Applications for the VCU Accelerate Fundare due Feb. 1
IRB oversight doesn't end after obtaining approval for an initial submission. There are post-approval submissions such as problem reporting, amendments, continuing reviews, and closure requests. The IRB may also request post-approval monitoring of a study. Click on each of the corresponding accordions below to learn more about each type of post-approval submission and VCU's Post-Approval Monitoring and Quality Improvement Program (PAMQuIP).
All unanticipated problems must be reported to the IRB within five working days of learning of the event. Evaluating whether an event is an unanticipated problem is the responsibility of the principal investigator.
An unanticipated problem involving risk to subjects or others (UP) is any event that meets all of the following three criteria:
It is important to note that only those AEs that meet all three criteria above are unanticipated problems that need to be reported promptly to the IRB.
Read more about identifying unanticipated problems in WPP VII-6.
Noncompliance in the conduct of the research must be reported to the IRB. There may also be times when a sponsor requires reporting to the IRB or there is other information the investigator feels the IRB should know, in which case a report may be submitted to the IRB.
Once an initial submission is approved an external, non-VCU IRB such as NCI Central, Western IRB, Advarra or another academic IRB, the principal investigator is responsible for directly submitting all reportable events to that external IRB, including unanticipated problems, in accordance with that IRB's policies. All unanticipated problem determinations made by an external IRB regarding a VCU research setting should subsequently be submitted in a report to the VCU IRB via the procedure described above.
For questions regarding research reviewed by external, non-VCU IRBs contact irbreliance@vcu.edu or visit the IRB reliance webpage.
Most modifications to exempt research may be done at the discretion of the principal investigator without prior IRB approval. Some changes do require IRB approval before being implemented. For a list of changes that must be submitted to the IRB for review and approval, see the conditions of approval attached to your initial exemption letter from the IRB or refer to WPP X-1.
All proposed changes to expedited research must be submitted for IRB review and approval prior to initiating the change.
All proposed changes to full board research must be submitted for IRB review and approval prior to initiating the change. Some types of minor changes to full board studies may be reviewed in an expedited fashion by a single reviewer. This determination is made by the IRB reviewer, not the principal investigator.
If you need to amend a study to change the Principal Investigator (PI) for the study, you must submit this change in an amendment in RAMS-IRB. In addition, you must also complete the VCU IRB PI Change Instrument in REDCap. The IRB is requiring use of the REDCap PI Change Instrument because it is important for the new PI to be aware of what they are taking on when they agree to be the PI, and the RAMS-IRB system does not have a mechanism for documenting that the new PI certified to all of the PI responsibilities outlined in WPP IX-1. Instructions for use of this instrument are contained within the REDCap form.
This instrument must be used in tandem with an amendment submitted in RAMS-IRB. This instrument must be used for all studies proposing a change of PI, including exempt, expedited, and full board research that is reviewed by the VCU IRB. This instrument is not applicable to studies reviewed by an IRB other than VCU's IRB (i.e.: WIRB). When changing the PI on an externally-reviewed study, email irbreliance@vcu.edu for guidance.
Please see the RAMS-IRB researcher gif guide for details on submitting an amendment.
Once an initial submission is approved by WIRB, the principal investigator is responsible for directly submitting all future submissions to WIRB, including changes in research (amendments).
A copy of all submissions must be provided to the Human Research Protection Program via IRBIntake@vcu.edu, as well as to WIRB.
Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.
All full board research must be re-reviewed by the IRB at least annually through a continuing review process. Some, but not all, expedited research also requires continuing review. Exempt research does not require continuing review. Well in advance of an expiration date, reminders are sent to investigators prompting preparation and submission of a continuing review submission. For more information on continuing review, see WPP VIII-4.
Once an initial submission is approved by WIRB, the principal investigator is responsible for directly submitting all future submissions to WIRB, including:
A copy of all submissions must be provided to the Human Research Protection Program via IRBIntake@vcu.edu, as well as to WIRB. WIRB will send continuing review reminder notices to principal investigators. Please pay close attention to the reminders. WIRB strictly enforces deadlines.
Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.
Expedited research that does not require ongoing continuing review must submit a status update to the IRB at least annually through RAMS-IRB. Well in advance of an expiration date, reminders are sent to investigators prompting submission of a status update.
For expedited studies, investigators can tell whether their study requires continuing review by the current state listed for their study in RAMS-IRB.
Pre 2018 Common rule Continuing Review [View Image]
2018 common rule status update [View Image]
NOTE: Certain expedited studies require continuing review. If your study requires a continuing review, see accordion above titled, "Continuing review of approved IRB study."
You will receive an email with either:
If the issue(s) noted in the status update are not resolved with the VCU IRB prior to the expiration date, then the study will expire, and all research activities (including data analysis) must stop.
Allowing the study to expire may result in the IRB making a determination of noncompliance.
RAMS-IRB will not allow you to submit the status update if you indicate in your status update that the study is ready to close. You will be prompted to submit a closure request instead of a status update.
For more information about study closure, please review WPP X-4 Closure of Study from VCU IRB Oversight.
For instructions on how to submit a closure request, see next accordion panel, "Study close out."
If your status update indicates that the study has had an unanticipated problem that has not already been submitted to the IRB, you will be required to submit a report to the IRB within five working days.
The expiration date for your study will be extended by 30 days to give you time to submit the report and for the IRB to review it before the study expires.
To determine whether a problem is an unanticipated problem, the following questions should be asked:
If the answer to all three questions is yes, then the problem is an unanticipated problem and must be reported to the IRB immediately.
For more information about unanticipated problems, please review WPP VII-6 Required Reporting of Unanticipated Problems Involving Risk.
For instructions on how to submit a report, see first accordion on this page, "Problem reporting."
If your status update indicates that the study has made changes to the study protocol, procedures or study documents that have not already been approved by the VCU IRB, you will be required to submit an amendment to the IRB as soon as possible.
One of the conditions of IRB approval is that investigators must “obtain approval from the VCU IRB before implementing any changes in the approved research.” This applies for any site (VCU or non-VCU) that is under the VCU IRB’s oversight.
The expiration date for your study will be extended by 30 days to give you time to submit the amendment and for the IRB to review it before the study expires.
For more information about amendments, please review WPP VIII-5 Review of Modifications to Research.
For instructions on how to submit an amendment, see second accordion panel on this page, "Amending an approved study."
Call the IRB coordinator assigned to your study before the study’s expiration date. The IRB coordinator’s name is listed in RAMS-IRB in the header information of your study, and their direct contact information is available at Contact ORSP. You may also call the IRB’s main phone number, (804) 828-0868.
When a study meets the criteria for closure, IRB oversight is no longer needed and a study may be closed with the IRB.
VCU IRB oversight may end (following a request for closure) only when ALL of the following conditions are met:
Note regarding multicenter studies: Continuing review of the research by the VCU IRB is no longer required once the above conditions are met (following a request for closure), even if (i) interactions or interventions with subjects may be occurring at study sites other than those under the VCU IRB approval; or (ii) data analysis of identifiable private information is ongoing at another central site (site other than those under the VCU IRB approval) that collects and analyzes data from all study sites. For studies closed with the VCU IRB under these conditions, investigators may still respond to queries from the statistical center at the other institution regarding previously collected data about subjects who were enrolled under the VCU IRB approval.
As a reminder, principal investigators should retain all VCU IRB correspondence, approved documents and raw data for a minimum of five years; longer retention may be necessary based on applicable regulatory requirements and/or sponsor requirements. Refer to the VCU Research Data Ownership, Retention and Access policy and the VCU Record Retention Policy for specific requirements. Data security must be ensured even after study closure if identifiable information (including coded data) is retained.
Alternatively, a study can be closed at the time of continuing review by selecting the close study option within the continuing review activity.
Please see this RAMS-IRB researcher gif guide for details on submitting a closure request.
Once an initial submission is approved by WIRB, the principal investigator is responsible for directly submitting all future submissions to WIRB, including study closure requests.
A copy of all submissions must be provided to the Human Research Protection Program via IRBIntake@vcu.edu, as well as to WIRB.
Be aware that WIRB updates its submission forms as much as twice yearly to improve the review of research and protection of human subjects. When preparing to submit research for review, be sure to use the most current versions of WIRB submission forms by referring directly to the WIRB forms site.
The purpose of the Post-Approval Monitoring and Quality Improvement Program (PAMQuIP) is to assist the university and investigators in conducting human research of the highest ethical quality and compliant with federal, state, and local requirements. The PAMQuIP team works toward this goal by improving investigator/IRB performance through monitoring, education, and measurement of overall quality, effectiveness, and efficiency. In addition, the PAMQuIP team acts as a resource for the VCU/VCU Health research community by offering help through problem-solving tips, templates, focused educational services, external/internal audit preparation, and referrals.
For cause
Visits requested by the IRB, Human Research Protection Program (HRPP) staff, institutional officials, department chairs, etc., are generally due to concerns regarding study compliance and/or research subject rights and welfare. For-cause visits may also be initiated due to complaints, repeated errors, or a lack of responsiveness by the principal investigator to IRB/HRPP requests.
Examples of the types of for-cause reviews are:
Routine
Routine visits to studies are not initiated by any cause for concern. Studies may be selected based on any number of criteria, including:
Examples of routine visits are:
Most PAMQuip visits follow the process outlined below. Educational visits or consultations requested by the study team may have a slightly different process.
There may be communication back and forth after the visit to clarify any additional questions that arise while the report is being written.
Visits will be completed in a timely fashion and flow more smoothly if the following preparation is done prior to the scheduled visit:
The PAMQuIP team is available for education and consulting sessions, as well as assistance. PAMQuIP can:
Please use the "Schedule a consultation" button above to reserve a time to meet with a member of the PAMQuIP Team for education, consulting, or assistance. You can also contact PAMQuIP at pamquip@vcu.edu with questions or requests for additional information.
Click here to view the study conduct toolkit, which contains a wide variety of templates to assist investigators and study coordinators with study organization and conduct.
Contact us
Consultation
Schedule a consultation with IRB staff
General questions
orsp@vcu.edu
(804) 828-0868
Questions related to IRB submissions
irbpanela@vcu.edu
Questions related to single IRB, reliance agreements and/or external IRBs
irbreliance@vcu.edu
Questions related to IRB education offerings
irbeducation@vcu.edu
Questions related to Post-Approval Monitoring and Quality Improvement (PAMQuIP)
pamquip@vcu.edu
For individual staff email addresses
See Contact us page for staff directory