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A Data Use Agreement (DUA) (also referred to as a “Data Transfer and Use Agreement”) is a contractual agreement used to transfer non-public or otherwise restricted data from one party to another. DUAs memorialize the terms and conditions upon which the data will be transferred, including the ways in which
the data may be used and how it must be protected. DUAs are needed for providing or receiving deidentified data sets, as well as limited data sets under HIPAA.

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Why would you need a DUA?

If you are transferring a data set to an outside entity/person for use and the data set was developed at a nonprofit, government, or private industry, where the data are nonpublic or are otherwise subject to use restrictions. Alternatively, you need a DUA if you are requesting access to use a data set developed by an external entity.

How To

  1. JHURA approaches DUAs just like any other non-funded agreement. Faculty and departments are advised to send in DUAs that they may receive to the JAWS system where a contracts associate will review and negotiate. Alternativley,

Faculty may send in a request to JAWS to
  1. faculty can initiate a DUA with another entity by submitting the request through JAWS as well where a

JHU
  1. DUA template agreement will be created.

  2. Review and negotiations may take two weeks or more (timeline dependant on other parties responsiveness). JHURA is presented with DUA terms that discuss ownership of data created, publications, indemnification, liability and use of the JHU name or logo. These must terms must be negotiated in line with JHU policies.

  3. The JAWS intake system allows for the staff or faculty to provide clarifying information re the DUA. At times, after the review of the JAWS record JHURA will reach out to the faculty lead to clarify the data being shared, data provider and receiver, and the type of activity being done.

Resources

https://www.dlapiperdataprotection.com/index.html?t=world-map&c=RU

JHURA Agreement Workflow System (JAWS): The JHURA Agreement Workflow System (JAWS) is the Johns Hopkins University Research Administration’s (JHURA’s) centralized, on-line database for tracking and managing all sponsored agreements, including negotiation, workflow and document storage. To see the status of an agreement, search by PI name, sponsor or a number of other fields.

Steps for JAWS system:

  1. Make sure you have a JAWS account – click here to request an account.

  2. Complete the JAWS Intake Form by logging into JAWS. Instructions for completing the form can be found here.

  3. JHURA will review the Intake Form. If there are any discrepancies in the Intake Form, it will be returned to the Requestor for editing.

  4. The Intake Form will become a new record.

  5. Records can be viewed anytime by logging into JAWS. All users with a valid JHED account will be able to access JAWS on a read-only level for their assigned department

**The need for a DUA may arise during IRB review.  In an IRB application, the faculty person may reference data sharing in their respective protocol.  In such cases, SPH IRB may refer the faculty person to JHURA to ensure a DUA is in the works related to the project.  If data is coming from the School of Medicine, we will refer the faculty person to SOM guidelines and potentially the Data Trust Committee. If the data exchange is more an exchange of biological materials, then we will refer the faculty person to JHTV in order to complete and enter into a Material Transfer Agreement.JHURAnews

View file
nameSub Agreement Issues Quick Guide for Faculty (1).pdf
View file
nameDUA Info Sheet 2021.pdf

Contacts

John Evermann, Director JHURA: jeverma1@jhujhura@jhu.edu

Related Links

JHM Clinical Data Access Wiki Page

https://hub.jhu.edu/announcements/2021/10/04/new-patient-data-guidance-for-jhu-researchers/

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