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Author Notes:
Correspondence: 735 Gatewood Road NE, Atlanta, Georgia 30322; Phone: (404) 712-8520; Fax: (404) 712-8467; Email: amlang@emory.edu
Acknowledgments: The authors gratefully acknowledge the nursing and medical records staff at the Emory Family Medicine and Grady Neighborhood Health Centers who facilitated access to outpatients for performance of this study.
Subjects:
Research Funding:
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:
- clinical trial
- consent form
- HIPAA
- minority groups
- patient participation
The Impact of HIPAA Authorization on Willingness to Participate in Clinical Research
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.
Copyright information:
© 2007, Elsevier
This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommerical-NoDerivs 3.0 Unported License (http://creativecommons.org/licenses/by-nc-nd/3.0/).
