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. Studies proposing to […]
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 […]
New NIH Guidance on Informed Consent for Secondary Research with Data and Biospecimens
The VCU HRPP would like to draw the research community’s attention to a new resource made available by the NIH, on the topic of informed consent considerations for secondary research with data and specimens. This resource addresses only consent for the storage and sharing of data and biospecimens collected during a primary research protocol, for […]
Researcher Guidance for Using RAMS-IRB 9.0
On 9/15/2021, RAMS-IRB was updated to version 9.0, which resulted in significant changes to the look and feel of the system, specifically relating to navigation and the reviewer notes interface. This blog post compiles resources for researchers who need to navigate RAMS-IRB following the update. The VCU Human Research Protection Program (HRPP) has developed video […]
REDCap eConsent Templates Now Available for Use in Human Research
The VCU Human Research Protection Program and the C. Kenneth and Dianne Wright Center for Clinical and Translational Research are pleased to announce that REDCap eConsent templates are now available for use in human research. Full IRB guidance on the use of REDCap eConsent will be available under the “Informed Consent” accordion on the VCU […]
Deep Dives: Data Identifiability Terms and Definitions
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 terms used for data identifiability and their definitions. […]
IRB Mythbusters – Social Media Recruitment
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB! In this issue, “myths” surrounding social media recruitment are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog. MYTH #1: If I have an approved physical […]
New Recruitment Guidance Available: Social Media and Cold Calling
The VCU Human Research Protection Program is pleased to offer two new guidance documents to the research community. VCU IRB’s guidance to researchers on cold calling recruitment methods offers guidance on using “cold calling” for recruitment efforts. It defines “cold calling,” explains when cold calling should and should not be used, and discusses best practices […]
Investigator Responsibilities Regarding COVID during the VCU Winter Closure
Dear Members of the VCU Research Community, As we approach the VCU Winter Closure, the HRPP and IRB would like to thank the research community for their collaboration with us this year. We faced some new challenges, and we are proud that we worked together to facilitate research that benefits our patients, students, and community. […]
IRB Mythbusters: Over-Enrollment and Study Expirations
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB! In this issue, “myths” surrounding over-enrollment of research participants and study expirations are addressed. MYTH #1: Enrolling more participants in a study than the IRB approved in my research plan is okay; […]