Key takeaways:

• The ACR issued a comment to the White House OMB expressing concern over proposed grantmaking changes.
• The provisions would increase federal oversite on grant-funded research.

The American College of Rheumatology has issued formal comment to the U.S. Office of Management and Budget expressing “deep concern” with proposed changes to federal grant regulations and the grantmaking process.

In a press release, the ACR said the proposed changes “would harm the competitiveness of the U.S. research enterprise and the nation’s ability to advance scientific discovery and public health, while wasting taxpayer resources.” In addition, the changes would allow “arbitrary grant termination without a process for recourse,” according to the ACR.

“We are putting our futures at risk when science is not lead by scientists,” William F. Harvey, MD, MSc, FACR, president of ACR, told Healio. “These changes are all designed to centralize the decision-making around what science to pursue amongst the people least qualified to make that decision.”

In an interview, Harvey expressed concern that the proposed changes could ultimately slow the grantmaking process or halt research altogether if such authority is executed inappropriately.

“The administration should involve the scientific community to propose reforms that accelerate, not retard the progress we need to make in advancing the health and wellness of the American public,” he said.

Specifically referencing the provision that may allow for grant termination, Harvey said this would “have a chilling effect on the progression of science.”

“Ending a research study before completion is also a profound waste of tax-payer dollars, particularly if the decision is made by political appointees who do not understand the science,” he added. “They will not know that they are missing out on the next important discovery.”

According to the release, the ACR is petitioning for a revision that includes advance warning of potential termination and an appeal process for grant termination.

Madelaine Feldman, MD, FACR, vice president of advocacy and government affairs for the Coalition of State Rheumatology Organizations, and a member of the Healio Rheumatology Peer Perspective Board, agreed that the proposed changes are reason for concern.

“Medical research should be guided by scientific merit, rigorous peer review and the expertise of researchers, not by political priorities that change from one administration to the next,” she told Healio. “Clinical trials do not stop and start with election cycles. Patients volunteer for studies and researchers make long-term commitments based on the expectation that federally funded research will be allowed to run its course.”

Feldman added that the proposed changes require federal grant programs to be designed with goals that explicitly align with administration policies and priorities, yet those goals and priorities are currently unclear.

“If researchers can lose funding because of an undefined ‘disqualifying affiliation,’ the rules need to be clear, objective and consistently applied,” she said. “Scientific integrity depends on transparency, not uncertainty.”

According to Harvey, other pending provisions to the grantmaking process include restrictions on diversity, equity and inclusion policies, as well as risk assessment of applicants.

“This allows agencies to deny funding to people with a history of questionable practices,” Harvey said. “While at face value this may seem like an appropriate step, the vague definitions could allow the blacklisting of scientists who have political disagreements with any administration.”

Harvey added that the proposed rule changes could impact the future of American research and discovery.

“We cannot forget that some of the most important treatments we use in rheumatology, like TNF inhibitors, came from fundamental discoveries at NIH,” he said. “In terms of the rule itself, I am asking everyone to reach out to their members of congress and voice their concerns. The ACR Legislative Action Center has some pre-drafted language.”

For more information:

Madelaine Feldman MD, FACR, can be reached at madelainefeldman@gmail.com.

William F. Harvey, MD, MSc, FACR, can be reached at tarnold@rheumatology.org.