In this issue of the ARCHIVES, Tait et al1 describe a randomized controlled trial to test the effects of a modified informed consent form on parents’ understanding of pediatric research. This work is an important step forward by contributing to the empirical study of pediatric ethics, particularly with respect to intervention research. A knowledge base founded on scientific data is critical for the development of recommendations to improve the informed consent process. However, their article also reflects several problems with the conceptualization and measurement of informed consent in prior research.
Miller VA, Nelson RM. Moving Beyond the Consent Document in Research on Informed Consent. Arch Pediatr Adolesc Med. 2005;159(4):396–397. doi:10.1001/archpedi.159.4.396