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From: UF IRB Mailing List <[log in to unmask]<mailto:[log in to unmask]>> On Behalf Of Simic,Ivana
Sent: Friday, March 27, 2020 2:03 PM
To: [log in to unmask]<mailto:[log in to unmask]>
Subject: Office of Research Guideline Update: Tier 2 Studies and Continuing Enrollment


Researchers and Research Staff,



The Office of Research has released the following change to the "Conducting Approved Human Subject Research during the COVID-19 Pandemic" guideline sent by Dr. Norton on 3/24/2020.  Link to revised guideline is https://research.ufl.edu/wp-content/uploads/humanresearchcovid.pdf

To avoid unnecessary work, the guideline for when a Tier 2 study can continue to enroll new study subjects is clarified below.  It is now up to the PI of a study to make that determination.  Please follow the guideline below.  Thanks!



Enrollment of new subjects must be paused unless there is a compelling reason to enroll new subjects.



*      Compelling reasons include:



o   There is a potential life or limb savings for the new study subject if enrollment is delayed over the next 2 months.

o   The study interventions cannot be obtained outside of the approved research protocol

o   Any direct contact by research personnel with study subjects must follow CDC and any state and UF COVID 19 guidelines



*      If study personnel must come on campus for research purposes only the PI must obtain approval from their dean or department chair.

*      Compliance with this guideline is the responsibility of the Principal Investigator.  Violations of this guideline will be considered serious protocol violations that would be reported the FDA or OHRP per UF policy.

*      Should the PI determine that there is a compelling reason to allow his or her protocol to continue study enrollment, the PI must document in their study records how they justified that decision.



*  If you are unsure and would like the IRB to make the decision, please submit a miscellaneous reportable event submission within myIRB.  You must complete and upload this request form :  http://irb.ufl.edu/wp-content/uploads/tier2exception.docx.<http://irb.ufl.edu/wp-content/uploads/tier2exception.docx.%20>



Thank you!

--
Ivana Simic, PhD
Assistant Director of Institutional Review Boards
University of Florida | Shepard Broad Building 130b
1300 Center Drive | Gainesville, FL 32610
Tel: 352-273-9604
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