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Category: IRB

New VCU IRB Notification

Please note that as of Sept. 28, the VCU Human Research Protection Program has revised the scope of human research data considered to be Private Health Information (PHI).  This scope has been narrowed to provide a closer interpretation of the HIPAA regulations, which helps to limit the institution’s liability if data breaches occur in a research […]

New Subpart C Certification Submission Form

The Office for Human Research Protections (OHRP) would like to highlight the new Subpart C Certification Submission Form recently posted on the OHRP website. This form is intended to standardize the information submitted by institutions and reduce administrative delays caused by insufficient submissions. Institutions should submit the completed form as part of a Subpart C […]

IRB Consulting Hours

The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by our colleagues in the Wilder School. IRB staff will be available for drop-in consultations with faculty, students, and staff from any school or department […]

Revised Return to Research (R2R) Guidance Available

The VCU Human Research Protection Program would like to inform the VCU research community of an update to the HRPP’s Phased Return to Research (R2R) guidance. Minor clarifications were made to both the “Investigator Responsibilities to the IRB During the R2R” document and the “Supplemental Flowchart for Investigator Responsibilities During the R2R” document, to clarify […]

IRB drop-in consulting hours

Monday, July 6th from 12:30 p.m. – 3:30 p.m. The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by the Wilder School IRB staff will be available for drop-in consultations with faculty, students, and […]

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

(6/2/2020) – FDA is issuing this “Guidance for IRBs and Clinical Investigators” to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19. See document here: https://www.fda.gov/media/138496/download

IRB Consulting Hours – VIRTUAL

The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by our colleagues in the Psychology Department. IRB staff will be available for drop-in VIRTUAL consultations with faculty, students, and staff from any school or […]

Wright Center Consulting Hours – HRPP

The Wright Center for Clinical and Translational Research in collaboration with the VCU Human Research Protection Program are pleased to offer virtual open consulting hours, in partnership with our colleagues on the Monroe Park Campus. These open consulting hours will be hosted VIRTUALLY using Zoom, and will be sponsored by the Psychology Department. The consulting hours […]

IRB Consulting Hours — VIRTUAL

The VCU Human Research Protection Program is pleased to continue offering open IRB consulting hours. The next of these open consulting hours will be hosted VIRTUALLY using Zoom, and is sponsored by our colleagues in the Wilder School. For more information as well as the zoom meeting link, please click here.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The U.S. Food and Drug Administration FDA today issued guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. LINK: www.fda.gov/media/136238/download The FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.  Challenges may arise, for example, from quarantines, […]

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