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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.
Shares Patients lack understanding, navigation and agency, Trials enrol too few, too slowly.
Shares Patients lack understanding, navigation and agency, Trials enrol too few, too slowly.
Shares Patients lack understanding, navigation and agency, Trials enrol too few, too slowly.