On May 29, the Office of Management and Budget (OMB), along with federal grantmaking agencies, proposed an overhaul to the government-wide framework that has governed for more than a decade how federal grants are reviewed, awarded, and managed.

The proposed rules to the Uniform Guidance, the framework’s formal name, would significantly change the way federally funded research is selected and overseen, giving political appointees a larger say in funding decisions and expanding the government’s ability to cancel grants already underway.

The proposal drew nearly 500,000 public comments before the window closed on July 13, with a large majority opposing the new rules. A final rule could come as early as Oct. 1.

Harvard submitted comment letters from the University , the Medical School , and the T.H. Chan School of Public Health , which urge OMB not to move forward with the proposed changes.

The Gazette spoke with John H. Shaw, senior vice provost for research, who wrote the University’s comment letter, about what the proposed changes would mean for researchers and for the federal research partnership. This interview has been edited for clarity and length.

What has historically been the purpose and scope of the Uniform Guidance? Can you give us an overview as to what’s happened recently?

The Uniform Guidance that’s issued by OMB is a framework that governs how the federal government allocates taxpayer dollars to fund its grant-making to research universities like Harvard, to other nonprofits, and to a wide range of organizations across the nation that the federal government seeks to support.

This framework represents the “rules of the road”: It ensures that those dollars are spent efficiently and effectively, and are consistent with the federal government’s expectations in providing that resource.

The scope and the breadth of the proposed changes, and the broad community they would impact has, I think, inspired such a strong response.

It’s typical when a proposed change to the Uniform Guidance is issued that the federal government calls for comment so that the various stakeholders have an opportunity to respond. The government, in turn, has a legal obligation to respond to those major criticisms — either to revise the policies or proposals or to explain why they’re not going to do so.

How do the proposed changes alter the current framework? What is the scope of these revisions?

They are vast in scope. They would affect more than a trillion dollars of federal spending across the range of areas in which the federal government awards grants and resources to help support the general public.

The document is hundreds of pages long. It’s very dense, and as a result, it reflects an amalgamation of a lot of different things that the administration has sought to accomplish through executive orders and other means over the last two years.

There are areas that represent a fundamental change in terms of how research is conducted at universities, at affiliated hospitals, and other types of entities. That is ultimately what has motivated Harvard to respond in a way that is thoughtful and responsible. There are a couple of areas that really are the underpinnings of the ecosystem of innovation that the federal government has supported over the last 75 years in higher education.

That innovation ecosystem is the reason that U.S. universities are world leaders in so many areas of technology and science more broadly. People feel as though these changes, if implemented, threaten to significantly reduce the competitiveness of the United States. They could have very direct and immediate impacts on areas of national importance — like national security, the health and well-being of patients, and the development of crucial technologies that we need to maintain our competitiveness and continue to support a vibrant economy.

How has Harvard responded to these proposed new rules?

Well, naturally, Harvard would have responded to something of this scale and this potential impact, but that was actually strengthened by a chorus of interest and concern that came from almost every part of the University community — from our faculty, researchers, students, and alumni — recognizing that these changes would have dire consequences for the U.S. research enterprise.

We were certainly motivated to plan a formal comment, and we did that by reaching out to the people in the University ecosystem who would be impacted. We received a tremendous amount of very constructive and thoughtful input, which we used to inform the University’s formal comment to these proposed changes.

In addition, the Medical School and the T.H. Chan School of Public Health have submitted their own comments focused on the specific concerns of their communities. Many other individuals, as researchers, as faculty, have also submitted responses. And finally, we’ve aligned with major national associations that support higher education and research, like the Association of American Universities and Council on Governmental Relations, that also recognize the threats posed by these recommended changes and want to have a thoughtful and aligned response.

You mentioned two key focuses in the University’s comment letter, the first being the introduction of new political oversight of federal grants. Can you tell me more about this?

This is probably the most impactful change. The relationship that the federal government has had with higher education and other institutions to conduct research has been successful because it placed the merit of proposed work as the standard by which decisions are made to allocate resources.

It’s important to clarify that the federal government and the various agencies that help support this science always determine what the priorities for the nation are. There are program managers and others who work in these agencies who consult with stakeholders and determine that these are areas that warrant federal investment, and those areas are not static. They change over time.

In my 30 years as a federally supported researcher, in my own lab, the priorities for national research have varied substantially, and that’s good. That’s healthy. That’s something that needs to continue to evolve.

But what’s being threatened here is that once those priorities are established by a funding agency — that we want to prioritize research on a particular form of cancer, or on a particular area of technology — the decisions about what awards to make would be political, not based on merit.

That will have dire consequences. Making something political means that those priorities are going to change depending on the nation’s political leadership. Research is not something that survives well when it has to be turned off and turned on with great frequency. It needs to be sustained.

I’d also say that merit-based peer review is a process that is very challenging to get through.

Many federal agencies that award grants have a less than 10 or 15 percent success rate. So, really, to get an award approved based on merit is a very high bar. It means that your proposal has gone through scrutiny, often in a highly specialized area of research, by the world’s leading experts in that field — it is a very strong process.

The answer to any individual investigator isn’t always favorable. Most of the time it’s not. But it motivates you to work toward an even higher standard. This is the best way to allocate taxpayer money to achieve the goals of the agencies and the federal government.

The other focus you mention is federal agencies’ expanded authority to suspend or terminate grants. Can you talk more about this?

Research doesn’t often hinge on a single eureka moment. It’s usually something that needs to be sustained over years to make important breakthroughs and to innovate. The ability, once awarded, to have confidence that you can conduct that research over the term of the award — whether that be three years or five years — is critical, because you need to bring on staff and students to help enable that research, and we, as an academic institution, make multiyear commitments to our researchers.

And so, if there is this prospect that political changes or whims will turn research on and off midstream, it limits the University’s ability to invest in, and sustain, the most important part of the research enterprise, namely the students, staff, and faculty who enable it.

Frankly, this uncertainty will make faculty risk-averse. They won’t be able to bring in as many students, bring in as many researchers to conduct as wide a range of research, because they’ll have this threat hanging over them that their grants can be terminated.

This would not include grants that are terminated for cause. That capacity already exists and should be maintained. The OMB’s suggested shift would permit midstream terminations that really reflect changing political winds, which would truly threaten the opportunity to fulfill the potential of the research that’s been supported.

This is not only a waste of taxpayer dollars, but poses the risk of long-term harm to research outcomes. If you fund something and only get 25 percent along the way before it’s canceled, we never have the potential to realize the benefit of that investment — and affected patients and the public never get to benefit from that research.

What are indirect costs? And what does the proposed rule say about their role in funding?

To many, indirect costs are one of the least understood aspects of supporting a research enterprise. Essentially, these are funds within each federal research grant that support the costs of the research’s associated administrative and facilities expenses. We have seen, over the last few years, threats to reduce indirect cost recovery to very small percentages.

What’s proposed in the OMB guidance is something different because, essentially, those attempts to just reduce it to smaller levels have already been stopped by the courts and by Congress. The OMB guidance is suggesting that a university’s indirect cost recovery rate is something that can tip the scales of whether that award should be made to that institution or another.

In contrast to direct costs, like salaries, equipment, materials, and supplies, which are assignable to research activities on a specific project, indirect costs are other essential expenses that reflect the true cost of that work — costs like building infrastructure, laboratory facilities, electricity and utilities, and administrative staff to support administration and compliance.

Indirect costs are critically important to the conduct of research, but they aren’t easily attributed to a single project, because they support state-of-the-art facilities and labs and the infrastructure necessary to ensure that research is conducted safely and in compliance with federal and state laws and institutional policies, ranging from environmental health and safety to research security.

The facilities are where the work is done. Without them, work could obviously not continue. And of course, the administrative costs are necessary because we need to conduct our research in ways that comply with the rules that the federal government has set for us. And we’re committed to adhering to those because they are critically important — like how we treat human subjects who are engaged in research.

The critical challenge with using this rate as a thumb on the scale in deciding to award funding is that the administrative part of this is already capped so the differences between institutions are really in the facilities.

If you start awarding federal grants preferentially to institutions that have lower indirect costs, it means one of two things: It means you’re awarding them to places where the cost of buildings and infrastructure is less, or it means you’re awarding them to institutions that are less willing to invest in their own research enterprise.

At Harvard, a lot of the research we conduct is lab-based. It requires major University infrastructure investments to have the capacity to do the research, and indirect cost recovery is a way that we partially recover some of the costs associated with making those investments. And so, if we disincentivize making those investments, universities will make fewer of them, and will have less capacity to do research, and certainly less capacity to innovate.

In addition, we want to ensure that decisions to fund proposals are based on scientific merit and transformative potential, not what costs the least.

What problems could the new rules present for scientists and researchers?

Well, for the scientists and researchers themselves, it comes back to this issue of sustaining their work — whether they are running a lab and looking to hire research staff, or whether they are students who are trying to meet academic degree requirements and have the capacity to go on and start their own labs in other universities or other research institutions across the country. It’s a commitment, of course, that we make to those students when we admit them — that we’re going to be there to support them through that process.

Moreover, the subjects of this research are important, deepening our knowledge of the world, while also creating new technologies, medicines, systems of understanding and other insights that lead to practical benefits for people in their everyday lives.

If grants can be terminated based on changing political considerations, that creates tremendous fiscal uncertainty, and so we may be forced to admit fewer students. We may hire fewer postdoctoral fellows.

The lack of certainty regarding the commitment that we make to these researchers will also undermine our ability to recruit the best talent from around the world, which is so critically important to the U.S. research enterprise.

If you look at any university, including Harvard, the impact of international students and researchers is profound. It’s to the real benefit of our nation that we maintain the opportunity to attract the best and brightest, because they help enable this innovation, which obviously benefits our nation and our allies across the world. The kinds of changes proposed by OMB would sow unpredictability, and therefore they would clearly reduce the scale of our research enterprise, and therefore its impact.

Are there examples you can share as to how these proposed changes could slow or halt current research, and how that translates into impact? How do rules that disproportionately affect universities like Harvard harm our national scientific competitiveness?

For the second question, research is a collective enterprise. We at Harvard are the beneficiaries of awards from many federal agencies, and we take very seriously the responsibility to conduct that research thoughtfully and capably.

We also, through many areas of research, interact with other research universities and institutions across the country, and in some cases around the world. And again, that’s truly important to enable the best and brightest minds to come together to solve some of the most important challenges that we have in terms of breaking through barriers in biomedical research and advancing critical technologies like quantum science.

The ability to arbitrarily terminate an award in one place will not be isolated in its impact. It will have a ripple effect through this ecosystem. Threats to universities like Harvard will be felt by our important research partners across the nation, which exist in almost every state, and of course span organizations beyond universities, like research hospitals.

To address the first part of the question, there are just so many examples where the outcome of research that’s had a major positive societal impact wasn’t clearly foreseen at the inception of that research. So much of our fundamental research takes decades to come to fruition, and examples of that illustrate the need for a sustained commitment to the best and most promising fundamental research.

Its potential can’t be foreseen by a political appointee or someone who is not intimately familiar with the area of science and technology. But someone with deep scientific and technical experience can — through a merit-based review process — assess whether this research will help gain fundamental understanding of a system, biological or physical, that allows us to decipher the code to unlock doors that are closed to us right now.

That will have value, not only in generally increasing our knowledge, but potentially enabling us to translate that research in impactful ways for society.

What are a few examples of this research?

A major revolution in biomedical treatments today results from our ability to do gene editing. Technologies like CRISPR, of course, are examples of one of the fundamental ways in which gene editing is enabled.

Some of the most exciting and impactful research in this area today had its foundations, at least in part, at Harvard University, through faculty at Boston Children’s Hospital who were affiliated with Harvard Medical School. In one example, our scientists helped develop a capacity to turn on and off fetal hemoglobin in ways that could allow us to treat the blood diseases sickle cell anemia and thalassemia.

It took decades from the time that fundamental research was conducted to the point where these therapies were available to patients. Now, of course, their success has been widely recognized and heralded. They’re not just incremental advances. They represent a fundamental change to the way we treat these diseases that are very, very impactful to patients — with their roots in fundamental research.

In quantum sciences and engineering, fundamental technologies that enable us today to develop quantum computers and quantum sensors were a relatively niche area of physics decades ago. But they were supported by the federal government, and by research universities, for their potential to contribute to fundamental insights, and ultimately have proven to have such important societal impact in ways that we might not have originally foreseen.

One of these is in solving complex problems of molecular interactions that can help us unlock insights into optimizing the development of therapeutics to treat disease.

They also can help us, of course, in the context of securing streams of data. Quantum is widely understood to have the capacity to do code-breaking, but it also holds potential to help us transmit information in secure ways. It’s critical to the security of our nation, and this is why these types of programs are supported not only by the National Science Foundation, but by the military and other parts of the federal government that, like us, view them as vital areas of research.

Twenty or 30 years ago, when we were laying the foundations of research projects like these, no one could have foreseen their full potential. If they were susceptible to political winds — if these projects started and stopped, started and stopped — we simply would not have reached the degree of impact that we currently have. And this is true in an area like quantum where, frankly, it’s come much faster than many of us anticipated it would.

Another final example is work done at the Wyss Institute for Biologically Inspired Engineering that has developed technologies for something called an “organ on a chip.” These are physical devices that enable populations of cells to work together, akin to complex tissues within the body in performing specific functions, allowing scientists to test those cells’ response to different drugs or environmental factors. They’re valuable in many ways, including that they offer an alternative approach to animal models, one that’s more specific to human biology.

This is an area of research at the University recently funded by the federal government in which we explored how astronauts are exposed to radiation in space and what the impacts of that could be, and how that could be mitigated. And these devices flew on the recent Artemis mission.

As Harvard experienced the wave of mass federal grant terminations in 2025 — and we saw all the destructive effects — this project was an example of something so vital that you couldn’t just stop it. We had living cells, human cells from the Artemis astronauts, on these chips that were planned to launch with this mission. If we had not been able to sustain that work, we wouldn’t have been able to participate in that critically important mission for the nation.

What are the next steps in the comment process?

OMB is legally responsible for reviewing all the comments that have been submitted and to respond to them, either modifying their proposed rule changes to address those concerns or explaining why they’re not making the changes.

What’s remarkable here, again, is both the scale of the comments that they have received and the speed at which they want to implement these proposed changes. We think it’s critically important that the comments that we provided, that our Schools have provided, that our community members have provided, and those that have come from across the nation, are considered carefully and thoughtfully. It’s critically important to consider all feedback, and to recognize that it’s a consultative process.

And so, we’re certainly encouraging the time be taken to get this right. It’s important that we do that. It’s critical for the nation’s interests and to the many Americans who stand to benefit from the next treatment, cure, or advance in technology.