Category: IRB Members
Updated WPPs Available
The IRB’s Written Policies and Procedures (WPPs) were updated as of 4/15/2021 and are now available on the IRB’s website. Many of the updates were minor, such as adding new links to resources on state-mandated disease reporting, IRB guidance on cold calling and use of social media, and an IRB video about reconsenting children when they turn […]
RAMS-IRB is back online after patch
The RAMS-IRB patch today 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 for your study or ORSP@vcu.edu if problems are encountered.
IRB Mythbusters – HIPAA and Research
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 HIPAA and research are addressed. Access previous editions of IRB Mythbusters by visiting the “mythbusters” tag on our blog. MYTH #1: When collecting HIPAA-covered data, I can […]
Data Identifiability Terms and Definitions
What is “Data Identifiability”? “Data Identifiability” refers to the ability of a researcher to identify specific individuals within a research dataset. There are varying degrees of data identifiability, ranging from data that is easily linked to specific individuals based on information present in the dataset, to data for which it is impossible to identify specific […]
New IRB requirement for amendments that change the Principal Investigator of a study
New Requirement for VCU IRB studies: All amendments submitted on or after March 15, 2021 that propose to change the Principal Investigator (PI) on a VCU IRB study will be required to have the new PI complete the PI Change Instrument and upload a copy of the completed responses. The PI Change Instrument can be […]
IRB Satisfaction Survey
The VCU Office of Research Subjects Protection 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 ORSP […]
Investigator Responsibilities Regarding COVID during the VCU Winter Closure
Dear Members of the VCU Research Community, As we approach the VCU Winter Closure, the HRPP and IRB would like to thank the research community for their collaboration with us this year. We faced some new challenges, and we are proud that we worked together to facilitate research that benefits our patients, students, and community. […]
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 […]
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.