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 […]
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 […]
FREE CEU: Free Workshop on Assent with Individuals with Communication Difficulties
The VCU HRPP Would like to notify the research community about a free workshop offering CEUs on the topic of assent with individuals with communication difficulties. The workshop is being held on Wednesday, June 29 at 3pm ET. Toward an Understanding of Assent with Individuals with Communication Difficulties. Presenter: Cody Morris, Ph.D., BCBA-D, LBA Seeking […]
Reminder: Researchers Separating From VCU Must Close or Amend Studies Prior to Separation
IRB Requirements for Separating PIs A Principal Investigator (PI) who is leaving the institution and who no longer meets the PI eligibility requirements may not continue to serve as Principal Investigator on research conducted under the VCU IRB approval. When a PI is planning to separate from VCU, they must address any studies they have […]
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 […]
*High Importance* – Human Subject Research Impacted by Iodine-based IV Contrast Shortage at VCUHS
Dear Members of the VCU Research Community, The Virginia Commonwealth University Human Research Protection Program (HRPP) is aware of the iodine-based IV contrast shortage at Virginia Commonwealth University Health System (VCUHS) due to supply chain issues related to COVID-19. The potential impact on human subjects research may require submission of a protocol amendment to adjust […]
Integrity and Ethics, Community Engagement, and the VCU HRPP
As part of the VCU Human Research Protection Program’s (HRPP) commitment to continual improvement, we generate metrics to evaluate how well our program complies with regulations, engages the community, and upholds VCU’s core values. View the infographic below to learn more about some facts and figures behind the VCU HRPP! Alt text for the infographic […]