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ReadabilityThe Consent Form should be written at a reading level that prospective subjects clearly understand the proposed research and what will be expected of them as participants
The Consent Form should be written at a reading level that prospective subjects clearly understand the proposed research and what will be expected of them as participants
A prospective subject’s ability to understand informed consent is a function of intelligence, education, maturity, and language skills. It is, therefore, necessary to adapt the language level of the Consent Form to fit the subject’s capabilities. The Consent Form must be written in simple enough language so that it is readily understood by the least educated, least sophisticated among the prospective subjects.
The IRB recommends that the language consist of short concise sentences arranged in relatively short paragraphs. Bear in mind that terms commonly used by researchers and members of a profession often use language particular to a given field. Many people outside of that profession do not understand the language. For example, common words in medicine such is “catheter, intravenous, CT scan, magnetic resonance imaging” are not understood by many laypersons. In the fields of psychology or sociology, terms such as “cognitive style, attrition and social sufficiency” are equally misunderstood. Also, avoid using abbreviations, such as MMPI or BDI.
If you doubt that a term likely will be misunderstood, use a more simple term or provide a definition. For example, “. . . intravenous (given directly into a vein by way of a needle) . . .” or “. . . 4 cc (a teaspoon).
