The Impact of HIPAA Authorization on Willingness to Participate in Clinical Research

• Type of Material: Article
• Authors: Anne Lang Dunlop, Emory University; Tracie Graham, Emory University; Zanie C. Leroy, Emory University; Karen Glanz, Emory University; Boadie W Dunlop, Emory University
• Language: English
• Date: 2007-11
• Publisher: Elsevier: 12 months
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2007, Elsevier
• License: Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported
• Final Published Version (URL): http://dx.doi.org/10.1016/j.annepidem.2007.05.006
• Title of Journal or Parent Work: Annals of Epidemiology
• ISSN: 1047-2797
• Volume: 17
• Issue: 11
• Start Page: 899
• End Page: 905
• Grant/Funding Information: Support for the conduct of this research study was provided by the Greenwall Foundation and by the General Clinical Research Center at Emory University, funded by the National Center for Research Resources (NCRR M01-RR00039).
• Keywords: consent form; minority groups; clinical trial; HIPAA; patient participation
• Research Categories: Health Sciences, General; Health Sciences, Public Health

Abstract

Purpose This study systematically examines the impact of inclusion of HIPAA authorization on the willingness of African Americans of diverse sociodemographic characteristics to participate in a clinical research study and explores reasons for non-participation. Methods For a purposive sample of 384 African American outpatients at 4 metropolitan primary care clinics from August 2005 through May 2006, willingness to participate in a hypothetical clinical research study of an antihypertensive medication under one of two experimental conditions was compared. Interviewees were randomly assigned to undergo informed consent alone (control group) or informed consent with HIPAA authorization (HIPAA group). They were asked whether they would participate and reasons for their decision. Results A smaller proportion of interviewees in the HIPAA group were willing to enroll in the study (27% vs. 39%; p=.02), with an adjusted odds ratio = 0.56 (95% confidence interval: 0.36 – 0.91). Those in the HIPAA group were more likely to give reasons related to privacy (p<.001), poor understanding of the form (p=.01), and mistrust or fear of research (p=0.04) for non-participation. Conclusions The inclusion of HIPAA authorization within the informed consent process may adversely affect the willingness of African Americans to participate in clinical research and may raise concerns about privacy, understanding the forms, and mistrust or fear of research.