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 […]
Free Webinar on Final Rule for ClinicalTrials.gov Registrations and Results Submission
Final Rule Webinar Series ClinicalTrials.gov is offering a series of three live webinars to provide responsible parties with information about the final rule for Clinical Trials Registration and Results Information Submission (42 CFR part 11). Each webinar will cover a different aspect of the final rule, including an overview of which applicable clinical trials are covered, what […]
Updated COI Review Process for External IRB Submissions
The Office of Research Subjects Protection (ORSP) will initiate a process change for all External IRB Submissions beginning September 6, 2016. External IRB submissions will only be approved and returned to the Principal Investigator for submission to the external IRB after a Conflict of Interest (COI) review is complete. The current process allows the ORSP […]
IRB Training Schedule – Fall 2016 Semester
The Office of Research Subject Protection will be holding a variety of submission and regulatory based training. We will hold the basic introduction to submitting to the IRB and using RAMS-IRB, as well as some other new & repeat regulatory topic trainings. As always, these trainings are not required, but we hope you find them […]
EHR Data Integrity Not Robust Enough for Clinical Trial Use
In a letter to the FDA regarding the use of EHR data in clinical trials and research, the AMIA says researchers and industry professionals should not rely on EHRs for accurate, complete, and meaningful information when conducting medical research and clinical trials. HealthITAnalytics, July 19, 2016 http://healthitanalytics.com/news/ehr-data-integrity-not-robust-enough-for-clinical-trial-use
Fall Semester Research
Just a reminder: If you are planning on doing research during the fall semester, including doing research with classes, protocols should be submitted to the IRB via RAMS-IRB as soon as possible, especially if you are planning on beginning research soon after the semester starts. Access RAMS-IRB
New OHRP Webinars
Please consider checking out some of OHRP’s new webinars! Back to the Basics: Does My Project Fall Within the Scope of the Regulations? This webinar provides an overview of OHRP, the Common Rule, and how the HHS regulations on human subject protections are applied. It is intended for investigators or IRB professionals seeking basic training […]
Informed Consent Process
Informed consent of research subjects is critical, and is more than just a document & signature – it is an ongoing process. Here are a few reminders about the Informed Consent document and process: A potential subject must have plenty of time to consider whether or not to participate Consent Document must be signed unless a waiver is […]
VCU Restructuring Announcement
The Office of Research Subjects Protection has some exciting news. Click the link to watch and find out! VCU IRB Announcement Video Any questions, please contact us at [email protected]. Thank you!