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Obtaining Informed consent for research-participant with mild aphasia.

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The video is an example of how to obtain informed consent for a research project when a participant is impacted by mild aphasia. Consent form language was modified with IRB approval to a maximum 6.2 grade level to facilitate comprehension. In addition, we administered a tenitem comprehension screen as the consent progressed to insure that the participant understood the main points of the project and her 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.

posted by Cobellismx