AGRMT RE DATA USE WITH BOSTON CHILDRENS HOSPITAL.PDF

DATA USE AGREEMENT FOR RESEARCH
This Data Use Agreement (“AGREEMENT”) is entered into by and between Children’s Hospital
Corporation d/b/a Boston Children’s Hospital, a charitable corporation duly organized and existing under
the laws of the Commonwealth of Massachusetts and having a place of business located at 300 Longwood
Avenue, Boston, MA 02115 (“BCH”), and Maricopa County by and through its Department of Public
Health (“SITE”) and effective as of the date of the last signature (“EFFECTIVE DATE”).
WHEREAS, SITE is interested in obtaining certain anonymized data collected under the IRB approved
protocol # [IRB-P00007333] entitled (“Using existing Flu Near You and Salud Boricua online, survey-
based, participatory syndromic surveillance data for research”) by BCH (“DATA”).
WHEREAS, SITE agrees to use the Data for local public health surveillance and as further defined in
Appendix A (“PURPOSE”) and under the direction of Dr. Jessica White (“SITE INVESTIGATOR”)
WHEREAS, BCH agrees to grant SITE access to DATA under this AGREEMENT.
NOW, THEREFORE, BCH and SITE agree as follows:
1. Use of Data. The SITE warrants that it shall use DATA exclusively and only for PURPOSE and
any subsequently amended and mutually agreed purposes. The SITE use of the DATA shall be
used in accordance with all applicable laws and regulations, including, but not limited to the
Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as codified at 45 CFR
Parts 160 and 164.
2. Permitted Users. The SITE agrees to use and allow access to DATA only to SITE
INVESTIGATOR and SITE personnel who are so authorized for such access by the SITE’s
Institutional Review Board (IRB) (“PERMITTED USERS”), as applicable.
3. Other Use, Transfer or Disclosure. SITE agrees that it will not disclose, transfer or allow access
to DATA to anyone other than SITE INVESTIGATOR and PERMITTED USERS except as
required by law.
4. BCH’s Access to Results: Upon the request of BCH, SITE agrees to share any of the results of
the information generated from the use of the DATA for BCH’s own internal research, teaching
and academic purposes.
5. Safeguards. SITE agrees to and shall ensure that SITE INVESTIGATOR and the PERMITTED
USERS use appropriate safeguards to prevent use, access to or disclosure of DATA to anyone
other than as provided by this AGREEMENT.
6. Reporting. SITE agrees to report in writing to BCH, and if applicable SITE’s IRB, any
unauthorized use or disclosure of DATA that it becomes aware of within five (5) business days of
its discovery.
Should disclosure or access other than SITE INVESTIGATOR and PERMITTED USERS be
required by law, SITE shall notify BCH promptly of any request, warrant or order or of any
access or disclosure.
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7. Liability and Indemnification. Except to the extent permitted by law, SITE assumes all liability
from and against any and all claims, losses, liabilities, costs and other expenses to the extent
resulting from its use of DATA, except when caused by the gross negligence or willful
misconduct of BCH. To the extent allowable by law, SITE assumes responsibility for, and agrees
to indemnify and hold harmless BCH and BCH’s trustees, officers, agents, students, and
employees from any liability, loss, or damage they may suffer as a result of, any claims, demands,
costs, or judgments against them arising out of the use, handling, storage, or disposal of the
DATA by SITE and/or SITE INVESTIGATOR, except as such claims, demands, costs, or
judgments may arise from BCH’s gross negligence or willful misconduct.
8. Term. This AGREEMENT shall become effective on the EFFECTIVE DATE of the
AGREEMENT and shall continue in effect for the duration of [one (1) year] from the
EFFECTIVE DATE. Upon completion of the AGREEMENT, DATA shall be either destroyed or
returned to SITE.
9. Termination. Either party may terminate this AGREEMENT in writing upon thirty (30) days
notice to the other. Upon the termination of this Agreement, SITE shall immediately terminate its
use of the DATA. Upon request by BCH, SITE shall return the DATA and copies thereof to
BCH. Termination of this Agreement shall not relieve either party of the obligations arising
hereunder.
10. Publication. SITE INVESTIGATOR shall have the right to publish, present, share, or use DATA
in accordance with the highest academic and publication standards and for its own instruction,
and agrees to provide appropriate acknowledgement of BCH or co-authorship by BCH where so
specified, or if not so specified then as per the most recently released version of “Uniform
Requirements for Manuscripts Submitted to Biomedical Journals” guidelines produced by the
International Committee of Medical Journal Editors.
11. Publicity. Neither party will use the name of the other party in any publicity, advertising, or news
release without the prior written approval of the authorized representative of the other party.
12. Disclaimer of Warranty. BCH makes no warranties, expressed or implied, regarding the quality
of any product produced under this Agreement.
13. Governing Law. This Agreement will be governed by and construed exclusively in accordance
with the laws of the Commonwealth of Massachusetts without regard to conflict of law
principles.
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SIGNATURE PAGE
Boston Children’s Hospital
By:
Title:
Signature:
Date: __________________________
SITE
AGREED AND ACCEPTED: ACKNOWLEDGED AND ACCEPTED:
By SITE: By SITE INVESTIGATOR:
Title: __________________________ Title: __________________________
Signature: _____ Signature: ______________________
Date: __________________________ Date: __________________________
IN WITNESS WHEREOF, the parties agree to enter into this agreement:
FOR AND ON BEHALF OF
MARICOPA COUNTY
BY: __________________________
Denny Barney
Title: Chairman, Board of Supervisors
Date: __________________________
ATTEST:
_______________________________
Clerk of the Board Date
APPROVE AS TO FORM:
_______________________________
Attorney for Maricopa County Date
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Appendix A
Maricopa County Department of Public Health (MCDPH) is seeking deidentified line-level Flu Near You
date (all variables) from 10/01/2012 through 10/01/2016 for the state of Arizona. MCDPH was awarded
a grant by the Council of State and Territorial Epidemiologists (CSTE) and Skoll Global Threats Fund
(SGTF) to complete a Flu Near You Data Implementation Pilot Project and is requesting these data to
make analyses for this project more robust. The following three data analysis objectives were included in
the original project proposal.
Specific Aim #1: Increase MCDPH public health professionals’ knowledge and awareness of the
potential uses of participatory surveillance and Flu Near You (FNY) data for public health decision-
making and action
Public health professionals rely heavily on traditional surveillance systems to make decisions and
implement prevention efforts. Traditional surveillance tends to depend on data generated by healthcare
facilities and is limited to individuals who seek care while ill. Participatory surveillance is a novel way
for community members to share their health status with public health professions; a method that has
great potential. [1, 2] The first aim of this project is to educate local public health professionals about this
potential. Without buy-in by MCDPH at all levels, it will be difficult to effectively recruit users from the
general public.
Early in the project period, project staff will prepare a brief report of Maricopa County FNY data
available during the 2015-2016 season. The report will provide descriptive statistics of recent
participation, user demographics, and trends of ILI during the most recent influenza season. The brief
report will be presented to the MCDPH Office of Epidemiology (approx. 50 employees) during an
internal “Epi Presents” meeting. Presenters will challenge employees to become sustaining contributors
to the application and request that at least 10 employees commit to participate >85% of the weeks during
the 2016-2017 season. At 1 month and 8 months following the initial presentation, attendees will be
asked to complete a survey that measures perceptions about FNY system attributes (e.g., simplicity and
acceptability; standard surveillance evaluation measures outlined by CDC). [3]
In the process of developing the brief report, a SAS program will be created, which can be used for
analyzing data from previous seasons and monitoring real-time FNY ILI data during the 2016-2017
season. Weekly reports of county FNY data will be emailed to the Office of Epidemiology email list to
encourage use.
Towards the end of the project period, investigators will prepare an in-depth report of county FNY data
available from 2012 – 2017 (5 influenza seasons). The larger report will be presented at a department-
wide meeting. This will capture the attention of public health professionals outside the Office of
Epidemiology.
Success will be measured by the completion of 2 reports and 2 presentations; attendance records, which
will be tallied to count the number of MCDPH public health professionals reached during the
presentations; and evaluations, which will assess awareness and understanding of the potential uses of
FNY before and after the presentations as well as FNY system attributes.
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Specific Aim #2: Compare FNY ILI data to existing MCDPH influenza surveillance sources and
determine how to utilize data in weekly and annual reports
Investigators have found promising correlations between FNY ILI data and traditional influenza
surveillance data on national, regional, state, and city scales. [4-6] Key methods include: creating a time
series of ILI rates for each data source; using first-time user and noise-filtering adjustments; calculating
Pearson correlation coefficients and root-mean-square error; and identifying peak ILI week. [4-6]
MCDPH will use similar methods to determine whether FNY ILI correlates with existing influenza data
in Maricopa County. MCDPH is an ideal location to assess FNY on a county scale because it is large,
diverse, and receives influenza data from multiple sources. FNY can be compared to data from CDC
ILINet, hospital discharge data, confirmed positive laboratory reports (mandated), NSSP BioSense, and
the Arizona Prehospital Information and EMS Registry System. Notably, all of the existing sources are
provided by healthcare providers. By surveying community members directly, FNY has the potential for
capturing data regarding household and community transmission among those who do not seek
healthcare. [7]
Measurable outcomes of this aim will be: a report that shows time series of ILI rates and correlations
between FNY data and existing influenza surveillance data from 2012-2017; an abstract submission to
CSTE; and a surveillance evaluation document that includes recommendations for integrating FNY into
routine influenza surveillance at MCDPH.
Specific Aim #4: Develop new analyses for non-ILI FNY data
Every week, FNY receives information regarding the community’s most prevalent symptoms, healthcare
seeking behavior, and vaccination status, but previous studies with FNY have focused on ILI data. [4-6, 8,
9] The FNY database, which may hold valuable information regarding other prevalent conditions,
remains largely unexplored at a local scale. In addition to the untapped existing data, the FNY platform is
scalable and has potential for capturing additional symptoms; an enhancement largely supported by
current users. [7, 10]
MCDPH investigators aim to determine FNY’s potential for monitoring non-ILI syndromes. The
statistical methods will be similar to those outlined in Specific Aim #2, but will focus on syndromes such
as acute respiratory illness (ARI), respiratory syncytial virus (RSV), and fever+rash (possible measles).
Non-ILI FNY data will be compared to syndromic surveillance data from NSSP – BioSense Platform to
look for correlations and biases within each data source.
Measurable outcomes of this aim will be: a report that shows time series of non-ILI rates and correlations
between FNY data and BioSense data from 2012-2017; an abstract submission to CSTE; and a brief
report that provides recommendations for using non-ILI syndromes from FNY data.
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References
1. Wojcik, O.P., et al., Public health for the people: participatory infectious disease
surveillance in the digital age. Emerg Themes Epidemiol, 2014. 11: p. 7.
2. Freifeld, C.C., et al., Participatory epidemiology: use of mobile phones for community-
based health reporting. PLoS Med, 2010. 7(12): p. e1000376.
3. German, R.R., et al., Updated guidelines for evaluating public health surveillance
systems: recommendations from the Guidelines Working Group. MMWR Recomm Rep,
2001. 50(RR-13): p. 1-35; quiz CE1-7.
4. Smolinski, M.S., et al., Flu Near You: Crowdsourced Symptom Reporting Spanning 2
Influenza Seasons. Am J Public Health, 2015. 105(10): p. 2124-30.
5. Baltrusaitis, K. Analysis of Flu Near You as a Flu-Tracking Tool for Multiple Spatial
Scales in the US. in Council of State and Territorial Epidemiologists Annual Conference.
2016. Anchorage, AK.
6. Murray, E.L. Exploration of Flu Near You Data for Influenza Surveillance Use in
California. in Council of State and Territorial Epidemiologists Annual Conference. 2016.
Anchorage, AK.
7. Chunara, R., et al., Flu Near You: An Online Self-reported Influenza Surveillance System
in the USA. Online J Public Health Inform, 2013. 5(1): p. e133.
8. Chunara, R., et al., Estimating influenza attack rates in the United States using a
participatory cohort. Sci Rep, 2015. 5: p. 9540.
9. Bakota, E.V., E.R. Santos, and R.R. Arafat, Estimating FluNearYou Correlation to
ILINet at Different Levels of Participation. Online Journal of Public Health Informatics,
2016. 8(1): p. e8.
10. Flu Near You, Flu Near You: Preliminary 2015-16 Report. 2016.
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