{"entity":{"id":"idea-tr1-mutual-recognition-ethics-review","kind":"idea","name":"Mutual recognition of ethics review across countries","aka":[],"tldr":"A trial approved by a qualified ethics committee in one country would not need to repeat the full review in another; the second country would accept the first review and check only local issues.","summary":"Building on the EU Clinical Trials Regulation single-assessment model and the US single-IRB requirement, a treaty or regulatory reliance agreement would allow ethics committees in participating countries (EU, UK, Switzerland, Canada, Australia, Japan) to rely on a lead committee's scientific and ethical assessment, with local review limited to consent language, insurance and site suitability.","asOf":"2026-09-08","links":[{"label":"EU Clinical Trials Information System","url":"https://euclinicaltrials.eu/"},{"label":"NCI Central IRB","url":"https://www.ncicirb.org/"}],"tags":[],"related":["eudract-ctis"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["curie-nki-eortc"],"institutions":["esmo"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-enrolment","b-regulatory-fragmentation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Multinational oncology trials in participating countries will start enrolment 2-4 months earlier in second and later countries, and more small countries will be included in pivotal trials.","rationale":"Regulatory reliance already works for drug approvals (Access Consortium, Project Orbis). Duplicate ethics review rarely changes a protocol but routinely delays it.","test":"Pilot reliance between two willing jurisdictions for cooperative-group trials; measure time from lead approval to first patient in the second country compared with matched historical trials.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":4},"route":"/ideas/idea-tr1-mutual-recognition-ethics-review/","neighbours":{"collection":[{"id":"eudract-ctis","kind":"collection","name":"EU Clinical Trials Register / CTIS","route":"/collections/eudract-ctis/"}],"company":[{"id":"curie-nki-eortc","kind":"company","name":"EORTC","route":"/companies/curie-nki-eortc/"}],"institution":[{"id":"esmo","kind":"institution","name":"European Society for Medical Oncology (ESMO)","route":"/institutions/esmo/"}],"bottleneck":[{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}