New Requirement for NIH Funded Clinical Trial Researchers
As of January 1, 2017, all NIH funded researchers involved in the conduct, oversight,or management of clinical trials must be trained in Good Clinical Practice (GCP). NIH defines clinical trial as “a research study in which one or more humans are prospectively assigned to one or more interventions (which may include placebo or other control) […]
QI vs Research// Exempt vs Expedited Guidance
Based on feedback, we have created two additional guidance documents. Distinguishing between Exempt vs. Expedited research, as well as Determining QI vs. Research are among our most frequently asked questions, and we are confident these documents will be helpful! These guides are attached, and will also be posted on our website in the next day […]
IRB Review Timelines for Exempt and Expedited Studies
IRB Review Timelines for Exempt and Expedited Studies The Office of Research Subjects Protection (ORSP) is currently experiencing a high volume of studies being submitted for IRB review. This high volume is also coupled with a temporary reduction in ORSP staffing. With this, investigators may experience an increase in the timeline for completion of exempt […]
Office of Research Subjects Protection – VCU Winter Closing Holiday – 12/23 through 1/2/2017
The Office of Research Subjects Protection will be closed for the VCU Winter Closing holiday Friday, December 23, 2016 through Monday, January 2, 2017. Despite the closing, investigators are still responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. In addition, as always, investigators are responsible […]
RAMS-IRB to be Down for Maintenance/Updates Friday, December 16th, 2016
RAMS-IRB will be unavailable on Friday, December 16, 2016 to allow for the installation of system updates. Users will be unable to access the system during the update process and therefore are reminded to consider any approaching deadlines that may be impacted. We apologize for any inconvenience this may cause. A summary of changes/updates applicable […]
Thanksgiving Holiday Schedule
The Office of Research Subjects Protection will be closed for Thanksgiving beginning at noon on Wednesday, November 23, 2016, and will reopen on Monday, November 28, 2016. Despite the closing, investigators are still responsible for reporting to the IRB any unanticipated problems involving risk to subjects or others that occur during this time. In addition, […]
IRB Quality Improvement Survey Results
Dear Members of the VCU and VCU Health Research Community, Last May, the Institutional Review Board (IRB) administered a quality improvement survey to the full time faculty and staff at VCU and VCUHS to measure the IRB’s current performance and to identify actionable areas for improvements. Attached is a letter that outlines the results of […]
Measuring the Quality and Process of Informed Consent: AAHRPP October Webinar
The Office of Research Subjects Protections will be hosting an AAHRPP webinar, Measuring the Quality and Process of Informed Consent, on October 27th. If this is of interest and you would like to attend, please use the following link to register. REGISTER HERE October 27th 3:30 – 5:00 pm BioTech One Rm 3060 Please let […]
COI Reviews No Longer Required for Exempt Research
Effective immediately, COI reviews are not required for studies determined to be exempt research. If a study is submitted as exempt and does not qualify for an exemption, the COI review must be completed. WPP VIII-10 has been updated to reflect the change in policy. Please contact our office with any questions.
WIRB – WCG Smartform – New Question for Institutional Site Submissions
WIRB (Western IRB) has announced a recently released WCG Initial Review Submission Form, including a new question on the form that asks submitters to identify their institution. This information will help WIRB link our research program to the site’s submission when WIRB receives it. The question (on page 1) appears when the submitter selects “WIRB” as the IRB […]