# Mutual recognition of ethics review across countries

Source: https://onco.cc/ideas/idea-tr1-mutual-recognition-ethics-review/  
OnCo record `idea-tr1-mutual-recognition-ethics-review` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- EU Clinical Trials Information System: https://euclinicaltrials.eu/
- NCI Central IRB: https://www.ncicirb.org/

## Connected records

- collections: [EU Clinical Trials Register / CTIS](https://onco.cc/collections/eudract-ctis/)
- companies: [EORTC](https://onco.cc/companies/curie-nki-eortc/)
- institutions: [European Society for Medical Oncology (ESMO)](https://onco.cc/institutions/esmo/)
- bottlenecks: [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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