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A data-use agreement (DUA) is the rulebook for a research collaboration that uses information another organization controls. It identifies the approved project and people, limits what they may do with the data, requires privacy and security safeguards, controls onward sharing, and explains what happens to copies and derivatives when the work ends. In practice, it determines who can join a team, which analyses are allowed, how files may move between institutions, how incidents are reported, and whether data must be deleted or retained.
There is no universal biomedical DUA. A repository, funder, consent language, institution, country, state law, and negotiated terms can all change the obligations. NIH’s Data Use Certification (DUC) Agreement is a useful current example for controlled-access human genomic data, but the agreement governing your project always takes priority.
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What a DUA actually governs
A DUA turns a broad collaboration idea into an authorized, auditable use of specified data. It normally answers seven questions:
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- Purpose: What scientific question, disease area, ancestry analysis, or other activity is approved?
- People: Which principal investigator (PI), staff, students, analysts, contractors, and external collaborators may access the data?
- Data: Which datasets, fields, linked records, and derived outputs are covered?
- Safeguards: What technical, organizational, privacy, and confidentiality controls are required?
- Sharing: May files move to another institution, cloud service, vendor, or collaborator, and under what approval?
- Publication: What acknowledgements, reporting, review, or disclosure duties apply?
- End of use: When must copies be destroyed, returned, renewed, or retained for a defined reason?
Those terms make a DUA operational rather than merely administrative. A team can have an otherwise valid scientific plan and still breach the agreement by adding an unapproved analyst, using a dataset for a new question, placing a copy in an unapproved cloud account, or keeping a derivative after the authorized period.
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Why collaborations need special attention
Biomedical projects often span a repository, a PI’s institution, a hospital, a sequencing center, a statistical group, and commercial or nonprofit partners. Each party may have a different security environment and a different legal status. The fact that one institution has been approved to access a dataset does not automatically authorize every person working with its researchers.
Approval follows people and projects
Most controlled-access arrangements tie access to both an identified project and named users. A new collaborator can therefore require an amendment, a separate institutional approval, a collaboration letter, or a new access request. A person who changes institutions may need to be reapproved through the new institution even if the scientific role is unchanged.
Scope follows the approved research statement
The project description is not background text. It is the boundary of use. If the approved statement covers a specific cancer outcome, a later study of medication adherence or an unrelated population may require a new request. Combining the data with another source, attempting an additional re-identification analysis, or creating a new dataset for a different team can also exceed the approved scope.
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NIH’s DUC Agreement as a current example
For people accessing data on or after January 25, 2025, NIH’s DUC Agreement sets terms for controlled-access datasets held in NIH-designated repositories under the NIH Genomic Data Sharing Policy, including datasets in dbGaP. The agreement works together with the approved Data Access Request (DAR) and its Research Use Statement.
What the request identifies
The DAR identifies the PI, approved personnel, and the project for which access is sought. A dataset addendum supplies dataset-specific information, including:
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- the permitted data-use limitation;
- the sponsoring NIH Institute or Center;
- the responsible Data Access Committee;
- a description of the study; and
- a suggested publication acknowledgement.
The addendum matters because two datasets in the same repository can carry different restrictions. Examples include General Research Use, Health/Medical/Biomedical limitations, and Collaboration Required conditions. A Collaboration Required designation can make a collaboration letter or equivalent documentation part of eligibility.
What the agreement permits
Use is limited to the requested data and derivatives needed for the approved project. The agreement prohibits using the data to identify or contact participants or their families, except for stated exceptions and applicable institutional review board (IRB)-approved research. A user cannot treat the files as a general-purpose biomedical database simply because the files are technically available.
Who counts as an approved user?
The PI and the approved personnel listed through the access process are the starting point. NIH describes an external collaborator as someone outside the PI’s direct supervision, such as a person who is not part of the PI’s laboratory. External collaborators must be independently approved for controlled-access NIH genomic data.
Adding an external collaborator
- Confirm that the person’s role is necessary for the approved project.
- Check the dataset’s limitation and the applicable Data Access Committee procedure.
- Obtain the collaborator’s approval through their home institution when required.
- Document the collaboration in the approved request or required collaboration letter.
- Give the collaborator the agreement, security rules, data dictionary, and incident-reporting instructions before access.
- Remove access promptly when the person leaves the project, changes role, or no longer needs the data.
Secure transmission within a collaborative group is allowed when the collaboration is described in the approved request and every member is an approved user through the appropriate home institution. Distribution to an unapproved person or entity is otherwise restricted. A shared folder, project mailing list, or informal permission from the PI does not replace approval.
Privacy is not solved by calling data “anonymous”
Genomic and clinical information can carry residual identification risk when combined with public records, genealogy resources, rare-disease details, or other datasets. NIH privacy guidance says institutions should consider protections even when data meet technical or legal definitions of de-identified information.
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“Researchers and institutions should proactively assess the protections needed for sharing scientific data from participants, including determining whether sharing should be restricted through controlled access, regardless of whether the data meet technical and/or legal definitions of ‘de-identified’ and can legally be shared without additional protections (e.g., the activity does not meet the definition of ‘human subjects research’ under the Common Rule).”
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Accordingly, a DUA may prohibit re-identification, recontact, or attempts to identify relatives even when names and direct identifiers have been removed. If an IRB-approved exception exists, it should be documented in the controlling agreement and research approvals rather than assumed from a general consent form.
Responsibilities must reach every person with access
NIH’s supplemental privacy notice, NOT-OD-22-213, states: “Agreements for data users should delineate responsibilities of all parties having access to the data and clearly inform parties about data use limitations as well as responsibilities regarding privacy and confidentiality, including those required by Certificates of Confidentiality, as applicable.” That means the PI should not be the only person trained. Students, data managers, statisticians, cloud administrators, and approved vendors need role-appropriate instructions and a way to report concerns.
Security, transfer, and cloud operations
A DUA often specifies authentication, authorization, encryption, logging, least-privilege access, secure disposal, and incident handling. The exact controls vary by agreement. Before transferring a file, the team should know whether encrypted transfer is required, whether removable media is prohibited, which cloud environments are permitted, and who must be notified after suspected loss or unauthorized access.
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NIH’s 2026 security transition
NIH states that, effective February 25, 2026, users accessing NIH controlled-access repositories under new or renewed agreements are expected to follow updated security standards. Users approved before that date follow the security standards written into their existing agreement until close-out or renewal. This is a date-specific NIH rule for those new or renewed arrangements, not a universal security deadline for every biomedical DUA.
Transfers inside a collaboration
Map the data path before work begins: repository to institutional environment, institutional environment to an approved collaborator, and any movement into analysis workspaces or backup systems. For each step, record the sender, recipient, approval basis, encryption method, and retention period. A transfer that is technically secure can still violate a DUA if the recipient, purpose, or location is not authorized.
Derived data, outputs, and copies
Do not limit compliance to the original download. Agreements may cover transformed files, linked datasets, model inputs, intermediate tables, extracts, and other derivatives. The team should classify which outputs still contain controlled information and which have been reviewed for release.
Practical derivative controls
- Keep a data inventory that distinguishes source files, working copies, backups, and derivatives.
- Record whether each derivative can be shared, published, or used only inside the approved project.
- Apply the same access controls to analysis workspaces and cloud snapshots as to the source dataset when the agreement requires it.
- Review aggregate tables and visualizations for small-cell, rare-variant, or linkage risks before release.
- Prevent downstream users from treating a derivative as permission to start a new research question.
Publication, acknowledgement, and reporting
Many agreements require a particular acknowledgement, repository citation, study identifier, or notification of publications and presentations. NIH dataset addenda can include suggested acknowledgement language. Follow the controlling addendum and repository instructions rather than replacing them with a generic statement.
Publication permission is not permission to disclose restricted data. Manuscripts, code, summary statistics, and supplementary files should be screened for prohibited individual-level information, re-identification risk, and any required review. Keep a record of the approval and the version of the data used so that a later audit can reconstruct the analysis.
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Close-out, retention, and renewal
At close-out, the NIH DUC generally requires destruction of copies, versions, and derivatives on local systems and cloud infrastructure. It permits retention only of encrypted minimum data needed for institutional retention, legal duties, or scientific-transparency requirements. Retained data remain subject to the agreement and may support findings from the approved research, but they may not be used to pursue new questions without a new approved request.
Close-out checklist
- Confirm the agreement’s end date, renewal process, and any notice deadline.
- Inventory laptops, servers, shared drives, cloud buckets, snapshots, backups, and portable media.
- Separate records that must be retained from copies that must be destroyed.
- Encrypt and restrict any permitted retained minimum dataset.
- Delete source files and derivatives from systems covered by the agreement and document completion.
- Remove user accounts, keys, tokens, and automated transfers.
- Record the final publication, acknowledgement, incident, and destruction details required by the repository or institution.
Because retention language differs, check the specific agreement, institutional records policy, sponsor terms, and applicable law before deleting or keeping anything.
How to compare two biomedical data-use arrangements
When a project involves multiple repositories or institutions, compare the controlling documents on the same axes. The most restrictive applicable term usually determines how the collaboration must operate.
| Comparison area | Questions to answer |
|---|---|
| Purpose and limits | Is use limited by disease, ancestry, phenotype, method, or a named project? Can a new question be added by amendment? |
| Approved users | Who qualifies, how are students and vendors handled, and how are external collaborators approved? |
| Sharing and derivatives | Can data move between institutions or into a cloud service? Do transformed files and summary outputs remain covered? |
| Privacy | What bans apply to re-identification, recontact, relatives, linkage, and disclosure of rare characteristics? |
| Security | Which authentication, encryption, logging, location, backup, and incident-reporting controls are mandatory? |
| Publication | What acknowledgement, repository citation, review, reporting, or notification is required? |
| End of project | When do access and retention end? What must be destroyed, returned, renewed, or preserved? |
A workable governance process for a collaboration
Before access
- Have research-contracts, privacy, information-security, and IRB reviewers identify conflicting obligations.
- Map the approved question to the exact datasets and fields requested.
- List every person and organization that will touch the data, including support staff and cloud operators.
- Design the minimum necessary access and a secure analysis environment.
During the study
- Maintain a current user and dataset register.
- Review new analyses, data linkages, and collaborators against the approved Research Use Statement.
- Log transfers and investigate unusual access or suspected disclosure immediately.
- Train new team members before granting access and retrain when the agreement changes.
When circumstances change
Pause the affected transfer or analysis if the PI changes, a collaborator leaves, a cloud provider changes, a security incident occurs, or the team wants to ask a materially different question. Contact the repository, Data Access Committee, sponsor, and institutional office named in the agreement. Continuing first and seeking permission later can turn a correctable scope change into a breach.
Common mistakes and their fixes
- “Our institution has access, so everyone on the project can use it.” Fix: verify each user’s approval and role.
- “The data are de-identified, so privacy controls are unnecessary.” Fix: assess residual identification and follow controlled-access terms.
- “Only the original files are regulated.” Fix: inventory derivatives, backups, extracts, and cloud snapshots.
- “A secure file-transfer tool makes any recipient acceptable.” Fix: confirm recipient, purpose, and location are authorized.
- “Close-out means deleting the folder on the lab server.” Fix: check every local, cloud, backup, and automated copy.
- “A new scientific question is a minor extension.” Fix: compare it with the approved statement and obtain a new request or amendment when required.
For a specific collaboration, the controlling DUA and institutional review—not a general summary of NIH practice—determines the result. Obtain the relevant contracts, privacy, security, and research-compliance review when the agreement or local law requires it.
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