Easing the regulatory burden on U.S. academic research certainly isn’t as sexy as curing cancer or understanding how the brain works. But creating an advisory body focused on eliminating government red tape—a tiny provision in a 996-page bill to accelerate medical research that could become law next month—is no less important to maintaining the health of the research community than is the infusion of billions of dollars, higher education lobbyists say.
“It’s very good news that it’s in the bill,” says Tobin Smith, vice president for policy at the Association of American Universities, a coalition of top research universities based in Washington, D.C., about the Research Policy Board that would be set up as part of the 21st Century Cures Act (HR 34). “We’re pleased that the issue is finally getting the attention it deserves.”
University administrators and faculty members have long complained that some of the never-ending stream of rules designed to ensure that precious federal research dollars are spent wisely are time-consuming, unnecessary, and occasionally even conflicting. In September 2015 a committee of the National Academies of Sciences, Engineering, and Medicine proposed a quasi-independent board to ride herd on those regulations.
The academies’ committee, chaired by University of Texas in Austin President Emeritus Larry Faulkner, had the ear of an influential legislator, Senator Lamar Alexander (R-TN), who requested the study. And Alexander made sure its report wasn’t buried. As chairman of the Senate Committee on Health, Education, Labor and Pensions, Alexander was also a key negotiator in hammering out agreements between the Senate and the House of Representatives on the Cures bill unveiled last Friday. And he inserted a five-page section of his own bill creating the research board into the broader legislation.
The new board would be housed within the White House Office of Management and Budget’s (OMB’s) regulatory shop, the Office of Information and Regulatory Affairs (OIRA). Its 20-some members would be divided between representatives of federal agencies that conduct research and those from the research community. In addition to its own reports, the board also would have the authority to ask additional experts for “timely analyses on pressing issues” and for their help “in anticipating future regulatory challenges … emerging from new scientific advances.”
At year 4 the General Accountability Office (GAO), the congressional watchdog, would evaluate the board’s contribution. The board would go out of business in 2021 unless Congress decided to renew its charter.
The panel Faulkner led envisioned a muscular board that would have its own staff and a budget drawn from an annual assessment of the country’s research institutions. The operation would be run out of the White House Office of Science and Technology Policy (OSTP), by a new senior administrator dedicated to preserving good ties between the government and the research community.
That structure wasn’t too popular among universities or on Capitol Hill in Washington, D.C. However, the underlying idea of a board that would examine excessive regulation of research was sufficiently attractive to spur several members of Congress to draft bills that offered various ways to tackle the problem.
Those bills were limited in their scope to a few agencies because they had to be tailored to fit the jurisdictions of the committees reviewing them. The latest version doesn’t suffer from such restrictions, however, and both Faulkner and Smith expect the board to have jurisdiction over the entire federal research enterprise.
The bill assigns seats to OSTP; OIRA; the Department of Health and Human Services (HHS), which oversees the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention; and the National Science Foundation (NSF). That leaves open up to six slots for “other departments and agencies that support or regulate scientific research,” giving OMB the authority to choose. Although there are some two dozen federal agencies that carry out research, more than 95% of the federal portfolio is handled by seven agencies—HHS, NSF, NASA, and the departments of defense, energy, agriculture, and commerce. The OMB director gets to make the final call on filling both the federal seats and the representatives from the external research community.
Faulkner declined to comment on the specific legislation before Congress. But he notes that the panel believed strongly that the board needs the authority to anticipate regulatory issues that might arise and the wherewithal to pursue such studies. “It’s important to have someone in the government who wakes up every day thinking about the partnership between the government and academia,” he says. He believes that a sunset clause is appropriate for any federal advisory body, but that such a provision doesn’t mean the board will go out of business in 5 years. “If it turns out to be useful,” he says about the mandated GAO review, “then I’m confident that it will be sustained.”
It is still not certain the board will become reality. The House is expected to approve the Cures bill this week, but some senators have objected to certain provisions. However, Senate Majority Leader Mitch McConnell (R-KY) has said that completing Cures is a priority for the current Congress, which adjourns next month.