UConsent: Addressing the gap in measuring understanding of informed consent in clinical research.

ABSTRACT: The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficul

SUBMITTER: Ittenbach RF 

PROVIDER: S-EPMC10719467 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature