IRB Archives

VCU WINTER CLOSING - IRB Instructions (December 4, 2007)
VCU Human Research Protections Bulletin (September 30, 2007)
Notice of Revisions to Selected Forms, WPPs, and Related Policy (June 30, 2007)
VCU Human Research Protection Program Earns Full Accreditation (June 26, 2007)
VCU Human Research Protections Bulletin (June 5, 2007)
VCU IRB: National Standards Survey Report (June 1, 2007)
Shift in Continuing Review Schedule (April 13, 2007)
NIH's Commitment to Protect Sensitive Data Used in Research (March 19, 2007)
Sample exempt review survey synopsis inv. a student researcher (March 18, 2007) Revisions to forms and Written Policies & Procedures (WPPs) (February 12, 2007) Update about the CITI website (January 12, 2007)

(December 4, 2007)
VCU WINTER CLOSING - IRB Instructions
The Office of Research Subjects Protection and the Office of Education and Compliance Oversight will be closed during the VCU Winter Closing (December 21 – January 1).  Despite the closing, investigators still are responsible for reporting to the IRB any serious unanticipated problems (SUPs) that occur at a VCU site during this time.  In addition, as always, investigators are responsible for taking any actions necessary to ensure the ongoing safety of research participants.

To report a serious unanticipated problem, or to seek guidance regarding any emergency situation during the Winter Closing, please call 828-0868 and leave a message including a phone number where you can be reached.  Your call will be returned. 

(September 30, 2007)
VCU Human Research Protections Bulletin (September, 2007)
The "Bulletin" is jointly prepared by the OECO and the ORSP as a quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Monika Markowitz at msmarkow@vcu.edu.

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(June 30, 2007)
Notice of Revisions to Selected Forms, WPPs, and Related Policy
A selected group of VCU IRB forms, Written Policies and Procedures (WPPs), and Reviewer Documents have been updated. In addition, the VCU Office of Research Conflict of Interest Policy has been updated. All of these changes, effective June 30, 2007, are summarized within the following PowerPoint file: 6-30-07 IRB Updates .

(June 26, 2007)
VCU Human Research Protection Program Earns Full Accreditation - click here for details

(June 5, 2007)
VCU Human Research Protections Bulletin
The VCU OECO and ORSP have jointly prepared this bulletin to be produced at least quarterly as an outreach measure for Principal Investigators, the IRB, and all of the VCU Research Community. For comments or additional information, contact Monika Markowitz at msmarkow@vcu.edu. Click here for the June, 2007 Bulletin.

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(June 1, 2007)
VCU IRB: National Standards Survey Report
The VCU ORSP and the VCU OECO jointly executed a survey of principal investigators of VCU IRB human research protocols. The survey was designed to gather specific information regarding how VCU investigators rate the VCU IRB against a nationally tested list of IRB “operational ideals”. The information collected through this survey activity is part of the institutional evaluation of the VCU Human Research Protection Program and will help facilitate research through ongoing development of processes that are customer-oriented, transparent, and fully compliant. This report describes the survey and results.

(April 13, 2007)
Shift in Continuing Review Schedule
The VCU Human Research Protection Program is pursuing accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP). AAHRPP has an area of concern regarding our continuing review practices (i.e., granting two-month approvals to allow time for PIs to respond to requests for changes). In response to their suggestion, we are modifying our continuing review cycle for full board studies (to a 10-month review cycle) to allow the IRBs to request changes (if necessary) and the PIs to respond before the studies expire.

This modification requires us to shift our continuing review schedule. Full Board Studies that expire at the end of July 2007 are the first studies that will be moved up in the review schedule. As usual, our Continuing Review Notices will indicate the due dates for your continuing review reports.

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(March 19, 2007)
Reiteration of NIH's Commitment to Protect Sensitive Data and Information Used in Research
NIH issued a reminder of its commitment to the protection of sensitive data and information used in research on March 9th. In response to security breaches at a number of institutions, especially a recent breach at a VA facility, NIH reaffirms that grantees must take reasonable measures to safeguard information entrusted to them by research participants. The VA incident involved a missing portable hard drive that was not encrypted and potentially contained information on hundreds of thousands of physicians and veterans. Link to NIH notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-054.html

(March 18, 2007)
Sample exempt review survey synopsis involving a student researcher
The first in a series of sample IRB documents has been posted - exempt review survey synopsis - under "IRB Guidance" and at the Research Synopsis Template. This sample is intended to provide guidance to investigators, research staff, and students as they complete the synopsis. Remember that for some research projects, especially social-behavioral-education projects, the 'synopsis' is the 'protocol.'

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Revisions appear on the Continuing Review and Children’s Addendum Forms that can be accessed at http://www.research.vcu.edu/forms/vcuirb.htm.

Revisions appear in quite a few WPPs. Revisions are based on AAHRPP recommendations for clarification or to better reflect current review practice. This powerpoint presentation (prepared by Lisa Ballance) gives a listing of these WPPs and provides a capsule summary of what has been revised. Again, these are largely non-substantive changes. The recommendation is to open the WPPs at http://www.research.vcu.edu/irb/wpp/flash/wpp_guide.htm and click on Table of Contents so that you can view the newest WPPs by effective date as you follow through the powerpoint.

This IRB NEWS section on the IRB website will be regularly used for human subject protection news or IRB review updates.

(January 12, 2007)
Update about the CITI website
Completion of the CITI Biomedical or Social-Behavioral Course is required of all investigators and key personnel on a protocol submitted to the IRB. The CITI website, which is housed and administered at the University of Miami, is being updated and improved. As a result, CITI has limited the number of concurrent users of the website until work is completed. One recommendation is to use CITI during off-peak hours. Please click here for further information. Thank you for your patience.

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