Agreement to Rely on the Lurie IRB - Chicago House and Social Service Agency

Expedited Initial Review 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: November 8, 2016
IRB EXPIRATION DATE: October 31, 2017
This protocol was approved under the following risk/benefit determination as described in 45 CFR 46, Subpart D/21
CFR 50, Subpart D:
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) reviewed
and approved as authorized by 45 CFR 46.111/21 CFR 56.111 and via expedited review as authorized by 45 CFR
46.110/21 CFR 56.110 the above-named protocol.
The IRB approved and stamped documents for this submission are located in a comment posted by ORIC staff in
the section titled "Supporting Documents" 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.
This research was reviewed and approved under expedited review category #2 (a): Collection of blood samples by
finger stick, heel stick, ear stick, or venipuncture as follows: a) from healthy, non-pregnant adults who weigh at least
110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection
many not occur more frequently than 2 times per week
This research was reviewed and approved under expedited review category #3: Prospective collection of biological
specimens for research purposes by noninvasive means.
This research was reviewed and approved under expedited review category #5: Research involving materials (data,
documents, records, or specimens) that has been collected, or will be collected solely for non-research purposes
(such as medical treatment or diagnosis).

This research was reviewed and approved under expedited review category #6: Collection of data from voice, video,
digital, or image recordings made for research purposes.
This research was reviewed and approved under expedited review category #7: Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance
methodologies.
The IRB also waives the requirement of obtaining a signed consent form for this study in accordance with 45 CFR
46.117(c): (1) That the only record linking the subject and the research would be the consent document and the
principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether
the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or (2)
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which
written consent is normally required outside of the research context.
For a full list of documents included with this submission, refer to the PDF of the Cayuse application. 
Federal regulations require that an IRB conduct continuing review of research not less than once per year,
regardless of whether initial approval was via full board or expedited procedures. Please note the expiration date for
your current IRB approval and be aware that you must submit a progress report for IRB review prior to the expiration
in order to obtain IRB approval for the next approval period. If the current approval expires and you do not obtain
approval for another approval period, research on this study, including subject enrollment, must cease until you
regain approval. If you have questions about your obligations as principal investigator, please contact the ORIC staff
as listed on the ORIC website:
https://www.luriechildrens.org/en-us/research/management/toolkit/Pages/research-directory.aspx
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.
Sincerely,
Institutional Review Board
Ann & Robert H. Lurie Children's Hospital of Chicago