Congressional desire for NIH reform is apparent

Rachel Edens
July 15, 2024
Exterior view of the main historic building (Building 1) of National Institutes of Health (NIH) inside Bethesda campus.
Image licensed from istockphoto.com

As a graduate student and scientist, I rely on funding from The National Institutes of Health (NIH). NIH funding provides me and my peers with materials and a stipend to perform cutting-edge research as our full-time job while earning a graduate degree. Similarly, the NIH funds labs that make life-saving discoveries such as the mRNA vaccine technology that was quickly employed in the SARS-Cov2 pandemic.

However, discrepancy in proper reporting by the NIH has recently caused congress to turn a critical eye on the publicly funded agency.

The NIH received $48.1B in federal funding last year and has requested a budget of $50.1B for 2025. This year’s budget approval process has representatives pondering how effectively the NIH is using its funding to ensure competitive advancement of science in the United States.

Both the House and Senate have raised significant concerns about NIH operations. Senator Bill Cassidy, M.D. published a White Paper report in May detailing feedback on his Request for Information from stakeholders on the NIH’s activity and framework. This was followed up in June with an extensive NIH reform proposal from Congresswoman Cathy McMorris Rogers. The push for reform comes four years after the start of the SARS-Cov2 pandemic, mirroring the 2006 NIH Reform Act that followed the SARS-Cov1 outbreak in 2002. 

Senator Cassidy’s White Paper report outlined common stakeholder concerns about the NIH’s operations and efficacy and offered suggestions on policy reform to address them. These included ways to balance the NIH’s current funding portfolio, maintain the country’s competitive biomedical research advantage and restore public trust in the NIH after the pandemic. The report maintained a tone of positivity and hoped for collaboration between congress and stakeholders. As the ranking member of the Senate Health, Education, Labor, and Pensions Committee, he concluded his report with excitement to work towards policies that will further strengthen the NIH.

Congresswoman Rogers, chair of the House Energy and Commerce Committee, took a more direct approach in calling for NIH reform with the publication of her NIH Reform Framework for Discussion. The framework puts forward both structural and policy reforms. 

"The NIH remains the largest funder of public research in the world and its operation is imperative to continued competitive scientific advancement in the United States."

-- Rachel Edens

The proposed structural reform would pair-down the NIH’s current 27 institutes and centers to a meager 15. The framework achieves this by combining institutes with common research missions and reallocating current funding. Some of the changes being considered include establishing a larger Institute on Body Systems Research that would absorb current organ-focused institutes. However, other suggestions seem arbitrary including the renaming of the National Institute on Aging to The National Institute on Dementia without another NIH home for non-dementia related aging research.

Also noteworthy from Congresswoman Rogers' proposal was the suggested policy reform which was organized into three subsections: mission and leadership reform, funding reform, and grant reform. Each subsection concluded with its own major recommendations.

Mission and leadership reform aims to address concerns about the tenure of NIH Institute directors by establishing five-year terms with a consecutive two-term limit. The proposal claims that these term limits would help usher in fresh ideas on the research that should be funded by each institute. This section of the proposal also called on the NIH to improve current reporting practices by establishing a congressional comprehensive review of the NIH and requiring individual institutes and centers to issue biennial reports. Additionally, the installment of new comprehensive policies by the NIH is proposed to ensure appropriate action is taken in regard to sexual and research misconduct reports.

The funding reform section aims to tighten current federal regulations that outline NIH funding sources and increase transparency on indirect costs. The NIH’s independent authority to operate is currently expired, but the agency still receives renewed annual funding under Section 301 of the Public Health Service Act (PHSA). The proposal specifically calls for the repeal of a discretionary funding “tap” authorized under the PHSA but does not call for an overall reduction in the NIH’s budget.

Congresswoman Rodgers' grant reform would likely impact researchers most directly. The framework suggests limiting new grant awards to primary researchers who do not have more than three active NIH engagements. This suggestion would address a common stakeholder concern of awarding more established researchers over early-career researchers since the investment in established researchers is considered less risky. This practice, however, can be extremely discouraging to the younger generation of academic scientists and has recently boosted a labor shift towards industry.

The grant reform section also makes suggestions that directly address public mistrust of the NIH as a result of the SARS-Cov2 pandemic. These suggestions include continued prohibition of risky gain-of-function research and the establishment of an independent review board for the proposed Institute of Infectious Disease to review and approve gain-of-function research proposals. More stringent restrictions on foreign collaborations are also encouraged to address national security concerns.

Additional oversight of animal research is suggested in the proposed grant reform. This recommendation is made despite the existence of facility Institution Animal Care and Use Committees (IACUC) at each domestic NIH-funded institution, which enforce stringent and ethical animal care and use safety protocols.

The recent scrutiny of the NIH by congress demonstrates a strong legislative desire for large-scale reform of the agency. This desire is understandable given the NIH’s dissatisfactory engagement with public reporting and outreach during the SARS-Cov2 pandemic. The agency has also not seen any major reform since the 2016 Cures Act. If enacted as-is, the recommended changes in Congresswoman Rogers' Reform Proposal would mean extreme changes for the NIH and NIH-funded researchers, such as myself.

The NIH remains the largest funder of public research in the world and its operation is imperative to continued competitive scientific advancement in the United States. Similar to scientific discovery, operations of such a critical federal agency can always be improved. Congressional NIH reform seems inevitable in the near future. Fortunately, elected officials recognize the fundamental role of NIH-funded scientists in this continued improvement.

The framework remains open to stakeholder input until August 16th, 2024. Those who wish to submit feedback on the reform proposal and further ideas can do so by emailing NIHReform@mail.house.gov.