Subjects with limited ability to read, hear, or see require special protection. Individuals in this group may be unable to read consent forms or instructional materials, or hear answers to questions.
When individuals in this group are subjects in research, all information and communication must be provided in a way that is understandable to the subject. (For example, people who cannot read or see should be provided with verbal descriptions of all procedures, requirements, potential risks, etc. For people who cannot hear, all communications should be provided in writing or via sign language, or in some other way that is clearly understandable to the subject.)
Informed consent, likewise, must be obtained in a form that is clearly understandable to the subject. When consent is obtained verbally, the subject and a witness should sign forms to confirm that adequate information has been provided