Data Use/Data Transfer Agreements (DUA/DTUA)
Learn more about Data Use/Data Transfer Agreements (DUA/DTUA)
A Data Use/Transfer Agreement (DUA) is a legal agreement that allows one or more parties to provide access to, or transfer, data to or from a UC San Diego principal investigator for research purposes. In some cases, a mutual DUA may be negotiated to enable both UC San Diego and the collaborating party or parties to exchange data. The agreement establishes appropriate protections to prevent unauthorized disclosure or misuse of the data and ensures compliance with applicable laws and regulations, such as HIPAA when human subjects data is involved. At the same time, the DUA is designed to preserve UC San Diego’s ability to publish research findings and share results for academic purposes. While data use terms can be incorporated into broader agreements, such as sponsored research or collaborative research agreements, a standalone DUA is typically used when the primary purpose of the project is the transfer or use of data itself.Requests for dbGaP Data
Effective April 2, 2025, the NIH implemented a new requirement as part of its Genomic Data Sharing (GDS) Policy that all NIH genomic datasets be secured in NIST SP 800-171-compliant systems (see NOT-OD-24-157). This applies to ALL NEW OR RENEWED data requests. Please work with ITS to ensure that your IT environment is compliant with the NIST standard and obtain a written confirmation from ITS. Please note that the Sponsored Projects Office cannot approve any data requests until you have provided ITS’ written confirmation of your compliance.
NIH/NCBI dbGaP Data Access Requests:
The National Institutes of Health’s National Center for Biotechnology Information (NIH NCBI) advances science and health by providing access to biomedical and genomic information. UCSD researchers who wish to receive data from the dbGaP database are required to submit a Data Access Request through eRA Commons, and the Request must be approved by an authorized SPO Signing Official. Please follow this process to obtain access to dbGaP datasets:
- Submit a Data Access Request through eRA Commons as a New, Renewal, or Close-out request
- Your eRA Commons application requires you to list an IT Director:
- IT Director for Health Science departments: Kenneth Wottge (wottge@ucsd.edu)
- IT Director for General Campus departments: Arlene Yetnikoff (ayetnikoff@ucsd.edu)
- Reach out to ITS’s OIA Research Support at OIA-Research-Support@ucsd.edu for an assessment of your IT environment. Once your environment is compliance with this NIST standard, ITS will provide you with a written confirmation. A dedicated website with information about available services, guidance, and resources to support compliance with NIST SP 800-171 is now available.
- Complete and submit this internal form so that the SPO Signing Official can review and approve the request. You will need to complete this internal form every time a Signing Official signature is needed, which can happen at 3 timepoints: New, Renewal, and Close-out.
Be sure to include the NCBI dbGaP project# so that we may locate your request and attach ITS’ written confirmation of your compliant environment.
You will need to certify that:- your current IT environment is compliant with NIST SP 800-17
- you will not store or share data outside of the NIST-compliant environment
- you will delete all dbGaP data from the environment at conclusion of the project period; and
- you will be responsible for any additional costs needed to ensure that your IT environment is compliant
Please note: this internal form should only be used if you are requesting data from the dbGaP database. You do not need to submit a separate KR PD record.
If you are submitting data to dbGaP as part of your Data Sharing & Management Plan, please see information regarding NIH GDS Certifications.
Requests for Genomic Data from other NIH Controlled-Access Databases Subject to the NIH’s Genomic Data Sharing (GDS) Policy
Effective April 2, 2025, the NIH implemented a new requirement as part of its Genomic Data Sharing (GDS) Policy that all NIH genomic datasets be secured in NIST SP 800-171-compliant systems (see NOT-OD-24-157). This applies to all new or renewed data requests. Please work with ITS to ensure that your IT environment is compliant with the NIST standard and obtain a written confirmation from ITS. Please note that the Sponsored Projects Office cannot approve any data requests until you have provided ITS’ written confirmation of your compliance.
- Reach out to ITS’s OIA Research Support at OIA-Research-Support@ucsd.edu for an assessment of your IT environment. Once your environment is compliance with this NIST standard, ITS will provide you with a written confirmation. A dedicated website with information about available services, guidance, and resources to support compliance with NIST SP 800-171 is now available.
- Submit data use agreement to KR PD
Please see the NIH’s webpage on affected repositories and the data request process.
Non-Exhaustive List of affected NIH-Controlled Access Databases:
- Database of Genotypes and Phenotypes (dbGaP) - see related drawer
- BioData Catalyst
- The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-Space (AnVIL)
- National Cancer Institute (NCI) Genomic Data Commons
- Cancer Research Data Commons (CRDC) – Trusted Partner
- Kids First Data
- INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Data Hub
- National Institute of Mental Health Data Archive (NDA)
- The Neuroscience Multi-omic Data Archive Brain/NeMo
- National Institute on Aging (NIA) Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS)
- Accelerating Medicines Partnership® Parkinson's Disease (AMP PD)
- Parkinson’s Disease Biomarkers Program Data Management Resource (PDBP DMR)
- PEGS: Personalized Environment and Genes Study
- NIMH Repository and Genomics Resources (NRGR)
- NIDCR FaceBase
- NEI BRICS
- NIH Brain Development Cohorts (NBDC) Data Sharing Platform
- Aging Research Biobank
- Amyotrophic Lateral Sclerosis Knowledge Portal (ALS KP)
- NCATS National Clinical Cohort Collaborative (N3C)
- NIDDK-CR R4R
- NIDA Center for Genetic Studies
- Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System
- TB Portals
- NIA Data LINKAGE Program
- Clinical Trial Data Commons (CTDC)
- NCI Cancer Data Access Systems (CDAS)
- NIAID AccessClinicalData
- SEER Specialized Databases
- SEER-CAHPS Linked Data Resource
- SEER-MHOS Data Resource
- Archived Clinical Research Datasets
- COVID RADx Data Hub
- The Immunology Database and Analysis Portal (ImmPort; Private)
- NIAAA Controlled Data
- NCCR Data Platform
- mapME/CFS CCR
- BioLINCC
- NICHD DASH
NIH Genomic Data Sharing (GDS) Certification (depositing data)
The National Institutes of Health’s Genomic Data Sharing Policy requires broad and responsible sharing of human and non-human genomic data resulting from NIH-funded research. When applicable, PIs are required to submit to the NIH a Genomic Data Sharing (GDS) certification, which must be cross-signed by a SPO Signing Official. NIH GDS certifications are not considered data use/transfer agreements and should not be submitted to Kuali PD.
- When a certification is required at pre-award stage (proposal or Just-In-Time): work with your SPO proposal officer to complete and submit the certification
- When a certification is required at post-award stage: email researchadmin@ucsd.edu. A SPO award officer will reach out to you directly