Approval Letter - Lurie Children's Hospital of Chicago Institutional Review Board

Expedited Modification Approval Letter
Lisa Kuhns, MD
Adolescent Medicine
PROTOCOL TITLE: Evaluation of TransLife Center: A Locally-Developed Combination Prevention Intervention for
Transgender Women at High Risk of HIV Infection
IRB 2017-767
IRB APPROVAL DATE: June 6, 2017
IRB EXPIRATION DATE: October 31, 2017
Approved as Risk/Benefit Category:
45 CFR 46.404/21 CFR 50.51 Research not involving greater than minimal risk.
The Ann & Robert H. Lurie Children's Hospital of Chicago Institutional Review Board (Lurie Children's IRB) has
reviewed and approved the modification to the protocol referenced above by expedited review. The modification
includes the study protocol (version date 4/26/17) which includes a revised primary outcome to reflect the one
month recall, increased study sample size to 150, modified inclusion criteria, revised follow-up scheduling, and
procedure revisions. The participants will now be compensated in cash. Recruitment methods were revised to
include flyer based marketing only. The study questionnaire was revised and the estimated duration of interviews
was reduced to 60 minutes. The informed consent form was revised to reflect the changes made in this modification.
The study flyer, case report forms, screening form, and the fully executed IAA with Chicago House and Social
Service Agency. Amy Johnson was added to the study personnel.
The IRB approved and stamped document(s) for this submission is/are located in a comment in the "Supporting
Documents" section of the Cayuse IRB application. Only the current Lurie Children's IRB stamped consent forms
are to be used when enrolling participants into this study.
For a full list of documents included with this submission, refer to the PDF of the Cayuse IRB application.
YOUR OBLIGATIONS AS PRINCIPAL INVESTIGATOR:
As the Principal Investigator, you are ultimately responsible for the conduct of the use, the protection of the rights
and welfare of human subjects and adherence to the Lurie Children’s IRB and hospital policies and procedures (
Lurie Children's IRB Policy and Procedure Manual), including, but not limited to Section 5: Investigator
Responsibilities and the following:

1. Ensure that all individuals who will work on the approved protocol are qualified, listed as Research Personnel in
the Cayuse IRB application, and have completed the human subject protections education requirement.
2. Submit the renewal progress report for review and approval in advance of the expiration date.
3. Do not implement changes in the approved protocol or consent form(s) without prior IRB approval (except to
eliminate apparent immediate hazards to safeguard the well-being of human subjects).
4. Obtain the legally effective written informed consent from human subjects or their legally authorized
representatives as is applicable, using only the currently approved Lurie Children's IRB stamped consent form(s).
5. Report any unanticipated problems or noncompliance per IRB policies.
6. Wait until the study contract/award (if applicable) is fully executed before beginning work on the study. Contact
the Office of Sponsored Programs for information about the status of the clinical trial agreement or grant award.
7. Register your study: Applicable clinical trials (i.e., interventional studies of FDA-regulated drugs, biological
products, or devices) must be registered on clinicaltrials.gov by the responsible party, typically the sponsor or a PI if
designated by the sponsor (refer to FDAAA 801). In addition, the International Committee of Medical Journal Editors
(ICMJE) recommends that all medical journal editors require registration of clinical trials in a public trials registry at,
or before, the time of first patient enrollment as a condition of consideration for publication. Their definition of a
clinical trial is much broader than federal requirements. Please refer to the ICMJE recommendations Section IIIK.
Your study will be listed on the Clinical and Translational Research webpage for the hospital. If you do not wish your
trial to be listed on this webpage, contact Marianne Reed within 10 days of this approval letter.
8. Notify any departments providing research support of modifications to the protocol that would impact services
provided (e.g., pharmacy, medical imaging, laboratory services, etc.).
Sincerely,
Institutional Review Board
Ann & Robert H. Lurie Children's Hospital of Chicago