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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**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.
RAMS-IRB Launch Announcement
RAMS-IRB (Research Administration Management System-IRB) will launch on August 1, 2013. This custom-designed electronic submission and review system is based on the Click Commerce platform, which has been successfully in use for IACUC protocols for more than a year and for over six months for AIRS (Conflict of Interest) reporting. The system will make it simple for investigators to view, in a single location, all studies they have approved or under review. All communications from the IRB and all approved documents will be maintained with each study in RAMS-IRB. A quick login to a study will immediately show the status of a study and where it may be in the review process. Implementation of RAMS-IRB will provide a much-needed, valuable tool for managing the IRB review and approval process.
RAMS-IRB will first be available for initial submissions to external IRBs (WIRB and NCI-CIRB) on August 1, then for VCU IRB initial submissions on August 22. Existing studies will convert to RAMS-IRB on a rolling schedule based on expiration date. Training to use the system will be offered in a variety of formats including online resources such as videos and tip sheets, hand-on training in computer labs, and group training scheduled on request. Click here to read more about the implementation schedule and training opportunities.
(Effective 9/1/12; Required 10/1/12)
Updated Forms - (Effective 9/1/12; Required 10/1/12)
A number of VCU IRB forms have been updated. When using an updated form, please review the questions and instructions carefully, as they have changed. The most current versions of all IRB forms are posted on the ORSP Forms page here. 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 one month following the new postings; use of the updated forms will be required as of 10/1/12. Below is an overview of some of the changes.
Designation of COI Investigators – (Effective 9/1/12; Required 10/1/12)
The VCU "Conflict of Interests in Research" policy was revised effective August 24, 2012. Information regarding this new policy can be viewed here. IRB processes necessary to comply with this revised Policy will be phased in at the time of Initial or Continuing Review, and will be required for all initial and continuing review submissions received on or after 10/1/12.
With the new process, the Principal Investigator must designate, via the newly revised (IRB template rev. date 9/1/12) Study Personnel Roster, which study personnel are considered a "COI Investigator". For Exempt studies, this designation will be captured on the Exempt Review Submission Form. Designated COI Investigators must ensure their reported financial interests (FI) and research relatedness, if relevant, are up to date in the Activity and Interest Reporting System (AIRS) at the time of IRB submission.
IRB approval cannot be granted until financial interest reports and a COI review are completed for all designated COI Investigators.
Below is some general information about this new process for COI Investigator designation:
- VCU Initial Submissions - All initial submissions to the VCU IRB are to include an updated Study Personnel Roster which includes COI Investigator designations.
- Phase-In Process for Previously Approved Studies – Upon submission of the next continuing review*, Principal Investigator must convert the existing Study Personnel Roster to the updated format which includes a COI Investigator designation (IRB template rev date on or after 9/1/12). If the Study Personnel Roster varies from the personnel on the previously approved Study Personnel Roster (adding or removing personnel), also follow instructions to Add or Remove Personnel. *For existing studies, the next Continuing Review will not be approved until the study has been converted to the updated Study Personnel Roster and all financial interest reports and a COI Review are complete for all COI Investigators.
- Change in PI prior to scheduled Continuing Review – If requesting a change in PI prior to the scheduled conversion to the updated Study Personnel Roster, revise the existing roster to reflect the PI change. In addition, the new PI will need to ensure that his/her reported financial interests (FI) and research relatedness, if relevant, are up to date in the Activity and Interest Reporting System (AIRS). A COI review in AIRS will be conducted for the new PI.
- Any non-VCU affiliates who have been designated as COI Investigators will need to indicate whether they are complying with the VCU COI policy or that of their own institution. Independent Investigators who are designated as COI Investigators must comply with the VCU COI policy. The PI should carefully consider whether non-VCU affiliates meet the definition of a COI Investigator when completing the Personnel Roster.
- If complying with the VCU policy, the VCU PI and PI department must ensure that all COI Investigators are entered into the VCU Affiliate database. Instructions for creating affiliate relationships can be found here. Once the names have been entered and a VCU eID is issued for each, the individuals should be instructed to log in to the VCU eRA Activities and Interests Reporting System (AIRS) to complete training and enter their financial interests.
Additional information and instructions are found within the Study Personnel Roster and other forms. See the IRB Forms page to access these new forms for further information.
Study Personnel Roster and Study Personnel Information & Change Form Instructions - (Effective 9/1/12; Required 10/1/12)
The instructions have been revised on the Study Personnel Roster and Information & Change forms. In addition to the new notation of COI Investigators on the Study Personnel Roster, the instructions have been revised to note that the Personnel Roster is to include Non-VCU affiliates (affiliated with another institution/site) and independent investigators (who have no institutional affiliation) who are also engaged but do not have IRB approval for this protocol from their own institution.
Other Form Changes - (Effective 9/1/12; Required 10/1/12)
Changes have also been made to the Initial Review Submission Form, Continuing Review Submission Form, Research Plan Template, and Exempt Review Submission Form. Changes include the addition, revision, or removal of questions, as well as updates to the instructions. When completing these forms, please review these forms carefully.
Pre-Review of Full Board Initial Submissions Resumes
Pre-review of full board initial submissions to the IRB by the ORSP Protocol Analyst will resume beginning May 1, 2012. The goal of the pre-review process is to have many of the administrative, regulatory issues addressed early on in the submission process, which will allow IRB members to focus greater effort on ensuring human participants are adequately protected.
For this pre-review, an electronic copy of all submission materials for initial full board applications should be submitted to IRBIntake@vcu.edu; the email subject line should reference "New Full Board Pre-Review". Documents should be attached in the order noted in the Number of Copies Required section of the Initial Review Submission Form. Submissions with attachments too large to send via standard email should be uploaded to FileDrop. To use FileDrop, visit https://filedrop.vcu.edu/ and click on Send a File.
PI and Department Chair signatures are NOT required on the electronic copy submitted for pre-review, but are required once paper copies are requested.
The Protocol Analyst will correspond with the PI and/or study coordinator regarding any issues that should be resolved prior to IRB review. In some cases, the Protocol Analyst may send comments embedded in the electronic application documents. Once the pre-review process is complete, the PI will be instructed to submit 25 paper copies of the application to the ORSP office. When the 25 copies are submitted, the study will be assigned to an IRB panel for full review.
Questions about the pre-review process or completing an application may be directed to Nichole Haywood, Protocol Analyst, at 827-2272 or firstname.lastname@example.org.
(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 email@example.com.
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 IRBIntake@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 firstname.lastname@example.org. 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 email@example.com by February 25, 2009.
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