Welcome Tara Gaucher to IRB-HSR Staff (posted November 2014)
Please join me in welcoming Tara Gaucher to the IRB-HSR Staff. Tara is responsible for continuations for the 2nd IRB meeting of the month and for protocol closures.
Improvement Project vs. Research (posted November 2014)
The IRB-HSR continues to update the guidance to clarify improvement projects from research. The Determination of Human Subjects Research Form was revised recently. If you are performing what you consider to be an Improvement Project, you are strongly encouraged to review this form before you begin your project to determine if the project requires IRB approval.
Department Closure Reports Available (posted November 2014)
The IRB-HSR is now able to provide Department Closure Reports. The report provides a listing of all protocols of PI’s from a department. The report includes IRB #, protocol title, PI Name, Closure date and sponsor name. You may find this helpful as you comply with the UVa Records Management requirements. To obtain a report send an email to Susie Hoffman at firstname.lastname@example.org. Please include department name.
2014 Virginia IRB Consortium Conference (posted September 2014)
The University of Virginia (UVA), Virginia Union University (VUU), and Public Responsibility in Medicine and Research (PRIM&R) are pleased to announce
"Lifting the Fog: Issues of Informed Consent, Data Protection and Oversight in QI/Institutional Assessments and Research".
The conference will be held on November 14, 2014 at Newcomb Hall, University of Virginia, Charlottesville. For additional information, see conference agenda. To register, submit the registration for by October 30.
The University of Virginia School of Medicine awards a maximum of 5.5 hours of participation (equivalent to AMA PRA Category 1 Credit(s)TM) to each non-physician participant who successfully completes this educational activity. The University of Virginia School of Medicine retains a record of participants for six years. Educational transcripts may be obtained at www.cmevillage.com (click on Transcripts and follow the instructions).
Note on CME:
The University Of Virginia School Of Medicine is accredited by the ACCME to provide continuing medical education for physicians.
The University of Virginia School of Medicine designates this live activity for a maximum of 5.5 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Quality Improvement vs. Research (posted May 2014)
The IRB-HSR Guidance on QI vs Research has been updated. If the project falls in the gray zone between QI and Research, the team will be required to submit a Determination of Human Subjects Research Form
Submission of Large Documents on CD (posted May 2014)
The IRB-HSR strongly encourages the submission of all large documents on a CD. The documents on the CD must be in PDF format. Paper copies of these documents are no longer required. The CD must be attached to a Document Submission Form Complete instructions are found on the Document Submission Form
Submission of Documents for Receipt of Acknowledgment (posted May 2014)
If you are submitting hard copy documents to the IRB for Receipt of Acknowledgment, the IRB # must be written on each document. If you are submitting multiple documents at one time for Receipt of Acknowledgement, you must submit them with a completed Document Submission Form.
Revisions to IRB Application (posted May 2014)
Any modification to the IRB Application will require the change be made to the full document along with the use of tracked changes and updates to the version date. A signature on the Application Form from the PI will NOT be required UNLESS the modification is for a change in PI or a 5 year update.
Submission of Continuation Status Forms (posted May 2014)
You are strongly encouraged to send all requested continuation paperwork via email to email@example.com
The Continuation Status Report should NOT be submitted to the IRB before it is signed by the PI.
Without the signature, the continuation cannot be counted as received and will not be reviewed.
Legally Authorized Representative (posted May 2014)
Information on who may serve as a Legally Authorized Representative and provide Surrogate Consent for another person to participate in research has been added to the IRB-HSR website at http://www.virginia.edu/vpr/irb/hsr/surrogate_consent.html
Data Security and Approval from ISPRO (posted May 2014)
Any new protocol/5 year update will require review and approval from the UVa Office of Information Security, Policy & Records Office (ISPRO) prior to IRB submission if any of the following will be done in the protocol:
- Collecting data via a single use device (e.g. smart phone app, tablet, laptop)
- Collecting data via web based format (e.g. online consent, online surveys, online CRF’s)
- Storing identifiable health information or other highly sensitive data (e.g. SS#) on a server NOT managed by Health Systems Computing Services (HS/CS) or Information Technology Services (ITS)
Save the Date (posted May 2014)
The 2014 Virginia IRB Consortium Conference entitled “What Constitutes Human Subject Research in the 21st Century?” will be held at UVa’s Newcomb Hall on Friday, November 14th. Stay tuned for registration information.
Consent Form Template Changes for Studies involving Banking (posted February 2014)
In response to changes in the HIPAA regulations, the IRB-HSR has modified the consent form templates. Two signature sections are no longer required for studies that involve both a main study and banking for future unspecified research. These changes have been incorporated into Protocol Builder.
Receipt Acknowledgments of Submitted Documents (posted February 2014)
If you are submitting ANY documents in addition to the UVa IRB protocol and consents you are required to complete the Document Submission Form.
(Last update 11/06/2014)
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