DATA USE AGREEMENT BETWEEN
This Data Use Agreement is made and entered into on ______________ by and between
____________________________, hereafter “Data Owner”
MCC Oncology Medical Informatics & Services (OMIS), hereafter “Holder”
and ________________ , hereafter “Recipient.”
1. This agreement sets forth the terms and conditions pursuant to which Holder will provide
data which may include certain protected health information, hereafter “PHI” to the
Recipient.
2. Terms used, but not otherwise defined, in the Agreement shall have the meaning given the
terms in HIPAA Regulations at 45 CFR Part 160-164.
Data Source - A data source refers to any specified source of data: data within a
management application (e.g., OnCore), a database, a file, or other data collection.
3. Permitted Uses and Disclosures
3.1 OMIS will provide the Recipient with access to or a copy of the specific data as
defined in Attachment 1 to be used only for the purpose(s) delineated in the request.
OMIS will grant access to or a copy of the data only after:
1. Recipient has completed Attachment 1 which provides the Data Owner and
OMIS a detailed description of the specific data being requested, the purpose(s)
and intended use(s) of the data, and a list of any additional individuals for whom
access is requested;
2. The Data Owner has approved the Recipient’s data request;
3. Intended recipients have completed all training required by the Health
Information Privacy and Security Office;
4. Recipient has obtained any necessary Institutional Review Board (IRB)
approvals;
5. Recipient agrees to comply with all applicable policies, procedures, contractual
requirements, and direction of the Health Information Privacy and Security
Officer related to the access of University information and specifically related to
the data that is the subject of this agreement.
4. Recipient Responsibilities
4.1 Recipient will not use or disclose the data or any other information to which it is granted
access for any purpose other than permitted by this Agreement pertaining to the purpose(s)
described in the approved written data request or as required by law;
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4.2 Recipient will ensure that all computers used to access any identified and/or PHI data are
registered and supported by the AHC Information Systems (AHC IS) Office and that all
appropriate administrative, physical and technical safeguards to prevent use or disclosure of
the PHI other than as provided for by this Agreement will be implemented;
4.3 Recipient will report to OMIS any unapproved use or disclosure of the PHI not provided
for by this Agreement within 2 days of becoming aware of such use or disclosure; and
4.4 Recipient understands and agrees that any violation of the terms of this agreement or
inappropriate use or disclosure of the data that is the subject of this agreement may result in
disciplinary action up to and including termination of employment.
5. Term and Termination
5.1 This Agreement shall be effective until the date indicated in section 10 of Attachment 1.
5.2 Upon the Holder’s knowledge of a material breach of this Agreement by the Recipient,
this will be reported to the University Health Information Privacy and Security Officer.
6. General Provisions
6.1 This Agreement shall not be re-assigned to another party by the Recipient without
the prior written consent of the Holder and Data Owner.
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IN WITNESS WHEREOF, the parties hereto execute this agreement as follows:
Oncology Medical Informatics & Services
Masonic Cancer Center
University of Minnesota
Date: _____________________
By: ______________________________________
Sandeep Kataria
Manager, Oncology Medical Informatics & Services
Date: _____________________
By: ______________________________________
Data Owner
Date: _____________________
By: ______________________________________
Recipient
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Attachment 1
Request for Data
Masonic Cancer Center (MCC), University of Minnesota
Complete this form with as much detail as possible and send to
Oncology Medical Informatics & Services at omi-help@lists.umn.edu or fax to 612-625-1620
Recipient (Requestor): _____________________________
Request Date: ___________
first and last name
Recipient Email Address (x500 for UMN): ___________________________________________
Campus Address: ____________________________________
Telephone: _____________
Division/Department: _________________________________
Research Supervisor: _________________________________
first and last name
Projects from non-faculty or faculty investigators external to the
MCC must have a study supervisor/collaborator from the MCC.
Data Use:
1. Research Project/Study Title:___________________________________________________
___________________________________________________________________________
___________________________________________________________________________
2. Planned use of data (mark all that apply)
☐ abstract submission
☐ journal article/manuscript
☐ grant renewal
☐ talk or presentation
☐ outcomes/quality
☐ external collaboration
☐ grant submission
☐ regulatory
☐ other __________
3. Additional individuals for whom data access is being requested (list name, email
address/x500, and research supervisor for each): _____________________________________
______________________________________________________________________________
______________________________________________________________________________
4. Expected co-authors (Please list ALL authors expected to be on writing committee, and
specific order if requested by the Data Owner):
______________________________________________________________________________
______________________________________________________________________________
Authorship. Prior to data analysis, identify the list of anticipated authors. In the case of external
requests, an MCC faculty member is expected to be included. However, it is recognized that no one
set rules will account for every circumstance. Manuscripts including analyses by statisticians are
expected to include the statistician as an author, when appropriate.
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5. Hypothesis:
6. Study population and inclusion/exclusion critieria (e.g., date range, patient characteristics):
7. Data sources and data elements of interest (mark all that apply)
☐ BMT
☐ Cancer Registry
☐ Disease Registry
☐ LIMS
☐ OnCore
☐ TASCS
☐ OBL (integrated data)
☐ Other ________________
a. List the specific data elements that are needed in the data set. Please provide
attachment (if needed; a printed copy of the OMIS report/data request form can be
submitted). ___________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
8. Will additional data be collected? If so, describe:___________________________________
______________________________________________________________________________
______________________________________________________________________________
9. Timetable for completing this project:_____________________________________________
______________________________________________________________________________
______________________________________________________________________________
10. Date after which Data Owner rescinds permission for publication or use of data without a
new Data Use Agreement: _______________________________
11. Funding source (if applicable): ________________________________________________
OMIS is not a free resource. While the OMIS Director may approve the use of programmatic funds,
this must be approved prior to study initiation.
Note that requests for Transplant Biology and Therapy (TBT) program data and BMT-specific data may
require additional documentation.
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