University Times

Before Ian Reynolds can conduct what he calls “relatively trivial” lab experiments that involve harvesting tissue from the brains of rat fetuses, he must fill out a 22-page protocol and submit it to Pitt’s Institutional Animal Care and Use Committee (IACUC) for approval.

For another, similarly routine experiment that uses brains from freshly killed rats (“humanely sacrificed by the recommended method,” according to Reynolds), the IACUC requires another 22-page protocol.

Reynolds, a biomedical researcher here for 15 years, calls the paperwork “absurdly excessive” and cites it as an example of the escalating – and, in some cases, seemingly arbitrary – demands that the University and federal regulators are imposing on Pitt researchers.

“I agree that procedures that involve survival of animals or long-term experimentation need careful scrutiny, as do experiments that impose stressful circumstances,” Reynolds wrote in an e-mail last term to Randy Juhl, Pitt vice chancellor for research conduct and compliance. “However, as it currently stands there is clearly a serious mismatch in the amount of time, energy and paperwork devoted to regulating procedures that have absolutely no impact on the handling of the animals involved.”

Reynolds, who gave the University Times a copy of his e-mail correspondence with Juhl and other Pitt officials who oversee research compliance here, also complained that IACUC reviews are “highly inconsistent.”

“In a recent experience,” he wrote to the vice chancellor, “I submitted two identical IACUC applications (because we used the same procedures on two different grant projects) and received two completely different reviews from the IACUC reviewers about what we were doing right and wrong in the protocols.”

In a lengthy e-mail reply to Reynolds, and later in a University Times interview, Juhl readily agreed that Pitt over the last two decades has been placing more and more regulatory burdens on its federally funded researchers.

“Whether the research involves animal or human subjects, the pressure is being ratcheted up,” Juhl told the University Times. “But the real source of that pressure is in Washington, D.C. The University is basically just passing along the demands for accountability that the NIH [National Institutes of Health] and other funding agencies are imposing on us and other research universities. On the animal side, this pressure is aided and abetted by political activist groups like PETA [People for the Ethical Treatment of Animals] who would prefer that we not do any animal research of any kind.”

Juhl said Pitt’s IACUC is building a library of standardized protocols and procedures, which should reduce the paperwork burden on researchers while ensuring more consistent IACUC reviews.

Consistency and timeliness of IACUC reviews “are acknowledged problems in any peer review system, including the IACUC,” Juhl e-mailed Reynolds. “However, we are working to get better both through member education and occasional pruning” of IACUC members who are chronically tardy in their reviews and consistently wrong in their evaluations.

The IACUC, according to the committee’s mission statement, oversees Pitt’s animal programs, facilities and procedures “insuring the appropriate care, use and humane treatments of animals being used for research, testing and education.” The committee includes research faculty, a Pitt veterinarian and a non-scientist from the local community.

IACUC members “are volunteers and in the main do a very conscientious and efficient job in their reviews,” Juhl wrote to Reynolds. “However, our biggest problem related to timeliness is reviewers who don’t make the deadline.” Each of the five reviewers assigned to a particular protocol is given two weeks to review the document and return their comments. “It only takes one of the five to be late to hold up the entire process,” Juhl pointed out.

Bill Yates, who will begin chairing IACUC on July 1 after having served as vice chair for the last three years, said he and staff members from Levine’s office are planning to inaugurate a series of workshops this summer for new faculty and graduate students. “The idea is to help guide them through the morass of compliance issues and regulations that they will need to work through as they open their labs here,” said Yates, a professor of otolaryngology and neuroscience.

In an e-mail to Reynolds, Yates wrote: “I wouldn’t have accepted the position of IACUC chair unless I thought I could make a difference, and I will work hard to make the protocol review and approval process more efficient.”

In a University Times interview, Reynolds stressed that, with his litany of complaints about research compliance regulations, he did not mean to impugn the work of IACUC. “The members of that committee are in-the-trenches researchers who do a very important service to the research community here.

“The job they do is, at best, unpleasant – partly,” he said with a laugh, “because they have to deal with people like me complaining all of the time.”

Reynolds called the responses by Juhl and Yates to his criticisms “positive and helpful,” at least in part.

“Tuning up the [IACUC] review process, making it more prompt and consistent is a good thing,” said Reynolds, a pharmacology professor. “So is making it easier for researchers to complete protocol applications. I was happy to read what Randy and Bill had to say about those things.” But Reynolds said he remains concerned about some other recently imposed regulations and procedures, including a Pitt animal exposure surveillance program (AESP) introduced last year.

Reynolds pointed out that AESP demands complete medical records for all lab staff who are exposed to animals, “with no explicit assurance of confidentiality at all” – this at a time when the federal Health Insurance Portability and Accountability Act (HIPAA) is forcing doctors, hospitals and universities to go to extraordinary lengths to protect the confidentiality of patients’ health records as well as those of human subjects in clinical trials.

Worse, AESP’s definition of exposure to animals is “completely arbitrary” and fails to account for animal contact outside the lab, according to Reynolds, who wondered how his pets at home (a cat and two ferrets) figure in to AESP’s reporting requirements.

“There is nothing about this program that makes any sense at all,” Reynolds protested in his e-mail to Juhl, “and it has generated a burden for researchers and a substantial bureaucracy (and, implicitly, a substantial cost).”

Jay Frerotte, who heads Pitt’s Office of Health and Safety, told Reynolds in an e-mail that medical information acquired through AESP is handled “in the strictest confidence” and is available only Pitt clinical care providers “with a need to know.”

According to Frerotte, the University created AESP in response to criticism by the international Association for the Assessment and Accreditation of Laboratory Animal Care. AAALAC cited Pitt for, among other things, a lack of “evaluation of risk for animal allergies” among lab personnel.

Three years ago, the AAALAC put Pitt on “probationary accreditation” status pending the correction of problems that included risk evaluation for animal allergies. AAALAC accreditation is voluntary “but if the AAALAC doesn’t accredit you, then the NIH becomes suspicious and starts nosing around themselves,” IACUC chair-designate Yates told the University Times. Pitt animal research facilities also are regularly evaluated (13-15 unannounced inspections a year) by the U.S. Department of Agriculture, which looks for violations of USDA rules on humane treatment of “large” lab animals – that is, primates and others larger than rodents.

“If USDA inspectors were to issue a major citation, they could pull our USDA accreditation,” said Yates. “If that were to happen, Pitt would be forbidden to perform research involving animals bigger than mice and rats.” Of the thousands of lab animals at Pitt (the exact number varies), 95 percent are rodents or fish.

The USDA hasn’t issued a major citation against Pitt since the late 1970s “but they needle us with small stuff all the time,” Yates said. “Usually, it involves things like peeling paint and dirty air conditioning filters. If inspectors look hard enough, they can find something [to cite] in any university’s research operation.”

When Pitt toughens its compliance regulations, it’s usually the result of stricter guidelines imposed on the University by outside inspectors and accrediting organizations, according to Yates and Juhl.

“For example,” Yates said, “the USDA has really been cracking down recently against the use of expired drugs in animal research. When the USDA inspectors come in, they look at every single drug container in the room, and if one container is a single day out of date, we will get a citation. As a direct result, we’ve had to generate a very tough policy: ‘If we find expired drugs in your labs,’ we tell our researchers, ‘it’s going to be a very major issue.'”

Between 2000 and 2003, the USDA cited Pitt for 27 violations. That record prompted a Cincinnati-based animal rights organization called Stop Exploitation NOW (SAEN) to rank Pitt in April as the 9th worst offender among U.S. research institutions in violating animal research regulations. Other universities that made SAEN’s list included the University of California at San Francisco (No. 1 on the list, with a reported 51 violations) and the University of Pennsylvania (No. 4, with 36 violations).

Pitt officials replied that the University complies with all federal laws as well as USDA and NIH regulations on the use of animals in research. See April 29 University Times, available at: www.pitt.edu/utimes/ut.html. Click on Back Issues.

Reynolds said he and other faculty members understand that if Pitt fails to meet federal regulations, the feds could fine the University – the last time that happened was in 1987 – or even shut down Pitt’s whole research operation. “It doesn’t appear that we have any recourse at all,” Reynolds said. “It’s left me and many of my colleagues feeling powerless and disenfranchised.

“I guess the one thing that I was hoping to hear from Vice Chancellor Juhl, which I did not hear, is that Pitt has people who are going down to Washington and banging on the doors of federal regulators and saying, ‘Hey, wait a second, you’re not being reasonable here!'”

“There are things that the University administration can do,” said Juhl. “We’re working with the AAU [Association of American Universities], for example, to lobby for more sensible compliance guidelines.

“But the most power lies with professional and scientific organizations,” the vice chancellor said, emphatically. “Those same people who want to know what Pitt is doing…they need to get involved through their professional organizations and take their message to Washington. The chancellor and I can take it second-hand, and so can the AAU, but not with the credibility that the scientists and clinicians who deal with these regulations every day can bring.”

– Bruce Steele