Recruitment - 3 IRB Letter

WHBSirbapproval2012.webarchive

TO:

2/13/12 3:26 PM

Patrick Sullivan, PhD, DVM
Principal Investigator
Epidemiology

DATE: January 26, 2012
RE:

Continuing Review Expedited Approval
CR1_IRB00047676
IRB00047676
Web-based HIV behavioral trend analysis among men who have sex with men (MSM)

Thank you for submitting a renewal application for this protocol. The Emory IRB reviewed it by
the expedited process on 01/22/2012, per 45 CFR 46.110, the Federal Register expeditable
category(ies) F(6), F(7), and/or 21 CFR 56.110. This reapproval is effective
from 02/08/2012 through 02/07/2013. 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:
A request to waive documentation of written/signed informed consent has been reviewed
and renewed under 45 CFR 46.117(c)(1): 1) the research is not FDA-regulated AND; 2) the
only record linking the subject and the research would be the signed consent document
AND; 3) the principal risk of the research would be potential harm resulting from a breach
of confidentiality.
Document(s) reviewed with this application:
EmoryIRBprotocol_HIV_Behavioral_Analysis_10_13_11Editsv09
221995_Consent1_4800_MSM Web Surveillance Survey PILOT
Consent_Spanish_Version_Version Date: 06/09/2011
221995_Consent1_85000_MSM Web Surveillance Survey Consent_Spanish
Version_Version Date: 06/09/2011
MSM Web Surveillance Survey Consent CLEAN 2.11.11.v05
MSM Web Surveillance Survey Consent_10_13_clean
MSM Web Surveillance Survey PILOT Consent CLEAN 2.11.11.v01
WS.InPerson_FGD_Consent.2.10.11 CLEANv04
WS.Online_FGD_Consent.CLEAN.2.10.11v04

file:///Users/rsineat/Desktop/WHBSirbapproval2012.webarchive

Page 1 of 2

WHBSirbapproval2012.webarchive

2/13/12 3:26 PM

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, and 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,
Carol Corkran, MPH, CIP
Senior Research Protocol Analyst
This letter has been digitally signed

CC:

Khosropour
Sineath
Salazar

Christine
Robert
Laura

Public Health
Public Health

Behavioral Science

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

file:///Users/rsineat/Desktop/WHBSirbapproval2012.webarchive

Page 2 of 2