All samples submitted to the Translational Immunology Core must be accompanied by a completed submission form or approved project request. Each sample must have a unique, legible identifier that matches the accompanying documentation. Personally identifiable information, protected health information should, or sample group should not appear on sample labels unless specifically authorized through an approved workflow.

Investigators are responsible for ensuring that samples are collected, packaged, transported, and delivered according to the Core’s published requirements. These requirements may include acceptable collection tubes, minimum volume or cell number, temperature, processing interval, biosafety classification, and viability criteria.

The Core may reject, postpone, or process with qualification any sample that:

• Is unlabeled, mislabeled, leaking, damaged, contaminated, or received in an inappropriate container.
• Does not match the submitted documentation.
• Has insufficient volume, cell number, or viability.
• Was transported or stored outside the required conditions.
• Presents an undisclosed or unacceptable biological hazard.
• Lacks required regulatory or institutional approval.
• Arrives outside the agreed delivery window without prior arrangements.

When practical, the Core will contact the investigator before proceeding with a compromised sample. If the investigator asks the Core to process a nonconforming sample, the deviation and its potential effect on data quality will be documented. Processing fees still apply even when a sample produces unusable or limited results.

Investigators must disclose known or suspected infectious hazards before submission. Acceptance of a sample does not guarantee that the sample will generate interpretable data.

Investigators are strongly encouraged to consult with Core staff before collecting samples or beginning a new project. A consultation may be required for complex flow cytometry panels, clinical studies, longitudinal projects, assay development, limited specimens, specialized analysis, or work involving regulated materials.

During consultation, the investigator and Core may discuss:

• The scientific question and intended use of the results.
• Sample type, collection, processing, storage, and transport.
• Assay selection, panel design, controls, replicates, and expected sample numbers.
• Data-acquisition and analysis requirements.
• Project timeline, staffing, reagents, and estimated cost.
• Regulatory, biosafety, or data-security requirements.
• Responsibilities of the investigator and Core personnel.

The investigator is responsible for providing accurate and complete project information. Estimates are based on the scope known at the time and may change if sample numbers, methods, deliverables, or timelines change.

Substantial changes in project scope must be reviewed by the Core before implementation. Additional work—including assay redevelopment, repeat testing, expanded analysis, or expedited service—may require a revised estimate and timeline.

Consultation and technical recommendations support experimental planning but do not replace the investigator’s responsibility for scientific oversight, regulatory approval, or interpretation of the study as a whole.

Only users who have completed required training and demonstrated competency may operate Core instruments independently. Users must follow reservation, startup, shutdown, cleaning, and data-management procedures. 

Staff-assisted services must be scheduled with the Core. If an investigator schedules services with the Core but cancels the services prior to execution, the investigator will be charged when instrument time, staff time, or reagents have already been committed.

The following may be billed:

• Unused instrument time that could not be reassigned.
• Staff time reserved for the project.
• Reagents or consumables prepared specifically for the appointment.
• Work already performed before cancellation.

The Core reserves the right to cancel or move reservations because of instrument failure, failed quality control, staffing limitations, emergencies, or other circumstances beyond its control. When this occurs, the Core will notify affected users and reschedule the work as soon as reasonably possible. The Core is not responsible for downstream project costs resulting from unavoidable downtime.

Emergency exceptions to cancellation charges will be considered by the Core Director.

The Core provides temporary storage for data generated on Core instruments or by Core personnel. Investigators are responsible for transferring their data to an approved location and maintaining an independent backup.

Unless otherwise established by a study agreement, raw and analyzed data will be retained by the Core for at least one year after acquisition. Data may be permanently deleted after the retention period without additional notice. Longer retention may be available by prior arrangement and may involve a fee.

Users must:

• Verify that transferred files are complete and readable.
• Store data in accordance with institutional and sponsor requirements.
• Use approved methods for transferring sensitive or regulated data.
• Protect passwords and access credentials.
• Avoid storing the only copy of project data on an instrument computer.

Data containing protected health information, personally identifiable information, confidential information, or sponsor-restricted information must be handled through an approved workflow. Investigators should submit coded or de-identified data whenever possible.

The Core will take reasonable measures to protect stored data but cannot guarantee recovery following hardware failure, corruption, cybersecurity incidents, or events outside the Core’s control.

The Core performs applicable instrument and assay quality-control procedures before or during testing. Results will be released only after the required review has been completed, unless clearly identified as preliminary or exploratory.

Quality review may include:

• Instrument performance and calibration.
• Control-sample performance.
• Sample condition, recovery, and viability.
• Staining or assay quality.
• Compensation or spectral-unmixing performance.
• Event count and acquisition quality.
• Replicate agreement and standard-curve performance.
• Conformance with predefined assay acceptance criteria.

Results that do not meet established criteria may be rejected, repeated, or released with a qualification describing the limitation. The Core will notify the investigator when a significant issue may affect interpretation.

Repeat testing will be considered based on sample availability, the cause of failure, and the intended use of the results. If failure is attributable to Core equipment, reagents, or performance, the Core may repeat the work without an additional service charge. If failure is attributable to sample quality, investigator-provided materials, incomplete information, or circumstances outside the Core’s control, standard charges may apply.

Core results are for research use unless the assay and reporting process have been specifically approved for another intended use. Research results must not be used independently for clinical diagnosis, patient management, or product release.

Investigators remain responsible for the scientific interpretation and appropriate use of their results.

Before services begin, an Experiment Cost Estimate will be provided to the investigator that needs to be approved by the investigator in writing. The principal investigator or requesting organization is responsible for all authorized charges associated with the project. 

Charges may include:

• Instrument use.
• Staff-assisted acquisition or processing.
• Sample preparation.
• Reagents and consumables.
• Assay development or validation.
• Data analysis and reporting.
• Training.
• Sample or data storage.
• Shipping or project-specific purchases.
• Manuscript or grant writing.

Cost estimates are provided for planning purposes and are not fixed quotes unless explicitly stated. Final charges will reflect the services performed, time used, and materials consumed. Changes in scope may require a revised estimate.

Billable work may include unsuccessful testing when the Core has used staff time, instrument time, or reagents, particularly when failure results from poor sample quality or investigator-provided materials. Billing questions should be e-mail to the Core Director (zeb-zacharias@uiowa.edu).

Special-order materials may require advance authorization and may be nonrefundable once ordered. Work may be paused if funding information expires, an account becomes invalid, or invoices remain unpaid. Rates are reviewed periodically and may change with institutional approval.

Publications, abstracts, presentations, posters, grant applications, and other products resulting from Core services should acknowledge the Translational Immunology Core and applicable institutional or grant support.

Routine services—such as standard instrument use, routine sample processing, or established analysis—generally warrant acknowledgment but do not automatically qualify an individual for authorship.

Authorship should be considered when Core personnel make substantial intellectual contributions, such as:

• Developing or substantially modifying an assay or cytometry panel.
• Contributing to experimental design or study strategy.
• Developing a novel analytical approach.
• Performing extensive interpretation of results.
• Drafting or substantively revising manuscript content.
• Accepting responsibility for their contribution to the work.

Authorship decisions should follow the journal’s requirements and accepted institutional standards. Authorship and anticipated deliverables should be discussed early, particularly for collaborative or method-development projects.

Investigators should provide relevant manuscript sections to the Core for technical review before submission. This allows Core personnel to verify instrument descriptions, methods, analysis procedures, acknowledgments, grant support, and resource identifiers. Technical review does not grant the Core authority over the investigator’s scientific conclusions.

Where applicable, publications should include instrument identifiers, RRIDs, required funding acknowledgments, and citations for Core-developed or published methods. The Core will readily provide written descriptions for materials and methods. Contributions to other sections, such as introduction, results, discussion, etc. will be provided by the Core, but is not a primary responsibility of the Core and will occur when staffing permits.