|Research data is any qualitative or quantitative information that has been collected, observed, generated, or created through observation, experimenting, simulation, and derived methods in either digital or non-digital forms (e.g, laboratory notebooks, diaries, excel charts, etc).
|Case Western Reserve University (CWRU) is primarily concerned with securing the transfer of human subjects' research data, whether in hardcopy or digital format.
|Data Use Agreement
|A Data Use Agreement (DUA) is a legal mechanism used to transfer data from one party to another where the data is subject to some restriction on its use. This can also be called a Data Transfer Agreement or a Data Access Agreement.
A DUA is required by CWRU if (1) CWRU is the data provider; (2) CWRU is receiving human subjects' derived data; (3) CWRU is receiving any type of data and the Provider requires a DUA.
|If CWRU is the provider or recipient of a subaward where the transfer of human subjects’ research data is anticipated, you will need to complete a DUA Request Form. ORA DUA will most likely use an Attachment 7 Data Use Agreement Form to include in the subaward packet.
|Sponsored Research Agreement
|If CWRU is a party to a Sponsored Research Agreement (SRA) under which the transfer of human subjects’ research data is anticipated, you will need to complete a DUA Request Form. ORA DUA may add supplemental terms to the SRA prior to it being negotiated with the Sponsor. It is important that this issue be addressed PRIOR to the signing of an SRA.
|Stand Alone DUA
|If a CWRU principal investigator (PI) needs a DUA for an unfunded project, collaboration, or other purposes not addressed above, you will be requested to complete a DUA Request Form. ORA DUA will most likely use either a Federal Demonstration Partnership (FDP) Template (with member organizations) or an Institutionally approved CWRU DUA Template.
|Human Subjects Data
|Any data derived from a living individual.
|A living individual about whom an investigator, whether a professional or a student, conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, analyzes, or shares that information or biospecimen; OR (2) obtains, uses, studies, analyzes, shares, or generates identifiable private information or identifiable biospecimens.
|If you have protected health information (PHI), personally identifiable information (PII), or a limited data set (LDS), you will need to speak to the Institutional Review Board (IRB) to ascertain whether you need IRB approval to collect, share, or receive any PHI, PII, or LDS data.
|If you receive a Human Subjects EXEMPT designation from an IRB, it does NOT mean that your data is non-human subjects’ data, this simply means the data does not rise to the level of requiring federal protection (hence it is EXEMPT from the Health Insurance Portability and Accountability Act (HIPAA), Health Information and Technology for Economic Clinical Health (HITECH), and other federal rules governing the collection, use, and transfer of human subjects’ data.
|Nonhuman Subjects Data
|Any data derived from nonliving individuals, animals, or other non-human subjects.
|De-identified & Anonymized Data
|If you have de-identified, fully anonymized data, data derived from an animal, or other non-human subject data, ORA DUA will determine whether you need to speak with the IRB prior to processing your DUA request
|DUA Request Form
|Completing the DUA Request Form is the first step in determining if a DUA, IRB approval, or Data Security plan is necessary to receive, send or access data.
|DUA Request Form Guidance
|The DUA Request Form Guidance document will assist you with the completion of the form.
|An authoritative source for United States (US) cancer statistics. SEER stands for Surveillance, Epidemiology, and End Results Program. There are 2 main types of data products available to researchers: SEER Research and SEER Research Plus. SEER Research is typically for those non-Institutional requesters. SEER also has Specialized Data.
|SEER Research Plus Requests
|(1) Complete DUA Request Form; (2) Upon notification from ORA DUA, log into the Data Request System with your institutional eRA Commons account; (3) Complete the application form based upon the instructions provided to you by ORA DUA; (4) Acknowledge the SEER Research DUA, SEER Treatment Data Limitations (if applicable) and the BEST Practices Assurance (if applicable); (5) Submit the form.
|SEER Specialized Databases
|You must already have access to the Research Plus Data with a valid eRA Commons account before you can submit a proposal for review to apply for access to a specialized dataset.
|Blood, serum, urine, saliva, other bodily fluids, bone marrow, cells, stool, or tissue samples/specimens collected from Human Subjects under an approved IRB protocol. The term "Biospecimen" further includes, without limitation, any tangible material derived from such biospecimens collected under the Protocol from Human Subjects, such as genes, gene fragments, gene sequences, proteins, protein fragments, protein sequences, Deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and any subcellular structure, and their unmodified derivatives.
|Biospecimens Transfer Agreement
|The transfer of biospecimens and data between two organizations for use in a funded collaborative research project. Agreement language will be used in Attachment 7 subaward documents, funded SRAs, and any other funded agreement where the data transfer occurs with the inclusion of biospecimens.
|Material Transfer Agreement
|A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use it for their own research purposes. If the transfer of material is part of a research agreement, then an MTA is NOT appropriate.
|Notify ORA DUA
|When a faculty member leaves CWRU, they must notify ORA DUA in order to close out the existing DUAs and MTAs. Many of these DUAs have provisions requiring that they be returned or destroyed upon completion of the project or other triggering events. ORA DUA will work with the Technology Transfer Office (TTO) regarding the MTA closures.
|PIs are encouraged to keep a list of all DUAs and MTAs that they are a party to and under which they have received and provided data, biospecimens, and/or materials.
|Sharing data uploaded to online storage (cloud) with third parties. You can view or download the same data, but you do not send it directly to the other person.
|Sending a file from one point to another and handing over the data. The data is sent directly to the other side.
|NIH Data Sharing Policy
|The NIH Data Sharing Policy applies to final research data generated from grants, cooperative agreements, intramural research, contracts, or other funding agreements of $500,000 or more per year.
|DMS Policy Purpose
|NIH has issued the Data Management Sharing (DMS) Policy, effective as of 1/25/2023 to promote the sharing of scientific data. Sharing scientific c data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.
|NIH's general expectations for investigators and institutions under DMS: (1) Plan and budget for the managing and sharing of data; (2) Submit a DMS plan for review when applying for funding; and (3) Comply with the approved DMS plan.