Call for Nominations: Join the Institutional Review Board for 2024 *Updated deadline*
*The original deadline of January 5, 2024, has been extended to March 1, 2024. This post has been edited to reflect an updated deadline. Dear Research Community, We are excited to announce that the nomination period for membership on our esteemed Institutional Review Board (IRB) is now open for the 2024 annual calendar. As a […]
HRPP and IRB Operational Procedures for Thanksgiving and Winter Break
Please Note: This guidance is subject to change as the winter break approaches. Due to the implementation of the HRPP Transformation, the HRPP will be able to continue to process VCU IRB reviews during the upcoming university break periods. Thus, administrative operations will continue without interruption. Thanksgiving holiday VCU HRPP will pause operations at 1 […]
Huron Webinar: NIH Data Sharing and Management Policies: Perspective of the IRB
The stakes are higher than ever when it comes to data sharing and management – particularly within the academic research enterprise. Tune into Huron’s upcoming webinar Tuesday, October 31, 2023 at noon. The policies in place that protect data across institutions and the roles Institutional Review Boards and other key players have in helping implement […]
Guidance Document on the Importance of Scientific Review for Research Protocol Approval
Introduction: Protecting human subjects in research is paramount to ensure ethical, safe, and meaningful scientific advancements. Federal regulations, particularly 45 Code of Federal Regulations (CFR) 46, Subpart A, provide guidelines and requirements to protect the rights and well-being of research participants. One critical aspect of these regulations is the requirement for a scientific review of […]
In Person/Online VCU HRPP Training for the Research Community
Join us on September 12, 2023, from 9:30 am – 2:45 pm in the Richmond Salon III-IV at The VCU Student Commons for an in-person and online training on the new procedures and processes for IRB submissions following the release of the HRPP Toolkit by the VCU Human Research Protection Program. This training is designed […]
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 […]
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 […]
Data Management Plan Requirements – Presentation Available
The VCU Human Research Protection Program (HRPP) recently conducted training on VCU’s new Data Management Plan requirement. Research studies utilizing Category 1 data are now required to have a Data Management Plan (DMP) from VCU’s Data Management System (DMS). This requirement, implemented by VCU’s Audit and Compliance Services, is being enforced for all studies submitted […]
Data Management Plan Requirements and Training
Effective November 1, 2021, all human subjects research protocols using confidential or regulated data (i.e., category 1 data) are required to have an approved Data Management Plan (DMP) utilizing VCU’s Data Management System (DMS). Researchers must create, submit, and receive approval for the Data Management Plan prior to submitting to the IRB. DMPs are evaluated […]
You Can Now Use Your VCU eID to Log Into CITI Via Single Sign On
What is Single Sign On? Single Sign On (SSO) is a process that allows you to use your VCU eID and password, instead of a username and password created by CITI Program. You can log into the CITI Program after completing a login at your site without any additional authentication. How do I use Single […]