Fax: (312) 695-4307
Local perspective of the impact of the HIPAA privacy rule on research
Article first published online: 9 DEC 2005
Copyright © 2005 American Cancer Society
Volume 106, Issue 2, pages 474–479, 15 January 2006
How to Cite
Wolf, M. S. and Bennett, C. L. (2006), Local perspective of the impact of the HIPAA privacy rule on research. Cancer, 106: 474–479. doi: 10.1002/cncr.21599
- Issue published online: 5 JAN 2006
- Article first published online: 9 DEC 2005
- Manuscript Accepted: 8 AUG 2005
- Manuscript Received: 6 JUL 2005
- Pfizer Pharmaceuticals Health Literacy
- privacy rule;
The operational and economic impact of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was evaluated. The setting was a natural experiment which involved a single-site, clinical research study that was initiated before the enactment of HIPAA and subsequently modified to be compliant with the new policy.
A formative assessment was conducted of the recruitment process to a clinical trial evaluating the efficacy of an educational strategy to inform Veterans about the National Cancer Institute/Department of Veterans Affairs cosponsored Selenium and Vitamin E Cancer Prevention Trial (SELECT). Personnel time and costs were determined based on weekly accrual for study periods before and after the implementation of HIPAA. Root cause analysis was used to assess the recruitment protocol and to identify areas for improvement.
The implementation of HIPAA resulted in a 72.9% decrease in patient accrual (7.0 patients/wk vs. 1.9 patients/wk, P < 0.001), and a threefold increase in mean personnel time spent recruiting (4.1 hrs/patient vs. 14.1 hrs/patient, P < 0.001) and mean recruitment costs ($49/patient vs. $169/patient, P < 0.001). Upon review of the modified HIPAA-compliant protocol, revisions in the recruitment procedure were adopted. The revised protocol improved weekly accrual by 73% (1.9 patients/wk vs. 7.1 patients/wk, P < 0.001) and resulted in improvements in personnel time (5.4 hrs/patient) and recruitment costs ($65/patient).
Enactment of HIPAA initially placed a considerable burden on research time and costs. Establishing HIPAA-compliant recruitment policies can overcome some of these obstacles, although recruitment costs and time are likely to be greater than those observed before HIPAA. Cancer 2006. © 2005 American Cancer Society.