IRB and HRPP News and Information

Timely information supporting human research ethics, quality, and compliance. across the research enterprise.

Training for the Community: Foundational Toolkit Documents & Protocol Templates

This is a recording of the HRPP Toolkit Training for the Community: Foundational Toolkit Documents & Protocol Templates presented on Friday, April 21, 2023 from 12:00-1:00pm via Zoom.

New Tools to Assist with IRB Submissions

As part of the HRPP Transformation Project, the VCU HRPP Office is rolling-out protocol templates that are designed to: Minimize administrative burden by reducing the number of SmartForm fields investigators need to complete in RAMS-IRB Obtain all relevant information the IRB needs to complete their review Provide prompts and instrtuction that will enable investigators to […]

HRPP Transformation Project Kick-off Video

The VCU Human Research Protection Program (HRPP) is pleased to announce the initiation of the HRPP Transformation Project to improve human research compliance with federal, state and institutional requirements, enhance review process efficiency, and minimize administrative burden for the VCU human research community. VCU is partnering with HRPP consultants from Huron to facilitate transformation efforts. […]

Research Community Feedback Survey

Please take a moment to share your opinion by completing the Research Community Feedback Survey (less than a few minutes to complete). Please submit your responses by Friday, May 19, 2023.

Training for the Community: Schedule and Registration Links

Please join us for upcoming training for the community. Register for each session using the links below. Sessions will be virtual (Zoom), recorded, and offered live to facilitate Q&A. Recordings will be made available on the VCU HRPP Blog in the HRPP Transformation Project section. Date Time Topic Registration Link Friday, April 21, 2023 12:00pm-1:00pm Foundational […]

Process Improvement and Transformation

What is happening? Human subjects research at Virginia Commonwealth University (VCU) has grown in complexity and volume over the last five years. Therefore, the VCU Human Research Protections Program (HRPP) is transforming its processes to meet the needs of the institution’s exponential growth. Hence, the VCU HRPP is proud to announce that the HRPP has a […]

HRPP Newsletter Volume 005 | March 2023

Download the latest volume of the VCU HRPP Newsletter.

The HRPP Transformation Project

With the start of the 2023 year, the VCU Human Research Protection Program (HRPP) launched a plan to transform the submission, review, and ongoing oversight of all of its Institutional Review Boards (IRB): The HRPP Transformation Project. This project is specifically designed to improve the quality, efficiency, and effectiveness of the HRPP and to reduce […]

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.

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