Att 15 - IRB Approval

Friday, January 20, 2012
Dear Darrell Wheeler,
On Friday, January 20, 2012 the Loyola University Chicago Institutional Review Board (IRB) reviewed and approved your Initial
application for the project titled "Critical Thinking and Cultural Affirmation (CTCA): Evaluation of a Locally Developed HIV
Prevention Intervention ". Based on the information you provided, the IRB determined that:
the risks to subjects are minimized through (i) the utilization of procedures consistent with sound research design and do not
unnecessarily expose participants to risk, and (ii) whenever appropriate, the research utilizes procedures already being
performed on the subjects for diagnostic or treatment purposes
the risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the
knowledge that may reasonably be expected to result
the selection of subjects is equitable
informed consent be sought from each prospective subject or the subject's legally authorized representative, in accordance with,
and to the extent required by §46.116
informed consent be appropriately documented, in accordance with, and to the extent required by §46.117
when appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of
subjects
when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant
women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been
included in the study to protect the rights and welfare of these subjects
Documented consent will be obtained from all subjects enrolled.

This review procedure, administered by the IRB, in no way absolves you, the researcher, from the obligation to adhere to all Federal,
State, and local laws and the Loyola University Chicago policies. Immediately inform the IRB if you would like to change aspects of your
approved project (please consult our website for specific instructions). You, the researcher, are respectfully reminded that the
University's ability to support its researchers in litigation is dependent upon conformity with continuing approval for their work.

Please notify the IRB of completion of this research and/or departure from the Loyola University Chicago by submitting a Project
Closure Report using the CAP system. In all correspondence with the IRB regarding this project, please refer to IRB project number #733
or IRB application number #718.
The IRB approval granted for this project expires on 1/18/2013 12:00:00 AM

If you have any questions regarding this approval, the IRB, or the Loyola University Chicago Human Subject Protection Program, please
phone the Assistant Director for Research Compliance at (773) 508-2689 or email the IRB at [email protected].

Best wishes for your research,

Raymond H. Dye, Jr., Ph.D.
Chairperson, Institutional Review Board