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 […]
New Investigator Tips: Do I Need to Submit Exempt Research to the VCU IRB?
Federal regulations for the protection of human subjects contain various areas of flexibility, where institutions are allowed to set policy and procedures for certain aspects of the conduct of human research. While many aspects of conducting human research remain the same between institutions, there are certain areas that can vary between institutions. This means investigators […]
New Investigator Tips: What Should I Do if I am Bringing a Research Study from My Old Institution to VCU?
Federal regulations for the protection of human subjects contain various areas of flexibility, where institutions are allowed to set policy and procedures for certain aspects of the conduct of human research. While many aspects of conducting human research remain the same between institutions, there are certain areas that can vary between institutions. This means investigators […]
New Investigator Tips: What are the CITI Training Requirements at VCU?
Federal regulations for the protection of human subjects contain various areas of flexibility, where institutions are allowed to set policy and procedures for certain aspects of the conduct of human research. While many aspects of conducting human research remain the same between institutions, there are certain areas that can vary between institutions. This means investigators […]
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 […]