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 […]
Integrity and Ethics, Community Engagement, and the VCU HRPP
As part of the VCU Human Research Protection Program’s (HRPP) commitment to continual improvement, we generate metrics to evaluate how well our program complies with regulations, engages the community, and upholds VCU’s core values. View the infographic below to learn more about some facts and figures behind the VCU HRPP! Alt text for the infographic […]
2022 Annual IRB Satisfaction Survey Available
The VCU Human Research Protection Program invites members of the VCU and VCU Health research communities who are familiar with the Institutional Review Board (IRB) to take an anonymous satisfaction survey. This annual satisfaction survey includes questions about the following topics: perceptions of the IRB, RAMS-IRB use, customer service provided by the HRPP staff […]
Investigator Responsibilities during COVID-19 Pandemic
Dear Members of the VCU Research Community, As we respond to the rising number of local COVID-19 cases, the HRPP is reissuing the following guidance: 1. Continue to work with your Department Chairs, Deans, Building Managers, Human Resource Representatives, and the facility where your research takes place regarding the study’s approvals and permissions for building […]
VCU Human Research Protections Program – Winter Closing Holiday Schedule 2021
The VCU Human Research Protection Program (IRB) Office will be closed for the holidays December 23, 2021 through January 2, 2022, and will reopen on Monday, January 3, 2022. 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, […]
Updated Consent Templates
Revised consent templates are now available on the IRB forms webpage. The following changes were made: HIPAA authorization language was revised to add an option for naming VCU Dental Care instead of VCU Health as the source of PHI. A new section for obtaining FERPA consent was added to the Social-Behavioral Consent Template. The Exempt Information […]
VCU Human Research Protections Program – Holiday Schedule 2021
Thanksgiving Holiday The Human Research Protection Program (IRB) office will be closed for Thanksgiving beginning at noon on Wednesday, 11/24/21 and will reopen on Monday, 11/29/21. 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 […]