Consent Form Issues (February 2013)
The IRB-HSR has modified its policy regarding consents in medical records. You are now required to send the signed consent form to medical records ONLY if the study involves research of a drug, device or biologic, or involves an intervention that might significantly affect the clinical care of the subject.
Privacy Plan Issues (February 2013)
The template for the Privacy plan found in the IRB-HSR protocol has been modified to allow the study team to FAX identifiable info to the sponsor under certain conditions-
FAXING outside of UVa is only allowed if the receiving fax machine is in a restricted-access location, the intended recipient is clearly indicated, and that recipient has been alerted to the pending transmission and is available to pick it up immediately. Also verify FAX numbers before faxing and use FAX cover sheet with a confidentiality statement.
Study Documents (February 2013)
Please note that adding, deleting or revising things like questionnaires, is considered a modification. The IRB-HSR cannot process them through a Receipt of Acknowledgement process.
AGENT FORM(April 2012)
The IRB-HSR has developed a process and forms to help you determine if you are working as an AGENT of UVa while performing research. If you are NOT working as an agent of UVa, you may not need approval from the UVa IRB-HSR. There are two common situations where you might not need IRB-HSR approval (see below) . For more information see the IRB-HSR Website at http://www.virginia.edu/vpr/irb/hsr/activities_examples.html
August 2011- LEAVING UVA?
If you are a researcher leaving UVa please be aware of requirements. Please take advantage of the Exit Checklist found under FORMS on our website at http://www.virginia.edu/provost/facultyexit.pdf
What Needs IRB Review?
New Learning Shot: The IRB-HSR has teamed up with Dr. Ron Turner, Assistant Dean for Research of the School of Medicine on a new Learning Shot entitled What Needs IRB Review. We hope you find it helpful in answering this sometimes difficult question.
Health System Device Approvals
No medical device (supplies, accessories, or equipment), whether purchased, contracted, donated, loaned or for trial, may be used in the UVa Health System without first being evaluated by the UVa Health System. The approval process is now being done by Clinical Engineering instead of the Office of Supply Chain Management. The submission form and the contact information have been updated on the New Medical Device Request form which can be found on the IRB-HSR Website under “FORMS”.
Continuation Review Dates
Have a question about when your protocol is due for continuation review? The next review date may be found by logging into IRB Online and clicking on IRB Schedule (Removed 05/30/09)
Did You Know A Protocol Violation is any unapproved deviation from the protocol, GCPs, or IRB policies whether or not it is intentional and whether or not it is under the control of the Investigator. (Removed 12/12/08)
Did You Know Unless approved by the IRB, study subjects must provide the study team with a SS# or TIN #(Tax ID Number) or they cannot be compensated for being in the study (cash or gift card).
They may enroll, but
may not be paid. (Removed 08/18/08)
Protocol Builder Assistance:
The staff of the IRB-HSR provides assistance with Protocol Builder at no charge. If you are using Protocol Builder and need assistance please contact Margaret Ball at email@example.com or 243-0639.