WIRB: Revising your study

IRB-04 Links

STEP 1:

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.
	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".

STEP 2:

If the protocol and/or Investigator Brochure has been revised, submit the revised paperwork to Pharmacy prior to submitting it to WIRB. Complete and print the Pharmacy revision cover letter, enclose a copy of the protocol and Investigator Brochure, and mail to:

HSC	Debbie Kahler, PharmD Box 100316 Gainesville, FL 32610-0486 kahled@shands.ufl.edu
AGH	Peter Iafrate, PharmD 801 SW 2nd Ave Gainesville, FL 32601 iafrate@shands.ufl.edu

Shands Pharmacy Cover Letter (revision)