Enrolling Subjects Who Are Legally Blind, Illiterate, or Cannot Talk or Write

Legally Blind Subjects
Illiterate Subjects
English-Speaking Subjects Who Cannot Talk or Write

Important note: It is always the investigator’s responsibility to judge the subject’s comprehension of the consent information including the understanding that participation is voluntary and that the subject has the right to withdraw at any time during the study. If you doubt the subject’s consent comprehension, do not enroll the subject in the study.

If you are obtaining informed consent from a community that doesn’t have a written language (e.g., Mam): Oral presentation of the informed consent form and Bill of Rights in their native language via interpreter, and follow the instructions for Illiterate Subjects.

Legally Blind Subjects

If you are enrolling subjects who cannot read the consent materials due to blindness, or if the subject’s legally authorized representative is legally blind:

Documentation/signatures

These recommendations are consistent with guidance endorsed by the FDA and set forth by the ICH E-6 4.8.9. If the subject (or subject’s legally authorized representative) verbally agrees to participate in the study:

Subject (if capable of doing so): Signs and personally dates the consent form.
Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.
Person obtaining consent: Signs and dates the consent form.
Give a signed copy to the subject.

Illiterate Subjects

If you are enrolling subjects who cannot read the consent materials due to illiteracy:

Documentation/signatures

These recommendations are consistent with guidance endorsed by the FDA and set forth by the ICH E-6 4.8.9. If the subject verbally agrees to participate in the study:

Subject (if capable of doing so): Signs or marks an X to signify consent.
Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood the information, and informed consent was given freely.
Person obtaining consent: Signs and dates the consent form.
Give a signed copy to the subject.

English-Speaking Subjects Who Cannot Talk or Write

Consistent with the FDA guidance, a person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means.

If the person (1) retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, he/she may be entered into the study. Obtain and document informed consent as follows:

Documentation/signatures

If the subject indicates agreement to participate in the study:

Annotate the consent form by hand to describe the method used for communication with the subject and the specific means by which the subject communicated agreement to participate in the study.
Witness: Signs and personally dates the consent form. By doing so, the witness attests that the consent information was accurately explained and that the subject apparently understood and informed consent was given freely.
Person obtaining consent: Signs and dates the consent form.
Give a signed copy to the subject.