Assessing for Quality Informed Consent With Subjects Enrolling in Clinical Research


Research subjects are asked to participate in the informed consent process before participating in research. The elements and regulatory requirements of informed consent are well documented. However, there is less known about the quality of informed consent discussions that are occurring with potential subjects. There is evidence that these discussions may be lacking in quality to effectively meet the intended goals. Research professionals may need additional training, skills, and tools to help increase subject’s understanding of informed consent. It is necessary to identify the characteristics of quality informed consent. In addition, tools and strategies, such as Teach Back and Documentation of Informed Consent process, can be utilized to operationalize the assessment of understanding when conducting informed consent. Quality may lead to increased engagement and compliance with study protocols and reductions in subject withdrawals. Both research staff and participants will benefit with increased confidence by addressing quality in informed consent.

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