This section will provide the Case Western Reserve University investigators information on the processes and procedures for transferring and sharing data.
It is quite common for a research, service, or collaboration project to require the transfer of research data to, from, or between organizations. If you have data that is from a human subject or is confidential, proprietary, or sensitive in some way, the party providing/sending the data will often require the receiving party to enter into a legally binding written agreement outlining the terms and conditions that will govern the data transfer.
This is commonly referred to as a data use agreement, data transfer and use agreement, data access agreement, and/or a research collaboration agreement. For purposes of clarity, we shall call them collectively “data use agreements (“DUAs”).” DUA’s are required under the Privacy Rule and must be entered into before there is any use or disclosure of data to an outside institution or party. There are varying types of data, which require varying levels of protection.
A comprehensive guide for the transfer of data is located in the 2022 DUA Guide. In order to facilitate the transfer of data for research purposes it is strongly recommended that investigators refer to the DUA guide.
CWRU is primarily concerned with securing the transfer of human subjects’ research data, whether in hardcopy or digital format. A Data Use Agreement may be requested by the CWRU investigator in situations where the investigator wishes to protect the confidentiality of the data.
When needed: A DUA is required by CWRU if
- CWRU is the data provider;
- CWRU is receiving human subjects’ derived data;
- CWRU is receiving any type of data and the Provider requires a DUA.
DUA Agreement Mechanisms
It is CWRU’s preference to include data transfer language within subcontract agreements and research agreements. All DUAs require that the PI complete a Data Use Request/Access Form.
There are three mechanisms CWRU will utilize to enable the transfer of data for research purposes.
- A Stand Alone DUA: Used when a CWRU PI needs to transfer data for an unfunded project, collaboration, other purpose, or when the collaborator requires a stand alone DUA.
- As part of a subaward/subcontract: Used when CWRU is the provider or recipient of a subaward/subcontract and the transfer of human subjects’ research data is anticipated or required. Language enabling the transfer of data will be included in an ATTACHMENT 7 Data Use Agreement Form or Addendum and be included in the subaward/subcontract agreement.
- As part of a SRA/Sponsored Research Agreement: Used when CWRU is a party to an SRA that requires the transfer of human subjects’ research data or if the CWRU investigator wishes to include data transfer language in the agreement. The CWRU DUA team will work with pre-award specialists to include terms to allow and govern the transfer of data.
Request to Access or Transfer Data from Federal or other Data Repositories
Occasionally, CWRU investigators wish to transfer or access data from federal or other data repositories where the repository requires institutional review prior to transferring or providing access to the data. Example repositories: dpGap, CMS, SEER, NIAGADS, and GenBank. CWRU facilitates the review and approval of transfer and access of data from repositories through the utilization of the DUA Request Form. Go to the DUA Request Form to request the transfer or access of data from a repository.
Data Use Agreements
The Office of Research Administration (ORA) is responsible for the review and negotiation of data use agreements (DUAs). We assist with the preparation and execution of these documents. Every DUA is required to be signed by an authorized signatory for the university; this can only be done by the ORA.
For your DUA:
In order to initiate a Data Use Agreement or Data Access Agreement, a Data Use/Access Request Form needs to be submitted.
- The form has questions designed to help DUA staff determine the type of DUA needed and regulatory requirements.
- As you are completing the form, please provide as much detail as possible.
- The form has branching logic and contains questions regarding funding, type of data to be accessed or transferred, data storage, data security, and human subjects’ information.
- To assist with the completion of the form all of the questions, branching logic and additional guidance are provided in the DUA Request Form and Guidance Document.
If you have questions about Data Use/Access Agreements, please email email@example.com with your questions and a DUA staff member will get back to you.
DUA Close Out
*When a faculty member leaves CWRU, he/she/they must notify the DUA team at firstname.lastname@example.org in order to close out the existing DUAs. Many of these DUAs have provisions requiring that they be returned or destroyed upon completion of the project or other triggering events.
*PI’s are encouraged to keep a list of all DUAs that they are a party to and under which they have received and provided data, biospecimens, and/or materials.
Transfer of Data Upon Leaving CWRU
When a PI leaves Case Western Reserve University it is the responsibility of the PI to make arrangements for the custody, archival, and destruction of research data in accordance with this policy. Ownership of data for closed, active, and on-going research projects belongs with the University.
Principal Investigators wishing to transfer research data to the new institution will work with the management center and the DUA team Office of Research Administration for approval and negotiation of the transfer of requested data. Original data for active and on-going research must remain at Case Western Reserve University with an assigned custody unless permission is granted by the associate vice president for research and both the PI and the new institution that guarantees:
- Acceptance of custodial responsibilities for the data, and
- That Case Western Reserve University be given access to the data should that become necessary.
Original data for closed projects that have not been archived or destroyed may be taken by the PI without additional oversight. If the PI chooses not to take this data it must be destroyed prior to the PI leaving CWRU.
When individuals involved in research projects who are not PI’s at Case Western Reserve University leave the University, they may take copies of research data for projects on which they have worked. The PI must, however, retain original data, at Case Western Reserve University, unless specific permission to do otherwise is granted by the Senior Vice President for Research and Technology Transfer or his/her designee.
In the case of student research where the student is not the PI, the PI may allow the student to take the original data (except for original informed consent documents if the study involves human subjects) when the student leaves the university as long as the student signs a written agreement (also signed by the PI and the associate vice president for research or their designee) agreeing to accept custodial responsibilities for the data and that Case Western Reserve University will be given access to the data should that become necessary.
Share Your Data Using OSF (Open Science Framework)
OSF (Open Science Framework) is a free, open source platform created and maintained by the Center for Open Science. OSF provides a cloud-based platform for the storage, sharing, and version control of all types of data, documents, and files. As a project collaboration and research management tool, it allows users to share data, files, and workflows amongst collaborators or students, and it integrates with services you already use like Box, Drive, Github, and many more. OSF should NOT be used for identifiable human subjects’ data and is not HIPAA compliant
OSF can assign DOIs to any data or files uploaded, making it a great place to publicize your work.
With OSF, users create project pages to upload data, invite collaborators, and manage research workflows. CWRU's institutional account with OSF means that you can affiliate your research, projects, and datasets with Case Western Reserve University and make them discoverable on our institutional landing page.