*Extended VCU IRB Nomination Period: Providing Additional Time for Nominations
The Human Research Protection Program has some important updates regarding the VCU Institutional Review Board (IRB) membership nomination process that we would like to share with the VCU Community. Recognizing the significance of the work of the VCU research community in nominating individuals for the VCU IRB, the Human Research Protection Program (HRPP) understands that […]
HRPP and IRB Operational Procedures for Winter Break
Please Note: This guidance is subject to change as the winter break approaches. This information was originally posted on the HRPP blog on 11/17/2023 and has been updated. ***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, […]
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 […]
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 […]
NOTICE: Avoiding PHI and PII Transmission at VCU
The below guidance document aims to provide a clear set of instructions to the research community (i.e., principal investigator, research coordinators, and other research personnel) involved in conducting human subject research on emphasizing the need to securely handle the PHI and PII of human subjects when submitting documents to the Human Research Protections Program (HRPP) […]
NOTICE: Guidance on the Local Human Rights Committee Review Requirements
12VAC35-115-130 applies to all individuals receiving services from a public or private provider of services operated, licensed, or funded by the Department of Behavioral Health and Developmental Services (DBHDS), except those operated by the Department of Corrections. This Virginia law addresses the protection of human research subjects and is vital for researchers, institutions, and Institutional […]
REMINDER: New Tools to Assist with IRB Submissions
PLEASE NOTE: Updated links to Protocol Templates provided 8/30/2023 Protocol templates are required for use effective today, June 1, 2023. New IRB submissions that do not contain a protocol will be returned to the researcher after today. If the IRB submission does not have a protocol provided by the sponsor, the use of HRP-503 or […]
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 […]
Reminder: Researchers Separating From VCU Must Close or Amend Studies Prior to Separation
IRB Requirements for Separating PIs A Principal Investigator (PI) who is leaving the institution and who no longer meets the PI eligibility requirements may not continue to serve as Principal Investigator on research conducted under the VCU IRB approval. When a PI is planning to separate from VCU, they must address any studies they have […]
*High Importance* – Human Subject Research Impacted by Iodine-based IV Contrast Shortage at VCUHS
Dear Members of the VCU Research Community, The Virginia Commonwealth University Human Research Protection Program (HRPP) is aware of the iodine-based IV contrast shortage at Virginia Commonwealth University Health System (VCUHS) due to supply chain issues related to COVID-19. The potential impact on human subjects research may require submission of a protocol amendment to adjust […]