Researchers Criticize New HIPAA Regulations

By Suria Santana

Just a year after implementation of the Health Insurance Portability and Accountability Act (HIPAA), researchers in medical schools are growing frustrated with some of the regulation's requirements.

Medical school officials complain that the increased documentation required by HIPAA has made the research process unduly cumbersome, at times even making it difficult to recruit subjects to participate in low-risk studies. Some officials fear that the extra layer of paperwork is also discouraging researchers from participating in some areas of human subjects research.

Emory University's studies involving migrant farm workers and geriatric patients are examples of research being hindered by the new regulations.

"Everything is a lot more complicated now," said Kristin West, associate vice president and director at Emory University's office of research compliance. "Anything involving human research subjects has acquired an entire new layer of paperwork."

Researchers already have a difficult time explaining the workings and the rationale of informed consent forms to migrant workers, West said. An additional HIPAA authorization makes the process even more awkward and can discourage participation.

"In addition, minority seniors who are already kind of suspicious of the research process have also complained and questioned why they are having to sign more paper," she added.

Paper Weight

The paperwork burden imposed by HIPAA varies according to the type of research being performed and the specifics of particular projects. At Penn State University College of Medicine, some researchers have had to add at least two additional pages to their studies' consent forms, according to Institutional Review Board Chair Kevin Gleeson, M.D.

"Our consent forms have become unwieldy to the point that in some cases they even frustrate their primary purpose," Dr. Gleeson said.

Not all institutions have encountered much difficulty with the regulations, however. At the University of Minnesota Medical School the transition to HIPAA last year was "pretty much a non-event," according to Carol Siegel, director of the department of research subjects protection.

Her department heard some complaints about the paperwork burden when HIPAA first came into effect, but the frequency of the complaints has diminished with time.

"There was a terrific fear factor among most principal investigators that all this paper signing was going to deter subjects from enrolling, but they haven't necessarily found that to be true," Siegel said.

Paperwork is not the only pitfall for researchers. The intricacy of the regulations has caused a few institutions to exercise extreme caution before releasing patient information, which has obstructed the progress of even low-risk studies.

Ann Hirshfield, Ph.D., M.S., assistant dean for research at the University of Maryland School of Medicine, said that some organizations that have collaborated with the medical school's research activities for many years have grown increasingly concerned about the effect of the regulations on their ability to provide patient information.

Maryland's researchers conduct a variety of minimal risk studies that rely on data from nursing homes and community hospitals, according to Dr. Hirshfield. HIPAA has made it a lot more difficult to obtain access to these institutions' patient information, primarily because many of them don't fully understand the new requirements and fear that they might be breaking the law when providing patient information.

Greater Confusion

But even seasoned specialists in research compliance are confused by some of the clauses in the regulations and have to spend hours just learning the new, and often convoluted, vocabulary contained in the regulations before they actually read the new requirements.

"Our [research compliance] team has sat down quite often and just read the regulations over and over, trying to interpret them properly," West said.

Compliance officers and legal counsels are not the only ones baffled by the new regulations. Dr. Hirshfield said that after attending a recent NIH conference on HIPAA, she realized that even officials from affected government agencies are still in the process of clarifying some of the regulations.

"This is quite problematic for all of us," she said. "We need more guidance. People are very eager to comply with the regulations as fully as possible, so we really need to understand what the expectations are."

Dr. Gleeson believes that HIPAA's requirements are so complex that very few investigators and research subjects understand them sufficiently and often end up entering contracts without full knowledge of their impact.

"Dealing with HIPAA in this scenario is like buying a house and not having someone who is properly trained explain things to you," he said.

When HIPAA went into effect, the AAMC's Division of Biomedical Research and Health Sciences conducted a survey to assess the privacy rule's impact on research. Based on the survey results, AAMC made several recommendations to the Department of Health and Human Services (HHS) Advisory Committee on Human Research Protections.

The recommendations included: eliminating authorization requirements for data when informed consent is provided, matching privacy protections in HIPAA with the common rule that governs federally funded human subjects research and dropping the requirement for accounting of research disclosures. The HHS advisory committee will build on AAMC's recommendations during its meeting this month and send the results to HHS Secretary Tommy Thompson for review.

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