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Moving Beyond the Consent Document in Research on Informed Consent
Arch Pediatr Adolesc Med. 2005;159:396-397.
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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.
In their study, parents of children scheduled for minor elective surgical procedures were randomized to receive information about a clinical study in 1 of 4 ways: a standard consent form, the standard form with verbal disclosure, a modified form designed to meet federal standards of readability and processability, and the modified form with verbal disclosure. The verbal disclosure . . . [Full Text of this Article] AUTHOR INFORMATION
Victoria A. Miller, MA;
Robert M. Nelson, MD, PhD
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Improving the Readability and Processability of a Pediatric Informed Consent Document: Effects on Parents Understanding
Alan R. Tait, Terri Voepel-Lewis, Shobha Malviya, and Sandra J. Philipson
Arch Pediatr Adolesc Med. 2005;159(4):347-352.
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