Veterans Affairs

Announcements Regarding VA Studies

Updated 6/8/09
JBVAMC Privacy Officer (HIPAA) Contact Information:
Thomas Beatty
312-569-7698
Thomas.Beatty@va.gov

*Exempt Review of Research, v 1.1 04/21/09.
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/0282.pdf
Revised section V.D.4. to include "For VA Research, if exemption category 4 is claimed, the investigator may not retain any of the 18 identifiers outlined in the HIPAA Privacy Rule, and the investigator may not have access to any code by which the information may be linked to individuals. When the investigator will review PHI for the research, a waiver of authorization is required."

*Operating and Coordinating Procedures for the Administration of the Collaborative JBVAMC/NU/UIC IRB (UIC IRB#4), v1.3 04/10/09
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/policies/0292.pdf
Reassignment of medical record flagging determination from R&D Office to Collaborative IRB starting February, 2009.

*Guidelines for Investigators Conducting Research at Jesse Brown VAMC, v2.6 04/10/09 (R&D Packet)
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/jbvamc/Getting%20Started.pdf
Added hyperlinks to consent document; corrected office phone numbers; Reassignment of medical record flagging determination from R&D Office to Collaborative IRB starting February, 2009; Added final report & prompt reporting form to IRB protocol submission checklist; Updated FHPP policy; Updated Privacy Officer contact information; Removed bottom section of Scope of Individual's Work form; Clarified RCO function re: audits in the Research Subjects in CPRS Training Certification by PI document.

* Research and Development Standard Operating Procedures, v3.6, 4/10/09
http://tigger.uic.edu/depts/ovcr/research/protocolreview/irb/jbvamc/JBVAMC_SOP.pdf
Revised the Policy for Flagging Medical Records document

For information on the research impacts of the American Recovery & Reinvestment Act of 2009, please visit our web site at www.research.uic.edu/recovery.

For additional information, please review the Guidelines For Investigators Conducting Research At Jesse Brown VAMC document or contact OPRS.

Forms to be used for the Combined VA Panel

Panel IV

The process on your end will remain the same, except you may see the following differences:

All deferred, pending and approval letters will be on UIC letterhead. The consent forms, however, will contain the NU IRB approval stamp.
Please refer to the UIC website for differences in AE reporting.
You will receive an approval letter for all types of submissions, even though they require expedited review.
Piper Hawkins-Green, from our office will be copied on all correspondence

If your study involves radiation procedures that are to be performed on human subjects, please submit your application to Radiation Safety Officer for review prior to submitting your study to the IRB. The Radiation Safety Officer completes the Human Research Protocol Radiation Dose Supplement form and provides specific consent language for VA studies. Please contact the JBVAMC Radiation Safety Officer, David Derenzo at: 312-569-6596 / Page: 312-389-3674 / e-mail:david.derenzo@med.va.gov.

When submitting your continuing review submissions:

Submit your continuing review submission to our office 90 days prior to expiration in order to avoid lapse in approval.
Use the most current Continuing Review for Research Form and VA consent form template.
For those projects that have been converted into eIRB, upload the additional questions as a supporting document.
If you wish to remove the VA as a study site, we would recommend that you do so either before or at the time of continuing review.

After your IRB Project has been transferred to the Combined IRB Panel:

Continue to use NU IRB forms submitting Revisions and Prompt Reports to the IRB until further notice
Refer to the UIC website for differences in AE reporting.

Forms to be used for the Combined VA Panel

Contact Information

Northwestern University
Piper Hawkins-Green
IRB Coordinator, Panel Q & Panel V
Office of the Protection of Research Subjects
Institutional Review Board
750 North Lake Shore Drive
Suite 700
Chicago, IL. 60611
Phone (312) 503- 7929
Fax (312) 503-0555

University of Illinois, Chicago Campus
Barbie Maleckar
Institutional Review Board Coordinator
University of Illinois at Chicago
Office for the Protection of Research Subjects (OPRS)
Office of the Vice Chancellor for Research (M/C 672)
1737 West Polk Street - AOB Room 203
Chicago Illinois 60612-7227
IRB Phone: (312) 413-8457
ESCRO Phone: (312) 355-5288
FAX: (312) 413-2929