Principal investigator
Dr. Rina Hayashi, DVM PhD
Veterinary critical care and cerebral ischaemia. Designed the graded reoxygenation schedule; certified death in theatre and recused herself from all subsequent intervention decisions.
Section 5
A result of this kind is only as credible as its oversight. Everything below is stated so that it can be checked: the governance chain, the consent instrument, the funding arithmetic, the declared interests, and the identity of the person who held the authority to stop the procedure at any moment.
Principal investigator
Veterinary critical care and cerebral ischaemia. Designed the graded reoxygenation schedule; certified death in theatre and recused herself from all subsequent intervention decisions.
Co-investigator, perfusion
Cardiothoracic perfusion and deep hypothermic circulatory arrest. Led cannulation and the KRP-7 washout.
Neurophysiology lead
Quantitative EEG and cortical coherence analysis. Responsible for the pre-registered primary endpoint definition and blinded scoring.
Perfusate chemistry
Mitochondrial permeability transition pharmacology. Formulated KRP-7 and the KI-118 analogue.
Behavioural assessment
Canine cognition. Ran the day-9 discrimination and navigation batteries against the institute's control cohort.
Independent monitor
External to the institute. Held unilateral authority to halt the protocol at any point, including after return of circulation.
5.1
Program 07 operates under a single non-negotiable rule: no intervention may influence the determination of death. Certification was completed before enrolment, by clinicians with no role in the salvage protocol, using criteria fixed in advance.
Owner consent was obtained in writing months before the arrest, as part of a standing post-mortem research programme, and re-confirmed verbally at T+00:04. Consent included explicit acknowledgement that a recovered animal might survive with neurological impairment, and a pre-agreed threshold at which euthanasia would be the required outcome.
An independent monitor external to the institute was present for the full 14-hour theatre period with unilateral authority to stop. Continuous video of the entire procedure is retained and available to the ethics committee and to peer reviewers on request.
Six flash-reperfusion control animals were enrolled under the same programme and the same certification standard. Their outcomes are reported in full, including the four in which the protocol was withdrawn on welfare grounds.
The governance chain is deliberately separated into four bodies with distinct membership. The institutional review board (KITC-IRB-2024-118) approved the protocol and holds no operational role. The animal welfare and ethics committee holds authority over welfare thresholds and euthanasia criteria and includes two lay members and one veterinary anaesthetist drawn from outside the institute. The independent monitor holds the sole real-time stop authority in theatre. The data and safety board, convened quarterly, reviews follow-up telemetry and welfare scoring and may terminate follow-up independently of the investigators.
Welfare thresholds were quantitative and fixed in advance rather than left to judgement in the moment. Sustained absence of coordinated cortical activity at 6 hours, a modified Glasgow canine neurological score below 9 at 72 hours, refractory seizure activity, uncontrolled pain scoring above 4 on the short-form composite measure pain scale, or inability to maintain voluntary nutrition by day 5 each mandated euthanasia without further deliberation. None of these thresholds was reached in MU-01. Four of the six control animals reached at least one threshold, and the protocol was withdrawn in each case within the interval specified.
The institute publishes the fact that the framework itself is contested. A standing external ethics review, commissioned in March 2026 and published in full, records a minority position holding that consent obtained months before an unforeseeable arrest cannot be genuinely informed as to the specific circumstances of that arrest. That position has not been adopted, but it is on the record and is being addressed in the consent instrument for the successor trial.
5.2