University Times

Randy Juhl, vice chancellor for research conduct and compliance, responds to faculty concerns about HIPAA.

Besides inducing writer’s cramp in patients suddenly required to sign reams of release forms, the federal Health Insurance Portability and Accountability Act (HIPAA) is having an enormous impact on institutions — such as Pitt — that do research involving human subjects.

Protected health information under HIPAA includes a patient’s name, address, phone number, diagnosis and test results, among other things.

The law, which took effect in April, was intended to protect patients against fraud and abuse, but it also restricts researchers’ access to, and use of, identifiable health information in recruiting research subjects. In addition, HIPAA limits investigators’ use of existing, identifiable health information in conducting retrospective research studies.

“I must stress that these are very difficult problems that institutions face now,” professor Carey D. Balaban told Senate Council on Dec. 1, in reporting for the Senate’s tenure and academic freedom committee (TAFC).

Faculty and administrators must work together, Balaban said, to find the right balance between protecting traditional values of academic freedom and meeting HIPAA requirements — which, if not met, could give the federal government cause to shut down Pitt’s whole research operation.

“Carey has really struck the proper tone here,” Chancellor Mark A. Nordenberg said. “There is a tendency sometimes, when we look at issues like this one, to reduce it to matters of bureaucratic mishandling or something like that.”

The collegial tone of that exchange contrasted with the mood of the Nov. 25 Faculty Assembly meeting.

At the latter meeting, TAFC chairperson Michael R. Pinsky reported results of a TAFC survey strongly suggesting that interpretations of HIPAA by Pitt’s Institutional Review Board (IRB) “are overly strict, inconsistent with local and national standards, and do interfere with the conduct of research to a degree that rises to the level of infringement on academic freedom.”

The IRB, a federally mandated group of medical researchers and other faculty volunteers, oversees Pitt investigators’ compliance with HIPAA. According to TAFC’s survey of peer universities, the Pitt IRB has interpreted HIPAA “in an unnecessarily stringent manner.”

By a unanimous vote, Assembly members on Nov. 25 approved a resolution calling on Provost James V. Maher to appoint an ad hoc committee “to recommend revisions to the policies and procedures of the Pitt IRB so that research with human volunteers may be conducted under guidelines and interpretation of relevant laws and regulations consistent with peer institutions.”

But Maher said this week that the appointment of such a group, if it happens at all, must wait until after a HIPAA policy meeting next week involving Arthur S. Levine, Pitt senior vice chancellor for Health Sciences and dean of the medical school, IRB leaders and chairpersons of the medical school’s clinical departments.

“Before any broader committee looks at [HIPAA-related issues], I think it’s necessary for these experts to really march through the issues and frame things in such a way that others could then react to it,” the provost told Senate Council.

“It’s critical,” Levine added, “that we give our faculty, our clinical chairs and the IRB leadership an opportunity to work through these daunting issues in the hope that we can reach a position that reflects more harmony than might otherwise be the case.”

Randy Juhl, vice chancellor for research conduct and compliance, pointed out that next week’s HIPAA meeting involving Levine, IRB leaders and clinical chairs is simply “an extended and extraordinary” session of a group that meets regularly.

Under the impression that Levine was forming a special committee to study HIPAA implications for Pitt, Senate members had asked to be represented, only to be told by Levine that it wouldn’t be appropriate for them to attend the meeting. “This led to all kinds of consternation and, I think, some ruffled feathers,” Juhl noted, in an understatement. Privately, several members of TAFC and the Senate’s executive committee had fumed at what they interpreted as both a snub of the Senate by Levine and a dismissal of their academic freedom concerns.

Provost Maher said TAFC’s survey results gave him “faint hope” that Pitt can find better ways to satisfy HIPAA without hindering research on human subjects, but he also said the survey questions that TAFC posed to other universities “were framed in such a way that it’s very hard to evaluate where we would fall on the spectrum of answers. And I’m not at all sure that we will find that we are out of line with the national norm. In fact, I would have said before seeing that [TAFC] study that we were clearly very much in the mainstream, which would mean that the trouble may be in the HIPAA legislation.”

Maher and Chancellor Nordenberg said the University community needs to learn more about HIPAA and the IRB review process. If more faculty members volunteered to serve on the IRB, Nordenberg said, it would speed up the process of reviewing proposals for human subject research and give that many more professors hands-on experience with HIPAA.

“Some departments have reached the point where only 10 percent of their [human subject research] proposals need to be reworked” before final approval by the IRB, said Maher. “Others have a much larger fraction that fail on the first pass.”

If the entire Pitt research community were up to speed on HIPAA privacy demands and “the very real challenges” the law presents to research universities, “we would probably be able to do much, much better, independent of whether there’s a way to fine-tune the work of our Institutional Review Board,” Maher said.

Vice Chancellor Juhl noted that Congress enacted HIPAA in 1996 but did not issue regulations until this year. “This has been a work in progress for a long period of time, and with anything this complex you can expect there to be some bumps along the road,” he said.

“We need to understand boring, mundane details of the [HIPAA] regulation in order to understand how we can improve the situation, whether it be with better proposals or better ways of reviewing those proposals.”

Echoing earlier comments by Nordenberg and Maher defending Pitt’s IRB, Juhl called the board “a group of hard-working people who have to make some really tough decisions. I want to make sure that their work is not impugned.”

—Bruce Steele