University Times

Medical professor Carey Balaban raises HIPAA-related research issues at Senate Council.

 Though Pitt administrators dispute both the survey’s methodologies and its findings, the University Senate’s tenure and academic freedom committee (TAFC) concluded after surveying other research universities that restrictions placed by Pitt’s Institutional Review Board (IRB) on research involving human subjects here are:

• Overly strict.
• Inconsistent with local and national standards.
• Interfering with faculty members’ ability to conduct research, so much so that it infringes on faculty’s academic freedom.

The Senate committee alleged that Pitt’s IRB forbids waivers of the HIPAA requirement of written informed consent/authorization for retrospective studies involving the recording of identifiable health information. According to TAFC, this has forced researchers to use what HIPAA calls an “honest broker” — someone with legitimate access to medical records who can remove details that would identify individual patients. “This makes retrospective chart reviews expensive (and therefore, beyond the purview of medical students, residents, fellows and unfunded junior faculty),” TAFC wrote.

But Randy Juhl, vice chancellor for research conduct and compliance, said Pitt’s IRB does grant waivers of HIPAA’s written informed consent rule when research proposals meet certain criteria such as: the research involves only minimal risk, the waiver will not adversely affect subjects’ rights and welfare, and the research could not be practically carried out without the waiver.

In this respect, Juhl said — contrary to TAFC’s conclusion — the Pitt IRB’s policy on HIPAA waivers is similar to those of IRBs at the six peer institutions surveyed by the committee: Johns Hopkins, Harvard Medical School Children’s Hospital, Children’s Hospital of Pennsylvania, Emory Medical Center, Duke University Medical Center and the University of Cincinnati.

Juhl added that Pitt, unlike most other universities, maintains an electronic records system that can strip out patient identifiers from retrospective data. “So, if you have patients who were treated here five or 15 or 20 years ago and you can’t find them to ask permission to use their patient data, even if you wanted to, it’s within the law using this system to remove any identifiable information and just throw their data in with everybody else’s,” the vice chancellor said.

He complained that TAFC did not share its survey results with him or anyone else from Pitt’s IRB before going to Faculty Assembly with a resolution criticizing the board’s policies. “No one invited an IRB representative to Faculty Assembly to discuss these issues. We found out about all of this after the fact, and that to me is distressing,” Juhl said. “To balance that, I was very pleased with the collegial tone that was struck by Professor Balaban at Senate Council.”

—Bruce Steele