NIH fears good-government bill would hamper peer review

The much-admired system to review grant proposals at the National Institutes of Health (NIH) in Bethesda, Maryland, has become the latest flashpoint in a long-running battle between Congress and the executive branch over how the U.S. government manages advisory bodies.

NIH’s parent body, the Department of Health and Human Services (HHS) in Washington, D.C., opposes legislation moving rapidly through Congress that is aimed at making those committees more transparent. The department says that if the bill becomes law, its requirements could cause monthslong delays in appointing reviewers to NIH study sections and create massive amounts of additional paperwork. In addition, “requiring [NIH peer reviewers] to go through this process could be a major disincentive to service,” HHS argued in a 9 April letter to Senate Majority Leader Mitch McConnell (R–KY).

Supporters of the bill say they responded to HHS’s concerns, first expressed in a similar letter sent to McConnell last year, by tweaking the bill to exempt NIH study sections. But HHS officials are now demanding the exclusion of all HHS advisory bodies, including those at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention, they say. Such a blanket exemption would gut the proposed reforms, proponents argue.

An NIH spokesperson, Renate Myles, says “NIH does not comment on pending legislation.” But NIH officials are fuming about the bill, according to one congressional staffer who’s familiar with the issue and requested anonymity. “We’ve been told that NIH will burn down the Capitol if this passes,” the staffer says.

Advocacy groups, meanwhile, have split on the issue. Biomedical research groups are worried about the bill’s potential impact on NIH. But environmental groups say any additional red tape is a small price to pay for increased government transparency.

Long-running effort

At issue is a 1972 law called the Federal Advisory Committee Act (FACA). FACA governs the thousands of advisory committees serving federal agencies. It sets rules for appointing members and conducting meetings, often requiring panels to include members with varying points of view and backgrounds and to open their work to the public.

For decades, however, there have been complaints that many federal agencies have found ways to defeat FACA’s requirements. Under former President George W. Bush, for example, watchdog groups complained that some advisory panels were inappropriately hiding their work, and that administration officials were requiring pledges of political loyalty from prospective appointees to panels dealing with energy and environmental regulations.

In response to such practices, Representative William Lacy Clay (D–MO) has repeatedly introduced bills to reform FACA that have won overwhelmingly bipartisan support. For example, the chairman of the staunchly conservative House Freedom Caucus, Representative Mark Meadows (R–NC), praised the liberal Clay as a “tireless advocate for this important reform” shortly before the U.S. House of Representatives unanimously passed this year’s version, H.R. 1608, on 12 March.

Now, the Senate Homeland Security and Governmental Affairs Committee is set to take up the bill on Wednesday. In advance of that vote, HHS delivered its 9 April letter detailing its concerns.

Differing views

“HHS opposes this bill,” the letter declares, citing several elements it finds objectionable.

One is a provision requiring agencies to designate advisory panel members who review grant applications as special government employee (SGEs). That would put into law what is already supposed to be a government-wide policy. Such SGEs must declare any conflicts of interest on a standard government form that remains confidential, as well as filling out other documents pertaining to their professional activities.

At NIH, defining reviewers as SGEs would be a big change. The agency now classifies its study section members as consultants in order to exempt them from the paperwork requirements that come with being an SGE. NIH also uses its own form for panelists to report potential conflicts. The variations are permitted under the Public Health Service Act that governs NIH’s behavior, according to HHS, and H.R. 1608 would wreak havoc with long-standing NIH practices.

“It could jeopardize NIH’s peer review process,” wrote Matthew Bassett, HHS’s assistant secretary for legislation. “Appointing individual SGEs requires the completion of 13 forms, one of which must be notarized, totaling 94 pages. … The appointment and ethics review process could take months.”

Many scientists may not be willing to run that gauntlet, the letter speculates. Reviewers volunteer their time “out of professional courtesy,” Bassett writes. “Requiring [reviewers] to go through this process could be a major disincentive to service.”

Some biomedical research advocacy groups have echoed those concerns. Clay’s bill “could have unintended consequences harmful to patients and taxpayers,” Mary Woolley of Research!America in Arlington, Virginia, and Jeff Allen of Friends of Cancer Research in Washington, D.C., warned McConnell last year after the House approved a similar bill. “These consequences include hamstringing the peer-review process at NIH, compromising the ability of the Food and Drug Administration to thoroughly and efficiently evaluate the safety and effectiveness of new medical advances, and adding more administrative time and costs to the advisory committee process than is necessary to meet legislative intent,” they wrote in April 2018.

But environmental activists view the changes in a much more positive light. “I don’t think the scientific community should set itself apart” from meeting the goals of FACA, says Andrew Rosenberg, head of the Union of Concerned Scientists’s Center for Science and Democracy in Washington, D.C., which has filed numerous suits claiming the Environmental Protection Agency and other federal agencies haven’t followed FACA rules.

Complying with FACA “might become a little more inconvenient” for agencies under the new law, “but I don’t think it’s crippling,” says Rosenberg, a professor of natural resources at the University of New Hampshire in Durham and former senior official at the National Oceanic and Atmospheric Administration. “And there are a lot of benefits from being able to say that the [peer-review] process is totally transparent.”

At the National Science Foundation (NSF) in Alexandria, Virginia, which also relies on advisory panels to review mountains of grant applications annually, officials have not yet taken an official stance on the legislation, says Lawrence Rudolph, NSF’s general counsel. But the agency has long followed requirements that are included in the bill, Rudolph says, and “we have not found them to be onerous or burdensome.”

What FACA requires

To understand what’s at stake, it’s necessary to look at differences between how NIH and NSF implement FACA when it comes to assembling the panels that review funding applications.

At NIH, most of the peer-review work is done through standing committees called study sections, which typically meet three times a year. Scientists typically serve a 4-year term, although study sections also use ad hoc members for their expertise in specialized areas. In contrast, NSF merit review is conducted by one-off panels convened by program managers to handle each round of proposals that come in over the transom or in response to a particular solicitation.

It’s a massive logistical challenge. NIH enlists as many as 35,000 reviewers for 173 study sections in any given year; NSF taps roughly half that number of scientists. Last year, it cost NSF $56 million to run the panels; NIH’s costs are much higher because of the larger volume.

At both agencies, the grant review groups already fall within the purview of FACA, as do the higher-level bodies that provide strategic advice (councils for each NIH institute, and committees for every NSF directorate). NIH and NSF provide a limited amount of information about the makeup of those review panels—NIH posts the name and institutional affiliations of every member before each study section meets, for example, while NSF posts an annual master list of its reviewers on a government-wide website without identifying the specific panel on which they served.

One reason HHS says it objects to H.R. 1608 is because it would require NIH to collect and provide more information about each committee member, including their expertise and any potential conflicts of interest. That requirement, which goes along with defining reviewers as special government employees, will create burdensome paperwork and delays in appointments, HHS argues.

At NSF, in contrast, Rudolph says meeting the bill’s requirements won’t be a problem. That’s because NSF has defined its reviewers as special government employees and collected the needed information ever since FACA went into effect. “We thought it would be a good way to ensure the integrity of the review process,” he explains. “And we don’t think the time frame required to appoint them is of any consequence. Finding the people most qualified in that particular area is the real controlling factor.”

H.R. 1608 would also prevent agencies from creating advisory bodies, such subcommittees or working groups, that are not subject to FACA’s open-meetings requirement because they technically report only to a FACA committee, not the agency itself. At NIH, if that ban had been in effect last year, it would have affected the way agency officials organized an advisory group that examined the hot-button issue of foreign influences on U.S.-funded researchers. Created in August 2018 and comprised of university presidents and other senior academic leaders, it met in private and surfaced only to report its findings in December 2018 to the NIH director’s advisory council, which is covered by FACA.

Is NIH exempt?

Biomedical advocacy groups admit they were caught by surprise when the bill passed the House in March. They are still reviewing what was changed since last year’s version, but most appear skeptical the changes go far enough.

“We want a blanket exemption for all NIH study sections,” says Jennifer Zeitzer, director of legislative relations for the Federation of American Societies for Experimental Biology in Bethesda, which is preparing a public statement on the legislation. “The intent [of Clay’s bill] is good, but we worry about the negative impact on individuals who agree to serve.”

Clay says his bill would grant NIH an exemption and that HHS has misrepresented the outcome of negotiations held last fall after Senator Lamar Alexander (R–TN), at the request of NIH and HHS officials, blocked a previous version of the bill from coming up for a Senate vote.

“The fixes made in the current version of the bill are much more accommodating than ever before,” Clay says. “I have included significant changes requested by HHS/NIH. But exempting all HHS panels is simply not acceptable.”

“The [new] language came from HHS,” says a Democratic committee aide. “This is what they asked us to put in to solve the problem, and we did. Now they are running around telling people that the bill is terrible and that the sky is going to fall, without acknowledging the significant concessions that we made.”

The broader exemption that HHS is arguing for raises numerous problems, supporters of H.R. 1608 say. It would allow FDA, for instance, to appoint representatives from drug companies or other parties with potential conflicts of interest to influential advisory committees that are not subject to FACA. That “is absurd,” says the committee aide. “We’re never going to agree to that.”

Exempting NIH “is not the ideal scenario,” the aide adds. “But in a show of good faith, Mr. Clay and [the authorizing Senate committee] agreed to add the language that HHS requested to exempt NIH from certain provisions because agency officials felt it would such a burden and harm their peer-review groups.”

It’s unlikely that the Senate panel will have found a compromise by the time it takes up the bill on Wednesday. But Rosenberg is hoping that legislators will keep trying.

“We are facing some serious problems because of how this administration is managing scientific advisory panels,” he says. “Would I like to exempt NIH panels? Sure. But not at the expense of righting the ship.”

Rosenberg worries that Alexander or another senator might again accede to HHS’s wishes and block the bill from being taken up by the full Senate. “Another hold could kill it,” he says. “And we need to make sure that FACA is doing what it’s supposed to do.”