Leveraging Department of Energy Authorities and Assets to Strengthen the U.S. Clean Energy Manufacturing Base

Summary

The Biden-Harris Administration has made revitalization of U.S. manufacturing a key pillar of its economic and climate strategies. On the campaign trail, President Biden pledged to do away with “invent it here, make it there,” alluding to the long-standing trend of outsourcing manufacturing capacity for critical technologies — ranging from semiconductors to solar panels —that emerged from U.S. government labs and funding. As China and other countries make major bets on the clean energy industries of the future, it has become clear that climate action and U.S. manufacturing competitiveness are deeply intertwined and require a coordinated strategy.

Additional legislative action, such as proposals in the Build Back Better Act that passed the House in 2021, will be necessary to fully execute a comprehensive manufacturing agenda that includes clean energy and industrial products, like low-carbon cement and steel. However, the Department of Energy (DOE) can leverage existing authorities and assets to make substantial progress today to strengthen the clean energy manufacturing base. 

This memo recommends two sets of DOE actions to secure domestic manufacturing of clean technologies:

  1. Foundational steps to successfully implement the new Determination of Exceptional Circumstances (DEC) issued in 2021 under the Bayh-Dole Act to promote domestic manufacturing of clean energy technologies.
  2. Complementary U.S.-based manufacturing investments to maximize the DEC’s impact and to maximize the overall domestic benefits of DOE’s clean energy innovation programs.

Challenge and Opportunity

Recent years have been marked by growing societal inequality, a pandemic, and climate change-driven extreme weather. These factors have exposed the weaknesses of essential supply chains and our nation’s legacy energy system. 

Meanwhile, once a reliable source of supply chain security and economic mobility, U.S. manufacturing is at a crossroads. Since the early 2000s, U.S. manufacturing productivity has stagnated and five million jobs have been lost. While countries like Germany and South Korea have been doubling down on industrial innovation — in ways that have yielded a strong manufacturing job recovery since the Great Recession — the United States has only recently begun to recognize domestic manufacturing as a crucial part of a holistic innovation ecosystem. Our nation’s longstanding, myopic focus on basic technological research and development (R&D) has contributed to the American share of global manufacturing declining by 10 percentage points, and left U.S. manufacturers unprepared to scale up new innovations and compete in critical sectors long-term.

The Biden-Harris administration has sought to reverse these trends with a new industrial strategy for the 21st century, one that includes a focus on the industries that will enable us to tackle our most pressing global challenge and opportunity: climate change. This strategy recognizes that the United States has yet to foster a robust manufacturing base for many of the key products —ranging from solar modules to lithium-ion batteries to low-carbon steel — that will dominate a clean energy economy, despite having funded a large share of the early and applied research into underlying technologies. The strategy also recognizes that as clean energy technologies become increasingly foreign-produced, risks increase for U.S. climate action, national security, and our ability to capture the economic benefits of the clean energy transition. 

The U.S. Department of Energy (DOE) has a central role to play in executing the administration’s strategy. The Obama administration dramatically ramped up funding for DOE’s Advanced Manufacturing Office (AMO) and launched the Manufacturing USA network, which now includes seven DOE-sponsored institutes that focus on cross-cutting research priorities in collaboration with manufacturers. In 2021, DOE issued a Determination of Exceptional Circumstances (DEC) under the Bayh-Dole Act of 19801 to ensure that federally funded technologies reach the market and deliver benefits to American taxpayers through substantial domestic manufacturing. The DEC cites global competition and supply chain security issues around clean energy manufacturing as justification for raising manufacturing requirements from typical Bayh-Dole “U.S. Preference” rules to stronger “U.S. Competitiveness” rules across DOE’s entire science and energy portfolio (i.e., programs overseen by the Under Secretary for Science and Innovation (S4)). This change requires DOE-funded subject inventions to be substantially manufactured in the United States for all global use and sales (not just U.S. sales) and expands applicability of the manufacturing requirement to the patent recipient as well as to all assignees and licensees. Notably, the DEC does allow recipients or licensees to apply for waivers or modifications if they can demonstrate that it is too challenging to develop a U.S. supply chain for a particular product or technology.

The DEC is designed to maximize return on investment for taxpayer-funded innovation: the same goal that drives all technology transfer and commercialization efforts. However, to successfully strengthen U.S. manufacturing, create quality jobs, and promote global competitiveness and national security, DOE will need to pilot new evaluation processes and data reporting frameworks to better assess downstream impacts of the 2021 DEC and similar policies, and to ensure they are implemented in a manner that strengthens manufacturing without slowing technology transfer. It is essential that DOE develop an evidence base to assess a common critique of the DEC: that it reduces appetite for companies and investors to engage in funding agreements. Continuous evaluation can enable DOE to understand how well-founded these concerns are.

Yet, the new DEC rules and requirements alone cannot overcome the structural barriers to domestic commercialization that clean energy companies face today. DOE will also need to systematically build domestic manufacturing efforts into basic and applied R&D, demonstration projects, and cross-cutting initiatives. DOE should also pursue complementary investments to ensure that licensees of federally funded clean energy technologies are able and eager to manufacture in the United States. Under existing authorities, such efforts can include: 

These complementary efforts will enable DOE to generate more productive outcomes from its 2021 DEC, reduce the need for waivers, and strengthen the U.S. clean manufacturing base. In other words, rather than just slow the flow of innovation overseas without presenting an alternative, they provide a domestic outlet for that flow. Figure 1 provides an illustration of the federal ecosystem of programs, DOE and otherwise, that complement the mission of the DEC.

Figure 1

Programs are arranged in rough accordance to their role in the innovation cycle. TRL and MRL refer to technology and manufacturing readiness level, respectively. Proposed programs, highlighted with a dotted yellow border, are either found in the Build Back Better Act passed by the House in 2021 or the Bipartisan Innovation Bill (USICA/America COMPETES)

Figure 1Programs are arranged in rough accordance to their role in the innovation cycle. TRL and MRL refer to technology and manufacturing readiness level, respectively. Proposed programs, highlighted with a dotted yellow border, are either found in the Build Back Better Act passed by the House in 2021 or the Bipartisan Innovation Bill (USICA/America COMPETES).

Plan of Action

While further Congressional action will be necessary to fully execute a long-term national clean manufacturing strategy and ramp up domestic capacity in critical sectors, DOE can meaningfully advance such a strategy now through both long-standing authorities and recently authorized programs. The following plan of action consists of (1) foundational steps to successfully implement the DEC, and (2) complementary efforts to ensure that licensees of federally funded clean energy technologies are able and eager to manufacture in the United States. In tandem, these recommendations can maximize impact and benefits of the DEC for American companies, workers, and citizens.

Part 1: DEC Implementation

The following action items, many of which are already underway, are focused on basic DEC implementation.

Part 2: Complementary Investments

Investments to support the domestic manufacturing sector and regional innovation infrastructure must be pursued in tandem with the DEC to translate into enhanced clean manufacturing competitiveness. The following actions are intended to reduce the need for waivers, shore up supply chains, and expand opportunities for domestic manufacturing:

Updating the State Energy Program to Promote Regional Manufacturing and Economic Revitalization

Summary

Congress, the White House, and federal agencies are growing increasingly concerned about the decline in U.S. industrial leadership. The emergence of China’s industrial dominance and the supply chain challenges exacerbated by the Covid pandemic have opened a political window of opportunity. With the Infrastructure Investment and Jobs Act, as well as pending U.S. competitiveness legislation, Congress and the White House are poised to direct significant investments to regions that have suffered from the decline of legacy industries, ranging from the Rust Belt to coal communities. Innovative energy technologies are at the center of this effort. Not only will clean energy supply chains be necessary for the U.S. to rise to the climate challenge, but they have emerged as the main battleground in global industrial competitiveness, as major economies around the world make significant investments in renewables, electric vehicles, and emerging technologies like clean hydrogen. 

There are a range of interventions underway across federal agencies to strengthen U.S. manufacturing and promote regional economic and workforce development. The Department of Energy (DOE) is a key player in fostering innovative manufacturing ecosystems around clean energy technologies and low-carbon industries. 

For nearly half a century, DOE’s State Energy Program (SEP) has supported state leaders as they plan for a clean energy future. However, a resilient, secure, and prosperous clean energy economy increasingly demands investments in advanced energy manufacturing and supply chains. This memo proposes that the Administration update SEP to the State Energy and Manufacturing Program (SEMP), and outlines a specific set of reforms — many of which fall within existing program authorities — that will empower states and regions to foster a strong clean energy manufacturing base and enhance U.S industrial leadership.

Challenge and Opportunity

This Administration and Congress have identified regional innovation as a critical area to advance U.S. competitiveness and economic revitalization. This regional approach is woven throughout the bipartisan Infrastructure Investment and Jobs Act (IIJA), which includes regional hubs for clean hydrogen and other emerging technologies; the U.S. Innovation and Competition Act (and its House companion, the America COMPETES Act), which includes funding for regional innovation clusters; the Build Back Better Regional Challenge funded under the American Rescue Plan, which devotes $1 billion to revitalizing regions suffering from disinvestment; the Interagency Working Group on Coal and Power Plant Communities and Economic Revitalization; and the White House’s supply chain and industrial decarbonization efforts.

These investments also recognize that global growth sectors align with decarbonization. Despite U.S. leadership in R&D for solar photovoltaics, electric vehicles, advanced nuclear reactors, and more, the U.S. has failed to retain significant domestic manufacturing capacity for the energy technologies of the future, posing risks to middle-class jobs, energy security, and climate action in the years ahead. 

Today, China owns 80 percent of the solar supply chain, produces roughly half the globe’s electric vehicles, and leads the world in clean energy investments, spending more than double that of the U.S. While major announcements from U.S. automakers in the past year have brought hope of American electric vehicle leadership, other clean energy industries are struggling in the absence of U.S. manufacturing incentives. 

DOE’s recent supply chain report highlights the need to “leverage regional assets, including resources and workforce development, to support the creation and expansion of industrial clusters” and identifies a range of avenues to provide regional technical assistance. It also states that DOE should “consider whether new authority is needed to enable federal awards, matching grants, direct loan, and loan guarantees to support creation of these clean energy manufacturing clusters and leverage existing public programs (federal, state, local) for regional innovation and manufacturing ecosystems.”

One existing program which could be leveraged in this effort is the State Energy Program (SEP). SEP was authorized by the Energy Policy and Conservation Act of 1975, passed in response to the energy crises of the 1970s. The program has historically provided cost-shared technical assistance to states to aid in energy conservation planning, as well as some limited financial assistance (i.e., revolving loan funds) for states to increase energy efficiency and clean energy in public operations, such as municipal buildings and schools. The program has five goals:

SEP is considered highly effective, with a leverage ratio of 1:11 between federal and non-federal (including private) funds, annual energy cost savings of $7 for every $1 spent, and hundreds of thousands of students educated in energy efficiency.

Congress and DOE have proposed expansions to the scope, scale, and targeting of SEP in the past (see FAQ #2). These increases in funding and prioritization for low-income and environmental justice communities are well-warranted given the SEP’s strong track record and high return-on-investment, but so too should the scope of funds be updated to reflect our modern supply chain challenges. Energy supply chains and clean U.S. manufacturing have become bipartisan priorities and critical elements of meeting U.S. climate goals.

In the absence of additional support for regional clean energy supply chains, it is highly likely that the U.S. will continue to cede ground to foreign competitors in the energy technologies of the future and grow increasingly reliant on materials manufactured abroad. This poses risks to our ability to mitigate climate change, ensure energy security and national security, and capture the economic benefits of the clean energy revolution. It also is likely to inhibit energy innovation, as regional manufacturing clusters promote “learning-by-doing” and drive advances in material sciences and processes that are simply not possible to achieve in the lab. Finally, maintaining a narrow focus on energy conservation could limit the ability for all states to plan effectively for the clean energy future and develop comparative advantages; even after accounting for population, states do not participate evenly in all aspects of the program based on their needs, interests, and capabilities (see ORNL program evaluation, Figures 3-32). An expanded mandate could increase uptake of the program among states that may have a strong manufacturing base but have been unable to maximize the benefits of a program with a more narrow scope.

Therefore, DOE should leverage its existing authority to rename the program to the State Energy and Manufacturing Program (SEMP) and expand technical and financial assistance to include clean energy supply chain planning. At the same time, Congress should reauthorize, update, and increase funding for the program to ensure states have the ability to develop robust regional clean manufacturing hubs. As domestic clean energy supply chains emerge as a critical element of the national climate, manufacturing, and jobs agenda, this remains pursuant to the program’s goals of promoting energy security, resilience, and economic growth.

Plan of Action

The following action plan includes both executive and legislative actions to update SEP to enable states to plan for and develop a strong U.S. manufacturing base for clean energy. These actions should be implemented in Program Year 2023, with new program guidance issued in early 2023.

Recommendation 1. Make manufacturing an explicit goal of SEP and begin providing technical assistance for clean energy supply chain and manufacturing planning.

Manufacturing is critical to the program goals of energy security, resilience, and economic growth. To indicate its expanded mission, DOE should update the name of SEP to the “State Energy and Manufacturing Program (SEMP)” and begin providing technical assistance to support local and state clean energy supply chains and manufacturing capacity. While Congress should codify this goal, DOE can begin today by leveraging existing authorities like the Energy Technology Commercialization Services Program (42 U.S. Code § 6322(f)). This optional program helps small businesses and start-ups manufacture clean energy technologies (see FAQ #1). DOE can also consider whether to reinstate Renewable Energy Market Development programs, which under the American Recovery and Reinvestment Act (ARRA) covered efforts to “develop or expand existing manufacturing capacity for renewable energy equipment and components and support development of specific renewable energy facilities.” 

Recommendation 2. Extend eligibility of technical assistance to consortia of states to support regional planning. 

SEP is an arrangement between DOE and designated state energy offices. DOE should foster regional clean manufacturing ecosystems by issuing new program guidance that enables states to submit collaborative energy plans, particularly for optional plan components. 

Recommendation 3. Increase scale of funding and expand funding mechanisms. 

To enable more robust utilization of existing programs and expansion to manufacturing activities, Congress should increase overall funding for core SEMP activities to roughly $400 million per year (not including additional funding for challenge grants), commensurate with levels proposed by Congress in the CLEAN Future Act (see FAQ #2). Additionally, Congress should explicitly include clean energy and low-carbon manufacturing planning within the core SEMP planning and technical assistance process, and create a new revolving loan fund, the State Advanced Energy Manufacturing Fund, to provide additional financial support to states to use on manufacturing projects. As with SEP’s existing revolving loan fund for building efficiency, these funds could be distributed once the state has “demonstrated a commitment” to promoting clean energy manufacturing through state and private efforts.

Recommendation 4. Direct states to consider opportunities to coordinate with the Department of Commerce, Regional Commissions, and other DOE-led manufacturing initiatives. 

Several federal government programs, including the Economic Development Administration and Appalachian Regional Commission, already focus heavily on regional development strategies, which tend to consider advanced manufacturing opportunities. There are several existing DOE-led and DOE-adjacent initiatives that contribute to this mission as well, including DOE’s Advanced Manufacturing Office, the National Institute of Standards and Technology’s Manufacturing Extension Program (MEP), the Manufacturing USA institutes, and DOE battery manufacturing grants and hydrogen hubs authorized in IIJA. IIJA also authorized a new State Manufacturing Leadership program to provide competitive financial assistance to states that develop smart manufacturing programs.1 This program is fundamentally different from SEP – it provides short-term competitive assistance rather than long-term block grants, and focuses on advanced manufacturing techniques regardless of sector rather than clean energy supply chains specifically. However, it could be merged with an expanded SEMP, or at least closely coordinated. Additional legislation, such as the COMPETES Act — which contains funding for regional innovation hubs, microelectronics research centers, and direct grants for solar and semiconductor manufacturing — could build upon these regional ecosystems.

SEMP can and should complement these efforts by providing consistent, long-term support directly to state governments, rather than specific projects or companies, to effectively plan and coordinate regional development strategies focused on clean energy technologies. This will enable states to develop and execute on regional manufacturing roadmaps over the course of decades. To do so effectively, SEMP should coordinate with related programs and agencies to identify strategic opportunities for clean energy manufacturing, particularly during the guidance development process.

Recommendation 5. Direct states to dedicate at least forty percent of funds to low-income, environmental justice, and energy communities. 

Under the Biden-Harris Administration’s Justice 40 commitment, forty percent of DOE funds are to be directed to underserved communities. Clean manufacturing can be a crucial tool for promoting economic revitalization and environmental justice in these communities, including those that have historically hosted emissions-intensive manufacturing facilities or fossil fuel production. DOE’s Office of Economic Impact and Diversity should help to connect states with tools, such as its energy justice dashboard and the funding clearinghouse from the Interagency Working Group on Coal & Power Plant Communities, and provide technical assistance to identify and prioritize these communities in SEMP-supported initiatives. 

Frequently Asked Questions
Are these reforms to the State Energy Program within statutory authority?

Yes. Under existing authority, SEP technical assistance and funds support state energy plans that include a series of mandatory components focused on efficiency, but may also include additional measures to promote renewable energy commercialization, manufacturing, and deployment. During the ARRA-era expansion of SEP, more than $250 million in assistance went to the purpose of “Renewable Energy Market Development,” which aimed to “develop or expand existing manufacturing capacity for renewable energy equipment and components and support development of specific renewable energy facilities.” Three specific provisions that may support manufacturing efforts are 42 U.S. Code § 6322(d)(11), “programs to promote energy efficiency as an integral component of economic development planning;”[1] 42 U.S. Code § 6322(d)(7), “programs to promote the adoption of integrated energy plans which provide for . . . evaluation of a State’s . . . available energy resources . . . and . . . energy supplies;”[2] and 42 U.S. Code § 6322(f),  the Energy Technology Commercialization Services Program. Under the latter, states can devise plans to:



  1. aid small and start-up businesses in discovering useful and practical information relating to manufacturing and commercial production techniques and costs associated with new energy technologies;

  2. encourage the application of such information in order to solve energy technology product development and manufacturing problems;

  3. establish an Energy Technology Commercialization Services Program affiliated with an existing entity in each State;

  4. coordinate engineers and manufacturers to aid small and start-up businesses in solving specific technical problems and improving the cost effectiveness of methods for manufacturing new energy technologies;

  5.  assist small and start-up businesses in preparing the technical portions of proposals seeking financial assistance for new energy technology commercialization; and

  6.  facilitate contract research between university faculty and students and small start-up businesses, in order to improve energy technology product development and independent quality control testing.


[1] “[E]nergy efficient, next-generation materials and innovative process technologies” align with DOE’s efforts on advanced manufacturing. See DOE Advanced Manufacturing Office, Research & Development.


[2]  Integrated resource planning often addresses fuel (e.g., coal, natural gas) availability, and with the 21st century’s rapid deployment of renewable energy and battery storage facilities, it is now additionally critical to analyze and promote plans to strengthen the supply chain for renewable energy and battery storage components.

Has SEP been expanded in the past?

While annual block funding for states has settled at $62.5 million in recent years, Congress has pursued significant expansions to SEP. ARRA provided more than $3 billion to SEP, with no matching requirements for states, as part of its temporary green stimulus (the program created more than 100,000 jobs). ARRA also temporarily expanded SEP’s activities to broader clean energy market development, including manufacturing. In the current Congress, the CLEAN Future Act proposes an infusion of $3.6 billion over ten years in formula grants to states to enable states, localities, and tribes to reduce emissions, deploy clean energy, and improve efficiency at public facilities. At least 40% of funds would need to be set aside for environmental justice and/or low-income communities. Last year, IIJA authorized a State Manufacturing Leadership program that, while not explicitly a part of SEP, could provide a blueprint for an expanded state block grant program. Finally, DOE’s FY22 budget justification also requested $300 million to enable “Build Back Better Challenge grants to incubate novel approaches to clean energy technology deployment, prioritizing investments that meet energy needs at the local level, and are inclusive in elevating impoverished and disenfranchised communities, and/or communities that have been marginalized or overburdened.” The final FY22 appropriations bill provided $70 million for SEP and $20 million for the challenge grants, per the Senate report.

Why are existing SEP funding levels insufficient?

By many measures, the U.S. is not deploying energy efficiency, clean electricity, and other decarbonization technologies at the speed necessary to avoid the worst effects of climate change. According to the International Energy Agency, if we hope to get on track to net-zero emissions by 2050, the global community will need to roughly triple investment in clean technology to more than $4 trillion by 2030. Our top economic competitor, China, is poised to capture a much larger share of this economic opportunity than the U.S., largely due to their proactive work to build out their supply chains. For instance, in the next two years, analysts forecast that China’s manufacturing capacity for wind and batteries will grow 42 and 150 percent, respectively. All of this points to the need for significant additional funding for programs that accelerate deployment of clean energy in the United States.


The ARRA-era expansion of SEP showed that states have the capacity to absorb significantly larger sums while maintaining strong returns-on-investment, leverage ratios, and job creation figures. For instance, ARRA funds amounted to a highly-efficient $14,000 per job created, inclusive of direct, indirect, and induced jobs. The funding levels proposed in this policy brief are an order of magnitude smaller than those in ARRA, but are aligned with recommendations from the Biden Administration’s DOE and the current Congress.

Why is SEP funding for manufacturing planning needed on top of related EDA funding and initiatives?

SEP funding provides consistent, direct support to state governments to enable effective long-term planning for clean energy and energy security, of which manufacturing and supply chains are a critical component. As the U.S. looks to strengthen its energy sector industrial base (ESIB), sustained and strategic regional planning efforts will be paramount. Since SEP provides regular block funding to states every year and has enjoyed decades of bipartisan support and a strong evidence base of success, a reauthorized SEMP can ensure that state, local, and Tribal governments have the tools they need to plan effectively over the long haul. While coordination with EDA technical assistance, public works, and other programs will be important, EDA provides more project-based funding at the local level, operates on shorter timeframes, and may or may not be ESIB-oriented.

Are state energy offices likely to be enthusiastic about expanded support?

The cost-shared structure of SEMP ensures that states are committed to the projects they undertake, and the historically high leverage ratio of federal to non-federal funds, sustained under a major funding influx through ARRA, suggests that states have an interest in more robust state energy planning and project development, and are therefore likely to welcome additional support. This extends to private actors as well. According to a 2015 program evaluation, “A number of studies of SEP activities have found that sponsors of ratepayer-funded programs collaborated closely with state energy offices to leverage their own resources, especially with the influx of ARRA funding. This means that, ‘in the absence of the program, the array of resources available to market actors in the [programmatic activity] would have been reduced not only by the absence of the SEP [programmatic] activities, but by a reduction in the level of resources available from other program sponsors.”

Eliminating Childhood Lead Poisoning Worldwide

An estimated 815 million children (one in three) around the globe have dangerous levels of lead in their bloodstream, levels high enough to cause irreversible brain damage and impose severe health, economic, and societal consequences. 96% of these children live in low- and middle-income countries (LMICs), where collectively only about $6–10 million from non-governmental organizations is available each year to address the problem. To help eliminate childhood lead poisoning worldwide, the U.S. Federal Government should (1) add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey Program, (2) create a Grand Challenge for Development to end childhood lead poisoning, and (3) push forward a global treaty on lead control.

Challenge and Opportunity

Lead is a potent toxin that causes irreversible harm to children’s brains and vital organs. Elevated body lead levels result in reduced intelligence, lower educational attainment, behavioral disorders, violent crime, reduced lifetime earnings, anemia, kidney disease, and cardiovascular disease. Impacts of lead on cognitive development are estimated to cause nearly $1 trillion of income loss in LMICs annually. Adverse health effects related to lead poisoning account for 1% of the global disease burden, causing 1 million deaths annually and substantial disability.

This enormous burden of lead poisoning in LMICs is preventable. It results from a combination of sources of exposure, some of the most important being:

These sources of lead exposure have been effectively regulated in the United States and other high-income countries, which have seen average blood lead levels in their populations decline dramatically over the last 40 years. To achieve the same success, LMICs will need to prioritize policies such as:

LMICs generally face three major barriers to implementing such policies:

  1. Lack of data on blood lead levels and on the scale and severity of lead poisoning. Most LMICs have no studies measuring blood lead levels. Policymakers are therefore unaware of the extent of the problem and hence unlikely to act in response. 
  2. Lack of data on which sources of lead exposure are the biggest local contributors. Causes of lead poisoning vary spatially, but the vast majority of LMICs have not conducted source-apportionment studies. This makes it difficult to prioritize the most impactful policies. 
  3. Limited access to equipment needed to detect lead in paint, spices, water, other sources, or the environment. Without needed detection capabilities, regulators cannot investigate the lead content of potential sources, nor can they monitor and enforce regulation of known sources. 

These barriers are relatively simple to overcome, and when they are overcome do indeed result in action. As an example, at least 20 LMICs introduced legally binding lead paint regulation after the Global Alliance to Eliminate Lead Paint and its partners helped those countries confirm that lead paint was an important source of lead poisoning. Moreover, addressing childhood lead poisoning is in line with the priorities of the Biden Administration and the U.S. Agency for International Development (USAID). The Administration has already proposed an ambitious $15 billion plan to address childhood lead poisoning in the United States by eliminating lead pipes and service lines. By contributing to global elimination efforts (for only a fraction of what it will cost to solve the problem domestically), the Administration can multiply its impact on reducing childhood lead poisoning. Doing so would also advance USAID’s mission of “advanc[ing] a free, peaceful, and prosperous world”, since a reduction in childhood lead poisoning worldwide would improve health, strengthen economies, and prevent crime and conflict.

Plan of Action

Lead poisoning, from a variety of sources, affects one in three children worldwide. This is an unacceptable situation that demands action. The United States should adopt a three-part roadmap to help LMICs implement and enforce policies needed to achieve global elimination of childhood lead poisoning. 

Recommendation 1. Add blood lead level (BLL) testing to the USAID-led Demographic and Health Survey. 

USAID, through its Demographic and Health Survey (DHS), is in an ideal position to address the first barrier that LMICs face to implementing anti-lead poisoning policies: lack of data and awareness. The DHS collects, analyzes, and disseminates accurate and representative data on health in over 90 countries. Including BLL testing in the DHS would:

As such, USAID should add BLL testing of children into the DHS Biomarker Questionnaire for all host countries. This could be done in DHS revision for Phase 9, beginning in 2023. Including BLL testing in the DHS is also the first step to addressing the second barrier that LMICs face: lack of data on sources of lead exposure. BLL data collected through the DHS would reveal which countries and populations have the greatest lead burdens. These data can be leveraged by researchers, governments, and NGOs to investigate key sources of lead exposure.

BLL testing of children is feasible to carry out in the context of the DHS. It was successfully piloted in 1998 and 2002 via the DHS presence in India and Uzbekistan, but not rolled out further. Testing can be carried out using finger-stick capillary sampling and portable analyzers, so venipuncture and laboratory analysis are not required. Further, such testing can be carried out by health technicians who are already trained in capillary blood testing of children for anemia as part of the DHS. The testing can be conducted while questionnaires are administered, and results and any follow-up actions can be shared with the parent/guardian immediately. Alternatively, laboratory lead tests can be added onto sample analysis if blood draws are already being taken. Costs are low in both cases, estimated at around $10 per test. 

Recommendation 2. Create a Grand Challenge for Development to end childhood lead poisoning.

Childhood lead poisoning in LMICs is dramatically neglected relative to the scale of the problem. Though childhood lead poisoning costs LMICs nearly $1 trillion annually and accounts for 1% of the global disease burden, only about $6–10 million per year is dedicated to addressing the problem. A USAID-led Grand Challenge for Development to end childhood lead poisoning would mobilize governments, companies, and foundations around generating and implementing solutions. In particular, the Challenge should encourage solutions to the second and third barriers presented above: lack of data on sources of lead exposure and limited detection capacity. 

Recommendation 3. Push forward a global treaty on lead control.

A global push is needed to put childhood lead poisoning on the radar of decision-makers across the world and spur implementation and enforcement of policies to address the issue. The Biden Administration should lead an international conference to develop a global treaty on lead control. Such a treaty would set safe standards for lead in a variety of products (building on the Global Alliance to Eliminate Lead Paint’s toolkit for establishing lead-paint laws) and recommend regulatory measures to control sources of lead exposure. The success of the UN’s Partnership for Clean Fuels and Vehicles in bringing about global elimination of leaded gasoline illustrates that international political will to act can indeed be generated around lead pollution. 

Conclusion

By implementing this three-part roadmap the Biden administration and USAID can make a historic and catalytic contribution towards global elimination of lead poisoning. There is true urgency; the problem becomes harder to solve each year as more lead enters the environment where it will remain a source of exposure for decades to come.  Acting now will improve the health, wellbeing and potential of hundreds of millions of children. 

Frequently Asked Questions
How do we know that childhood lead poisoning is a global problem if there is very little data on it?

Though relatively little investigation has been done on childhood lead poisoning in LMICs, the studies that do exist have consistently shown very high levels of lead poisoning. A recent systematic reviewidentified studies of background levels of childhood lead exposure in 34 LMICs. According to the review, “[o]f the 1.3 billion children (aged 0–14 years) living in the 34 LMICs with acceptable data on background blood lead levels in children, approximately 632 million…were estimated to have a level exceeding the CDC [Centers for Disease Control and Prevention] reference value of 5 μg/dL, and 413 million…were estimated to exceed the previous reference value of 10 μg/dL.” Data collected by the Institute of Health Metrics and Evaluation and analyzed in a joint UNICEF/Pure Earth report published in 2020 similarly concluded that dangerously elevated BLLs affect over 800 million children worldwide.

Why are levels of lead poisoning so high in LMICs and what are the sources?

Major sources of lead poisoning in LMICs include paint, spices, cookware, pottery, pipes, cosmetics, toys, unsafe lead-acid battery recycling, unsafe e-waste recycling, and poorly controlled mining and smelting operations. High-income countries like the United States have relatively low levels of lead poisoning due to strong regulations around these sources of lead poisoning. Most high-income countries have, for instance, banned lead in gasoline and paint, set enforceable standards around the lead content of water, and imposed strong regulations around food adulteration. As a result, median BLLs in high-income countries have declined dramatically (in the United States, from 15ug/dL in the 1970s to <1µg/dL today). LMICs generally lack many of these effective controls around lead exposure and therefore have very high levels of childhood lead poisoning.

What policies and interventions need to be in place in LMICs to eliminate childhood lead poisoning?

The most important thing that can be done to tackle the scourge of childhood lead poisoning is to impose source controls that prevent lead from entering the environment or consumer products. Though the relative contributions of different sources to childhood lead poisoning differ by country, effective policies and interventions tend to include:



  • Regulations limiting the lead content of paint available on the market.



  • Regulation of lead-acid battery and e-waste recycling practices.



  • Inclusion of lead parameters in national drinking-water-quality standards.



  • Regulation of the use of lead compounds in other locally important sources, such as spices, ceramics, cookware, toys, and cosmetics. 


To enforce these policies, LMICs need testing capacity sufficient to monitor lead levels in potential exposure sources and in the environment. LMICs also need BLL monitoring to track the impact of policies and interventions. Fully eliminating childhood lead poisoning will ultimately involve abatement: i.e., removing lead already in the environment, such as by taking off lead paint already on walls and by replacing lead pipes. However, these interventions are extremely costly, with much lower impact per dollar than preventing lead from entering the environment in the first place.

Why is global childhood lead poisoning such a neglected issue despite its enormous scale?

An extreme lack of awareness, lack of data, and lack of advocacy around childhood lead poisoning in LMICs has created a vicious cycle of inattention. A large part of the problem is that lead poisoning is invisible. Unlike a disease like malaria, which causes characteristic cyclical fevers that indicate their cause, the effects of lead poisoning are more difficult to trace back.

Deploy a National Network of Air-Pollution and CO2 Sensors in 300 American Cities by 2030

Summary

The Biden-Harris Administration should deploy a national network of low-cost, co-located, real-time greenhouse gas (GHG) and air-pollution emission sensors in 300 American cities by 2030 to help communities address environmental inequities, combat global warming, and improve public health. Urban areas contribute more than 70% of total GHG emissions. Aerosols and other byproducts of fossil-fuel combustion — the major drivers of poor air quality — are emitted in huge quantities alongside those GHGs. A “300 by ‘30” initiative establishing a national network of local, ground-level sensors will provide precise and customized information to drive critical climate and air-quality decisions and benefit neighborhoods, schools, and businesses in communities across the nation. Ground-level dense sensor networks located in community neighborhoods also provide a resource that educators can leverage to engage students on co-created “real-time and actionable science”, helping the next generation see how science and technology can contribute to solving our country’s most challenging issues.

Challenge and Opportunity

U.S. cities contribute 70% of our nation’s GHG emissions and have more concentrated air pollutants that harm neighborhoods and communities unequally. Climate change profoundly impacts human health and wellbeing through drought, wildfire, and extreme-weather events, among numerous other impacts. Microscopic air pollutants, which penetrate the body’s respiratory and circulatory systems, play a significant role in heart disease, stroke, lung cancer, and asthma. These diseases collectively cost Americans $800 billion annually in medical bills and result in more than 100,000 Americans dying prematurely each year. Also, health impacts are experienced more acutely for certain communities. Some racial groups and poorer households, especially those located near highways and industry, face higher exposure to harmful air pollutants than others, deepening health inequities across American society. 

GHG emissions and ground-level air pollution are both negative products of fossil-fuel combustion and are inextricably linked. But our nation lacks a comprehensive approach to measure, monitor, and mitigate these drivers of climate change and air pollution. Furthermore, key indicators of air quality — such as ground-level pollutant measurements — are not typically considered alongside GHG measurements in governmental attempts to regulate emissions. A coordinated and data-driven approach across government is needed to drive policies that are ambitious enough to simultaneously and equitably tackle both the climate crisis and worsening air-quality inequities in the United States.

Technologies that are coming down in cost enable ground-level, real-time, and neighborhood-scale observations of GHG and air-pollutant levels. These data support cost-effective mapping of carbon dioxide (CO2) and air-quality related emissions (such as PM2.5, ozone, CO, and nitrogen oxides) to aid in forecasting local air quality, conducting GHG inventories, detecting pollution hotspots, and assessing the effectiveness of policies designed to reduce air pollution and GHG emissions. The result can be more successful, targeted strategies to reduce climate impacts, improve human health, and ensure environmental equity.

Pilot projects are proving the value of hyper-local GHG and air-quality sensor networks. Multiple universities, philanthropies, and nongovernmental organizations (NGOs) have launched pilot projectsdeploying local, real-time GHG and air-pollutant sensors in cities including Los Angeles, New York City, Houston, TX, Providence, RI, and cities in the San Francisco Bay Area. In the San Francisco Bay Area, for instance, a dense network of 70 sensors enabled researchers to closely investigate how movement patterns changed as a result of the COVID-19 pandemic. Observations from local air-quality sensors could be used to evaluate policies aimed at increasing electric-vehicle deployment, to demonstrate how CO and NOx emissions from vehicles change day to day, and to prove that emissions from heavy-duty trucks disproportionately impact lower-income neighborhoods and neighborhoods of color. The federal government can and should incorporate lessons learned from these pilot projects in designing a national network of air-quality sensors in cities across the country. 

Components of a national air-quality sensor network are in place. On-the-ground sensor measurements provide essential ground-level, high-spatial-density measurements that can be combined with data from satellites and other observing systems to create more accurate climate and air-quality maps and models for regions, states, and the country. Through sophisticated computational models, for instance, weather data from the National Oceanic and Atmospheric Administration (NOAA) are already being combined with existing satellite data and data from ground-level dense sensor networks to help locate sources of GHG emissions and air-pollution in cities throughout the day and across seasons. The Environmental Protection Agency (EPA) is working on improving these measurements and models by encouraging development of standards for low-cost sensor data. Finally, data from pilot projects referenced above is being used on an ad hoc basis to inform policy. Data showing that CO2 emissions from the vehicle fleet are decreasing faster than expected in cities with granular emissions monitoring are that policies designed to reduce GHG emissions are working as or better than intended. Federal leadership is needed to bring the impacts of such insights to scale on larger and even more impactful levels.

A national network of hyper-local GHG and air-quality sensors will contribute to K–12 science curricula. The University of California, Berkeley partnered with the National Aeronautics and Space Administration (NASA) on the GLOBE educational program. The program provides ideas and materials for K–12 activities related to climate education and data literacy that leverage data from dense local air-quality sensor networks. Data from a national air-quality sensor network would expand opportunities for this type of place-based learning, motivating students with projects that incorporate observations occurring on the roof of their schools or nearby in their neighborhoods to investigate the atmosphere, climate, and use of data in scientific analyses.Scaling a national network of local GHG and air-quality sensors to include hundreds of cities will yield major economies of scale. A national air-quality sensor network that includes 300 American cities — essentially, all U.S. cities with populations greater than 100,000 — will drive down sensor costs and drive up sensor quality by growing the relevant market. Scaling up the network will also lower operational costs of merging large datasets, interpreting those data, and communicating insights to the public. This city-federal collaboration would provide validated data needed to prove which national and local policies to improve air quality and reduce emissions work, and to weed out those that don’t. 

Plan of Action

The National Oceanic and Atmospheric Administration (NOAA), in partnership with the Bureau of Economic Analysis, the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), the National Aeronautics and Space Administration (NASA), the National Institute of Standards and Technology (NIST), and the National Science Foundation (NSF) should lead a $100 million “300 by ’30: The American City Urban Air Challenge” to deploy low-cost, real-time, ground-based sensors by the year 2030 in all 300 U.S. cities with populations greater than 100,000 residents.

The initiative could be organized and managed by region through an expanded NOAA Regional Collaboration Network, under the auspices of NOAA’s Office of Oceanic and Atmospheric Research. NOAA is responsible for weather and air-quality forecasting and already manages a large suite of global CO2 and global air-quality-related observations along with local weather observations. In a complementary manner, the “300 by ‘30” sensor network would measure CO2, CO (carbon monoxide), NO (nitric oxide), NO2 (nitrogen dioxide), O3 (ozone), and PM2.5 (particulate matter down to 2.5 microns in size) at the neighborhood scale. “300 by ‘30” network operators would coordinate data integration and management within and across localities and report findings to the public through a uniform portal maintained by the federal government. Overall, NOAA would coordinate sensor deployment, network integration and data management and manage the transition from research to operations. NOAA would also work with NIST and EPA to provide uniform formats for collecting and sharing data.

Though NOAA is the natural agency to lead the “300 by ‘30” initiative, other federal agencies can and should play key supporting roles. NSF can support new approaches to instrument design and major innovations in data and computational science methods for analysis of observations that would transition rapidly to practical deployment. NIST can provide technical expertise and leadership in much-needed standards-setting for GHG measurements. NASA can advance the STEM-education portion of this initiative (see below), showing educators and students how to observe GHGs and air quality in their neighborhoods and how to link ground-level observations to observations made from space. NASA can also work with NOAA to merge high-density ground-level and wide-area space-based datasets. BEA can develop local models to provide the nonpartisan, nonpolitical economic information cities will need to inform urban air-policy decisions triggered by insights from the sensor network. Similarly, the EPA can help guide cities in using climate and air-quality information from the sensor network. The CDC can use network data to better characterize public-health threats related to climate change and air pollution, as well as to coordinate responses with state and local health officials. 

The “300 by ‘30” challenge should be deployed in a phased approach that (i) leverages lessons learned from pilot projects referenced above, and (ii) optimizes cost savings and efficiencies from increasing the number of networked cities. Leveraging its Regional Collaboration Network, NOAA would launch the Challenge in 2023 with an initial cohort of nine cities (one in each of NOAA’s nine regions). The Challenge would expand to 25 cities by 2024, 100 cities by 2027, and all 300 cities by 2030. The Challenge would also be open to participation by states and territories whose largest cities have populations less than 100,000.

The challenge should also build on NASA’s GLOBE program to develop and share K–12 curricula, activities, and learning materials that use data from the sensor network to advance climate education and data literacy and to inspire students to pursue higher education and careers in STEM. NOAA and NSF could provide additional support in promoting observation-based science education in classrooms and museums, illustrating how basic scientific observations of the atmosphere vary by neighborhood and collectively contribute to weather, air-quality, and climate models.

Frequently Asked Questions
Has something like the “300 by ‘30” initiative been tried before?

Recent improvements in sensor technologies are only now enabling the use of dense mesh networks of sensors to precisely pinpoint levels and sources of GHGs and air pollutants in real time and at the neighborhood scale. Pilot projects in the San Francisco Bay Area, Los Angeles, Houston, Providence, and New York City have proven the value of localized networks of air-quality sensors, and have demonstrated how data from these sensors can inform emissions-reductions policies. While individual localities, states, and the EPA are continuing to support pilot projects, there has never been a national effort to deploy networked GHG and air-quality sensors in all of the nation’s largest cities, nor has there been a concerted effort to link data collected from such sensors at scale.

If the proposed sensor networks will be inherently local, then why does the federal government need to get involved?

Although urban areas are responsible for over 70% of national GHG emissions and over 70% of air pollution in urban environments, even cities with existing policy approaches to GHGs and air quality lack the information to rapidly evaluate whether their emissions-reduction policies are effective. Further, COVID-19 has impacted local revenue, strained municipal budgets, and has understandably detracted attention from environmental issues in many localities. Federal involvement is needed to (i) give cities the equipment, data, and support they need to make meaningful progress on emissions of GHGs and air pollutants, (ii) coordinate efforts and facilitate exchange of information and lessons learned across cities, and (iii) provide common standards for data collection and sharing.

Is there precedent for this initiative in other countries?

A pilot project including a 20-device sensor network was led by U.S. scientists and developed for the City of Glasgow, Scotland as a demonstration for the COP26 climate conference. The City of Glasgow is an active partner in efforts to expand sensor networks, and is one model for how scientists and municipalities can work together to develop needed information presented in a useful format.

Where will the sensors come from?

Sensors appropriate for this initiative can be manufactured in the United States. A design for a localized network air-quality sensors the size of a shoe box has been described in freely available literature by researchers at the University of California, Berkeley. Domestic manufacture, installation, and maintenance of sensors needed for a national monitoring network will create stable, well-paying jobs in cities nationwide.

Which organizations are already working in this space?

Leading scientific societies Optica (formerly OSA) and the American Geophysical Union (AGU) are spearheading the effort to provide “actionable science” to local and regional policymakers as part of their Global Environmental Measurement & Monitoring (GEMM) Initiative. Optica and AGU are also exploring opportunities with the United Nations Human Settlements Program (UN-Habitat) and the World Meteorological Organization (WMO) to expand these efforts. GHG- and air-quality-measurement pilot projects referenced above are based on the BEACO2N Network of sensors developed by University of California, Berkeley Professor Ronald Cohen.

What about methane

Creating a Judicial Innovation Fellowship to Strengthen America’s Court Infrastructure and Improve Access to Justice

Summary

People in the United States face a persistent gap in access to justice. Complex and outdated processes of the judicial system and court administration present significant barriers for individual litigants, who are, for the most part, poor and not represented by lawyers. Unfortunately, despite a willingness to innovate, court administrators often lack budget, staff, or time to address underlying technical challenges effectively.

To overcome these issues, Congress should create and fund a Judicial Innovation Fellowship that brings experienced technologists and service designers into state, tribal, and federal courts to improve judicial administration, transparency, and access to justice. Like programs in the U.S. federal executive and legislative branches (such as the United States Digital Service and Tech Congress), the Judicial Innovation Fellowship will embed mid-career technology professionals for “tours of duty” in state, tribal, and federal judiciaries. The Fellowship will bring much-needed talent and resources to America’s underfunded courts, creating a multiplier effect that will increase the quality of justice in the United States. 

Challenge and Opportunity

Technical shortcomings of state courts exacerbate twin national crises: (1) the access-to justice-gap, and (2) mass incarceration. Each year across the United States, 55 million Americans experience 260 million civil legal problems—including issues with eviction, consumer debt, domestic violence, veterans’ benefits, disability access, and health care—with little to no support. 86% of low-income individuals facing a legal problem receive inadequate or no civil legal help. This is the justice gap. Meanwhile, an average of 630,000 people sit in pretrial detention every day. We know very little about this population, including to what extent pretrial detention is merited. In addition to representing a moral failure, unresolved legal issues can cause medical problems and lost wages or employment. Such issues cost the United States nearly 1.5% of GDP every year. 

These problems have gotten worse over the past decade. The World Justice Project, which tracks the rule of law, has shown that Americans’ ability to access counsel declined from 2010 to 2020. State and federal courts have long faced accessibility and backlog challenges that have deferred, if not denied, access to justice for those who seek help. The COVID-19 pandemic has exacerbated the issue, with states around the country facing unprecedented delays of civil and criminal hearings. Federal courts have also faced problematic delays and “staggering” caseloads as a result of the pandemic. While many courts have shown impressive flexibility and creativity in adopting new technologies—sometimes on the fly during the pandemic—there remains a significant need to rethink and redesign fundamental aspects of court procedures and tools to meaningfully improve court administration. 

Indeed, shortcomings in court technology and data clearly exacerbate the access-to-justice gap and hinder court administration. For example, collection, storage, and sharing of data related to trials and courts is limited and piecemeal around the country. This means that there are not reliable numbers on the use of bail in criminal matters or self-represented litigants in civil court, making informed decision making and analysis nearly impossible. Increased need for digital court contact during the pandemic has also created new technical challenges for electronic filing, real-time translation, and security.

Courts are aware of the need for improved data and technology. The federal judiciary’s September 2020 Strategic Plan made “harnessing technology’s potential” a priority, including “develop[ing], operat[ing], and secur[ing] cost-effective national and local systems and infrastructure. State courts have underscored their commitment to achieving “100% effective assistance for essential civil legal needs“ and set forth a “tactical plan for technology“ to improve court functioning. Accomplishing these goals will require a comprehensive national effort to attract and nurture a technical talent pipeline to the judiciary. 

The state and federal judiciaries have in-house IT staff to manage legacy court systems [e.g., the federal judiciary’s case management/electronic case files (CM/ECF system)] and networks. To date, however, there have been only a few examples of programs to systematically bring new technology and design talent into the judiciary. One such effort is the American Association for the Advancement of Science (AAAS)’s Judicial Branch Fellowship. This program “allows an accomplished scientist or engineer to contribute their scientific and technical expertise to federal judicial administration and case management.” The program supports one to two fellows each year in serving as a resource for the staff of the Federal Judicial Center. AAAS Judicial Branch Fellows have tackled legal issues involving technology as well as courthouse technology directly. For example, one fellowfocused on the accessibility of courts and court records for individuals with disabilities. Other fellows developed resources for judges on neuroscience and empirical research on how court rules impact litigants’ behavior. Though impactful, the AAAS Judicial Branch Fellowship remains modest in scale and there have not yet been any efforts to replicate or expand it. 

There have been similarly few efforts to bring new technology and design talent into state and tribal judiciaries. In 2018, the Judicial Council of California hired service designers to conduct a research project to improve digital services for self-represented civil litigants. As a part of this project, the team observed and interviewed self-represented litigants, court staff, courtrooms, and attorneys to understand needs and how to design solutions to improve the process for self-represented litigants. At Sacramento State University, the Center for California Studies’ Judicial Fellowship Program has helped superior courts throughout California adopt self-help tools to aid litigants during the COVID-19 crisis, including live-chat functionality and video appearances. In August 2020, the Utah Supreme Court launched the Office of Legal Services Innovation Office to support its innovation sandbox, a program designed to foster experimentation in the delivery of legal services in the state. Again, these examples showcase the promise of concerted efforts to advance judicial use of data and technology but have not been meaningfully integrated or scaled.

In contrast, both the executive and legislative branches have developed and deployed effective models for government innovation. In 2012, President Obama launched the Presidential Innovation Fellows (PIFs), a program managed by the General Services Administration (GSA) that recruits innovators from outside of government for one-year “tours of duty” within federal agencies to develop and launch innovative projects. The Obama-era White House later established the U.S. Digital Service (USDS) and 18F to serve as permanent technology units within the Executive Office of the President and GSA, respectively. In August 2021, the Biden Administration announced a U.S. Digital Corps through which early-career technologists join the federal government for two-year “tours of duty” within federal agencies.  Digital Corps is designed to complement the work of USDS, 18F, and the PIFs. 

The federal legislative branch similarly welcomes external talent for limited “tours of duty” through the Congressional Innovation Fellows (CIF) program run by TechCongress, a non-governmental effort. While CIF, like PIF, embeds mid-career technologists into the federal government, the former effort is intended to help “Congress aim for more informed decisions regarding technology and policy by allowing Congress to gain technical insight.” In effect, CIFs are policy advisors whereas PIFs are process innovators. The upshot is that programs like these can deliver impact through multiple avenues. The CIF, PIF, USDS, and 18F models provide a useful roadmap for similarly ambitious innovation initiatives in the judiciary. 

Plan of Action

Congress should fund a federal Judicial Innovation Fellowship (JIF) program with a primary responsibility of improving and maintaining our national judicial digital infrastructure—the data, technology, processes, and talent at the heart of the U.S. justice system. Funding will support both a permanent staff to ensure long-term sustainability and ownership of projects, as well as rotating fellows (technologists and designers motivated by working for the public interest) to bring fresh ideas and energy to judicial innovation both during and after their formal engagement in the JIF program. 

The JIF program, like the PIF and CIF programs, will comprise a one- or two-year “tour of duty” in the federal or state judiciary. During this time, the fellows will receive training in justice issues and court administration and will be embedded in federal and state court administrative offices to assist permanent staff and leverage leading-edge practices and technology to improve judicial workflows and expand equitable access to justice. Fellows will meet with each other once a month to share experiences and exchange feedback on their work. Fellowship managers will also meet with fellows one-on-one to check in on experiences and to provide support to fellows and the cohort at large. In the long term, the JIF program will provide a “pathway to permanence” for high-performing fellows to continue to work within the judiciary. A two-year pilot JIF program will cost $3 million to administer, a cost that includes salary for ten fellows and two permanent program staff, training, travel, and administrative costs.

Like the PIF and CIF programs, the JIF program will target mid-career professionals with design, data, technology, and product expertise. Most fellows will be housed in the local administrative offices for the specific courts where they are serving. Some fellows will serve from a state or federal central office (e.g., the Administrative Office of the U.S. Courts). Placing talent at both the federal and state levels will differentiate the JIF program from the PIF and CIF programs, which are federal programs that feed federal agencies and Congressional offices, respectively. 

Just as mid-career professionals will apply to serve as JIFs, courts and offices will apply to host JIFs. Applications will identify needs for process or technology improvements to advance public access to justice, equity, and court administration, and outline specific projects for JIFs to work on. Selected proposals will be honed with the help of the JIF program’s permanent staff. After a JIF is placed, staff at the hosting court or office will work closely with the JIF throughout the design, development, and deployment process of any proposed solutions. Initially, at least, we expect that JIFs will primarily support court administrative offices (e.g., clerks of the court or chief information officers) by: 

By focusing on these core issue areas, courts will be better suited to meet existing and emerging challenges. They will have better data to inform more effective administration themselves, tools to assist self-represented litigants, fresh perspectives to help close the yawning justice gap, and more. 

We propose launching the JIF program with an initial two-year pilot in partnership with at least three state courts. Courts will be picked based on their project proposals, capacity to host fellows, and ability to manage fellowship projects after the placement is complete. During the pilot, an inaugural team of fellows will work alongside existing court staff to prototype and implement an achievable project, to be memorialized in a final report and playbook. Due to limited resources within the judiciary, we expect that this initial pilot will be managed within a university center, non-governmental organization, or foundation, and funded by private foundations or non-governmental organizations. 

The pilot will be used to refine and support expansion of the JIF program, including by hiring a larger permanent staff and growing the fellowship class. In time, the JIF program will serve as a core pillar of a nationwide judicial innovation strategy to ensure a robust, secure judicial infrastructure that significantly improves access to justice well into the future. 

Conclusion

The ongoing coronavirus pandemic has significantly exacerbated a growing access-to-justice gap within America’s judicial infrastructure. Overcoming this gap calls for a bold and long-term solution. A Judicial Innovation Fellowship program would drive technology and design talent to state, tribal, and federal judiciaries—and in so doing, would create a novel talent pipeline to help our courts tackle their most pressing justice issues. 

Frequently Asked Questions
Why should JIF be federally administered and funded?

The justice crisis is a national crisis that requires an organized, national response. There is precedent for a program like the JIF program. The Legal Services Corporation and the State Justice Institute were created by Congress so that federal funding and technical support could be shared with state and local justice agencies. Doing so centralizes administration, which builds procedures and institutional knowledge that can be shared across jurisdictions while streamlining overhead costs.

Where will the Judicial Innovation Fellowship be housed?

For the pilot phase of the program, we propose that the Judicial Innovation Fellowship be located within an existing university center that focuses on civic technology and access to justice.


After the pilot phase, the Judicial Innovation Fellowship could be stationed within the Administrative Office of the Courts (AO) or spun out as an independent nonprofit with Congressional support, like the Legal Services Corporation. JIFs will typically be stationed within administrative offices of state, tribal, and federal courts, working closely with court staff on their innovation projects. If a fellow is working on a cross-court project (e.g., developing standards), it may be more appropriate for the fellow to be stationed at the AO rather than at a specific court administrative office.

Why focus on state, tribal, and federal courts? Why not just choose one?

The national access-to-justice crisis requires coordinated action at all levels of the judiciary. While many of the most pressing justice issues arise at the state-court level, many important legal issues also arise at the federal level (e.g., immigration, civil rights, and criminal justice). A comprehensive approach to advance innovation across federal, state, and tribal courts, will (1) enable coordinated sharing of best practices and solutions across courts, (2) ensure that no court is left behind and that all have access to tech talent, and (3) consider cross-jurisdictional solutions where appropriate.

How much will the Judicial Innovation Fellowship program cost?

We estimate that the two-year pilot will cost $3 million. Most of the budget will cover two full-time staff and up to eight fellows. We estimate that annual per-fellow salary will be approximately $150,000, a level on par with PIF salaries. Once the program is fully established, we anticipate an annual budget of $10 million.

Would launching the JIF program require new legislation?

A pilot JIF program could be launched without new federal or state legislation. However, federal funding appropriated directly for JIFs through legislation would support a more durable and robust program.

How will courts interested in supporting JIFs be identified?

Several federal and state courts have already taken particularly forward-thinking approaches to innovation. At the federal level, these include the U.S. Courts for the Northern District of California and for the Southern District of Texas. At the state level, these include the judiciaries of Arizona, California, Michigan, Texas, and Utah. We propose engaging with chief justices and clerks of these courts as likely early supporters of the JIF program.


A key lesson from the PIF program is that innovation fellows—particularly those from outside traditional political and legal fields—must have support from and access to agency decision-makers in order to achieve their goals. Assigning fellows to placements where their reception is lukewarm at best is a recipe for failure. To that end, we recommend establishing a formal process for courts to request JIF support—a request that would include a commitment to work collaboratively with any JIFs placed in their offices. Courts should also be encouraged by JIF program staff to take a co-leading role in defining priorities for assigned JIFs and to take a co-development role once a JIF-managed project is underway.

How might funding and resources be secured to sustain the JIF program for the long term?

There are a number of potential public and private sources of funding for the JIF program. Public funding would be best secured through dedicated Congressional appropriations. This public funding could then attract private funding from grant-making foundations. Universities could also support the JIF program through in-kind support (e.g., training) provided through law schools such as those at Stanford University and Georgetown University, both of which have strong technology and access-to-justice programs.

How would JIFs be selected?

The JIF program would source applicants from government, universities, and the private sector. The best applicants would be mid-career technology or service-design professionals with a passion for improving access to justice and strong technology or design skills. We will also solicit good practices for fellow recruitment from leaders behind other, similar innovation fellowship programs.

How would fellows be effectively onboarded so that they understand court culture and legal, financial, and institutional constraints?

The JIF program would provide structured training to all accepted fellows. The training would draw on key texts in court innovation, judges, and court reform leaders, and would include an overview of the U.S. judicial system (in particular, the functioning and administration of U.S. courts). Fellows would also receive training tailored to the court or office to which they are assigned, (e.g., information about court- and office-specific court issues and rules).

How can the JIF program promote sharing and reuse of solutions across courts?

The JIF program will need to be built for sustainability and transferability across jurisdictions, while recognizing and accounting for local differences. To that end, the program will ensure support from and collaboration with institutional decision makers, commit to open-source projects and open-access procedures, and allow for sufficient flexibility and independence to work creatively while prioritizing regular communication between fellows, JIF leadership, and court stakeholders.

Piloting and Evaluating NSF Science Lottery Grants: A Roadmap to Improving Research Funding Efficiencies and Proposal Diversity

This memo was jointly produced by the Federation of American Scientists & the Institute for Progress

Summary

The United States no longer leads the world in basic science. There is growing recognition of a gap in translational activities — the fruits of American research do not convert to economic benefits. As policymakers consider a slew of proposals that aim to restore American competitiveness with once-in-a-generation investments into the National Science Foundation (NSF), less discussion has been devoted to improving our research productivity — which has been declining for generations. Cross-agency data indicates that this is not the result of a decline in proposal merit, nor of a shift in proposer demographics, nor of an increase (beyond inflation) in the average requested funding per proposal, nor of an increase in the number of proposals per investigator in any one year. As the Senate’s U.S. Innovation and Competition Act (USICA) and House’s America COMPETES Act propose billions of dollars to the NSF for R&D activities, there is an opportunity to bolster research productivity but it will require exploring  new, more efficient ways of funding research. 

The NSF’s rigorous merit review process has long been regarded as the gold standard for vetting and funding research. However, since its inception in the 1950s, emergent circumstances — such as the significant growth in overall population of principal investigators (PIs) — have introduced a slew of challenges and inefficiencies to the traditional peer-review grantmaking process: The tax on research productivity as PIs submit about 2.3 proposals for every award they receive and spend an average of 116 hours grant-writing per NSF proposal (i.e., “grantsmanship”), corresponding to a staggering loss of nearly 45% of researcher time; the orientation of grantsmanship towards incremental research with the highest likelihood of surviving highly-competitive, consensus-driven, and points-based review (versus riskier, novel, or investigator-driven research); rating bias against interdisciplinary research or previously unfunded researchers as well as reviewer fatigue. The result of such inefficiencies is unsettling: as fewer applicants are funded as a percentage of the increasing pool, some economic analysis suggests that the value of the science that researchers forgo for grantsmanship may exceed the value of the science that the funding program supports.

Our nation’s methods of supporting new ideas should evolve alongside our knowledge base.

Our nation’s methods of supporting new ideas should evolve alongside our knowledge base. Science lotteries — when deployed as a complement to the traditional peer review grant process — could improve the systems’ overall efficiency-cost ratio by randomly selecting a small percentage of already-performed, high quality, yet unfunded grant proposals to extract value from. Tested with majority positive feedback from participants in New Zealand, Germany, and Switzerland, science lotteries would introduce an element of randomness that could unlock innovative, disruptive scholarship across underrepresented demographics and geographies. 

This paper proposes an experimental NSF pilot of science lotteries and the Appendix provides illustrative draft legislation text. In particular, House and Senate Science Committees should consider the addition of tight language in the U.S. Innovation and Competition Act (Senate) and the America COMPETES Act (House) that authorizes the use of “grant lotteries” across all NSF directorates, including the Directorate of Technology and Innovation. This language should carry the spirit of expanding the geography of innovation and evidence-based reviews that test what works.

Challenge and Opportunity

A recent NSF report pegged the United States as behind China in key scientific metrics, including the overall number of papers published and patents awarded. The numbers are sobering but reflect the growing understanding that America must pick which frontiers of knowledge it seeks to lead. One of these fields should be the science of science — in other words not just what science & technology innovations we hope to pursue, but in discovering new, more efficient ways to pursue them. 

Since its inception in 1950, NSF has played a critical role in advancing the United States’ academic research enterprise, and strengthened our leadership in scientific research across the world. In particular, the NSF’s rigorous merit review process has been described as the gold standard for vetting and funding research. However, growing evidence indicates that, while praiseworthy, the peer review process has been stretched to its limits. In particular, the growing overall population of researchers has introduced a series of burdens on the system. 

One NSF report rated nearly 70% of proposals as equally meritorious, while only one-third received funding. With a surplus of competitive proposals, reviewing committees often face tough close calls. In fact, empirical evidence has found that award decisions change nearly a quarter of the time when re-reviewed by a new set of peer experts. In response, PIs spend upwards of 116 hours on each NSF proposal to conform to grant expectations and must submit an average of 2.3 proposals to receive an award — a process known as “grantsmanship” that survey data suggests occupies nearly 45% of top researchers’ time. Even worse, this grantsmanship is oriented towards writing proposals on incremental research topics (versus riskier, novel, or investigator-driven research) which has a higher likelihood of surviving a consensus-driven, points-based review. On the reviewer side, data supports a clear rating bias against interdisciplinary research or previously unfunded researchers PIs, while experts increasingly are declining invitations to review proposals in the interests of protecting their winnowing time (e.g., reviewer fatigue). 

These tradeoffs in the current system appear quite troubling and merit further investigation of alternative and complementary funding models. At least one economic analysis suggests that as fewer applicants are funded as a percentage of the increasing pool, the value of the science that researchers forgo because of grantsmanship often exceeds the value of the science that the funding program supports. In fact, despite dramatic increases in research effort, America has for generations been facing dramatic declines in research productivity. And empirical analysis suggests this is notnecessarily the result of a decline in proposal merit, nor of a shift in proposer demographics, nor of an increase (beyond inflation) in the average requested funding per proposal, nor of an increase in the number of proposals per investigator in any one year. 

As the Senate’s U.S. Innovation and Competition Act (USICA) and House’s America COMPETES Act propose billions of dollars to the NSF for R&D activities, about 96% of which will be distributed via the peer review, meritocratic grant awards process, now is the time to apply the scientific method to ourselves in the experimentation of alternative and complementary mechanisms for funding scientific research. 

Science lotteries, an effort tested in New Zealand, Switzerland, and Germany, represent one innovation particularly suited to reduce the overall taxes on research productivity while uncovering new, worthwhile initiatives for funding that might otherwise slip through the cracks. In particular, modified science lotteries, as those proposed here, select a small percentage of well-qualified grant applications at random for funding. By only selecting from a pool of high-value projects, the lottery supports additional, quality research with minimal comparative costs to the researchers or reviewers. In a lottery, the value to the investigator of being admitted to the lottery scales directly with the number of awards available. 

These benefits translate to favorable survey data from PIs who have gone through science lottery processes. In New Zealand, for example, the majority of scientists supported a random allocation of 2% total research expenditures. Sunny Collings, chief executive of New Zealand’s Health Research Council, recounted: 

“Applications often have statistically indistinguishable scores, and there is a degree of randomness in peer review selection anyway. So why not formalize that and try to get the best of both approaches?”

By establishing conditions for entrance into the lottery — such as selecting for certain less funded or represented regions — NSF could also over-index for those applicants less prepared for “grantsmanship”.

What we propose, specifically, is a modified “second chance” lottery, whereby proposals that are deemed meritorious by the traditional peer-review process, yet are not selected for funding are entered into a lottery as a second stage in the funding process. This modified format ensures a high level of quality in the projects selected by the lottery to receive funding while still creating a randomized baseline to which the current system can be compared.

The use of science lotteries in the United States as a complement to the traditional peer-review process is likely to improve the overall system.  However, it is possible that selecting among well-qualified grants at random could introduce unexpected outcomes. Unfortunately, direct, empirical comparisons between the NSF’s peer review process and partial lotteries do not exist. Through a pilot, the NSF has the opportunity to evaluate to what extent the mechanism could supplement the NSF’s traditional merit review process. 

By formalizing a randomized selection process to use as a baseline for comparison, we may discover surprising things about the make up of and process that leads to successful or high-leverage research with reduced costs to researchers and reviewers. For instance, it may be the case that younger scholars who come from non-traditional backgrounds end up having as much or more success in terms of research outcomes through the lottery program as the typical NSF grant, but are selected at higher rates when compared to the traditional NSF grantmaking process. If this is the case, then there will be some evidence that something in the selection process is unfairly penalizing non-traditional candidates. 

Alternatively, we may discover that the average grant selected through the lottery is mostly indistinguishable from the average grant selected through the traditional meritorious selection, which would provide some evidence that existing administrative burdens to select candidates are too stringent. Or perhaps, we will discover that randomly selected winners, in fact, produce fewernoteworthy results than candidates selected through traditional means, which would be evidence that the existing process is providing tangible value in filtering funding proposals.By providing a baseline for comparison, a lottery would offer an evidence-based means of assessing the efficacy of the current peer-review system. Any pilot program should therefore make full use of a menu of selection criteria to toggle outcomes, while also undergoing evaluations from internal and external, scientific communities.

Plan of Action

Recommendation 1: Congress should direct the NSF to pilot experimental lotteries through America COMPETES and the U.S. Innovation and Competition Act, among other vehicles. 

In reconciling the differing House America COMPETES and Senate USICA, Congress should add language that authorizes a pilot program for “lotteries.” 

We recommend opting for signaling language and follow-on legislation that adds textual specificity. For example, in latest text of the COMPETES Act, the responsibilities of the Assistant Director of the Directorate for Science and Engineering Solutions could be amended to include “lotteries”: 

Sec. 1308(d)(4)(E). developing and testing diverse merit-review models and mechanisms, including lotteries, for selecting and providing awards for use-inspired and translational research and development at different scales, from individual investigator awards to large multi-institution collaborations;

Specifying language should then require the NSF to employ evidence-based evaluation criteria and grant it the flexibility to determine timeline of the lottery intake and award mechanisms, with broader goals of timeliness and supporting the equitable distribution among regional innovation contenders. 

The appendix contains one example structure of a science lottery in bill text (incorporated into the new NSF Directorate established by the Senate-passed United States Innovation and Competition Act), which includes the following key policy choices that Congress should consider: 

Recommendation 2: Create a “Translational Science of Science” Program within the new NSF Technology, Innovation and Partnerships Directorate that pilots the use of lotteries with evidence-based testing: 

First, the NSF Office of Integrative Activities (OIA) should convene a workshop with relevant stakeholders including representatives from each directorate, the research community including NSF grant recipients, non-recipients, and SME’s on programmatic implementation from New Zealand, Germany, and Switzerland in order to temperature- and pressure-test key criteria for implementing piloted science lotteries across directorates. 

Appendix: Bill Text

Note: Please view attached PDF for the formatted bill text

H. ______

To establish a pilot program for National Science Foundation grant lotteries.

In the House of Representatives of the United States

February 2, 2022

______________________________

A BILL

Title: To establish a pilot program for National Science Foundation grant lotteries.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, 

SEC. _____. Pilot Program to Establish National Science Foundation Grant Lotteries

Right to Review.—Nothing in this section shall affect an applicant’s right to review, appeal, or contest an award decision.

Supporting Market Accountability, Workplace Equity, and Fair Competition by Reining in Non-Disclosure Agreements

Summary

Overuse of non-disclosure agreements (NDAs) is a pervasive problem in the United States. Companies apply these silencing tools to prevent their workers from sharing critical information with one another and the public. This in turn threatens economic growth, limits competition, and inhibits workplace equity. Workers need reliable information about corporate practices to assess job quality, ensure personal safety, and obtain pay commensurate with their worth. The public needs information about corporate practices to decide how to use their investment and purchasing power. Yet existing laws give companies enormous latitude to designate information as confidential, allowing them to impose NDAs and other contract clauses and internal policies that prevent workers from sharing information with those who need to know.

It is time for government to rein in corporate secrecy. The #MeToo movement revealed how NDAs enable and perpetuate misconduct at work, prompting public outrage and support for legislative action. New empirical evidence has exposed just how widely NDAs are being used in the corporate world: researchers estimate that between 33% and 57% of U.S. workers are constrained by an NDA or similar mechanism.1 2 At recent hearings and public events, regulators have signaled their concern about the anti-competitive effects of restrictive employment agreements.3 Policymakers should seize this moment of support to pursue a comprehensive legislative and multi-agency agenda limiting inappropriate use of NDAs. A strong action plan should include proactive enforcement of existing laws governing NDAs; new legislation prohibiting the most harmful uses of NDAs; and interagency collaboration to educate the public, collect data, and support research on impacts of corporate secrecy practices. Together, these efforts to limit NDA abuse will promote market accountability, workplace equity, and fair competition.

Challenge and Opportunity

NDAs are contracts in which parties agree not to disclose any information designated confidential by the agreement. In some cases, NDAs may be used appropriately to protect valuable trade secrets or other intellectual property. But employers often draft these agreements broadly to conceal many other types of information, sometimes in ways that overstep existing legal bounds. For instance, the Weinstein Company required employees to sign NDAs that prohibit disclosure of “any confidential, private, and/or non-public information obtained by Employee during Employee’s employment with the Company concerning the personal, social, or business activities of the Company, the Co-Chairmen, or the executives, principals, officers, directors, agents, employees of, or contracting parties (including, but not limited to artists) with, the Company.”4 Some companies require employees to sign non-disparagement agreements. These particularly broad NDAs prohibit employees from disclosing any information that might, as a non-disparagement agreement for employees of Task Rabbit reads, “disparage the Company, and the Company’s officers, directors, employees, investors and agents, in any manner likely to be harmful to them or their business, business reputation or personal reputation.”5  NDAs and non-disparagement agreements often purport to apply indefinitely, preventing workers from sharing information long after they have left employment.

NDAs are imposed on workers at various points during the employment relationship. They are regularly included as part of a bundle of mandatory HR forms that new hires must sign as a condition of employment. They can also be imposed and enforced through confidentiality policies contained6 in personnel manuals or codes of conduct that prevent employees from sharing information about the company with outsiders and sometimes even with co-workers. They are also routinely included in standardized as well as negotiated severance agreements that workers sign when ending their employment. Lastly, they are also often included in settlement agreements that resolve workplace disputes and in agreements that force employees to arbitrate disputes in secret. By preventing workers from disclosing information on everything from workplace harassment and abuse to compensation practices and safety conditions, NDAs stifle competition, limit the free flow of ideas,7 and allow toxic workplace conditions to fester.8 9 10

Prevalence of NDAs

Researchers estimate that between 33% and 57% of U.S. workers are constrained by an NDA or similar mechanism.11 12 Yet it is difficult to precisely determine how many employees are silenced by NDAs because NDAs are designed to conceal information. In fact, NDAs often provide that the mere existence of the agreement is itself a secret. Lawyers regularly encourage firms13 to use broad NDAs as a condition of employment—not only to protect trade secrets, but also to discourage employees from revealing bad employment experiences.14 NDA prevalence also varies by sectors.

For instance, 73% of workers in “computer or mathematical jobs” report having an NDA with their employer.15 16

How NDAs Hurt Workers, the Public, and the Economy

The overuse of broad NDAs can have harmful economic and social effects. Depending on how they are drafted and enforced, NDAs may undermine law enforcement and regulatory compliance, distort labor and investment markets, constrain fair competition, allow toxic workplace conditions such as harassment and discrimination to persist, and undercut efforts to make workplaces more diverse and equitable.

Interference with Law Enforcement and Regulatory Compliance

Social, psychological, and economic disincentives already discourage employees from blowing the whistle on harmful and illegal corporate behavior.17 NDAs add another barrier preventing this critical information from reaching regulators and the public. NDAs have been used by companies to cover up illegal behavior. They have been used to silence whistleblowers who disclose information about products that threaten public health and safety.18 They have even been used to prevent employees from disclosing illegal conduct to government regulators despite countervailing law. A complaint filed by the California Department of Fair Employment and Housing (DFEH) against gaming company Activision Blizzard alleges that, contrary to law, the company pressured employees to sign contracts waiving their right to speak to investigators and requiring them to notify the company before disclosing information to DFEH.19 Some companies have required employees to agree to secrecy about corporate pay practices and diversity statistics, thereby depriving regulators of vital information about companies’ compliance with pay equity and anti-discrimination laws.20 The dangers of overly aggressive NDAs have become especially clear during the COVID-19 pandemic, when it is vital for the public to know if companies are disregarding essential health and safety guidelines designed to reduce virus spread.

Market Distortion

NDAs deprive individuals of information they need to assess competing job offers and make informed decisions about where to work. They also degrade the reliability of employer reviews that workers post to online job platforms. This is because workers subject to broad NDAs are more likely to censor themselves and withhold negative information. New research shows that on Glassdoor, workers in states with more stringent limits on NDAs are 16% more likely to give a one-star review, write 8% more about the “cons” of working at the firm, and discuss harassment at work 22% more often.21 That same research also shows that states with more stringent limits on NDAs increase reporting of sexual harassment and safety violations to federal agencies. NDAs hence remove an important check on corporate behavior, since companies have been shown to improve their practices in response to negative job reviews and investigations into their practices.22 NDAs thus enable bad employers to hide their flaws and make it difficult for good employers to distinguish themselves in the market.

Accurate information about workplace conditions is also valuable to investors, who have increasingly come to recognize that the ways companies treat their workers impact corporate financial performance.23 A nonprofit investment group recently called on the Securities and Exchange Commission to develop a standardized set of workplace-practice metrics as part of a comprehensive framework for evaluating socially responsible corporate governance.24 NDAs can hide information about workplace conditions that investors value.

Constraints on Fair Competition

Broad NDAs can impede fair competition. Research has demonstrated that non- compete agreements—which prohibit departing workers from joining competitors— impede worker mobility, economic growth, and new firm entry. Broad NDAs pose some of the same competitive risks as non-competes because they limit workers’ ability to share and apply knowledge gained through on-the-job experience. This in turn diminishes workers’ human capital and makes them less competitive in the labor market.25 Indeed, employers in states that ban non-competes have illegally attempted to use broad NDAs as an alternative mechanism to impede employee mobility.26

Harassment and Discrimination

NDAs conceal harassment, discrimination, and abuse in the workplace. As the #MeToo movement showed, perpetrators of harassment and discrimination are often repeat offenders.27 28 NDAs may prevent victims of harassment and discrimination from warning co-workers and prospective employees about a company’s toxic workplace environment, leaving others at risk. NDAs may also prohibit or inhibit employees from disclosing information to government agencies, shielding offenders from outside investigation. By limiting what employees can share, NDAs allow harmful and abusive behavior to persist.

Diversity, Equity, and Inclusion

Restrictions on employee disclosure of harassment and discrimination undermine the goal of achieving diverse and equitable workplaces. Workers of color, women, and LGBTQ+ workers are disproportionately likely to suffer harassment and discrimination in the workplace. Such adverse experiences can have significant psychological and professional consequences, including driving workers out of certain jobs and even out of certain industries.29 30 NDAs exacerbate these harms by suppressing information about systemic workplace inequities and by denying workers a forum to expose and discuss harassment and discrimination.

Corporate-secrecy practices shrouding employee compensation similarly undermine efforts of diverse employees to achieve pay equity. Contrary to law, some NDAs and confidentiality policies prohibit employees from discussing their compensation, which makes it challenging for those employees to negotiate fair salary terms commensurate with their value.31 Studies have found that states that adopted anti-secrecy pay laws increased gender wage equality relative to states that did not.32 33

National Leadership Is Needed

As described above, overly broad NDAs and the organizational secrecy practices they support pose serious risks to our economy and our society. Yet absent government intervention, these challenges will persist. Individual firms have incentives to maintain their reputations using corporate-secrecy tactics despite the social costs of such behavior. Many of those who value the information concealed by NDAs lack the capacity and power to pressure companies to change. Policymakers have an imperative to use the levers of government to curb NDA abuse.

A minority of states, including California, Illinois, New Jersey, New York and Washington, passed legislation in the wake of #MeToo regulating some uses of NDAs. But these laws comprise an inconsistent and incomplete regulatory patchwork. State laws differ in scope of coverage and impose different compliance standards, making it difficult for employees and companies to determine what employee disclosures are legally protected where. Moreover, the harms caused by NDAs do not stop at state lines. In fact, uneven regulation of NDAs further distorts markets by making it easier for companies to conceal information and restrict competition in some states than in others. Multi-state firms can use choice of law and choice of forum provisions to exploit inter-state legislative discrepancies, i.e., to apply the most lenient state-level secrecy laws to the entirety of a multi-state workforce.

The upshot is clear. National leadership is the only way to support market accountability, workplace equity, and fair competition by reining in non-disclosure agreements.

Plan of Action

Multiple policy interventions could curtail NDA misuse. Select options are presented below.

Better Enforce Existing Laws

Existing laws restrict some of the harmful uses of NDAs. But laws must be enforced to be effective. Research shows that some employers include unlawful non-compete clauses in their employment contracts, capitalizing on workers’ ignorance of the law and fears of being sued. Employers may similarly use NDAs in ways that violate existing law.34 35 Ensuring that employers are following laws that protect certain disclosures and forms of communication is a common-sense place to start when it comes to curbing NDA abuse.36

The Federal Trade Commission (FTC) has an important role to play in enforcement. The FTC has broad authority to punish companies engaging in unfair or deceptive practices that harm consumers or competitors, as NDA misuse often does.37 Unfair practices include practices that offend public policy as established by state statutes and common law,38 which already restrict use of overly broad NDAs as well as NDA misuse to silence disclosures of employer wrongdoing. Stronger enforcement by the FTC would give these laws some needed teeth and would help establish norms governing responsible NDA use. The FTC could also work with companies to develop standards and best practices around NDA use and to encourage companies to engage in robust self-regulation and police one another.39

Stronger enforcement of existing laws could also come from the various federal agencies that help oversee labor and employment in the United States. For example, the National Labor Relations Act protects workers who make common cause in seeking to discuss the terms and conditions of their employment. Regional offices of the National Labor Relations Board (NLRB) have the authority to investigate employers’ use of policies that discourage this type of communication, and to file unfair labor practice charges against employers acting unlawfully. The NLRB can and should exercise this authority more forcefully. Similarly, the Occupational Safety and Health Administration (OSHA) could better use its power to enforce whistleblower laws protecting employees who report unlawful behavior. The Equal Employment Opportunity Commission (EEOC) and the Department of Labor (DOL) also receive complaints about unlawful employment practices, including retaliation against employees who report or object to discriminatory behavior, wage theft, and other violations. The EEOC and DOL should actively seek information about NDAs and related practices in the course of their investigations and should make pursuit of retaliation claims a top priority.

In addition to redoubling enforcement efforts in their respective spheres of jurisdiction, the aforementioned agencies should collaboratively develop and implement strategies for amplifying the collective impact of their oversight.

Prohibit the Most Pernicious Uses of NDAs

New federal laws should be enacted to ban employer-imposed secrecy regarding key categories of essential information, including firm diversity, harassment and discrimination, compensation practices, and workplace health and safety. The recently proposed Ending the Monopoly of Power Over Workplace Harassment through Education and Reporting Act (EMPOWER Act) would make it illegal for an employer to require or enforce an NDA or nondisparagement clause related to workplace harassment based on a range of protected characteristics, including sex, race, national origin, disability, age, or religion. The proposed law, which enjoys bipartisan support, would also establish a confidential tip line for reporting systematic workplace harassment.

The EMPOWER Act is a step in the right direction, but federal legislation should go even further. New laws are needed to protect a wider range of disclosures and to ensure that employees know their rights. A section of California’s Silenced No More Act provides one example. It prohibits companies from using NDAs to silence employees not only about harassment, but also about discrimination and other illegal conduct. To ensure that employees know their rights, the act requires employers who use NDAs for lawful purposes to include in these contracts language clarifying that “[n]othing in this agreement prevents you from discussing or disclosing information about unlawful acts in the workplace, such as harassment or discrimination or any other conduct that you have reason to believe is unlawful.”

The federal Defend Trade Secrets Act (DTSA) provides another example of a provision that could be incorporated into new legislation aimed at reining in NDAs.40 Signed into law by President Obama in 2016, the DTSA requires employers to include language in all employment contracts notifying employees that they are immune from liability when blowing the whistle on unlawful employer behavior, even if doing so involves revealing trade secrets. This notice requirement could be expanded to cover any discussions about workplace conditions. It could also clarify that the NDAs may cover only technical information that is truly secret and not general skills, know- how, and job-related experience. This would give workers more freedom to leverage their knowledge in competing for quality jobs and market-based terms of employment.

Enacting a reform agenda that impacts the widest possible swath of employers requires Congressional action. However, President Biden could act immediately to limit NDA use by federal contractors. The president has the power to issue an executive order restricting or prohibiting the federal government from entering into contracts with companies that fail to adhere to certain rules. President Biden could issue an executive order requiring that federal contractors adhere to new rules prohibiting use of NDAs to conceal essential information, including information on firm diversity, harassment and discrimination, compensation practices, workplace health and safety, and other areas of regulatory compliance. In addition to the benefits discussed above, such rules could help prevent concealment of fraud by government contractors.

Collect Data and Require Disclosure

Research tells us that NDAs are common in American workplaces. Recent events have shown that some employers use NDAs to cover up unlawful behavior. Yet information on the prevalence and content of NDAs is still relatively scarce. Employers are not currently required to disclose their NDAs to any outside party or government regulator. Employers are also free to prohibit employees who sign NDAs from even revealing that the agreement exists. Without adequate information on the scope and nature of the NDA problem, it is difficult for lawmakers to craft well-tailored policy solutions that account for a variety of stakeholder concerns. Any law limiting NDAs must balance the damage that concealing information from the public imposes against the value of NDAs for employers when used appropriately. Legislation must also consider the personal interests of victims of misconduct who may prefer to keep their experiences secret.

Policymakers should therefore require organizations to disclose their NDAs and related clauses in employment agreements. The FTC should use its investigative authority under Section 6(b) of the FTC Act41 to gather and study these documents. The SEC should also consider requiring disclosure of companies’ use of NDAs as part of its broader response to investor demand for credible information about human- capital management42 43and environmental, social, and governance performance.44

In addition, the various agencies that investigate violations of employment laws should collaborate to conduct more research on the scope and effects of NDAs (as well as other corporate-secrecy practices) across states and industries. For instance, the EEOC already receives annual reports from employers about worker demographics, salary breakdowns by gender and race, and other employment information. A coordinated agency effort could provide insight into how NDAs affect diversity and equity in employment. Developing this type of data will help lawmakers assess the anti-competitive effects of corporate secrecy, balance competing policy interests, and draft effective legislation.

Fund Organizations, Not Projects: Diversifying America’s Innovation Ecosystem with a Portfolio of Independent Research Organizations

Summary

Dominant research-funding paradigms constrain the outputs of America’s innovation systems. Federal research-funding agencies like the National Institutes of Health (NIH) and the National Science Foundation (NSF) operate largely through milestone-scoped grants that fail to incentivize high-risk research, impose highly burdensome reporting requirements, and are closely managed by the government. Philanthropically-funded research organizations are an excellent mechanism to experiment with different research management approaches. However, they are perennially underfunded and rarely have a path to long-term sustainability.

A single program with two pieces can address this issue: 

First, the NSF’s new Technology, Innovation, and Partnership (TIP) Directorate should pilot a “organizations, not projects” program in which philanthropically matched grants fund a portfolio of independent research organizations instead of funding specific research initiatives. Partnering with philanthropies will leverage the diversity of American donors to identify a portfolio of research organizations with diverse constraints (and therefore the potential to create outlier outcomes). To have a significant impact, this pilot funding opportunity should be funded at $100 million per year for 10 years.

Second, drawing on the ideas of Kanjun Qiu and Michael Nielsen, the NSF should set aside an additional $100 million per year to sponsor independent research organizations with impressive track records for extended periods of time. This commitment to “acquire” successful organizations will complement Part One’s research-funding opportunity in two ways. First, it will encourage philanthropic participation by making philanthropies feel like their money is going towardssomething that won’t die the moment they stop funding it. Additionally, it will enable the federal government to leverage the institutional knowledge created by successful experiments in research funding and management.

If successful, this two-part program can be later replicated by other federal agencies. The Administration and Congress should prioritize funding this program in recognition of three converging facts: one, that federal spending on research and development (R&D) is increasing; two, that the American innovation ecosystem is not working as well as it once did; and three, that the proliferation of new institutional structures for managing research (e.g., Focused Research Organizations, private Advanced Research Projects Agencies (ARPAs), “science angels”, etc. Swift action could use the increased budgets to empower new organizations to experiment with new ways of organizing R&D in order to address the current system’s sclerosis!

Challenge and Opportunity

There is a growing consensus that there is a gap between the speed and efficiency of R&D projects closely managed by the government and R&D projects managed by the private sector. 

Federal funding is a major part of the American R&D ecosystem. However, most federal research funding comes with a litany of constraints: earmarks that prevent researchers from spending grant money on things they think are most important (like equipment or lab automation), onerous reporting requirements, the need to get every proposal through a committee, and dozens of hours of grant writing for shockingly small amount of money. Moreover, studies have found that with a mandate to fund innovative research, federal funding decisions tend to be risk-averse.

As a result, in situations where there’s a head-to-head comparison between government-managed research and technology development and privately-managed counterparts, there’s little question which is more efficient.

This efficiency gap exists largely because privately-managed organizations often push control over research funds to the organization or level where the “research design” occurs. This yields powerful results. Former Defense Advanced Research Projects Agency director Arati Prabhakar argues that this mechanism, in the form of empowering program managers, is a big part of why the ARPA model works. In the business world, coupling power (money) and responsibility (research design) is simply common sense. In the research world, the benefits of “embedded autonomy” are straightforward. Autonomy enables an organization or individual to react quickly to unexpected circumstances. Research is highly uncertain by nature. Coupling embedded autonomy with research design means that funding will be spent in the most useful way possible at a given moment based on knowledge gained as experimentation progresses — not in the way that a researcher thought would be most useful at the time they submitted their grant proposal.

Recognizing the power of embedded autonomy to enable powerful, diverse research, there is currently an explosion of experiments in non-academic research organizations. Many are too new to have clear results, but non-academic research organizations — including HHMI Janelia, Dynamicland, Willow Garage, and early SpaceX — have created new fields, won Nobel prizes, and changed the paradigms of entire industries. But even the most successful research organizations struggle to raise money unless there is a clear business case, which leaves public-goods oriented research in the lurch. Philanthropists are strongly motivated by legacy, so they want to fund things that will last. As a result, Private funders often hesitate to fund research organizations that produce public-good R&D.

Understanding this problem suggests a potent new way of deploying the federal government’s R&D budget: partnering with philanthropists to build a diverse portfolio of research organizations with autonomy over their own budgets, and then providing long-term support to the most effective of those organizations.

In other words, the federal government should experiment with funding organizations rather than projects.

Such an approach would position the federal government to act like a limited partner (LP) in multiple venture capital funds. In this capacity, the federal government would avoid setting overly specific requirements around how a particular grant is spent. The government would instead set very high-level priorities (e.g., “create new manufacturing paradigms” or simply “do impactful research”), give funded organizations the autonomy to figure out how to best achieve this goal, and then evaluate success after the fact.

The time is right to invest in creative federal research-funding approaches. There is bipartisan support for large increases to federally funded R&D. But pushing huge amounts of money through outdated R&D funding structures is like slamming on the accelerator of a car that needs an engine repair: incredibly inefficient and with the potential to backfire. By contrast, embedding autonomy in a diverse portfolio of organizations could unlock the sort of unexpected, game-changing inventions and discoveries that have driven the American economy: electricity, airplanes, the internet, the transistor, cryptography, and more.

Plan of Action

The current Administration should launch a two-part program at NSF to test a research-funding system that prioritizes organizations over projects.

As Part One of this program, the NSF’s TIP Directorate should pilot a research-funding opportunity in which philanthropically matched grants fund a portfolio of independent research organizations instead of funding specific research initiatives. This pilot funding opportunity should be funded at $100 million per year for 10 years. The Directorate should target funding between 5 and 15 organizations this way, quadratically matching philanthropic funds at values between 100% and 1000% depending on the number of participating philanthropic donors.

As Part Two of this program, NSF should set aside an additional $100 million per year to sponsor independent research organizations with impressive track records for extended periods of time. The Directorate should set a goal of identifying two organizations during the ten-year pilot that would be good candidates for this long-term funding, funding each at $50 million per year.

More detail on each of these program components is provided below.

Part One: Philanthropically matched grants

Partnering with private donors is key to the success of the proposed organization-focused funding opportunity. By funding only organizations that have already raised philanthropic dollars, the federal government will leverage philanthropists’ due diligence on screening applicants to ensure high-potential awardees. Similarly, the funding opportunity should employ quadratic matching funding to use donors’ confidence as an indicator of how much money to give each organization and to reduce bias favoring organizations that are able to raise a large amount of money from a small number of donors. 

Leveraging philanthropic opinion in this way does come with the risk of biasing awards towards organizations working on particularly popular areas or that are particularly good at sales or marketing. The organization-focused funding opportunity could address this risk by establishing a parallel funding pathway whereby a large number of researchers can file a petition for an organization to be selected for funding.

The TIP Directorate obviously must impose additional criteria beyond the endorsements of the philanthropic and research communities. It will be tempting for the Directorate to prioritize funding organizations working on specific, high-interest technology areas or themes. But the goal of this program is to advance the long term health of the American innovation ecosystem. Often, tomorrow’s high-priority area is one that doesn’t even exist today. To that end, the Directorate should evaluate potential grantee organizations on their “counterfactual impact”: i.e., their capacity to do work that is disincentivized in other institutional structures. 

The question of how best to evaluate success of the funding opportunity is a challenging one. It is notoriously hard to evaluate long-term research output. The whole point of this proposal is to move away from short-term metrics and rigid plans, but at the same time the government needs to be responsible to taxpayers. Metrics are the most straightforward way to evaluate outcomes. However, metrics are potentially counterproductive ways to evaluate new and experimental processes because existing metrics presume a specific way of organizing research. We therefore recommend that the TIP Directorate create a Notice of Funding Opportunity to hire an independent, nonpartisan, and nonprofit board whose job is to holistically evaluate funded organizations. The board should include people working in academia, industrial research, government research, and independent research organizations, as well as some “wildcards”. The board should collectively have deep experience performing and guiding high-uncertainty, long-term research and development.

The board would regularly (but not over-frequently) solicit opinions on output and impacts of funded organizations from the program’s philanthropic partners, members of the government, people working with the organizations, unaffiliated researchers, and members of the organizations themselves. At the end of each year, the board should give each organization an evaluation “report card” containing a holistic letter grade and an explanation for that grade. Organizations that receive an F should immediately be expelled from the funding program, as should organizations that receive a D for three years in a row.

Part Two: Invest deeply in demonstrated success

Kanjun Qiu and Michael Nielsen have proposed an important piece of the puzzle: In the same way that governments took over funding libraries once they were started by Gilded Age philanthropists, the government should take over funding immensely successful research organizations today.

At the five-year midpoint and ten-year endpoint of the pilot funding program, the evaluation board should identify any funded organizations that have produced outstanding output. The TIP Directorate should then select up to two of these candidates to receive indefinite government support, at a funding level of $50 million per organization per year. These indefinitely funded organizations would become a line item in the TIP’s budget, to be renewed every year except in extreme circumstances. The possibility of indefinite federal support as an “exit strategy” for philanthropic funders will encourage participation of additional philanthropic partners by providing (i) philanthropically funded organizations a pathway for becoming self-sustaining, and (ii) philanthropies with a clear opportunity to establish a legacy.  

What qualifies as “outstanding output”? Like evaluating success, it’s a challenging question. We recommend using the same board-based grading scheme outlined above. Any organization that receives an A grade in two of the past five years or an A+ in any one of the past five years should be eligible for indefinite support. This approach will require grading to be very strict: for instance, an A+ should only be given to an organization that enables Nobel-prize-quality work.

Conclusion

Building portfolios of independent research organizations is an incredibly effective way of spending government research money. The total federal research budget is almost $160 billion per year. Less than 1% of that could make a massive difference for independent research organizations, most of which have budgets in the $10 million range. Funding especially promising independent research organizations with an additional $10 million or more per year would have a huge effect, empowering organizations that are already doing outstanding work to take their contributions to the next level. 

Even the highest-performing private research organizations in the world — like Google DeepMind and HHMI Janelia Farm — have budgets in the range of $200 million per year. Sponsoring a select number of especially high-performing research organizations with an additional $100 million per year would hence have similarly transformative impacts. These large indefinite grants would also provide the major incentives needed to bring the world’s leading philanthropies to the table and to encourage the most cutting-edge independent research organizations to dedicate their talents to the public sector. The sum total of achieving these outcomes would still account for only a tiny fraction of the overall federal R&D budget.

Finally, we emphasize that the goal of this pilot program is not solely to establish an independent research organization portfolio in the TIP Directorate. It is also an opportunity to test a novel research-funding mechanism that could be replicated at numerous other federal agencies.

Creating Advanced Market Commitments and Prizes for Pandemic Preparedness

As part of its American Pandemic Preparedness plan, the Biden Administration should establish an interagency working group (IWG) focused exclusively on the design, funding, and implementation of advance market commitments (AMCs) and prizes for vaccine development. Under an AMC, pharmaceutical companies commit to providing many vaccine doses at a fixed price in return for a per-dose federal subsidy. Prizes can support AMCs by rewarding companies for meeting intermediate technical goals.

The IWG would immediately convene experts to identify suitable targets for ambitious vaccine-development and deployment efforts. The group would then work with stakeholders to implement AMCs and prizes crafted around these targets, offering a concrete and durable demonstration of the Administration’s commitment to proactive pandemic preparedness. As the American Pandemic Preparedness plan argues, an important part of rapid vaccine deployment is maintaining “hot manufacturing capacity”. Clear federal AMCs would create the market incentive needed to sustain such capacity, while simultaneously advancing procurement expertise within the federal government, in line with recent recommendations from a government review on the US supply chain. 

Challenge and Opportunity

Vaccines are very cost-effective medical interventions that have played a large role in reducing pathogen-induced deaths over the last 200 years. But vaccines do not yet exist for many diseases, including diseases concentrated in the developing world. Vaccines are undersupplied relative to their social benefit because their target populations are often poor and because strong political pressure for lower prices leads to low expected profits. When new vaccines are approved, scaling up production to fully supply low and middle-income countries (LMICs) can take up to 15 years. AMCs solve these issues by incentivizing vaccine development and hastening production scale-up. Prizes play an intermediate role by offering rewards for meeting technical goals along the way.


Vaccine AMCs have a track record of success. In 2007, GAVI, a public-private global health partnership based out of Geneva, launched an AMC for a pneumococcal conjugate vaccine (PCV) that covered pneumococcal strains more common in the developing world. The partnership received its first supply offers in 2009 (a fairly rapid response enabled by the fact that some PCV candidates were already in late-stage clinical trials). Compared to the rotavirus vaccine — which was developed around the same time but did not receive an AMC — PCVs achieved 3–4x greater coverage (defined as the fully vaccinated fraction of the target population). Moreover, new vaccines typically take about 10–15 years to become widely available in LMICs. PCV became available in those countries within a year. This example demonstrates the capacity of AMCs to incentivize rapid scaling. More recently, the United States (through Operation Warp Speed) and several other countries and organizations purchased substantial COVID-19 vaccine doses far in advance of approval, albeit using a more flexible AMC model that prioritized scaling production before data from clinical trials were available.

Plan of Action

To build on the progress and demonstrated success outlined above, the Biden Administration should invest in AMCs and prizes for vaccine development and deployment as part of its American Pandemic Preparedness plan. Below, we detail three specific recommendations for moving forward.

Recommendation 1. Form an Interagency Working Group (IWG) on Rapid Vaccine Innovation

Roles and responsibilities

Vaccine development and manufacturing is a multi-stage process that is too complicated for any single federal agency to manage. The Biden Administration should issue an Executive Order establishing an IWG on Rapid Vaccine Innovation.

Under emergency circumstances, the IWG would be the government hub for time-sensitive vaccine-procurement efforts. Under normal (non-pandemic) circumstances the IWG would focus on extant communicable diseases with a high disease burden and on potential future threats. This latter function would be carried out as follows.

1. Vaccine targeting. A “horizon scanning” IWG subgroup would identify priority targets for rapid vaccine development and broad deployment. The subgroup would consider factors such as pandemic potential, current disease burden, and vaccine tractability. The IWG would also consult with scientists at the VRC (whose work was essential to the rapid development of COVID-19 vaccines, and who already focus on viruses with pandemic potential) and at the CDC (which already performs pathogen surveillance) in making its determinations. Options for initial vaccine targets could include:

2. Incentive design. Once one or more vaccine targets are identified, an IWG subgroup comprising health economists and budget officers would design the AMC(s) and intermediate prizes intended to spur development and deployment of the target(s). Incentive design would (i) be carried out with substantial input from BARDA, which is familiar with the vaccine-manufacturing landscape, and (ii) consider both the technological distance of the target and market competitiveness. An output from this step would be a Vaccine Incentive Roadmap describing the different prizes and incentives that federal agencies will offer to ensure fast, consistent progress towards development and deployment of the target(s) in question. In other words, the linked prizes included in the roadmap will produce sustained incentives for continued forward progress on vaccine development. More information on this roadmap is provided below.

Structure and participation

The IWG should be structured as an integration, with each participating agency providing specific expertise on each aspect of the IWG’s charge. Participants should include senior leaders from the Biomedical Advanced Research and Development Authority (BARDA), the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Agency for International Development (USAID), US International Development Finance Corporation (DFC), and the Vaccine Research Center (VRC). BARDA has a track record of successful procurement of vaccines and expertise in negotiating with manufacturers. VRC’s founding mission is vaccine development and it has collaborated with manufacturers on large-scale production for multiple vaccines. They would provide expertise on vaccine tractability. Through upfront guidance on minimum efficacy requirements, the FDA will ensure vaccine standards. FDA will also work with global regulators on the possibility of regulatory reciprocity, akin to their PEPFAR program, which assists low-resource regulators in low and middle-income countries with decision-making.

The IWG should be chaired by a biosecurity expert housed at the White House Office of Science and Technology Policy (OSTP). 

Congressional notification

The IWGs recommendations (regarding both targets and AMC/prize design), once finalized, would be submitted to the Senate Health and House Ways and Means Subcommittee to request funding. Because federal agencies must notify Congress if they plan to disburse large prize sums (with agency-specific thresholds), this submittal would also serve as the required formal notification to Congress of prize amounts. 

Recommendation 2. Carry out the IWG’s Vaccine Incentive Roadmap

After the IWG has issued its recommendations on vaccine target(s) and incentive (AMC and prizes) design, implementation must follow. Where implementation support comes from will depend on the “technological distance” of the target(s) in question. 

Early-stage development focused on in-vitro or animal research should be supported with prizes from BARDA, the Department of Health and Human Services (HHS), and NIH. All federal agencies already have the authority to award prizes under the America Competes Act. Initial prizes could be awarded to vaccine candidates that successfully protect an animal model against disease. Later prizes could be awarded to candidates that hit clinical milestones such as completion of a successful Phase 1 trial in humans. We note that while agencies can theoretically pool funds for a multi-stage prize, cumbersome interagency processes mean that it will likely be easier to have separate agencies fund and oversee the separate prizes included in the roadmap. 

Later-stage development should be supported with larger prizes or purchases from USAID and DOD. Once a vaccine candidate has reached early-stage human clinical testing, larger prizes and/or different funding mechanisms will likely be required to advance that candidate to later-stage human testing. This is because costs of moving a vaccine candidate from the preclinical stage to the end of phase 2A (early-stage human clinical testing) range from $14 to $159 million dollars.

It is unlikely that a single federal agency would have the discretionary funds or willingness to sponsor a prize sufficient to incentivize participation in this process. Federal partnerships with private-sector entities and/or philanthropies could supplement federal prize funding. The promise of being a government-approved vendor of a vaccine or a DOD-supported prototype would serve as incentive for external entities to enter into such partnerships. USAID could also leverage its relationships with global health stakeholders and funders to provide incentive funding. Of course, external funding partnerships would be unnecessary if Congress appropriated sufficient designated funding for large vaccine-incentive prizes to relevant agencies.

An alternative to prize funding that would be appropriate for incentivizing later-stage R&D is use of the DOD’s Defense Commercial Solutions Opening (CSO) purchasing authority. DOD could use its CSO authority to pre-purchase vaccine doses in large quantities, effectively creating an AMC. Purchases of up to $100 million can be made through CSO authority. Early prize negotiations would use the leverage provided by becoming a government-approved vendor of vaccines (part of the CSO process) to negotiate for fair prices.  A second DOD purchase authority that could be used as an AMC-like incentive is the Other Transaction Authority (OTA), which exempts the DOD from some federal procurement regulations. OTA authority could likely be used to support vaccine research, purchase vaccine prototypes, and pay for some manufacturing of a successful prototype. OTA has also been used to fund research consortia, a possible alternative to a multi-stage prize roadmap. Purchases of up to $20 million can be made through OTA authority. In the context of diseases that affect low and middle income countries, a loan from the US International Development Finance Corporation (DFC) may be an option for supplementing an AMC.

Recommendation 3. Permanently expand BARDA’s mandate to include all communicable diseases, expand BARDA’s funding, and make BARDA the IWG’s permanent home

An IWG is a powerful tool for bringing federal agencies together. With existing prize authority and an administration that prioritizes vaccine development and deployment, much could be accomplished through only the steps outlined above. However, achieving truly transformative results requires a permanent and sustainably funded federal agency to be working consistently on advancing vaccines. Otherwise, future administrations may cancel ongoing IWG projects and/or fail to follow through. As the part of the federal government with the most expertise in therapeutics procurement, BARDA is an ideal permanent home for the IWG’s functions. 

BARDA’s mandate is currently limited to biological, chemical, or radiological threats to the health of Americans. This mandate should be expanded to include all important communicable diseases. The newly empowered BARDA would manage public-private partnerships for vaccine procurement, while  the NIH would remain the fundamental health-research arm of the U.S. government. Expanding BARDA’s mandate would require Congressional action. Congress would need to amend the Pandemic and All-Hazards Preparedness and Advancing Innovation Act appropriately, and would also need to appropriate specific funding for BARDA to carry out the roles and responsibilities of the IWG over the long term.

Frequently Asked Questions
What if we give pharmaceutical companies a bunch of taxpayer money to develop vaccine targets and they fail?

Prizes and AMCs only pay out when a product that meets pre-specified requirements is approved, so taxpayers won’t pay for any failures.

Tell me more about AMC design. What changes if a vaccine candidate is in the early-stage as opposed to the later-stage?

For technologically “close” vaccine targets with a high chance of imminent Phase 3 trial success, an AMC incentivizes rapid scale-up of manufacturing and ensures that more doses reach more people sooner. The AMC does this by circumventing a type of “hold-up” problem wherein purchasers negotiate vaccine prices down to per-unit costs. The 2007 GAVI Pneumococcus AMC was of this type. A GAS or malaria vaccine would similarly be “close” targets.


For more technologically distant targets, AMCs should incorporate “kill switches” that give future customers of the vaccine an effective veto over the AMC by way of not paying co-payments. This feature is designed to be a final check on the utility of a vaccine and avoids the difficulty of specifying standards for a vaccine many years ahead of time. An AMC structured in this way works well if a company manufactures a vaccine that meets pre-specified technical details but for hard-to-predict reasons is not useful.


For an especially distant target, a series of prize competitions could substitute for a traditional AMC. In this scenario, an initial prize could be awarded for any vaccine candidates that successfully protect an animal model against disease. A later prize could be awarded to candidates that hit clinical milestones such as completion of a Phase 1 trial in humans.


Other details of AMC and/or prize implementation depend on the market structure and cannot be determined ahead of time. For instance, the optimal AMC design is very different in monopoly versus competitive markets.

Why does this memo you propose a complicated multi-stage prize process instead of something simple like Operation Warp Speed?

Operation Warp Speed spent about $12 billion dollars on COVID-19 vaccine development and purchased hundreds of millions of vaccine doses far in advance of approval or clinical trials. While this was very effective, it is unlikely that Congress would be willing to appropriate such a large sum of money — or see that money disbursed so freely — in non-pandemic situations. A multi-stage prize process still incentivizes vaccine development and deployment but does so for a lower cost.

How can the federal government carry out these recommendations without provoking anti-vax sentiment?

The government could fund research into market segmentation for vaccines, since many who are vaccine-hesitant are avid consumers of alternative health products/supplements. There may be marketing and promotional strategies inspired by “natural” supplements that can increase vaccine uptake.

Doesn’t the federal government already fund influenza vaccine preparation? Why do we need a universal flu vaccine?

The federal government does fund influenza vaccine preparation, but that funding is only for a seasonal flu vaccine that works with 40–60% efficacy: a rate that is well below what other vaccines, such as the measles (97%) and mumps vaccines (88%) achieve. A pandemic influenza with an unexpected genetic background could still catch us by surprise. Investing in a universal influenza vaccine is essential in preparing for that eventuality.

What are the most likely points of failure for the steps outlined in this memo?

One issue is staffing. Drafting a high-quality AMC contract may require legal and economic expertise that isn’t available in-house at federal agencies, so the administration may need to engage external AMC experts. Another issue may be ensuring that activities outlined herein do not fall between interagency “cracks”. Assigning dedicated staff to oversee each activity will be important. A third issue is the potential for interagency friction. The more agencies that are involved with prize design, the longer it may take to design and authorize a given prize. One possible solution is to have only one agency administer each prize, with informal input from staff in other agencies when required.

Broadening the Knowledge Economy through Independent Scholarship

Summary

Scientists and scholars in the United States are faced with a relatively narrow set of traditional career pathways. Our lack of creativity in defining the scholarly landscape is limiting our nation’s capacity for innovation by stifling exploration, out-of-the-box thinking, and new perspectives.

This does not have to be the case. The rise of the gig economy has positioned independent scholarship as an effective model for people who want to continue doing research outside of traditional academic structures, in ways that best fit their life priorities. New research institutes are emerging to support independent scholars and expand access to the knowledge economy.

The Biden-Harris Administration should further strengthen independent scholarship by (1) facilitating partnerships between independent scholarship institutions and conventional research entities; (2) creating professional-development opportunities for independent scholars; and (3) allocating more federal funding for independent scholarship.

Challenge and Opportunity

The academic sector is often seen as a rich source of new and groundbreaking ideas in the United States. But it has become increasingly evident that pinning all our nation’s hopes for innovation and scientific advancement on the academic sector is a mistake. Existing models of academic scholarship are limited, leaving little space for any exploration, out-of-the-box thinking, and new perspectives. Our nation’s universities, which are shedding full-time faculty positions at an alarming rate, no longer offer as reliable and attractive career opportunities for young thinkers as they once did. Conventional scholarly career pathways, which were initially created with male breadwinners in mind, are strewn with barriers to broad participation. But outside of academia, there is a distinct lack of market incentive structures that support geographically diverse development and implementation of new ideas. 

These problems are compounded by the fact that conventional scholarly training pathways are long, expensive, and unforgiving. A doctoral program takes an average of 5.8 years and $115,000 to complete. The federal government spends $75 billion per year on financial assistance for students in higher education. Yet inflexible academic structures prevent our society from maximizing returns on these investments in human capital. Individuals who pursue and complete advanced scholarly training but then opt to take a break from the traditional academic pipeline — whether to raise a family, explore another career path, or deal with a personal crisis — can find it nearly impossible to return. This problem is especially pronounced among first-generation students, women of color, and low income groups. A 2020 study found that out of the 67% of Ph.D. students who wanted to stay in academia after completing their degree, only 30% of those people did. Outside of academia, though, there are few obvious ways for even highly trained individuals to contribute to the knowledge economy. The upshot is that every year, innumerable great ideas and scholarly contributions are lost because ideators and scholars lack suitable venues in which to share them.

Fortunately, an alternative model exists. The rise of the gig economy has positioned independent scholarship as a viable approach to work and research. Independent scholarship recognizes that research doesn’t have to be a full-time occupation, be conducted via academic employment, or require attainment of a certain degree. By being relatively free of productivity incentives (e.g., publish or perish), independent scholarship provides a flexible work model and career fluidity that allows people to pursue research interests alongside other life and career goals. 

Online independent-scholarship institutes (ISIs) like the Ronin Institute, IGDORE, and others have recently emerged to support independent scholars. By providing an affiliation, a community, and a boost of confidence, such institutes empower independent scholars to do meaningful research. Indeed, the original perspectives and diverse life experiences that independent scholars bring to the table increase the likelihood that such scholars will engage in high-risk research that can deliver tremendous benefits to society. 

But it is currently difficult for ISIs to help independent scholars reach their full potential. ISIs generally cannot provide affiliated individuals with access to resources like research ethics review boards, software licenses, laboratory space, scientific equipment, computing services, and libraries. There is also concern that without intentionally structuring ISIs around equity goals, ISIs will develop in ways that marginalize underrepresented groups. ISIs (and individuals affiliated with them) are often deemed ineligible for research grants, and/or are outcompeted for grants by well-recognized names and affiliations in academia. Finally, though independent scholarship is growing, there is still relatively little concrete data on who is engaging in independent scholarship, and how and why they are doing so. 


Strengthening support for ISIs and their affiliates is a promising way to fast-track our nation towards needed innovation and technological advancements. Augmenting the U.S. knowledge-economy infrastructure with agile ISIs will pave the way for new and more flexible scholarly work models; spur greater diversity in scholarship; lift up those who might otherwise be lost Einsteins; and increase access to the knowledge economy as a whole.

Plan of Action

The Biden-Harris Administration should consider taking the following steps to strengthen independent scholarship in the United States: 

  1. Facilitate partnerships between independent scholarship institutions and conventional research entities.
  2. Create professional-development opportunities for independent scholars.
  3. Allocate more federal funding for independent scholarship.

More detail on each of these recommendations is provided below.

1. Facilitate partnerships between ISIs and conventional research entities.

The National Science Foundation (NSF) could provide $200,000 to fund a Research Coordination Network or INCLUDES alliance of ISIs. This body would provide a forum for ISIs to articulate their main challenges and identify solutions specific to the conduct of independent research (see FAQ for a list) — solutions may include exploring Cooperative Research & Development Agreements (CRADAs) as mechanisms for accessing physical infrastructure needed for research. The body would help establish ISIs as recognized complements to traditional research facilities such as universities, national laboratories, and private-sector labs. 

NSF could also include including ISIs in its proposed National Networks of Research Institutes (NNRIs). ISIs meet many of the criteria laid out for NNRI affiliates, including access to cross-sectoral partnerships (many independent scholars work in non-academic domains), untapped potential among diverse scholars who have been marginalized by — or who have made a choice to work outside of — conventional research environments, novel approaches to institutional management (such as community-based approaches), and a model that truly supports the “braided river” or ”ecosystem” career pathway model. 

The overall goal of this recommendation is to build ISI capacity to be effective players in the broader knowledge-economy landscape. 

2. Create professional-development opportunities for independent scholars. 

To support professional development among ISIs, The U.S. Small Business Administration and/or the NSF America’s Seed Fund program could provide funding to help ISI staff develop their business models, including funding for training and coaching on leadership, institutional administration, financial management, communications, marketing, and institutional policymaking. To support professional development among independent scholars directly, the Office of Postsecondary Education at the Department of Education — in partnership with professional-development programs like Activate, the Department of Labor’s Wanto, and the Minority Business Development Agency — can help ISIs create professional-development programs customized towards the unique needs of independent scholars. Such programs would provide mentorship and apprenticeship opportunities for independent scholars (particularly for those underrepresented in the knowledge economy), led by scholars experienced with working outside of conventional academia.

The overall goal of this recommendation is to help ISIs and individuals create and pursue viable work models for independent scholarship. 

3.  Allocate more federal funding for independent scholarship.

Federal funding agencies like NSF struggle to diversify the types of projects they support, despite offering funding for exploratory high-risk work and for early-career faculty. A mere 4% of NSF funding is provided to “other” entities outside of private industry, federally supported research centers, and universities. But outside of the United States, independent scholarship is recognized and funded. NSF and other federal funding agencies should consider allocating more funding for independent scholarship. Funding opportunities should support individuals over institutions, have low barriers to entry, and prioritize provision of part-time funding over longer periods of time (rather than full funding for shorter periods of time).

Funding opportunities could include: 

Conclusion

Our nation urgently needs more innovative, broadly sourced ideas. But limited traditional career options are discouraging participation in the knowledge economy. By strengthening independent scholarship institutes and independent scholarship generally, the Biden-Harris Administration can help quickly diversify and grow the pool of people participating in scholarship. This will in turn fast-track our nation towards much-needed scientific and technological advancements.

Frequently Asked Questions
What comprises the traditional academic pathway?

The traditional academic pathway consists of 4–5 years of undergraduate training (usually unfunded), 1–3 years for a master’s degree (sometimes funded; not always a precondition for enrollment in a doctoral program), 3–6+ years for a doctoral degree (often at least partly funded through paid assistantships), 2+ years of a postdoctoral position (fully funded at internship salary levels), and 5–7 years to complete the tenure-track process culminating in appointment to an Associate Professor position (fully funded at professional salary levels).

What is independent scholarship?

Independent scholarship in any academic field is, as defined by the Effective Altruism Forum, scholarship “conducted by an individual who is not employed by any organization or institution, or who is employed but is conducting this research separately from that”.

What benefits can independent scholars offer academia and the knowledge economy?

Independent scholars can draw on their varied backgrounds and professional experience to bring fresh and diverse worldviews and networks to research projects. Independent scholars often bring a community-oriented and collaborative approach to their work, which is helpful for tackling pressing transdisciplinary social issues. For students and mentees, independent scholars can provide connections to valuable field experiences, practicums, research apprenticeships, and career-development opportunities. In comparison to their academic colleagues, many independent scholars have more time flexibility, and are less prone to being influenced by typical academic incentives (e.g., publish or perish). As such, independent scholars often demonstrate long-term thinking in their research, and may be more motivated to work on research that they feel personally inspired by.

What is an independent scholarship institute (ISI)?

An ISI is a legal entity or organization (e.g, a nonprofit) that offers an affiliation for people conducting independent scholarship. ISIs can take the form of research institutes, scholarly communities, cooperatives, and others. Different ISIs can have different goals, such as emphasizing work within a specific domain or developing different ways of doing scholarship. Many ISIs exist solely online, which allows them to function in very low-cost ways while retaining a broad diversity of members. Independent scholarship institutes differ from professional societies, which do not provide an affiliation for individual researchers.

Why does a purportedly independent scholar need to be affiliated with an institute?

As the Ronin Institute explains, federal grant agencies and many foundations in the United States restrict their support to individuals affiliated with legally recognized classes of institutions, such as nonprofits. For individual donors, donations made to independent scholars via nonprofits are tax-deductible. Being affiliated with a nonprofit dedicated to supporting independent scholars enables those scholars to access the funding needed for research. In addition, many independent scholars find value in being part of a community of like-minded individuals with whom they can collaborate and share experiences and expertise.

What are some examples of existing independent scholarship institutes?
How do ISIs differ from universities?

Universities are designed to support large complex grants requiring considerable infrastructure and full-time support staff; their incentive structures for faculty and students mirror these needs. In contrast, research conducted through an independent-scholarship model is often part-time, inexpensive, and conducted by already trained researchers with little more than a personal computer. With their mostly online structures, ISIs can be very cost effective. They have agile and flexible frameworks, with limited bureaucracy and fewer competing priorities. ISIs are best positioned to manage grants that are stand alone, can be administered with lower indirect rates, require little physical research infrastructure, and fund individuals partnering with collaborators at universities. While toxic academic environments often push women and minority groups out of universities and academia, agile ISIs can take swift and decisive action to construct healthier work environments that are more welcoming of non-traditional career trajectories. These qualities make ISIs great places for testing high-risk, novel ideas.

What types of collaboration agreements could traditional knowledge-economy institutions enter into with ISIs?

Options include:


Curing Alzheimer’s by Investing in Aging Research

Summary

Congress allocates billions of dollars annually to Alzheimer’s research in hopes of finding an effective prophylactic, treatment, or cure. But these massive investments have little likelihood of paying off absent a game-changing improvement in our present knowledge of biology. Funds currently earmarked for Alzheimer’s research would be more productive if they were instead invested into deepening understanding of aging biology at the cell, tissue, and organ levels. Fundamental research advances in aging biology would directly support better outcomes for patients with Alzheimer’s as well as a plethora of other chronic diseases associated with aging — diseases that are the leading cause of mortality and disability, responsible for 71% of annual deaths worldwide and 79% of years lived with disability. Congress should allow the National Institute on Aging to spend funds currently restricted for research into Alzheimer’s specifically on research into aging biology more broadly. The result would be a society better prepared for the imminent health challenges of an aging population.

Challenge and Opportunity

The NIH estimates that 6.25 million Americans now have Alzheimer’s disease, and that due to an aging population, that number will more than double to 13.85 million by the year 2060. The Economist similarly estimates that an estimated 50 million people worldwide suffer dementia, and that that number will increase to 150 million by the year 2050. These dire statistics, along with astute political maneuvering by Alzheimer’s advocates, have led Congress to earmark billions of dollars of federal health-research funds for Alzheimer’s disease.

President Obama’s FY2014 and FY2015 budget requests explicitly cited the need for additional Alzheimer’s research at the National Institutes of Health (NIH). In FY2014, Congress responded by giving the NIH’s National Institute on Aging (NIA) a small but disproportionate increase in funding relative to other national institutes, “in recognition of the Alzheimer’s disease research initiative throughout NIH.” Congress’s explanatory statement for its FY2015 appropriations laid out good reasons not to earmark a specific portion of NIH funds for Alzheimer’s research, stating:

“In keeping with longstanding practice, the agreement does not recommend a specific amount of NIH funding for this purpose or for any other individual disease. Doing so would establish a dangerous precedent that could politicize the NIH peer review system. Nevertheless, in recognition that Alzheimer’s disease poses a serious threat to the Nation’s long-term health and economic stability, the agreement expects that a significant portion of the recommended increase for NIA should be directed to research on Alzheimer’s. The exact amount should be determined by scientific opportunity of additional research on this disease and the quality of grant applications that are submitted for Alzheimer’s relative to those submitted for other diseases.”

But this position changed suddenly in FY2016, when Congress earmarked $936 million for Alzheimer’s research. The amount earmarked by Congress for Alzheimer’s research has risen almost linearly every year since then, reaching $3.1 billion in FY2021 (Figure 1).

This tsunami of funding has been unprecedented for the NIA. The seemingly limitless availability of money for Alzheimer’s research has created a perverse incentive for the NIH and NIA to solicit additional Alzheimer’s funding, even as agencies struggle to deploy existing funding efficiently. The NIH Director’s latest report to Congress on Alzheimer’s funding suggests that with an additional $226 million per year in funding, the NIH and NIA could effectively treat or prevent Alzheimer’s disease and related dementias by 2025. 

This is a laughable untruth. No cure for Alzheimer’s is in the offing. Progress on Alzheimer’s research is stalling and commercial interest is declining. Of the 413 Alzheimer’s clinical trials performed in the United States between 2002 and 2012, 99.6% failed. Recent federal investments seemed to be paying off when in 2021 the Food and Drug Administration (FDA) approved Aduhelm, the first new treatment for Alzheimer’s since 2003. But the approval was based on the surrogate endpoint of amyloid plaques in the brain as observed by PET scans, not on patient outcomes. In its first months on the market, Aduhelm visibly flopped. Scientists subsequently called on the FDA to withdraw marketing approval for the drug. If an effective treatment were likely by 2025, Big Pharma would be doubling down. But Pfizer announced it was abandoning Alzheimer’s research in 2018.

The upshot is clear: lavish funding on treatments and cures for a disease can only do so much absent knowledge of that disease’s underlying biological mechanisms. We as a society must resist the temptation to waste money on expensive shots in the dark, and instead invest strategically into understanding the basic biochemical and genetic mechanisms underlying aging processes at the cell, tissue, and organ levels.

Plan of Action

Aging is the number-one risk factor for Alzheimer’s disease, as it is for many other diseases. All projections of an increasing burden of Alzheimer’s are based on the fact that our society is getting older. And indeed, even if a miraculous cure for Alzheimer’s were to emerge, we would still have to contend with an impending onslaught of other impending medical and social costs. 

Economists and scientists have estimated extending average life expectancy in the United States by one year is worth $38 trillion. But funding for basic research on aging remains tight. Outside of the NIA, several foundations in the United States are actively funding aging research: the American Federation for Aging Research (AFAR), The Glenn Foundation for Medical Research, and the SENS Foundation each contribute a few million per year for aging research. Privately funded fast grants have backed bold aging projects with an additional $26 million. 

This relatively small investment in basic research has generated billions in private funding to commercialize findings. Startups raised $850 million in 2018 to target aging and age-related diseases. Google’s private research arm Calico is armed with billions and a pharmaceutical partner in Abbvie, and the Buck Institute’s Unity Biotechnology launched an initial public offering (IPO) in 2018. In 2021, Altos Labs raised hundreds of millions to commercialize cellular reprogramming technology. Such dynamism and progress in aging research contrasts markedly with the stagnation in Alzheimer’s research and indicates that the former is a more promising target for federal research dollars.

Now is the time for the NIA to drive science-first funding for the field of aging. Congress should maintain existing high funding levels at NIA, but this funding should no longer be earmarked solely for Alzheimer’s research. In every annual appropriation since FY2016, the House and Senate appropriations committees have issued a joint explanatory statement that has force of law and includes the Alzheimer’s earmark. These committees should revert to their FY2015 position against politically directing NIH funds towards particular ends. The past six years have shown such political direction to be a failed experiment.

Removing the Alzheimer’s earmark would allow the NIA to use its professional judgment to fund the most promising research into aging based on scientific opportunity and the quality of the grant applications it receives. We expect that this in turn would cause agency-funded research to flourish and stimulate further research and commercialization from industry, as privately funded aging research already has. Promising areas that the NIA could invest in include building tools for understanding molecular mechanisms of aging, establishing and validating aging biomarkers, and funding more early-stage clinical trials for promising drugs. By building a better understanding of aging biology, the NIA could do much to render even Alzheimer’s disease treatable.

Frequently Asked Questions
How did Congress get so interested in Alzheimer’s disease? What recent actions has Congress taken on funding for Alzheimer’s research?

In 2009, a private task force calling itself the Alzheimer’s Study Group released a report entitled “A National Alzheimer’s Strategic Plan.” The group, co-chaired by former Speaker of the House Newt Gingrich and former Nebraska Senator Bob Kerrey, called on Congress to immediately increase funding for Alzheimer’s and dementia research at the NIH by $1 billion per year.


In response to the report, Senators Susan Collins and Evan Bayh introduced the National Alzheimer’s Project Act (NAPA), which was signed into law in 2011 by Barack Obama. NAPA requires the Department of Health and Human Services to produce an annual assessment of the nation’s progress in preparing for an escalating burden of Alzheimer’s disease. This annual assessment is called the National Plan to Address Alzheimer’s Disease. The first National Plan, released in 2012, established a goal of effectively preventing or treating Alzheimer’s disease by 2025. In addition, the Alzheimer’s Accountability Act, which passed in the 2015 omnibus, gives the NIH director the right and the obligation to report directly to Congress on the amount of additional funds needed to meet the goals of the national plan, including the self-imposed 2025 goal.

Why is treating Alzheimer’s so hard?

Understanding diseases that progress over a long period of time such as Alzheimer’s requires complex clinical studies. Lessons learned from past research indicate that animal models don’t necessarily translate into humans when it comes to such diseases. Heterogeneity in disease presentation, imprecise clinical measures, relevance of target biomarkers, and difficulty in understanding underlying causes exacerbate the problem for Alzheimer’s specifically.


Alzheimer’s is also a whole-system, multifactorial disease. Dementia is associated with a decreased variety of gut microbiota. Getting cataract surgery seemingly reduces Alzheimer’s risk. Inflammatory responses from the immune system can aggravate neurodegenerative diseases. The blood-brain barrier uptakes less plasma protein with age. The list goes on. Understanding Alzheimer’s hence requires understanding of many other biological systems.

What is the amyloid hypothesis?

Alzheimer’s is named after Alois Alzheimer, a German scientist credited with publishing the first case of the disease in 1906. In the post-mortem brain sample of his patient, he identified extracellular deposits, now known as amyloid plaques, clumps of amyloid-beta (Aβ) protein. In 1991, David Allsop and John Hardy proposed the amyloid hypothesis after discovering a pathogenic mutation in the APP (Aβ precursor protein) gene on chromosome 21. Such a mutation led to increased Aβ deposits which present as early-onset Alzheimer’s disease in families.


The hypothesis suggested that Alzheimer’s follows the pathological cascade of Aβ aggregation → tau phosphorylation → neurofibrillary tangles → neuronal death. These results indicated that Aβ could be a drug target for Alzheimer’s disease.


In the 1990s, Elan Pharmaceuticals proposed a vaccine against Alzhiemer’s by stopping or slowing the formation of Aβ aggregates. It was a compelling idea. In the following decades, drug development centered around this hypothesis, leading to the current approaches to Alzhiemer’s treatment: Aβinhibition (β- and γ-secretase inhibitors), anti-aggregation (metal chelators),  Aβ clearing (protease-activity regulating drugs), and immunotherapy.


In the last decade, the growing arsenal of Aβ therapies fueled the excitement that we were close to an Alzheimer’s treatment. The 2009 report, the 2012 national plan, and Obama’s funding requestsseemed to confirm that this was the case.


However, the strength of the amyloid hypothesis has declined since then. Since the shutdown of the first Alzheimer’s vaccine in 2002, numerous other pharmaceutical companies have tried and failed at creating their own vaccine, despite many promising assets shown to clear Aβ plaques in animal models. Monoclonal antibody treatments (of which aducanamab is an example) have reduced free plasma concentrations of Aβ by 90%, binding to all sorts of Aβ from monomeric and soluble Aβ to fibrillar and oligomeric Aβ. These treatments have suffered high-profile late-stage clinical trial failures in the last five years. Similar failures surround other approaches to Alzheimer’s drug development.


There is no doubt these therapies are successful at reducing Aβ concentration in pre-clinical trials. But combined with the continuous failure of these drugs in late-stage clinical trials, perhaps Aβ does not play as major a role in the mechanistic process as hypothesized.

Smarter Zoning for Fair Housing

Summary

Exclusionary zoning is damaging equity and inhibiting growth and opportunity in many parts of America. Though the Supreme Court struck down expressly racial zoning in 1917, many local governments persist with zoning that discriminates against low-wage families — including many families of color.1 Research shows that has connected such zoning to racial segregation, creating greater disparities in measurable outcomes.2

By contrast, real-world examples show that flexible zoning rules — rules that, for instance, that allow small groups to opt into higher housing density while bypassing veto players, or that permit some small areas to opt out of proposed zoning reforms — can promote housing fairness, supply, and sustainability. Yet bureaucratic and knowledge barriers inhibit broad implementation of such practices. To facilitate zoning reform, the Department of Housing and Urban Development should (i) draft model smarter zoning codes, (ii) fund efforts to evaluate the impact of smarter zoning practices, (iii) support smarter zoning pilot programs at the state and local levels, and (iv) coordinate with other federal programs and agencies on a whole-of-government approach to promote smarter zoning.

Challenge and Opportunity

Economists across the political spectrum agree that restrictive zoning laws banning inclusive, climate-friendly, multi-family housing have made housing less affordable, increased racial segregation and damaged the environment. Better zoning would enable fairer housing outcomes and boost growth across America.

The Biden-Harris administration is actively working to eliminate exclusionary zoning in order to advance the administration’s priorities of racial justice, respect for working-class people, and national unity. But in many states with unaffordable housing, local politics have made zoning reform painfully slow and/or precarious. In California, for instance, zoning-reform activists have garnered significant victories. But a recently launched petition to limit state power over zoning might undo some of the progress made so far. There is an urgent need for strategies to overcome political gridlock limiting or inhibiting zoning reform at the state and local levels.

Fortunately, a suite of new smarter zoning techniques can achieve needed reforms while alleviating political concerns. Consider Houston, TX, which faced resistance in reducing suburban minimum lot sizes to allow more housing. To overcome political obstacles, the city gave individual streets and blocks the option to opt out of the proposed reform. That simple technique reduced resistance and allowed the zoning measure to pass. The powerful incentives from increased land value meant that although opt outs reached nearly 50% in one neighborhood, they were rare in many others.3 The American Planning Association similarly published a proposal to allow opt-ins for upzoning at a street-by-street level — a practice that would allow small groups to bypassing those who currently block reform in order capture the huge incentives of upzoning.

In fact, opt-ins and opt-outs are proven methods of overcoming political obstacles in other policy fields, including parking reform and “play streets” in urban policy. Opt-ins and opt-outs reduce officials’ and politicians’ concerns that a vocal and unrepresentative group will blame them for reforms. While reformers may fear that allowing exemptions may weaken zoning reforms, the enormous increase in land value created by upzoning in unaffordable areas provides powerful incentives for small groups of homeowners to choose upzoning of their own lots. And by offering a pathway to circumvent opposition, flexible smarter zoning reforms can expedite construction of abundant new affordable housing that substantially improves equity, opportunity, and quality of life for working-class Americans. 

Absent action by HUD to encourage trials of innovative techniques, the pace of reform will continue to be much slower than it needs to be. Campaigners at state and local government level will continue to face opposition and setbacks. The pace of growth and innovation will be damaged, as bad zoning continues to block the benefits of mobility and opportunity. And disadvantaged minorities will continue to suffer the most from unjust and exclusionary zoning rules.xc

Plan of Action

The Department of Housing and Urban Development (HUD) should take the following steps to facilitate zoning reform in the United States: 

1. Create a model Smarter Zoning Code

HUD’s Office of Policy Development and Research, working with the Environmental Protection Agency (EPA)’s Office of Community Revitalization, should produce a model Smarter Zoning Code that state and local governments can adopt and adapt. The Smarter Zoning Code would provide a variety of options for state and local governments to minimize backlash against zoning reforms by reducing effects on other streets or blocks. Options could include:4

A draft of a model Smarter Zoning Code could be developed for $1 million and could be tested by seeking views from a range of stakeholders for $5 million. The model code should be highlighted in HUD’s Regulatory Barriers Clearinghouse.

2. Collect and showcase evidence on effectiveness and impacts of smarter zoning practices

As part of the list of policy-relevant questions in its systematic plan under the Foundations for Evidence-Based Policymaking Act of 20187, HUD should include the question of which types of zoning approaches, including smarter zoning, can best (i) help to address or overcome political and other barriers to meeting fair-housing standards, and (ii) support plentiful supplies of affordable housing to address equity and other issues.

HUD should also provide research grants under the Unlocking Possibilities Program8, once passed, to evaluate the impact of Smarter Zoning techniques, suggest improvements to the model Smarter Zoning Code, and prepare and showcase successful case studies of flexible zoning.

Finally, demonstrated thought leadership by the Biden-Harris Administration could kickstart a new wave of innovation in smarter zoning that helps address historic equity issues. HUD should work with the White House and key stakeholder groups (e.g., the American Planning Association, the National League of Cities, the National Governors’ Association) to host a widely publicized event on Planning for Opportunity and Growth. The event would showcase proven, innovative zoning practices that can help state and local government representatives meet housing and growth objectives.

3. Launch smarter-zoning pilot projects

Subject to funding through the Unlocking Possibilities Program, the HUD Secretary should direct HUD’s Office of Technical Assistance and Management to launch a collection of pilot projects for the implementation of the model Smarter Zoning Code. Specifically, HUD would provide planning grants to help states, local governments, and potentially other groups improve skills and technical capacity needed to implement or promote Smarter Zoning reforms. The technical assistance to help a local government adopt smarter zoning, where possible under existing state law, should cost less than $100,000; technical assistance for a state to enable smarter zoning on a state-wide basis should cost less than $500,000.

4. Promote federal incentives and coordination around smarter zoning

Model codes, evidence-based practices, and planning grants can help advance upzoning in areas that are already interested. The federal government could also provide stronger incentives to encourage more reluctant areas to adopt smarter zoning. It is lawful to condition a portion of federal funds upon criteria that are “directly related to one of the main purposes for which [such funds] are expended”, so long as the financial inducement is not “so coercive as to pass the point at which ‘pressure turns into compulsion’”.9 For instance, one of the purposes of highway funds is to reduce congestion in interstate traffic. Failure to allow walkable urban densification limits the opportunities for travel other than by car, which in turn increases congestion on federal highways. It would therefore be constitutional for the federal government to withhold 5% of federal highway funds from states that do not enact smarter zoning provisions. Similarly, funding for affordable home care proposed under the Build Back Better Act will be less effective in areas where exclusionary zoning makes it less affordable for carers to live. A portion of such funding could be withheld from states that do not pass smarter zoning laws. Similar action could be taken on federal funds for education, where unaffordable housing affects the supply of teachers, and on federal funds to fight climate change, because sprawl driven by single-family zoning increases carbon emissions.

HUD’s Office of Fair Housing and Equal Opportunity should consult with other federal bodies on what federal funding can be made conditional upon participation by state and local governments in smarter zoning programs, as well as on when implementing such conditions would require Congressional approval. HUD should similarly consult with other federal bodies on creative opportunities to incentivize smarter zoning through existing programs. If Congress does not wish to amend the law, it may be possible for other agencies to condition funding upon implementation of smarter zoning provisions at state or local level. Although smarter zoning will also benefit existing residents, billions of dollars of incentives may be needed for the most reluctant states and local governments to overcome existing veto players to get more equitable zoning.

Conclusion

Urgent reform is needed to address historic damage caused to equity by zoning rules, originally explicitly racist in language, that remain economically exclusionary in intent and racially discriminatory in impact. By modeling smarter zoning practices, demonstrating their benefits, providing financial and technical assistance for implementation, and conditioning federal funding upon adoption, HUD can accelerate and expand adoption of beneficial flexible zoning reforms nationwide.

Frequently Asked Questions
1. Why expend effort on flexible smarter zoning as opposed to more traditional, sweeping zoning reforms?

Many proposed zoning reforms that, if implemented, would go the furthest to improve equity and provision of fair housing have encountered considerable political challenges in areas where exclusionary zoning is most prevalent and damaging. Flexible zoning reforms may have apparently less sweeping impacts than traditional zoning reforms, but are also far more feasible in practice. Providing additional ideas to help overcome those political barriers may be a powerful way to unlock improvements in equity.

2. Would giving small groups the power to opt into upzoning really produce additional housing? Would giving small groups the power to opt out considerably weaken zoning reforms?

To be clear, there is no suggestion to give small groups the power to opt into zoning that is more restrictive than current rules. Flexible zoning reform can often be more powerful than traditional zoning reform. Members of the Squamish Nation recently demonstrated the enormous power of economic incentives to upzone when 87% voted to approve the construction of 6,000 new homes on their territory. Similarly, a large fraction of the residents of Houston — recognizing that upzoning could make their properties more valuable — did not choose to opt their blocks out of recent zoning reform. Incentives for apartment owners to vote for redevelopment under the TAMA 38 scheme in Israel accounted for 35% of the new homes built in Tel Aviv in 2020.


If no individual landowners wanted to gain the economic benefits of being permitted to develop their lots, there would be no demand from others for zoning rules to stop development from proceeding. Most existing processes governing upzoning give disproportionate weight to the opinions of vocal but unrepresentative groups who want no change, even in areas where a large majority would otherwise support reform. Direct democracy at very small scales can let small groups of residents bypass those veto players and capture the economic benefits of allowing more housing.

3. Why would any state or local government implement flexible smarter zoning?

Many state and local leaders are aware of the enormous equity and growth benefits that better, more inclusionary zoning can deliver. However, such leaders are often frustrated by political and public resistance to simple upzoning attempted via traditional zoning processes. Smarter zoning techniques can allow upzoning to proceed in the many blocks and streets where it is popular, without being frustrated by the resistance from the few residents among whom it is not.

4. Would smarter zoning practices crowd out more sweeping zoning reforms?

Smarter zoning proposals are designed to supplement and assist traditional zoning reforms, not replace them. “Opt-in” zoning mechanisms are designed to allow opt-ins only to more equitable upzoning, not to more exclusionary zoning, so they cannot make matters worse. Similarly, “opt-out” mechanisms only apply where the promoters of an ambitious new pro-equity reform want a way to overcome strong political resistance to that specific reform.


 


Another objection is that smarter zoning might be seen to perpetuate local zoning control. But existing local zoning processes are structured to block change and empower local veto players. By contrast, smarter zoning techniques are designed so that groups who wish to capture the economic benefits of upzoning can use direct democracy to bypass existing veto players, in a way that has proven successful in other fields. Where smarter zoning is imposed by state law, it can hardly be said to be entrenching local control. And in any case, existing state powers to override local zoning will remain, as will the potential for future federal action on zoning.

5. Could smarter zoning policies harm renters?

Not if designed correctly. As explained above, smarter zoning codes can and should include strong provisions to protect renters.

6. How quickly could HUD and EPA develop a Smarter Zoning Code?

An initial draft of a model Smarter Zoning Code could likely be produced within three months. Testing with stakeholders should take no more than six months, meaning that a final code could be published by HUD within one year of the effort beginning.

7. Who is likely to object to smarter zoning?

  • Officials wedded to traditional zoning processes may not wish to try innovative methods to improve equity, but smarter zoning proposals have been published by the American Planning Association and have little risk of harm.

  • Resistance will arise from some residents of areas with exclusionary zoning. However, such resistance will be less than the resistance to universal upzoning mandates. And this resistance will be counterbalanced and often outweighed by the support of the many residents drawn by the economic benefits of upzoning for them and their families.

  • Advocates of aggressive zoning reform may complain that smarter zoning is not sufficiently assertive. One response to this objection is that federal powers to impose such upzoning are highly constrained by political gridlock and partisanship. Smarter zoning is a politically feasible way to advance equitable zoning in the near term, while the campaign for broader national zoning reform continues in the long term.