OnCo
ideasIdea

Two-page plain-language consent with teach-back for every cancer trial and treatment

Replace 30-page consent forms with a short plain summary the patient explains back in their own words before signing, so consent means understanding.

Trial consent documents run to tens of pages at university reading level; comprehension studies show many participants cannot state the purpose of the study or that treatment is experimental. The proposal is a regulatory requirement that every consent process include a two-page plain-language summary (reading age 12, translated, with pictograms for risk) followed by a documented teach-back, with the long form as an appendix. The EU Clinical Trials Regulation already requires lay summaries of results; this extends the principle upstream.

Hypothesis
Short-form consent with teach-back raises objective comprehension scores (e.g., QuIC) by 20 points or more without reducing enrolment, and reduces later withdrawal for misunderstanding.
Rationale
Comprehension is a product of format, not patient intelligence. Teach-back is standard in patient safety, and shorter consent has performed as well or better than long forms in randomised comparisons of consent formats.
What would test it
Randomised comparison of standard versus short-form-plus-teach-back consent across ten trials; primary endpoint comprehension score at 24 hours, secondary endpoints enrolment, withdrawal and time to consent.
Maturity
early clinical
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

Connected

2top