Featured Research Program
VETERANS AFFAIRS (VA) Science and Health Initiative to Combat Infectious and Emerging Life-Threatening Diseases (SHIELD)
VA SHIELD is a comprehensive repository of biospecimens and associated data that was developed in response to COVID-19 to improve the Nation’s preparedness for national emergencies and emerging pathogens of concern. VA SHIELD was established to rapidly and efficiently capture critical biospecimens early in an outbreak or pandemic.
The organizational structure of VA SHIELD includes an Executive Steering Committee that meets quarterly and provides oversight as it pertains to operational activities and strategic planning. The Programmatic and Scientific Review Board that reviews all requests submitted to use biospecimens or data contained in VA SHIELD biorepository and the associated Laboratory Information Management System.
The day-to-day management and coordination between the organizational committees and the 14 collection sites across the US is directed by the VA SHIELD Coordinating Center. Dr. Robert A. Bonomo (Louis Stokes Cleveland VAMC) is the Director of the Coordinating Center (CC) of VA SHIELD. Other members of the CC include, the Associate Director of Data & IT, Dr. Saiju Pyarajan (VA Boston Healthcare System), the Associate Director of Biospecimens, Dr. Ian Robey (Southern Arizona VA Healthcare System), the Associate Director for Strategic Research Initiatives, Dr. Carey L. Shive (Louis Stokes Cleveland VAMC), and the Associate Administrative Director, Mr. Emerson B. Padiernos, (PHRL, Palo Alto). Dr. Holly K. Krull, Deputy Director, Biomedical Laboratory Research & Development, oversees the entire VA SHIELD program at the ORD level.
Currently, VA SHIELD has approval to collect discarded samples from the VA Clinical Laboratories after all clinical testing has been completed. These samples primarily consist of nasal or wound swabs or remaining serum or plasma. The VA SHIELD SWEEP Protocol is cIRB approved and allows sites to collect, store, and send discarded samples. VA SHIELD has submitted an addendum to the SWEEP Protocol that will allow for informed consent of veterans to collect VA SHIELD samples and to allow VA SHIELD to incorporate legacy collections of veteran samples into VA SHIELD.
As mentioned, the VA SHIELD repository was originally developed in response to COVID-19, but the power of having a national VA biospecimen and data repository for other disease of concern for veterans, was quickly realized. In response, VA SHIELD has established a number of scientific working groups composed of VA researchers to help guide the collection and use of VA SHIELD specimens and resources. The working groups meet periodically to discuss possible projects to best use samples from the biorepository, as well as to discuss what sample collections will have the most meaningful impact on veteran health and VA research. VA SHIELD is establishing working groups for 1) Antimicrobial Resistance, 2) Host Response to Infection, 3) Epidemiology and Sequencing, 4) Long COVID/PASC, 5) Cancer and Cancer Biomarkers, and soon, 6) Vector Borne Diseases.
For more information about VA SHIELD visit https://www.research.va.gov/programs/shield/about.cfm. Or, email VASHIELD@va.gov, Carey Shive at carey.shive@va.gov, or Robert Bonomo at Robert.bonomo@va.gov
Research Forums
Research forums will be held monthly at the VA in Room K119. Our spring schedule for forums is listed below. We encourage you to attend in person if you can. If you are unavailable to attend in person, you will have the option to view the presentation via Teams.
Tuesday, July 18 @ 1:00pm
Privacy Q & A:
presented by Joe Picklo and Tomica Jefferson, Privacy Specialists
Microsoft Teams meeting; Join on your computer, mobile app or room device
Meeting ID: 216 390 136 01 Passcode: vvDwK7
Or call in (audio only)
+1 872-701-0185,,643 542 369#
Click here to join the meeting
Tuesday, August 15 @ 1:00pm
Non-Veterans in VA Research: presented by Christina Bennett, Health System Specialist
Tuesday, September 19 @ 1:00pm
Modifications and Closures with IRB: presented by, Jacqueline Charles, IRB Administrator & Joy Volpi IRB Coordinator
Updated SOP's
https://www.clevelandvaresearch.org/research-sops
HSP-003 Documentation in CPRS- changes were made to clarify what should be included in CPRS record (updated 7/6/2023)
For questions, contact Candice Toney, Education/Policy Specialist candice.toney@va.gov
Research Compliance Office
Consenting Subjects
When consenting a subject, remember to always thoroughly check the documents for completeness and accuracy – before the subject leaves the room. This helps ensure you’ve covered everything, to check again that the subject has understood everything presented to them, and it gives you an opportunity to catch mistakes while they are still easily fixable. Come prepared to consenting appointments with pens that work well and a checklist to help yourself remember all aspects of the consenting process. Finally, don’t forget to provide the subject a complete copy of all consenting documents that they sign.
Informed Consent Audit Report
We have begun to enter informed consent/HIPAA document audit results into IRBNet so going forward, our audits that have no findings will appear in IRBNet and you will not receive an email from the Compliance Office with no finding results as this is repetitive. For audits that have findings, we will continue to email these to you, along with communication during findings resolution- as well as upload into IRBNet initial findings and resolutions.
Questions can be directed to the Compliance Office: Brian Williams brian.williams5@va.gov (Acting Research Compliance Officer) or Heba Alhmidi heba.alhmidi@va.gov (Research Compliance Auditor)
Office Hours (Research Compliance & Education)
Research Compliance Office & Research Service (Education) have an open forum via teams the 2nd & 4th Friday of each month from 12:30pm-1:00pm
During the office hours you can come and ask any questions that you may have about Research Compliance/Research Education.
If you have a topics that you would like for us to discuss in future office hours, please feel free to send an email to candice.toney@va.gov
Please use the link below to join us Friday, July 21st at 12:30pm
Join on your computer, mobile app or room device
Click here to join the meeting
Meeting ID: 272 015 014 191 Passcode: kDx3KT
Study Initiation Visits
What is a Study Initiation Visit?
The study initiation visit encompasses a review of regulatory requirements as they apply to your specific study, good clinical practice guidelines, the informed consent and HIPAA documents as well as a review of how to maintain study records (regulatory binder and subject files).
The Research Compliance Office is required to perform a triennial regulatory audit of studies (human subjects' research, animal protocols, and basic science studies) and informed consent and HIPAA audits if applicable. The intent of a study initiation visit is to help the researcher avoid the most common audit findings before they occur.
Did you know that you can schedule a Study Initiation Visit with the Research Service?
The study initiation visit is available to all research staff. If you are new to research or need a refresher, you can schedule a study initiation visit today.
For scheduling or questions contact Candice Toney at Candice.Toney@va.gov or 216-791-3800 x66785
Upcoming VA Research Funding Deadlines
VA BLR&D, CSR&D and RR&D SPiRE funding applications will be submitted in September. if you are planning to submit a grant application this upcoming Fall cycle, please contact Joe Bennett (Joseph.Bennett2@va.gov).
RR&D SPiRE Pre-Applications will be due on August 1st.
All submissions must be reviewed and approved by the R&D Committee prior to submitting. See below.
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R&DC Submission Deadline
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Meeting Date
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July 25
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August 3
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August 8
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August 17 (This is the last meeting for NEW submissions)
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August 29
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September 7 (Only resubmissions will be reviewed at this meeting)
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Office of Research & Development
Upcoming Webinars: Office of Research Protections, Policy, and Education Webinars (va.gov)
Archived webinars can be found at: ORPP&E Webinar Archive (va.gov)
Stay Connected
VA Northeast Ohio Healthcare System
Cleveland Research Website
Office of Research & Development
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