Скачать или смотреть Informed consent for research-participant with moderate aphasia (reading) and limited verbal output.

The video is an example of how to obtain informed consent for a research project when a participant is impacted by moderate aphasia affecting the reading modality and has severely limited verbal output. Consent form language was modified with IRB approval to a maximum 6.2 grade level to facilitate comprehension. Key points of the consent document were further reinforced by using enlarged visual elements (pictures and words). In addition, we administered a ten-item comprehension screen as the consent progressed to insure that the participant understood the main points of the project and his privacy rights under HIPAA. The video reflects our strong position that all prospective participants with aphasia should be presumed competent to consent for themselves unless there is documented evidence of "decisional impairment". The onus is fully on researchers to determine if the individual before them is able to comprehend the voluntary nature of research participation, the nature of the research procedures, the potential benefits and risks, and then, to make a personal judgment about the value of participation. The participant in this video has provided full consent to use the video for educational purposes.