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Submit a new study to WIRB
STEP 1:

Obtain a Financial Language Assessment (FLA) from the Research Administration and Compliance (RAC) office. Effective 11/2009 you must include a copy of the FLA in order for WIRB to accept any new studies that involve the Gainesville Campus. In order to obtain a FLA for your study you will need to submit a completed RAC Study Registration Packet to COM-RESEARCH-ADMIN-COMP-L@LISTS.UFL.EDU. Start by filling out the RAC Study Initiation Checklist to determine what forms you will need to include in the RAC Packet. 

Note:

You must factor in the time it will take you to prepare a correct & complete RAC packet (plan additional time if you need to obtain Shands Confirmation of Services Forms).  The RAC will not assess your packet until AFTER it is complete and accurate. Allow a minimum of 5 working days for review of your complete RAC packet when considering upcoming IRB deadlines.

Researchers must be proactive and provide a completed RAC packet to RAC as soon as possible to initiate the compliance review process.

   
STEP 2: 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 insure:
  (1) 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.
  (2) that UF and it's research related offices are properly notified about the status of your research.
NEW! (3)

New WIRB Submission Requirement

Beginning May 9th, 2012, all University of Florida Gaineville study submissions to Western IRB (WIRB) will require provision of an “Institutional Number”. This institutional number is a unique UF identifier that will allow UF to map WIRB approval data back to specific UF proposals. This new WIRB requirement applies to all submissions - new and continuing.

How do I get the Institutional Number for my Study?

UF will be using the Research Administration and Compliance (RAC)# as the Institutional Number.    Since November 2009, the RAC# has been provided on the RAC Financial Language Assessment (FLA) form on the right-side of the study information box at the top of the FLA form. Labels for this number varied slightly over time; some older FLAs labeled this number “PS Proposal #” or “RAC Logbook #”.  FLAs will now include the label “Institutional /RAC#”.   

For older, continuing studies that have never had a FLA issued, the Institutional Number can be obtained from the RAC office via COM-RESEARCH-ADMIN-COMP-L@LISTS.UFL.EDU. Be sure to include the following information in the request:

  • PI Name and UFID
  • Study Title
  • PeopleSoft Proposal  number (if applicable)
  • WIRB number
 

Failure to complete and include our UF coverletter 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:When a study involves a device that has to be purchased, received, or stored by Shands Healthcare, the Shands Supply Chain Services department should be contacted to determine whether a contract between the sponsor and Shands is required.  Since the contracting process may take several weeks, it is recommended that researchers contact Shands as early in the start-up process as possible. Researchers should ensure their sponsors contact Shands to make appropriate arrangements for device procurement and/or storage, as appropriate:

Sponsors should contact:
Dawn Watkins, Shands Strategic Sourcing Manager
352-733-0370
watkid@shands.ufl.edu

When completing the Device Table as part of the Study Registration and Initiation Checklist for the Research Administration and Compliance (RAC) office, you will be asked to provide the name of the person contacted at Shands and the date of contact.

Please note that accurate billing and reimbursement information is important for the "costs section" of the Informed Consent form. However, for some device studies, Medicare coverage is contingent upon pre-approval from the local Medicare contractor, First Coast Service Options, Inc. (FCSO). Shands is not able to request pre-approval from FCSO until after the study receives IRB approval. Depending upon the decision from FCSO, you may be required to amend the approved Informed Consent form to provide updated information for the “costs section”. More information on Device Studies and Medicare Pre-Approval may be found on the RAC website.

   
   
STEP 3:

Submissions can be entered electronically or submitted via downloaded forms:

WIRBNet login is available on the top right side of any WIRB webpage: http://wirb.com
--Note: you must register with WIRB Client Services to access WIRBNet.

Downloadable forms are available at: http://wirb.com/Pages/DownloadForms.aspx

Inital Review FAQs: http://wirb.com/Pages/FAQ.aspx?LinkedClickable=44

   
STEP 4:

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.

Study costs template

Injury related costs template

   
NOTE 2: if WIRB or your sponsor writes your informed consent for you, it is still your responsibility to insure that the approved consent form is in UF's template and includes the appropriate language.
   
NOTE 3: if your study involves any clinical procedures that might result in subjects being billed you must verify with the Clinical Trials Compliance office at (352) 273-5946 that the language matches the Clinical Trial Agreement (if needed) and that billing mechanisms are appropriate.
   
STEP 5: 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

HURRC Cover Letter
STEP 6:

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 at UF Pharmacy prior to submitting the study to WIRB. Complete and print a copy of the Pharmacy Cover Letter, enclose a copy of the protocol and Investigator Brochure, and mail to:
 
HSC Susan Beltz, PharmD
Box 100316
Gainesville, FL 32610-0486
IDS@shands.ufl.edu
Shands Pharmacy Cover Letter (initial submission)
   
(B) When submitting your project to WIRB you need to include a copy of the WIRB Pharmacy cc letter (this is different than the Pharmacy Letter named above). This will insure that WIRB directly notifies the Shands at UF 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.

 

STEP 7:

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.

 

 

UF IBC
Box 112190
UF
Gainesville, FL 32611

Click here for additional information about submitting paperwork to the UF IBC.

IBC Cover Letter

 


 
University of Florida Last updated August 22, 2013 13:57