Printer-friendly version
Some common problems with the Informed Consent Document include the use of technical and scientific terms or jargon that a lay person would not understand, and units of measure given in metric rather than in imperial units (the unit system used in the U.S.). Ordinary language should replace technical terms (e.g., upper extremities are better referred to as arms, hematoma as a bruise, venipuncture as taking blood from your arm with a needle, and so forth.) A website that is helpful for converting medical terminology to lay language can be found by clicking on the following link, Medical Terminology in Lay Language.
Perhaps the most common problem with Informed Consent Documents is that they are written at a reading level several grades higher than the average subject would understand.
Informed Consent Documents should be written at a reading level that potential subjects would understand. For most projects, an eighth grade reading level is suggested. Most word processing programs can determine a document's reading level.
Tips for writing a "user-friendly" Informed Consent Document include the following:
- Write the Consent as though you were speaking to the person who will read it, using “you” and “your,” “we” and “our,” rather than third person.
- Use language that could be understood by a junior high student.
- Put technical jargon into lay terms (e.g., describe the amount of a blood draw in teaspoons rather than milliliters; use “cancer” rather than “carcinoma”).
- Clearly define complicated terms (e.g., randomization means the study treatment you’ll receive will be decided by chance, like flipping a coin).
- Don’t give a lot of technical information that participants don’t need to know (e.g., complicated methods of determining drug doses, exhaustive lists of specific lab tests).
- Use bulleted lists rather than long sentences.
- Use headings and subheadings as appropriate with logical and consistent formatting.
- Use tables and charts to explain when/where each procedure will take place.
- Use pictures and diagrams to help describe devices.
- Number each page of the document.
- Use hard page breaks to eliminate “widow” and “orphan” lines of text.
- Use consistent and reasonable font size (e.g., 12 point).
- Do not “right justify” the text.