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Deficits in patients' understanding of informed consent may be partially related to poorly conceived, written, or organized informed consent materials; these deficits may be remediable with educational interventions.
Therefore all informed consent materials have been translated into Xhosa.
At the time of interview, the informed consent materials were re-explained and signed.
All participants were provided with written informed consent materials and the opportunity to discuss the research, and to ask questions.
Referred patients who were eligible for the trial were sent full informed consent materials and a brief baseline questionnaire for them to return by post.
First, the CAB made helpful contributions towards instrumental goals such as improved informed consent materials, recruitment strategies and protecting research participants and the community from research-related risks.
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Participants are presented with informed consent material in the Xhosa language that explains the SAX study.
Feedback from the CAB also allowed the research team to gauge the accessibility and appropriateness of their informed consent material before introducing it to potential research participants.
Dr. Benjamin agreed that the brochure about the trials and informed-consent material given to parents "must address in plain language the risks, and severity of risks, of adverse events".
These comments suggest that, beyond information required for informed consent, educational material should be presented in a format that allows patients to select as much or as little information as they wish.
Dermal fibroblasts were obtained from two patients with FRDA and two age-matched unrelated healthy individuals after informed consent (see Materials and Methods).
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