University Times

The half-a-billion dollars in sponsored research funding that Pitt’s faculty annually attracts comes with strings attached – among them, ever-increasing government regulations intended to protect the safety and privacy of human subjects and to ensure humane treatment of laboratory animals.

To lessen the compliance burden on Pitt researchers, the University next fall will launch a computerized system that is expected to simplify the submission of research protocols to Pitt’s Institutional Review Board (IRB).

“Currently, when you prepare a protocol for the IRB it’s like writing a term paper,” said Randy Juhl, Pitt vice chancellor for research conduct and compliance. “You’re given a procedure manual that lists everything that needs to be in your submission, and you sort of filter your research through this manual as you write a rather lengthy document and an informed consent form.”

In contrast, the electronic process will follow a question-and-answer format. Data will be stored on a secure, password-protected Internet site. “The system will walk the investigator through the entire protocol submission process, from the beginning stages – ‘What is the name of your study?’ and so forth – through questions like ‘Are children involved in your project?’ and ‘Will your project use a placebo?’ Investigators will type their answers on a computer instead of actually producing a written document,” Juhl explained.

“By the time investigators have completed the new process, they will know that they have answered the key questions that the IRB needs to have answered,” the vice chancellor said.

The most common reason that the IRB sends protocols back to researchers to be reworked is that they’re missing one or more required pieces of information, he noted.

The electronic submission system – developed for Pitt by Webridge, Inc., a global web development and consulting company – will drastically reduce IRB paperwork. “Currently, when you submit an IRB proposal you need to provide 26 copies so we can send it to the 20 members of the IRB as well as the NIH [National Institutes of Health], the NSF [National Science Foundation] or whoever the relevant funding agencies may be,” said Juhl. “It’s a huge paperwork mess.”

Under the new system IRB members, each equipped with a laptop computer on which to read electronically submitted protocols, will continue to meet together to discuss protocol details.

“Hopefully,” Juhl said, “the new system will improve the quality of submissions, make them easier for the IRB to consider and decrease the angst among investigators.”

“Angst” accurately describes Pitt researchers’ feelings about complying with research regulations imposed by the University and federal legislation such as the Health Insurance Portability and Accountability Act (HIPPA), which restricts the use and availability of health information of human research subjects and patients. The law, which took effect in April 2003, 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.

The University’s IRB oversees Pitt investigators’ compliance with HIPAA. And, according to some professors, Pitt has taken extreme measures to avoid possible HIPAA violations.

Last fall, the University Senate’s tenure and academic freedom committee surveyed HIPAA compliance at peer universities and concluded that Pitt’s IRB interprets the law “in an unnecessarily stringent manner.” The committee accused the IRB of interfering with faculty members’ ability to conduct research, so much so that it infringes on faculty’s academic freedom.

Pitt administrators, including Juhl, refuted the committee’s report, including its allegation that Pitt’s IRB forbids waivers of the HIPAA requirement of written informed consent/authorization for retrospective studies involving identifiable health information. In fact, Juhl said, the Pitt IRB does grant waivers for research projects that meet certain criteria such as: the research involves only minimal risk and could not be practically carried out without a waiver. See stories in the Dec. 4, 2003, University Times, available at: www.pitt.edu/utimes/ut.html. Click on Back Issues.

“The increasing demands that federal regulatory agencies are placing on academic institutions to document their good behavior is a national issue,” Juhl said in a recent interview. “It’s not Pitt-specific. Investigators all over the country are complaining bitterly about it.

“Last December, I was at a meeting of IRB staff and administrators – IRB gurus, if you will – from all around the United States. At one point, the group was asked: How many of you have heard in the last year that your university’s IRB is the worst and toughest one in the country, and IRB demands at other schools are a lot easier? All of the people in the room raised their hands.”

Two external review of Pitt’s IRB (which currently is going through an accreditation process) found that the group is doing a good and fair job, according to Juhl. “Some instances have been pointed out to us where we haven’t been scrupulous and demanding enough,” he said. “We have never, ever had a reviewer tell us, ‘You’ve got to ease off on your researchers. You’re asking too much of them.'”

The stakes involved in research compliance are enormous, as some research universities (including the University of Alabama at Birmingham, the University of Chicago Duke, Penn and UCLA, among others) have found when federal regulators cited them for lax compliance. Donelson R. Forsyth, a psychology professor at Virginia Commonwealth University, described what happened when the U.S. Office for Human Research Protections gave VCU the “death penalty” revoking its access to federal research dollars: “We received that penalty for one reason only: shoddy oversight by our IRB. We did not follow the federally mandated procedures, and we lost our certificate of compliance as a result.

“Special permission was required to keep patients on their treatments in clinical trials. We had to outsource all grants to an external, pay-by-the-grant IRB. Virtually all non-grant supported research was stopped, for as long as a year. All student research was stopped – we had to waive the requirement for data-based dissertations for two years. The costs in terms of science and education was extraordinary.”

To illustrate both the growth in sponsored research at Pitt and the exponential increase in federally mandated compliance, Juhl noted that 15 years ago Pitt made due with one IRB, which met once a month. In the early 1990s, the University went to weekly meetings of four IRB sections, each with 18-20 members.

“We now have 11 IRBs. Most weeks, each of these groups holds a couple of meetings,” Juhl said.

HIPAA was part of what the vice chancellor called “a series of upheavals in federal accountability requirements” put on universities and individual investigators. “I’m hopeful that within a couple of years, our faculty researchers and IRB will have grown accustomed to what’s now required of them. We’re adapting to HIPAA and the overall increase in regulatory responsibility. I think it’s plateau-ed for a while.”

So, the worst is over?

“I hope so,” Juhl said, cautiously. “But we’re always just one well-publicized violation away from reigniting the interest of Congress, and having the demand for more public accountability start up all over again.”
– Bruce Steele