Evidence: historical governance case. Imported from the supplied 65-Case Master Edition, dated September 19, 2026. Source links and classifications are retained as an attributed case account; import is not an independent source review.

Case at a glance

Case number
015
Date / range
2007
Sector
Consent, ownership, and biospecimens
Genetic asset
Donated tissue repository and associated records
Security principle
Custody, Ownership, and Withdrawal Are Distinct

Event summary

The Catalona litigation shows that donated research specimens can sit inside overlapping relationships among participants, investigators, and institutions. A donor's wish to redirect a specimen does not necessarily determine legal ownership or repository control.

Source: Court opinion — Washington University v. Catalona.

The case in context

The Catalona dispute concerned a research repository and efforts to move specimens when an investigator changed institutions. The court's treatment of the donations and institutional ownership depended on the documents and circumstances before it. Participants' wishes, the investigator's research plans, and the university's responsibilities did not automatically lead to the same transfer decision.

A repository needs rules for changes in personnel as well as ordinary research use. Clear terms should explain what withdrawal does, who may authorize a transfer, and what happens to information already derived from a sample. Those distinctions help keep scientific continuity from becoming an argument for undefined control.

Acquisition and processing

participant donation → institutional repository → investigator departure → competing transfer instructions → litigation over control

The sequence of events

  1. participant donation
  2. institutional repository
  3. investigator departure
  4. competing transfer instructions
  5. litigation over control

What became inferable or exposed

Donated tissue repository and associated records

The Catalona litigation shows that donated research specimens can sit inside overlapping relationships among participants, investigators, and institutions. A donor's wish to redirect a specimen does not necessarily determine legal ownership or repository control.

Security dimensions

Confidentiality

The confidentiality question concerns donated tissue repository and associated records. Exposure and further inference must be distinguished from the fact of collection or availability.

Integrity

The integrity question is whether the described material, permissions, processing, or interpretation can be relied upon. Custody, Ownership, and Withdrawal Are Distinct identifies the particular boundary examined here.

Availability

Access and continuity are assessed for the described event; potential effects are not presented as confirmed outages or losses.

Provenance

The relevant chain follows donated tissue repository and associated records through the stages shown below. Missing public detail is not proof that internal records did not exist.

GeneticSecurity.org analysis

Genetic Exposure Radius

Not assessed

No single level is assigned where the supplied dossier gives a range, conditional outcome, or broad institutional consequence. The affected parties and proposed assessment are shown separately.

Confidence: not assigned. Classification: GeneticSecurity.org analysis.

Genetic Persistence Risk

Not assessed

Persistence depends on the specific biological material or information retained. A potential effect is not treated as an observed genomic disclosure.

Confidence: not assigned. Classification: GeneticSecurity.org analysis.

Genetic Provenance Integrity

Not assessed

A numeric provenance level is not inferred from the existence of a source or court record. It requires evidence of the relevant custody and processing controls.

Confidence: not assigned. Classification: GeneticSecurity.org analysis.

Proposed classification and its limits

Suggested GER: GER-2/3 due to a large repository. Suggested GPR: GPR-4/5 depending on material and derived data. Suggested GPI: GPI-4 where repository custody is well documented.

These are proposed classifications from the supplied case dossier. Conditional scores describe an assumed exposure; they are not evidence that it occurred. A single numeric value is left unassigned when the asset or outcome is not sufficiently bounded.

What this case does not prove

The outcome does not establish that every institution owns every donated specimen. Consent forms, policy, applicable law, and the case record matter.

Mitigations and lessons

  • Plain-language repository ownership terms
  • Withdrawal consequences
  • Transfer rules
  • Investigator-departure plans
  • Chain-of-custody
  • Governance committees
  • Separate treatment of physical samples versus copied data

Primary sources

Secondary sources

No additional source listed. See the evidence notes for limitations.

Policy and standards

Genetic Security Policy and Standards

Review and correction history

Source edition: September 19, 2026. Imported case account; no substantive corrections recorded.

Correction policy and log

Cite this case

GS-CASE-015. Catalona: When Donors, Researchers, and Institutions Claimed the Same Samples. GeneticSecurity.org. https://geneticsecurity.org/cases/015-catalona-biobank-sample-custody/