ChiCAS IRB Amendment Lewis

Of f i ce o f R es earch
INSTITUTIONAL REVIEW BOARD.

MEMORANDUM

______________________________________________________________________________________

To:

Scott Rhodes, Ph.D.
PHS-Social Sciences

From:

Deborah Wesley, Assistant Director, Institutional Review Board

Date:

9/11/2019

Subject:

Human Protocol: IRB00040441
HIV Prevention among Latina transgender women who have sex with men: Evaluation of
a locally developed intervention
Amendment 28 for IRB Study #IRB00040441 (Personnel Change Request)

Study Documents:
Protocol Version: ChiCAS Protocol (08 22 19).docx; Informed Consent Version: Appendix C1_English
Consent Form.doc.docx (approved), Appendix C2_Spanish Consent Form.docx (approved);
Advertisements: Appendix H1_English Informational Flyers.pdf, Appendix H2_Spanish Informational
Flyers.pdf; Other Documents: Appendix B1_English Participant Screening Form.docx, Appendix
B2_Spanish Participant Screening Form.docx, Appendix D1_English Questionnaire.docx, Appendix
D2_Spanish Questionnaire.docx, Appendix E_Spanish-language ChiCAS Curriculum Manual.docx,
Appendix F_Implementation Observer's Guide.docx, Appendix G_Participant Attendance Log.docx,
Appendix I_Medical Chart Abstraction Form.docx, Appendix J_Data Sharing and Use Agreement.docx,
Appendix K1_English Qualitative In-Depth Interview.docx, Appendix K2_Spanish Qualitative In-Depth
Interview.doc, Appendix L1_English Stay In Touch Cards.docx, Appendix L2_Spanish Stay In touch
Cards.docx, Appendix M1_English Appointment Card.docx, Appendix M2_Spanish Appointment
Card.docx, Appendix N_Individual Investigator (Trent) IRB Agreement.pdf, Appendix O_UNC
Greensboro IRB Agreement.pdf, Appendix P1_English script for DVD1 (HIV impacts).docx, Appendix
P2_Spanish script for DVD1 (HIV impacts).docx, Appendix Q1_English outline for DVD2 (PrEP
etc.).docx, Appendix Q2_Spanish script for DVD2 (PrEP etc.).docx, Appendix R_Hormone Therapy PPT
curriculum (Sp).pptx, Appendix S_HIV and STDs PPT curriculum (Sp).pdf, Appendix T_PrEP PPT
curriculum (Sp).pptx
The amendments listed below have been approved in accordance with HHS regulations for the protection
of human research subjects that provides for the expedited review and approval of minor changes in
previously approved research [45 CFR 46.110(b)(2)]. This action of the Board does not extend the term of
approval for this protocol.
The amendment includes the following:
Adding Lisa Lewis as study coordinator.

The Wake Forest School of Medicine IRB is duly constituted, has written procedures for initial and continuing review of
clinical trials; prepares written minutes of convened meetings, and retains records pertaining to the review and

Medical Center Boulevard, Winston -Salem, NC 2715 7-1023

(336) 716-4542 / fax (336) 716 -4480

approval process; all in compliance with requirements of FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45
CFR 46, and International Conference on Harmonisation (ICH) E6, Good Clinical Practice (GCP), as applicable. WFSM IRB
is registered with OHRP/FDA; our IRB registration numbers are IRB00000212, IRB00002432, IRB00002433,
IRB00002434, IRB00008492, IRB00008493, IRB00008494, and IRB00008495.
WFSM IRB has been continually fully accredited by the Association for the Accreditation of Human Research Protection
Programs (AAHRPP) since 2011.