Section 5

Team, ethics and funding

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

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.

Co-investigator, perfusion

Dr. Michael Okonkwo, MD

Cardiothoracic perfusion and deep hypothermic circulatory arrest. Led cannulation and the KRP-7 washout.

Neurophysiology lead

Dr. Lucia Vasquez-Reed, PhD

Quantitative EEG and cortical coherence analysis. Responsible for the pre-registered primary endpoint definition and blinded scoring.

Perfusate chemistry

Dr. Sora Tanabe, PhD

Mitochondrial permeability transition pharmacology. Formulated KRP-7 and the KI-118 analogue.

Behavioural assessment

Dr. Adele Brenner, DVM

Canine cognition. Ran the day-9 discrimination and navigation batteries against the institute's control cohort.

Independent monitor

Prof. Elin Lindqvist, MD PhD

External to the institute. Held unilateral authority to halt the protocol at any point, including after return of circulation.

5.1

Ethical framework

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 Their outcomes are reported in full, including the four in which the protocol was withdrawn on welfare grounds.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

Funding and conflicts

Primary funding
Kanto Institute internal translational fund (₩3.94B, 2024 to 2027). No commercial input into study design, analysis or reporting.
Secondary funding
Nordic Resuscitation Foundation grant NRF-2025-084 (instrumentation only) and Korean National Research Council award NRC-2026-0117 (imaging and long-term follow-up).
Declared interests
S. Tanabe is named on a pending patent covering the KI-118 analogue (KR2026-114882, filed 04 February 2026). The institute holds no equity in any entity licensed to manufacture KRP-7. All other authors declare no competing interests.
Data availability
Raw telemetry, EEG and perfusion logs released as MU-EEG-001 under CC BY 4.0. Perfusate formulation released without restriction.
Peer review
Four reviewers, two rounds, 61 days. Submitted 12 June 2026, accepted 12 August 2026. Reviewer reports and the full response letter are published alongside the accepted manuscript.