Abstract
Subject comprehension of the informed consent form can be improved by ensuring that the readability level of the informed consent form is at the sixth to 10th grade level. Readability can be increased by decreasing the length of sentences and reducing the number of syllables per word. The words for the informed consent form must be understood by nonmedical people. Correct grammar and form should be used to convey the message.
Word processing software analyze for readability. However, one should be cautioned that using negative worlds or jargon can indicate poor writing. Negative words, used in the informed consent form, are no doubt necessary to the informed consent process.
Out of about 160 informed consent forms, 80 changes were chosen as appropriate to present as incorrect use of the English language; some are explanations of medical terms and/or procedures. A check list is offered for documenting that the research personnel are aware of the consent process as it applies to individuals.
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