Updated WPPs Available
The IRB’s Written Policies and Procedures (WPPs) were updated as of 10/30/2020 and are now available on the IRB’s website. Links throughout the document were corrected and cross-linked. Clarification was added to 3 WPPs about how the IRB reviews corrective actions or substantive changes that occur in response to an unanticipated problem – in particular changes […]
Training for NEW WIRB Electronic Submission System: WCG IRB Connexus
WIRB has announced the rollout of their new electronic submission system WCG IRB Connexus. Training will be held on Tuesday November 10th at 10am. Please ensure that a member of the study team either attends the training or reviews the recorded session prior to initiating registration in the new Connexus system. Study teams should continue to use […]
Wright Center Consulting Hours — VIRTUAL (11/11/2020)
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 Wednesday, November 11th. The following consultants will be present: IRB, Research Navigation, Informatics, Biostatistics, and Recruitment Specialist. […]
OHRP Exception Determination: Single IRB (sIRB) Requirements
On October 8, 2020, the Office for Human Research Protections (OHRP), on behalf of the Department of Health and Human Services (HHS), issued an exception determination (as permitted by 45 CFR 46.114(b)(2)(ii)) stating that certain categories of cooperative research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply […]
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.
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 […]