Att 4_Emory IRB Ltr of Approval

Date: April 19, 2016
Paula Frew, Ph.D., MA, MPH
Principal Investigator
SOM: Medicine: Infectious Dis

RE:

Exemption of Human Subjects Research
IRB00086980
Local Effectiveness Assessment Project, Part II: Case Studies of Local
Jurisdictions Providing HIV Services to Men Who Have Sex with Men
(MSM)

Dear Dr. Frewr:
Thank you for submitting an application to the Emory IRB for the above-referenced
project. Based on the information you have provided, we have determined on
04/19/2016 that although it is human subjects research, it is exempt from further IRB
review and approval.
This determination is good indefinitely unless substantive revisions to the study design
(e.g., population or type of data to be obtained) occur which alter our analysis. Please
consult the Emory IRB for clarification in case of such a change. Exempt projects do
not require continuing renewal applications.
This project meets the criteria for exemption under 45 CFR 46.101(b)(2). Specifically,
you will .In this project, you will conduct four cross-sectional case studies in Houston,
Miami, New Orleans, and Washington, DC. You seek to identify and describe the set
of local conditions that currently promote or impede successful delivery of HIV
prevention, care, and treatment services to MSM residing in the city. You will take a
comprehensive approach and assess jurisdiction-wide factors affecting the
effectiveness of MSM services being delivered by local health departments, Ryan
White clinical programs, community based organizations, and other private nongovernmental organizations in each city. You will also utilize an integrated approach to
gather and analyze information, including qualitative and structured data collection
methods.

The following documents were reviewed as part of the approval process:
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Appendix B LEAP 2 consent 4.0.DOCX
LEAP 2 Study Protocol 6.0. DOCX
Appendix A Scripts and materials v3.0.DOCX
Appendix C LEAP - 2 Revised KPI Guide - CM Version 4.0.DOCX
Appendix C LEAP - 2 Revised KPI Guide - HD CBO Version 6.0. DOCX
Appendix D LEAP - 2 Structured Observation tools v4.0.DOCX
Appendix E LEAP - 2 Document review tools.docx

Please note that the Belmont Report principles apply to this research: respect for
persons, beneficence, and justice. You should use the informed consent materials
reviewed by the IRB unless a waiver of consent was granted. Similarly, if HIPAA
applies to this project, you should use the HIPAA patient authorization and revocation
materials reviewed by the IRB unless a waiver was granted. CITI certification is
required of all personnel conducting this research.
Unanticipated problems involving risk to subjects or others or violations of the HIPAA
Privacy Rule must be reported promptly to the Emory IRB and the sponsoring agency
(if any).
In future correspondence about this matter, please refer to the study ID shown
above. Thank you.
Sincerely,
Will Smith, MPH
Research Protocol Analyst
This letter has been digitally signed

CC:

Randall Laura SOM: Medicine: Infectious Dis

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