A survey of informed consents from FDA's center for devices and radiological health

Legally effective informed consent has been a long-standing requirement for FDA-regulated clinical studies. However, informed consent forms (ICFs) are often thought to be too long, too complex, and too difficult for participants to understand. In this article, investigators from the FDA's Center for Devices and Radiological Health (CDRH) surveyed 399 ICFs from approved investigational device exemption (IDE) applications for fiscal years 2015 and 2016 to evaluate the readability of ICFs.The investigators collected data from the ICFs, using variables related to structure, readability, and comprehension.

Source: Contemporary Clinical Trials - August 20, 2019 Category: Radiology Authors: Fabienne Santel, Isatu Bah, Katherine Kim, Ja-An Lin, Jack McCracken, Adaeze Teme Source Type: research