# Drop the 'must speak English' rule: translated consent and questionnaires as standard

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

## TL;DR

Trials quietly exclude people who do not speak the local language because consent forms and questionnaires exist only in that language. Sponsors should provide validated translations for any language spoken by at least 5 percent of the catchment and fund interpreters; translations of common instruments already exist for dozens of languages.

## Summary

Protocols may not exclude on language; sponsors provide certified translations of consent and patient-reported outcome instruments in the languages spoken by at least 5 percent of the catchment population (with linguistically validated PRO versions), and fund professional interpreters for visits. Validated translations of common PRO instruments already exist for dozens of languages.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Removing language exclusions and funding translations will increase enrolment of non-native-speaking patients to their share of the catchment population and will not reduce PRO completion rates.
- Rationale: Language exclusions are common and rarely justified scientifically; PRO instruments have validated versions in many languages, so the cost is coordination rather than development.
- Proposed test: Audit a sample of protocols for language exclusions; sponsor pilot removing them at multilingual sites and compare enrolment by language.
- Maturity: early-clinical
- Actor: industry

## Sources

- EORTC Quality of Life Group (translated instruments): https://qol.eortc.org/

## Connected records

- companies: [EORTC](https://onco.cc/companies/curie-nki-eortc/)
- bottlenecks: [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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