The National Institutes of Health (NIH): Background and Congressional Issues
Congressional research reportJan 13, 2025
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The National Institutes of Health (NIH):
Background and Congressional Issues
Updated January 13, 2025
Congressional Research Service
https://crsreports.congress.gov
R41705
SUMMARY
The National Institutes of Health (NIH):
Background and Congressional Issues
The National Institutes of Health (NIH), under the Department of Health and Human Services
(HHS), is the leading federal agency for biomedical and health research. In FY2024, NIH used its
over $47 billion budget to support more than 300,000 scientists and research personnel working
at over 2,500 institutions across the United States and abroad, as well as to conduct research and
training at its own facilities. The agency consists of the Office of the Director, in charge of
overall policy and program coordination, and 27 institutes and centers, each of which focuses on
particular diseases, research areas, or agency support services. Over 80% of NIH-supported
research is funded through a highly competitive system of peer-reviewed grants and contracts.
R41705
January 13, 2025
Kavya Sekar
Analyst in Health Policy
For a copy of the full report,
please call 7-5700 or visit
www.crs.gov.
The Public Health Service Act (PHSA) provides the statutory basis for NIH programs, and funding levels are provided
mostly through the annual appropriations process. In December 2016, Congress introduced major reforms and programs at
NIH through the 21st Century Cures Act (P.L. 114-255). Prior to 2016, the last time Congress addressed NIH with
comprehensive legislation was in December 2006 through the NIH Reform Act (P.L. 109-482). Congress also gives some
direction to NIH through appropriations report language and some program-specific authorizations. In recent decades,
Congress has accepted, for the most part, the scientific and public health priorities established by the agency through its
planning and grant-making activities that involve members of the scientific community and the general public.
NIH has seen budget fluctuations throughout its history. From FY1998 to FY2003, Congress doubled the NIH budget from
$13.7 billion to $27.1 billion, which rapidly increased NIH’s purchasing power and subsequently the nation’s funded
research workforce and projects. The agency then saw low funding growth or cuts from FY2004 to FY2015, which resulted
in increased competition for NIH funding as the agency’s purchasing power decreased. Starting in FY2016, Congress
provided NIH with funding increases each year, raising the program level from about $30 billion in FY2015 to $47.7 billion
in FY2023. In FY2024, NIH’s funding level slightly decreased from the prior year.
NIH officials and scientific observers have cited funding variability and uncertainty as a challenge for the agency. Along with
funding uncertainty, other challenges facing the agency and the broader research enterprise include
•
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whether to change NIH’s large and decentralized structure, and if so, how;
•
how to address geopolitical and security dimensions of NIH research, particularly interference from foreign
governments and other potential biosecurity issues;
•
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how to balance the public and private sectors’ relative roles in biomedical research;
determining NIH’s research priorities across disease types, areas of human health, and types of research;
how to balance new and existing funding commitments amid budget fluctuations;
how to ensure a robust research workforce pipeline, particularly to enable early-career researchers to enter
the field;
whether and how to formulate policies around pharmaceutical drugs developed, in part, through NIHfunded research, and, in particular, how to address issues associated with access and affordability of such
drugs.
This CRS report provides background and analysis on NIH’s organization, mission, budget, and history; outlines the
agency’s major responsibilities; and discusses some of the issues facing Congress as it works to guide and monitor the
nation’s investment in medical and health research through NIH.
Congressional Research Service
The National Institutes of Health (NIH): Background and Congressional Issues
Contents
Introduction ..................................................................................................................................... 1
Background on NIH ........................................................................................................................ 2
History ....................................................................................................................................... 2
Organizational Structure ........................................................................................................... 3
Recent Major Legislative History ............................................................................................. 4
Authority ................................................................................................................................... 6
Recent Authorization of Appropriations ............................................................................. 7
NIH Research Activities .................................................................................................................. 7
Types of Research at NIH ......................................................................................................... 8
Extramural Research ............................................................................................................... 10
Scientific Peer Review Process for Extramural Funding ................................................... 11
Grants Policy..................................................................................................................... 15
Grants Administration and Oversight ............................................................................... 16
Research Grants: By the Numbers .................................................................................... 17
Intramural Research ................................................................................................................ 18
Research Training.................................................................................................................... 19
Information Dissemination...................................................................................................... 20
Budget ........................................................................................................................................... 20
Foundation for the NIH ........................................................................................................... 23
Setting NIH Research Priorities .................................................................................................... 23
NIH Process in Setting Research Priorities ............................................................................. 24
Strategic Planning ............................................................................................................. 25
Coordinating Across NIH ................................................................................................. 25
Coordinating Across the Federal Government .................................................................. 26
Congressional Involvement in NIH Research Priorities ......................................................... 27
Appropriations .................................................................................................................. 27
Authorizations ................................................................................................................... 28
Research Restrictions ........................................................................................................ 29
Selected Recent Research Initiatives ............................................................................................. 30
Alzheimer’s Disease and Related Dementias Research .......................................................... 30
21st Century Cures Act Innovation Projects ............................................................................ 32
Coronavirus Disease 2019 (COVID-19) and Long COVID Research.................................... 35
Selected Issues for Congress ......................................................................................................... 40
Changing NIH’s Structure ....................................................................................................... 40
Determining NIH’s Research Priorities................................................................................... 42
Balancing New and Existing Funding Commitments ............................................................. 45
NIH and the Research Workforce Pipeline ............................................................................. 48
Next Generation Researchers Initiative ............................................................................ 49
Postdoctoral Workforce..................................................................................................... 50
Geopolitical and Security Dimensions of NIH Research ........................................................ 52
Balancing Federal and Industry Support of Research ............................................................. 55
NIH Funded Research and Pharmaceutical Drug Development ............................................. 59
Intramural Research .......................................................................................................... 61
Extramural Research ......................................................................................................... 63
Looking Ahead .................................................................................................................. 64
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The National Institutes of Health (NIH): Background and Congressional Issues
Figures
Figure 1. NIH Organization ............................................................................................................. 4
Figure 2. FY2023 NIH Obligations, by Funding Mechanism ......................................................... 8
Figure 3. “Continuum” of Biomedical Research at NIH ................................................................. 9
Figure 4. NIH Scientific Peer Review Process for Extramural Funding ....................................... 14
Figure 5. Research Grants Awarded, by Fiscal Year, 2009-2023................................................... 17
Figure 6. R01-Equivalent Grant Average Cost: 2000 to 2023 ....................................................... 18
Figure 7. NIH Funding, FY1998-FY2024 ..................................................................................... 22
Figure 8. Research Project Grants (RPG) Awarded by NIH and Success Rates for New
Grant Applications...................................................................................................................... 46
Figure 9. R01-Equivalent Grant Application Success Rates for First-Time and Established
Investigators ............................................................................................................................... 50
Figure 10. NIH Distribution of Budget Authority, Basic and Applied Research........................... 58
Tables
Table 1. NIH Alzheimer’s Disease Research Funding Directed by Congress ............................... 30
Table 2. Authorization of Appropriations for NIH Innovation Projects Under the Cures
Act .............................................................................................................................................. 33
Table 3. Components of NIH, with History and Scope ................................................................. 65
Appendixes
Appendix. Selected NIH Research Policies .................................................................................. 70
Contacts
Author Information........................................................................................................................ 72
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The National Institutes of Health (NIH): Background and Congressional Issues
Introduction
The National Institutes of Health (NIH) is the leading federal agency for biomedical and health
research. The agency has major roles in training biomedical researchers and disseminating health
information. The NIH mission is “to seek fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to enhance health, lengthen life, and
reduce illness and disability.”1 NIH supports two categories of research: extramural research,
performed by nonfederal scientists using NIH grants or other awards, and intramural research,
performed by federal NIH scientists in NIH-operated research facilities.
Congress maintains a high level of interest in NIH for a variety of reasons. NIH funds research in
every state, and widespread constituencies contact Congress about funding for particular diseases
and levels of research support in general. NIH is the largest and most visible contributor to the
federal medical and health research effort; it represents about one-fifth of total federal research
and development (R&D) funding and represents close to half of all federal R&D spending outside
of the Department of Defense.2 NIH has the largest budget of the nine health-related agencies that
make up the Public Health Service (PHS) within the Department of Health and Human Services
(HHS).3
NIH-funded research has contributed to major scientific advances. To date, 174 NIH-funded
researchers have received Nobel Prizes for their work.4 NIH-funded research has led to major
medical innovations, such as treatments for heart disease, cancer, and HIV/AIDS. Such advances
have been credited with helping increase life expectancy and prevent millions of deaths.5
In recent years, NIH has drawn Congress’s attention for many additional reasons. First, during the
Coronavirus Disease 2019 (COVID-19) pandemic, NIH played a major role in supporting
research related to the novel virus; in particular, NIH helped develop new tests, vaccines, and
therapeutics. In addition, NIH leaders became a public face of the federal government during the
pandemic, communicating health and scientific information. At the same time, NIH faced
increased scrutiny, in particular, during investigations into the origins of the virus. These
investigations drew public attention to NIH’s funding of coronavirus research in China and to the
agency’s challenges in monitoring laboratories in China that received subawards from other NIH
grantees. These discussions also drew attention to NIH’s support of so-called “gain-of-function”
research, or research that can make viruses more transmissible or pathogenic. These
conversations have led to policy discussions around broader geopolitical and security issues
associated with NIH research.
NIH has also seen a major leadership shift recently: NIH’s longtime Director Dr. Francis Collins
stepped down in 2021, after serving under three presidential administrations, and was replaced by
Director Dr. Monica Bertagnolli in 2023. Additionally, a new complementary independent agency
1 National Institutes of Health (NIH), “About the National Institutes of Health,” at https://www.nih.gov/about-nih/what-
we-do/mission-goals.
2 CRS analysis of federal research and development budget data provided by the Office of Management and Budget.
3 The Public Health Service also includes the Centers for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), the Agency for Healthcare Research and Quality (AHRQ), the Health Resources and Services
Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Indian
Health Service (IHS), the Agency for Toxic Substances and Disease Registry (ATSDR), and the Administration for
Strategic Preparedness and Response (ASPR). For further information, see CRS Report R48060, Department of Health
and Human Services: FY2025 Budget Request.
4 NIH, “Nobel Laureates,” https://www.nih.gov/about-nih/what-we-do/nih-almanac/nobel-laureates.
5 NIH, “Report of the Director: National Institutes of Health: Fiscal Years 2014 and 2015,” pp. 9-10,
https://dpcpsi.nih.gov/sites/default/files/NIH_Directors_Biennial_Report-2014-2015.pdf.
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housed within NIH was established in 2022, the Advanced Research Projects Agency for Health
(ARPA-H), which is focused on boosting health and medical innovation. In recent years, many
within and outside of Congress have discussed whether NIH warrants further reform in light of
the challenges the agency faces as discussed further in this report.
NIH is the largest single funder of health and medical research in the world, though the agency’s
funding has fluctuated over time. From FY1998 to FY2003, Congress doubled the NIH budget
over a five-year period, from $13.7 billion to $27.1 billion. The agency then saw low funding
growth or cuts from FY2004 to FY2015. From FY2016 through FY2023, Congress provided NIH
with funding increases each year, until FY2024 when NIH saw a slight decrease in its overall
budget.6
Aside from funding, other potential issues of interest for many in Congress and the research
community include
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•
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•
•
•
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whether to change NIH’s large and decentralized structure, and if so, how;
determining NIH’s research priorities across disease types, areas of human
health, and types of research;
how to balance new and existing funding commitments amid budget fluctuations;
how to ensure a robust research workforce pipeline, particularly how to support
early-career researchers to enter the field;
how to address geopolitical and security dimensions of NIH research, particularly
interference from foreign governments and other potential security biosecurity
issues;
how to balance the public and private sectors’ relative roles in biomedical
research;
whether and how to formulate policies around pharmaceutical drugs developed,
in part, through NIH-funded research, and, in particular, how to address issues
associated with access to and affordability of such drugs.
This report provides background and analysis on NIH’s history, organization, authorities, and
budget; outlines the agency’s major responsibilities; and discusses some of the issues facing
Congress as it works to guide and monitor the nation’s investment in medical research through
NIH.
Background on NIH
History
NIH traces its roots to 1887, when a one-room Laboratory of Hygiene was established at the
Marine Hospital in Staten Island, NY. Relocated to Washington, DC, in 1891 and renamed the
Hygienic Laboratory, it operated for its first half century as a research lab for the Public Health
Service.7 Congress designated the research laboratory the National Institute of Health in 1930
(P.L. 71-251). NIH moved to donated land in the Maryland suburbs in 1938. By 1948, several
new institutes and divisions had been created, and the agency was renamed as the National
Institutes of Health (P.L. 80-655). Congress and the executive branch created new institutes and
6 CRS Report R43341, National Institutes of Health (NIH) Funding: FY1996-FY2025.
7 NIH, “History,” “Chronology of Events,” at https://www.nih.gov/about-nih/who-we-are/history.
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centers (ICs) over the following decades, resulting in the 27 ICs that exist today (see Table 3).
The most recent institute was established in 2011, the National Center for Advancing
Translational Sciences (NCATS, P.L. 112-74; see Table 3). NIH now occupies a 322-acre main
campus in Bethesda, MD, and several off-campus sites, including locations in Maryland, North
Carolina, Montana, and Arizona.8
In addition, the Advanced Research Projects Agency for Health (ARPA-H) was established
recently in 2022 as an independent agency housed within NIH to advance “high-potential, highimpact” biomedical and health research. ARPA-H was first established by an appropriation in
FY2022 (P.L. 117-103) and then codified in FY2023 (P.L. 117-328). ARPA-H is modelled after
other “ARPA” agencies within the federal government, in particular, the Defense Advanced
Research Projects Agency (DARPA).
The ARPA-H Director directly reports to the
HHS Secretary; ARPA-H is not considered an
NIH IC. 9 In March 2023, the HHS Secretary
exempted ARPA-H from all of NIH policies,
except where the ARPA-H Director identifies
a need to follow NIH policy.10 Therefore, most
of the policies discussed in this report do not
apply to ARPA-H. For more information on
ARPA-H, see CRS Report R47568, Advanced
Research Projects Agency for Health (ARPAH): Overview and Selected Issues.
Organizational Structure
Selected NIH Resources
https://www.nih.gov/
Background: https://www.nih.gov/about-nih.
Budget: https://officeofbudget.od.nih.gov/index.htm.
Research, condition and disease funding
estimates: https://report.nih.gov/funding/categoricalspending#/
Health information: https://www.nih.gov/healthinformation.
Office of the Director, Institutes and Centers:
https://www.nih.gov/institutes-nih.
Grants and grants policy: https://grants.nih.gov/
grants/oer.htm.
Funded projects database: https://reporter.nih.gov/.
Peer review: https://grants.nih.gov/grants/peerreview.htm.
Chronologies (historical and legislative):
https://www.nih.gov/about-nih/what-we-do/nihalmanac/timelines.
Congressional Liaison: 301-496-3471,
https://www.nih.gov/institutes-nih/nih-office-director/
olpa.
Today, NIH is a large and complex
organization. NIH consists of the Office of the
Director and 27 components—20 research
institutes, three research centers, the National
Library of Medicine (NLM), and three other
support centers (see Figure 1). As detailed in
Table 3, NIH’s ICs were established over time
through separate laws or administrative
actions, starting with the National Cancer Institute, established in 1937.
The Office of the Director (OD) sets overall policy for NIH and coordinates the programs and
activities of all NIH components, particularly transinstitute research initiatives and issues. The
individual ICs focus on particular diseases (e.g., the National Cancer Institute), body systems
(e.g., National Heart, Lung, and Blood Institute), life stages (e.g., the National Institute on
Aging), and scientific fields (e.g., the National Institute of Biomedical Imaging and
Bioengineering). Each IC plans and manages its own research programs in coordination with OD.
Congress provides separate appropriations to 24 of the 27 ICs. This includes all 20 institutes,
8 NIH Intramural Research Program, “Research Campus Locations,” at https://irp.nih.gov/about-us/research-campus-
locations.
9 CRS Report R47568, Advanced Research Projects Agency for Health (ARPA-H): Overview and Selected Issues.
10 Pursuant to statutory authority provided in Public Health Service Act Section 499A(a)(3). See Advanced Research
Projects Agency for Health, Department of Health and Human Services, “Exemption of the Advanced Research
Projects Agency for Health (ARPA-H) From Policies and Requirements of the National Institutes of Health (NIH),” 88
Federal Register 19157, March 30, 2023.
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NLM, the three research centers, to OD, and to a buildings and facilities account (see the
“Budget” section). The three research centers include the John E. Fogarty International Center for
Advancing Study in the Health Sciences, the National Center for Advancing Translational
Sciences, and the National Center for Complementary and Integrative Health. The three support
centers are funded through transfers from other NIH components: the Clinical Center, the Center
for Information Technology, and the Center for Scientific Review.11 The institutes, NLM, the
three research centers, and OD have the authority to award research grants; the three operational
support centers do not award research grants.12
Figure 1. NIH Organization
Office of the Director and 27 Institutes and Centers
Source: Adapted based on information from NIH, “Organization,” https://www.nih.gov/about-nih/who-we-are/
organization and Public Health Service Act Title IV.
Notes: Does not include the Advanced Research Projects Agency for Health (ARPA-H), an independent agency
housed within NIH. The ARPA-H Director reports to the HHS Secretary.
Recent Major Legislative History
Since the 1980s, Congress has passed comprehensive NIH laws about once a decade. This is in
addition to many laws that have addressed specific NIH programs (discussed further in the
“Authorizations” section). Major laws have included the following:
The Health Research Extension Act of 1985 (P.L. 99-158) created the current structure of
Public Health Service Act (PHSA) Title IV, NIH’s main authorizing title (see the “Authority”
11 The three support centers are financed by the NIH Management Fund, through collections from other NIH ICs for
services provided by the support centers. See NIH, “FY2020 Congressional Budget Justification, Overview Vol. I,”
p. 94, https://officeofbudget.od.nih.gov/pdfs/FY20/br/Overview-Volume-FY-2020-CJ.pdf.
12 Authorities of the ICs are detailed in Title IV of the Public Health Service Act (PHSA). See the “Authority” section.
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The National Institutes of Health (NIH): Background and Congressional Issues
section), providing explicit statutory authority for all of NIH and its institutes, including the
authority and duties of the NIH Director and the institute directors.13 Specifically, the law
authorized 14 research institutes and centers, the National Library of Medicine, and the Division
of Research Resources. Some of these institutes and components were newly authorized in this
law. The law also included authority for the HHS Secretary to establish new or abolish existing
NIH institutes with advance notice to Congress. The law also included new statutory
requirements for the ethical treatment of both humans and animals in research.
The NIH Revitalization Act of 1993 (P.L. 103-43) extended NIH authorizations of
appropriations for three years and included many amendments throughout PHSA Title IV. A
major provision was the establishment of requirements to include women and minorities in
clinical research as appropriate for the scientific question under study (see the “Inclusion
Policies” section). The law also codified several offices at NIH, such as the Office of Women’s
Health, the Office of Research on Minority Health, and the Office of Behavioral and Social
Sciences Research. The law included several provisions focused on research integrity, and it
codified an Office of Research Integrity, along with new protections for whistleblowers and new
requirements to protect against financial conflicts of interest among researchers. In addition, the
law included many provisions focused on specific diseases, particularly many HIV/AIDS
provisions to enhance NIH-wide coordination on related research.
The NIH Reform Act of 2006 (P.L. 109-482) included major revisions to NIH’s authorizations.
Specifically, it sought to limit the creation of new NIH institutes and centers, as well as to
enhance the NIH Director’s ability to coordinate across the agency. The law followed a
congressionally requested report published in 2003 by the Institute of Medicine and National
Research Council (IOM/NRC) that had examined NIH’s structure and need for organization
reform.14 The report noted some challenges with NIH’s large and decentralized organizational
structure, made up of 27 Institutes and Centers (ICs), but stated that any proposals for changing
the number of ICs or OD program offices should be subject to a public evaluation process.15
Many of the recommendations in the 2003 IOM/NRC report were incorporated into the NIH
Reform Act of 2006 (P.L. 109-482). Among many other reforms, the act created the Scientific
Management Review Board (SMRB) to provide advice on NIH’s organization and management.
SMRB is charged with formally and publicly reviewing NIH organizational structure at least once
every seven years. The law also required a biennial report to Congress on NIH activities and
strategic planning, as well as the creation of a comprehensive database on NIH research.16 The
Reform Act also consolidated many authorizations of appropriations for specific NIH programs to
a single authorization of appropriations for the entire agency, extended from FY2007 to FY2009.
13 Prior to enactment, most of NIH’s Institutes and Centers were explicitly authorized in law, whereas others were not.
See U.S. Congress, House Energy and Commerce Committee, Health Research Extension Act of 1985, 99th Cong., 1st
sess., June 4, 1985, 99-158, pp. 19-20.
14 Institute of Medicine and National Research Council, Enhancing the Vitality of the National Institutes of Health:
Organizational Change to Meet New Challenges, 2003, https://nap.nationalacademies.org/catalog/10779/enhancingthe-vitality-of-the-national-institutes-of-health-organizational. The IOM is now known as the National Academy of
Medicine.
15 Ibid., p. 7. The IOM/NRC report recommended more rigorous and frequent review of the performance of top NIH
and IC leaders, including the possibility of term limits; reassessment by Congress of the National Cancer Institute’s
special status regarding appointments and budget authority; and reform of the advisory council system so that it is more
independent and protected from political influences.
16 Now known as the Research Portfolio Online Reporting Tools (RePORT) system. See https://report.nih.gov/. All
other duplicative reporting requirements were eliminated. The law added new reporting requirements on clinical trials,
human tissue storing and tracking, whistleblower complaints, and special consultant hires (all had been the subject of
investigations by the House Energy and Commerce Committee, the committee of jurisdiction for NIH).
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The 21st Century Cures Act (P.L. 114-255), enacted in 2016, reauthorized appropriations for
NIH until FY2020 and introduced several administrative reforms at NIH. The act required the
NIH Director to develop and make publicly available an NIH-wide Strategic Plan every six years
(see the “Strategic Planning” section). The act also introduced accountability measures, such as
five-year terms for IC Directors. Other reforms included efforts to reduce administrative burden
at NIH, such as by exempting NIH research from requirements of the Paperwork Reduction Act,
and efforts to prevent and eliminate duplicative research across the agency. The act also
authorized several programs and research efforts at NIH, in particular, by creating a new NIH
Innovation Account for funding four major research initiatives (detailed further in the “21st
Century Cures Act Innovation Projects” section).
Authority
NIH derives most of its statutory authority for its programs from the Public Health Service Act
(PHSA) of 1944, as amended (42 U.S.C. §§201-300mm-61):
PHSA Section 301 (42 U.S.C. §241) grants the HHS Secretary broad and permanent authority to
conduct and sponsor research.
PHSA Title IV, “National Research Institutes,” (42 U.S.C. Chapter 6A, Subchapter III) is the
main authorizing title for NIH. It defines the agency’s overall structure, the responsibilities of the
NIH Director and the IC Directors, overall policy requirements, and the research areas of each IC.
Key governing provisions include the following:
•
•
•
•
•
PHSA Section 401 (42 U.S.C. §281) establishes NIH as an agency within the
Public Health Service that consists of 27 ICs and the Office of the Director, and
caps the number of ICs at 27. This section also provides authority for NIH
reorganization to the HHS Secretary, as advised by the Scientific Management
Review Board (see the “Recent Major Legislative History” section).
PHSA Section 402 (42 U.S.C. §282) establishes the position of the NIH Director
and outlines its responsibilities.
PHSA Section 405 (42 U.S.C. §284) establishes the positions of IC Directors
and specifies their responsibilities, including to oversee funded research and to
make final decisions for new research grant awards.
PHSA Section 406 (42 U.S.C. §284a) establishes advisory councils and boards
for each of the ICs to oversee their programs.
PHSA Title IV, Part C-Part E (42 U.S.C. Chapter 6A, Subchapter III, Part CPart E) outlines the specific statutory authorizations for each of the research ICs.
All of the research ICs are covered by specific provisions in these sections, but
the provisions vary considerably in the amount of detail included in the statutory
language.
Some NIH programs are authorized elsewhere in the PHSA or in other laws. For example, PHSA
Title XXIII authorizes the NIH Office of AIDS Research (PHSA Section 2351)17 and other
HIV/AIDS research programs and authorities.18 As another example, the 21st Century Cures Act
(P.L. 114-255) authorizes NIH Innovation projects (see the “21st Century Cures Act Innovation
Projects” section).
17 42 U.S.C. §300cc-40.
18 42 U.S.C. §§300cc-1 et seq.
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Recent Authorization of Appropriations
In 2016, the 21st Century Cures Act (P.L. 114-255) amended the PHSA (§ 402A), authorizing
overall appropriations for NIH in FY2018 ($34,851,000,000), FY2019 ($35,585,871,000), and
FY2020 ($36,472,442,775) to carry out activities authorized in Title IV of the PHSA. The current
authorization of appropriations for NIH expired at the end of FY2020.
The overall authority for NIH, or explicit authorizations of individual ICs, has lapsed at times,
including currently. However, NIH has continued to receive annual appropriations even when its
authorization of appropriations has lapsed. In general, when Congress appropriates funds for a
program whose funding authorization has expired, that appropriation provides sufficient legal
basis to continue the program during that period of availability absent indication of congressional
intent to terminate the program.19
NIH Research Activities
NIH research spans all fields of medical, health, and behavioral research, from basic investigation
of biological mechanisms to testing new therapeutics in clinical research. The ICs sponsor two
categories of research: extramural research, performed by nonfederal scientists using NIH grants
or other awards, and intramural research, performed by federal scientists in the NIH-operated
research facilities and the Clinical Center. NIH also supports a range of extramural and intramural
research training programs, especially to prepare early-career investigators for research careers,
and it engages in a number of information dissemination activities to reach various audiences.
Funding for research makes up most of NIH spending. Figure 2 shows the breakdown of NIH
obligations by funding mechanism. Displaying budget data by mechanism reveals the balance
between extramural (e.g., research grants, research centers, and R&D contracts) and intramural
funding, as well as the relative emphasis on support of individual investigator-led research (e.g.,
research grants and intramural research) versus funding of contracted projects (e.g., R&D
contracts).
19 CRS Report R46497, Authorizations and the Appropriations Process.
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Figure 2. FY2023 NIH Obligations, by Funding Mechanism
Dollars in Millions
Source: Developed by CRS using budget data from NIH, “FY2025 Justification of Estimates for Appropriations
Committees, Vol I: Overview–History of Obligations by Total Mechanism,” p. 87. Amounts shown do not
account for the Public Health Service Evaluation Set-Aside funding or ARPA-H.
Notes: “Total main extramural” category includes the main NIH mechanisms of research support, including
research project grants, contracts, research center grants, training grants, and other mechanisms of support.
Some extramural programs are integrated into the “Other” category, particularly for the “Office of the Director,
Superfund, and Other” category. Figure is based on NIH’s categorization system used in source linked above.
Types of Research at NIH
According to NIH, the agency conducts and supports the “full continuum” of biomedical, health,
and behavioral research to understand the causes and mechanisms of disease, and then translates
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that knowledge into clinical practice and health interventions. NIH defines the continuum of
research as follows (see Figure 3):20
•
•
•
•
•
Basic research involves studying the fundamental mechanisms of biology and
behavior.
Preclinical translational research involves developing and testing new
diagnostics, therapeutics, and preventive measures. This research is conducted
using laboratory animals, cell cultures, samples of human or animal tissues,
computer modeling, or other approaches.
Clinical research is conducted with human subjects. Clinical research can
include (1) clinical trials of diagnostics, therapeutics, and preventive measures, as
well as any basic or other research conducted with patients; (2) epidemiological
and behavioral studies; and (3) outcomes research and health services research.
Postclinical translational research investigates the best methods to enhance
access to and the implementation of newly discovered biomedical interventions.
Clinical and community practice involves translating new biomedical research
discoveries into widespread clinical and community practice. It includes NIH’s
effort to ensure that scientific findings are communicated rapidly and clearly to
the public.
Figure 3. “Continuum” of Biomedical Research at NIH
Source: NIH, “Report of the Director of the National Institutes of Health: Fiscal Years 2012 & 2013,” at
https://report.nih.gov/biennialreport1213/NIH_OD_Biennial_report_2012-2013_508complete.pdf, p. 25. The
same figure appears in NIH’s most recent triennial report. See page 55 of NIH, Report of the Director National
Institutes of Health: Fiscal Years 2019-2021, https://dpcpsi.nih.gov/sites/default/files/2023-09/FY1921%20Triennial_Report_FINAL_508C.pdf.
In addition, NIH has identified population-based, epidemiological research as one of the key
drivers behind the research continuum. This type of research provides statistical evidence of the
association between disease and human biology, behavior, and environmental circumstances. In
addition, NIH’s investment in research tools and resources helps drive the continuum.21
20 All definitions based on NIH, Report of the Director of National Institutes of Health: Fiscal Years 2019- 2021,
pp. 55-57, at https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
21 Ibid.
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NIH reports that about half of its funding is for basic research.22 NIH emphasizes that the research
continuum is not always linear. Progress in research may involve moving back and forth between
different stages. For instance, a failed clinical trial on a therapeutic for a given disease may lead
to new questions that then require more basic research to make progress in treating that disease,
rather than advancing directly into postclinical translational research or other stages.23
Extramural Research
NIH extramural research funding makes up nearly 83% of the overall NIH budget and supports
300,000 scientists and research personnel affiliated with over 2,500 universities, medical schools,
and other research institutions in every state and around the world.24 Extramural awards include
multiple types of research and training grants (see the text box below), cooperative agreements,
and contracts, Within the large “research grants” category, the bulk of the funding goes to
research project grants (RPGs) awarded to individual investigators and small teams, most of
whom are based at universities and medical centers. Other types of grants are provided to groups
of researchers who work in collaborative programs or in multidisciplinary centers that focus on
particular diseases or areas of research, often called “centers of excellence.” Data on awards and
recipients by state, congressional district, type of institution, and subject of the research are
available on the NIH website.25
Types of Extramural NIH Grants
NIH awards many types of grants and uses activity codes to differentiate its programs. Not all NIH ICs fund all
types of grant programs. Common types of grants and their activity codes include the following:
Research Grants: NIH’s research grants fall into its R-series. NIH’s most commonly used grant program, the
standard independent Research Project Grants (RPG, R01) are used to support a discrete, specified research
project carried out by an independent Principal Investigator. This grant mechanism is used by all ICs, and grants
are generally awarded for three to five years. NIH can also award RPGs for smaller, more exploratory grants (e.g.,
R03, R15, R21) and award grants to small businesses under the federal governmentwide Small Business
Technology Transfer (STTR)/Small Business Innovative Research (SBIR) program (e.g., R41 R43, and R44). (For
more information on STTR/SBIR, see CRS Report R43695, Small Business Research Programs: SBIR and STTR.)
Career and Training Grants: Several NIH grant programs support training and career development, including
its Research Career Development Awards (K-series), Institutional Training Grants (T-series), and Individual
Fellowships program (F-series). (For more information, see the “Research Training” section.)
Program Project/Center Grants: The P-series consists of grants for large, multiproject efforts, including
grants for research centers (e.g., P30, P50) that support shared resources and facilities or projects by a number of
different investigators within the same research category (e.g., National Cancer Institute Cancer Centers).
Resource Grants: NIH also awards research resource grants that fund research-related support or access to
resources, rather than a specific research project, which includes support for research resources or infrastructure
(e.g., R24) or for research education projects (e.g., R25).
Sources: NIH, “Types of Grant Programs,” https://grants.nih.gov/grants/funding/funding_program.htm, and NIH
Research Training and Career Development, “Programs,” https://researchtraining.nih.gov/programs.
22 NIH, “FY 2003–FY 2023 Distribution of Budget Authority: Percentage for Basic and Applied Research,”
https://officeofbudget.od.nih.gov/pdfs/FY25/spending_hist/Basic%20and%20Applied%20FY%202003%20%20FY%202023%20(V).pdf.
23 NIH, Report of the Director of National Institutes of Health: Fiscal Years 2019- 2021, pp. 57, at
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
24 NIH, “What We Do—Budget,” https://www.nih.gov/about-nih/what-we-do/budget.
25 See the NIH Awards by Location & Organization, at https://report.nih.gov/award/index.cfm. See also the “Selected
NIH Resources” text box above for other resources on awards.
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Scientific Peer Review Process for Extramural Funding
Scientists who seek to compete for NIH extramural research funding, whether for new proposals
or for the renewal of previous awards, submit detailed plans in their funding applications
describing the research they plan to undertake. In 2023, NIH received 70,746 applications for
competing (new) research and training grants, and awarded a total of 16,670 grants.26 All NIH
grant, cooperative agreement, and R&D contract concept applications (referred to as “grants”
throughout this report for simplicity and as consistent with NIH sources) undergo review through
a two-tiered system of peer review, which includes a competitive and committee-based process to
evaluate the applications.27 The peer review system is pursuant to statute, especially Section 492
of PHSA (42 U.S.C. §289a),28 and federal regulations (42 C.F.R. Part 52h). The first stage of peer
review assesses the application on scientific and technical merit. In the second stage, the NIH IC
makes a funding decision, weighing the project’s scientific merit against the IC’s research
priorities and funding availability (see Figure 4).29 According to one IC, it typically takes
between 8 to 20 months after the due date for an investigator to receive an award (known as the
“Notice of Award”).30
Grant solicitations and receipt: Researchers can submit applications in response to NIH Notices
of Funding Opportunity (NOFO); applications are either investigator-initiated or in response to a
specific notice for targeted research.31 Most applications are investigator-initiated, meaning that a
scientist or group of scientists generates an original research project idea and then submits a grant
application through an NIH-wide submission process.32 Some applications are submitted in
response to solicitations by ICs for research areas the ICs seek to target or for which they have set
aside funding.33
NIH’s Center for Scientific Review (CSR) receives most applications. CSR assigns each
application that meets basic eligibility requirements to a Scientific Review Group for the first
stage of review and then to a potential awarding IC for the second stage.34 The potential awarding
26 NIH Data Book, “Research and Training Grants” https://report.nih.gov/nihdatabook/category/24.
27 42 C.F.R. §52h.1.
28 Other statutes also govern aspects of NIH peer review requirements, such as PHSA Sections 402(b)(16) and PHSA
Sections 402(b)(25), 405(b)(1)(B), 405(b)(2), and 406(a)(3)(A).
29 NIH, NIH Peer Review: Grants and Cooperative Agreements, https://grants.nih.gov/grants/
peerreview22713webv2.pdf.
30 NIH National Institute of Allergy and Infectious Diseases, “Timeline for Funding Decisions,” September 30, 2024,
https://www.niaid.nih.gov/grants-contracts/timelines-funding-decisions.
31
NIH, “Understanding Funding Opportunities,” https://grants.nih.gov/grants/how-to-apply-application-guide/prepareto-apply-and-register/understand-funding-opportunities.htm.
32 Called “Parent Announcements”; see NIH, “Parent Announcements (For Unsolicited or Investigator-Initiated
Applications),” https://grants.nih.gov/grants/guide/parent_announcements.php.
33 These include Program Announcements and Requests for Applications. Program Announcements are issued by one
or more ICs to highlight areas of scientific interest, and Requests for Applications are funding opportunities issued by
one or more ICs to highlight well-defined areas of scientific interest to accomplish specific program objectives. See
NIH, “Understanding Funding Opportunities,” https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-toapply-and-register/understand-funding-opportunities.htm.
34 NIH, NIH Peer Review: Grants and Cooperative Agreements, https://grants.nih.gov/grants/
peerreview22713webv2.pdf.
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IC is the one whose mission best aligns with the objectives of the research proposal.35 In some
cases, ICs directly receive and provide initial review of applications.36
First stage: In the first stage of peer review, the applications are assigned for review by a
Scientific Review Group (SRG), which is a peer-review committee composed of roughly 12 to 22
scientists who are experts in the relevant fields of research.3738 NIH convenes many SRGs to
review applications. As of 2023, there were over 250 chartered or recurring study sections (or
SRGs) in addition to temporary SRGs. About 19,000 distinct peer reviewers participated in
approximately 1,200 peer review meetings each year.39
Per statute, no more than one-fourth of the members of any SRG may be federal employees.40
Peer reviewers are expected to disclose conflicts of interest and may not participate in evaluations
of grant applications where they have conflicts of interest.41
The SRG is responsible for evaluating a grant proposal on the basis of scientific merit and
potential impact of the research.42 (See the “Changes to Peer Review Criteria for Research
Grants” text box below for new developments). SRGs also review applications for certain NIH
policy requirements, such as plans for protecting animals and humans involved in research (see
the Appendix).43 After discussing the application, each member gives the application a final score
for scientific and technical merit, and an overall impact score is determined from the average of
members’ final scores.44 The application may also be given a percentile ranking based on how the
overall impact score compares with other applications reviewed by the SRG in the preceding two
review rounds.45
Second stage: In the second stage, the funding decisions are refined by the National Advisory
Councils or Boards of the potential awarding ICs, which are advisory committees that oversee
each IC’s research priorities and portfolios.46 Advisory Councils and Boards are composed of
scientific and lay representatives.47 No federal employees may serve as regular voting members.48
35 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, p. 14,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
36 NIH, 2.4.1 Initial Review, NIH Grants Policy Statement, April 2024, https://grants.nih.gov/grants/policy/nihgps/
HTML5/section_2/2.4.1_initial_review.htm.
37 NIH, NIH Peer Review: Grants and Cooperative Agreements, https://grants.nih.gov/grants/
peerreview22713webv2.pdf; NIH, NIH Peer Review: Grants and Cooperative Agreements, https://grants.nih.gov/
grants/peerreview22713webv2.pdf; and Jeffrey Mervis, “Peering into peer review,” Science, vol. 343 (February 7,
2014), pp. 596-598.
38 NIH Office of Extramural Research, “Managing Conflict of Interest in NIH Peer Review of Grants and Contracts,”
https://grants.nih.gov/grants/peer/peer_coi.htm.
39 NIH Center for Scientific Review, “CSR Data and Evaluations: CSR Overview,” https://public.csr.nih.gov/
AboutCSR/Evaluations#overview.
40 PHSA Section 402(b)(29); 42 U.S.C. §282(b)(29).
41 42 C.F.R. §52h.5.
42 Review criteria are outlined broadly in regulations at 42 C.F.R. §§52h.8 and 11 and then further specified in each
notice of funding opportunity announcement for the specific award. See NIH, NIH Peer Review: Grants and
Cooperative Agreements, https://grants.nih.gov/grants/peerreview22713webv2.pdf.
43 42 C.F.R. §§52h.8 and 11 and NIH, NIH Peer Review: Grants and Cooperative Agreements, https://grants.nih.gov/
grants/peerreview22713webv2.pdf.
44 NIH, “Peer Review-Scoring,” https://grants.nih.gov/grants/peer-review.htm#scoring2.
45 NIH, “Funding Decisions,” https://grants.nih.gov/grants-process/award/funding-decisions.
46 Authorized in PHSA Section 406, 42 U.S.C. §284a.
47 PHSA Section 406(b)(3), 42 U.S.C. §284a(b)(3).
48 CRS Communication with NIH Office of Federal Advisory Committee Policy, June 30, 2022.
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These groups examine summary statements of applications recommended for funding, place their
impact scores and percentile rankings in the context of the IC’s research priorities, and then make
recommendations for final funding decisions.49 Many ICs establish a “payline,” or percentile
cutoff for applications that get funded, though ICs may prioritize applications outside of the
payline based on other considerations.50 The IC director then makes final funding decisions.51 The
21st Century Cures Act of 2016 (P.L. 114-255) added a requirement that the IC Director weigh the
Advisory Council or Board’s advice against the IC’s mission and research priorities, the NIHWide Strategic Plan, and programs or projects funded by other ICs on similar topics before
awarding a research grant.52
49 NIH, 2.4.3 National Advisory Council or Board Review, NIH Grants Policy Statement, April 2024,
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.4.1_initial_review.htm.
50 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, pp. 15-16,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
51 PHSA §405(b)(3).
52 See Section 2033 of the act.
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Figure 4. NIH Scientific Peer Review Process for Extramural Funding
Sources: Developed by CRS based on 42 C.F.R. Part 52h, NIH, Public Health Service Act Section 405; NIH, 2.4.
The Peer Review Process, NIH Grants Policy Statement, April 2024, https://grants.nih.gov/grants/policy/nihgps/
HTML5/section_2/2.4_the_peer_review_process.htm. NIH Peer Review: Grants and Cooperative Agreements,
https://grants.nih.gov/grants/peerreview22713webv2.pdf; and NIH, “Grants and Funding: Peer Review,”
https://grants.nih.gov/grants/peer-review.htm.
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Changes to Peer Review Criteria for Research Grants
In October 2023, NIH announced simplified peer review criteria for the scientific and technical review of research
proposals, to be in effect for grant receipt deadlines as of January 25, 2025, and beyond. These new criteria were
developed in response to concerns about the complexity of peer review and the burden on reviewers. NIH also
sought to mitigate reputational bias in review. The agency has faced long-standing concerns that its review process
favors experienced—and therefore often older—researchers at the expense of enabling new researchers to enter
the field (see the “NIH and the Research Workforce Pipeline” section for further discussion). In addition, NIH
working groups that helped develop the criteria stated that “persistent racial disparities in NIH funding raise the
question of whether review criteria in any way perpetuate an unfair advantage or disadvantage.”
The new criteria are designed to reduce NIH’s five-factor rating framework to a three-factor framework. Prior to
these changes, the five factors were: (1) Significance, (2) Innovation, (3) Approach, (4) Investigator, and (5)
Environment, derived from factors listed in regulations governing the peer review process (42 C.F.R. §52h.8). The
new criteria group these five into three factors: (1) Importance of the Research (Significance, Innovation); (2)
Rigor and Feasibility (Approach); and (3) Expertise and Resources (Investigators, Environment). The first and
second new factors are to receive scores from reviewers, while the third (Expertise and Resources) is to be
considered, but not scored, in an effort to reduce reputational bias.
The new criteria are the result of a multiyear process to solicit feedback on the peer review criteria, develop
proposed changes, and then solicit feedback on the proposal. According to an NIH summary of public comments,
the majority of respondents favored the changes. Some disagreed with certain aspects of the changes. For
example, some disagreed with making “Expertise and Resources,” an unscored factor because they thought such
criteria are critical to the work. Others argued that the changes did not go far enough to address bias in peer
review. Many stressed the need for reviewer training to make the new criteria effective.
Sources: NIH, “Simplified Peer Review Framework,” https://grants.nih.gov/policy/peer/simplifying-review/
framework.htm; “Developing the Simplified Framework” in NIH, “Background—NIH Peer Review Process,”
https://grants.nih.gov/policy/peer/simplifying-review/background.htm; NIH Center for Scientific Review,
“Announcing a Simplified Review Framework for NIH Research Project Grant Applications,” October 19, 2023,
https://www.csr.nih.gov/reviewmatters/2023/10/19/announcing-a-simplified-review-framework-for-nih-researchproject-grant-applications/; Center for Scientific Review Advisory Council Simplifying Review Criteria Working
Groups, “Recommendations for Simplifying R01 Review Criteria,” April 27, 2021, https://public.csr.nih.gov/sites/
default/files/2021-04/Recommendations_of_the_CSRAC_Working_Group_on_Simplifying_Review-nonCT_and_CT.pdf; and NIH, “Simplifying Review Framework: Feedback from the Request for Information,” April 28,
2023, https://grants.nih.gov/sites/default/files/
NIH%20SRF%20RFI%20Content%20Analyses%20April%202023%20508c.pdf.
Grants Policy
NIH grantees must comply with NIH policies governing their award. NIH grant requirements are
based in laws, regulations, and NIH-developed policies. As summarized in the “Authority”
section above, NIH’s statutory authorizations, especially in PHSA Title IV, form the statutory
basis for NIH grant requirements along with other HHS and federal-wide requirements elsewhere
in law. Key regulations underpinning NIH grants include general HHS award regulations (45
C.F.R. Part 75)53 and NIH-specific regulations (42 Parts 50-52i and 59a, with variation by grant
type).
NIH maintains an annually updated “Grants Policy Statement” on the standard terms and
conditions of NIH grant awards.54 Grantees are also informed of specific award requirements in
their “Notice of Award.” For the most part, extramural researchers must comply with the same
53 These regulations reflect HHS’s adoption of uniform federal award regulations promulgated by the Office of
Management and Budget in 2 C.F.R. Part 200. (Uniform Administrative Requirements, Cost Principles, and Audit
Requirements for Federal Awards). HHS follows the federal government-wide requirements with a few variations
specific to the department.
54 NIH Office of Extramural Research, “NIH Grants Policy Statement,” https://grants.nih.gov/policy/nihgps/index.htm.
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research policy requirements as intramural researchers. Some of these policy requirements are
summarized in the Appendix.
Selected NIH Grants Terminology
Authorized Organization Representative (AOR): The individual, named by the applicant organization, who
is authorized to act for the applicant and to assume the obligations imposed by the federal laws, regulations,
requirements, and conditions that apply to grant applications or grant awards.
Grants Management Officer (GMO): An NIH official responsible for the business management aspects of
grants and cooperative agreements, including review, negotiation, award, and administration, and for the
interpretation of grants administration policies and provisions. GMOs are delegated the authority from the Chief
Grants Management Officer to obligate NIH to the expenditure of funds and permit changes to approved projects
on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular
programs or awards.
Program Director/Principal Investigator (PD/PI): The individual(s) designated by the applicant organization
to have the appropriate level of authority and responsibility to direct the project or program to be supported by
the award. The applicant organization may designate multiple individuals as program directors/principal
investigators (PD/PIs), who share the authority and responsibility for leading and directing the project,
intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the
applicant organization or, as appropriate, to a collaborating organization for the proper conduct of the project or
program, including the submission of all required reports. The presence of more than one PD/PI on an application
or award diminishes neither the responsibility nor the accountability of any individual PD/PI.
Program Official/Program Officer/Project Officer (PO): The NIH official responsible for the
programmatic, scientific, and technical aspects of a grant or cooperative agreement.
Source: NIH, “Grants-Glossary,” https://grants.nih.gov/grants/glossary.htm.
Grants Administration and Oversight
While NIH-funded research projects are typically led by Program Directors/Principal
Investigators (PD/PIs; see the text box above), grant awards are generally made to the institutions
that employ those researchers. At funded institutions, an Authorized Organization Representative
(AOR) is responsible for the administrative aspects of NIH grants. AORs are responsible for
signing grant applications submitted by PD/PIs and, in doing so, ensure that the institution will
comply with all applicable federal requirements. According to NIH, AORs, PD/PIs, and other
research administration staff share overall responsibility for the successful implementation of an
NIH grant.55 If an NIH awardee collaborates with another research institution on the grant, the
awardee is responsible for overseeing their collaborators (with prior approval required from NIH
in some cases), regardless of whether the NIH awardee provides any funding or support to the
collaborator.56 The NIH Division of Grants Compliance and Oversight provides training and
resources to grantees and institutions to ensure compliance.57
NIH monitors its awardees through reporting requirements, such as financial reporting and
research progress reports.58 Every funded NIH grant has an assigned Grants Management Officer
(GMO) responsible for overseeing business and nonprogrammatic (e.g., financial) aspects of the
grant, as well as a Program Official (PO) responsible for overseeing programmatic, scientific, and
55 NIH, 2.1.2 Roles and Responsibilities-Recipient Staff, NIH Grants Policy Statement, April 2024,
https://grants.nih.gov/grants/policy/nihgps/HTML5/section_2/2.1.2_recipient_staff.htm.
56 See NIH, 2.15.1 Consortium Agreements: General, NIH Grants Policy Statement, April 2024, https://grants.nih.gov/
grants/policy/nihgps/HTML5/section_15/15.1_general.htm.
57 NIH Grants & Funding, “Grants Compliance & Oversight,” https://grants.nih.gov/policy/compliance.htm.
58 NIH Grants & Funding, “Post-Award Monitoring and Reporting,” https://grants.nih.gov/grants/post-awardmonitoring-and-reporting.htm.
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technical aspects of the grant (see the text box above).59 NIH may also conduct site visits to
ensure compliance as needed.60 NIH and funded research institutions share responsibility for
ensuring that NIH-funded research complies with federal requirements.61
Research Grants: By the Numbers
In FY2023, NIH funded over 52,000 research grants (including RPGs, center grants, and other
research awards). Figure 5 illustrates funding trends, showing the percentage of research grants
each year for R01-equivalent awards.
Figure 5. Research Grants Awarded, by Fiscal Year, 2009-2023
Includes number and percentage of R01-equivalent grants of total research grants awarded
Source: CRS analysis of data from NIH Data Book, including “Research Grants: Awards, by Institute/Center,”
https://report.nih.gov/nihdatabook/report/205, and “R01-Equivalent Grants: Awards as a Percentage of All
Research Grants,” https://report.nih.gov/nihdatabook/report/32.
Notes: Research grants are defined as extramural awards made for Research Centers, Research Projects, Small
Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Grants, and Other Research
Grants. Research Grants are defined by the following NIH activity codes: R, P, M, S, K, U (excluding UC6), DP1,
DP2, DP3, DP4, DP5, D42, and G12. R01-equivalent grants are defined as grants awarded under NIH activity
codes DP1, DP2, DP5, R01, R37, R56, RF1, RL1, U01, and R35 from select NIGMS and NHGRI program
announcements (PAs).
59 NIH, 2.1.1 Roles and Responsibilities-NIH and HHS Staff, NIH Grants Policy Statement, April 2024,
https://grants.nih.gov/grants/policy/nihgps/html5/section_2/2.1.1_nih_and_hhs_staff.htm.
60 NIH Grants & Funding, “Grants Compliance & Oversight,” https://grants.nih.gov/policy/compliance.htm.
61 Ibid.
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As shown in Figure 5, the total number of grants rose slightly following the end of the NIH
budget doubling period (FY2003) and then began to fall when NIH saw decreases in its
purchasing power by FY2009 (see the “Budget” section). With funding increases, the total
number of grants awarded began to increase in FY2016 and eventually exceeded the prior peak
level in FY2004 (47,464 grants) by FY2019 (49,092). The majority of grants awarded are R01equivalent independent research project grants, ranging from 56% to 64% of all grants awarded in
any year.
In FY2022, the average cost of an R01-equivalent grant was $585,307.62 Average costs vary by
type of grant. For example, the average cost of research center grants in FY2022 was over $2.4
million.63 As shown in Figure 6, while the average cost of an R01-equivalent grant rose in current
dollars from FY2000 to FY2023, the average cost rose slightly when adjusting for inflation ($288
thousand in 2022 compared with $247 thousand in FY1998).
Figure 6. R01-Equivalent Grant Average Cost: 2000 to 2023
Source: NIH Data Book, “R01-Equivalent Grants: Average Size,” https://report.nih.gov/nihdatabook/report/158.
Notes: Inflation adjustment used the Biomedical Research and Development Price Index (BRDPI).
Intramural Research
The NIH intramural research program (IRP), at about $5.0 billion in FY2023, accounts for
approximately 11% of the total NIH budget.64 IRP employs approximately 1,150 principal
investigators and 6,000 trainees, ranging from high school students to postdoctoral and clinical
62 NIH Data Book, “R01-Equivalent Grants: Average Size,” https://report.nih.gov/nihdatabook/report/158.
63 NIH Data Book, “Research Center Grants: Average Size,” https://report.nih.gov/nihdatabook/report/160.
64 CRS analysis of data from NIH, “FY2025 Justification of Estimates for Appropriations Committees, Vol I:
Overview–History of Obligations by Total Mechanism,” p. 50, https://officeofbudget.od.nih.gov/pdfs/FY25/br/
Overview%20of%20FY%202025%20Presidents%20Budget%20corrected%20Jul%2015.pdf.
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fellows in NIH-operated laboratories.65 Other IRP personnel include administrative support staff,
guest researchers, and contractors. Intramural research takes place at the 322-acre main campus in
Bethesda, MD, and several off-campus sites, including locations in Maryland, North Carolina,
Montana, Arizona.66
Almost all of the ICs have an intramural research program, but the size, structure, and activities
of the programs vary greatly.67 As with extramural funding, most intramural research proposals
are investigator-initiated. However, NIH sets the direction for its intramural research program by
hiring scientists of targeted expertise, allocating resources to certain laboratories and programs,
and conducting reviews by panels of external experts. 68 In addition, intramural researchers are
generally subject to the same research policy requirements as extramural researchers (see the
Appendix section) but adhere to these requirements through internal NIH processes.69 Each
intramural scientist is evaluated by an external Board of Scientific Counselors from their IC every
four years to review their work and research portfolio. Each IC’s intramural research program is
also reviewed by an external panel every 10 years, concerning the entire research portfolio and
impact of the research.70
Some intramural scientists work in the Clinical Center, which houses both basic research
laboratories and clinics for scientists involved with patient care in clinical research studies. The
Clinical Center is the nation’s largest hospital devoted solely to clinical research. Along with
scientists, the Clinical Center employs over 1,000 nurses and allied health professionals to
support its work.71 Most ICs with intramural research programs fund research at the Clinical
Center.
Research Training
As stated by the agency, “NIH’s ability to ensure that it remains a leader in scientific discovery
and innovation is dependent upon a pool of creative, diverse, and highly talented researchers.”72
Research training activities are designed to support every stage of a biomedical research career
(see the “Stages of a Research Career” text box below) in both the extramural and intramural
research programs. Programs range from summer internships for high school students to
mentoring programs for independent investigators. Predoctoral and postdoctoral training
opportunities are available through a variety of training grants, fellowships, and loan repayment
programs.73 The largest extramural program is called the Ruth L. Kirschstein National Research
Service Awards (NRSA) program, authorized by PHSA Section 487, which supports pre- and
65 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, p. 17,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
66 NIH Intramural Research Program, “Research Campus Locations,” at https://irp.nih.gov/about-us/research-campuslocations.
67 See links to individual IC programs at https://irp.nih.gov/about-us/our-programs. ICs that do not have an intramural
research component are the National Institute of General Medical Sciences (NIGMS) and the Fogarty International
Center (FIC).
68 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, p. 18,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
69 See NIH, “Policy Manual,” https://policymanual.nih.gov/.
70 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, p. 18,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
71 Ibid, pp. 19-20.
72 NIH, “The Biomedical Research Workforce,” https://researchtraining.nih.gov/dbrw/biomedical-research-workforce.
73 NIH, “Research Training and Career Development,” https://researchtraining.nih.gov/.
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postdoctoral research training awards to both institutions and individuals. In 2023, the NRSA
program supported over 17,000 graduate students and postdoctoral fellows.74
Stages of a Scientific Research Career
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Undergraduate and Postbaccalaureate. Current students or recent recipients of bachelor’s degrees
who are studying or working in scientific research.
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Predoctoral/Graduate Training. Graduate students working toward a research or clinical doctorate
degree. Usually involves working on highly structured research projects under the supervision of an
experienced mentor.
•
Postdoctoral/Clinical Residency. New doctorate recipients who gain further training to help transition to
a career as an independent researcher.
•
Early Career Researcher. Scientists who have recently obtained independent positions as investigators,
faculty members, clinician scientists, or industry scientists.
•
Established Investigator. Scientists who have demonstrated expertise in their research field through a
record of independent and original scientific contributions. They often serve as mentors to trainees at
undergraduate, predoctoral, and postdoctoral levels.
Source: NIH, “Research Training and Career Development- Career Path,” at https://researchtraining.nih.gov/
career-path.
Information Dissemination
NIH has important roles in translating the knowledge gained from biomedical research into
medical practice and useful health information for the general public. The individual ICs carry
out many relevant activities, such as sponsoring seminars, meetings, and consensus development
conferences to inform health professionals of new findings; answering thousands of telephone,
mail, and online inquiries; publishing physician and patient education materials on the internet
and in print; supporting information clearinghouses and running public information campaigns on
various diseases; making specialized databases available; and fostering partnerships for educating
clinicians and other health care professionals on the latest science.75
Budget
At roughly $47 billion for FY2024 (excluding ARPA-H funding), NIH’s budget is much larger
than those of other PHS agencies such as the Food and Drug Administration (FDA), Centers for
Disease Control and Prevention (CDC), Health Resources and Services Administration (HRSA),
Indian Health Service (IHS), and the Substance Abuse and Mental Health Services
Administration (SAMHSA). In FY2023, about 32% of all discretionary HHS funding was
provided to NIH.76 Moreover, as of FY2023, NIH represented about one-fifth of total federal
R&D funding and close to 45% of federal spending on R&D outside of the Department of
Defense.77
NIH has seen budget fluctuations, as shown in Figure 7. Prior to 2004, Congress had doubled the
NIH program level over a five-year period, from its FY1998 base of $13.7 billion to the FY2003
74 CRS analysis of numbers available in NIH, “Data Book- Kirschstein-NRSA Training Grants and Fellowships: Pre-
and Post-Doctoral Full-Time Training Positions Awarded,” https://report.nih.gov/nihdatabook/report/52.
75 NIH, Report of the Director of the National Institutes of Health: Fiscal Years 2019-2021, pp. 50-53,
https://dpcpsi.nih.gov/sites/default/files/2023-09/FY19-21%20Triennial_Report_FINAL_508C.pdf.
76 Analysis of data used for CRS Report R48060, Department of Health and Human Services: FY2025 Budget Request.
77 CRS analysis of federal research and development budget data provided by the Office of Management and Budget.
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level of $27.2 billion. Subsequently, NIH experienced a decade of stagnant growth in the
agency’s budget. Congress provided budget increases generally around 1.0%-3.2% from FY2004
to FY2015, often lower than the rate of inflation for biomedical research, which resulted in
reduced purchasing power for the agency. In some years (FY2006, FY2011, and FY2013),
funding for the agency decreased in nominal dollars. Starting in FY2016 through FY2023,
Congress provided NIH with funding increases each year, mostly over 5% annually, increasing
the program level from $30.3 billion in FY2015 to $47.7 billion in FY2023.78 NIH once again
saw a slight reduction in its overall program level in FY2024, decreasing -0.7% compared with
FY2023. In inflation-adjusted FY2023 dollars, the FY2024 NIH program level remains roughly
6% below the peak 2003 level.79 For more information, see CRS Report R43341, National
Institutes of Health (NIH) Funding: FY1996-FY2025.
78 FY2023 level excludes funding for the Advanced Research Projects Agency for Health (ARPA-H).
79 Analysis excludes funding for ARPA-H.
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Figure 7. NIH Funding, FY1998-FY2024
Program Level Funding in Current and Constant (FY2023) Dollars
Source: FY2024 request and FY2024-enacted numbers from Congressional Record, daily edition, vol. 170, no.
51, Book 11, March 22, 2024, pp. H2022-H2025, accessed at https://www.congress.gov/118/crec/2024/03/22/170/
51/CREC-2024-03-22-bk2.pdf, and P.L. 118-47. FY2023 final and FY2025 request numbers from NIH, Overview
of FY2025 President’s Budget, pp. 100, 101, at https://officeofbudget.od.nih.gov/pdfs/FY25/br/
Overview%20of%20FY%202025%20Presidents%20Budget.pdf, and ARPA-H, Congressional Justification: FY2025,
p. 9, accessed at https://arpa-h.gov/sites/default/files/2024-03/ARPA-H%20FY%202025.pdf. The FY2022 (and
earlier) program levels are from NIH Budget Office, Appropriations History by Institute/Center (1938 to
Present), at http://officeofbudget.od.nih.gov/approp_hist.html. Inflation adjustment reflects the Biomedical
Research and Development Price Index (BRDPI), updated January 2024, at https://officeofbudget.od.nih.gov/
gbiPriceIndexes.html.
Notes: Program level includes all budget authority, including transfers noted in budget documents. Amounts
provided to NIH designated for emergency requirements are excluded from these totals (e.g., the FY2020 and
FY2021 amounts do not include the amounts provided in the coronavirus supplemental appropriations acts).
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Foundation for the NIH
NIH also works with the Foundation for the National Institutes of Health (FNIH), a 501(c)(3)
charitable organization that raises private funding and manages public-private partnerships to
support NIH’s mission. FNIH was established by statute in 1990 (P.L. 101-613) and was amended
in 1993 (P.L. 103-43). The organization initially began operations in 1996. FNIH supports
research projects and programs, education and training, conferences and events, and other support
activities for NIH.80 Pursuant to PHSA Section 499 (42 U.S.C. §290b), there are terms and
restrictions on activities, requirements for the board of directors, reporting requirements, and
other requirements for FNIH.
As of 2023, FNIH has raised over $1.5 billion in support of NIH’s mission.81 FNIH also receives
some transfers of NIH’s appropriations for its administrative and operational expenses (averaging
less than 0.01% of NIH’s annual budget).82 For more information on FNIH, see the relevant
section in CRS Report R46109, Agency-Related Nonprofit Research Foundations and
Corporations.
Setting NIH Research Priorities
NIH funds research on hundreds of diseases, conditions, and areas of human health.83 NIH
funding is highly competitive—21.4% of all research project grant applications were funded in
FY2023.84 NIH and Congress face trade-offs in allocating funding in a fair manner that balances
the scientific merit of proposals with meeting the diverse health needs of the population. Funding
decisions are especially difficult because science is a process of discovery. Even experts cannot
always predict which proposals will lead to breakthroughs. Historic tensions have included
•
•
•
•
•
whether to designate funding for specific diseases and areas of research or to
allow untargeted funding for the most meritorious proposals identified through
the peer review process;
how to balance funding for basic scientific research with applied research;
whether funding should go to certain ethically contentious research areas, such as
embryonic stem cell research;
how to fund research on the most pervasive diseases and conditions while also
funding research on rare diseases or emerging health issues;
how to allocate funding among established and successful scientists while
enabling new scientists to enter the field;
80 FNIH, “About Us,” https://fnih.org/about, and FNIH, “Our Programs,” https://fnih.org/our-programs/.
81 FNIH, “FNIH Health Impact Report: 2023 Facts and Figures,” https://fnih.org/story-2023-facts-figures/.
82 CRS Report R46109, Agency-Related Nonprofit Research Foundations and Corporations.
83 The NIH “Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC)” table includes
over 280 categories of diseases, conditions, and research areas for which NIH categorizes its funding. The table is not
comprehensive of all possible ways to categorize NIH research. See NIH, “Estimates of Funding for Various Research,
Condition, and Disease Categories (RCDC)” table, last updated May 14, 2024, https://report.nih.gov/funding/
categorical-spending#/.
84 NIH, “Justification of Estimates for Appropriations Committees FY2025, Overview Vol. I,” p. 113.
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•
and how to determine the appropriate way to fund research among available
mechanisms, including extramural grants, contracts, and intramural research.85
In recent decades, Congress allowed NIH ICs, for the most part, to fund research based on their
own internal prioritization process, which involves scientific experts, patient advocates, and other
constituencies. At times, including in recent years, Congress has provided direction to NIH
funding in both appropriations report language and legislation. The following sections summarize
(1) NIH internal processes for setting research priorities through strategic planning and advisory
groups, and (2) congressional involvement in NIH research priorities, including recent major
efforts, legislation, and research restrictions.
NIH is not the only federal agency that supports biomedical and health research. The Department
of Defense (DOD) and the Department of Veterans Affairs (VA) and others also support medical
research programs.86 In addition, other HHS agencies support health research, such as the Centers
for Disease Control and Prevention (CDC) and the Agency for Healthcare Quality and Research
(AHRQ). Although the below discussion focuses on research priorities at NIH, Congress may
consider how to prioritize and coordinate funding for medical and health research across the
federal government.
NIH Process in Setting Research Priorities
Each NIH IC has separate research priorities, which are specified in statutory authority in varying
levels of detail.87 IC research priorities are also broadly captured by their mission statements.88
ICs establish research priorities through strategic planning, annual planning, and periodically
reviewing and assessing their research portfolios. Each IC has an advisory council that makes
recommendations for IC research priorities and funding decisions. Per statute, the advisory
councils consist of no more than 18 members appointed by the HHS Secretary. Two-thirds of the
members represent leading representatives of the relevant health and scientific disciplines. Onethird of the members are appointed from the general public and include leaders from other fields,
such as law, health policy, economics, and management.89 According to the agency,
decisionmakers at NIH seek advice from many groups when setting research priorities, including
scientific researchers and professional science societies, patient organizations and voluntary
health associations, IC Advisory Councils, Congress and the Administration, the Advisory
Committee to the NIH Director, the SMRB, and NIH staff.90
85 See discussions in U.S. Congress, House Energy and Commerce Committee, Health Subcommittee, Scientific
Opportunities and Public Needs: Balancing NIH’s Priority Setting Process, 108th Cong., 2nd sess., June 2, 2004, and
U.S. Congress, Senate Health, Education, Labor, and Pensions Committee, Labor Subcommittee, Biomedical Research
Priorities: Who Should Decide?, 105th Cong., 1st sess., May 1, 1997.
86 See CRS In Focus IF10349, Congressionally Directed Medical Research Programs Funding for FY2024, and section
on “Medical Care and Medical Research Discretionary Programs Funding” in CRS Report R48056, Department of
Veterans Affairs FY2024 Appropriations.
87 Title IV of PHSA includes statutory authorities for all NIH ICs. See the “Authority” section of this report.
88 NIH, “List of Institutes and Centers,” last updated July 2023, https://www.nih.gov/institutes-nih/list-institutescenters.
89 Most NIH advisory councils are authorized in PHSA Section 406; 42 U.S.C. §284a. That section specifies
membership and responsibilities for each advisory council.
90 NIH, “NIH Research Planning,” https://www.nih.gov/about-nih/nih-research-planning.
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Strategic Planning
For many years, most ICs have undergone a periodic strategic planning process to determine its
funding priorities among the research areas in each IC’s broadly defined mission and
programmatic areas.91 Statute specifies that the NIH Director “shall ensure that scientifically
based strategic planning is implemented in support of research priorities as determined by the
agencies of the National Institutes of Health.”92 The Cures Act (P.L. 114-255) added a
requirement for an NIH-Wide Strategic Plan, in part to facilitate IC collaboration and
coordination, to be updated every six years.93 This followed a prior directive for NIH to develop
an agency-wide strategic plan in the FY2015 appropriations law (P.L. 113-235).94 (See the
“Recent Major Legislative History” section.)
In the latest NIH-wide strategic plan for 2021-2025, NIH states that it seeks to meet its mission
“by pursuing scientific opportunities when they arise, responding to ongoing and emerging public
health needs, and addressing rare diseases.” The plan specifies overarching agency objectives
around advancing research, supporting research capacity, and ensuring research integrity. In
addition, the plan names specific themes that NIH intends to support across its research
portfolios. These include (1) Improving Minority Health and Reducing Health Disparities, (2)
Enhancing Women’s Health, (3) Addressing Public Health Challenges Across the Lifespan, (4)
Promoting Collaborative Science, and (5) Leveraging Data Science for Biomedical Discovery.95
According to NIH, the Strategic Plan was developed with input from external stakeholders,
including “members of the scientific and health care communities, professional societies,
advocacy organizations, industry, other federal agencies, and the general public” and in
collaboration with leadership and staff of NIH’s Institutes, Centers, and Offices.96
Coordinating Across NIH
The NIH Reform Act of 2006 (P.L. 109-482) enhanced the authority of the NIH Director’s Office
to perform strategic planning, especially facilitating and funding transdisciplinary, cross-institute
research initiatives. The Reform Act also created a special office, the Division of Program
Coordination, Planning, and Strategic Initiatives (DPCPSI), that “identifies important areas of
emerging scientific opportunity or rising public health challenges to assist in the acceleration of
research investments in these areas.”97 The Office of Strategic Coordination within DPCPSI
manages the NIH Common Fund, which supports large, complex research efforts that involve the
collaboration of two or more research institutes or centers. The Office of Strategic Coordination
works with staff and leadership across NIH to identify and promote NIH-wide scientific
opportunities that receive Common Fund support.98
Each individual IC strategic plan specifies its planning process; from NIH, “NIH Strategic Plans and Visions,” at
https://report.nih.gov/reports/strategic-plans.
92 PHSA Section 402(b)(5); 42 U.S.C. §282(b)(5).
93 42 U.S.C. §282(m).
94 See 128 STAT. 2475.
95 NIH, “NIH-Wide Strategic Plan: Fiscal Years 2021-2025,” p. 3, https://www.nih.gov/sites/default/files/about-nih/
strategic-plan-fy2021-2025-508.pdf.
96 Ibid, pp. 44-45.
97 NIH, “NIH Research Planning,” http://www.nih.gov/about/researchplanning.htm.
98 NIH, “Office of Strategic Coordination—The Common Fund,” https://commonfund.nih.gov/about.
91
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Coordinating Across the Federal Government
As mentioned above, several agencies within and outside of HHS fund health research. NIH
program staff use applicant information and other agencies’ funding databases to avoid
duplicating funding with another agency for the same recipient for the same project.99 In addition,
NIH holds regular meetings to collaborate and align priorities with other HHS research agencies,
DOD, and VA.100 NIH publishes an annual report and maintains a database of its collaborations
with other HHS agencies.101
The executive branch and Congress have also established some interagency strategies and
committees aimed at aligning research priorities across agencies, usually in an effort to ensure
that funded research across agencies furthers overarching health goals. These strategies or
committees are often specific to certain disease or research areas. The next section provides a few
examples established by Congress.
Selected Examples of Interagency Coordinating Committees
Interagency Pain Research Coordinating Committee (IPRCC): The Patient Protection and
Affordable Care Act (ACA; P.L. 111-148, as amended) established the Interagency Pain Research
Coordinating Committee,102 which is now led by NIH.103 The committee, made up of federal and
nonfederal members, oversees scientific progress across the government under the Federal Pain
Research Strategy, which focuses on advancing pain prevention and management, along with
other efforts to advance pain research.104
Muscular Dystrophy Coordinating Committee (MDCC): As authorized in statute,105 the
Muscular Dystrophy Coordinating Committee coordinates research across NIH and with other
federal agencies on all forms of muscular dystrophy. The committee, currently supported by
National Institute of Neurological Disorders and Stroke (NINDS), includes both federal and
nonfederal members and is tasked with developing a plan for research and education on muscular
dystrophy across HHS to encompass health, psychosocial, public services, and rehabilitative
issues related to the disease.106
Interagency Autism Coordinating Committee: As initially established by the Children’s Health
Act of 2000 (P.L. 106-310), the Interagency Autism Coordinating Committee (IACC), composed
of federal and nonfederal public members, coordinates federal efforts related to autism spectrum
99 U.S. Government Accountability Office (GAO), Biomedical Research: Actions Needed to Adopt Collaboration
Practices to Address Research Duplication, GAO-24-106757, February 2024, https://www.gao.gov/assets/870/
866837.pdf, and GAO, Biomedical Research: Observations on DOD’s Management of Congressionally Directed
Medical Research Programs, GAO-22-105107, January 31, 2022, pp. 6-7, https://www.gao.gov/assets/gao-22105107.pdf.
100 Ibid.
101 See NIH, “Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2022,” https://crs.od.nih.gov/
CRSPublic/.
102 Authorized at PHSA Section 409J(b); U.S.C. 42 §284q.
103 NIH, “About the NIH IPRCC,” https://www.iprcc.nih.gov/about/nih-iprcc. Specifically, the Director of the National
Center for Complementary and Integrative Health currently chairs the committee. See “Membership,”
https://www.iprcc.nih.gov/about/membership.
104 NIH, “Federal Pain Research Strategy Overview,” https://www.iprcc.nih.gov/federal-pain-research-strategyoverview.
105 PHSA Section 404E(d); 42 U.S.C. §283g(d).
106 PHSA Section 404E(e) and NIH, “Charter: Muscular Dystrophy Coordinating Committee,”
https://www.ninds.nih.gov/sites/default/files/documents/MDCC_Charter_508C.pdf.
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disorder (ASD), including both research and services and supports activities.107 The National
Institute of Mental Health manages the committee and provides administrative support.108
Congressional Involvement in NIH Research Priorities
Congress has shaped NIH by establishing its overall authorizing statutes (see the “Authority”
section), which govern the agency’s overall structure, its award and review processes, and the
responsibilities of each of its ICs. Congress also provides annual appropriations to the IC
accounts, which drive NIH’s overall research direction by setting different funding levels for ICs
with different missions. From time to time, Congress has also authorized or funded specific
research programs—often disease-specific research programs—either within or across NIH ICs.
Congress has supported major large-scale research initiatives on specific diseases at NIH,
including during the War on Cancer in the 1970s, for the HIV/AIDS epidemic in the 1980s and
1990s, and through several research initiatives discussed in the “Selected Recent Research
Initiatives” section.109 A long-standing debate has centered on whether and to what extent
Congress should specify funding for certain diseases or programs within NIH, or whether
Congress should allow the agency to determine research funding allocations through its own
priority setting and review processes.110 The following sections discuss how Congress has shaped
NIH’s research priorities through both appropriations and authorizations legislation. Congress at
times has also enacted certain restrictions on NIH research.
Appropriations
For many years prior to FY2015, appropriators avoided specifying dollar amounts for particular
disease areas, fields of research, or mechanisms of funding in both report and bill text, aside from
the level of the IC accounts. Generally, specific amounts were appropriated to each IC, and then
funding was awarded through competitive grants, through contracts, or to intramural
researchers.111
Changes in congressional practice have occurred most notably with research funding for
Alzheimer’s disease (discussed further in the “Alzheimer’s Disease and Related Dementias
Research” section). From FY2001 through FY2014, Congress provided broad directives to NIH
in report language, encouraging the agency to prioritize Alzheimer’s disease and to increase
resources toward its research through the National Institute on Aging (NIA).112 The explanatory
statement accompanying the FY2014 omnibus included the following language:
In keeping with longstanding practice, the House and Senate Appropriations Committees
do 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
107 PHSA Section 399CC; 42 U.S.C. §280i-2.
108 NIH, “Interagency Autism Coordinating Committee Charter,” https://iacc.hhs.gov/about-iacc/charter/.
109 NIH National Cancer Institute, “National Cancer Act of 1971,” https://www.cancer.gov/about-nci/overview/history/
national-cancer-act-1971, and Department of Health and Human Services (HHS), “A Timeline of HIV and AIDS,”
HIV.gov, https://www.hiv.gov/hiv-basics/overview/history/hiv-and-aids-timeline.
110 Rachel Kahn Best, “Chapter 4: Ranking Diseases,” in Common Enemies: Disease Campaigns in America (New
York, NY: Oxford University Press, 2019), pp. 84-108.
111 CRS review of appropriations documents.
112 Based on CRS search of “Alzheimer’s” and related terms in enacted appropriations laws, accompanying committee
reports, and House and Senate committee appropriations bills from FY2001 to FY2014.
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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 the 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. 113
The explanatory statement for the FY2015 omnibus included similar language but noted that the
agreement provided a $25 million increase for Alzheimer’s disease research at NIA; still, it did
not direct NIH to reserve a specific total dollar amount.114 Then, in a departure from recent
precedent, the explanatory statements accompanying FY2016 appropriations directed NIH to
reserve a specific amount for Alzheimer’s disease research.115
In recent years, appropriations reports for NIH have specified dollar amounts for some research
related to certain diseases or topics, though annual appropriations have left most of each IC’s
funding flexible and untargeted. For example, the explanatory statement accompanying FY2024
appropriations for NIH included over 40 line items directing specific dollar amounts for certain
research or program areas.116 A Senate FY2024 appropriations report (S.Rept. 118-84) explained
the committee’s approach to targeting NIH funding as follows:
As in previous years, the Committee has targeted NIH funding in areas of promise of
scientific advancement and urgency, while allowing NIH to maintain flexibility to pursue
unplanned scientific opportunities and address unforeseen public health needs. 117
Authorizations
At times, Congress has enacted authorizations for specific programs or research areas within NIH
ICs. Congress has, for example, enacted provisions targeting new types or approaches to research
to be supported by NIH. For example, the Cures Acceleration Network (P.L. 111-148) in 2010
sought to advance technologies to improve drug development. Laws have also been enacted
targeting specific disease or health program areas within NIH ICs. For example, since 2010,
specific laws were enacted related to research on hearing loss screening and detection (P.L. 111337), pancreatic and lung cancer (P.L. 112-239), pediatric cancer (P.L. 113-94, P.L. 115-180),
muscular dystrophy (P.L. 113-166), and pain (P.L. 114-198), to name a few examples.
In some cases, these laws have provided NIH or its ICs with new authorities or funding sources
for research and, at times, have included new requirements for NIH research (e.g., strategic
planning or reporting requirements).118 However, in many cases, NIH does not need a specific
authorization to fund research on a certain health topic. NIH is able to support research on nearly
all areas of human health through its existing authorizations.
Some policymakers have long questioned whether considering disease-specific legislation for
NIH research is a productive use of limited committee and floor time, and whether such
113 Congressional Record, January 15, 2014, vol. 160, no. 9—Book II, H1037.
114 Congressional Record, December 11, 2014, vol. 160, no. 151—Book II, H9832.
115 Congressional Record, December 17, 2015, vol. 161, no. 184—Book III, H10285.
116 See Table A-1 in CRS Report R43341, National Institutes of Health (NIH) Funding: FY1996-FY2025. Includes
funding directives incorporated by reference from S.Rept. 118-84.
117 S.Rept. 118-84, p. 89.
118 For example, the Gabriella Miller Kids First Research Act (P.L. 113-94) created a new funding source for research
by directing transfers of certain amounts from the Presidential Election Campaign Fund to a new 10-Year Pediatric
Research Initiative Fund to be made available for pediatric research as authorized by the law. The authorization for the
Cures Acceleration Network (P.L. 111-148) granted NIH new authorities to support research, including through Other
Transactions authority and through requiring matching funds from certain recipients under the program. P.L. 115-180
added new reporting requirements for NIH on childhood cancer research projects.
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legislation leads to the best outcomes at NIH.119 At the same time, Members of Congress
frequently hear from stakeholders—particularly disease-specific advocates—calling for NIH
research on certain topics.120 These stakeholders may express concern that NIH is inadequately
funding research in certain areas or that the agency’s funded research approaches are not meeting
health needs.121 In an effort to be responsive to these stakeholders, Congress has sometimes
considered and passed disease-specific legislation for NIH research. To illustrate, in 1993, an
exchange between a House Representative and then-HHS Secretary during a hearing on the NIH
Revitalization Act (H.R. 4, 103rd Congress) showed the considerations at hand with disease- and
program-specific provisions in the bill:
Rep Greenwood: “H.R. 4 is a nice, big, thick, 170-page bill that gives a lot of direction to
the NIH with regard to research. The question I have is this: Is there anything in here that
the institutes could not do without this legislation? Do you really need this kind of
direction? Or, are we guilty of micro-managing in response to all of the well intentioned
disease groups, if you will, pressuring for research funding.”
Sec. Shalala: “Of course, there is nothing that we could not do without those directives.
The question is whether our own strategic planning process would produce that specific
list which is what you are asking. My answer to this is that this is government money and
those elected by the government have a right to give us-to nudge us, to set the standards
for us, to give us a list of what they think is important. We also have a right to come back
and argue what we think the priorities ought to be privately or publicly. It is just if I am
going to keep my own integrity as part of this process, I am not going to pretend that we
would not prefer to have more flexibility. I certainly wanted that as I headed any agency,
but what I am suggesting to you is that this bill, as structured, is one that we believe on
balance we can support. There are obviously parts of it that we might not think are terrific
at this point in time.”122
Research Restrictions
From time to time, Congress has placed restrictions on NIH research, often in annual
appropriations legislation. Restrictions for FY2024 related to, for example, advocating or
promoting gun control, payment for abortions, human embryo research, and promoting
119 See, for example, statement by Rep. Bliley in 1993 during consideration of the NIH Revitalization Act (H.R. 4,
103rd Congress), “I personally have serious reservations that world-renowned institution such as the NIH really needs
this much detailed Congressional direction in order to conduct the best possible scientific research” (from U.S.
Congress, House Energy and Commerce Committee, Health and Environment Subcommittee, NIH Revitalization Act,
103rd Cong., 1st sess., February 3, 1993), and statement by Senator Kennedy in 1997 hearing, “Setting research
priorities, a complex process that must be informed by the concerns of many groups—the patients, women, children
and the elderly. But the final judgment on the direction of the biomedical research must be left largely to NIH. They
have the knowledge and experience to make the wisest decision” (from U.S. Congress, Senate Committee on Labor and
Human Resources, Subcommittee on Public Health and Safety, Biomedical Research Priorities: Who Should Decide?,
105th Cong., 1st sess., May 1, 1997).
120 To illustrate, an analysis found that beginning in the 1980s, witnesses representing disease-specific organizations or
patient advocacy groups made up over 20% of all witnesses at annual House LHHS appropriations hearings that are
open to all public witnesses. By the 1990s, such witnesses made up about one-third of all witnesses at such hearings.
This is particularly notable because LHHS appropriations fund a wide a wide array of health, education, labor, social
services, and other programs. See Rachel Kahn Best, “Chapter 4: Ranking Diseases,” in Common Enemies: Disease
Campaigns in America (New York, NY: Oxford University Press, 2019), pp. 87-88.
121 Rachel Kahn Best, “Chapter 4: Ranking Diseases,” in Common Enemies: Disease Campaigns in America (New
York, NY: Oxford University Press, 2019), pp. 84-108.
122 U.S. Congress, House Energy and Commerce Committee, Health and Environment Subcommittee, NIH
Revitalization Act, 103rd Cong., 1st sess., February 3, 1993.
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legalization of controlled substances.123 In many cases, these restrictions reflected ethical and
political decisions that Congress made about the types of research that NIH should support. As an
example, the restriction on human embryo research dates back to FY1996 and prohibits HHS
from creating human embryos for research purposes or “for research in which a human embryo or
embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than
that allowed for research on fetuses in utero” under referenced laws and regulations.124
Selected Recent Research Initiatives
Alzheimer’s Disease and Related Dementias Research
As noted in the “Appropriations” section, Congress began directing specific funding levels for
Alzheimer’s and related dementias research in appropriations reports from FY2015 through
FY2024, reflecting an overall recent change in congressional practice around specifying funding
for certain diseases at NIH.
Table 1. NIH Alzheimer’s Disease Research Funding Directed by Congress
Fiscal Year
Amount
FY2015
Increase of $25 million (no total specified)
FY2016
$926 million (+350 million)
FY2017
$1,391 million (+400 million)
FY2018
$1,828 million (+414 million)
FY2019
$2,340 million (+425 million)
FY2020
$2,818 million (+350 million)
FY2021
$3,118 million
FY2022a
Increase of $289 million
FY2023
Increase of $226 million
FY2024
Increase of $100 million
Source: Reports and explanatory statements accompanying annual Departments of Labor, Health and Human
Services, and Education, and Related Agencies Appropriations (LHHS) appropriations laws.
Notes: Amounts shown in parentheses from FY2016 to FY2020 show increases from the prior fiscal year. In
some years, language directed funding for Alzheimer’s disease research. In other years, language directed funding
for Alzheimer’s disease and related dementias research. The table does not show allocations to specific institutes
and centers named in the directives.
a. Beginning in FY2022, the reports did not state a total provided for Alzheimer’s disease and related
dementias research, but rather stated that the appropriations law provided an increase for such research.
These funding increases have been driven by the National Plan to Address Alzheimer’s Disease,
first announced in 2012.125 Established by the National Alzheimer’s Project Act (NAPA; P.L. 111375), the National Plan includes “Prevent and Effectively Treat Alzheimer’s Disease and Related
123 NIH, “Notice of Legislative Mandates in Effect for FY2024,” from https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-24-110.html.
124 Specifically, 45 C.F.R. §46.204(b) and PHSA Section 498(b) (42 U.S.C. §289g(b)). See Section 508 of Division D
in Further Consolidated Appropriations Act, 2024 (P.L. 118-47), for current language of the restriction.
125 HHS, “Obama Administration Presents National Plan to Fight Alzheimer’s Disease,” press release, May 15, 2012,
https://aspe.hhs.gov/obama-administration-presents-national-plan-fight-alzheimers-disease.
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Dementias by 2025” as the first of five key goals.126 To help meet this goal, NIH began to publish
an annual bypass budget in FY2015 to estimate funding needs for Alzheimer’s disease research,
starting for FY2017. A bypass budget, also known as a professional judgement budget, is a budget
proposal submitted directly by NIH to Congress to estimate research funding needs based on
scientific opportunity, rather than as determined by the regular budgeting process. The bypass
budget was mandated by the Consolidated and Further Continuing Appropriations Act of 2015
(P.L. 113-235), which specified that the NIH Director is to submit an annual independent
Alzheimer’s research budget request directly to Congress, pursuant to the National Alzheimer’s
Plan. To determine its bypass budget proposal, NIH has convened research summits starting in
2012 and has worked across its ICs to determine recommendations and funding needs for
Alzheimer’s disease research. To meet its research goals, NIH has used targeted funding
opportunity notices to solicit research proposals related to Alzheimer’s disease from scientists.127
Alzheimer’s disease research represents an area of major congressional involvement, in which
large amounts of research funding are directed toward a specific disease. In recent years, some
advances have been made in preventing, diagnosing, and treating Alzheimer’s disease and related
dementias, many of which have been linked to NIH research. For example, recent diagnostic
advances in imaging and certain fluid-based tests have helped improve the ability to identify and
diagnose Alzheimer’s disease and related dementias in conjunction with other clinical
evaluations.128 NIH helped fund the development of the first blood test of amyloid, a biomarker
(or biological indicator) of Alzheimer’s disease.129 NIH-funded research contributed to the
imaging technologies used in clinical trials to assess the efficacy of drugs to treat Alzheimer’s
disease and related dementias.130 In addition, NIH-funded research has contributed to an
understanding of prevention; for instance, that controlling high blood pressure may reduce agerelated cognitive impairment that may ultimately lead to Alzheimer’s disease.131 In recent years,
the U.S. Food and Drug Administration has approved three drugs for treating mild or early-stage
Alzheimer’s disease.132 NIH funded basic research into amyloid, the brain protein targeted by
these drugs that helped inform their scientific basis.133
There is still much progress to be made in research on Alzheimer’s disease and related dementias,
including better understanding the contributions of genetics, environmental exposures, and life
events to the disease and for improving diagnosis, including through digital tools or improved
126 HHS, National Plan to Address Alzheimer’s Disease, 2012, p. 6, https://aspe.hhs.gov/system/files/pdf/102526/
NatlPlan2012%20with%20Note.pdf.
127 NIH, Open Science, Big Data, and You: Working Together to Treat and Prevent Alzheimer’s Disease and Related
Dementias. NIH Bypass Budget Proposal for Fiscal Year 2020, July 30, 2018, https://www.nia.nih.gov/sites/default/
files/2018-07/fy2020-bypass-budget-report-final.pdf.
128 W.M van der Flier, M.E de Vugt, E.M.A Smets, et al., “Towards a Future Where Alzheimer’s Disease Pathology is
Stopped Before the Onset of Dementia,” Nature Aging, vol. 3 (May 18, 2023), pp. 494-505.
129 National Institute on Aging (NIA), “Small Business Spotlight: C₂N Diagnostics’ Blood Test Detects Alzheimer’s,”
November 1, 2022, https://www.nia.nih.gov/news/small-business-spotlight-c2n-diagnostics-blood-test-detectsalzheimers, and National Institute on Aging, “Biomarker Research,” in 2020–2021 Report of Scientific Advances for
the Prevention, Treatment, and Care of Alzheimer’s Disease and Related Dementias, https://nia.nih.gov/report-20202021-scientific-advances-prevention-treatment-and-care-dementia/biomarker-research.
130 NIH, “10 Years of Alzheimer’s Disease and Related Dementias Research,” September 2023,
https://www.nia.nih.gov/10-years-alzheimers-disease-and-related-dementias-research.
131 NIA, “Intensive Blood Pressure Control May Slow Age-Related Brain Damage,” press release, August 13, 2019,
https://www.nia.nih.gov/news/intensive-blood-pressure-control-may-slow-age-related-brain-damage.
132 Alzheimer’s Association, “FDA-Approved Treatments For Alzheimer’s,” https://www.alz.org/media/Documents/
alzheimers-dementia-fda-approved-treatments-for-alzheimers-ts.pdf.
133 NIH, “2024 NIH Alzheimer’s and Related Dementias Research Progress Report: Advances and Achievements,”
https://www.nia.nih.gov/sites/default/files/2024-08/2024-alzheimers-progress-report.pdf.
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fluid-based tests, among many other topics. In addition, while drugs for treating Alzheimer’s
disease are now available, they serve a relatively small patient population with early or mild
disease and can have significant side effects.134 As of March 2024, the National Institute on Aging
reported funding 72 different clinical trials on potential pharmacological treatments for
Alzheimer’s disease and related dementias that take many different treatment approaches.135 More
broadly, as of January 2024, there were 171 clinical trials assessing 134 drugs for treating
Alzheimer’s disease (funded by both the public and private sectors). One expert has argued that
this level of drug development is much less than the level of development for cancer drugs.136
It may take decades to see the full scientific and medical impact of recent NIH investments in
Alzheimer’s disease and related dementias research. New drugs for any given disease generally
build upon a body of science that takes decades to fully develop and then translate to practical
application. According to a 2015 study, some of the first drugs approved to treat symptoms
associated with Alzheimer’s disease were approved 22 years after the body of science
underpinning those drugs became established.137 For the recent FDA-approved drugs that target
amyloid, the body of science underlying those technologies became established in the early
2000s, fitting the same general trend with the related drug approvals occurring in 2022 to 2024.138
21st Century Cures Act Innovation Projects
The 21st Century Cures Act (P.L. 114-255; the Cures Act), enacted in December 2016, authorized
$4.8 billion for NIH for four specific innovation projects over a 10-year period (FY2017FY2026), with varying amounts allocated each fiscal year (see Table 2). The Cures Act
established the “NIH Innovation Account,” to which specified amounts were transferred for each
of FY2017 through FY2026 (see Table 2) for the purpose of carrying out the following four NIH
Innovation Projects, with funds made available in subsequent appropriations acts:
•
The All of Us Research Program ($1.5 billion for FY2017 through FY2026),
which aims to collect clinical, environmental, lifestyle, and genetic data from a
large patient cohort over many years—with a goal of recruiting over 1 million
134 National Academies of Sciences, Engineering, and Medicine, “Preventing and Treating Alzheimer’s Disease and
Related Dementias: Promising Research and Opportunities to Accelerate Progress: Proceedings of a Workshop–in
Brief,” Washington, DC, 2024, https://nap.nationalacademies.org/catalog/27784/preventing-and-treating-alzheimersdisease-and-related-dementias-promising-research-and-opportunities-to-accelerate-progress.
135 NIA, “NIA-Funded Active Alzheimer’s and Related Dementias Clinical Trials and Studies,” last updated March
2024, https://www.nia.nih.gov/research/ongoing-AD-trials.
136 National Academies of Sciences, Engineering, and Medicine, “Preventing and Treating Alzheimer’s Disease and
Related Dementias: Promising Research and Opportunities to Accelerate Progress: Proceedings of a Workshop–in
Brief,” Washington, DC, 2024, https://nap.nationalacademies.org/catalog/27784/preventing-and-treating-alzheimersdisease-and-related-dementias-promising-research-and-opportunities-to-accelerate-progress.
137 Jennifer M. Beierlein, Laura M. McNamee, Michael J. Walsh et. al, “Patterns of Innovation in Alzheimer’s Disease
Drug Development: A Strategic Assessment Based on Technological Maturity,” Clinical Therapeutics, vol. 37, no. 8
(August 1, 2015).
138 Jennifer M. Beierlein, Laura M. McNamee, Michael J. Walsh et. al, “Patterns of Innovation in Alzheimer’s Disease
Drug Development: A Strategic Assessment Based on Technological Maturity,” and email communication with Dr.
Fred Ledley, one of the study authors in September 2024.
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•
•
•
participants139 (formerly named the Precision Medicine Initiative Cohort
Program).140
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN)
Initiative ($1.5 billion for FY2017 through FY2026), which involves developing
and implementing new technology to understand how individual cells and the
neural circuits they form interact in time and space—scientific understanding that
may help treat, cure, or prevent brain-related disorders.141
The Beau Biden Cancer Moonshot ($1.8 billion for FY2017 through FY2023),
which began in 2016 and sought to make a decade’s worth of progress in
preventing and treating cancer in just five years.142
The Regenerative Medicine project ($30 million for FY2017 through FY2020),
which supported clinical research using adult stem cells in coordination with
FDA.143
To date, amounts authorized for the Innovation Projects shown in Table 2 have been fully
appropriated.
Table 2. Authorization of Appropriations for NIH Innovation Projects
Under the Cures Act
Millions of dollars
Fiscal Year
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Total
PMI/All of US
40
100
186
149
109
150
419
235
BRAIN
10
86
115
140
100
152
450
172
36
91
31
1,455
195
1,511
Cancer
Moonshot
300
300
400
195
195
194
216
Regenerative
Medicine
2
10
10
8
Total
Innovation
Account
352
496
711
492
404
496
1,085
407
127
1,800
30
226
4,796
Source: P.L. 114-255, Section 1001(b)(4).
139 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf, and NIH, “About,”
All of Us Research Program, https://allofus.nih.gov/about.
140 NIH, “PMI Cohort Program announces new name: the All of Us Research Program,” October 13, 2016,
https://allofus.nih.gov/news-events/announcements/pmi-cohort-program-announces-new-name-all-us-researchprogram.
141 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf, and NIH, The
BRAIN Initiative, “Overview,” https://braininitiative.nih.gov/about/overview.
142 National Cancer Institute, “History of the Cancer Moonshot,” December 2023, https://www.cancer.gov/research/
key-initiatives/moonshot-cancer-initiative/history.
143 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf.
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Cures Act Innovation Project funding is unique from most of the funds NIH receives through the
annual appropriations process. These funds are subject to different budget enforcement rules: for
appropriated amounts to the account—up to the limit authorized for each fiscal year—the
amounts are subtracted from any cost estimate for enforcing discretionary spending limits (i.e.,
the budget caps). In effect, appropriations to the NIH Innovation Account as authorized by the
Cures Act are not subject to discretionary spending limits.144 Therefore, Congress does not need
to consider the Innovation Account funds when determining the amount of NIH funding within
the discretionary spending allocations. The funds are also “no-year” funds that are available until
expended. Most NIH appropriations are made available for one fiscal year.
As shown in Table 2, funding for each of the four different Innovation Projects was made in
variable amounts across fiscal years. After the Cures Act was enacted, NIH was required to
submit a workplan to Congress on how the agency planned to use Innovation Project funding and
manage changes from year to year.145 In its workplan, NIH set out plans to achieve scientific
goals for each of the Innovation Projects, with different strategies to use the Innovation Account
funding for each. For example, for the All of Us research program, NIH had planned to carry over
certain funding from year to year to manage anticipated large year-to-year increases and
decreases in funding authorized in the Cures Act. For the BRAIN initiative, NIH had estimated
that the agency would need annual funds in addition to the authorized Cures Act funding in order
to meet that program’s scientific goals.146
As of this report’s publication, two of the Innovation Project funding authorizations have expired:
the Regenerative Medicine project in FY2020 and the Cancer Moonshot in FY2023. The Biden
Administration proposed to reauthorize the Cancer Moonshot authorization in its FY2024 and
FY2025 budget requests; to date, Congress has not adopted either of these proposals.147 NIH
continues to fund the All of Us research program and the BRAIN Initiative. Both programs have
been supported by a combination of Cures Act Innovation funding and allocations from other
NIH accounts.
Both the All of Us research program and the BRAIN initiative saw large decreases in FY2024
funding compared with FY2023 when accounting for Cures Act innovation funding and
allocations from regular appropriations toward the programs. An overall decrease in NIH’s
regular budget authority in FY2024 may have affected the agency’s ability to allocate resources to
these programs. For the All of Us program, NIH had originally planned to carry over certain
Cures Act funds from FY2023 to FY2024 to mitigate the effects of the decrease.148 Both
programs have reported consequences from the decrease in funding. The All of Us CEO reported
that because of the funding decrease in FY2024, the program would reduce most program awards,
which would result in a “decrease in the rate of new enrollments, a delay in the launch of
pediatric enrollment, and a slowing of new data collection.”149 The BRAIN Initiative reduced
144 CRS Report R45778, Exceptions to the Budget Control Act’s Discretionary Spending Limits.
145 Section 1001(c) of 21st Century Cures Act, P.L. 114-255.
146 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf, and NIH, The
BRAIN Initiative, “Overview,” https://braininitiative.nih.gov/about/overview.
147 CRS Report R43341, National Institutes of Health (NIH) Funding: FY1996-FY2025.
148 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf, and NIH, The
BRAIN Initiative, “Overview,” https://braininitiative.nih.gov/about/overview.
149 NIH, “From the All of Us CEO: Keeping Our Momentum Amidst Funding Uncertainties,” April 23, 2024,
https://allofus.nih.gov/news-events/announcements/all-us-ceo-keeping-our-momentum-amidst-funding-uncertainties.
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some award amounts and cancelled several planned funding opportunities in FY2024, citing a
40% decrease to its budget.150
Looking forward, authorized Cures Act funding for both All of Us and the BRAIN Initiative will
see significant decreases from FY2024 to FY2025, as shown in Table 2, and will expire in
FY2026. Both programs were designed as long-term, multifaceted projects and have remaining
scientific goals to achieve. For the All of Us research program, the program has so far made
significant progress toward but ultimately fallen short of its goal to enroll and have data on 1
million participants. As of December 29, 2024, over 849,000 participants had consented to join
the program and over 574,000 had completed all the initial steps to submit data.151 Recruitment
slowed during the COVID-19 pandemic when in-person enrollment activities were paused; the
enrollment rate has since increased.152 For the BRAIN initiative, the program has reported several
major scientific milestones in 2023 and 2024, including the first complete cell atlas of a whole
mammalian brain (the mouse brain), the most granular subcellular mapping of human brain
tissues to date, and some of the first complete visualizations of brain neuron connections (in
insects) and blood vessel networks (in mice).153 Many of these recent developments are seen as
“proof of concept” for further study. As the BRAIN Initiative Director stated in a blog post
reflecting on 10 years of the initiative, “We are still just at the beginning of this neuroscience
revolution.” CRS could not identify independent (non-NIH) evaluations of either program and
their scientific progress. Both programs have set short- and long-term goals throughout their
history, but CRS could not identify an independent evaluation of whether the programs have met
these goals, any challenges faced, and what, if any, further funding may be needed to achieve
them.154
Coronavirus Disease 2019 (COVID-19) and Long COVID Research
NIH played a major role supporting COVID-19 research during the pandemic, alongside other
agencies such as the Biomedical Advanced Research and Development Authority.155 NIH’s
activities included efforts to better understand the fundamental biology of the virus, to better
understand the epidemiology and clinical presentation of the disease, and to help develop new
medical products such as tests, vaccines, and treatments.156 NIH also published and maintained
treatment guidelines for COVID-19 as scientific and medical understanding was evolving during
150 NIH, “Notices of Change for Select BRAIN Initiative Funding Opportunities,” May 14, 2024,
https://braininitiative.nih.gov/news-events/blog/notices-change-select-brain-initiative-funding-opportunities.
151 NIH All of Us Research Program, “Data Snapshots,” https://www.researchallofus.org/data-tools/data-snapshots/.
152 Geoffrey S. Ginsburg, Joshua C. Denny, and Sheri D. Schully, “Data-Driven Science and Diversity in the All of Us
Research Program,” Science Translational Medicine, vol. 15, no. 726 (December 13, 2023).
153 See NIH, “The BRAIN Initiative Factsheet,” https://braininitiative.nih.gov/sites/default/files/documents/
brain_initiative_scientific_advancements_508c.pdf; NIH Director’s Blog, “Most Detailed 3D Reconstruction of Human
Brain Tissue Ever Produced Yields Surprising Insights,” May 30, 2024, https://directorsblog.nih.gov/2024/05/30/mostdetailed-3d-reconstruction-of-human-brain-tissue-ever-produced-yields-surprising-insights/; NIH, “Complete Wiring
Map of the Insect Brain,” March 28, 2023, https://www.nih.gov/news-events/nih-research-matters/complete-wiringmap-insect-brain; and NIH, “Blood Flow Makes Waves Across the Surface of the Mouse Brain,” May 29, 2024,
https://www.nih.gov/news-events/news-releases/blood-flow-makes-waves-across-surface-mouse-brain.
154 NIH, Implementation of Funding Plan for the NIH Innovation Projects Under the 21 st Century Cures Act,
https://www.nih.gov/sites/default/files/research-training/initiatives/nih-cures-innovation-plan.pdf, and NIH, The
BRAIN Initiative, “Overview,” https://braininitiative.nih.gov/about/overview.
155 For broader background, see CRS Report R46427, Development and Regulation of Medical Countermeasures for
COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions.
156 NIH COVID-19 Research, “NIH’s Strategic Response,” https://covid19.nih.gov/nih-strategic-response-covid-19.
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the pandemic. (NIH stopped publishing these guidelines in 2024.)157 NIH reports having received
close to $4.9 billion for COVID-19 research.158
Much of NIH’s COVID-19 research activities were supported through its regular and ongoing
intramural and extramural research programs. Many of its COVID-19 research efforts built upon
long-standing coronavirus, vaccine, and other infectious disease research programs. For example,
since 2016, NIH and Moderna (a pharmaceutical and biotechnology company) have collaborated
on mRNA vaccines. 159 In January 2020, scientists at the National Institute of Allergy and
Infectious Diseases’ intramural Vaccine Research Center shifted ongoing vaccine research to
develop a new mRNA-based COVID-19 vaccine with Moderna in response to early clusters of
the disease. This vaccine was ultimately authorized by FDA by the end of 2020.160 This and other
COVID-19 vaccines also drew upon prior NIH research on coronaviruses; specifically, research
that determined how to potentially design coronavirus vaccines that would provide robust
immunity.161
For extramural research, NIH also has specific authority to issue extramural supplemental
research funding and to expedite the peer review process for research awards related to public
health emergencies.162 NIH used this authority to award COVID-19 research supplements and to
issue new funding opportunities on an expedited basis.163
NIH also supported several large-scale and coordinated COVID-19 research initiatives. NIH
participated in the federal government-wide Operation Warp Speed (OWS) partnership to develop
COVID-19 vaccines and therapeutics. Specifically, NIH helped coordinate and oversee clinical
trials on five of the six OWS vaccine candidates, among other activities.164 Major NIH COVID19 related programs included the following:
157 NIH stopped updating the treatment guidelines in February 2024 and then shut down the COVID-19 treatment
guidelines website in August 2024. See Pien Huang, “In a Pandemic Milestone, the NIH Ends Guidance on COVID
Treatment,” March 19, 2024, https://www.npr.org/sections/health-shots/2024/03/19/1239276507/nih-covid-treatmentguidelines. For an archived version of the treatment guidelines, see https://web.archive.org/web/20231220204947/
https://www.covid19treatmentguidelines.nih.gov/.
158 NIH COVID-19 Research, “COVID-19 Funded Research Projects,” https://covid19.nih.gov/funding. Some of the
COVID-19 relief laws appropriated funds directly to NIH accounts, while others appropriated funding to HHS
Secretary accounts with the ability to allocate funds to specific operating divisions such as NIH. For more information
on COVID-19 relief appropriations to HHS public health agencies, see CRS Report R46711, U.S. Public Health
Service: COVID-19 Supplemental Appropriations in the 116th Congress, and CRS Report R46834, American Rescue
Plan Act of 2021 (P.L. 117-2): Public Health, Medical Supply Chain, Health Services, and Related Provisions.
159 NIH COVID-19 Research, “COVID-19 Vaccine Development: Behind the Scenes,” https://covid19.nih.gov/newsand-stories/vaccine-development; NIH, “Decades in the Making: mRNA COVID-19 Vaccines,”
https://www.niaid.nih.gov/diseases-conditions/decades-making-mrna-covid-19-vaccines; and Anthony Fauci, “The
Story Behind COVID-19 Vaccines,” Science, vol. 372, no. 6538 (April 9, 2021).
160 NIH COVID-19 Research, “COVID-19 Vaccine Development: Behind the Scenes,” https://covid19.nih.gov/newsand-stories/vaccine-development; NIH, “Decades in the Making: mRNA COVID-19 Vaccines,”
https://www.niaid.nih.gov/diseases-conditions/decades-making-mrna-covid-19-vaccines; and Anthony Fauci, “The
Story Behind COVID-19 Vaccines,” Science, vol. 372, no. 6538 (April 9, 2021).
161 See patent on which many coronavirus vaccines are based: NIH Technology Transfer, “Prefusion Coronavirus Spike
Proteins and Their Use,” https://www.techtransfer.nih.gov/tech/tab-3261, and Anthony Fauci, “The Story Behind
COVID-19 Vaccines,” Science, vol. 372, no. 6538 (April 9, 2021).
162 PHSA Section 494, 42 U.S.C. §289c.
163 NIH Extramural Nexus, “COVID-19 Funding and Funding Opportunities,” April 13, 2020, https://nexus.od.nih.gov/
all/2020/04/13/covid-19-funding-and-funding-opportunities/.
164 Francis Collins, Stacey Adam, Christine Colvis, et al., “The NIH-led Research Response to COVID-19,” Science,
vol. 379, no. 6631 (February 2, 2023), pp. 441-444, and Moncef Slaoui and Matthew Hepburn, “Developing Safe and
(continued...)
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Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Partnership: In
April 2020, NIH launched ACTIV, a public-private partnership to coordinate research and clinical
trials on new vaccines and therapeutics that involved several federal agencies, nonprofit
organizations, and private companies, as facilitated by FNIH (see the “Foundation for the NIH”
section). The initiative was designed to prioritize promising vaccine and therapeutic candidates,
streamline clinical trials and their design, coordinate regulatory processes, and leverage resources
among partners.165 The initiative sought to create a national framework for coordinating among
disparate entities that might otherwise compete with one another.166 For example, as part of
ACTIV, NIH helped coordinate and oversee clinical trials on 29 of the most promising potential
COVID-19 therapeutic candidates, which ultimately led to six drugs being approved for clinical
use as of February 2023.167
Rapid Acceleration of Diagnostics (RADx) Initiative: As funded by supplemental
appropriations provided by Congress, NIH launched the RADx program in April 2020.168 Prior to
launch, two Senate committee chairs had proposed a competitive “shark tank” program to
develop new COVID-19 tests.169 The RADx initiative was different from many other NIH
programs in that it was designed to facilitate commercialization and scale-up of new technologies.
As stated by NIH officials, RADx represented a “dramatic extension of the usual NIH mode of
supporting research.”170 RADx consisted of four components, the largest of which was the RADx
Tech program that involved the “shark tank”-like three-phase process to rapidly develop and scale
up new testing technologies. The program began with a solicitation of potential proposals,
followed by an expert review of the technologies in Phase 0. Selected technologies then received
further technical assistance and validation in Phase 1, and then a smaller group of technologies
was selected for clinical testing and scale-up in Phase 2, with substantial financial assistance
provided.171 RADx helped develop the first FDA-authorized over-the-counter COVID-19 test in
the United States and ultimately led to 55 FDA authorized COVID-19 tests.172
RECOVER Long COVID Initiative: In December 2020 (P.L. 116-260), Congress provided
NIH with $1.15 billion in supplemental appropriations for research on the long-term health
Effective Covid Vaccines—Operation Warp Speed’s Strategy and Approach,” The New England Journal of Medicine,
vol. 383 (August 26, 2020), pp. 1701-1703.
165 NIH, “NIH to Launch Public-Private Partnership to Speed COVID-19 Vaccine and Treatment Options,” press
release, April 17, 2020, https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speedcovid-19-vaccine-treatment-options.
166 Francis Collins and Paul Stoffels, “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): An
Unprecedented Partnership for Unprecedented Times,” JAMA, vol. 323, no. 24 (May 18, 2020).
167 Francis Collins, Stacey Adam, Christine Colvis, et al., “The NIH-led Research Response to COVID-19,” Science,
vol. 379, no. 6631 (February 2, 2023), pp. 441-444.
168 RADx was initially funded by $1.5 billion provided in the Paycheck Protection Program and Health Care
Enhancement Act (P.L. 116-139); see CRS Report R46711, U.S. Public Health Service: COVID-19 Supplemental
Appropriations in the 116th Congress. See also National Institute of Biomedical Imaging and Bioengineering (NIBIB),
“RADx® Tech and ATP Programs,” https://www.nibib.nih.gov/covid-19/radx-tech-program.
169 Senator Lamar Alexander and Senator Roy Blunt, “Opinion: We Need More Covid-19 Tests. We Propose a ‘Shark
Tank’ to Get Us There,” Washington Post, April 20, 2020, https://washingtonpost.com/opinions/2020/04/20/howspeed-up-testing-shark-tank-government/.
170 Bruce J. Tromberg, Tara A. Schwetz, Eliseo J. Pérez‑Stable, et al., “Rapid Scaling Up of Covid-19 Diagnostic
Testing—The NIH RADx Initiative,” The New England Journal of Medicine, vol. 383, no. 11 (September 10, 2020),
pp. 1071-1077.
171 Ibid, pp. 1071-1077.
172 NIBIB, RADx Tech: Delivering COVID-19 Diagnostic Technologies at Unprecedented Speed and Scale, March
2024, p. 4, https://www.nih.gov/sites/default/files/research-training/initiatives/radx/RADx-Tech-White-Paper-March2024.pdf.
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effects of COVID-19. NIH used these funds, in addition to later allocations, to establish the
RECOVER Initiative for studying Long COVID, or the long-term health effects of COVID-19
infections. The initiative supports scientific networks of researchers who study the clinical
presentation and biology of Long COVID along with clinical trials of potential treatments and
data resources for research.173
Other major efforts included the NIH Community Engagement Alliance (CEAL) Against
COVID-19 disparities, which helped recruit people from underserved communities to participate
in COVID-19 clinical trials.174 In addition, NIH developed many data resources for COVID-19
research, including the National COVID Cohort Collaborative, a nationwide repository of
electronic health record (EHR) data that ultimately became one of the largest health research
datasets on COVID-19 patients in the world.175
NIH saw some successes from its COVID-19 programs, including the vaccine and test
development examples described above. NIH also faced some criticisms. In particular, NIH faced
criticism for its perceived inability to generate robust evidence on potential COVID-19 treatments
quickly.176As summarized above, NIH’s ACTIV ultimately led to new COVID-19 treatments, but
many of the clinical trials were not completed until 2022 or 2023.177 The earliest FDA-authorized
COVID-19 therapeutic drug in May 2020, remdesivir, had mixed evidence of its effectiveness in
treating COVID-19 at the time of authorization, including one NIH-run clinical trial involving
slightly over 1,000 patients.178 In comparison, in June 2020, the United Kingdom’s Randomized
Evaluation of COVID-19 Therapy (RECOVERY) trial generated robust data on a highly effective
drug to improve survival in hospitalized COVID-19 patients (the steroid dexamethasone), based
on a trial involving several thousand patients. This drug quickly became the standard of care.179
Some critiqued NIH for its inability to stand up clinical trials at a similar scale as quickly as the
U.K. trials, despite the NIH’s much larger budget.180 One company reported pulling a COVID-19
173 NIH, About RECOVER Funding, https://recovercovid.org/funding.
174 Francis Collins, Stacey Adam, Christine Colvis, et al., “The NIH-led Research Response to COVID-19,” Science,
vol. 379, no. 6631 (February 2, 2023), pp. 441-444, and Michele P. Andrasik, Gail B. Broder, and Stephaun E.
Wallace, “Increasing Black, Indigenous and People of Color Participation in Clinical Trials Through Community
Engagement and Recruitment Goal Establishment,” PLoS One, vol. 16, no. 10 (October 19, 2021).
175 NIH, “NIH Launches Analytics Platform to Harness Nationwide COVID-19 Patient Data to Speed Treatments,”
press release, June 15, 2020, https://www.nih.gov/news-events/news-releases/nih-launches-analytics-platform-harnessnationwide-covid-19-patient-data-speed-treatments, and Cat Ferguson, “It Took a Pandemic, But the US Finally Has
(Some) Centralized Medical Data,” MIT Technology Review, June 21, 2021, https://www.technologyreview.com/2021/
06/21/1026590/us-covid-database-n3c-nih-privacy/.
176 Cary P. Gross and Ezekiel J. Emanuel, “The Missing Part of America’s Pandemic Response,” The Atlantic, June 5,
2022, https://www.theatlantic.com/ideas/archive/2022/06/nih-covid-vaccine-research-studies/661182/.
177 NIH ACTIV, “COVID-19 Therapeutics Prioritized for Testing in Clinical Trials,” https://www.nih.gov/researchtraining/medical-research-initiatives/activ/covid-19-therapeutics-prioritized-testing-clinical-trials.
178 FDA, “FDA Approves First Treatment for COVID-19,” press release, October 22, 2020, https://www.fda.gov/newsevents/press-announcements/fda-approves-first-treatment-covid-19; FDA, “Coronavirus (COVID-19) Update: FDA
Issues Emergency Use Authorization for Potential COVID-19 Treatment,” press release, May 1, 2020,
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-useauthorization-potential-covid-19-treatment; H. Clifford Lane and Anthony S. Fauci, “Research in the Context of a
Pandemic,” The New England Journal of Medicine, vol. 384, no. 8 (July 17, 2020); and Yeming Wang, Dingyu Zhang,
Guanhua Du, et al., “Remdesivir in Adults with Severe COVID-19: A Randomised, Double-Blind, Placebo-Controlled,
Multicentre Trial,” The Lancet, vol. 395, no. 10236 (May 16, 2020), pp. 1569-1578.
179 The RECOVERY Collaborative Group, “Dexamethasone in Hospitalized Patients with Covid-19,” New England
Journal of Medicine, vol. 384, no. 8 (July 17, 2020), pp. 693-704 and H. Clifford Lane and Anthony S. Fauci,
“Research in the Context of a Pandemic,” The New England Journal of Medicine, vol. 384, no. 8 (July 17, 2020).
180 Cary P. Gross and Ezekiel J. Emanuel, “The Missing Part of America’s Pandemic Response,” The Atlantic, June 5,
(continued...)
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drug candidate out of the NIH-run trials, reportedly because of its slow progress (the drug was
authorized by FDA a year later).181 Many credit the U.K.’s clinical trial success in large part to its
nationalized health system and associated clinical trial infrastructure, which was able to enroll
10% of all patients hospitalized with COVID-19 in the country in 2020.182 Several U.S. federal
agencies now have ongoing efforts to develop enhanced national clinical trial infrastructure that
could be used in future public health emergencies.183
NIH has also received considerable scrutiny for its RECOVER Long COVID research initiative
from certain patient advocates, policymakers, and researchers. NIH faced significant scientific
challenges in studying and researching new treatments for Long COVID given that it is a new
condition with hundreds of reported symptoms. NIH faced the challenge of working to
characterize and understand the disease while also testing potential treatments on a rapid basis.184
In particular, NIH has faced criticism about the Long COVID research initiative not being led by
researchers with specific expertise in other post-infection syndromes. According to critics, the
lack of relevant experts in leadership led to several challenges with the research questions
explored, the design of the research, and the treatments tested in clinical trials. In addition, NIH
was criticized because after three years, the NIH initiative still had not met many of its original
research objectives and, in particular, faced slow enrollment in clinical studies. Patients also
reported lack of meaningful engagement in the research plans and priorities.185 Observers have
also praised certain aspects of the initiative, for example, its pediatric research program and its
data and biospecimen resources.186 After receiving considerable criticism, in February 2024, NIH
announced an additional $515 million allotted to the RECOVER Long COVID Initiative to
2022, https://www.theatlantic.com/ideas/archive/2022/06/nih-covid-vaccine-research-studies/661182/ and The COVID
Crisis Group, “Chapter 9: Fighting Back with Drugs and Vaccines,” in Lessons from the COVID War: An Investigative
Report (New York, NY: PublicAffairs, 2023), pp. 225.
181 Specifically, Merck pulled Molnupiravir from the NIH-run clinical trials in December 2020. The drug received FDA
authorization in December 2021. See The COVID Crisis Group, “Chapter 9: Fighting Back with Drugs and Vaccines,”
in Lessons from the COVID War: An Investigative Report (New York, NY: PublicAffairs, 2023), pp. 225-226.
182 H. Clifford Lane and Anthony S. Fauci, “Research in the Context of a Pandemic,” The New England Journal of
Medicine, vol. 384, no. 8 (July 17, 2020) and Derek C. Angus, Anthony C. Gordon, and Howard Bauchner, “Emerging
Lessons From COVID-19 for the US Clinical Research Enterprise,” Journal of the American Medical Association, vol.
325, no. 12 (February 26, 2021), pp. 1159-1161.
183 See, for example, the Biomedical Advanced Research and Development Authority, “BARDA Launches the DCOHRe Program, Seeking to Enhance Clinical Innovation with Decentralized Care Capabilities,” July 5, 2023,
https://medicalcountermeasures.gov/newsroom/2023/d_cohre/ and Advanced Research Projects Agency for Health
(ARPA-H), “ARPA-H Advances Initiative to Improve Clinical Trials,” October 20, 2023, https://arpa-h.gov/news-andevents/arpa-h-advances-initiative-improve-clinical-trials.
184 Department of Health and Human Services (HHS), “National Research Action Plan on Long COVID,” August
2022, https://www.covid.gov/sites/default/files/documents/National-Research-Action-Plan-on-Long-COVID08012022.pdf.
185 Betsy Ladyzhets, “NIH Documents Show How $1.6 Billion Long Covid Initiative Has Failed so Far to Meet its
Goals,” STAT, May 31, 2024, https://www.statnews.com/2024/05/31/long-covid-nih-recover-initiative-falls-short-oncauses-treatments/ and Betsy Ladyzhets, “‘They Bungled It:’ NIH Documents Reveal how $1.6 Billion Long Covid
Initiative has Failed so Far to Meet its Goals,” The Sick Times, May 31, 2024, https://thesicktimes.org/2024/05/31/theybungled-it-nih-documents-reveal-how-1-6-billion-long-covid-initiative-has-failed-so-far-to-meet-its-goals/, and Max
Kozlov, “NIH Launches Trials for Long COVID Treatments: What Scientists Think,” Nature, August 1, 2023.
186 Betsy Ladyzhets, “NIH Documents Show How $1.6 Billion Long Covid Initiative Has Failed so Far to Meet its
Goals,” STAT, May 31, 2024, https://www.statnews.com/2024/05/31/long-covid-nih-recover-initiative-falls-short-oncauses-treatments/; Betsy Ladyzhets, “‘They Bungled It:’ NIH Documents Reveal how $1.6 Billion Long Covid
Initiative has Failed so Far to Meet its Goals,” The Sick Times, May 31, 2024, https://thesicktimes.org/2024/05/31/theybungled-it-nih-documents-reveal-how-1-6-billion-long-covid-initiative-has-failed-so-far-to-meet-its-goals/;, and Max
Kozlov, “NIH Launches Trials for Long COVID Treatments: What Scientists Think,” Nature, August 1, 2023.
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pursue further studies intended to be responsive to stakeholders.187 NIH has defended some of its
decisions and research progress while also acknowledging some of the challenges. As NIH
Director Bertagnolli stated at a 2024 congressional hearing with respect to the program, “We are
not where we want to be in terms of a rapid nimble clinical trials enterprise that’s testing
promising treatments very quickly. That is our focus right now moving forward to do that.”188
Selected Issues for Congress
Changing NIH’s Structure
NIH’s large and decentralized organizational structure has been an issue of concern for
decades.189 There are costs and complexities of administering an agency comprising 27 ICs, each
with its own mission, budget, staff, review office, and other organizational apparatuses. The
resulting fragmentation may create potential for research overlap or gaps, and might adversely
affect NIH’s ability to respond appropriately to new scientific and public health challenges. At the
same time, any large-scale reorganization could disrupt the agency’s ongoing programs and
activities. Some have argued that NIH’s large and decentralized structure allows the agency to be
responsive to the diverse constituencies interested in NIH’s work.190 Some laws have addressed
organization and structure at NIH, including the NIH Reform Act of 2006 and the 21st Century
Cures Act, but have stopped short of large-scale agency reorganization.
NIH’s current structure evolved from a series of separate congressional and executive branch
decisions made over the course of decades. After the National Cancer Institute was first
established in 1937, Congress and the Administration established many specific institutes within
NIH from the 1940s to 2011 (see Table 3). Several external reviews have examined NIH’s
organizational structure at points throughout its history.191 A congressionally requested 2003
report that preceded the NIH Reform Act of 2006 examined NIH’s structure and found that “the
most common mechanism of origin of the institutes has been the congressional mandate
responding to the health advocacy community.”192 A common pattern historically was that
advocacy groups pushed for an NIH office on a certain disease or health topic that was ultimately
187 NIH, “NIH to Bolster RECOVER Long COVID Research Efforts Through Infusion of $515 Million,” press release,
February 13, 2024, https://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-bolster-recover-long-covidresearch-efforts-through-infusion-515-million.
188 U.S. Congress, Senate Appropriations Committee, Review of the President’s FY2025 Budget Request for the
National Institutes of Health, 118th Cong., May 23, 2024.
189 Many prior reports have explored NIH’s structure and the need for reform, including Institute of Medicine,
Responding to Health Needs and Scientific Opportunity: The Organizational Structure of the National Institutes of
Health, October 1984, and National Research Council and Institute of Medicine, Enhancing the Vitality of the National
Institutes of Health: Organizational Change to Meet New Challenges, 2003. Various articles from the scientific
community have critically examined NIH’s organizational structure, including Harold Varmus, “Proliferation of
National Institutes of Health,” Science, vol. 291 (March 9, 2001), pp. 1903-1905; Richard A. Rettig, “Reorganizing The
National Institutes Of Health,” vol. 23, no. 1 (January/February 2004), pp. 257-262; and Michael M. Crow, “Time to
Rethink the NIH,” Nature, vol. 471 (March 31, 2011), pp. 569-571.
190 See discussion in Chapter 1 of National Research Council and Institute of Medicine, Enhancing the Vitality of the
National Institutes of Health: Organizational Change to Meet New Challenges, 2003.
191 See, for example, Institute of Medicine, Responding to Health Needs and Scientific Opportunity: The
Organizational Structure of the National Institutes of Health, October 1984, and National Research Council and
Institute of Medicine, Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New
Challenges, 2003.
192 National Research Council and Institute of Medicine, Enhancing the Vitality of the National Institutes of Health:
Organizational Change to Meet New Challenges, 2003.
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created, then elevated to a center, and then, in some cases, to an institute.193 At the same time, the
report noted that NIH’s many different ICs have “provided for the expression of a broader set of
priorities and expanded political support and budget success both for the specific interests
involved and for NIH in the aggregate.”194 This report ultimately did not find a compelling
argument for major reorganization and consolidation of NIH’s ICs and instead proposed several
reforms to improve agency coordination and management.195
As discussed in the “Recent Major Legislative History” section, the NIH Reform Act of 2006
ultimately established a Scientific Management Review Board to conduct public reviews of
NIH’s organizational structure and processes and to recommend reforms. In its first report on
organizational change and effectiveness at the agency in 2010, SMRB “recognized that a farreaching overhaul of the NIH structure is neither advisable nor feasible.”196 Instead, SMRB
proposed a framework for considering and evaluating potential organizational changes at NIH.197
This was the last report that SMRB published on NIH’s overall structure. Although SMRB is
required by statute to review NIH’s overall organizational structure every seven years,198 media
reporting and congressional investigations have found that SMRB had not convened since
2015.199 NIH reestablished SMRB in 2024.200
In 2024, some leaders in committees of jurisdiction for NIH published white papers or proposals
for NIH reform. For example, in the Senate, then-ranking member Cassidy of the Senate
Committee on Health, Labor, Education and Pensions (HELP) proposed reforms in a white paper
published in May 2024, which included proposals to reduce redundancies and find efficiencies
within and across NIH ICs. The paper did not propose a specific NIH restructuring.201 On the
House side, then-House Energy and Commerce committee chair Rodgers proposed restructuring
NIH’s current 27 ICs into 15, with overall policy goals to reduce duplication and silos, and to
“ensure each IC is considering the whole individual and all populations across the entire
lifespan”; this proposal was announced in June 2024.202 The House FY2025 Departments of
Labor, Health and Human Services, and Education, and Related Agencies (LHHS) appropriations
bill (H.R. 9029 , 118th Congress) included a new NIH account structure that reflected the
proposed reorganization. It is unclear what, if any, practical effect this account structure would
193 Ibid.
194
Ibid.
195 Ibid.
196 Scientific Management Review Board, Report on Deliberating Organizational Change and Effectiveness,
November 2010, p. 4, https://web.archive.org/web/20240801213248/https:/smrb.od.nih.gov/documents/
announcements/DOCE_112010.pdf.
197 Ibid.
198 PHSA Section 401(e)(2)(A) and 42 U.S.C. §281(e)(2)(A).
199 Lev Facher, “The Panel Was Supposed to Improve Efficiency at the NIH. It Hasn’t Even Met for 7 Years,” STAT,
May 9, 2022, and U.S. Congress House Energy and Commerce Committee, “E&C Committee Probes NIH for Failing
to Convene Scientific Management Review Board,” press release, March 13, 2023, https://energycommerce.house.gov/
posts/e-and-c-committee-probes-nih-for-failing-to-convene-scientific-management-review-board.
200 See HHS NIH, “Charter: Scientific Management Review Board,” filed April 11, 2024, available at
https://www.facadatabase.gov/.
201 Senator Bill Cassidy, ranking member, NIH in the 21st Century: Ensuring Transparency and American Biomedical
Leadership, Senate Committee on Health, Education, Labor and Pensions, May 2024, https://www.help.senate.gov/
imo/media/doc/nih_modernization_5924pdf.pdf.
202 U.S. Congress House Energy and Commerce Committee majority, “Reforming the National Institutes of Health:
Framework for Discussion,” June 2024, https://energycommerce.house.gov/posts/chair-rodgers-unveils-framework-fornih-reform-requests-stakeholder-input.
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have had on NIH’s organizational structure if adopted, particularly since the bill would not have
amended PHSA Title IV, which currently governs NIH’s structure and organization.
Reactions to the House-proposed changes were mixed. Some agreed with all or some aspects of
the reorganization plan or with the underlying intention to reform NIH. Others disagreed with
certain aspects of the reorganization proposal. Many voiced concerns about the process,
especially the choice to reflect the proposed reorganization in the House LHHS FY2025
appropriations bill.203 A letter signed by 223 stakeholder organizations argued that “a policy of
this magnitude—and one affecting one of our nation’s preeminent research institutions—should
not be included in an appropriations bill. It must be considered by an authorizing body through an
open, transparent process that includes input from a variety of key stakeholders and follows a
thorough review of NIH operations and portfolios.”204
Moving forward, if Congress considers reorganizing NIH a priority, Congress might consider
how to structure a process for determining NIH’s new structure with input from relevant
stakeholders. Congress might also consider what, if any, evidence might inform how NIH could
best be structured to achieve its mission.
Determining NIH’s Research Priorities
How should NIH prioritize its research funding across diseases, population groups, scientific
fields, technologies, and many other possible categories? To what extent should Congress weigh
in on NIH’s research priorities and how? How can Congress ensure that diverse constituencies
have input into NIH’s research priorities? Members of Congress, NIH leaders, and outside
stakeholders such as scientists and patient advocates have debated these questions since NIH was
first founded.205
As mentioned above, Congress has set NIH’s overall statutory authorizations and provides annual
funding to each of its ICs, but otherwise, it has predominately deferred to NIH’s internal prioritysetting and award processes to determine research funding allocations. These appropriations
levels ultimately drive NIH’s overall research priorities as some ICs receive more funding than
others. In recent years, Congress has mostly followed a practice of setting funding levels and
authorizations for certain priority diseases and health issues within ICs (e.g., Alzheimer’s disease,
ALS) but has otherwise left most of each IC’s funding untargeted (see the “Congressional
Involvement in NIH Research Priorities” section). As detailed further in the next section, most of
NIH’s annual budget is already committed for multiyear projects in any given fiscal year.
203 Sarah Owermohle, “With Sweeping NIH Reform on the Table, GOP Previews New Era of Research Scrutiny,”
STAT, June 18, 2024, https://www.statnews.com/2024/06/18/nih-reform-proposal-gop-reaction-analysis/ and Max
Kozlov, “Major Biomedical Funder NIH Poised for Massive Reform Under Trump 2.0,” Nature, vol. 635 (November
28, 2024).
204 Letter from NIH Stakeholder Organizations to Representatives Tom Cole and Rosa DeLauro, chair and ranking
member of House Appropriations Committee, July 9, 2024, https://d3dkdvqff0zqx.cloudfront.net/groups/apaadvocacy/
attachments/LHHSFY25RestructuringSignOnLetter_7.9.24.pdf.
205 For related histories, see Stephen P. Strickland, Politics, Science, and Dread Disease: A Short History of United
States Medical Research Policy (Cambridge , MA: Harvard University Press, 1972), and Bhaven Sampat, The History
and Political Economy of NIH Peer Review, The Brookings Institution, May 2023, https://www.brookings.edu/wpcontent/uploads/2023/05/SampatFinal-3.pdf. See also discussions in congressional hearings, for example, U.S.
Congress, House Energy and Commerce Committee, Health Subcommittee, Scientific Opportunities and Public Needs:
Balancing NIH’s Priority Setting Process, 108th Cong., 2nd sess., June 2, 2004, and U.S. Congress, Senate Labor and
Human Resources Committee, Subcommittee on Public Health and Safety, Labor Subcommittee, Biomedical Research
Priorities: Who Should Decide?, 105th Cong., 1st sess., May 1, 1997.
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