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.
Updates
(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.
(September 24, 2008) IRB Member Survey Summary Report 2008 In May of 2008, VCU conducted a survey of the IRB members aimed at collecting information that would help with member recruitment and retention.
(September 23, 2008) VCU Human Research Protections Bulletin (August 2008) The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Lisa Ballance.
(July 29, 2008) New Requirement for CITI Refresher Course Consistent with national best practice, VCU is transitioning to required continuing education in human research protections. VCU uses the Collaborative IRB Training Initiative (CITI) out of the University of Miami for baseline human research protection education. The Basic course in either Biomedical or Social-Behavioral Research has been required of all investigators and key personnel in order for their protocol to be reviewed by the IRB and to verify training in research ethics to sponsors.
Effective January 1, 2009, completion of the CITI Refresher course in Biomedical or Social-Behavioral Research will be required by investigators and key personnel who took the Basic course prior to or during the year 2006. Completion of this requirement is verified after January 1st upon submission to the IRB or upon request of the Office of Sponsored Programs. For new investigators and key personnel, or those new to VCU (from an institution that did not utilize CITI), completion of the Basic CITI course continues to be required at the time of IRB submission. The Basic CITI will expire at the end of 2009 for those who completed it any time in 2007. It expires at the end of 2010 for those completing in 2008. Note that a printed completion date that does not confom to these requirements is no longer applicable.
The Refresher course will expire 2 years after completion, at the end of the year. It is highly recommended that you retain your CITI completion record. The Refresher course takes about 2 hours to complete and can be accomplished in multiple sittings. CEU/CME credits for the Refresher course are available for a fee.
More information about the new Refresher requirement and accessing CITI is available on the VCU IRB website at: http://www.research.vcu.edu/irb/education.htm
(July 15, 2008) REVISION TO NEW REQUIREMENTS FOR PROTOCOL DOCUMENTS
(June 1, 2008) NEW REQUIREMENT FOR PROTOCOL DOCUMENTS Effective June 1, 2008, the VCU IRB is adopting a new format and submission requirement for protocol documents to more effectively address both OHRP and AAHRPP requirements. This format will require submission of a VCU Research Plan (formerly known as Research Synopsis) AND Sponsor’s protocol (if applicable) when submitting a: (1) new protocol, (2) amendment (involving changes to the Sponsor’s protocol or VCU Research Synopsis/Research Plan), or (3) continuing review report. Prior to this date, when there was a Sponsor’s Protocol, the VCU IRB may not have required submission of a Research Synopsis except at the time of initial review. This policy has changed, and the Research Plan must now be updated and maintained.
TIMELINE FOR IMPLEMENTATION While this policy is effective June 1, 2008, it will not be mandatory until: New Protocols - July 1, 2008 Protocol Amendments and Continuing Review Reports - August 1, 2008
NOTE: For existing studies which utilized an earlier template of the Research Synopsis, investigators are not required to use the new Research Plan template. HOWEVER, the Research Synopsis (now known as Research Plan) MUST be updated to reflect the current protocol, including any amendments submitted after the initial review. The Research Synopsis/Plan may reference the Sponsor’s protocol and cite appropriate page numbers. If the Sponsor’s protocol does not provide all of the information required in each Section Heading, then this information must be provided in the Research Synopsis/Plan.
(May 1, 2008) VCU Human Research Protections Bulletin (Jan-April 2008) The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Monika Markowitz.
(January 15, 2008) Addition and revision of forms and WPPs
The following forms and IRB Polices (WPPs) have been added or enhanced:
Click on the following Powerpoint tutorial for more information about the reporting process and reporting forms: IRB Evaluation of Unanticipated Problems (UPs) Involving Risk in Research: Reporting Forms and WPP
(December 18, 2007) VCU Human Research Protections Bulletin (December 2007) The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Monika Markowitz.
(December 4, 2007) PROTECTION of RESEARCH DATA is an ON-GOING RESPONSIBILITY A letter from the Vice President for Research reminding investigators and research staff to safeguard personal and identifiable data at all stages of research (from preparatory work through data storage). Click here to view the letter .
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