At a glance
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The NEAT Study: An Examination of a Novel Consent Form Design in a Real-world Setting
In Brief
A clinical study evaluating NEAT Form and Standard Form for Comprehension and Informed Consent. Completed, enrolled 101 participants across 1 site.
Detailed Summary
There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their ability to make informed decisions about participation. The need for revisions to the informed consent document design is supported by empirical research.This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) form when used in the consent process for individuals participating in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study.
Study Details
Timeline
Interventions
The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.
The regular IRB approved version.