Submit a New Study to WIRB

Steps

I.     Obtain a Financial Language Assessment (FLA) from the Office of Clinical Research (OCR)

Financial Language Assessments are issued by the Office of Clinical Research (formerly Research Administration and Compliance-RAC) to ensure that the fiscal language in study informed consents accurately reflects the correct terms for Costs and Subject Injury. You must include a copy of the FLA in order for WIRB to accept any new studies that involve the Gainesville Campus.

To obtain a FLA for your study, you will need to submit a completed Study Registration Packet to the OCR/RAC via COM-RAC-L@LISTS.UFL.EDU.

Start by filling out the Study Registration Initiation Checklist to determine what forms you will need to include in the packet.    Note: You must factor in the time it will take you to prepare a correct & complete  packet (plan additional time if you need to obtain Shands Confirmation of Services Forms). The OCR/RAC will not assess your packet until AFTER it is complete and accurate.

Allow a minimum of 5 working days for OCR/RAC review of your complete packet when considering upcoming IRB deadlines. Researchers must be proactive and provide a completed study packet to OCR/RAC as soon as possible to initiate the compliance review process.

II.     Obtain the Institutional Number for Your Study

All University of Florida Gainesville study submissions to WIRB require provision of an “Institutional Number.” This institutional number is a unique UF identifier that allows UF to map WIRB approval data back to specific UF protocols. This WIRB requirement applies to all submissions – new and continuing.

How Do I get the Institutional Number for my Study? UF will be using the OCR/RAC# issued by the Office of Clinical Research as the Institutional Number. Since November 2009, the OCR/RAC# has been provided on the Financial Language Assessment (FLA) form on the right side of the study information box at the top of the FLA form.

Note: Labels for this number have varied slightly over time; some older FLAs labeled this number “PS Proposal #” or “RAC Logbook #”. FLAs currently include the label “Institutional /OCR#.”

III.     Complete a UF Cover Letter

All submissions from UF and Shands researchers to WIRB must include a copy of our UF Cover Letter.  You must include the UF Cover Letter with your submission to WIRB to ensure:

A. that the paperwork approved by WIRB complies with UF specific requirements. For example- UF requires certain language in the Informed Consent form that WIRB does not necessarily require in consent forms for other institutions. Of considerable importance is that the Consent includes our local language for (a) payment related to injuries and (b) HIPAA authorizations.

B. that UF and its research related offices are properly notified about the status of your research.

Failure to complete and include our UF cover letter can result in compliance issues for you later, the least of which may be having to revise your paperwork and resubmit to WIRB (which will obviously include a fee).

NOTE 1: Sometimes sponsors complete the paperwork and submit it to WIRB on your behalf. It is incumbent upon you, the PI, to insure that the UF cover letter is included with the submission. The administration is not likely to absolve you in a compliance situation if your excuse is “the sponsor submitted it for me”.

NOTE 2: DEVICE TRIALS: Since Shands is responsible for acquiring, storing, and billing for devices researchers must contact Shands prior to submitting to WIRB in order to facilitate the hospital’s acquisition and compliant billing of the devices. Please see http://rac.med.ufl.edu/preparation/billing-plan/device_study/ and the OCR/RAC Device Table for details.

IV.     Submit to WIRB

V.     Write your Informed Consent form(s) in the special UF Informed Consent form template for WIRB

NOTE 1: WIRB or your sponsor may have their own version of the consent. This must be adapted into UF’s template for WIRB consent forms. Please note that this template must include UF’s specific language for (a) HIPAA authorization and (b) costs / payment associated with study and study-related injuries. UF Costs and Subject Injury language must be reviewed and approved by the Office of Clinical Research (see FLA section I above).

NOTE 2: If WIRB or your sponsor writes your informed consent for you, it is still your responsibility to ensure that the approved consent form is in UF’s template and includes the appropriate language.

VI.     Submit to HURRC

Submit all new protocols (regardless of whether you believe the protocol includes radiation or not) to HURRC prior to submitting to WIRB. Complete and print our HURRC Cover Letter, enclose a copy of the protocol, and mail to: Susan Stanford Box 118340 Gainesville, FL 32611-8340 sstanford@ehs.ufl.edu.

VII.     Obtain Pharmacy Verification

If your protocol involves drugs, biologics, or other agents you must complete both of the following steps:

A. Submit a copy of the sponsor’s protocol and Investigator Brochure (if available) to the Shands Pharmacy prior to submitting the study to WIRB. You may submit by email to the following address: IDS@shands.ufl.edu or by campus mail to: HSC Investigational Drug Service Pharmacy, Box 100316, Gainesville, FL 32610-0316.  Please include current protocol, Investigator Brochure, and Pharmacy Manual (if available).

B. When submitting your project to WIRB you need to include a copy of the WIRB Pharmacy cc letter. This will insure that WIRB directly notifies the Shands Pharmacy about all of the approvals for your project: initial, continuing review, as well as amendments. Failure to send this letter to WIRB can result in your project/treatment being delayed while pharmacy verifies that your project or project revisions have been approved by WIRB.

VIII.     Obtain Institutional Biosafety Committee Review (if applicable)

If your study involves Human Gene Therapy, you MUST

A. Notify Michael Mahoney at (352) 273-9601 prior to submitting the study to WIRB.

B. Submit a copy of your project to the Institutional Biosafety Committee (IBC) at UF. You may not use the IBC at WIRB. A project that needs IBC review cannot begin until it has the approval of both the UF IBC and IRB. Click here IBC Cover Letter for additional information about submitting paperwork to the UF IBC. For more information, contact UF IBC, Box 112190, UF, Gainesville, FL 32611.