Current Affairs |
DISCLAIMER: The views expressed are the author’s own and do not represent those of SRAI or any other institution. SRAI does not recommend responding on behalf of your institution unless authorized to do so.
Proposed rewrite of the Uniform Guidance (2 CFR Part 200) reshapes how federal awards are selected, terminated, and monitored. A research contracts manager walks through four provisions with direct operational consequences for research administrators, shares where he lands on each, and explains why your comment matters before the submission deadline.
Institutions conducting clinical research under a federal award are, in a sense, tenants of the federal government. The basis for this analogy is that while the landlord (government) retains ownership of their property (funding), tenants (research institutions) have the legal right to possess, occupy, and use this property in accordance with the terms of the lease. For more than a decade, the Uniform Guidance (2 CFR Part 200) has served as the tenancy agreement that defines the terms and shapes the relationship between the landlord and the tenants. However, on May 29, 2026, the landlord proposed substantial revisions to the Uniform Guidance. By extension, these revised federal rules will bring significant changes to the tenancy agreement. (Office of Management and Budget, 2026)
In this piece, I analyze four specific clauses in the proposal that govern how the tenant may take possession, occupy, and vacate the property, all at the landlord's discretion. I begin by examining the proposed changes regarding possession (Section 200.205), continue with the lease term and conditions for repossession (Section 200.340), then address responsibility for repairs (Section 200.432), and conclude with issues surrounding inspections (Sections 200.220, 200.303, 200.332). I argue that these key clauses in the proposed rewrite fundamentally alter the tenancy relationship by redefining the conditions for the possession, occupation, and termination of the tenancy agreement.
Taking Possession — Who Approves? (Section 200.205)
In standard tenancy transactions, before a tenant is given possession of any property, the tenant must first submit an application to the landlord. The landlord reviews the application to confirm if the tenant qualifies. Once the tenancy agreement is approved and signed, the tenant takes possession of the property.
In biomedical research, scientific peer review is the process that landlords like the NIH use to assess whether a tenant is qualified to be given possession of the property for the stated objective.
In the proposed rewrite of the tenancy agreement, the landlord is now seeking to add a pre-possession review by senior political appointees while relegating the prior determinative peer review to a mere advisory role. (Graham, Fallin, and Hummel 2026)
To better understand how this proposed change impacts the tenants, imagine handing final approval of a building's structural blueprints to someone who is not a structural engineer and has never read load calculations. While the building may still go up, you have moved the decision away from the people trained to know whether it will stand.
My recommendation is that the determinative scientific peer review should be retained. However, if the landlord wants a senior political appointee to review applications before possession is granted, the political job should only be to ensure that each application meets legal requirements and agency goals. The final decision about possession should stay with the scientific peer reviewers.
The Term: When Can the Landlord Repossess? (Section 200.340)
The foundation of a tenancy relationship is that the tenant takes possession of the property for a pre-determined period of time. The landlord is generally permitted to terminate the lease and retake possession if the tenant breaches its obligations under the lease. That is, the landlord can evict the tenant for breach where the lease permits it, and the tenant knows those terms before signing the lease agreement.
The new proposal would let the landlord end the lease whenever he decides the property no longer suits him. This change applies even if nothing has changed for the tenant. Tenants could be evicted at any time, making it hard to feel secure long-term. (Jr., Locaria, and Sheffler 2026)
Interestingly, the landlord-tenant metaphor has its limitations in the context of clinical research. Unlike a tenant vacating a building, researchers cannot simply halt or withdraw from a study without consequences. For instance, children participating in clinical trials require ongoing follow-up care to monitor late-arising side effects and to ensure their continued safety. If these follow-ups are abruptly disrupted, the research loses validity, and participants may be placed at significant risk (Marlow et al. 2019).
Though some may argue that federal agencies ought to retain broad discretion to terminate studies to uphold public interests or fiscal responsibility, independent of participant considerations. However, this perspective underestimates the ethical obligations involved, particularly when research subjects are vulnerable populations. A failure to provide appropriate follow-up not only undermines the integrity and usefulness of the research but also exposes participants to harm, highlighting why arbitrary or abrupt terminations entail high ethical and scientific costs that must be carefully weighed against administrative considerations (Brass 2003, 595).
These concerns can be solved, but doing so requires careful attention to both procedural fairness and the ethical implications for research participants. The landlord should only be able to end the lease for a clear reason, as arbitrary or unpredictable terminations pose direct ethical risks, particularly when clinical research involves vulnerable groups such as children. If the landlord wishes to retain the right to terminate for other reasons, there must be transparent, pre-established rules ensuring that any decision aligns with initial agreements and adheres to core ethical principles, such as nonmaleficence and justice. Sudden or random changes not only disrupt institutional planning but also jeopardize participants' welfare, thereby undermining the ethical integrity of research. With appropriate protections in place, the landlord can still terminate the lease for substantive problems, while affording the tenants greater security and better safeguarding everyone’s interests.
The Repairs: Who Is Responsible? (Section 200.432)
Landlords are generally responsible for cost of the building's structural repairs and maintenance to ensure it remains habitable for the tenant. The tenant is only responsible for minor upkeep and for repairing damage they caused themselves.
In clinical research, conferences are not just details. They are essential to the work. Like repairs in a building, conferences keep research strong. They help investigators get fast feedback, form partnerships, and share results before publication. (Kochetkov et al., 2020)
The new proposal says the landlord will pay for major repairs only if approved in advance. (Jr., Locaria, and Sheffler 2026) But you can’t predict every repair that might come up. For example, a researcher might be asked at the last minute to present new findings at a major conference, requiring quick funding. Many important conferences take place after the award is given and don’t fit within the slow federal approval process. (Levin n.d.) If every expense needs pre-approval, tenants might not report problems or pay out of pocket. My view is clear: the landlord should drop this change and keep the existing rule.
The Inspections: How Often, and at What Cost? (Sections 200.220, 200.303, 200.332)
Finally, let's discuss inspections.
There are already sufficient rules for monitoring subrecipients under Sections 200.331–200.333. Oversight is not in question. (2 CFR § 200.331 - Subrecipient and contractor determinations, 2026) The new proposal adds much more oversight for foreign collaborations. It would require regular, detailed inspections, even when there's no sign of a problem. (Office of Management and Budget, 2026) This would bring more work for tenants: more risk checks, more reviews, more paperwork, and extra participant screening. These steps cost real money. For large NIH-funded groups, this could mean hiring more staff, adding compliance teams, and buying better monitoring tools. That takes resources from research. (Subrecipient Monitoring and Management, n.d.) Look at the Sarbanes-Oxley Act. Its new oversight improved transparency but raised costs and reduced efficiency. (Office n.d.) Too many property inspections disrupt tenants. Too much research supervision slows science. OMB should weigh these costs and focus new rules on real risks rather than applying them everywhere.
The Question I Would Leave You With
Instead of ending with a typical summary, I ask research leaders, administrators, and faculty in federally funded research to consider these issues. If you knew from the start that your funding could be taken away at any time, would you still hire faculty, approve IRB forms, or sign subawards? If your honest answer is no, you need to tell OMB directly. Share your concerns clearly, with real examples and data from your institution. Your feedback is vital to OMB's understanding of the real impact of these changes.
While providing feedback may be time-consuming, it is essential to explicitly restate your institution’s core concerns and to reiterate the central thesis of this analysis: the proposed changes to the Uniform Guidance fundamentally shift the balance of authority and obligations in federally funded research relationships by redefining the conditions for issuance, usage, monitoring, and termination of funding. When preparing your comments, you should clearly consolidate and articulate these key recommendations: advocate for the preservation of rigorous, merit-based peer review as the primary basis for award decisions; recommend that terminations be limited to clear, pre-established reasons; urge the continuation of flexible conference-related expense policies; and request that oversight requirements be proportional to actual risk. Explicitly presenting these points together reinforces the argument that maintaining procedural fairness and ethical safeguards is paramount. The comment period ends July 13, 2026. For submission, consult the full text and submit your comments at Regulations.gov under Docket OMB-2026-0034. When commenting, begin each point with the relevant section number in brackets, such as [200.340], as per OMB’s guidelines.
References
Brass, E. P. (2003). Premature termination of clinical trials. JAMA, 290(5), 595. https://doi.org/10.1001/jama.290.5.595-a
Graham, D. P., Fallin, E., & Hummel, E. (2026, June 11). OMB proposes major overhaul of Uniform Guidance. McDermott Law. https://www.mcdermottlaw.com/insights/omb-proposes-major-overhaul-of-uniform-guidance/
Griesedieck, C., Jr., Locaria, D., & Sheffler, S. S. (2026, June 3). The administration’s proposed revisions to the Uniform Guidance are here! And there is a lot here to consider! Venable LLP. https://www.venable.com/insights/publications/2026/06/the-administrations-proposed-revisions
Kochetkov, D., et al. (2020). The importance of conference proceedings in research evaluation: A methodology for assessing conference impact. arXiv. https://doi.org/10.48550/arXiv.2010.01540
Levin, A. G. (n.d.). Understanding federal agency grant disbursement, payment processes, and "freezes". Congressional Research Service. https://www.congress.gov/crs-products/product/pdf/IF/IF12924
Marlow, N., Doyle, L. W., Anderson, P., Johnson, S., Bhatt-Mehta, V., Natalucci, G., Darlow, B. A., Davis, J. M., Turner, M. A., & International Neonatal Consortium. (2019). Assessment of long-term neurodevelopmental outcome following trials of medicinal products in newborn infants. Pediatric Research, 86(4). https://doi.org/10.1038/s41390-019-0526-1
Office of Management and Budget. (2014). Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 2 C.F.R. Part 200 (Uniform Guidance). https://ecfr.io/Title-2/Part-200
Office of Management and Budget. (2026). Proposed revisions to Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance). Federal Register, 89(103), 45678–45734. https://www.federalregister.gov/documents/2026/05/29/omb-uniform-guidance-rewrite
Subrecipient and contractor determinations, 2 C.F.R. § 200.331 (2026). https://ecfr.io/Title-2/Section-200.331
U.S. Government Accountability Office. (2025). Sarbanes-Oxley Act: Compliance costs are higher for larger companies but more burdensome for smaller ones (Report No. GAO-25-107500). https://www.gao.gov/products/gao-25-107500
University of Louisville. (n.d.). Subrecipient monitoring and management. https://louisville.edu/research/researchers/awards-agreements/subrecipient-monitoring