Regulatory Affairs

Office of the Vice President and Innovation

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Wright Center Consulting Hours

Tuesday, January 28 from 1:00 p.m. – 4:00 p.m. Richmond Academy of Medicine (1200 E. Clay St.) – Garden Level The consulting hours are open to anyone with a question regarding human research including investigators, research study team members, research administration, and students. Consultants will be available from the areas of: human subjects protection, grants/contracts, […]

Public Workshop – Medical Extended Reality

Today, the U.S. Food and Drug Administration (FDA) is announcing a public workshop entitled “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine,” which will be held on March 5, 2020. Extended reality (XR) devices incorporate objects and environments from both the physical and digital or virtual world. During this […]

Submitting an IRB application? School of Medicine Brown Bag Session: “An IRB How-To”

Join John Horigan, MA, CIP, Executive Director – Human Subjects Protection, and colleagues as they share tips to ensure your IRB application is successful.  At the end of this session, participants will be able to: Explain the purpose of the IRB Describe characteristics of a successful IRB application Navigate to the IRB website and application […]

Pediatric Research Unit (PRU) New Scheduling Process

The PRU is available for all pediatric research teams as a welcoming, controlled environment for research participants and their families to be confidently involved in clinical research studies.  As a result of increased demand, all PRU spaces must now be reserved through an established pathway, which can be found on the attached document. This new […]

One VCU Clinical Research Teams Monthly Meeting

Date: Tuesday, January 14, 2020Time: 9:00 am.Location: The Learning Center – Main Hospital (across from Panera) All clinical and translational research team members are invited to this meeting. We will be discussing VCUHS Lab and Pharmacy changes. Presenters: Mary Pak, PharmDInvestigational Pharmacist Kareesha Fitzgerald, MLS (ASCP)Pathology Clinical Trials Coordinator Kristy KuhleMedical Technologist Supervisor

Two new compliance notices have been posted for review and comment:

Notice 20-001.1 – VCU Payments to VCUHS for Clinical Services Notice 20-002.1 – Approval of Cancer-Related Research Involving Human Subjects Comments are due to Susan Robb ( on or before Tuesday, January 14, 2020.

SAVE THE DATE: 2020 Public Training Courses, Workshops, and Meetings

January 28-30, 2020: ASM Biothreats (Arlington, VA) – Hosted by the American Society for Microbiology, to offer professionals in biodefense, biosecurity, and biological threats the opportunity to exchange knowledge and ideas, and explore the latest developments and emerging technologies. (fee) January 28-29, 2020: HHS Tick-Borne Disease Working Group public meeting (Washington, DC and webcast) – The Working Group will 1) […]

Thursday, December 12 NIH Data Management and Sharing Policy

NIH Data Management and Sharing Policy Town Hall VCU Libraries and the Office of the Vice President for Research and Innovation will be holding Town Hall meetings to review and discuss the proposed NIH Data Management and Sharing Policy.  The proposed policy is open for comment through January 10, 2020.  Comments will be used to inform […]

Public Workshop – Artificial Intelligence in Radiological Imaging

The U.S. Food and Drug Administration (FDA) announced a public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging,” will be held February 25-26, 2020. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics: Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended […]

Upcoming VCU IRB Office Closures

The Human Research Protection Program (IRB) office will be closed for Thanksgiving beginning at noon on Wednesday, 11/27/19 and will reopen on Monday, 12/2/19. Investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time.   For guidance on what constitutes an unanticipated problem, refer […]

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