95-96: The National Institutes of Health: An Overview

Pamela W. Smith

Analyst in Life Sciences
Domestic Social Policy Division

Updated September 1, 1999

Background

NIH is the primary agency of the federal government charged with the conduct and support of biomedical and behavioral research. It also has major roles in research training and health information dissemination. In both budget and personnel, it is the largest of the eight health-related agencies that make up the Public Health Service (PHS) within the Department of Health and Human Services (DHHS).⁽¹⁾ For FY1999, it has a total budget of over $15.6 billion and total employment of about 17,000 people.

NIH derives its statutory authority from the Public Health Service Act of 1944, as amended numerous times in the last half century (42 U.S.C. 201-300gg). Section 301 of the PHS Act grants the Secretary of DHHS broad permanent authority to conduct and sponsor research. In addition, Title IV authorizes in greater detail various responsibilities, activities, and functions of the NIH Director and the institutes. Several of the NIH institutes have specific time-and-dollar authorizations that require periodic renewal by Congress, as do such other activities as the programs for training grants and facilities construction awards. Authorizing committees with jurisdiction over NIH are the Senate Health, Education, Labor and Pensions Committee and the House Commerce Committee. Appropriations are handled by the House and Senate Appropriations Subcommittees on Departments of Labor, Health and Human Services, and Education and Related Agencies.

Organization

Begun in 1887 as a one-room Marine Hospital laboratory, NIH spent its first half century operating as an intramural research lab for the Public Health Service. It became the National Institute of Health in 1930, and the National Institutes of Health in 1948. Today, NIH comprises 18 institutes, 3 centers, and the National Library of Medicine (see Table 1). Each has a specialized focus on particular diseases, areas of human health and development, or aspects of research support, and each receives a separate appropriation.⁽²⁾ NIH has 77 buildings on a 300-acre main campus in Bethesda, Maryland, and also occupies off-campus sites in Maryland, North Carolina, Montana, and other locations.

Activities

Two categories of research are sponsored by the institutes and centers (I/Cs): extramural research, performed by scientists working in universities, academic health centers, hospitals, and independent research institutions using NIH grant or contract money; and intramural research, performed in the NIH laboratories and Clinical Center by NIH scientists. In both programs, the research projects are largely investigator-initiated, and span all fields of basic and clinical medical research. (Basic research is research in the fundamental medical sciences, sometimes called lab or bench research, while clinical research involves patients.) NIH also supports both extramural and intramural research training programs to prepare young investigators for research careers.

About 82% of the overall NIH budget goes for extramural awards in the form of research grants, research and development contracts, training awards, and a few smaller categories such as construction grants, facilities renovation grants, and medical library grants.⁽³⁾ The "research grants" category, by far the largest, includes traditional research project grants to individual investigators, as well as grants to groups of researchers who work in collaborative programs or in multidisciplinary centers that focus on particular diseases or areas of research. Nearly three-fourths of NIH's extramural funds go to researchers working in institutions of higher education, with 50% going to the nation's 124 medical schools.⁽⁴⁾ All applications for extramural research support are considered under a two-tiered system of peer review. First, they are reviewed for scientific merit by "study sections" of nongovernment experts and given priority scores. Second, they are considered for program relevance by the appropriate National Advisory Councils or Boards of the I/Cs. I/C staff make the final funding decisions among the top priority proposals. The NIH Office of Extramural Research reports that about 24,150 applications for research project grants were reviewed in FY1998, with 31% receiving funding.

Table 1. Components of the National Institutes of Health (NIH) with year of establishment and major research focus

The NIH intramural research program includes more than 9,000 scientists and technical support staff. Each of the institutes has an intramural research program, but the structure and activities of the programs vary greatly. Many intramural scientists work in the Clinical Center, which facilitates interdisciplinary collaboration and the direct clinical application of new knowledge derived from basic research.

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 institutes and centers sponsor seminars, meetings, and consensus development conferences to inform health professionals of new findings; answer thousands of telephone and mail inquiries; publish physician and patient education materials (many of them available on the Internet); support information clearinghouses and run public information campaigns on various diseases; and make specialized databases available. Free searching of Medline citations and other NLM databases, together with resources for health questions, is available at http://medlineplus.nlm.nih.gov/medlineplus.

Budget

At $15.61 billion for FY1999, NIH's budget (see Table 2) represents about 40% of federal civilian (i.e., nondefense) spending for research and development (R&D). The agency has enjoyed strong bipartisan support from Congress, reflecting the interest of the American public in promoting medical research. Even in the face of pressure to reduce the deficit, Congress nearly doubled NIH's appropriation over the last decade. In real terms, from FY1989 to FY1998, the budget stayed about 24% ahead of inflation as measured by the Biomedical Research and Development Price Index (BRDPI), a special inflation index developed for NIH to measure changes in the prices of items and services required for its R&D activities.⁽⁵⁾

For FY1998, Congress increased NIH funding by 7.0%, to a total of $13.62 billion (P.L. 105-78). For FY1999, the President proposed a large increase for NIH, requesting a total of $14.8 billion, up 8.4% over FY1998. The House and Senate Appropriations Committees responded by recommending increases of 9.1% and 14.4%, respectively. The final appropriation, incorporated into the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (P.L. 105-277), gave NIH an increase of 14.6% to a total of $15.61 billion. For FY2000, the President has proposed a 2.1% increase for NIH, citing the need to balance support to other areas of science. The budget reflects continuation of NIH's FY1999 priorities, with added emphasis in a few new areas. For further details, see the NIH section of CRS Issue Brief IB10018, Research and Development Funding: Fiscal Year 2000.

Issues for Congress

Budgetary and appropriations issues continue to be the focus of congressional attention to NIH. Reauthorization legislation for various NIH programs was last enacted in 1993 (P.L. 103-43), with authorizations expiring in FY1996. A few of the expired authorities were extended in health bills passed at the end of the 105^th Congress.

In giving NIH its $2 billion increase for FY1999, Congress responded to calls to double the agency's budget in 5 years (to $27 billion by FY2003), a process that would require increases of about 15% per year. Several "doubling" proposals have been introduced in the 106^th Congress, either focusing on support of NIH alone (e.g., S.Res. 19 and H.Res. 89), or authorizing a doubling of the budgets of a number of federal R&D agencies, including NIH, over a longer period. One such bill, the Federal Research Investment Act (S. 296), has been reported in the Senate. Since health research has received much more substantial increases than other science funding in recent years, Congress will be weighing whether continued large increases for NIH are sustainable in the face of other priorities. Several other bills have been introduced that seek to provide extra funding for NIH beyond its annual appropriation by establishing research trust funds in the Treasury, to be supported by income tax checkoffs, health plan premium set-asides, or special taxes. No action has been taken on any of these measures.

Over the past three years, both the appropriations and the authorizing committees have held several hearings examining the NIH process for priority setting and resource allocation. Questions have been raised about how NIH can responsibly spend large increases in funding, and about how funds are allocated among the NIH institutes, among various disease categories, and between laboratory and clinical research (see CRS Report 97-917, Disease Funding and NIH Priority Setting). The FY1998 appropriations act mandated a study of NIH research priority setting, to be done by the Institute of Medicine of the National Academy of Sciences. The study, entitled Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at NIH, was released July 8, 1998 http://www.nap.edu/readingroom/books/nih/. It made 12 recommendations relating to allocation criteria, the decision-making process, mechanisms for public input, and the impact of congressional directives. It particularly stressed that NIH needs to engage the public to a greater extent in informing the process of research priority setting. A new Council of Public Representatives has been formed to serve as an advisory committee to the NIH director.

Several bills addressing authorization issues have been introduced this year. Topics include clinical research, research facilities, alternative medicine, domestic and global health disparities, and research on women's health, biomedical imaging, prostate cancer, and various specific diseases. Related issues that may spark continued debate include stem cell research (see CRS Report RS20266, Human Embryonic Stem Cell Research), the use of human fetal tissue or human embryos in research (see CRS Report 95-886, Human Fetal Tissue Transplantation Research, and CRS Report 95-910, Human Embryo Research), and attempts to prohibit human cloning research (see CRS Report 97-335, Cloning: Where Do We Go From Here?).

Table 2. National Institutes of Health Appropriations
(dollars in millions)

Source: NIH FY2000 Justification of Estimates for Appropriations Committees

a. FY1998 comparable reflects these transfers: $25.5 million to DHHS for year 2000 conversion and other activities; $41 thousand to National Cancer Institute from Dept. of State; and $54.7 million for the Women's Health Initiative from Office of the Director to National Heart, Lung, and Blood Institute.

b. All years do not include these transfers: $27 million to National Institute of Diabetes and Digestive and Kidney Diseases for diabetes research (funding from the Balanced Budget Act of 1997 for FY1998-FY2002); and $9.5 million to National Institute on Drug Abuse from Office of National Drug Control Policy.

c. FY1998 and FY1999 are comparable for Clinical Center formula adjustment among institutes/centers, and comparable transfer from OD to National Center for Complementary and Alternative Medicine.

d. FY2000 amount includes $40 million advance appropriation from FY1999 appropriation.

e. All AIDS funding is shown distributed to the individual institutes, although the FY2000 request places the money in a consolidated OAR account. Total AIDS spending, as reported by NIH, is shown on the last line. The FY1998 and FY1999 appropriations acts did not specify amounts for AIDS.

Footnotes

1. ^(back)The Public Health Service also includes the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Agency for Health Care Policy and Research (AHCPR), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Indian Health Service (IHS), and the Agency for Toxic Substances and Disease Registry (ATSDR).

2. ^(back)Three other centers are also components of NIH: the Center for Scientific Review, which receives, reviews, and refers research and training grant applications; the Center for Information Technology, which coordinates NIH's information technology services; and the Clinical Center, NIH's hospital and outpatient clinic. These centers do not receive their own appropriations, but are funded through the NIH Management Fund, financed by taps on other NIH appropriations. For further information on each component, see the NIH Almanac, 1998 (NIH Pub. No. 98-5), http://www.nih.gov/welcome/almanac/index.html.

3. ^(back)The intramural research program accounts for about 10% of the budget, with the remaining 8% for management costs, buildings and facilities, interagency agreements, etc.

4. ^(back)NIH Office of Extramural Research. NIH Extramural Awards: Characteristics of Awardee Organizations. http://silk.nih.gov/public/cbz2zoz.@www.awards.instchar.htm For more discussion of the research role of medical schools and academic health centers, see CRS Report 94-870, Health Care Reform: Where Does Medical Research Fit In?, by Pamela Smith.

5. ^(back)NIH Office of Financial Management. The BRDPI Defined and The 1998 Update and Projections for Future Years. http://www4.od.nih.gov/ofm/brdpi/index.stm