Welcome to our HRPP transformation journey
We are thrilled to announce a significant leap forward in our commitment to protecting human research participants through the HRPP Transformation powered by the Huron Consulting Toolkit. This transformative initiative introduces new policies, procedures, work instructions and an investigator's guide, reinforcing our dedication to excellence in research ethics and participant safety.
VCU’s Human Research Protection Program is transforming the HRPP and Institutional Review Board operations to respond to the needs and requests of the VCU research community. HRPP transformation aims 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.
You can learn more about the HRPP transformation journey below and in the March edition of the VCU HRPP newsletter.
Key components of the HRPP transformation
New policies and procedures
The HRPP now boasts a comprehensive set of updated human research protection program plans, policies and procedures aligned with the latest industry standards. These changes are designed to streamline processes, enhance clarity and ensure the highest level of ethical conduct in human research.
Investigator's guide
The new investigator's guide equips researchers with a valuable resource to navigate the complexities of the research process. This guide serves as a roadmap, providing step-by-step instructions and best practices to promote adherence to ethical standards and regulatory compliance.
Work instructions
Our detailed work instructions offer practical insights and guidance on executing research protocols within the framework of ethical and regulatory requirements. These instructions are tailored to support researchers at every stage of their projects, fostering a culture of meticulous and responsible research conduct.
Milestones achieved
Reduced turnaround time
The implementation of the Huron Consulting Toolkit has resulted in a significant reduction in turnaround time for protocol reviews and approvals. This efficiency not only accelerates the research process but also demonstrates our commitment to supporting timely and responsible research.
Quality assurance
Our HRPP transformation places a strong emphasis on quality assurance measures. Rigorous internal audits and reviews ensure that our processes meet the highest standards, providing researchers with confidence in the integrity and reliability of our human research protection program.
Robust educational opportunities
As part of the transformation, we have expanded educational opportunities for researchers, staff and the broader community. Regular training sessions, workshops and online resources aim to enhance understanding of ethical considerations and regulatory requirements, fostering a culture of continuous learning.
Enhanced community engagement
Our commitment to community engagement has been strengthened through the HRPP transformation. We actively seek input from the community, collaborate with stakeholders and communicate transparently about our research activities. This inclusive approach ensures that our research aligns with community values and concerns.
HRPP Transformation Project FAQs
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.
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.
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.
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.
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!
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.
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.
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.
Looking ahead, we remain dedicated to continuous improvement. Future initiatives include ongoing refinement of processes, regular updates to policies and procedures, and the exploration of innovative technologies to further enhance the efficiency and effectiveness of our HRPP.
We invite you to explore the resources and information on this page and to reach out with any questions or feedback. Together, we are advancing the highest standards of ethical research and human participant protection.
Thank you for being a part of our HRPP transformation journey!