A new shot at reducing research red tape

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A new shot at reducing research red tape

No matter how much scientists complain about it, federal oversight of academic research isn’t going away. But could it be done better?

The chair of a new National Academies panel examining how the government keeps tabs on its $40-billion-a-year investment wants that oversight “to be sensible enough so that investigators have more time to do research.” That’s a reference to an often-cited 2005 survey in which faculty say that “administrative tasks”—such as complying with agency reporting requirements—take up 42% of the time they devote to federally supported research projects.

Speaking yesterday during a break at the panel’s first meeting in Washington, D.C., Larry Faulkner, president emeritus of the University of Texas (UT), Austin, told ScienceInsider that “it would be a mistake to think that the only purpose of this study is to lighten the regulatory burden on universities. Regulation is required, it’s justified, and it’s needed. What we’re trying to do is guide both government and higher education to find more efficient ways to address those needs.”

The new study is the latest attempt by the academic research community to seek relief from what it sees as the steady accretion of unreasonable and costly government-wide regulations and policy directives from individual agencies. Faulkner says he witnessed that growth firsthand as UT president from 1998 to 2006.

“The job of vice president for research was transformed before my eyes,” he recalls. “It used to be about fostering large, complex, multidisciplinary research projects and removing any stumbling blocks. By the time I left, the job was consumed by coping with regulatory requirements—human subjects, animal research, environmental and safety practices, conflicts of interest, and so on. The scale of it really took off.”

The opening session was replete with stories about policies that university administrators and scientists described as misguided—or worse. One outside speaker, Arthur Bienenstock, a physics professor emeritus and special assistant to the president of Stanford University in Palo Alto, California, for federal research policy, cited a proposal to change how universities are reimbursed for the cost of supporting federally funded research that would have resulted in scientists spending less time in the lab. “It took us 3 years to kill that idea,” said Bienenstock, who led a 2014 study by the National Science Board on how to improve government oversight of academic research.

Two panelists chimed in with their own cautionary tales. Microbiologist Arturo Casadevall of Johns Hopkins University in Baltimore, Maryland, took a swipe at the federal rules for conducting animal research. He’s written a tongue-in-cheek essay proposing that anyone shopping for a mouse trap at Home Depot should be required to abide by the same 200-page regulatory protocol he must follow in caring for his research animals. “If government oversight is so useful, then it should apply to everyone,” he explained about his idea, which he says colleagues have urged him to shelve.

Lee Ellis of the University of Texas MD Anderson Cancer Center in Houston pointed out that “I have to get recertified every 10 years as a surgeon, but I have to take a compliance course annually” to meet federal requirements relating to human subjects, biosafety, and other topics. “Which is more important to society?” he asked rhetorically.

But other speakers warned the panel about the hidden dangers that could result from requesting changes to any existing federal rule or policy. For example, the current rules on disclosure of potential conflicts of interest by National Institutes of Health (NIH) grantees were triggered by the high-profile case of scientist—psychiatrist Charles Nemeroff of Emory University in Atlanta, who failed to tell his university about a conflict, noted Tobin Smith of the Association of American Universities, in Washington, D.C., who did not mention Nemeroff by name. The new policies make the universities responsible for handling every potential conflict that is disclosed, he said—a significant workload given that NIH funds about half of all federal academic research. “But I’m afraid that what will come back to bite us is the conflict-of-interest that we don’t know about.”

Another long-standing complaint is that the federal government doesn’t provide sufficient funding for universities to comply with the new rules. Such “unfunded mandates” may cost universities as much as $4000 per student each year, Bienenstock told the panel, money that is often recouped by raising tuition. But Smith had warned the panel earlier that highlighting the cost of regulations by linking them to tuition may be an unwise political strategy.

“If you say that you could save this much on tuition,” Smith said, “then the next time the government eliminates a regulation, some state legislator may ask you, ‘So how much are you going to lower tuition?’ There is certainly a connection, but you need to be careful.”

Panelist David Korn, a professor at Harvard Medical School in Boston, said the same caution should apply to lifting the current federal ceiling on recoverable administrative expenses, which universities say is grossly inadequate. “We need to be very careful about going to Congress with a suggestion to review indirect costs,” he said. Many scientists don’t understand how the mechanism works, he said, and most members of Congress see it as some sort of profit stream, or other such nonsense.” Another panelist pointed out the contradictory nature of asking for full cost recovery from the federal government “while we’re willing to accept much lower reimbursement rates” from foundations.

The roots of the new study lie in a 2007 law reauthorizing federal programs for higher education. It ordered up a review of all regulations that apply to universities. The Department of Education was told to fund the study, but the money wasn’t appropriated until 2014. Last summer the House of Representatives passed a bill asking the White House science office to study ways to streamline federal regulations and reporting requirements, although the Senate never took action. A coalition of federal agencies and universities have been chipping away at the issue for several years, and a 2012 National Academies report on the health of research universities also recommended changes in federal oversight.

The new panel has been asked to develop a “framework and supporting principles” for how the government monitors university research. “I don’t think any of us know exactly what that means,” Faulkner admits. But the goal, he says, is to create “the intellectual structure against which regulations, old and new, would be tested.”

Bienenstock agreed that a better rationale for federal oversight would be very useful. But he feels that correcting the problem may require a more fundamental overhaul of the current system, in which the government agrees to finance campus research in exchange for having universities train the nation’s future scientists and engineers. He said that partnership, created after World War II, is no longer working properly, especially with respect to biomedical research—the “800-pound gorilla” in the room.

“The public wants more biomedical research done at universities than is consistent with the functions of those universities and academic medical centers,” Bienenstock told the panel. “If the public wants more research, we need a new funding model.”

Correction, 10:14am, 2/18/2015: An earlier version of the story reported incorrectly that Lee Ellis was speaking about compliance with federal rules relating to the disclosure of potential conflicts of interest.

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