Overview 

What is the Universal Consent Registry?

The Universal Consent Registry (UCR), also referred to as The Registry, is a record of patients who have provided consent for their de-identified clinical data and remnant clinical specimens to be used for future research.

What are remnant samples?

Remnant samples are leftover portions of clinical laboratory specimens that remain after all required clinical testing and reflex testing have been completed. These samples would otherwise be discarded and are made available for research only after clinical needs are fully met.

What is Bioexplorer?

Bioexplorer is an informatics-driven cohort discovery and biospecimen identification platform supported by a cross-disciplinary team with expertise spanning the Clinical and Translational Science Center (CTSC), the Department of Pathology and Laboratory Medicine (DOPLM), and Enterprise Analytics and Data Services (EADS).

Bioexplorer uses automated queries of Epic clinical data to identify large patient populations that meet broad, well-defined inclusion criteria. This approach enables efficient, reproducible identification of potential study cohorts across hundreds of thousands of patients.

Because Bioexplorer relies on structured EHR data and automated logic, it is designed for population-level cohort identification, not detailed, patient-by-patient chart review or clinical adjudication.

How do researchers access data and samples? 

Researchers access de-identified data and remnant specimens through BioExplorer, the institutional platform that supports feasibility review, regulatory documentation, and coordination with the Pathology Biorepository.

Specimen Types and Handling


What specimen types are available?

The most commonly available specimen types are whole blood, plasma, and serum. Availability depends on the clinical test performed and routine clinical workflows.

How are specimens preserved?

Whole blood is typically preserved using EDTA or heparin. Plasma may be preserved using EDTA, heparin, or citrate. The preservative used depends on the original clinical test.

What volume can I expect?

We provide aliquots of 500 ul (0.5 ml) for most sample types. Please reach out if a different volume is being requested. 

How should I choose the appropriate specimen type?

The appropriate specimen type depends on your planned analysis. For example, plasma may be suitable for some cell-free DNA assays, while whole blood may be preferable for genomic DNA extraction or for isolating specific cell populations. Investigators are encouraged to discuss assay requirements with the Biorepository team prior to submission.

How long after collection are samples stored?

Clinical laboratory specimens are typically stored at 4°C for at least 24 hours after collection to ensure that all required testing has been completed. This interval between collection and long-term storage may affect the viability or quality of certain analytes or cell types. Once samples are cleared for research use, they are aliquoted into new coded (de-identified) containers and stored at −80°C until retrieval.

Are samples processed immediately after collection?

No. Because these are remnant clinical samples, processing timelines are driven by clinical laboratory workflows rather than research-specific protocols.

How might storage conditions impact my study?

The time between collection and long-term storage, as well as storage temperature, may impact certain analytes or cell types. Feasibility should be evaluated on a study-by-study basis.

 

Study Feasibility and Appropriateness

How can I be sure patients have been consented?

Only patients who have provided consent through the Universal Consent Registry are included. Sample collection lists are generated daily and checked against up-to-date Registry records to ensure that only samples and data from consented patients are made available for research use.


Is the data identifiable?

No. Researchers receive de-identified data and specimens in accordance with IRB approval and institutional policies.

What clinical data are available?

Available data may include demographics, diagnosis codes, laboratory results, outcomes-oriented clinical data (e.g., OMOP), and other clinical variables, depending on IRB approval and data availability.

Can I request add-on blood draws?

No. The Registry supports access to remnant samples only and does not involve additional blood draws, protocol-driven collections, or changes to standard clinical care. 


How do I determine if there are enough samples for my study?

If you provide inclusion and exclusion criteria, the BioExplorer team can perform a preliminary feasibility review to estimate the number of eligible patients and expected sample throughput.

Can additional assays be performed by the Pathology Labs?

Yes. Add-on tests may be performed on de-identified remnant samples. Any costs associated with additional assays are the responsibility of the researcher. Results from these tests are not returned to the patient medical record and are provided to the research team as coded (de-identified) data. Please see the Laboratory Test Directory for more information on available tests.

Logistics, Costs, and Timelines

How long does it take to receive samples?

Timelines vary depending on IRB approval, feasibility review, and sample availability. The Biorepository/CROC team can provide study-specific estimates after project review.

How often will samples be delivered to researchers?

Researchers may choose the frequency of sample delivery based on study needs. Samples can be released at predefined intervals during the course of collection or delivered in a single batch once collection is complete. Please note that Pathology may assess storage fees for samples held longer than three months prior to release.

What is the cost to researchers?

Samples are provided at standard Pathology rates according to the approved institutional rate sheet. Current rates are $8 per specimen for Cancer Center members and $11 per specimen for other UC Davis researchers.

What other costs are involved?

At this time, there are no additional fees associated with study setup, regulatory review, or retrieval and delivery of de-identified data.

Is this right for my study?

The Registry and associated remnant clinical samples are a powerful resource, but they are not appropriate for every study design. Investigators should carefully consider the following when assessing feasibility:

  • Processing requirements: Because these samples originate from routine clinical care, they are collected, handled, and stored according to clinical laboratory workflows – not research-specific protocols. Studies that require highly prescriptive or rigid processing timelines (e.g., immediate processing, specific centrifugation steps, or controlled pre-analytical variables) may not be compatible.
  • Timing and storage conditions: Clinical specimens are typically held at 4°C for at least 24 hours after collection to allow completion of all required testing. This delay may impact certain analytes or cell populations.
  • RNA-based studies: RNA-focused analyses may be challenging due to degradation and variability in RNA quantity and quality that can occur during routine clinical handling and storage. Investigators should carefully evaluate whether remnant samples meet the needs of RNA-based assays.
  • Cell viability and specialized assays: Studies requiring highly viable cells, rare cell populations, or tightly controlled collection conditions may not be suitable.

Investigators are strongly encouraged to discuss assay requirements and study goals with the Biorepository and BioExplorer teams early in the planning process to determine whether remnant samples are appropriate.

How do I get started?

Submit your project details to the Bioexplorer team to initiate a feasibility review. A member of the team will follow up within four business days.

If the project is deemed feasible, the PI will be responsible for submitting the study for IRB and CROC approval. The appropriate templates, forms, and guidance will be provided as part of this process.

Resource Links:


Bioexplorer Project Initiation Request Form
Universal Consent Registry FAQs (for patients)
CROC/Pathology Intake Form
Pathology Lab Test Directory
Biorepository Shared Resource Recharge Rates
UC Davis Pathology Biorepository PPMS Ordering Page