Att 5a_Emory IRB Approval

6/18/2018

TO:

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Patrick Sullivan, DVM PhD
Principal Investigator
*SPH: Epidemiology

DATE: June 18, 2018
RE:

Expedited Approval
IRB00099710
iSTAMP (Implementation of Rapid HIV Self-Testing among MSM Project)

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 expedited
review categories F(1b, 2a, and 7) as set forth in the Federal Register. The Emory IRB reviewed it
by expedited process on 6/15/2018 and granted approval effective from 6/15/2018 through
6/14/2019. 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.
A request to waive documentation of informed consent (i.e. signature) for screening purposes only
has been approved. Signed consent must be obtained before doing any human subjects research
beyond the screening procedures described in the approved protocol. Please note that you are
required to consent subjects for screening with the verbal consent script approved with this
submission, and document this consent process. Informed consent has not been waived; only the
requirement for subject signature has been waived.
A complete waiver of HIPAA authorization and informed consent has been granted by the IRB.
Protected Health Information of which use or access has been determined to be necessary by the
IRB:
HIV Surveillance Data held by state and federal entities
The following documents are approved for use or otherwise acknowledged:
CDC Grant Application 1U01PS005181-01
Study Protocol, version date May 3, 2018
Research Instruments, undated:
Eligibility Screener
Registration
Baseline Survey
Follow-up Survey
HIV Test Result Reporting Survey
Recruitment Materials, undated:
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6/18/2018

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Consent Documents, both version date 05/22/2018:
Screening Assessment Consent form
Main Consent form
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,
Samuel Roberts
Senior Research Protocol Analyst
This letter has been digitally signed

CC:

Gravens
Weiss
Benkeser
Curran
Jones
Sanchez

Laura
Kevin
David
James
Jeb
Travis

*SPH: Epidemiology
*SPH: Epidemiology
*SPH: Biostatistics
EVP Health Affairs
*SPH: Epidemiology
*SPH: Epidemiology

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

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