The Health Insurance Portability and Accountability Act and the Informed Consent Process

Letters7 December 2004The Health Insurance Portability and Accountability Act and the Informed Consent ProcessPeter Breese, MSPH, William Burman, MD, Cornelis Rietmeijer, MD, PhD, and Dennis Lezotte, PhDPeter Breese, MSPHFrom Denver Public Health and the University of Colorado Health Sciences Center, Denver, CO 80204., William Burman, MDFrom Denver Public Health and the University of Colorado Health Sciences Center, Denver, CO 80204., Cornelis Rietmeijer, MD, PhDFrom Denver Public Health and the University of Colorado Health Sciences Center, Denver, CO 80204., and Dennis Lezotte, PhDFrom Denver Public Health and the University of Colorado Health Sciences Center, Denver, CO 80204.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-141-11-200412070-00034 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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 ...References1. Standards for Privacy of Individually Identifiable Health Information; Final Rule. Code of Federal Regulations. Title 45, parts 160 and 164. Accessed at aspe.hhs.gov/admnsimp/ on 13 August 2004. Google Scholar2. Kirsch I, Jungeblut A, Jenkins L, Kolstad A. Adult Literacy in America: A First Look at the Findings of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, United States Department of Education; 1993. Google Scholar3. Weiss BD, Coyne C. Communicating with patients who cannot read. N Engl J Med. 1997;337:272-4. [PMID: 9227936] CrossrefMedlineGoogle Scholar4. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. N Engl J Med. 2003;348:721-6. [PMID: 12594317] CrossrefMedlineGoogle Scholar5. Federman DD, Hanna KE, Rodriguez LL, eds. Responsible Research: A Systems Approach to Protecting Research Participants. Institute of Medicine. Washington, DC: National Academies Pr; 2002. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Denver Public Health and the University of Colorado Health Sciences Center, Denver, CO 80204. 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