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.
  1. 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.

  1. Permitted Uses and Disclosures

3.1 OMIS will provide the Recipient with access to or a copy ofthe 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 dataonly 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.
  1. 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;

4.2 Recipient will ensure that all computers used to access any identified and/or PHI dataare 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.

  1. 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.

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

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 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 submission

☐ grant renewal☐ talk or presentation☐ regulatory

☐outcomes/quality☐external collaboration☐ 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.

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 ______

  1. 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.

MCC Data Use AgreementPage 1