IRB Mythbusters: Over-Enrollment and Study Expirations
The VCU Human Research Protection Program presents IRB Mythbusters — a periodic newsletter clarifying common misconceptions about conducting human research and the IRB! In this issue, “myths” surrounding over-enrollment of research participants and study expirations are addressed. MYTH #1: Enrolling more participants in a study than the IRB approved in my research plan is okay; […]
Revised Definition of “Protected Health Information” Effective 9/28/2020
Effective 9/28/2020, VCU Health/VCU is narrowing the definition of “Protected Health Information” (PHI) [revised definition] Protected Health Information (PHI): Individually identifiable health information held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or oral, in relation to the provision of healthcare, healthcare operations and payment […]
Updated WPPs Available
The IRB’s Written Policies and Procedures (WPPs) were updated as of 9/28/2020 and are now available on the IRB’s website. This update includes a major policy change regarding HIPAA and the definition of Protected Health Information. Other changes include procedures for electronic consent signatures, Certificate of Confidentiality applications, and making minimal risk determinations.
RAMS-IRB is back online after patch
The RAMS-IRB patch this morning was completed successfully and is now back online. For a description of what updates are included in this patch, please refer to Please contact the assigned IRB coordinator or [email protected] if problems are encountered.
RAMS-IRB Patch on Monday 9/28/2020
The RAMS-IRB system will be down for system maintenance on 9/28/20. For a description of what updates are included in this patch, please refer to this Google Doc Remember to save your work and exit the system prior to the scheduled date and time. Any attempted use of the system during scheduled maintenance is subject to […]
Wright Center Consulting Hours — VIRTUAL (9/11/2020)
The Wright Center for Clinical and Translational Research, in collaboration with the VCU Human Research Protection Program, are pleased to offer consulting hours. These open consulting hours will be hosted VIRTUALLY using Zoom, from 11am to 2pm on Friday, September 11th. The following consultants will be present: IRB, Research Navigation, Informatics, Library, and Grants and […]
Part 11 DocuSign Available for FDA-Regulated Studies
FDA-regulated research study teams are now able to use a special DocuSign platform to obtain electronic signatures. This platform has special identity verification and authentication processes to meet FDA requirements, and it may only be used for adult consent and for certain FDA documents and forms. Learn more about this free resource and how to request […]
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. IRB staff will be available for drop-in consultations with faculty, students, and staff from any school or […]
Guidance Available: Re-Consenting in Research Involving Children
The VCU Human Research Protection Program would like to inform the VCU research community about the availability of a new educational resource on the topic of re-consenting children who reach the age of majority during a research study. This 15 minute video lecture covers relevant definitions, requirements for parental permission and assent, as well as […]
Training Opportunity: Advarra CIRBI training for VCU
On Tuesday July 14th, Advarra will host a web-based training opportunity in the CIRBI system. This training is appropriate for new Advarra users, and as a refresher for current users. To add this training to your google calendar, use the following link:https://calendar.google.com/event?action=TEMPLATE&tmeid=MDYzOG9scmtnaW5ucDFmaGY4OHRramV2OWEgb3JzcEB2Y3UuZWR1&tmsrc=orsp%40vcu.edu Or, join the training on Tuesday July 14th at 12PM using one of […]