HRPP Transformation Project
VCU’s Human Research Protection Program (HRPP) is transforming the HRPP and Institutional Review Board (IRB) operations to respond to the needs and requests of the VCU research community. The goal of the HRPP transformation is to streamline processes, align operations and policies with industry best practices and regulatory requirements, and improve the support provided to investigators conducting human subjects research.
To ensure an optimal outcome, VCU’s HRPP is collaborating with external consultants to achieve project goals and provide training on revised processes and procedures. You can learn more about the HRPP Transformation Project in the March edition of the VCU HRPP newsletter.
The HRPP transformation team will continue to post updates on the project in the VCU HRPP newsletter, the VCU HRPP blog, via listservs, and presentations. Please signup for the VCU HRPP newsletter if you are not already a subscriber.
HRPP Transformation Project FAQs:
Will the HRPP Transformation Project include changes to RAMS-IRB?
The RAMS-IRB system was already updated to minimize the number of questions and SmartForm pages for new initial applications and instead rely on protocol templates to obtain the information necessary for the IRB to complete their review.
A “new” RAMS-IRB system will launch in the fall and will be further streamlined to improve workflow and submission management with a goal of minimizing investigator burden.
What is the HRPP Toolkit?
The HRPP Toolkit is a comprehensive set of workflows, standard operating procedures, checklists, worksheets and templates. It is implemented by many human research protection programs of all sizes. Please see the HRPP toolkit overview deck for additional information on the components of the HRPP Toolkit.
The HRPP Toolkit includes specific resources for the research community that are designed to address management of IRB submissions through the study lifecycle, provide guidance on special topics like vulnerable populations, and protocol templates that help research teams develop and submit compliant protocols to the IRB. Currently, only the protocol templates are available for use by the VCU research community.
When should researchers use the HRPP Toolkit?
As of June 1, 2023, HRPP Toolkit protocol templates, a resource from the HRPP Toolkit, are required for use when submitting “new” initial submissions to the IRB for review. The remainder of the Toolkit will launch on July 14, 2023. Please see the VCU HRPP/IRB forms page to access the protocol templates.
How do I access the HRPP Toolkit?
The entirety of the HRPP Toolkit will be posted on the VCU HRPP website prior to the official go-live date of July 14, 2023. The new protocol templates are already available on the VCU HRPP/IRB forms page.
The “new” RAMS-IRB system is scheduled to go-live in early fall. Once the updated RAMS-IRB system is live, all HRPP Toolkit materials will be stored in the document library in the electronic system for easy access.
What training is offered for the HRPP Toolkit?
Our consultant partners from Huron have offered a series of trainings on the HRPP Toolkit and HRPP Transformation Project. Recordings are available “On-Demand” on the VCU HRPP blog.
Huron is also offering in-person training for the MCV campus on July 18th and another in-person training for the Monroe campus in August. Additional details for these trainings will be circulated via the VCU HRPP newsletter, VCU HRPP blog, and via email. If you have not done so, please sign up for the HRPP newsletter and be on the lookout for these announcements!
Why are researchers required to submit a research protocol with their submission?
Protocols are required to ensure that study teams design protocols that align with regulatory requirements, state laws, and institutional policy. The protocol templates are designed to cover all study types and any questions that are not applicable should be deleted from the template or marked as “N/A”. The comprehensive list of questions contained within the new template allows the Human Subjects Office to better determine at an early stage whether the protocol should be classified as exempt or should be routed for expedited or full committee review.
Is a protocol required for emergency use submissions?
A protocol is not required when submitting an emergency use of investigational drug, biologic, or device. However, a protocol is required for treatment use (expanded access to investigational product or treatment use); for expanded access submissions it is recommended to use the “Research project or clinical investigation” pathway in RAMS-IRB which contains fewer SmartForm pages.
For more information on emergency use requirements, including reporting use to the IRB within 5 days, see “What if I need to use an unapproved drug, biologic, or device and there is no time for IRB review?” in HRP-103 - Investigator manual in the HRPP Toolkit.
When is HRP-508 site supplement required?
HRP-508 site supplement is required for all studies involving a sponsored protocol. It is required as part of the submission to VCU when applying to rely on an external IRB. It does not need to be submitted to the external IRB unless requested by that IRB.
If you have questions, please reach out to a member of the VCU HRPP transformation team:
Sandy Brooks, DPS
Human subjects protection
Human subjects protection