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Study shows HIPAA privacy negatively affects research recruitment

HIPAA Weekly Advisor, February 7, 2005

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HIPAA privacy regulations have caused recruitment for research to decrease by half, according to findings published in the February Annals of Epidemiology. This study follows women through their pregnancies to determine the cause of preeclampsia, a complication that can be fatal for both a mother and her baby.

Before the April 2003 privacy compliance deadline, researchers for the study recruited, on average, 12.4 women per week. After the deadline, that number dropped to between 2.5 and 5.7, due to researchers' decreased ability to identify eligible participants, wrote Roberta B. Ness, MD, MPH, co-investigator of the study, and professor and chair of the department of epidemiology at the University of Pittsburgh's Graduate School of Public Health.

Waivers by institutional review boards (IRBs) at some academic institutions allow slightly more access to information protected under HIPAA, but the waiver criteria vary by university and are often rescinded after a short time, according to U.S. Newswire.

The American College of Epidemiology and the Association of American Medical Colleges called on HHS to modify HIPAA. "An HHS advisory committee proposed HIPAA modifications that include harmonizing HIPAA with the common rule that determines other IRB activities," Hess told U.S. Newswire. "We can only hope the new [HHS] secretary will adopt these modifications."

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