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Data Sharing Agreement
Between Maricopa County by and through its Department of Public Health
and
The Tuberculosis Epidemiologic Studies Consortium (TBESC)
Reguestor Information
Agency/Institution
Name: Maricopa County Department of Public Health (MCDPH)
Address: 1645 E. Roosevelt St, Phoenix AZ 85006
Phone #: 602-372-7413
E-mail address: aurimarayala@mail.maricopa.gov
X_ TBESC member, Site: MCDPH
TBESC affiliate, nature of affiliation
not-for-profit institution not affiliated with TBESC
for-profit institution not affiliated with TBESC
Requestor Principal Investigator:
Name: Dr. Renuka Khurana
Address: 1645 E. Roosevelt St, Phoenix, AZ 85006
Phone #: 602-506-6879
E-mail address: renukakhurana@mail.maricopa.gov
Period of Agreement: From: October 1,2017 To: September 30, 2022
This Agreement shall be effective when signed by representatives from both parties and shall continue until
terminated pursuant to the termination clause contained herein.
Background
A better understanding of new and existing diagnostic tests for tuberculosis and M. tuberculosis infection, and
their impact on TB control and prevention in the United States, are urgently needed. The Tuberculosis
Epidemiologic Studies Consortium was organized by the Centers for Disease Control and Prevention (CDC) to
conduct programmatically relevant clinical, laboratory, economic, and epidemiologic research concerning the
diagnosis and treatment of tuberculosis infection in order to prevent progression to TB disease. Data from TBESC
studies (TBESC Database) are collected and maintained by CDC staff and contractors. The TBESC recognizes
its responsibility, to the public and the scientific community, to encourage scientific progress as rapidly and
judiciously as possible using this resource. To take full advantage of such resources and maximize their research
value, it is important that the collected data be made available, on appropriate terms and conditions, to
investigators in a timely manner. The TBESC investigators and staff at the CDC have made a substantial long-
term contribution in establishing and maintaining the TBESC Database. We seek to encourage appropriate
collaborative relationships between investigators and to ensure that the contribution of the participating
investigators is appropriately acknowledged.
To protect the confidentiality and privacy of the included patients and their families, investigators granted access
to this data must adhere to the requirements of this Data Sharing Agreement. Failure to comply will result in
denial of further access to data. Violation of confidentiality requirements in this agreement is considered a breach
of confidentiality and may leave requesting investigators and their institutions liable to legal action on the part of
the TBESC Database patients, their families, or the U.S. Government.
Purpose of the Request
The data will be used by Requestor (including what studies will be performed and what the desired outcomes are
perceived to be as a result of obtaining the data), the data elements needed, and who will have access to the
data, as follows:
'1. Describe what study/studies will be performed and what the desired outcomes are perceived to be as a result
of obtaining the data.
The main goals of this analysis are to increase understanding of Latent Tuberculosis Infection (LTBI)
prevalence and of factors associated with LTBI treatment acceptance and completion among refugees
using data collected from the TBESC TO1 study.
2. Describe/list specific data elements that will be required.
The following data elements will be required: reason for enrollment, enrollment site, LTBI tests results { -1ST and
IGRAs), age, gender, country of birth, date of arrival to the United States, race/ethnicity, education, household
income, history of incarceration and length of time at refugee camp, TB contact history, comorbidities, alcohol and
smoking history, BCG status, prior history of TB infection, treatment acceptance and refusal, treatment regimen,
treatment follow-up information and treatment completion.
3. List who will have access to the data and in what capacity.
Aurimar Ayala, MCDPH-TBESC project coordinator and Senior Research Epidemiologist will have primary access to the
data for the purposes of performing data analysis. Dan Shen, MCDPH-TBESC Research Epidemiologist and Dr. Renuka
Khurana, MCDPH-TBESC PI will also have access to the data. Data analysis will be performed at the TBESC-MCDPH
office desktop computers in a password protected environment. All TBESC files are protected by an extra password for
TBESC staff only. Aurimar Ayala will keep the physical data file locked and stored in her office. MCDPH will not email
or otherwise transfer any copies of the database to anyone else, either inside or outside MCDPH.
AGREED UPON TERMS AND CONDITIONS
It is mutually agreed, by Requestor and the TBESC, as follows:
1. Provision of Data: The TBESC agrees to provide Requestor with data to facilitate the objectives as described
above. These may include specific items (variables) that Requestor requests or that TBESC suggests for timely,
efficient, and precise achievement of their objectives, either in raw form or derived constructs, and including data
dictionaries and/or keys to variable cod ings (with the exception of subject identifiers). Data will be provided in
either SAS or Excel formats, unless otherwise agreed upon. Data will be provided in a form mutually agreed upon
by Requestor and TBESC (e.g., CD, email, etc.)
2. IRB Approval/Compliance: Requestor represents and warrants that the conditions for use of this dataset are
as follows (check one).
1. X The Requestor is a TBESC member or affiliate whose In has granted approval for the parent
study/studies from which the shared data originates. Requestor agrees to fully comply with all such conditions
therein imposed by their IRB.
IRB Approval #(s): rely on CDC IRB B-IRB00000184 Date of Issue: 11/23/15
2. The Requestor is not subject to IRB review (check one):
a. Data received are completely de-identified (contains no subject identifiers, Requestor not
planning on any further linkage to additional TBESC data elements).
Date of Issue:
Requestor also agrees to fully comply with any additional conditions that may be imposed by the CDC Institutional
Review Board (IRB). It is intended that Requestor's agreements herein shall inure to the benefit of the research
subjects, as well as the parties to this agreement. Requestor agrees to report promptly to the TBESC any
proposed change in the research project and any unanticipated problems involving risks to subjects or others.
Requestor remains subject to applicable state and local laws and regulations and institutional policies, which may
provide additional protections for human subjects.
3. Non-Transferability: This Data Sharing Agreement is non-transferable. Requestor agrees that any substantive
changes made to Requestor's research project and/or appointment by Requestor of another Principal Investigator
to complete the research project will require an execution of a new Data Sharing Agreement in which the new
Principal Investigator and/or new Research Project are designated.
4. Publication: Prompt publication of the results of Requestor's Research Project is encouraged. None of the
shared data or results of analysis of shared data will be submitted for publication or public presentation without
written approval from TBESC. Requestor agrees to provide TBESC a copy of any abstract ten (10) days in
advance of submission for publication and any manuscript thirty (30) days in advance of submission for
publication, in order to permit review by the Publications and Presentations Committee, CDC clearance, and to
ensure compliance with the confidentiality requirements of this Agreement.
5. Acknowledgements: Requestor agrees to acknowledge the contribution of the TBESC in any and all oral and
written presentations, disclosures, and publications resulting from any and all analyses of shared data.
6. Confidentiality/Non-Identification/Security: Subject confidentiality will be strictly enforced. Requestor agrees
that data will not be used, either alone or in conjunction with any other information in any effort whatsoever to
establish the individual identities of any of the subjects from whom data was obtained. Requestor agrees to
establish appropriate administrative, technical, and physical safeguards to protect the confidentiality of the data
and to prevent its unauthorized use or access.
7. Distribution: Requestor agrees to retain control over data and further agrees not to transfer data or results
from any analyses, with or without charge, to any other entity or individual, without the written permission of
TBESC.
8. Costs/No Warranties: No warranties, expressed or implied, are offered to the merchantability or fitness for any
purpose of the data provided to Requestor under this agreement, or that the data may be exploited without
infringing on the intellectual property, proprietary rights, or other rights of any parties.
9. Non-Endorsement, Indemnification: Requestor agrees not to claim, infer, or imply Governmental/CDC
endorsement of their Research Project, the entity, or personnel conducting the research project or any resulting
commercial product(s) except as described in Section 5. To the extent permitted by law, Requestor agrees to
indemnify the United States Government, the Department of Health and Human Services, the CDC, and all other
investigator(s) and the agents and employees of each of them for all liabilities, demands, damages, expenses,
and losses arising out of Requestor's use for any purpose of the data, its byproducts, or modified or unmodified
derivatives.
10. Accuracy of Data: Requestor agrees that the United States Government, the Department of Health and
Human Services, the CDC, and all other investigator(s) and the agents and employees of each of them are not
responsible for the accuracy of the data provided.
11. Amendments: Any requests for amendments to this Data Sharing Agreement must be made in writing and
signed by authorized representatives of both parties.
12. Termination: Upon completion of the use of the data and termination of this Data Sharing Agreement at the
end of the period of agreement, Requestor agrees to destroy or return all data to the TBESC. The TBESC may
also terminate this Data Sharing Agreement if Requestor is in default of any condition of this agreement and such
default has not been remedied within 30 days after the date of written notice by the TBESC of such default.
13. Disqualification, Enforcement: Failure to comply with any of the terms specified herein may result in
disqualification of Requestor from receiving additional data. The United States Government and the CDC shall
have the right to institute and prosecute any proceeding at law or in equity against Requestor for violating or
threatening to violate the confidentiality requirements of this agreement, the limitations on the use of the data, or
both. Proceedings may be initiated against the violating party, legal representatives, and assigns, for a restraining
injunction, compensatory and punitive damages, mandamus, and/or any other proceeding in law or equity,
including obtaining proceeds from any intellectual property or other rights that are derived in whole or in part from
the breach of the confidentiality requirements or use limitations of this agreement. In addition, Requestor
acknowledges and agrees that a breach or threatened breach of the confidentiality requirements or use limitations
of this agreement may subject Requester to legal action on the part of the TBESC database subjects, their
families, or both.
14. Accurate Representation: Requester expressly certifies that the contents of any statements made or
reflected in this document are truthful and accurate.
FOR AND ON BEHALF OF MARICOPA COUNTY
By:
Denny Barney, Chairman, Board of Supervisors
Date
ATTEST
Clerk of the Board
Date
APPROVED AS TO FORM
Attorney for Maricopa County
Date
Signature and Date of Requestor, Principal Investigator, Maricopa County Department of Public Health:
Name: Dr. Renuka Khurana
Signature:
Date:
Signature and Date of TBESC Authorized Representative:
Name:
Signature:
Date: