IRB Letter

The Committee for the Protection of Human Subjects
Office of Research Support Committees

6410 Fannin, Suite 1100
Houston, TX 77030

Dr. Karen Chronister, PhD
UT-H - SPH - Ctr Health Prom & Prev Resrch
NOTICE OF APPROVAL TO BEGIN RESEARCH

June 13, 2011

HSC-GEN-11-0022 - Assessing the Accuracy of Self-Reported HIV Testing Behavior
Number of Subjects Approved: 900
PROVISIONS: This approval relates to the research to be conducted under the above
referenced title and/or to any associated materials considered at this meeting, e.g. study
documents, informed consent, etc.
NOTE: If this study meets the federal registration requirements and this is an investigatorinitiated study, or if the PI is the study sponsor or holds the IND/IDE applicable to this study, and
no one else has registered this trial on the national registry, you are required to register at
https://register.clinicaltrials.gov/ before enrollment or no later than 21 days after the first
patient is enrolled. For website access and further information visit
http://www.uth.tmc.edu/research/clinical/ctregistration.htm . For further information write to
clinicaltrials@uth.tmc.edu or call 713-500-7909.

APPROVED:

At a Convened Meeting on 04/08/2011

EXPIRATION DATE:

3/31/2012

CHAIRPERSON:

F Gerard Moeller, MD

Subject to any provisions noted above, you may now begin this research.
CHANGES: The principal investigator (PI) must receive approval from the CPHS before initiating
any changes, including those required by the sponsor, which would affect human subjects, e.g.
changes in methods or procedures, numbers or kinds of human subjects, or revisions to the
informed consent document or procedures. The addition of co-investigators must also receive
approval from the CPHS. ALL PROTOCOL REVISIONS MUST BE SUBMITTED TO THE
SPONSOR OF THE RESEARCH.
INFORMED CONSENT: Informed consent must be obtained by the PI or designee(s), using the
format and procedures approved by the CPHS. The PI is responsible to instruct the designee in
the methods approved by the CPHS for the consent process. The individual obtaining informed
consent must also sign the consent document. Please note that only copies of the stamped
approved informed consent form can be used when obtaining consent.

UNANTICIPATED RISK OR HARM, OR ADVERSE DRUG REACTIONS: The PI will immediately
inform the CPHS of any unanticipated problems involving risks to subjects or others, of any
serious harm to subjects, and of any adverse drug reactions.
RECORDS: The PI will maintain adequate records, including signed consent documents if
required, in a manner that ensures subject confidentiality.