University Times

With American policies prompting the exporting of jobs overseas, will U.S. clinical research funds be next?

That was the warning issued this week by Pitt researcher Roberta Ness at the annual meeting of the American College of Epidemiology in Boston.

Ness, professor and chair of the Department of Epidemiology at the public health school, moderated a policy forum discussion on “Confidentiality and HIPAA: What’s a Researcher to Do?”

HIPAA, the Health Insurance Portability and Accountability Act of 1996, with its attendant Privacy Rule that became effective in April 2003, is inhibiting significantly the recruitment of human subjects for clinical trials, maintained Ness, whose expertise is in women’s health-related research.

Under the Privacy Rule, patients have greater access to their medical records, but health professionals are more restricted in what they can do with the information.

Prior to HIPAA, identifying patients to participate in a clinical trial meant screening medical records directly for potential candidates and then getting the candidates’ permission to include them in a study.

Under HIPAA, contacts with patients now must be initiated by their physicians, who first must seek the patients’ permission to share the records. Targeting a particular group then may mean spending months compiling registries of patients who have given their doctors permission to share their records with researchers, or using other complicated and expensive alternatives.

Speaking from Boston, Ness told the University Times, “The way that HIPAA has hurt research, I believe, is a classic example of the law of unintended consequences. People do want privacy, but on the other hand, in their hearts, they also want the benefits of research and they do not want to see scientific research grinding to a halt.”

Both the American College of Epidemiology and the Association of American Medical Colleges (AAMC) have been active in raising awareness of HIPAA’s ramifications, Ness said. “The AAMC did a survey of about 400 researchers nationally that clearly demonstrated overwhelmingly that the great majority of clinical researchers felt that HIPAA impeded their ability to do clinical trials.”

She cited an ongoing clinical study where she’s the principal investigator. “Since the Privacy Rule, our ability to recruit subjects has been halved.”

AAMC already has taken these concerns to the federal Office of Health and Human Services, where HIPAA rules are implemented.

“Our intention over the next year is to build a consortium of scientists to continue to lobby for major changes in the law,” Ness said. “We’ve traded for nominal privacy and got instead a real breakdown in our ability to advance medicine. What I’m saying is that the federal government and industry may be forced to spend research dollars overseas in order to expedite clinical research, a kind of forced outsourcing of funding.”

Pitt’s James Roberts agrees with Ness. “We’ve seen a sharp drop-off in recruitment,” said Roberts, who is vice chancellor for research in the Department of Obstetrics, Gynecology and Reproductive Sciences at Pitt’s School of Medicine and the director of the Magee-Womens Research Institute. “For example, in a study we’ve been involved with for a number of years before the [Privacy Rule implementation], we used to get 80-90 percent of the women who were under our care by sharing their medical records. Afterwards, that fell off to 6 percent. It’s just so hard to get to the people you need for permission.”

Roberts testified this spring before the U.S. Commission on Civil Rights regarding the flaws of HIPAA. Researchers prior to HIPAA honored regulations that protected confidentiality through the Institutional Reviews Boards’ “common rule,” the federal human subject protection policy, he noted.

“Not only are the HIPAA restrictions onerous, the interpretation is often vague,” Robert said.

Roberts agreed with Ness that the HIPAA law was based on good intentions. “If there is a blame game, I think some of the blame falls on us as researchers, because we weren’t alert to the implications of HIPAA when it was being written,” Roberts said.

Randy Juhl, Pitt vice chancellor for Research Conduct and Compliance, takes a more neutral view toward HIPAA’s effects on clinical research. “It is true that the No. 1 problem in clinical research is subject recruitment. That was true before HIPAA, too,” Juhl said.

HIPAA regulations are grounded in a reasonable concern by citizens, he said. “In our society, most people want their medical records to be confidential. However, if you ask people, ‘Would you like your medical information used to help cure cancer?’ most people say ‘yes.’ So, there are two forces at work pushing against each other. The situation of two opposing, but noble and important, values calls for greater education of the public and the research community.”

The ability to obtain human subject permission is accomplished in a number of ways under HIPAA, Juhl pointed out. “If a doctor and the researcher are the same person, permission is a simple matter to get.”

Clinical institutions and departments also can employ what in medical research parlance is called an “honest broker” who can search records legally under HIPAA for a set of criteria needed for a clinical trial.

Another method, still under development, Juhl said, is to have hospitals and other health care facilities ask patients to sign a consent form permitting them to be approached about trials that are related to their conditions. “It’s not available yet, but we’re getting closer to that,” Juhl said.

“I’m not disagreeing with what Dr. Ness is saying,” Juhl maintained. “But she does not attempt to explain the importance of research in the context of the public’s demand for the confidential treatment of their records. Crying ‘wolf’ and demanding that the law be changed is not helpful to the bureaucrats and elected officials who will be called upon to address both sides of the argument.”

-Peter Hart