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UF has separate, specific instructions for submitting new studies or revisions to previously approved studies. All other submissions such as continuing reviews, deviations, adverse events, unanticipated problems, etc.
must meet the following:
| 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: 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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