IRB Archives
Vice President for Research: AAHRPP site visit and utilizing Click Commerce for electronic submission (March 17, 2010)
IRB Member Survey Summary Report 2008 (September 24, 2008)
VCU Human Research Protections Bulletin (August 2008) (September 23, 2008)
New Requirement for CITI Refresher Course (July 29, 2008)
Revision for New Requirements for Protocol Documents (July 15, 2008)
New Requirement for Protocol Documents (June 1, 2008)
VCU Human Research Protections Bulletin (Jan-April 2008) (May 1, 2008)
Addition and revision of forms and WPPs (January 15, 2008)
VCU Human Research Protections Bulletin (December 2007) (December 18, 2007)
Protection of Research Data is an On-going Responsibility (December 4, 2007)
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)
Vice President for Research: AAHRPP site visit and utilizing Click Commerce for electronic submission (March 17, 2010)
Dear Human Research Investigators,
As part of a regular update to the investigator community, I would like to keep you informed about activities taking place within the VCU Human Research Protection Program.
VCU's Human Research Protection Program is due for re-accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an international accrediting organization. Over 200 institutions have been AAHRPP accredited. See http://aahrpp.org/ for more information about AAHRPP. VCU proudly earned accreditation in July 2007 and our re-accreditation site visit is scheduled on Tuesday, March 23rd through Thursday, March 25, 2010. There will be 4 site visitors who have set up a rigorous interview schedule over the 3 days.
Accreditation involves more than just the IRB. All aspects of the VCU Human Research Protection Program contribute to its high quality. AAHRPP emphasizes Domains that have a role in human research protections. These Domains, for the purposes of our re-accreditation, are the Institution, the Research Review Unit, Investigators, Sponsors, and Research Subjects. An extensive application that describes how VCU meets Standards under each Domain was completed in December. As a result of that submission, AAHRPP has designated many of your colleagues from all aspects of the VCU Human Research Protection Program for interviews during the site visit.
Interviews with individuals and groups are intended to validate that our human research protection practices are consistent with institutional policies, IRB Written Policies & Procedures, and the federal regulations. A sampling of the types of interviews next week include: 1) investigators who work with investigational drugs and devices, 2) investigators who conduct exempt and expedited biomedical or social-behavioral research, 3) investigators who conduct research with children, pregnant women, and the cognitively impaired, 4) research coordinators working with selected investigators, 5) General Counsel, 6) Directors of Centers and Institutes, 7) a Department Chair and Dean, 8) Directors of Scientific Review and Research Training, 9) Coordinator of the Investigational Drug Service, 10) Sponsored Programs, 11) Directors of ORSP and ORCE, 12) Chair of the COI Committee, and 13) myself, as Institutional Official. Your colleagues have graciously agreed to make themselves available to be interviewed by the AAHRPP site visitors.
At the conclusion of the site visit we will be apprised of areas that need improvement. Pending AAHRPP’s acceptance of planned modifications, we will receive word of our accreditation status in June. VCU’s high regard for ethical human subjects research that is in compliance with federal regulations has been recognized through accreditation in 2007 and I am confident that AAHRPP will once again view us positively.
- We are enthusiastic abut adopting Click Commerce as the electronic platform for research protocol submission and review. A core group of investigators, coordinators, IRB members, and IRB administrators are working hard to maintain a timeline that calls for full deployment of the electronic system by late Fall. The system is being designed to be more intuitive and stream-lined, in order to facilitate higher quality submissions and more responsive IRB reviews. We will keep you posted as the system development calls for user input.
Francis L. Macrina, Ph.D.
Edward Myers Professor of Dentistry and
Vice President for Research
Virginia Commonwealth University
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(September 24, 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.
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(September 23, 2008)
The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Lisa Ballance.
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(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
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(July 15, 2008)
REVISION TO NEW REQUIREMENTS FOR PROTOCOL DOCUMENTS
- For EXISTING studies that have a Detailed Research Protocol (e.g., Sponsor’s Protocol) AND a VCU Research Synopsis (now known as a VCU Research Plan):
- Submission of a VCU Research Synopsis/Plan will NOT be required at the time of amendment or continuing review. However, the Sponsor’s Protocol will still be required.
- This process is currently being revisited. Further information will be available in the coming months.
- For NEW studies that have a Detailed Research Protocol (e.g., Sponsor’s Protocol) AND a VCU Research Plan, and are being submitted on or after July 1, 2008:
- The previously communicated requirements are still in effect. This includes submission of BOTH a VCU Research Plan AND Detailed Research Protocol when submitting a: (1) new protocol, (2) amendment (involving changes to the VCU Research Plan or Detailed Research Protocol), or (3) continuing review report.
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(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.
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(May 1, 2008)
The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Monika Markowitz.
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(January 15, 2008)
Addition and revision of forms and WPPs
The following forms and IRB Polices (WPPs) have been added or enhanced:
- Research Synopsis: Additional information is requested describing the investigator's plan for the management and control of investigational drugs, biologics, and devices.
- IRB WPP VIII-1 "Initial Review - Exempt" has been revised to reflect federal regulations permitting retention of identifiers for some categories.
- IRB WPP VIII-7 "Required Reporting of Unanticipated Problems (UPs) Involving Risk or Harm to Subjects or Others" has been revised to reflect the prompt reporting process for UPs.
- IRB Prompt Reporting Form for UPs
 - new title
- IRB Non-Prompt Reporting Form - NEW
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 
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(December 18, 2007)
The "Bulletin" is quarterly publication to enhance communications about the VCU Human Research Protection Program. For comments or additional information, contact Monika Markowitz.
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(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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(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.
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(September 30, 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  .
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(June 26, 2007)
VCU Human Research Protection Program Earns Full Accreditation - click here for details
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(June 5, 2007)
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.
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(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
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(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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(February 12, 2007)
Revisions to forms and Written Policies & Procedures (WPPs)
Revisions have been made to several forms and to some WPPs. These revisions are largely non-substantive changes for increased clarity and to further specify the information needed for comprehensive protocol review.
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.
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(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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