable private information at the research site(s) under the VCU IRB approval is complete.

Closure of a study must be requested within RAMS-IRB and must be reviewed and acknowledged by the IRB before the study is officially closed. 

Learn more about closures and how to submit a closure request in RAMS-IRB by visiting our Other submissions and monitoring webpage.

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.