People with difficulty reading are often ashamed—67% said they hid their illiteracy even from their spouses. In research situations they may also hide their illiteracy from investigators. Therefore investigators must demonstrate respect for persons (The Belmont Report) by writing the clearest possible consent forms, providing help by reading or recording consent documents, and evaluating comprehension participants’ through asking questions or other techniques. Suggestions for Improving Readability of Consent Documents Before You Write Know your target population. What is their likely age, education, race/ethnicity, SES, and location? How much and in what ways does the audience differ from you? How much experience do you have with this audience? If little or none, can you locate someone who has worked with this audience to advise you about communication strategies? When You Write Use a question and answer format to organize the informed consent (IC). See online templates for IC. This format results in shorter answers that are focused on a single topic, rather than running topics together. It seems more interactive to participants and it models the style of thought (questioning) we would like them to employ to promote comprehension. Use short sentences—try for a maximum of 10 words per sentence. Use parallel sentence structure as much as possible. Avoid semicolons. Use the active voice—“We will do X. You will do Y.” Use personal pronouns—“I”, and “we”, “you”. Limit use of words with more than 3 syllables. Look critically at words that are standard to you but may be jargon to other people. Eliminate them or provide a clear explanation. Look at words and consider whether they are likely to be known to “everyday” your target population. Given the prevalence of reading difficulties, this activity is at least as important as eliminating professional jargon. This table contains some words used in research that may be unfamiliar to many prospective participants and a more familiar word or phrase for each. Obviously this list can only be a sample.
People with difficulty reading are often ashamed—67% said they hid their illiteracy even from their spouses. In research situations they may also hide their illiteracy from investigators. Therefore investigators must demonstrate respect for persons (The Belmont Report) by writing the clearest possible consent forms, providing help by reading or recording consent documents, and evaluating participants’ comprehension through asking questions or other techniques. Suggestions for Improving Readability of Consent Documents Before You Write Know your target population. What is their likely age, education, race/ethnicity, SES, and location? How much and in what ways does the audience differ from you? How much experience do you have with this audience? If little or none, can you locate someone who has worked with this audience to advise you about communication strategies? When You Write Use a question and answer format to organize the informed consent (IC). See online templates for IC. This format results in shorter answers that are focused on a single topic, rather than running topics together. It seems more interactive to participants and it models the style of thought (questioning) we would like them to employ to promote comprehension. Use short sentences—try for a maximum of 10 words per sentence. Use parallel sentence structure as much as possible. Avoid semicolons. Use the active voice—“We will do X. You will do Y.” Use personal pronouns—“I”, “we”, and “you”. Limit use of words with more than 3 syllables. Look critically at words that are standard to you but may be jargon to other people. Eliminate them or provide a clear explanation. Look at “everyday” words and consider whether they are likely to be known to your target population. Given the prevalence of reading difficulties, this activity is at least as important as eliminating professional jargon. This table contains some words used in research that may be unfamiliar to many prospective participants and a more familiar word or phrase for each. Obviously this list can only be a sample.
191-G-Understandable-consent-forms-2-20-2012.docx