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.

Category results for: IRB Education and Training

Emergency Use of an Investigational Drug or Biologic

FDA’s IRB regulations at 21 CFR 56.102(d) define an emergency use as follows: (d) Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. The IRB regulations at 21 CFR […]

HRPP Newsletter Volume 004 | October 2022

Download the latest volume of the VCU HRPP Newsletter.

Agenda for “Research Ethics: Past, Present, and Future”

Please join us for the VCU HRPP Annual Conference 2022 on Thursday, September 29 from 9:00am – 3:00pm. Sessions will feature our conference theme, “Research Ethics: Past, Present, and Future.” To register, please visit https://bit.ly/3KBzed3. CEUs are available for this event.  9:00am – Welcome from Dr. Sanjur Brooks 9:05am – Keynote Address by Dr. Michael Dickinson […]

IRB Consulting Hours – VIRTUAL

The Wright Center for Clinical and Translational Research, in collaboration with the VCU Human Research Protection Program, are pleased to offer open consulting hours. These open consulting hours will be hosted VIRTUALLY using Zoom. The consulting hours will include the following consultants: Biostatistics Informatics IRB IND/IDE/FDA Research Library Services Designing and Conducting Research Community Engaged […]

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 […]

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 […]

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 […]

Next Page »