Privacy Rule Slows Scientific Discovery And Adds Cost To Research, Scientists Say

"HIPAA is adversely affecting our ability to conduct biomedical research," said Dr. Ness, who is chair of the department of epidemiology at the University of Pittsburgh Graduate School of Public Health (GSPH) and an advisor to the Institute of Medicine committee studying the issue. "The privacy rule has made research more costly and time consuming. As a result, some possibly important studies are just not being done."

Epidemiologists analyze the development and control of a wide array of illnesses and their impacts on public health. Survey responses from 1,527 epidemiology practitioners employed in academia, government, industry and other groups, revealed that two-thirds believed that HIPAA had made research "a great deal" more difficult to accomplish. In addition, a significant proportion of respondents reported more negative consequences for protecting human subjects than positive effects. All respondents are part of the Joint Policy Committee, Societies of Epidemiology, which co-sponsored the study.

"We asked questions about both positive and negative potential impacts from the HIPAA privacy rule, including the impact on subject privacy, confidentiality and public trust, as well as on research procedures," Dr. Ness said. "Almost 40 percent of respondents indicated that the privacy rule had increased research costs by a large degree, and nearly half said that significant additional time was required under the rule to complete projects."

Established in 2003, HIPAA was designed to enhance patient privacy by restricting access to medical records while preserving the legitimate use of such information for important social goals. In practice, however, academic institutional review boards (IRBs) and other institutional bodies that govern research on human subjects vary widely in their interpretation of the rule, resulting in a mishmash of conflicting procedures across the country, Dr. Ness noted, adding that some IRBs continue "business as usual," while others essentially shut research down.

"According to our survey, there is a perception that HIPAA may even be having a negative effect on public health surveillance practices, and a lot of it is because of this variability in interpretation," said Dr. Ness, who is president-elect of the American College of Epidemiology. "Some public health departments are defining a much broader portfolio of activities as research, and, therefore, are subject to HIPAA, more than other health departments. At this point, we're not absolutely sure what that means in terms of public health -- whether this poses any threat to combating epidemics or other dangers."

While documenting negative HIPAA effects on a nationwide basis has been difficult, single-institution experience indicates widespread problems. Recruitment for one study being conducted at the University of Pittsburgh, for example, declined from more than a dozen people a week prior to HIPAA to an average of five at best after the rule took effect. At the University of Michigan, patient consent for a study declined from more than 96 percent to 34 percent. In another study at the University of Michigan, the implementation of HIPAA resulted in a nearly 73 percent decline in patient recruitment and a threefold increase in research staff time spent recruiting.

At the same time, only a quarter of epidemiologists said they thought HIPAA had achieved its goal of improving the confidentiality of patient information.

"Public opinion polls show that over 90 percent of the public thinks it's a priority for us to proceed expeditiously in uncovering new causes of and treatments for disease," said Dr. Ness. "Without any question, this survey suggests that the HIPAA legislation is impeding the progress of such research. And for those institutions that may have a breakthrough in the offing, it's going to add months to years to discovery."

Journal reference: JAMA. 2007;298(18):2164-2170

The findings are part of the first national survey of epidemiologists commissioned by the Institute of Medicine, National Academies of Science.

Dysregulation of Human Subjects Research

A related editorial was also published in the same issue of JAMA. Norman Fost, M.D., M.P.H., of the University of Wisconsin School of Medicine and Public Health, Madison, and Robert J. Levine, M.D., of the Yale University School of Medicine, New Haven, Conn., highlight some of the issues and problems in the current national system for protecting human research participants.

"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation. A satisfactory resolution for this situation is urgently required. Resolution will necessarily require participation by federal oversight agencies, institutional officials, representatives of credentialing and certifying agencies, researchers, and research participants."

Reference for editorial: JAMA. 2007;298(18):2196-2198.