Going “beyond the regulations” that govern informed consent and understanding the perspective of research participants is crucial to obtaining truly informed consent. This article describes the aspects of informed consent that involve human experience and interactions. Positive and negative feedback from research participants is reviewed to illustrate common issues in participation in clinical research. Participant suggestions for improving comprehension and the overall informed consent experience are shared.
Disclaimers: The author is sharing her own views based on conversations with many research participants. The federal regulations are not reviewed because many of the problems with informed consent arise even when the study team follows the regulations.
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