Under FDA regulations, how can documentation of informed consent be completed for illiterate subjects?

The use of a short form consent document accompanied by an oral presentation is an appropriate method for obtaining informed consent from illiterate subjects under FDA regulations. This approach ensures that the subject has the opportunity to understand the key elements of the study by providing a clear, verbal explanation of the study's purpose, risks, benefits, and the rights of the subject.

The short form document includes a concise statement that the subjects are being informed about the study orally, along with the signature of the individual conducting the consent process, and requires a witness to confirm that the consent process occurred. This method is particularly important in maintaining ethical standards while ensuring that individuals who may not be able to read or write are still provided with the necessary information to make an informed decision about participation in the study.

Other options, such as solely summarizing the consent verbally, do not meet regulatory requirements as they lack formal documentation. Written documentation is not feasible for illiterate subjects, thus excluding that from viable options. Recording a video may not adequately capture the required elements of consent presentation or ensure that the subject has comprehended the information presented. Hence, the combination of a short form document and oral explanation aligns with regulatory standards for obtaining informed consent in these situations.