HomeMy WebLinkAbout2014-643 EMS - UNC Heart and Vascular Center - Data Use Agreement DATA USE AGREEMENT
This data use agreement(the"Agreement"), effective as of the 15 th day of January,2014(the"Effective
Date"),by and between Orange County EMS("Orange")and The University of North Carolina at Chapel
Hill for its Heart and Vascular Center("Recipient"),establishes the terms and conditions under which
Recipient will access and use certain data described below(the"Data"). Orange and Recipient are
sometimes referred to in this Agreement singularly as a"Party"and collectively as the"Parties."
WHEREAS, Recipient acknowledges that Orange is a"covered entity,"as such term is defined
under the Administrative Simplification regulations codified at 45 C.F.R. Parts 160 and 164, promulgated
pursuant to the Health Insurance Portability and Accountability Act of 1996, as amended(collectively,
"HIPAA"), and as such, is required to protect the privacy of Protected Health Information, as that term is
defined at 45 C.F.R. 160.103,maintained by covered entity;
WHEREAS,pursuant to 45 C.F.R. § 164.512(i), Orange is permitted to disclose Protected
Health Information to Recipient for research purposes,where Orange receives documentation that an
Institutional Review Board("MM")of competent jurisdiction, or other privacy board as defined at 45
C.F.R. § 164.512(i)(1)(i)(B),has approved an alteration to or waiver of the authorization otherwise
required by 45 C.F.R. § 164.508; and
WHEREAS,this Agreement is intended to meet the requirements of 45 C.F.R. § 164.512(i)and
to otherwise secure adequate assurances from Recipient that Recipient will restrict use or disclosure of the
Data received pursuant to this Agreement according to the terms and conditions herein;
NOW THEREFORE, in consideration of the mutual promises and covenants herein, and for
other good and valuable consideration,the receipt and sufficiency of which is hereby acknowledged,the
Parties agree as follows:
1. Description of Data. Recipient may obtain from Orange specific clinical data from selected
Orange EMS patients. Recipient acknowledges that Orange may provide Data to Recipient pursuant to a
waiver of authorization granted by an IRB of competent jurisdiction or by a privacy board as defined at
45 C.F.R. § 164.512(i), in accordance with 45 C.F.R. § 164.512(i)("Waiver").
2. Recipient's Use of Data. Except as otherwise specified herein, Orange grants Recipient the right
to use and disclose the Data solely in fulfillment of its professional obligations for determining cause of
sudden unexpected death, provided such use is consistent with the terms, conditions and purposes stated
in the relevant Waiver. Recipient acknowledges and agrees that,prior to Orange's release of Data to
Recipient,Recipient shall provide evidence of the Waiver and a copy of such Waiver shall be attached to
this Agreement as Exhibit A.
3. Restrictions on Recipient's Use of Data.
3.1 Recipient agrees to comply with all applicable federal and state laws and regulations concerning
the privacy and confidentiality of Protected Health Information and to use or disclose the Data
exclusively for the purposes set forth in Section 2 above or as required by law. Without limiting
the generality of the foregoing,Recipient agrees to use or disclose the Data solely as permitted
by the Waiver.
3.2 Recipient agrees to use appropriate safeguards to protect the Data from misuse and
unauthorized access or disclosure, including,without limitation,(i)maintaining adequate
physical controls and password protections for any server or system on which the Data may
reside; (ii)ensuring that Data is not stored on any mobile device(e.g. laptop, smartphone)or
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transmitted electronically unless encrypted; and(iii)taking any other measures reasonably
necessary to prevent any use or disclosure of the Data other than as provided in this Agreement.
3.3 Recipient will report to Orange any use or disclosure of the Data not provided for by this
Agreement of which Recipient becomes aware. Such report shall be made to Orange at the
address noted in Section 8 as soon as reasonably possible. Recipient will cooperate with any
remediation that Orange reasonably determines is necessary to(i)address any applicable
reporting requirements; and(ii)mitigate any effects of such unauthorized use or disclosure of the
Data.
3.4 Recipient will ensure that any agents, including subcontractors,to whom it provides the Data
agree to the same restrictions and conditions set forth in this Agreement.
4. License to Use Data for Research Purposes. This Agreement and the resulting transfer of Data
constitute a license to Recipient to use the Data solely for the research
purposes set forth in Section 2.
Recipient agrees that nothing herein shall be deemed a grant of any intellectual property rights or other
rights to use the Data for any products or processes for profit-making or commercial purposes.
5. Term and Termination. This Agreement shall be effective as of the Effective Date and shall
remain in effect as long as Recipient retains the Data. Either Party may terminate this Agreement with or
without cause upon thirty(30)days' written notice to the other Party.
6. Notice. Notice regarding termination or other matters relating to this Agreement shall be made in
writing sent to the following individuals:
If to Orange:
Director
Emergency Services
Post Office Box 8181
Hillsborough,North Carolina 27278
(9J 9)245-6100
If to Recipient:
Eugene Chung,M.D.
160 Dental Circle
6024 Burnette Womack Bldg
Chapel Hill,NC 27599
7. Miscellaneous Provisions.
7.1 Entire Agreement. This Agreement contains all of the terms and conditions agreed upon by
the Parties regarding the subject matter of this Agreement and supersedes any prior agreements,
oral or written, and all other communications between the Parties relating to such matters.
7.2 Severability. If any provision of this Agreement is determined to be invalid, such
determination shall not affect the validity of the remaining provisions.
7.3 Waiver.The waiver by any Party of any provision or breach of this Agreement shall not
operate or be construed as a waiver of any other provision of subsequent breach.
7.4 Representation to Others. Recipient has no rights to use the names,trademarks or other
symbols of Orange without prior written consent; provided,however,that Recipient may make
factual statements regarding its receipt of the Data pursuant to this Agreement.
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7.5 Amendments. This Agreement may be amended or modified only with mutual written consent
of the Parties.
7.6 Governing Law. This Agreement shall be governed by the laws of the State of North Carolina.
7.7 Change in Law. The Parties agree to negotiate in good faith to amend this Agreement to
comport with changes in law that materially alter either or both Parties' obligations under this
Agreement, provided however,that if the Parties are unable to agree to mutually acceptable
amendment(s)by the compliance date of the change in applicable law or regulations, either
Party may immediately terminate this Agreement.
7.8 Relationship of the Parties. Nothing in this Agreement shall be construed to create a
partnership,joint venture, agency, employment or other joint business relationship between the
Parties or any of their affiliates.
7.9 No Third Party Beneficiaries. Nothing in this Agreement shall confer upon any person other
than the Parties and their respective successors or assigns, any rights,remedies, obligations,or
liabilities whatsoever.
7.10 Assignment. This Agreement is non-assignable and non-transferrable by Recipient without the
prior written consent of Orange. Assignments made in violation of this provision are null and
void. Recipient acknowledges and agrees that Orange retains the right to assign or delegate any
of its rights or obligations hereunder to any of its affiliates or subsidiaries.
7.11 Authority. Each Party, and the person signing on its behalf,represents that it is authorized to
enter into this Agreement and the Party is capable of performing its obligations under this
Agreement.
7.12 Headings. The headings and other captions in this Agreement are for convenience and
reference only and shall not be used in interpreting, construing or enforcing this Agreement.
IN WITNESS WHEREOF,the Parties have executed this Agreement as of the day and year set forth
below.
ORANGE COUNTY EMS THE UNIVERSITY OF NORTH CAROLINA
AT CHAPEL HILL
By: By:
Name (printed): Q_ 6� �� Ot/" Name(printed):
Title: 0�S (rMQr-`Q` Title: K7W-- •
Date: / 02 Date: 194
Address: 5 l� ��w�4 � 1b1 Address: (bl
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Exhibit A
Copy of Waiver
1'111' UN1Vt'ItS1`1'Y
ol' NORT11 CAROLINA
11 4 II A 1't• I If 1 1 1,
April 11, 2013
Replaces letter dated 1/3/2013 and is revised to provide a more comprehensive study description
and to clarify that research is limited to decedents.
To: Eugene Chung
Heart And Vascular Center
From: Office of Human Research Ethics
Date: 4/11/2013
RE: Determination that Research or Research-Like Activity does not require IRB Approval
Study#: 12-0083
Study Title: NC Sudden Unexpected Cardiac Death Registry
This submission was reviewed by the Office of Human Research Ethics, which has determined
that this submission does not constitute human subjects research as defined under federal
regulations [45 CFR 46.102 (d or f) and 21 CFR 56.102(c)(e)(1)] and does not require IRB
approval.
The use or disclosure of PHI is sought solely for research on PHI of decedents. If the IRB
requests it, the researcher will provide documentation to the death of the individuals.
Study Description:
Background
Sudden unexplained death (SUD), also known as sudden cardiac arrest(SCA) and sudden
cardiac death (SCD) is the most common cause of death in the United States. Estimates of SUD
in the US vary widely, from 180,000 to >450,000 annually. The mechanisms of SUD are poorly
understood. Large population studies point to fatal cardiac arrhythmias as the culprit. Cohort
studies of SUD victims confirm this view, but generally these studies have been done on
homogeneous populations, largely consisting of Caucasians in Oregon and Europe.
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Objective
We propose to collect data on SUD victims in North Carolina in order to determine t1-,le rate of
sudden unexplained death by gender, race and socioeconomic class in NC. Further, vie will
evaluate the collected data to develop a risk stratification tool in order to improve the screening
process for patients at risk for sudden unexplained death.
Methods
Beginning March 1, 2013 all residents of Wake County North Carolina that undergo sudden
unexplained death will be ascertained from emergency medical services,the medical examiner,
and emergency rooms of area hospitals. A comprehensive evaluation will be performed,
including analysis of circumstances of death, medical records, and available autopsy data. A
DNA swab will be done on all candidates. An independent adjudication committee will
determine if subjects meet study criteria for sudden unexplained death. An independent lab will
perform DNA analysis. Annual incidence rates will be calculated for all residents and
demographic subgroups; complete phenotyping will be done on all subjects. The program will be
expanded to 36 other counties in North Carolina in the near future.
If your study protocol changes in such a way that this determination will no longer apply, you
should contact the above IRB before making the changes.
CC: Irion Pursell, Heart and Vascular Center
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