Privacy rule cuts research recruitment by more...( PITTSBURGH Jan. 31 The Health Insuran...),Health

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 HIP
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