WRITTEN CONSENT REQUIREMENT HURTS HEALTH RESEARCH
June 11, 2004
The Health Insurance Portability and Accountability Act (HIPAA) may be having a negative impact on certain kinds of health research, according to researchers from the University of Michigan.
HIPAA requires that researchers obtain written authorization from all patients participating in research studies. HIPAA compliance has drastically cut the participation of patients in long-term studies, while increasing costs per patient studied, say researchers. In a long-term, follow-up study of heart attack patients, they found:
- When researchers switched from the verbal consent to a HIPAA-compliant written authorization that had to be mailed to patients and mailed back, they found that the percentage of patients participating plummeted from 96.1 percent to 38.5 percent.
- Patients who consented were not representative of the entire patient population, potentially skewing results -- those who returned the HIPAA-compliant written consent were more likely to be older, to be married, or to have high blood cholesterol than those who didn't.
- In addition, the costs involved in asking for this written authorization were substantially larger than those for the verbal system; researchers estimate that getting consent costs $14.50 per patient in the first year of the study (including computer, training, staff, administrative and mailing costs), and $7.50 each year afterward.
Researchers say it would be cost-prohibitive and labor-intensive to ask patients for consent while they were still in the hospital.
HIPAA compliance will challenge researchers, institutions and ultimately patients as they try to learn about the outcomes of health care while trying to maintain patient privacy, concluded the researchers.
Source: Press release, "U-M study shows national medical privacy law makes health research harder and more expensive," University of Michigan Health System, March 11, 2004.
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