Att 6l_Wake County Health Department IRB agreement

DocuSign Envelope ID: A588A788-A094-4A67-9ED9-23A0B3865BBD

Institutional Review Board (IRB) Authorization Agreement
Name of Institution or Organization Providing IRB Review (Institution/Organization A):
Florida State University (FSU)
IRB Registration #: IRB00000446 Federalwide Assurance (FWA) #, if any: FWA00000168
Name of Institution Relying on the Designated IRB (Institution B): Wake County Health & Human
Services
IRB Registration #: _____________ Federalwide Assurance (FWA) # FWA00009724
_________________________________________________________________________________
The Officials signing below agree that may rely on the designated IRB for review and continuing
oversight of its human subjects research described below: (check one)
(___) This agreement applies to all human subjects research covered by Institution B’s FWA.
(__xx) This agreement is limited to the following specific protocol(s):
Name of Research Project: Expanding PrEP in Communities of Color (EPICC+) STUDY00003652
Name of Principal Investigator: Dr. Lisa Hightow-Weidman
Site Investigator at Wake County Health: Dr. Christopher Sellers
Sponsor or Funding Agency:
Award Number, if any:
(___) Other (describe):________________________________________________________________
The review performed by the designated IRB will meet the human subject protection requirements of
Institution B’s OHRP-approved FWA. The IRB at Institution/Organization A will follow written
procedures for reporting its findings and actions to appropriate officials at Institution B. Relevant minutes
of IRB meetings will be made available to Institution B upon request. Institution B remains responsible for
ensuring compliance with the IRB’s determinations and with the Terms of its OHRP-approved FWA. This
document must be kept on file by both parties and provided to OHRP upon request.
Signature of Signatory Official (Institution/Organization A):
________________________________________ Date: ___________

Print Full Name: T. Howard Stone, JD, LLM, CIP Institutional Title: Director Office for Human Subjects
Protection
Signature of Signatory Official (Institution B):
2/22/2023

________________________________________ Date: ___________
Kaufman
Health Director, Wake County Health & Human Services
Print Full Name: Rebecca
_____________
Institutional Title: ______________________