Letter of Collaboration required for research involving the VCU Emergency Medicine Department
Effective March 16, 2023, for any research protocol enrolling patients within the VCU Department of Emergency Medicine (EM) or seeking to utilize EM resources, a departmental letter of collaboration must be acquired by the study Principal Investigator (PI) from the EM research leadership. This letter must be submitted with the RAMS-IRB submission for the clinical […]
HRPP Newsletter Volume 005 | March 2023
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The HRPP Transformation Project
Just before the ball dropped in 2023, 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 […]
HRPP AND IRB OPERATIONAL PROCEDURES AS OF CLOSE OF BUSINESS 12/9/22
OVPRI is preparing an office-wide message, which will include the following information from the VCU and VCU Health HRPP: To avoid the last-minute rush of submissions please note that after December 9, 2022 (COB), non-emergency submissions may not be reviewed until we return from the winter holiday due to the high volume of submissions we […]
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 […]
VCU Human Research Protection Program Holiday and Winter Break Schedule 2022
The Human Research Protection Program (IRB) office will be closed for Thanksgiving beginning at noon on Wednesday, 11/23/22 and will reopen on Monday, 11/28/22. Investigators remain responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. For guidance on what constitutes an unanticipated problem, refer […]
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 Friday, November 11, from 10am until 1pm. Get more information here: https://bit.ly/registerconsulting For questions, please contact Maureen Olmstead at meolmsted@vcu.edu.
Impacts on HRPP Services and Timelines
During the next several weeks, the Human Research Protection Program (HRPP) will be undergoing additional changes in personnel that may impact HRPP services and timelines. Reliance Division Stacy West, Reliance Manager, will vacate her position on Friday, November 4 and Vanessa Hernandez, Reliance Consultant, will vacate her position on Friday, November 18. We are fortunate to […]
HRPP Newsletter Volume 004 | October 2022
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16th Annual Virginia IRB Consortium Conference
As you may be aware, the Virginia IRB Consortium holds an annual regional conference each year in the fall. This year it will be held virtually on Friday, October 28, 2022 from 8:30am-2:00pm. There is no fee to attend. This year’s conference sounds very interesting, with a keynote by the eldest grandson of Henrietta Lacks. There will also […]