Informed-consent readability

FAQ

What do Flesch Reading Ease and Flesch–Kincaid Grade Level measure?

Both are published formulas based on average sentence length and average syllables per word. Flesch Reading Ease returns a 0–100-style score (higher is easier). Flesch–Kincaid Grade Level estimates a U.S. school grade. They are useful screening metrics, not a judgment that subjects understood the consent.

Why do many IRBs aim for grade 6–8?

Informed consent must present information in language understandable to the subject or legally authorized representative (see 45 CFR 46.116 and 21 CFR 50.20). Many IRBs and institutions therefore set plain-language targets around grade 6–8 for patient-facing materials. Always follow your reviewing IRB’s written policy.

Does a grade-8 score mean the consent is IRB-ready?

No. Readability formulas ignore medical necessity of terms, layout, translations, teach-back, and whether required elements of consent are present. An IRB reviews the full document, not a grade-level number from a web tool.

Can I use this for IFUs and patient app copy as well?

Yes as a first pass. Instructions for use and patient-facing app text also benefit from shorter sentences and fewer rare words, and they feed human-factors and labeling files. Regulatory labeling rules and IEC 62366-1 usability expectations still apply separately.

How should I lower a high grade level?

Shorten sentences, split dense paragraphs, replace jargon with plain terms where clinically safe, define unavoidable technical words on first use, and re-run the checker. Keep required legal and risk disclosures intact — do not delete them to chase a score.

Does this tool send my consent text to a server?

The calculation runs in your browser from the text you paste. Treat any sensitive protocol language according to your own confidentiality policies before pasting it into any online tool.