{"entity":{"id":"idea-moon-plain-language-consent","kind":"idea","name":"Two-page plain-language consent with teach-back for every cancer trial and treatment","aka":[],"tldr":"Replace 30-page consent forms with a short plain summary the patient explains back in their own words before signing, so consent means understanding.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Patients lack understanding, navigation and agency): Basch et al., Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment (JAMA 2017)","url":"https://doi.org/10.1001/jama.2017.7156"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-patient-voice","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","test":"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","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-moon-plain-language-consent/","neighbours":{"bottleneck":[{"id":"b-patient-voice","kind":"bottleneck","name":"Patients lack understanding, navigation and agency","route":"/bottlenecks/b-patient-voice/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}