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

Abstract

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 ap…