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Pitt epidemiologist says privacy rule hinders research


A new study suggests that implementation of a health care law known as HIPAA is having a chilling effect on medical research.

Dr. Roberta Ness, a University of Pittsburgh researcher, found that about two-thirds of epidemiologists who responded to a national survey felt a HIPAA regulation known as the privacy rule has made research more difficult.

Only about one-fourth of respondents felt the rule enhanced study participants' confidentiality and privacy.

The results were published yesterday in the Journal of the American Medical Association.

"The privacy rule has made research more costly and time consuming," said Dr. Ness, who chairs the epidemiology department at the Pitt Graduate School of Public Health.

The Institute of Medicine commissioned the survey to help inform a committee studying the effects of the privacy rule. Epidemiologists were surveyed because their research often involves medical records and human subjects.

The privacy rule, implemented in 2003, places limits on disclosing certain health information for research purposes -- for example, requiring written authorization from individual patients in some cases to access their medical records. Patient approval is not required if identifying information is removed.

The rule resulted from the Health Insurance Portability and Accountability Act. Among its other provisions, the 1996 law aims to help workers maintain their health insurance when they change or lose their jobs.

The survey involved more than 1,500 epidemiologists, many of them from academic centers. All said they had submitted at least one application to an institutional review board -- committees that review and monitor research involving human subjects -- since the privacy rule was implemented.

The survey found that nearly 68 percent of respondents felt the rule had made research more difficult at a level of 4 to 5 on a five-point scale, 5 indicating "a great deal of added cost and time to study completion."

Dr. Ness noted that institutional review boards interpret the privacy rule differently and that wide variations in interpretation have occurred. Better guidance in interpreting the rule may help, she said, along with changes in aspects of the rule.

While documenting negative effects of the rule nationally has been difficult, individual centers have reported problems. A previous study by Dr. Ness found that recruitment for one Pitt study declined from about 12 people per week prior to the rule to no more than half that number or less after its implementation.

In a commentary also published in the latest journal, Drs. Norman Fost of the University of Wisconsin School of Medicine and Public Health and Robert Levine of the Yale University School of Medicine call the regulatory system for protecting human research subjects "increasingly dysfunctional."

They cite problems not only with the privacy rule, but also with federal oversight of institutional review boards. They say many requirements imposed by those agencies and the accreditation process "have little relationship" to the protection of study participants.

"I think HIPAA does get in the way of research," said Dr. Arthur Caplan, chairman of medical ethics at the University of Pennsylvania.

But he said change would be difficult unless others, including patients and their advocates, voice similar concerns.

By: Joe Fahy | Pittsburgh Post-Gazette
November 15, 2007

11/15/2007
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