Privacy rule cuts research recruitment by more than half

January 31, 2005

PITTSBURGH, Jan. 31 - The Health Insurance Portability and Accountability Act (HIPAA) designed to enhance patient confidentiality by restricting access to medical records is slowing the progress of critical biomedical research, according to an editorial published in the February issue of the journal Annals of Epidemiology. In perhaps the first quantitative study of recruitment trends following the rule's implementation in April 2003, Roberta B. Ness, M.D., M.P.H., reports a significant "chilling effect."

Dr. Ness, professor and chair of the department of epidemiology at the University of Pittsburgh's Graduate School of Public Health (GSPH), documented trends in recruitment of research subjects to the Prenatal Exposures and Preeclampsia Program Project (PEPP), an ongoing prospective study of women followed throughout pregnancy at the Magee-Womens Hospital of the University of Pittsburgh Medical Center, for which she is a co-investigator. The ultimate aim of the study is to determine the cause of preeclampsia, a devastating complication that affects up to 7 percent of first pregnancies and can be fatal for mother and baby.

The first phase of the PEPP study took place prior to HIPAA implementation from 1997 to 2001, with an average of 12.4 women being recruited each week, writes Dr. Ness, who also is chair of the policy committee for the American College of Epidemiology. After HIPAA, due to restrictions on researchers' ability to identify potentially eligible subjects, recruitment fell to an average range of 2.5 to 5.7 women a week.

Inconsistencies among academic institutions concerning interpretation of HIPAA regulations remain a potent threat to a wide range of clinical and biomedical research studies, she said. The University of Pittsburgh's Institutional Review Board (IRB), for instance, at first disallowed waivers of the rule. Investigators may seek a waiver to allow them easier access to health information protected as private under HIPAA, but waiver criteria vary among universities. In Pittsburgh, a waiver was granted in 2003 and rescinded in 2004.

"Recruitment with a HIPAA waiver decreased by half, and recruitment without a HIPAA waiver fell by half again," said Dr. Ness.

Internal university efforts continue to resolve these kinds of conflicts for researchers, but modifications to the rule itself would go a long way toward standardizing the way institutions view it, Dr. Ness said, adding that the University of Pittsburgh is not alone in its more conservative interpretation of the HIPAA rule.

"The post-HIPAA era brought an unwillingness on the part of the University of California system to continue its 16-year-long rapid cancer case reporting relationship with the California State Cancer Registry," she said. "For well over a year, researchers were barred from access to large numbers of recently diagnosed cancer patients in a case that also briefly engaged the state's court system. Fortunately, the University of California reversed its stance."

Still, concern continues among many researchers, Dr. Ness said. The American College of Epidemiology, on whose board Dr. Ness serves, and the Association of American Medical Colleges have called on the U.S. Department of Health and Human Services (HHS) to address the issue.

"An HHS advisory committee has proposed HIPAA modifications that include harmonizing HIPAA with the common rule that determines other IRB activities, among others," she said. "We can only hope that the new Secretary for Health and Human Services will adopt these modifications."
Founded in 1948 and fully accredited by the Council on Education for Public Health, GSPH is world-renowned for contributions that have influenced public health practices and medical care for millions of people. One of the top-ranked schools of public health in the United States, GSPH was the first fully-accredited school of public health in the Commonwealth of Pennsylvania, with alumni who are among the leaders in their fields of public health. A member of the Association of Schools of Public Health, GSPH currently ranks third among schools of public health in NIH funding received. The only school of public health in the nation with a chair in minority health, GSPH is a leader in research related to women's health, HIV/AIDS and human genetics, among others. For more information about GSPH, visit the GSPH Web site at

University of Pittsburgh Medical Center

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