Peter Breese, MSPH; William Burman, MD; Cornelis Rietmeijer, MD, PhD; Dennis Lezotte, PhD
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Breese P., Burman W., Rietmeijer C., Lezotte D.; The Health Insurance Portability and Accountability Act and the Informed Consent Process. Ann Intern Med. 2004;141:897-898. doi: 10.7326/0003-4819-141-11-200412070-00034
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Published: Ann Intern Med. 2004;141(11):897-898.
TO THE EDITOR:
Background: The informed consent documents required in clinical studies have become longer and more complex, and the Health Insurance Portability and Accountability Act (HIPAA) recently added another component to the process. HIPAA requires that research participants sign an authorization form detailing the “protected health information” to be collected in the study and the persons and entities that may have access to that information. To assess the potential effect of HIPAA on the informed consent process, we evaluated the readability and length of locally approved templates for authorization forms.
Methods and Findings: We tried to obtain templates of HIPAA authorization forms for research from the 125 academic medical centers receiving the most funding from the National Institutes of Health and from 31 independent institutional review boards (IRBs). Most forms were collected from institutional Web sites; we contacted by telephone and e-mail those institutions that did not have a template available on the Internet. We assessed readability of these templates with 3 commonly used formulas: the Simple Measure of Gobbledegook (SMOG), the Flesch–Kincaid reading level, and the Flesch Reading Ease score. Because the Privacy Act requires that authorization forms be written in “plain language” (1), we defined forms with a reading grade level above eighth grade (SMOG and Flesch–Kincaid scales) or a Flesch Reading Ease score less than 60 (more complex language than “standard English”) as having inappropriately complex language.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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