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| STEP 1: |
All submissions from UF and Shands researchers to WIRB must include a copy of our
UF Cover Letter. |
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You must include the UF Cover Letter with your submission to WIRB to insure: |
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(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. |
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(2) |
that UF and it's research related offices are properly notified about the status of your research. |
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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". |
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| 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 of the devices. Since this process can take some time, researchers are recommended to contact Shands when you start calculating the budget for your trial. Shands asks that you simply e-mail Theresa O'Connell at oconta@shands.ufl.edu with basic information such as:
- Device name & Description
- IDE #
- Device Category
- Anticipated cost
- Funding Source
- Storage location
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| You could complete this information as part of the Clinical Trials Compliance Office's "Study Registration Form" and simply e-mail Theresa a copy of the form. |
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You do not need all of the above information to initiate the process. Please note that negotiating the acquisition and billing/reimbursement for devices can take some time. Failure to contact Shands early in the initiation of your study (ideally when you are budgeting for the trial) could delay you from enrolling subjects - so please contact them early!
Also of note, accurate billing and reimbursement information is important for the "costs section" of the Informed Consent form. If Shands learns insurers won't cover the cost of the device your study could be further delayed because you may need to revise your study with WIRB before you can start. Please contact the Clinical Trials Compliance Office (http://ctc.health.ufl.edu/index.shtml) for additional information about billing compliance. |
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| STEP 2: |
Prepare your submission as described at : http://www.wirb.com/content/quick_new_study.aspx |
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| STEP 3: |
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 |
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| 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. |
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| 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. |
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| STEP 4: |
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: |
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Don
Munroe
Box 118340
Gainesville, FL 32611-8340
don@ehs.ufl.edu
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HURRC
Cover Letter |
| STEP 5: |
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: |
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Shands Pharmacy
Cover Letter (initial submission) |
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| (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. |
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| STEP 6: |
If
your study involves Human Gene Therapy, you MUST
| (A) |
notify Michael Mahoney or Robert Vomacka at (352) 846-1494 prior to submitting the study to WIRB. |
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| (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. |
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UF
IBC
Box 112190
UF
Gainesville, FL 32611
Click
here for additional information about submitting paperwork
to the UF IBC. |
IBC
Cover Letter |
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