The following information is provided to investigators to assist in the preparation of consent forms using language that potential research subjects can understand.
The University of Washington Human Subjects Manual (Part D.3.b.i., page 5,) states that informed consent must be written "in language readily understandable to potential subjects." The language must be tailored for the intended audience. Potential subjects drawn from a pool of university students can be assumed to have a reading ability at grade level 12 or better. But subjects recruited through a city newspaper, for example, cannot be assumed to have such a high reading level. The average reading level in the city of Seattle is reported to be at grade 6. Some populations may have a lower reading level or may, in fact, be illiterate.
Illiterate subjects:
Subjects who cannot read at a functional level, but wish to participate in research, may be consented orally as long as the consent process is witnessed and they sign their name (or make their mark) on the consent form.
Subjects for whom English is not a first spoken language:
Consent forms should be presented to potential subjects in their first language. If this is not feasible, a competent translator should be available to translate the consent form orally into the subject's native language. It is the responsibility of the investigator to assure that the translator can accurately translate both the consent form and questions and answers about the research between the subject and the investigator.
There are several tests investigators can use while drafting their consent forms to make sure that the language is not too complex. One is called the Frye test
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