Editing National Institutes of Health (section)

==Funding==
===Budget and politics===
{| class="wikitable floatright" style="text-align:right"
|+Historical NIH budget<ref>{{cite news |title=Appropriations |url=https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-2 |access-date=January 27, 2024 |work=National Institutes of Health}}</ref>
!Year
!$ millions
|-
|1938
|0.5
|-
|1940
|0.7
|-
|1945
|2.8
|-
|1950
|52.7
|-
|1955
|81.2
|-
|1960
|399.4
|-
|1965
|959.2
|-
|1970
|1,061.0
|-
|1975
|2,092.9
|-
|1980
|3,428.9
|-
|1985
|5,149.5
|-
|1990
|7,567.4
|-
|1995
|11,299.5
|-
|2000
|17,840.5
|-
|2005
|28,594.4
|-
|2010
|31,238.0
|-
|2015
|30,311.4
|-
|2016
|32,311.4
|-
|2017
|34,300.9
|-
|2018
|37,311.3
|-
|2019
|39,311.3
|-
|2020
|41,690.0
|-
|2021
|42,940.5
|-
|2022
|45,183.0
|-
|2023
|47,683.5
|}
To allocate funds, the NIH must first obtain its budget from Congress. This process begins with institute and center (IC) leaders collaborating with scientists to determine the most important and promising research areas within their fields. IC leaders discuss research areas with NIH management who then develops a budget request for continuing projects, new research proposals, and new initiatives from the Director. The NIH submits its budget request to the [[Department of Health and Human Services]] (HHS), and the HHS considers this request as a portion of its budget. Many adjustments and appeals occur between the NIH and HHS before the agency submits NIH's budget request to the [[Office of Management and Budget]] (OMB). OMB determines what amounts and research areas are approved for incorporation into the President's final budget. The President then sends the NIH's budget request to Congress in February for the next fiscal year's allocations.<ref>{{cite web|title=Funding|url=https://fas.org/sgp/crs/misc/RL33695.pdf|url-status=live|archive-url=https://web.archive.org/web/20160304060502/http://www.fas.org/sgp/crs/misc/RL33695.pdf|archive-date=March 4, 2016}}</ref> The House and Senate Appropriations Subcommittees deliberate and by fall, Congress usually appropriates funding. This process takes approximately 18 months before the NIH can allocate any actual funds.<ref>{{cite web|title=Funding|url=http://officeofbudget.od.nih.gov|url-status=live|archive-url=https://web.archive.org/web/20111207114012/http://officeofbudget.od.nih.gov/|archive-date=December 7, 2011}}</ref>

When a [[government shutdown in the United States|government shutdown]] occurs, the NIH continues to treat people who are already enrolled in [[clinical trial]]s, but does not start any new clinical trials and does not admit new patients who are not already enrolled in a clinical trial, except for the most critically ill, as determined by the NIH Director.<ref>{{cite news|url= https://www.nytimes.com/2013/10/10/health/in-shutdown-clinical-trial-enrollment-slows-but-doesnt-halt.html |title=Clinical Trials Continue, but Only at a Crawl|author=Sabrina Tavernese|newspaper=New York Times|date=October 9, 2013|url-status=live|archive-url= https://web.archive.org/web/20171104143540/http://www.nytimes.com/2013/10/10/health/in-shutdown-clinical-trial-enrollment-slows-but-doesnt-halt.html|archive-date=November 4, 2017}}</ref><ref>{{cite news|first=Lauran|last=Neergaard|url= http://www.huffingtonpost.ca/2013/10/09/nih-admits-a-dozen-critic_n_4073447.html |title=NIH admits a dozen critically ill, making exceptions to no-new-patient policy during shutdown |work=Huffington Post |agency=The Associated Press |date=October 9, 2013 |access-date=September 10, 2015 |url-status=live |archive-url= https://web.archive.org/web/20170301013202/http://www.huffingtonpost.ca/2013/10/09/nih-admits-a-dozen-critic_n_4073447.html |archive-date=March 1, 2017}}</ref><ref>{{cite news|url= https://www.foxnews.com/health/government-slimdown-blocks-some-seeking-nih-research-treatment/ |title=Government slimdown blocks some seeking NIH research treatment |work=Fox News Channel |agency=The Associated Press |date=October 2, 2013 |url-status=live |archive-url= https://web.archive.org/web/20131005124430/http://www.foxnews.com/health/2013/10/02/government-slimdown-blocks-some-seeking-nih-research-treatment/ |archive-date=October 5, 2013}}</ref><ref>{{cite web|url= https://www.hhs.gov/budget/fy2014/fy2014contingency_staffing_plan-rev6.pdf |title=Department of Health and Human Services Fiscal Year 2014 Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations |url-status=dead |archive-url=https://web.archive.org/web/20131028125958/http://www.hhs.gov/budget/fy2014/fy2014contingency_staffing_plan-rev6.pdf |archive-date=October 28, 2013 }}</ref>

==== Historical funding ====
Over the last century, the responsibility to allocate funding has shifted from the OD and Advisory Committee to the individual ICs and Congress increasingly set apart funding for particular causes. In the 1970s, Congress began to earmark funds specifically for cancer research, and in the 1980s there was a significant amount allocated for AIDS/HIV research.<ref name="Funding" />

Funding for the NIH has often been a source of contention in Congress, serving as a proxy for the political currents of the time. During the 1980s, President Reagan repeatedly tried to cut funding for research, only to see Congress partly restore funding. The political contention over NIH funding slowed the nation's response to the AIDS epidemic; while AIDS was reported in newspaper articles from 1981, no funding was provided for research on the disease. In 1984 National Cancer Institute scientists found implications that "variants of a human cancer virus called HTLV-III are the primary cause of acquired immunodeficiency syndrome (AIDS)," a new epidemic that gripped the nation.<ref name=":2"/>

In 1992, the NIH encompassed nearly 1 percent of the federal government's operating budget and controlled more than 50 percent of all funding for health research and 85 percent of all funding for health studies in universities.<ref name="Laurie J. Price 1992 128–146"/> From 1993 to 2001 the NIH budget doubled. For a time, funding essentially remained flat, and for seven years following the financial crisis, the NIH budget struggled to keep up with inflation.<ref>[https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-1 NIH Appropriations (Section 1)] {{webarchive|url=https://web.archive.org/web/20170507125120/https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-1 |date=May 7, 2017 }} and [https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-2 NIH Appropriations (Section 2)] {{webarchive|url=https://web.archive.org/web/20180105133440/https://www.nih.gov/about-nih/what-we-do/nih-almanac/appropriations-section-2 |date=January 5, 2018 }} April 7, 2016, retrieved May 4, 2016, U.S. Department of Health and Human Service</ref>

In 1999 Congress increased the NIH's budget by $2.3 billion<ref name="Funding">{{cite web|url=https://www.nih.gov/about-nih/what-we-do/nih-almanac/legislative-chronology|title=The NIH Almanac: Legislative Chronology|access-date=13 February 2025}}</ref> to $17.2 billion in 2000.<ref name="OfficeOfBudget">{{cite web|url=http://officeofbudget.od.nih.gov/pdfs/FY13/spending%20list/Mechanism%20Detail%20for%20Total%20NIH%20FY%202000%20-%20FY%202011.pdf|title=Funding|url-status=live|archive-url=https://web.archive.org/web/20130215111157/http://officeofbudget.od.nih.gov/pdfs/FY13/spending%20list/Mechanism%20Detail%20for%20Total%20NIH%20FY%202000%20-%20FY%202011.pdf|archive-date=February 15, 2013}}</ref> In 2009 Congress again increased the NIH budget to $31 billion in 2010.<ref name="OfficeOfBudget" /> In 2017 and 2018, Congress passed laws with bipartisan support that substantially increasing appropriations for the NIH, which was 37.3 billion dollars annually in FY2018.<ref>Office of Management and Budget [https://www.gpo.gov/fdsys/pkg/BUDGET-2018-BLUEPRINT/pdf/BUDGET-2018-BLUEPRINT.pdf America First. A Budget Blueprint to Make America Great Again.] {{webarchive|url=https://web.archive.org/web/20170504104551/https://www.gpo.gov/fdsys/pkg/BUDGET-2018-BLUEPRINT/pdf/BUDGET-2018-BLUEPRINT.pdf |date=May 4, 2017 }} Budget of the United States Government, Fiscal Year 2018. Government Publishing Office, March 16, 2017.65 pp</ref><ref>{{Cite web|url=https://fas.org/sgp/crs/misc/R43341.pdf |archive-url=https://web.archive.org/web/20140328195650/http://www.fas.org/sgp/crs/misc/R43341.pdf |archive-date=2014-03-28 |url-status=live|title=NIH Funding: FY1994-FY2019|website=Congressional Research Service|access-date=March 17, 2017}}</ref>

===== Funding freezes =====
From the outset of 2025, NIH funding operations have faced interruptions on an unprecedented scale under the direction of the current executive branch of the U.S. government; disruptions as of March 2025 include:

• impeding grants for [[dementia]] and [[ALS]] research;

• hindering procurement of necessary resources, such as those for transporting patient blood samples;

• preventing a research scientist from consulting with physicians treating children with a devastating rare condition;

• interrupting the supply of mice for genetic studies, with years of research being imperiled as a result;

• cutting research grants for training doctoral and postdoctoral students.<ref>{{Cite news |last=Kolata |first=Gina |date=2025-03-24 |title=‘Chaos and confusion’ at the N.I.H., the crown jewel of American science |url=https://www.nytimes.com/2025/03/24/health/nih-doge-trump.html |access-date=2025-03-24 |work=The New York Times |language=en-US |issn=0362-4331}}</ref>

===Extramural research===
{{main|NIH grant}}
Researchers at universities or other institutions outside of the NIH can apply for [[NIH grants|research project grants]] (RPGs) from the NIH. There are numerous funding mechanisms for different project types (e.g., basic research, clinical research, etc.) and career stages (e.g., early career, postdoc fellowships, etc.). The NIH regularly issues "requests for applications" (RFAs), e.g., on specific programmatic priorities or timely medical problems (such as [[Zika virus]] research in early 2016). In addition, researchers can apply for "investigator-initiated grants" whose subject is determined by the scientist.

The total number of applicants has increased substantially, from about 60,000 investigators who had applied during the period from 1999 to 2003 to slightly less than 90,000 in who had applied during the period from 2011 to 2015.<ref name=":0">{{Cite web|url=https://nexus.od.nih.gov/all/2016/05/31/how-many-researchers/|title=How Many Researchers?|last=Lauer|first=Mike|date=May 31, 2016|website=Open Mike|publisher=NIH|access-date=June 6, 2016|url-status=live|archive-url=https://web.archive.org/web/20160825174823/https://nexus.od.nih.gov/all/2016/05/31/how-many-researchers/|archive-date=August 25, 2016}}</ref> Due to this, the "cumulative investigator rate", that is, the likelihood that unique investigators are funded over a 5-year window, has declined from 43% to 31%.<ref name=":0" />{{Anchor|R01 grant}}

R01 grants are the most common funding mechanism and include investigator-initiated projects. The roughly 27,000 to 29,000 R01 applications had a funding success of 17-19% during 2012 though 2014. Similarly, the 13,000 to 14,000 R21 applications had a funding success of 13-14% during the same period.<ref>{{Cite web|url=https://nexus.od.nih.gov/all/2015/04/10/looking-at-recent-data-on-r21-and-r01-equivalent-grants/|title=Looking at Recent Data on R21 and R01-equivalent Grants|last=Rockey|first=Sally|date=April 10, 2015|website=Rock Talk|publisher=NIH|access-date=October 2, 2016|url-status=live|archive-url=https://web.archive.org/web/20161008215446/https://nexus.od.nih.gov/all/2015/04/10/looking-at-recent-data-on-r21-and-r01-equivalent-grants/|archive-date=October 8, 2016}}</ref> In FY 2016, the total number of grant applications received by the NIH was 54,220, with approximately 19% being awarded funding.<ref name=2016funding>{{cite web|title=NIH Research Portfolio Online Reporting Tools (RePORT)|url=https://report.nih.gov/success_rates/Success_ByIC.cfm|website=report.nih.gov|url-status=live|archive-url=https://web.archive.org/web/20180202133251/https://report.nih.gov/success_rates/Success_ByIC.cfm|archive-date=February 2, 2018}}</ref> Institutes have varying funding rates. The National Cancer Institute awarded funding to 12% of applicants, while the National Institute for General Medical Science awarded funding to 30% of applicants.<ref name=2016funding/>

===Funding criteria===
The NIH employs five broad decision criteria in its funding policy. First, ensure the highest quality of scientific research by employing an arduous peer review process. Second, seize opportunities that have the greatest potential to yield new knowledge and that will lead to better prevention and treatment of disease. Third, maintain a diverse research portfolio to capitalize on major discoveries in a variety of fields such as cell biology, genetics, physics, engineering, and computer science. Fourth, address public health needs according to the disease burden (e.g., prevalence and mortality). And fifth, construct and support the scientific infrastructure (e.g., well-equipped laboratories and safe research facilities) necessary to conduct research.<ref>{{cite web |title=Statement on Funding Allocation for Disease Research by Harold Varmus, M. D., Director, National Institutes of Health |publisher=Assistant Secretary for Legislation, Department of Health and Human Services |url=https://www.hhs.gov/asl/testify/t990506a.htm |date=May 6, 1999}}</ref>

Advisory committee members advise the institute on policy and procedures affecting the external research programs and provide a second level of review for all grant and cooperative agreement applications considered by the Institute for funding.<ref>{{cite web |url=http://www.ninds.nih.gov/find_people/nands/index.htm |title=National Advisory Neurological Disorders and Stroke Council (NANDSC) |publisher=Ninds.nih.gov |access-date=April 28, 2013 |url-status=live |archive-url=https://web.archive.org/web/20130428004009/http://www.ninds.nih.gov/find_people/nands/index.htm |archive-date=April 28, 2013 }}</ref>

====Gender and sex bias====
In 2014, it was announced that the NIH is directing scientists to perform their experiments with both female and male animals, or cells derived from females as well as males if they are studying cell cultures, and that the NIH would take the balance of each study design into consideration when awarding grants.<ref name="nytimes.com">{{cite news |first=Roni Caryn |last=Rabin |url= https://www.nytimes.com/2014/05/15/health/nih-tells-researchers-to-end-sex-bias-in-early-studies.html |title=Labs Are Told to Start Including a Neglected Variable: Females |newspaper=The New York Times |date=May 14, 2014 |access-date=September 10, 2015 |url-status=live |archive-url= https://web.archive.org/web/20150906202122/http://www.nytimes.com/2014/05/15/health/nih-tells-researchers-to-end-sex-bias-in-early-studies.html |archive-date=September 6, 2015 }}</ref> The announcement also stated that this rule would probably not apply when studying sex-specific diseases (for example, ovarian or testicular cancer).<ref name="nytimes.com"/>

===Stakeholders===
====General public====
One of the goals of the NIH is to "expand the base in medical and associated sciences in order to ensure a continued high return on the public investment in research."<ref>{{cite web|title=Stakeholders|url= http://www.nih.gov/about/mission.htm|url-status=live|archive-url= https://web.archive.org/web/20111125135014/http://www.nih.gov/about/mission.htm |archive-date=November 25, 2011|date=October 31, 2014}}</ref> Taxpayer dollars funding the NIH are from the taxpayers, making them the primary beneficiaries of advances in research. Thus, the general public is a key stakeholder in the decisions resulting from the NIH funding policy.<ref>{{cite web|title=Stakeholders |url=http://acd.od.nih.gov/Roster.asp |url-status=dead |archive-url= https://web.archive.org/web/20111114231545/http://acd.od.nih.gov/Roster.asp |archive-date=November 14, 2011}}</ref>{{Failed verification|date=April 2022}} However, some in the general public do not feel their interests are being represented, and individuals have formed patient advocacy groups to represent their own interests.<ref>{{cite web|title=Stakeholders|url= https://www.hhs.gov/asl/testify/t990506a.html |url-status=live|archive-url= https://web.archive.org/web/20161104113818/http://www.hhs.gov/asl/testify/t990506a.html |archive-date=November 4, 2016}}</ref>

====Extramural researchers and scientists====
Important stakeholders of the NIH funding policy include researchers and scientists. Extramural researchers differ from intramural researchers in that they are not employed by the NIH but may apply for funding. Throughout the history of the NIH, the amount of funding received has increased, but the proportion to each IC remains relatively constant. The individual ICs then decide who will receive the grant money and how much will be allotted.

Policy changes on who receives funding significantly affect researchers. For example, the NIH has recently attempted to approve more first-time NIH R01 applicants or the research grant applications of young scientists. To encourage the participation of young scientists, the application process has been shortened and made easier.<ref>{{cite journal |journal=Science |year=2008 |volume=322 |issue=5905 |pages=1187–8 |doi=10.1126/science.322.5905.1187c |title=Changes to NIH grant system may backfire |vauthors=Karp PD, Sherlock G, Gerlt JA, Sim I, Paulsen I, Babbitt PC, Laderoute K, Hunter L, Sternberg P, Wooley J, Bourne PE |pmid=19023064|s2cid=47509185 }}</ref> In addition, first-time applicants are being offered more funding for their research grants than those who have received grants in the past.<ref>{{cite journal |journal=Acad Med |date=May 2010 |volume=85 |issue=5 |pages=775–9 |doi=10.1097/ACM.0b013e3181d74256 |pmid=20520024 |title=Perspective: is NIH funding the "best science by the best scientists"? A critique of the NIH R01 research grant review policies |author=Costello LC|doi-access=free }}</ref>