IRB_Approval_Letter_Part_1_and_2_09252012[1]

TO:

AD McNaghten
Principal Investigator
Epidemiology

DATE: September 25, 2012
RE:

Full Board Approval
IRB00057255
Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities

Thank you for submitting a new application for this protocol. The Emory IRB
reviewed it at its convened meeting on 8/1/2012, met all of its contingencies on
9/19/2012 and granted effective approval from 8/1/2012 through 7/31/2013.
Thereafter, continuation of human subjects research activities requires the submission
of another 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 reapproval:
Partial HIPAA waiver was granted
The following devices were determined to be non-significant risk:
SureCheck'
OraQuick
Also, these documents have been approved during the initial review:
eSTAMP Parts 1-2 Protocol 06132012
Eligibility Screener 05.18.2012
Focus Group Discussion Guide 05.18.2012
In Depth Interview Guide 05.18.2012
Proficiency Assessment Observation Forms 06132012
Proficiency Assessment Survey 05.18.2012
Proficiency Assessment Testing Panel Images 05.18.2012
Eligibility Screener Consent 06132012
Focus Group Consent 06132012
In Depth Interview Consent 06132012
Proficiency Assess Consent 06132012
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.
Sincerely,
Aric Edwards
Research Protocol Analyst
This letter has been digitally signed

CC:

Ricca
Sullivan

Alexandra
Patrick

Public Health
Epidemiology

Emory University
1599 Clifton Road, 5th Floor - Atlanta, Georgia 30322
Tel: 404.712.0720 - Fax: 404.727.1358 - Email: irb@emory.edu - Web: http://www.irb.emory.edu/
An equal opportunity, affirmative action university