The FDA has done a good job of supporting scientific research in the US: Pushing for the science funding of CHIPS and the Science Act
The shift, which has been years in the making, would be undertaken across all of the FDA’s centres, including ones that oversee the approval of new pharmaceuticals, medical devices, veterinary medicines, cosmetics and more. FDA scientists are conducting their own research in service of this goal and are collaborating extensively with colleagues in industry, academia and other sectors of the US government. Any methods eventually adopted in place of research involving animals would be rigorously vetted and “fully validated and based on the best science”, says Namandjé Bumpus, chief scientist at the FDA. Bumpus and her colleagues have not received any pushback from researchers about making this shift, she adds, or heard any concerns from the scientific community about cutting back on the use of animals.
The FDA said that a key to bringing about change is to do so at multiple regulatory agencies. “Drug-development programmes are global, and companies want to market their products in many countries around the world.”
“There’s a lot of moving pieces here,” he says. “The FDA has started the ball rolling, but we need more work to make sure we can use these new methodologies appropriately.”
If Republicans gain control of the House, it will become harder to move funds through the appropriations process, according to Deborah Altenburg, an associate vice-president at the Association of Public and Land-Grant Universities in Washington DC. We need to push for the science funding of the CHIPS and Science Act.
The party that holds the White House usually loses seats during mid-term elections, two years after the president takes office. The country is dealing with a growing inflation and an energy crisis, which was worsened by the war in Ukraine. Some fear that democracy itself is also on the line, as former president Donald Trump and many of the candidates he has endorsed at both the state and national level continue to question — without any evidence — the results of the 2020 election that put Biden in office. Already, some Republicans are threatening to impeach Biden if their party takes power.
The White House Office of Science and Technology Policy has a top climate official named Jane Lubchenco. She was sanctioned in August by the US National Academy of Sciences for violating scientific-integrity rules (she edited a paper published in the academy’s journal in 2020 that was authored by a family member). Observers who spoke to Nature say that this could be just the beginning if Republicans take charge.
Stricter scrutiny could also be troublesome for the nascent Advanced Research Projects Agency for Health (ARPA-H), an organization launched by the Biden administration in March that will fund high-risk, high-reward biomedical research. Congress has not yet passed a bill explicitly authorizing ARPA-H’s creation. Policymakers are still disagreeing about where the agency’s office should be, and how independent it should be. Peter Jensen, an immunologist who heads the public affairs committee of the American Association of Immunologists in Rockville, Maryland, said that if Republicans take over, there would be concern that the potential for ARPA-H would not come to fruition.
This could be a challenge for the CHIPS and Science Act, which authorized US$280 billion for science and technology programmes across multiple federal agencies, including what would be a historic boost in funds for the NSF. Although Congress passed the legislation in July, Republican leadership in the House had urged opposition.
The Trump administration officially closed the China Initiative, a Department of Justice programme that was launched to counter attempts by the Chinese government to steal US secrets, early this year. Concerns about research security remain high on both sides of the political aisle, but the justice department ended the programme partly because of the perception that the initiative discriminated unfairly against scientists of Chinese heritage.
Legislation to bring back the programme is being pushed by some Republicans. If both chambers of Congress become Republican-controlled, such legislation could gain momentum — but it would be hard to fully bring back the initiative as long as Biden is in charge, observers say.
Meanwhile, concerns about Chinese espionage, national security and economic competitiveness have created new space for bipartisanship among Democrats and Republicans. For instance, 24 House Republicans bucked the party leadership’s call by supporting the CHIPS and Science Act, arguing that the legislation could reduce reliance on China by fostering the domestic production of semiconductors.
The climate and energy arena is played by political forces in similar ways. The Republicans have always opposed legislation to curb greenhouse-gas emissions, but in recent times they’ve supported major investments in clean energy. More than half a trillion dollars in clean-energy investments have been locked in with the passage of a pair of major bills over the past year.
David Hart tracks energy issues at the Information Technology and Innovation Foundation in Washington DC and says that there is a solid front against both China and Russia. It was a unifying factor in this last Congress, Hart says, and it is likely to be the same in the next one.
The U.S. government needs to take bold actions against the GAO proposals, says a spokesman at the National Institute of Extramural Research
A spokesman for the Office of Extramural Research at theNIH said it is considering multiple activities in response to the GAO report. A policy that went into effect on January 25 requires researchers to plan how their data will be preserved and shared. When asking grant applicants to describe their strategies for ensuring rigorous experimental design for robust and unbiased results in their studies, the NIH tells candidates that they should strive to ensure that experimental design, methodology, analysis, interpretation and reporting of results are all robust and unbiased, the spokesperson says.
In addition to considering the race and gender of reviewers, ensuring that panels have representation from under-represented institutions could have a big impact, says Enrique Neblett, a public-health researcher at the University of Michigan. Given the persistence of funding disparities, the NIH needs to take bolder action, he says.
Researchers who spoke to Nature say that changes to the peer-review system are long overdue, and that the proposals are a good start. But some think the revisions don’t go far enough to correct these entrenched problems.
The final category, which won’t be scored under the proposal, is often misinterpreted. Reviewers sometimes score applicants and their institutions without taking into account the proposed research, the original intention of the category. This has led to better scores for high ranking institutions and individuals. Under the proposal reviewers would choose whether or not to give researcher expertise or institutional resources a thumbs up or down. If they select the latter, they can leave specific feedback about deficiencies in a text box on the review form. This will “prevent reviewers from waxing poetic about a really famous investigator that tilts the evaluation of the science”, Byrnes says.
“For a big funder like NIH, these changes are quite bold,” says Sandra Bendiscioli, a research policy specialist at the European life-sciences organization EMBO in Heidelberg, Germany, who has published about bias in peer review.
The advisers pushing back on the plan said that researchers and institutional resources are important factors in determining the merit of research projects. “I do think there’s some value in some objective score to assess the investigator,” said Shelley Berger, an epigeneticist at the University of Pennsylvania in Philadelphia. Without a score, Berger added, it could be difficult to understand the reviewer’s thinking and how they factored researcher expertise into their decision. The reviewers could leave comments about their concerns if they wished, which could be reflected in the impact score.
Public feedback regarding the revisions is due by 10 March 2023. Changes to the criteria for scoring grants will be released in the coming months.
The move by the NIH and NSF follows a July 2022 report by the US Government Accountability Office (GAO) on the reliability of federally funded research, and how the NIH, NSF and NASA assess the work that they fund. It was found that the three agencies do not promote many of the practices that the scientific community has developed for sharing and storing research data.
According to the report, the agencies “do not collect indicators of rigorous study design and transparency of research results such as study sample size, adherence to research plans, or the extent to which research data are findable, accessible, and usable”. They don’t have the information needed to improve the way grants are awarded or identify funding areas which should be prioritized.
Marcus Munaf is a biological psychologist at the University of Bristol, UK who believes transparency and open research are important parts of driving quality. He leads the UK Reproducibility Network, a consortium that aims to investigate the factors that contribute to robust research. It provides training and dissemination for this area. He says that force mandates can go a long way to achieving this.
NASA deputy chief scientist David Draper sent a letter to the director of the GAO. In it, Draper argued that NASA does not need to collect information from researchers on scientific rigour. “NASA believes that the best way to ensure research reliability is the peer review process, which has long been the gold standard for scientific credibility,” Draper wrote. “Accordingly, NASA relies on the peer review process in the scientific community to assess research rigour, quality, transparency, and relevance of scientific proposals submitted to NASA, as well as the scientific journal publications arising from NASA-funded research.”
Wright’s Report on the Commission on Global Warming and the First Year’s Budget: Prospects for the Trustees of the Conserved Funds
Wright says that funders will be given four years to roll out changes in full if the GAO does not check in with the agencies at least once a year. The GAO will only be interested in the legislation being passed by the US Congress if it is compatible with the report’s recommendations.