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We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.
The key elements of informed consent were defined as follows: information, understanding, competence, voluntariness, and decision-making.
The elements of informed consent are threshold, information, and consent.
Exclusion criteria were defined as follows: insulin allergy and inability to sign informed consent.
Using data from our randomized trial of methods to improve informed consent comprehension, we performed an additional analysis to define independent factors associated with improved patient understanding.
The critical issue is informed consent.
Participants signed informed consent.
Written informed consent.
All patients signed informed consent.
All subjects gave informed consent.
Patients' informed consent was obtained.
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