Research@UIC > Protocol Review > JBVAMC

Research at Jesse Brown VA Medical Center (JBVAMC)

ANNOUNCEMENTS

Research and Development at Jesse Brown VAMC

About JBVAMC

All research that engages the JBVAMC, including recruitment of JBVAMC staff, patients, and volunteers or use of JBVAMC resources, must have approval of the JBVAMC Research & Development (R&D) Committee before the research may begin at the JBVAMC. The UIC IRBs have responsibility for review of human subject research to be conducted at the JBVAMC and involving investigators with joint UIC and JBVAMC appointments or investigators with solely JBVAMC appointments. A protocol is first reviewed by the UIC IRBs, and must be approved before final review of the protocol by the JBVAMC R&D Committee.

For Investigators doing research with the JBVAMC, the following links provide helpful information, what you need to know to submit, and VA forms and guidelines.

Submission and Review Procedures for Human Subject Research Proposals to be conducted at the JBVAMC

Step 1: The investigator prepares both the UIC IRB and JBVAMC R&D Committee proposal applications. Please refer to the JBVAMC R&D IRB Protocol Submission Checklist to ensure that you have completed all required documents for submission. The investigator is responsible for ensuring the IRB application and implementation of research comply with the VHA Handbook 1200.5 and other applicable VA requirements.

Step 2: To ensure all applicable submission documents and requirements have been completed, a pre-review of the UIC IRB and JBVAMC R&D application materials is performed by the JBVAMC R&D office staff before submitting the IRB application to the UIC OPRS. Two (2) copies of the IRB and R&D applications, including all necessary forms, should be brought to the R&D office for the pre-review. Only after the pre-review is completed and the R&D Office staff sign-off on the JBVAMC R&D IRB Protocol Submission Checklist will the research project be accepted by UIC OPRS for IRB review.

Step 3: After obtaining the signed JBVAMC R&D IRB Protocol Submission Checklist from the R&D Office, the investigator is ready to submit the IRB application and applicable sections of the R&D application to the UIC OPRS. The following JBVAMC R&D application documents (as applicable) must be attached to each copy of the research protocol application for submission to the IRB:

VA consent document (printed on form 10-1086),
VA consent for use of picture and/or voice (form 10-3202),
VA HIPAA Authorization form,
VA Investigational Drug (form 10-9012),
VA Tissue Banking application,
Application for an Off-Site Tissue Banking Waiver (VA form 10-0436),
PI Certification of Storage and Security of VA Research Information,
Data Security Checklist, Radioactive Exposure Supplement,
and VA Conflict of Interest Form or Statement of Disclosure.

Three (3) copies of the signed JBVAMC R&D IRB Protocol Submission Checklist must also be submitted with the initial application to the IRB.

Step 4: Only after UIC IRB review and approval of the research will review by the JBVAMC R&D Committee occur. The UIC OPRS will provide the R&D committee with all IRB approved VA consent documents, HIPAA Authorizations and recruitment materials along with a copy of the IRB approval letter and approved IRB application submission (including revised protocol document, if applicable). On receiving these documents, the R&D office will schedule review of the research by the R&D committee and any relevant subcommittees. Although the research may begin at UIC once UIC IRB approval is granted, the research may not be initiated at JBVAMC until final R&D approval is obtained.

Step 5: Following JBVAMC R&D committee review, the investigator will be informed of the decision in writing and, if approved, all research related documents (consents, HIPAA authorizations, recruitment materials) approved and stamped for use at the JBVAMC will be distributed to the investigator.