Data Use Agreements
Fibi records are no longer requested to request a Data Use Agreement from the School of Medicine Office of Research Administration. A Data Use Agreement (DUA) will be required to send JHU data outside the University or received data from an outside entity.
DUA requests that do not include funding should be submitted to ORA for review via the new DUA Request Form. Requests that include nominal costs associated with the transfer of data are eligible to use this form.
Agreements that include incoming or outgoing funding should continue to be submitted to ORA via the Fibi routing system as a new contract (Proposal tab in Fibi).
Some outgoing transfers of JHM data will require the submission of a Change in Research (CIR) to the IRB and/or approval by the Data Trust prior to execution of the DUA. When submitting a Change in Research in eIRB2, please enter the MyRap number assigned to your DUA when prompted for a record number.
Do you have sample copies of the DUA form I can review before submitting a request in Qualtrics?
Yes, all versions of the DUA request forms are provided below – now include a DUA modification option. Please note that these are samples for reference only. All DUA requests must be submitted by completing the online DUA request form in Qualtrics here.
What happens after I submit my DUA request?
Your request will be sent to the ORA Contract Specialists team for initial review and triage. The assigned Specialist will then create a record of the DUA in MyRap and route your request to an ORA Contracts Associate for review. Once the MyRap record has been created, you will be able to track the status of your DUA through the negotiation process.
The status of any pending contract agreements in ORA are viewable in MyRap. Contact your ORA Contracts Team member for questions.
Please note, DUA requests for human subjects data being sent to a commercial entity will be triaged to the Clinical Research Contracting (CRC) office for review and negotiation.
How do I start a DUA request form over if I made a mistake? My browser keeps bringing me back to the middle of the survey – help!
The DUA survey is set up to save responses so that you can go back to the form later if you’re not able to finish it all at once. If you need to start over entirely, there are a few options:
- Open the DUA link in a new private window,
- Open the DUA link in a different browser, or
- Clear your browser cookies and it will restart the survey if you reload the link
Materials Transfer Agreements
Sending Human Biospecimens to External Collaborators
Outside entities wishing to access human biospecimens maintained or collected at JHM may only do so pursuant to a research collaboration with JHM researchers that is documented in a research agreement or MTA. If the biospecimens are collected and transferred as part of a clinical trial agreement (CTA) and IRB-approved protocol, the CTA will include terms that address the transfer and use of the samples. For other transfers, a JHM Outbound Human Biospecimen Transfer Information Sheet should be completed and submitted to the JHM IRB following the processes found here.
The applicable JHM IRB guidance and JHM police are available here:
JHM IRB Guidance on Transferring Human Biospecimens
JHM Policy on Transferring Human Biospecimens to Outside Organizations
Routing MTAs to ORA
MTAs related to a funded research project should be routed to ORA via a Fibi record.
Please do not submit the same MTA request to both ORA and JHTV – this causes confusion and significant delays.
