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Welcome
The Institutional Review Board (IRB) at VCU is charged with reviewing all research protocols involving humans to ensure compliance with federal, state, and local regulations. The IRB must review and approve all activities that meet the definition of both 'human subjects' and 'research' before work may begin. Specialized training is required for individuals conducting research involving human subjects.
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Updates
**NOTE: The DHHS Office of Human Research Protections (OHRP) has recently re-designed its website. We are aware that many links are being updated and, as a result, links to OHRP webpages within our documents may be broken. To link to specific OHRP webpages, please go to the main OHRP page - http://www.hhs.gov/ohrp/ - and use the menu to navigate to OHRP resources cited in VCU IRB materials or use key words with the search function.
IRB Updates
(Effective June 1, 2011)
Updated Forms (Effective 6/1/11)
A number of VCU IRB forms have been updated. The most current versions of all IRB forms are posted on the ORSP Forms page, at http://www.research.vcu.edu/forms/vcuirb.htm. Investigators and Staff are reminded to use the most up-to-date versions of all forms. For investigators who are currently in the process of preparing a submission, we accept the most recent prior versions for 30 days following the effective date of updated forms.
Revised Procedures for Identifying and Making Changes to Study Personnel (Effective 6/1/11)
The IRB has made a change in the way information about study personnel is collected and maintained. This change will reduce the burden to investigators when submitting requests for personnel changes.
With the new procedure, research personnel (with the exception of the principal investigator) will no longer be listed on the research plan. Investigators will now use the new Study Personnel Roster to list all “engaged” personnel. To request addition or removal of study personnel, investigators will submit an updated Roster, along with the new Study Personnel Information and Change Form. Revision of the Research Plan will no longer be required for personnel changes other than the PI. The Roster is intended to serve as an ongoing list of all personnel who are currently engaged in the project, as well as those who have been, but are no longer, involved. This list must be kept current throughout the approval period with the IRB and maintained in the investigator’s study documentation.
*For existing studies, this new process will be phased in at the next continuing review submission.
Below is some general information about this new process:
- VCU Initial Submissions - All initial submissions to the VCU IRB are to include a Study Personnel Roster identifying all individuals engaged in the project. In addition, a Study Personnel Information and Change Form is to be submitted for all individuals engaged in this study.
- Phase-In Process for Previously Approved Studies – Upon submission of the next continuing review*, Principal Investigators are to submit a Study Personnel Roster to the IRB. If the Roster varies from the personnel on the previously approved protocol/research plan (adding or removing personnel), also follow instructions to Add or Remove Personnel. *For existing studies, the next Continuing Review will not be approved until a Study Personnel Roster is on file.
- Add or Remove Personnel – Changes to personnel will be made using a Study Personnel Information and Change Form. This form should be accompanied by an updated Study Personnel Roster. Most changes to study personnel can be quickly reviewed by an ORSP IRB member.
- A change to the Principal Investigator also requires submission of a Change in Research Submission Form, along with a revised Research Plan and other documents referencing the Principal Investigator, and may be reviewed by primary single reviewer or referred to the full board.
Additional information and instructions are found within the Study Personnel Roster and the Study Personnel Information and Change Form. See the IRB Forms page to access these new forms for further information.
IRB Pre-Review Process for Full Board Initial Submissions
ORSP has implemented a pre-review process to strengthen human subject protections at VCU and demonstrate VCU’s commitment to continuous improvement in compliance with Federal Regulations. The pre-review, to be performed by the ORSP IRB Protocol Analyst, will review full board initial submissions for completeness and adherence to regulatory and institutional requirements. The goal of the pre-review process is to have more of the administrative, regulatory issues addressed early on in the submission process, which will allow IRB members to focus greater effort on review of research methodology and issues specific to participant protections.
With the start of the pre-review process, principal investigators are now asked to submit ONE copy of the initial submission package. PI and Department Chair signatures are NOT required on the single copy submission for pre-review. Following the pre-review, the Protocol Analyst will request that 25 copies of the revised submission package be submitted to ORSP for full committee review. PI and Department Chair signatures ARE required for the 25 copies.
When ORSP receives an initial submission for full board IRB review, the principal investigator will be notified within 24 to 48 hours that the submission is in the pre-review process. If a submission is incomplete or clarification is required, the IRB Protocol Analyst will contact the principal investigator for additional information. The pre-review checklist and template for returning comments to the investigator may be viewed on the IRB website at http://www.research.vcu.edu/irb/guidance.htm in the reviewer toolkit section. Once a submission is complete and meets preliminary regulatory requirements, the IRB Protocol Analyst will forward it to the next available IRB panel.
The Protocol Analyst also is available to consult with investigators and research coordinators who are seeking advice when designing a study and preparing the IRB application.
Questions about the pre-review process or completing an application may be directed to Nichole Haywood, IRB Protocol Analyst, at 827-2272 or nsrichar@vcu.edu.
Congratulations on AAHRPP re-accreditation! Letter from Vice President for Research (July 16, 2010) 
Modifications to Biomedical and Social-Behavioral Consent Templates
(June 15, 2010)
The Biomedical and Social-Behavioral Consent Templates have been slightly modified to reflect more meaningful language in the 'Compensation for Injury' sections. Note that this section, which represents a regulatory element for informed consent, is required for greater than minimal risk research as per §46.116(a)(6) and 21CFR50. It is not required, and generally not appropriate, for expedited research. No waiver of this element needs to be requested for minimal risk research.
For more information, see IRB WPP XI-1 at http://www.research.vcu.edu/irb/wpp/flash/XI-1.htm
Exempt Review Submission: Excerpted message from Betsy Ripley, MD, MS, Senior Chair, VCU IRB Leadership and Enhancement Committee
(November 30, 2009)
In an effort to improve the efficiency for both the investigator and the reviewer, we have streamlined the submission process for exempt research. Many of the questions currently asked are not relevant to exempt research and the detail which is asked for in the protocol is beyond that which is necessary to make an exempt determination. We have shortened both the submission form and the research plan template. Rather than two separate documents it is now one document. Other key changes you will notice are a check list for category determinations and a requirement for only the PI to sign and certify. Please note that the protocol must completely fit for one or more of the exempt categories and must not involve prisoners.
For protocols which are submitted using this shortened form but do not qualify for exempt they will be moved to expedited. You will be asked to submit the full submission form (this can be done via email). The reviewer may ask for more details in the protocol as needed to be able to review the protocol as expedited.
See IRB forms Exempt Review Submission Form (rev 9-30-10)
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(November 19, 2009)
Training requirements for CITI Refresher and Basic courses
Everyone who took the Basic CITI course(s) in the year 2007 or before will have expired status with CITI after December 31, 2009. Basic and Refresher courses through CITI are valid for 2 years, expiring at the end of the 2nd year in which the course was taken. (Taking a Refresher course now means that it expires at the end of 2011). You must have previously taken a BASIC CITI course in order to be eligible to take the Refresher course.
The CITI website can be accessed at citiprogram.org. Entering your previously used username/password will allow you to check your completion status and complete the Refresher course, if needed. The test needs to be completed at one sitting, the course does not. Each Refresher course takes less than 2 hours to complete.
If you would like to know your CITI status or to request your username/password please contact Zena Bailey, zbailey@vcu.edu. Requests will be on a first come first serve basis, please allow up to a week for a response. If you know your username and password, checking CITI status yourself is most efficient.
During the holiday break, when our office is closed (12/21/2009 - 1/4/2010), you can send your request directly to CITI at citisupport@med.miami.edu. Or you can create a new username/password to complete the course.
CITI Refresher status will be verified by IRB Intake beginning 1/4/2010. Protocols will not go forward for IRB review if the CITI Basic or Refresher status is not current.
(April 1, 2009)
NEW VCU IRB WPP: Identification and Recruitment of Research Participants
The IRB has adopted a new Written Policy and Procedure (WPP) to guide investigators and IRB reviewers regarding strategies for the identification and recruitment of research participants. In finalizing this WPP, the IRB considered helpful feedback provided by many investigators and other research personnel. As always, feedback regarding this, or any WPP, is welcome and an important part of our ongoing improvement efforts.
VCU Human Research Protections Bulletin (Spring 2009)
The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Lisa Ballance.
(February 6, 2009)
NEW DRAFT WPP Identification and Recruitment of Research Participants 
A new policy has been prepared to guide investigators and reviewers regarding strategies for the identification and recruitment of research participants. Investiator and IRB member feedback is important in this process. Please provide your comments and suggestions to lballanc@vcu.edu by February 25, 2009.
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