OVPRI Human Subject Research Protection Blog

The VCU Human Research Protection Program is dedicated to facilitating ethically and scientifically sound research through robust review of research projects and through effective education and outreach to the VCU research community.

VCU HRPP Annual Conference 2022 – Research Ethics: Past, Present, and Future on September 29, 2022

The VCU Human Research Protection Program (HRPP) is pleased to announce registration is now open for our annual conference to be held on Thursday, September 29, 2022, from 9:00am-3:00pm via Zoom. The event is free of charge and all members of the VCU research community are encouraged to attend and invite colleagues from other institutions.   The […]

Guidance Regarding Emergency Use and Expanded Access Protocols During a Public Health Emergency

During public health emergencies, it is common for new drugs, biologics, and therapies to be used under Emergency Use and Expanded Access protocols. As the number of cases of monkeypox continues to rise, the VCU HRPP would like to direct investigators to the available guidance on Emergency Use and Expanded Access protocols. For guidance on […]

Navigating RAMS-IRB to Communicate with IRB Staff and Reviewers

This RAMS Gif Guide is intended for researchers and research teams using the RAMS-IRB system to manage IRB submissions. This guide will walk users through the best ways to communicate with IRB staff and reviewers within RAMS-IRB, during a review. You can access more RAMS Gif Guides made for researchers by using the researcher gif guide […]

Delay in Protocol Screening for External IRB Reviews

Hello Esteemed Colleagues, During the next several weeks, the Human Research Protections Program (HRPP) will be undergoing a few changes in personnel that may impact the timeline for screening submissions pertaining to external IRB reviews and reliance agreements. Mr. Logan Clary, the IRB Reliance Coordinator, will be moving on to a new opportunity, and his […]

RAMS-IRB will be patched 7/27/2022 6pm

As a reminder, the RAMS-IRB system will be patched tonight (7/27/2022) from approximately 6pm – 9pm EDT. Be sure to save your work before the system goes down. For a description of what updates are included in this patch, please refer to the summary of the changes below: Please contact the assigned IRB coordinator for your […]

Wright Center Virtual Consulting Hours

Have questions about conducting research projects? Visit the Wright Center open consulting hours to get assistance from the inception of your project through to data analysis! Consulting hours will be held virtually on Monday, August 1st, from 10am until 1pm. Get more information here: https://redcap.vcu.edu/surveys/?s=9PEXYCJTYN For questions, please contact the Education & Outreach Manager at […]

New Guidance for Investigators using Juul Products in Their Research

On Thursday, June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Juul Labs, Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. This will impact some of the research that takes place at […]

Education & Outreach Perspectives: Effectively Interacting with the HRPP/IRB

By Nyssa Towsley, MS, CIP; Education & Outreach Manager, Human Research Protection Program The VCU HRPP recognizes that the process of undergoing IRB review can be a stressful experience for investigators. It is easy to become overwhelmed or feel defensive during an extensive external review process. Complex and heightened emotions can come with external review […]

HRPP Director Perspectives: Interacting with the HRPP/IRB

By Sanjur (Sandy) Brooks, DPS, MA; Director, Human Research Protections Program In response to the rapidly changing nature of the research enterprise, Human Research Protection Programs (HRPP) and Institutional Review Boards (IRB) are pivoting, revising, and expanding their policies, procedures, and operational needs. These needs speak to the constant and consistent oversight of all active […]

Deep Dives: What is the Difference Between “Exempt” Human Subjects Research, and Projects that are Not Human Subjects Research (NHSR)?

Many areas of the regulations for human subjects research are incredibly dense and nuanced. This “Deep Dives” blog post series is intended to delve into these thorny regulatory questions. View all the posts in this series by visiting the “deep dives” tag on our blog. This post focuses on the difference between “exempt” human subjects […]

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