Emory University IRB Approval

TO:

Patrick Sullivan, Ph.D., DVM
Principal Investigator
*SPH: Epidemiology

DATE:  February 25, 2016

RE:
Expedited Approval

IRB00085716

Mobile Messaging Intervention to Present New HIV Prevention Options for MSM
Thank you for submitting a new application for this protocol. This research is eligible for
expedited review under 45 CFR.46.110 and/or 21 CFR 56.110 because it poses minimal risk
and fits the regulatory categories F[(6) (7)] as set forth in the Federal Register. The Emory
IRB reviewed it by expedited process on 02/25/2016 and granted approval effective
from 02/25/2016 through 02/24/2017. Thereafter, continuation of human subjects research
activities requires the submission of a renewal application, which must be reviewed and
approved by the IRB prior to the expiration date noted above. Please note carefully the
following items with respect to this approval:
PS-15-002-Notice of Award and Research Project Cooperative Agreement (CDCCenters for Disease Control and Prevention)
MMI4MSM IRB Proposal (Nov 24)
Appendix A - Focus Group Discussion Guide
Appendix B - In-Depth Interview Guide
Appendix E - Eligibility Screener and information Collection Form
Appendix F - Core Messages.pdf
A Parital HIPAA waiver for identifying potential subjects and determining eligibility
was approved. 
Appendix G - Promotional Images and Guidelines.pdf
Appendix C - Focus Group Discussion Information Sheet
Appendix D - In-Depth Interview Information Sheet
Appendix H - Consent to Screen Form 
Waiver of Documentation of Consent was approved
Public Health Solutions_IAA_FullyExecuted_02222016.pdf
UMichigan_IAA_FullyExecuted_02232016.pdf
UMinnesota_IAA_FullyExecuted_02232016.pdf
Any reportable events (e.g., unanticipated problems involving risk to subjects or others,
noncompliance, breaches of confidentiality, HIPAA violations, protocol deviations) must be
reported to the IRB according to our Policies & Procedures at www.irb.emory.edu,
immediately, promptly, or periodically. Be sure to check the reporting guidance and contact

us if you have questions.  Terms and conditions of sponsors, if any, also apply to reporting. 
Before implementing any change to this protocol (including but not limited to sample size,
informed consent, study design, you must submit an amendment request and secure IRB
approval.
In future correspondence about this matter, please refer to the IRB file ID, name of the
Principal Investigator, and study title. Thank you
Will Smith, MPH
IRB Research Protocol Analyst
This letter has been digitally signed

CC:

Olansky
McKenney
Rosenberg
Siegler

Evelyn
Jennie
Eli
Aaron

*SPH: Epidemiology
*SPH: Epidemiology
*SPH: Epidemiology
*SPH: Epidemiology

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