The National Institutes of Health (NIH): Organization, Funding, and Congressional Issues

The National Institutes of Health (NIH):
Organization, Funding, and Congressional Issues
Updated April 25, 2008
Pamela W. Smith
Analyst in Biomedical Policy
Domestic Social Policy Division

The National Institutes of Health (NIH):
Organization, Funding, and Congressional Issues
The National Institutes of Health is the focal point for federal health research.
An agency of the Department of Health and Human Services (HHS), it uses its $29.2
billion budget to support more than 300,000 scientists and research personnel
working at over 3,100 institutions across the U.S. and abroad, as well as to conduct
biomedical and behavioral research and research 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 or research areas in human health. A range of basic and clinical research is
funded through a highly competitive system of peer-reviewed grants and contracts.
FY2003 was the final year of a five-year undertaking by Congress to double the
NIH budget from its FY1998 base of $13.7 billion to the FY2003 level of $27.1
billion. Since then, the growth rate has fallen to below the rate of inflation. In
FY2008, NIH funding was increased by 0.5% above FY2007. The President
requested an essentially flat budget of $29.2 billion for NIH for FY2009, while the
advocates in the research community recommended a 6.5% increase. The projected
increase in the inflation index is 3.5% for both FY2008 and FY2009. In inflation-
adjusted terms, the FY2008 funding level represents an estimated 11% decrease from
FY2003, while the FY2009 request level would be 14% below FY2003. The request
planned to support about the same number of grants as the FY2008 estimate. The
success rate for competing grant applications getting funded would be an estimated

18%, compared with 25% in FY2004 and 30%-32% during the doubling years.

Appropriators and authorizers face many issues in working with NIH to set
research priorities in the face of tight budgets. Congress accepts, for the most part,
the priorities established through the agency’s complex process of weighing scientific
opportunity and public health needs. While the Public Health Service Act (PHSA)
provides the statutory basis for NIH programs, it is primarily through appropriations
report language, not budget line items or earmarks, that Congress gives direction to
NIH and allows a voice for advocacy groups. Challenges facing the agency and the
research enterprise, all aggravated by restrained budgets, include attracting and
keeping young scientists in research careers; improving the translation of research
results into useful medical interventions through more efficient clinical research;
creating opportunities for transdisciplinary research that cuts across institute
boundaries to exploit the newest scientific discoveries; and managing the portfolio
of extramural and intramural research with strategic planning, openness, and public
accountability. In December 2006, Congress passed the NIH Reform Act (P.L. 109-

482), addressing many of these issues through changes to NIH authorities.

Implementation of the law’s provisions is under way on a number of fronts.
Congress also monitors ethics rules on conflicts of interest and tracks the efficacy of
procedures intended to make results of NIH-sponsored research publicly accessible.
NIH’s Internet home page is at []; budget information is at
[]; disease funding estimates are
at []; and legislative issues
tracking is at []. This report will be updated as events warrant.

Overview of the National Institutes of Health............................1
In troduction ..................................................1
Organization of NIH...........................................3
History ..................................................3
Structure .................................................3
Authority ................................................3
Activities ....................................................7
Extramural Research.......................................7
Intramural Research........................................9
Research Training.........................................9
Information Dissemination..................................9
Budget ......................................................9
Recent History............................................9
Sources of Funding.......................................14
FY2009 Request..........................................14
Budget Discussion by Funding Mechanism.....................15
Issues for Congress...............................................18
Appropriations: Budgeting within Constraints......................18
Background on Agency Budget Formulation....................18
Setting Research Priorities..................................19
Advocacy Groups.........................................19
Scarce Resources.........................................20
Success Rates............................................20
Young Investigators.......................................21
Research Restrictions......................................21
New Approaches?........................................22
Authorizations: Structure and Program Direction....................22
Organizational Complexity.................................22
The National Academies Study and Recommendations...........23
NIH Initiatives...........................................24
Congressional Activities on NIH Reauthorization (the NIH Reform
Act of 2006, P.L. 109-482).............................27
Oversight: Maintaining Trust and Transparency....................30
Public Access to Results of NIH-Sponsored Research............30
Ethics Regulations for NIH Employees Regarding Conflicts
of Interest...........................................32
Selected NIH Online Resources......................................34
NIH Home Page []........................34
NIH Budget []...34
Legislation Affecting NIH []...............34

Figure 1. NIH Appropriations FY1994-FY2009 Request..................13
Figure 2. Effect of Inflation on NIH Budget FY1994-FY2009 Program Level.13
Figure 3. FY2009 NIH Budget Request by Funding Mechanism............16
List of Tables
Table 1. Components of the National Institutes of Health (NIH).............5
Table 2. National Institutes of Health (NIH) Appropriations...............11
Table 3. NIH Budget by Funding Mechanism..........................17
Table 4. Components of NIH, with History and Scope...................36

The National Institutes of Health (NIH):
Organization, Funding, and
Congressional Issues
Overview of the National Institutes of Health
The National Institutes of Health 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 (HHS).1 For FY2008, it has a total budget of $29.2
billion and total employment of more than 18,000 people. The President’s FY2009
budget requested level funding.
Congress maintains a high level of interest in NIH for a variety of reasons:
!The NIH budget is by far the largest and most visible component of
federal civilian research and development spending. It garners great
interest during deliberations on the annual appropriations bill for the
Departments of Labor, Health and Human Services, and Education
and Related Agencies. NIH funds extramural researchers in every
state, and widespread constituencies contact Congress about funding
for particular diseases and levels of research support in general.
!NIH has increasingly come to the attention of Congress and the
American people in the last decade, thanks to greater awareness of
science advances (for example, the Human Genome Project and its
potential for guiding more personalized medicine) and public policy
debates (for instance, the use and regulation of human embryonic
stem cells). Special interest surrounded the five-year doubling of the
agency’s budget between FY1999 and FY2003. Since then, during
five years of low or no growth, Congress has increasingly scrutinized

1 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), and the Agency for Toxic Substances and Disease Registry (ATSDR). For further
information, see CRS Report RL34098, Public Health Service (PHS) Agencies: Background
and Funding, by Pamela W. Smith et al.

how NIH has used its expanded resources, how it can most
efficiently adapt to budgetary constraints, and how its 27 semi-
autonomous institutes and centers can best coordinate their efforts
in order to identify and respond nimbly to important public health
!At the end of the 109th Congress, the House and Senate agreed on the
first NIH reauthorization statute enacted since 1993, the NIH
Reform Act of 2006 (P.L. 109-482). For more than a dozen years,
most policy changes had come in the appropriations arena or through
agency initiatives under its broad research authority. Work by the
authorizing committees (the House Committee on Energy and
Commerce and Senate Committee on Health, Education, Labor, and
Pensions) had led to passage of a number of laws focusing on
individual diseases or other NIH-related topics, but no
comprehensive consideration of the agency’s structure and policies
had been undertaken. In the fall of 2006, after many hearings and
solicitation of comments and reactions from the disparate
stakeholders of the medical research community, Congress passed
H.R. 6164, which the President signed on January 15, 2007. The act
focused on enhancing the authority and tools for the NIH Director to
do strategic planning, especially to facilitate and fund cross-institute
research initiatives.
Other issues of concern to Congress and the research community include:
!clinical research, and more broadly, translational research, meaning
the movement of discoveries of basic science into new preventives,
diagnostics, therapies, and cures. Initiatives are under way to make
the process quicker and more efficient, and to encourage more
medically trained young scientists to work in clinical research;
!helping young investigators (both basic and clinical) obtain their first
independent research grants more quickly;
!congressional and/or administrative restrictions on types of research
funded, particularly human embryonic stem cell research;
!conflict-of-interest regulations for NIH scientists and other
employees concerning their financial holdings and their freedom to
consult with industry and outside colleagues, including questions of
impact on recruitment and retention; and
!development of policies for free public access to journal articles
stemming from NIH-supported research, and weighing that access
against the interests of publishers, including scientific societies. (A
voluntary policy for submission of articles had little participation, so
Congress made it mandatory.)
This report provides background and analysis on the organization, mission,
budget, and history of NIH as an agency, outlines its major responsibilities and
methods of fulfilling them, and discusses the issues facing Congress in considering
authorization legislation and its implementation, and as it works to guide and monitor
the nation’s investment in medical research. This report will be updated as events

Organization of NIH
History. NIH traces its roots to 1887, when a one-room Laboratory of Hygiene
was established at the Marine Hospital in Staten Island, New York. Relocated to
Washington, DC, in 1891, and renamed the Hygienic Laboratory, it operated for its
first half century as an intramural research lab for the Public Health Service.
Congress designated the lab the National Institute of Health in 1930 (P.L. 71-251).
It moved to donated land in the Maryland suburbs in 1938. By 1948, several new
institutes and divisions had been created, and the agency became the National
Institutes of Health (P.L. 80-655). Congress has continued to create new institutes
and centers, most recently in 2000.
Structure. Today, NIH consists of the Office of the Director and 27
components — 19 institutes, 4 research centers, the National Library of Medicine,
and 3 other centers that provide central services (for details, see Table 1 and Table
4). The Office of the Director (OD) sets overall policy for NIH and coordinates the
programs and activities of all NIH components, particularly trans-institute research
initiatives and issues. The individual institutes and centers (ICs), each of which
focuses on particular diseases, areas of human health and development, or aspects of
research support, plan and manage their own research programs in coordination with
the Office of the Director. Congress provides separate appropriations to 24 of the
27 ICs, to OD, and to a buildings and facilities account (see the budget discussion
later).2 NIH occupies a 317-acre main campus in Bethesda, Maryland, as well as
numerous off-campus sites, including locations in Maryland, North Carolina, and
Authority. The agency derives its statutory authority from the Public Health3
Service Act of 1944, as amended (42 U.S.C. § 201 through §300ii-4). Section 301
of the PHS Act (42 U.S.C. § 241) grants the Secretary of HHS broad permanent
authority to conduct and sponsor research. In addition, Title IV, “National Research
Institutes” (42 U.S.C. § 281-290b), authorizes in greater detail various activities,
functions, and responsibilities of the NIH Director and the institutes and centers. All
of the institutes and centers are covered by specific provisions in the PHS Act. Prior
to passage of the NIH Reform Act of 2006 (P.L. 109-482), nine of the ICs and a
variety of individual programs had time-and-dollar limits on their authorizations of
appropriations. Most of the authorizations had expired, but § 301 provided authority
for the programs. The other institutes and centers and most NIH programs did not
require periodic reauthorization by Congress, and there was no overall authorization
for the agency. The NIH Reform Act authorized total funding levels for NIH

2 The three centers that do not receive their own appropriations are the Center for Scientific
Review (CSR), which receives, refers, and reviews research and training grant applications;
the Center for Information Technology (CIT), which coordinates NIH’s information
technology services; and the Clinical Center (CC), NIH’s hospital and outpatient facility for
clinical research. Those centers are funded through the NIH Management Fund, which is
financed by taps on other NIH appropriations. For further information on each component,
see the NIH Almanac, 2006-2007, at [].
3 For a compilation of the Public Health Service Act as amended through December 31,

2004, see [].

appropriations for FY2007 to FY2009, and eliminated all of the other specific
authorizations in Title IV.

Table 1. Components of the National Institutes of Health (NIH)
(for additional details on the history and major research focus of each component, see Table 4)
FY2008 IC Budget
Website(Program Level) &Percent of Total NIH
Budget ($ in millions)
irector (OD) — includes program coordination offices for research on AIDS, Disease
ention (including Dietary Supplements, and Rare Diseases), Behavioral and Social Sciences, and[]$1,1093.8%
en’s Health
tional Cancer Institute (NCI)[]$4,80516.5%
g/wtional Eye Institute (NEI)[]$6672.3%
s.ortional Heart, Lung, and Blood Institute (NHLBI)[]$2,92210.0%
an Genome Research Institute (NHGRI)[]$4871.7%
httptional Institute on Aging (NIA)[]$1,0473.6%
nstitute on Alcohol Abuse and Alcoholism (NIAAA)[]$4361.5%
tional Institute of Allergy and Infectious Diseases (NIAID)[]$4,26614.6%
tional Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)[]$5091.7%
tional Institute of Biomedical Imaging and Bioengineering (NIBIB) []$2991.0%
tional Institute of Child Health and Human Development (NICHD) []$1,2554.3%
tional Institute on Deafness and Other Communication Disorders (NIDCD) []$3941.4%
tional Institute of Dental and Craniofacial Research (NIDCR)[]$3901.3%
tional Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)[]$1,8576.4%

FY2008 IC Budget
Website(Program Level) &Percent of Total NIH
Budget ($ in millions)
tional Institute on Drug Abuse (NIDA)[]$1,0013.4%
tional Institute of Environmental Health Sciences (NIEHS)[]$7202.5%
tional Institute of General Medical Sciences (NIGMS)[]$1,9366.6%
tional Institute of Mental Health (NIMH)[]$1,4054.8%
tional Institute of Neurological Disorders and Stroke (NINDS)[]$1,5445.3%
tional Institute of Nursing Research (NINR)[]$1370.5%
iki/CRS-RL33695 of Medicine (NLM)[]$3291.1%
leakarty International Center (FIC)[]$670.2%
://wikiplementary and Alternative Medicine (NCCAM)[]$1220.4%
tional Center on Minority Health and Health Disparities (NCMHD)[]$2000.7%
tional Center for Research Resources (NCRR)[]$1,1493.9%
nformation Technology (CIT)[]($39*)
nter for Scientific Review (CSR)[]($105*)
nuson Clinical Center (CC)[]($361*)
* Funded through the NIH Management Fund from taps on IC budgets (non-add)
rogram Level (includes Buildings and Facilities appropriation: $119m, 0.4% of total)$29,171100%

Two categories of research are sponsored by the institutes and centers:
extramural research, performed by non-federal scientists using NIH grant or contract
money, and intramural research, performed by NIH scientists in the NIH laboratories
and Clinical Center. In both the extramural and intramural programs, the research
projects are largely investigator-initiated, and span all fields of basic and clinical
medical and behavioral research. (Basic research is research in the fundamental
medical sciences, sometimes called lab or bench research, while clinical research
involves patients.) NIH also supports a range of extramural and intramural research
training programs to prepare young investigators for research careers, and engages
in a number of information dissemination activities to reach various audiences.
Extramural Research. The extramural research community includes more
than 300,000 scientists and research personnel affiliated with over 3,100 universities,
academic health centers, hospitals, and independent research institutions in the
United States and abroad.4 More than 82% of the overall NIH budget, some $24
billion, is spent on extramural awards in the form of research grants, research and
development contracts, training awards, and a few smaller categories. The “research
grants” category, by far the largest, includes research project grants to individual
investigators and small teams, 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. Over 70% of NIH’s extramural funds go to researchers
working in institutions of higher education, particularly the nation’s 129 medical
schools.5 Data on awards and recipients by state, by congressional district, by type
of institution, by subject of the research, and by a variety of other groupings may be
accessed from the website of the NIH Office of Extramural Research at
[ ts/award/award.htm] .
Peer Review. All applications for extramural research support are considered
under a two-tiered system of peer review. First, they are reviewed for scientific and
technical merit by committees (scientific review groups known as “study sections”)
composed primarily of nongovernment scientists who are experts in the relevant
fields of research. Most applications for research project grants are investigator-
initiated; they are assigned for review to study sections administered through the
Center for Scientific Review. Some applications are submitted in response to
solicitations by ICs for research areas the ICs wish to target and for which they have
set aside funding. The solicitations are known as RFAs and RFPs (for grants,
Requests for Applications, and for contracts, Requests for Proposals); applications
responding to them are reviewed by study sections within the ICs.
Three times a year, members of study sections convene to read, discuss, and
score the most recent batch of submitted research proposals. Each application that
appears strong enough upon first reading to have a chance of receiving funding is

4 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
p. O-7, at [].
5 NIH, Office of Extramural Research, Characteristics of Awardee Organizations, at
[] .

discussed and given a “priority score” that represents the average of the scores
assigned by the reviewers. That score becomes the main determinant in whether an
applicant will eventually receive funding from an IC for the research proposal. For
the most part, applications are funded in the order of their priority score percentile
until the IC has committed all of its available resources.
The funding decisions, however, are fine-tuned by a second level of peer review
in the ICs, when the applications are considered for program relevance by the
National Advisory Councils or Boards of the ICs. Advisory Councils and Boards are
composed of scientific and lay representatives. These groups sometimes recommend
funding certain applications that fall just outside the normal cutoff if the research is
of a type that an IC is particularly interested in promoting. IC staff make the final
funding decisions among the top priority proposals.
In FY2007, over 47,400 new and renewal applications competed for research
project grants (RPGs), and 10,100 received funding, for a “success rate” of 21.3%.6
Some researchers submit more than one proposal; the 47,455 applications in FY2007
were submitted by 33,886 individual applicants, of whom 9,233, or 27.2%, received
funding.7 Applicants who are not approved for funding, and who wish to try to
improve their scores based on comments from the reviewers, are allowed to revise
and resubmit their proposals twice.
Awards. The average length of an RPG award is just under four years; hence,
in any given year, about three-fourths of the grantees are in “noncompeting,” or
“continuation,” status. Each noncompeting grantee has to submit a project report to
the IC that supplied the funding, but the grantee does not have to compete for the
second, third, and fourth year of funding — the IC considers the award a budgetary
commitment. At the expiration of the award, the grantee may choose to compete for
a renewal of the project. In FY2007, in addition to awarding over 10,000 new or
competing renewal awards, NIH awarded more than 26,700 noncompeting awards
and nearly 1,800 small business awards, for a total of over 38,800 RPGs. The
average annual cost of an RPG award is about $400,000, including both direct and8
indirect costs. The direct costs, averaging 72% of the total award, cover
project-specific expenses, while the indirect costs, averaging 28%, pay for facilities
and administration costs (i.e., overhead) of the institution where the research is

6 NIH, Office of Extramural Research, “Success Rates by Institute” (data are available for
FY1997-FY2007) [].
7 NIH, Office of Extramural Research, NIH Extramural Data Book 2007. (Choose
“Research Projects Grants (RPGs),” then go to slide RPG-3.)
[htt p:// ch_Training_Investment/Research_Training_
8 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
table on “Research Project Grants: Total Number of Awards and Dollars,” p. TD-15, at
[ 2008/tabular%20data.pdf#page =14].
9 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
table on “Statistical Data — Grants, Direct and Indirect Costs Awarded,” p. TD-14

Intramural Research. The NIH intramural research program accounts for
nearly 11% of the budget. It includes more than 6,500 scientists and technical
support staff who are government employees, and several thousand additional
scientific fellows, guest researchers, and contractors. Almost all of the ICs have an
intramural research program, but the size, structure, and activities of the programs
vary greatly. Many intramural scientists are based in the Clinical Center, which
facilitates interdisciplinary collaboration and the direct clinical application of new
knowledge derived from basic research.
Research Training. Research training to prepare students and young
scientists for research careers is supported through both the extramural and
intramural research programs. Pre-doctoral and postdoctoral training opportunities
are available for both basic and clinical scientists through a variety of training grants,
fellowships, and loan repayment programs. Programs offered on the NIH campus
range from summer internships for high school students to employment for
postdoctoral scientists.
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 institutes and centers 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 and mail inquiries; publishing physician and patient education
materials (many of them available on the Internet); supporting information
clearinghouses and running public information campaigns on various diseases; and
making specialized databases available. Free searching of MEDLINE citations and
other NLM databases, together with resources for health questions, is available at
[] and at [].
Recent History. At $29.2 billion for FY2008, NIH’s budget (see Table 2)
represents about 20% of total federal funding for research and development (R&D)
and about half of federal civilian (i.e., nondefense) spending for R&D.10 It also
constitutes some 38% of all the discretionary spending of the Department of Health
and Human Services.11 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 approximately
doubled NIH’s appropriation in the decade between FY1988 and FY1998. At that
point, a coordinated lobbying effort in support of NIH and an improved budget and
economic outlook led Congress to start on a new path of doubling the NIH budget

9 (...continued)
[ 2008/tabular%20data.pdf#page =13].
10 See CRS Report RL34448, Federal Research and Development Funding: FY2009, by
John F. Sargent et al.
11 Department of Health and Human Services, FY2009 Budget in Brief (February 2008), p.

12, at [].

during the following five years. The base at the time was the FY1998 appropriation
of $13.6 billion, and the target was $27.2 billion for FY2003. The commitment was
essentially accomplished, although the makeup of the budget changed somewhat over
the five years.
In the post-doubling years, the pattern has been markedly different. The annual
increases for FY1999 through FY2003 were in the 14%-15% range each year. For
FY2004 and FY2005, Congress and the President, faced with competing priorities
and a changed economic climate, gave increases of between 2% and 3%, levels that
were below the then-estimated 3.5% and 3.3% biomedical inflation index for those
two years (see the discussion below). Final funding for FY2006 was $82 million
(0.3%) below the FY2005 level, marking the first time that the NIH appropriation
had decreased since 1970. The FY2007 final level was a 2.0% increase over
FY2006, and the final FY2008 funding level was 0.5% above FY2007. The FY2009
President’s budget requested a program level of $29.165 billion, an amount
essentially equal to the FY2008 appropriation. See Figure 1, which charts NIH
appropriations from FY1994 through the FY2009 request.
Figure 2 portrays the NIH appropriation adjusted for inflation (in constant 2008
dollars) using the Biomedical Research and Development Price Index (BRDPI).12
The index, developed each year for NIH by the Bureau of Economic Analysis (BEA)
of the Department of Commerce, reflects the increase in prices of the resources
needed to conduct biomedical research, including personnel services, supplies, and
equipment. It indicates how much the NIH budget must change to maintain
purchasing power.
With the projected value of the BRDPI at 3.5% for FY2008 and FY2009, the
NIH budget has been losing ground in real terms each year since the end of the
doubling in FY2003. In constant 2008 dollars, the FY2003 NIH budget was $32.8
billion. It fell to $32.6 billion in FY2004, and has decreased steadily to the FY2008
level of $29.2 billion, which is lower than the constant-dollar level of FY2002. The
FY2009 request level is $28.2 billion in 2008 dollars. In inflation-adjusted terms, the
FY2008 funding level represents an estimated 11% decrease from FY2003, while the
FY2009 request level would be 14% below FY2003.

12 See NIH Price Indexes [].

Table 2. National Institutes of Health (NIH) Appropriations
(dollars in millions)
% change
FY2007aFY2008bFY2009FY09 vs.
Institutes and Centers (ICs)actualenactedrequestFY08
Cancer (NCI)4,795.54,805.14,809.80.1%
Heart/Lung/Blood (NHLBI)2,919.22,922.12,924.90.1%
Dental/Craniofacial Research (NIDCR)389.8390.2390.50.1%
Diabetes/Digestive/Kidney (NIDDK)1,706.01,706.71,708.50.1%
Neurological Disorders/Stroke (NINDS)1,534.91,543.91,545.40.1%
Allergy/Infectious Diseases (NIAID)c,d4,366.44,560.74,568.80.2%
General Medical Sciences (NIGMS)1,935.61,935.81,937.70.1%
Child Health/Human Development (NICHD)1,254.11,254.71,255.90.1%
Eye (NEI)666.7667.1667.80.1%
Environmental Health Sciences (NIEHS)641.8642.3642.9 0.1%
Aging (NIA)1,046.51,047.31,048.30.1%
Arthritis/Musculoskeletal/Skin (NIAMS)508.1508.6509.10.1%
Deafness/Communication Disorders (NIDCD)393.5394.1395.00.2%
Nursing Research (NINR)137.3137.5137.60.1%
Alcohol Abuse/Alcoholism (NIAAA)436.1436.3436.70.1%
Drug Abuse (NIDA)1,000.01,000.71,001.70.1%
Mental Health (NIMH)e1,403.61,405.51,406.80.1%
Human Genome Research (NHGRI)486.4486.8487.9 0.2%
Biomedical Imaging/Bioengineering (NIBIB)298.4298.6300.30.5%
Research Resources (NCRR)1,143.81,149.41,160.51.0%
Complementary/Alternative Med (NCCAM)121.4121.6121.70.1%
Minority Health/Health Disparities (NCMHD)199.4199.6199.80.1%
Fogarty International Center (FIC)66.466.666.60.1%
National Library of Medicine (NLM)319.8320.5323.00.8%
Office of Director (OD)d1,047.51,109.11,056.8-4.7%
Common Fund (non-add)(483.0)(495.6)(533.9)7.7%
Buildings & Facilities (B&F)81.1119.0125.65.6%
Subtotal, Labor/HHS Appropriation28,899.329,229.529,229.50.0%
Superfund (Interior approp to NIEHS)f79.177.577.50.0%
Total, NIH discretionary budget authority28,978.529,307.129,307.10.0%
Pre-appropriated Type 1 diabetes fundsg150.0150.0150.00.0%
PHS Evaluation Tap fundingh8.
Global Fund transfer (AIDS/TB/Malaria)c-99.0-294.8-300.01.8%
Total, NIH program level29,037.729,170.5 29,165.30.0%
Source: Adapted by CRS from NIH, Justification of Estimates for Appropriations Committees, Fiscal
Year 2009, Tabular Data, p. TD-1, at [].
Details may not add to totals due to rounding.

a. FY2007 reflects transfer of $99.0 million from NIH to Office of the Secretary, per P.L. 110-28 (see
note d). FY2007 also reflects comparative transfers to HHS ($0.542m) and among NIH ICs.
b. The FY2008 program level is an increase of $132.8 million (0.5%) over FY2007. FY2008 includes
comparative IC transfers from NHLBI to NIDDK ($0.816 million) and from NLM to NIDCR
($0.455 million).
c. NIAID totals include funds for transfer to the Global Fund to Fight HIV/AIDS, TB, and Malaria.
d. For FY2007, the emergency supplemental appropriations act (P.L. 110-28) transferred funding for
the Advanced Development of Medical Countermeasures to Office of the Secretary ($49.5m
each from NIAID and OD).
e. FY2008 NIMH has $0.983m from Office of the Secretary to administer Interagency Autism
Coordinating Committee.
f. Separate account in the Interior/Environment appropriation for NIEHS research activities related
to Superfund.
g. Funds available to NIDDK for diabetes research under PHS Act § 330B (authorized by P.L. 106-
554, P.L. 107-360, and P.L. 110-173).
h. Additional funds for NLM from PHS Evaluation Set-Aside (§ 241 of PHS Act).

Figure 1. NIH Appropriations FY1994-FY2009 Request
Program Level ($ in billions)
$28. 6 $29. 0 $29. 2$30
$27.1Doubling: FY98-FY03
$27. 9 $28. 5 $29. 2$25
$20. 5
$23. 5
$15. 6$20
$12. 8 $17. 8$15
$11. 3
$13. 7$10
$10. 9 $11. 9
94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09
Source: Figure prepared by the Congressional Research Service (CRS).
Figure 2. Effect of Inflation on NIH Budget
FY1994-FY2009 Program Level

Purchasing Power in 2008 Dollars (Billions) Using
Biomedical R&D Price Index (BRDPI)
$32. 8 $32. 1$35
$32. 6 $30. 1 $28. 2$30
$26. 5 $29. 5 $30. 6 $29. 2
$21. 8$25
$23. 9
$17. 7 $18. 9$20
$19. 6
$17. 7 $18. 2$15
94 95 96 97 98 Y 99 00 01 Y 02 03 04 Y 05 06 07 08 09
Source: Figure prepared by CRS.

Sources of Funding. NIH’s budget comes from four sources: the bulk is
through the annual Labor-HHS-Education (Labor-HHS-ED) appropriation, with an
additional small amount for environmental research and training related to Superfund
coming from the Interior, Environment, and Related Agencies (Interior/Environment)
appropriation. Those two sources constitute NIH’s discretionary budget authority.
To reach the “program level” budget, other funds are counted that are added to or
transferred from NIH. NIH annually receives $150 million for the Type 1 Diabetes
Initiative appropriated by P.L. 107-360 and P.L. 110-173, and in recent years has
received an extra $8.2 million for the National Library of Medicine from a “program
evaluation” transfer within the Public Health Service (PHS) (see below). Conversely,
NIH loses part of its appropriation to a transfer to the Global Fund to Fight
HIV/AIDS, Tuberculosis, and Malaria. For several years, about $100 million of the
annual appropriation to NIAID was transferred to the Global Fund. For FY2008, the
amount was increased to $300 million in the request, and the final amount of the
transfer from the NIH appropriation was $295 million. The FY2009 budget again
proposed a transfer of $300 million to the Global Fund.13
The NIH and three of the other Public Health Service agencies within HHS are
subject to a budget “tap” called the PHS Program Evaluation Set-Aside, authorized
by section 241 of the PHS Act (42 U.S.C. § 238j). It is used to fund not only
program evaluation activities, but also functions that are seen as having benefits
across the Public Health Service, such as the National Center for Health Statistics in
CDC and the entire budget of the Agency for Healthcare Research and Quality.
These and other uses of the evaluation tap by the appropriators have the effect of
redistributing appropriated funds among PHS agencies. The FY2008 appropriation
kept the tap at 2.4%, the same as in FY2007. NIH, with the largest budget among the
PHS agencies, becomes the largest “donor” of program evaluation funds, and is a
relatively minor recipient. By convention, budget tables such as Table 2 do not
subtract the amount of the evaluation tap, or of other taps within HHS, from the
agencies’ appropriations.14
FY2009 Request. For FY2009, the President requested budget authority of
$29.230 billion in the L-HHS-ED appropriation and $78 million in the
Interior/Environment appropriation, for a total program level of $29.165 billion for
NIH (see Table 2). The FY2008 level, provided by the Consolidated Appropriations
Act, 2008 (P.L. 110-161), totaled $29.171 billion.15 The FY2009 request represents
a decrease of $5 million (-0.02%) below the FY2008 program level.
Within the FY2009 request, most of the institutes and centers would be
approximately level-funded from their FY2008 amounts, receiving increases of 0.1%
or 0.2%. Only the National Center for Research Resources (1.0%) and the National

13 The “NIH program level” cited in the Administration’s budget documents, however, does
not reflect the Global Fund transfer.
14 For further information on the Program Evaluation tap, see CRS Report RL34098, Public
Health Service (PHS) Agencies: Background and Funding, by Pamela W. Smith et al.
15 For information on the FY2008 appropriation, see the NIH section of CRS Report
RL34048, Federal Research and Development Funding: FY2008, by John F. Sargent et al.

Library of Medicine (0.8%) would receive increases greater than 0.5%. The two
biggest changes in the request are a 5.6% increase in the Buildings and Facilities
account, and a 4.7% drop in funding for the Office of the Director. Many of the
laboratories, animal facilities, and office buildings on the NIH campus are aging and
are in need of upgrading to stay compliant with health and safety guidelines and to
provide the proper infrastructure for the Intramural Research program. The budget
requests $126 million for Buildings and Facilities, an increase of $7 million.
The net $52 million drop in the OD account, from $1,109 million in FY2008 to
$1,057 million in the request, represents the proposed cancellation of a study
combined with increases for several other OD activities. The National Children’s
Study was funded at $111 million in FY2008. It is a long-term (25+ year), multi-
agency environmental health study that was mandated by the Children’s Health Act
of 2000 (P.L. 106-310). It plans to examine the effects of environmental influences
on the health and development of more than 100,000 children across the United
States, following them from before birth until age 21. The overall projected cost for
the whole study is about $2.7 billion. Starting with the FY2007 request, when the
study moved from the planning phase to the more costly implementation phase, the
Administration has proposed each year to end its funding. Congress has continued
to support the study.
Proposed increases within the OD account total $59 million, including a $38
million increase (7.7%) for the NIH Roadmap initiatives funded through the
Common Fund. The NIH Roadmap for Medical Research, discussed in more detail
below, is a set of trans-NIH research activities designed to support high-risk/high-
impact research in emerging areas of science or public health priorities. For FY2009,
planned funding for the Roadmap/Common Fund totals $534 million, up from $496
million in FY2008. The other major increase requested for OD is an additional $19
million (19.9%) for research on medical countermeasures against nuclear,
radiological, and chemical threats, increasing that program to $113 million from $94
million in FY2008. That is the only significant increase for NIH’s biodefense
portfolio, which totals $1,748 million in the President’s FY2009 request (up 1.2%).
Budget Discussion by Funding Mechanism. In addition to showing the
appropriation by institute, the other common way to describe the NIH budget is by
“funding mechanism.” Displaying budget data by mechanism reveals the balance
between extramural and intramural funding, as well as the relative emphasis on
support of individual investigator-initiated research versus funding of larger projects,
comprehensive research centers, agency-directed research contracts, research career
training, facilities construction, research management costs, etc. Figure 3 and Table

3 show the distribution of the NIH budget by the major funding mechanisms.

Figure 3. FY2009 NIH Budget Request by Funding Mechanism

Total NIH Program Level = $29,165 Million
(Dollars in Millions)
All OtherManagement
$651and Support
2.2%Intramural $1,361






Research Research
Research Project Grants
Cent ers Grant s$1, 786
$2, 963 $15, 5236. 1%


Source: Adapted from NIH: Summary of the FY2009 Presidents Budget, February 4, 2008, p. 5
[ h t t p : //o fficeofb ud get.od.nih.go v/ui/2008/Summa r y%20of%20FY%202009%20Budget-Press%
20Release.pdf]. That document presents NIH Budget Authority, totaling $29,457 million, whereas
this chart shows NIH Program Level. Program level excludes $300 million from the R&D Contracts
mechanism for the Global HIV/AIDS Fund transfer, and includes $8 million in the All Other category
for NLM Program Evaluation funds. See Table 2.
The NIH’s two major concerns in the face of tight budgets are maintaining
support of investigator-initiated research through research project grants, and
continuing to nourish the pipeline of new investigators. Total funding for RPGs, at
$15.5 billion, represents about 53% of NIH’s budget. The FY2009 request would
support an estimated 38,257 awards, about the same as in FY2008, but with $19
million less in funding. Within that total, 9,757 would be competing RPGs, 14 fewer
than in FY2008. No inflationary increases are proposed for noncompeting
(continuation) RPGs, and the average annual cost of competing RPGs would remain
at the FY2008 level, about $361,000. The expected “success rate” of applications

receiving funding would decline to about 18% from the estimated rate of 19% for
FY2008. Estimated success rates for the various ICs would range from 8% to 26%.16
Table 3. NIH Budget by Funding Mechanism
(dollars in millions)
MechanismFY2007actualFY2008enactedFY2009estimate% change2009/2008
Research Project Grants (RPGs)$15,627$15,543$15,523-0.1%
Research Centers$2,934$2,943$2,9630.7%
Other Research Grants$1,793$1,809$1,786-1.3%
Research Training$782$782$7860.6%
R&D Contractsa$2,886$2,947$2,9751.0%
Intramural Research$3,035$3,069$3,1191.6%
Res. Management & Support$1,317$1,341$1,3611.5%
All Otherb$664$736$651-11.6%
Total, NIH Program Level$29,038$29,171$29,165-0.02%
# new/competing renewal RPGs10,3239,7719,757-14 grants
# noncompeting RPGs26,74126,72826,759+31 grants
# small business grants1,7811,7401,741+1 grants
Total # of RPGs38,84538,23938,257+18 grants
Source: Adapted from NIH FY2009 Budget Justification, Tabular Data, p. TD-4, February 4, 2008
[]. Details may not add to totals
due to rounding.
a. Program level excludes funds from the R&D Contracts mechanism to be transferred to the Global
HIV/AIDS Fund (FY2007: $99 million; FY2008: $294.759 million; FY2009: $300 million).
See Table 2.
b.All Other includes Extramural Construction, Buildings and Facilities, Superfund, NLM Program
Evaluation, and OD funding that is not for Roadmap or Director’s Bridge Awards (that funding
is distributed by mechanism).
Several efforts are focused on supporting new investigators, to encourage young
scientists to undertake careers in research and to help them speed their transition
from training to independent research. The Pathway to Independence program would
support approximately 500 awardees, including 170 new awards, for a total of $71
million. Regular training mechanisms such as the National Research Service Awards
are proposed for an increase of $5 million (0.6%) to $786 million, including stipend
increases of 1% for both pre- and post-doctoral fellows. Clinical research training,
including the Clinical and Translational Science Awards, would be funded at a total
of $475 million. The request would support about 25 New Innovator Awards for a
total of $56 million in the Common Fund. The NIH Director’s Bridge Award is a

16 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
table on “Research Project Grants: Success Rates, FY2000-FY2009,” p. TD-16, at
[ 2008/tabular%20data.pdf#page =15].

program that can give short-term funding to established, meritorious investigators
who have just missed the funding cutoff for a renewal application and who have little
other support, giving them time to resubmit without disrupting the operation of their
laboratory. The request includes $91 million for 244 awards, an increase of $1.6
Changes proposed in the request for other funding mechanisms within the NIH
budget include increased support for research centers, up $20 million (0.7%) to
$2,963 million; a $28 million (1.0%) increase to $2,975 million for R&D contracts
(excluding the funding to be transferred for the Global HIV/AIDS Fund); $50 million
more (1.6%) for the NIH intramural research program, for a total of $3,119 million;
an increase of $20 million (1.5%) to a total of $1,361 million for research
management and support; and a decrease of $23 million (1.3%) for other research
grants totaling $1,786 million.
Issues for Congress
Congress has devoted considerable attention to NIH for decades, spurred by
constituents who have voiced their expectation that the federal government would
take the lead in cutting-edge research on prevention and treatment of disease. Since
the mid-1990s, the doubling of the NIH budget and big projects like the sequencing
of the human genome have fired the public’s imagination, generating much hope and
anticipation of further advances. More recently, however, budgetary realities and
various issues facing the research enterprise are challenging NIH and Congress to
rethink some approaches to NIH’s traditional mission. Congress is confronting those
challenges in the three spheres of appropriations, authorizations, and oversight.
Appropriations: Budgeting within Constraints
Background on Agency Budget Formulation. The NIH budget request
that Congress receives from the President each February for the next fiscal year
reflects both recent history and professional judgments about the future, because it
needs to support both ongoing research commitments and new initiatives. The
request is formulated through a lengthy process that starts more than a year before in
the institutes and centers. The budget then evolves over a number of months as it
progresses from the ICs to NIH, then to HHS and finally to the Office of
Management and Budget (OMB). At each stage, IC and NIH needs are weighed in
the context of the larger budget of which they are a part. Eventually, Congress is
called upon to make similar judgments.
As a continuing process, IC leaders, with input from the scientific community,
define the most important and promising areas in their respective fields. They
consider whether the research portfolio they are already supporting needs any
rebalancing, and they decide on possible new initiatives for the coming budget year.
An annual budget retreat in May brings together the IC leaders with top NIH
management to discuss policies and priorities under various budget scenarios. They
might consider, for example, what the different emphases in their programs would
be if the appropriation turned out to be a certain percent decrease, a flat budget, or

an increase. The presentations and discussions allow NIH management to develop
the budget request they will submit to HHS, taking into account the estimate of the
amount of funding needed to support the “commitment base” of continuing awards,
the funding desired for unsolicited new research proposals, the new initiatives that
the Director wants to incorporate, and guidance from the department about the
request (for example, there might be an instruction to pay no inflationary increases
on grants). At the HHS level, NIH’s request is considered in the context of the
overall department budget, resulting in a notice back to NIH on the department’s
allowance. There are usually appeals and adjustments made before the final HHS
budget goes to OMB. The process of submission, passback, and appeals is repeated
as OMB considers the entire federal budget and tells HHS what amounts and policy
approaches are approved for incorporation into the President’s final budget that will
be sent to Congress. Once the budget is made public in early February, all agency
comments about the request are expected to support the President’s proposed levels.
Setting Research Priorities. Some people feel that the main role of the
Congress in regard to NIH should be to provide money with as few strings attached
as possible. They favor trusting the creativity of investigator-initiated research and
the NIH priority-setting process (to the extent that “good science” is driving research
priorities), with funding targeted toward the maximum exploitation of scientific
opportunity, as defined by the peer review system. They object to influences that
skew research priorities in directions they would judge not scientifically sound. In
support of that general philosophy, appropriators have traditionally tried to minimize
congressional micromanagement of NIH’s budget, and have avoided specifying
dollar amounts for particular fields of research or mechanisms of funding below the
level of the Institute and Center accounts.
At the same time, it is recognized that both Congress and NIH do weigh
numerous other factors when they make priority-setting decisions. NIH has made
information about setting research priorities and other aspects of research planning
available on its website at []. Of
paramount importance are judgments about public health needs, which may reflect,
for example, information on the health and/or economic burdens posed by particular
diseases, the populations affected, and the degree of threat to the general public.
Another factor may be the potential applicability of research on one medical
condition to broader, related fields.
Advocacy Groups. In Congress, the annual appropriations process has
always been a magnet for those seeking to bolster funding for biomedical research
generally or to influence research priorities in favor of some disease or field of
science. Every congressional district includes multiple parties with an interest in
NIH. Patient advocacy organizations, sometimes termed “disease lobby groups,” are
active in sending information to their members by mail and over the Internet.
Advocacy groups have become more organized, and more demanding of a role in
setting research priorities. They educate their contacts and the interested public about
the latest developments in research and new therapies in their disease area. They
frequently track federal and state legislation pertaining to health research and health
care, and urge their members to contact their representatives for action in their areas
of interest, including support of funding for NIH. Appropriators often use report

language directing NIH to pay more attention to research on particular diseases as a
way of responding to the public’s requests.
Scientists working at universities and research institutions are also urged by
their professional organizations to contact Congress in support of more funding for
biomedical research and for federal science agencies generally. Their message is that
many advances against disease can be traced back to NIH-funded research, and that
continued improvements in human health require continued commitment to NIH. As
an example, the Federation of American Societies for Experimental Biology
(FASEB) provides advocacy information on legislative issues as well as materials
that scientists can customize with facts from their own institutions.17
Scarce Resources. Congress’s flexibility in helping NIH respond to
scientific opportunity and public health needs has been severely reduced since
FY2004. The prior five years, when Congress provided for the doubling of the NIH
budget, coincided with a time of economic expansion and federal budget surpluses.
More recent years, on the other hand, have been characterized by a return to federal
deficits and new commitments to spending on defense and homeland security. The
result has been a tightening of funds available for domestic discretionary programs.
Caps on spending in recent congressional budget resolutions have left the Labor-
HHS-ED appropriations subcommittees with difficult choices when allocating funds
for a range of social and public health programs. NIH’s budget shifted from annual
increases of around 6% to 7% before FY1999 to twice that (around 14% to 15%)
during the doubling to between 0% and 3% since FY2003, levels below the rate of
inflation. As indicated in Figure 2, above, if the amount proposed in the President’s
FY2009 request were to be accepted by Congress, NIH would have about 14% less
purchasing power than in FY2003.
The extra resources provided during the doubling period allowed the number of
new grants to be increased (though not doubled), the average dollar size of grants to
go up to cover the needs of more sophisticated research projects, and research
institutions, especially universities, to expand their research faculties and create more
laboratory space. Such increases tend to drive the need for yet more resources in the
future. It seems not to have been anticipated in some quarters that the NIH budget
increases might change so dramatically after the doubling. The research community
had hoped for a “softer landing” after the doubling, with increases of perhaps 8% to
10% per year to maintain the momentum of their work. In more recent years, the
advocates have urged Congress to again provide increases in the neighborhood of
6.5%. NIH appropriations that have consistently grown less than the rate of inflation
have strained certain areas of the biomedical research enterprise, particularly
investigator-initiated research.
Success Rates. A key marker for the research community of the adequacy
of NIH grant funding is the “success rate” of research project grant applications, that

17 FASEB, Office of Public Affairs, Legislative Action Center at
[]; and “FASEB Launches Grassroots Campaign for NIH,
‘Supporting Medical Research in Concept Is Not Enough,’” FASEB News, August 9, 2006,
at [].

is, the proportion of competing RPG applications that receive funding. NIH expects
that under the FY2009 request, the success rate would be at a historic low of about
18%, compared with 25% in FY2004. During the doubling years, the success rate
averaged 30% to 32%.18 Changes in the success rate can be driven by changes in
either the numerator (number of applications funded) or the denominator (number of
applications reviewed). The rate has dropped in some years even when the number
of competing awards increased, because the number of applications soared even
more. The increase in the number of applications received in the two years following
the doubling (FY2004 and FY2005) exceeded the increase of the previous four years,
at a time when the number of competing awards was dropping.19 In other words,
more and more applicants were chasing fewer and fewer awards, a pattern which has
continued. The increase in applications stems from both the expanded research
capacity at many academic medical centers and the increase in the number of
applications submitted per applicant, as researchers try more than one route to obtain
Young Investigators. NIH is concerned that prospects for a lower number
of grants and a lower success rate will further discourage young scientists from
pursuing careers in medical research. New investigators with creative ideas are the
lifeblood of the research enterprise, but the path to becoming an independent
researcher is long and challenging. Many young doctoral students and postdoctoral
scientists already observe that their more senior colleagues have had increasing
trouble in getting funded. Especially if they are physicians with the option of going
into clinical practice, they may wonder about the wisdom of devoting themselves to
years of research training that may not lead to successful competition for independent
grant support. Some may decide on other career paths, and some may choose to
pursue research opportunities overseas. In January 2006, NIH announced a new
“Pathway to Independence” program to increase support of young investigators in
order to address the ever-lengthening time that it has been taking them to get their
first grants. The program supports promising postdoctoral scientists through five-
year awards that have a two-year mentored phase and a three-year independent
phase.20 Starting with FY2007, NIH planned to support 150 to 200 awards each year
for five years.
Research Restrictions. Also generating uncertainty for some researchers
are congressional and/or administrative restrictions on types of research funded. The
major recent examples are controls on federal funding of research on human
embryonic stem cells, and congressional concerns over grant awards in certain areas
of behavioral research.

18 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
table on “Research Project Grants: Success Rates, FY2000-FY2009,” p. TD-16
[ 2008/tabular%20data.pdf#page =15].
19 NIH, Office of Extramural Research, “Success Rates by Institute” (data are available for
FY1997-FY2007), at [].
20 See [] for
information on this award, and []
for general information on NIH’s New Investigators Program.

During more than 25 years of debate on the science and ethics of stem cell
research, scientists have been able to get federal funding for only a limited number
of avenues of basic research, despite what many experts feel are promising long-term
prospects for advances against debilitating diseases. Current restrictions on funding
of embryonic stem cell research involve both congressional limits in appropriations
laws and an administration policy announced by President Bush in August 2001.
Some scientists who want to work with a wide range of stem cells have sought
support from private funding or from several new state research initiatives. For
further information, see the following CRS reports by Judith A. Johnson and Erin D.
Williams: CRS Report RL33540, Stem Cell Research: Federal Research Funding
and Oversight; CRS Report RL33554, Stem Cell Research: Ethical Issues; and CRS
Report RL33524, Stem Cell Research: State Initiatives. For legal issues, see CRS
Report RS21044, Background and Legal Issues Related to Human Embryonic Stem
Cell Research, by Edward C. Liu.
From time to time, the research community has also been troubled by
congressional attempts to cancel funding for specific existing peer-reviewed grants.21
The targeted studies have tended to be in fields of behavioral research, including
some in mental health and human sexuality research. Sponsors and supporters of
such amendments to the L-HHS-ED appropriations bills say that NIH should not be
devoting scarce resources to research studies whose value they question.
Researchers, however, including NIH leadership, have expressed alarm at what they
view as an assault on the peer review system, saying that such studies were funded
because of their technical merit and the important research questions they addressed.
New Approaches? While advocates warn that tight budgets will slow
research advances on the major chronic conditions that burden American society,
other commentators note that coping with the reality of budget constraints has
increasingly required NIH and the research community to rethink some of their
traditional approaches to planning and organizing research. As NIH Director Dr.
Elias Zerhouni has advised, “As science grows more complex, it is also converging
on a set of unifying principles that link apparently disparate diseases through
common biological pathways and therapeutic approaches. Today, NIH research
needs to reflect this new reality.”22 Scientific leaders in and out of NIH urge critical
examination of the best ways to transform knowledge into medical applications and
allocate resources into the most critical priorities to maximize return on the public’s
Authorizations: Structure and Program Direction
Organizational Complexity. A key element of such rethinking has been
consideration of NIH’s organizational structure, which expanded markedly over time
along with the growth in the budget. The institutes and centers, currently numbering
27, have always operated as a decentralized federation, with loose coordination by
the Office of the Director. The costs and complexities of administering the enterprise

21 Jocelyn Kaiser, “House ‘Peer Review’ Kills Two NIH Grants,” Science, vol. 309 (July 1,

2005), pp. 29-31.

22 Elias Zerhouni, “The NIH Roadmap,” Science, vol. 302 (Oct 3, 2003), pp. 63-64, 72.

have multiplied as new entities have been created by Congress (seven of them
between 1985 and 2000; see Table 4), each with its own mission, budget, staff,
review office, and other bureaucratic apparatus. Over the years, many observers had
wondered whether the agency had become too fragmented to be manageable, and
whether NIH was able to respond appropriately to new scientific and public health
challenges. Some commentators suggested consolidating the ICs into a smaller23
number of units encompassing broad areas of science. Others warned that such a
move could prove politically unfeasible because of the loyalties of the constituencies
of the individual ICs, and might result in a net loss of congressional and public
support. Further, although NIH wishes to emphasize a culture of inter-disciplinary
teamwork, many observers felt that the structure of multiple independently operated
institutes might undermine important initiatives in cross-disciplinary research,
especially in fields such as the neurosciences.
The National Academies Study and Recommendations. As part of the
FY2001 appropriation, Congress directed NIH to have the National Academy of
Sciences study “whether the current structure and organization of NIH are optimally
configured for the scientific needs of the Twenty-first Century” (S.Rept. 106-293, p.
179). The National Research Council (NRC) and the Institute of Medicine (IOM) of
the National Academies formed a Committee on the Organizational Structure of the
National Institutes of Health. The committee spent a year soliciting and assessing the
views of the basic science, clinical medicine, and health advocacy communities,
together with those of management experts and many current and former NIH
leaders. It released its recommendations in a 2003 report, Enhancing the Vitality of
the National Institutes of Health: Organizational Change to Meet New Challenges.24
The committee did not think that wholesale consolidation of institutes and
centers was the most useful approach to ensuring NIH’s ability to meet future
challenges. It did suggest a few possible consolidations, but said that those and any
other proposals for increasing or decreasing the number of ICs or OD program offices
should be subject to a public process for evaluating the scientific needs,
consequences, available resources, and level of public support for the proposed
changes. It strongly recommended mergers of some clinical research components of
the extramural and intramural research programs to improve leadership, funding, and
management of the NIH clinical research enterprise.
The committee recommended that Congress strengthen the role of the NIH
Director in strategic planning and budgeting for innovative, trans-NIH research.
Referring to “vast changes in the landscape of science and the nation’s health
concerns during the last half century,” the committee report noted in its executive
summary the increasingly complex environment in which scientists operate: “In
science, the importance of multi-institutional, multidisciplinary research that relies
more and more on large infrastructural investments is ever more apparent.” At NIH,

23 Harold Varmus, “Proliferation of National Institutes of Health,” Science, vol. 291 (March

9, 2001), pp. 1903-1905.

24 National Research Council and Institute of Medicine, Enhancing the Vitality of the
National Institutes of Health: Organizational Change to Meet New Challenges
(Washington: National Academies Press, 2003) [].

such crosscutting issues and initiatives go beyond the purviews of individual ICs.
The committee felt that more initiatives were needed and that they would require
more centralized leadership and budgeting. It recommended that the NIH Director
present such trans-NIH initiatives to Congress, with proposed funding amounting to
5% of the NIH budget in the first year, and more in subsequent years. It also
recommended that additional staff, budget, and reprogramming authority be provided
for OD operations in managing its new responsibilities, and that funding for research
management and support in all of NIH’s units be increased.
Other recommendations in the committee’s report addressed the need for more
highly innovative, high-risk research projects with potentially great payoffs, both in
extramural grants and in the intramural research program. It recommended that
Congress create a Director’s Special Projects Program to fund such research, with a
sustained commitment starting at $100 million per year and growing to as much as
$1 billion per year. To enhance public accountability and transparency, the
committee said that NIH should improve its data systems for tracking and reporting
spending by areas of research. It faulted NIH’s information management systems and
the lack of standardized coding across the ICs, and said that NIH should improve its
reporting and analysis of research accomplishments of scientists trained and
supported with NIH funds. A particular problem involves the question of how to
count research that is related but not directly applicable to a specific topic.
(Currently, NIH’s estimates of its funding for specific diseases and conditions may
be found at [].) Some final
recommendations by the committee were to have more rigorous and frequent review
of the performance of top NIH and IC leadership, including the possibility of term
limits; that Congress reassess the special status of the National Cancer Institute in
regard to appointments and budget authority; and that the advisory council system be
reformed so that councils are more independent, protected from political influences,
and more involved in priority setting and planning.
NIH Initiatives. Under the leadership of current NIH Director Dr. Elias A.
Zerhouni and with the concurrence of the appropriations committees, NIH has
undertaken several new initiatives and organizational changes that address many of
the issues highlighted by the NRC/IOM report. A number of these were put in place
prior to the major congressional response to the report.
NIH Roadmap. In September 2003, Dr. Zerhouni announced a series of
initiatives known collectively as the NIH Roadmap for Medical Research
[].25 The Roadmap had been developed over the previous
year and a half as a comprehensive plan to identify and address the major scientific
opportunities and gaps in medical research that no single institute or center at NIH
could tackle alone. NIH held meetings attended by more than 300 leaders in
academia, industry, government, and the public who had been invited to discuss
today’s most compelling scientific challenges and the most important knowledge
gaps (“roadblocks”) they felt were constraining rapid progress in research and its

25 NIH, Office of the Director, “NIH Announces Strategy to Accelerate Medical Research
Progress,” press release, September 30, 2003 [

application to useful prevention, diagnostic, and treatment strategies. NIH leaders
further refined the ideas and developed proposed initiatives and implementation
plans. They ultimately identified 28 trans-NIH priorities and initiatives, grouped into
three main themes. Additional cohorts of new initiatives have been developed
through subsequent planning processes.
The first theme, “New Pathways to Discovery,” addresses the “daunting
complexity of biological systems” and the need to know much more about networks
of molecules and their interactions, together with the need to develop new
technologies, databases, and other scientific “tools” to pursue research at the cellular
and molecular level. Examples of resources to be established include libraries of
chemical molecules, imaging probes, nanotechnology devices, and enhanced
computational capability.
The second theme, “Research Teams of the Future,” addresses collaborative
team efforts in interdisciplinary research, high-risk research, and public-private
partnerships. Modern biomedical science represents the convergence of biological,
physical, and information sciences, and NIH wants to encourage investigators to
break out of their traditional disciplines and take on new approaches. For example,
two programs are meant to stimulate highly innovative researchers. The NIH
Director’s Pioneer Award [] seeks to support
investigators who will “take on creative, unexplored avenues of research that carry
a relatively high potential for failure, but also possess a greater chance for truly
groundbreaking discoveries.”26 The NIH Director’s New Innovator Award
[] offers support to
extraordinarily creative new investigators who have never had a traditional research
project grant.
The third theme is “Re-engineering the Clinical Research Enterprise.” NIH
characterizes this as “undoubtedly the most challenging, but critically important, area
identified through the NIH roadmap process.”27 Translating the findings of
laboratory research into products and practices that improve people’s health is the job
of clinical researchers, and is the ultimate goal of performing fundamental research.
Traditional methods of conducting clinical studies, however, are slow, complex,
costly, and tend to be limited in the number of patients they can involve. To more
quickly develop, test, and deliver new interventions, researchers could work in closer
proximity to patients. The revamped clinical research enterprise will need integrated
networks of academic centers linked to community-based health care providers and
organized patient communities. It will also require new ways of handling
information, developing research protocols, assessing clinical outcomes, harmonizing
regulations, and training more people for the clinical research workforce. In 2005,
NIH launched a new Clinical and Translational Science Awards (CTSA) program.28

26 Ibid.
27 NIH, Office of Portfolio Analysis and Strategic Initiatives, “Overview of the NIH
Roadmap” [].
28 NIH, National Center for Research Resources, “Clinical and Translational Science

Administered by NIH’s National Center for Research Resources, the program has
been developed to foster transdisciplinary clinical research and training, with the goal
of speeding the translation of the findings of “discovery” research into clinical
Roadmap initiatives are funded through a “Common Fund” for trans-NIH
projects that is a separate line item in the appropriation for the Office of the Director.
Initially, the budgets of the ICs were tapped for some of the contributions to the
Common Fund, but since FY2007, all of the funding has been appropriated to OD.
Since FY2004, funding for Roadmap has increased from $132 million to $496
million in FY2008, now representing 1.7% of the total NIH budget. The FY2009
request proposes $534 million for the Common Fund, equal to 1.8% of the budget.29
OPASI, a New Home for Trans-NIH Initiatives. Besides the Roadmap for
Medical Research, NIH has organized other interdisciplinary, trans-institute
initiatives in recent years, such as the Strategic Plan for Obesity Research, started in
FY2005 [], and the
Neurosciences Blueprint [], commenced in
FY2006. The Blueprint pools resources among 16 ICs with an interest in the nervous
system for use in cooperative research, including development of research tools and
infrastructure that serve the entire neuroscience community. In September 2005, NIH
administratively established a new office within the Office of the Director to
“identify and integrate information to support the planning and implementation of
trans-NIH initiatives.”30 Called the Office of Portfolio Analysis and Strategic
Initiatives (OPASI) [], it was established to give the agency more
capability in analyzing and managing its research portfolio, especially in planning
and priority-setting for areas of interest to multiple ICs. The aim was to achieve a
“functional integration” of NIH (without the need for structural reorganization) by
bringing together diverse components of the agency in pursuit of common scientific
purposes. NIH leaders felt that, building on the effectiveness of the Roadmap
approach, OPASI would offer further “flexibility and nimbleness” in finding and
funding cutting-edge research.31
Two of the OPASI divisions focus on (1) resource development (such as
databases) and assessments to support priority setting among scientific areas and
research portfolio analysis and management (for example, to improve the coding of

28 (...continued)
Awards,” at [
29 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. I, Overview,
“NIH Common Fund/Roadmap,” p. 4, at [

20Roadmap.pdf#page =4].

30 HHS, NIH, “Statement of Organization, Functions, and Delegations of Authority,” 70
Federal Register 56730, September 28, 2005.
31 Carla Garnett, “New NIH Portfolio Analysis Office To Provide ‘Incubator Space’ for
Novel Ideas,” NIH Record, vol. 62, no. 25 (December 16, 2005), pp. 1, 6-7, at
[ ecord/12_16_2005/story01.htm] .

disease-specific resources); and (2) program evaluations, both IC-specific and trans-
NIH, and systematic assessments such as those required by the Government
Performance and Results Act (GPRA) and the OMB Program Assessment Rating
Tool (PART) — all in order to inform evaluation of the NIH research agenda and
decisions about NIH-wide resource allocations. The third division, the Division of
Strategic Coordination, manages the current trans-NIH initiatives, including the
Roadmap, and coordinates the decision-making processes that lead to formulation of
new trans-NIH strategic initiatives. OPASI does not have grant-making authority,
but it manages the Common Fund monies to support time-limited (five to 10 years)
priority projects that are administered by the ICs. Initiatives are reviewed frequently
for continuation, transfer to an IC, or completion, with no initiative to remain in
OPASI more than 10 years.32 With implementation of the NIH Reform Act of 2006
(P.L. 109-482) (see the next section), OPASI became an office within the new
Division of Program Coordination, Planning, and Strategic Initiatives, and is leading
several of the efforts required by the Act.
Congressional Activities on NIH Reauthorization (the NIH Reform
Act of 2006, P.L. 109-482). As discussed early in this report, statutory authority
for NIH is found primarily in Title IV of the Public Health Service Act (42 U.S.C.
§ 281-290b). Over the years since the PHS Act was first compiled in 1944, Congress
has amended Title IV by adding numerous sections delineating specific
responsibilities, activities, and functions of NIH. Before the 109th Congress,
systematic change to those authorities had been undertaken only twice, in the Health
Research Extension Act of 1985 (P.L. 99-158) and in the NIH Revitalization Act of
1993 (P.L. 103-43). Most of the specific authorities established or extended in the
1993 act expired in FY1996, and had not been updated. (The programs continued
under NIH’s general authority to conduct and sponsor research.) A number of
additional laws enacted since 1993 had addressed particular areas of research; most33
of those authorities had also expired. Over time, Congress has rearranged the
provisions of Title IV and added new program authorizations and reporting
requirements, but it has never initiated a major restructuring of the agency’s
organization, aside from the addition of institutes, centers, and offices.
The recommendations of the 2003 NRC/IOM report reawakened congressional
interest in using the reauthorization process to improve NIH management and
operations. The House Committee on Energy and Commerce, which had already

32 Information for this paragraph was taken from an August 2006 “Fact Sheet” on OPASI,
available at [].
33 Examples of such laws are the Women’s Health Research and Prevention Amendments
of 1998 (P.L. 105-340), Children’s Health Act of 2000 (P.L. 106-310), Public Health
Improvement Act of 2000 (P.L. 106-505), National Institute of Biomedical Imaging and
Bioengineering Establishment Act of 2000 (P.L. 106-580), MD-CARE Act (Muscular
Dystrophy Community Assistance, Research and Education Amendments of 2001, P.L. 107-

84), and Rare Diseases Act of 2002 (P.L. 107-280), among others. The NIH Almanac,

2006-2007, at [], includes a comprehensive
chronology of NIH-related legislation. The annual report by the Congressional Budget
Office on Unauthorized Appropriations and Expiring Authorizations may be consulted for
a chronological listing of public laws, arranged by authorizing committee, whose provisions
have expired [].

held a series of hearings on NIH and research-related issues, circulated a draft bill for
discussion and held a hearing in July 2005, taking testimony from the NIH Director.34
The disparate stakeholders of the medical research community, including those in
academia, government, industry, the nonprofit sector, patient advocacy groups, and
the general public, had opportunities during the following year to provide comments
and reactions to the proposal, which resulted in changes in a number of provisions
in the draft bill. On September 19, 2006, the committee held a legislative hearing on
the third draft of the “National Institutes of Health Reform Act of 2006,” during
which representatives of major stakeholder organizations expressed their support for
the revised legislation.35 An amended version of the draft was approved by the
committee in a markup session the next day.
The bill, H.R. 6164 (H.Rept. 109-687), was introduced by Chairman Joe Barton
on September 25, 2006, and was passed by the House under suspension of the rules
on September 26, 2006, by a vote of 414-2. In the Senate, action on the bill was
deferred until the last day of the 109th Congress. On December 8, 2006, the bill was
discharged from the Senate Committee on Labor, Health, Education, and Pensions,
and an amended version, the product of negotiations between the Senate and House
authorizers and appropriators, passed the Senate by unanimous consent. The House
agreed to the Senate amendment by voice vote. The measure was signed by President
Bush on January 15, 2007, and became P.L. 109-482.
The law made managerial and organizational changes in NIH, with a focus on
enhancing the authority and tools available to the NIH Director’s Office to do
strategic planning, and especially to facilitate and fund transdisciplinary, cross-
institute research initiatives. It contained no provisions relating to specific diseases
or fields of research, and did not eliminate or consolidate any existing ICs.
The law established a Division of Program Coordination, Planning, and
Strategic Initiatives (DPCPSI) within the Office of the Director, with many functions
similar to those of OPASI (described in the previous section). The law moved a
number of individual program offices in OD to the new Division (such offices
coordinate research on AIDS, women’s health, behavioral and social sciences,
disease prevention, dietary supplements, and rare diseases). As noted earlier, OPASI
also became an office in the Division. While not superseding the planning and
priority-setting responsibilities of the individual institutes and centers, the measure
charged the Director with overall program coordination of the entire research

34 U.S. Congress, House Committee on Energy and Commerce, Legislation to Reauthorize
the National Institutes of Health, hearing, 109th Cong., 1st sess., July 19, 2005, serial no. 109-

40 (Washington: GPO, 2005).

For links to Energy and Commerce hearings (archived webcasts and printed transcripts), see
[]. This hearing is found at
[ h t t p : / / energyc omme reparchive s/108/Hearings /07192005hearin g1590/
35 U.S. Congress, House Committee on Energy and Commerce, Improving NIH Management
and Operation: A Legislative Hearing on the NIH Reform Act of 2006, 109th Cong., 2nd sess.,
September 19, 2006. The archived webcast and testimony of the witnesses are available at
[http://energyc omme r ce 108/Hearings /09192006hearing2031/

portfolio of NIH. It required the creation of a comprehensive electronic reporting
system to catalogue research activities from all of the ICs in a standardized format.
Information from the tracking system is intended to assist the Director and the
Division in planning trans-NIH research initiatives that cannot be handled within
individual ICs.
Building on the approach of the NIH Roadmap, the act provided for funding of
trans-NIH initiatives through the Common Fund. The law requires the NIH Director
to reserve an amount for the Common Fund that, as a percentage of total NIH
appropriations, is at least as great as in the previous year. A new Common Fund
strategic planning report to the Congress is required; it is to estimate the funding
needed for trans-NIH research. The law established a new advisory body, the
“Council of Councils,” to review proposals for trans-NIH research. The Council is
composed of representatives from the IC advisory councils, OD offices, and the
Council of Public Representatives. Proposals from investigators who are first-time
applicants are to be given “appropriate consideration,” and NIH’s traditional
emphasis on peer-reviewed, investigator-initiated research is to be maintained. The
Council held its first meeting in March 2008.36
The law created a “Scientific Management Review Board” charged with
formally and publicly reviewing NIH’s organizational structure at least once every
seven years. The board may recommend restructuring, including the creation of new
institutes, but the number of ICs is capped at the current 27. The law set out time
frames for the Director to take action on such recommendations, and provided for
review by Congress.
The measure authorized total funding levels for NIH, although not for the
individual ICs, for FY2007-FY2009. This was the first time the PHS Act had
specified a ceiling for overall NIH funding. From an assumed FY2006 baseline of
$28.33 billion, authorized funding was increased by $2 billion (7%) to $30.33 billion
for FY2007, $2.5 billion (8.2%) to $32.83 billion for FY2008, and was authorized
for such sums as needed for FY2009. Within those amounts, appropriations were
authorized for the Office of the Director at such sums as needed for FY2007-
FY2009. The law eliminated a number of statutory authorizations of appropriations
for specific programs (including those for several institutes), but did not change
NIH’s authority to run the programs.
The law requires a biennial report from the Director to Congress assessing the
state of biomedical research and reporting in detail on the research activities of NIH,
including strategic planning and initiatives, and summaries of research in a number
of broad areas. 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 of those issues
had been the subject of investigations by the House Energy and Commerce
Committee). Two demonstration programs were authorized, one to award grants that

36 NIH, Office of Extramural Research, “Appointment of Members to the NIH Council of
Councils,” Extramural Nexus, March 2008 (see also links to Council materials)

“bridge the sciences” between the biological, behavioral, and social sciences and the
physical, chemical, mathematical, and computational sciences, and the other to fund
high-risk, high-reward research.
A more detailed summary of the provisions of the NIH Reform Act may be
found on the website of the NIH Office of Legislative Policy and Analysis (OLPA),
at []. Information
on NIH’s progress in implementing various requirements of the law is included in the
FY2009 budget justification narrative for the Office of the Director.37
Dozens of bills and resolutions related to NIH, to disease research, or to other
areas of public health have been introduced in the 110th Congress, and a few have had
further action. See the OLPA website for its Bill Tracking pages and other links to
congressional activity, at [].
Oversight: Maintaining Trust and Transparency
The same committees and subcommittees that handle authorizations and
appropriations for NIH have also engaged in oversight activities as specific issues or
problems have arisen. Two ongoing matters are discussed below.
Public Access to Results of NIH-Sponsored Research. The Internet
has given the general public unprecedented access to health and medical information.
In fact, so much is available that consumers have had to learn to be discriminating
about the reliability of what they retrieve. NIH tries to assist in this filtering effort
by providing information, links, and search capability on many of its websites, all
with the intent of helping people find information from accurate, current sources. A
well-regarded starting point is MedlinePlus [], the
consumer health site from the National Library of Medicine (NLM).
Access to the professional literature of medicine and biomedical research
remains limited, however. In the case of journal articles that stem from NIH-
sponsored research, there is growing sentiment that taxpayers should have easy
access to the results of that research. The public can search for journal articles on
NLM’s MEDLINE/PubMed database [] and retrieve
references from more than 17 million articles published in about 5,200 biomedical
journals dating back to the 1950s. Although the citation and an abstract are usually
available, only occasionally will there be a link to the full article. Most often, the
link leads to a publisher’s website where a subscription to the journal is required for
access to full-text articles. The alternative for most people is to visit a university,
medical school, or hospital library to consult the hard-copy journals.
For several years, NLM has been building up a digital repository of full-text,
peer-reviewed biomedical, behavioral, and clinical research journals called PubMed
Central (PMC) []. The aim is to have a publicly

37 NIH, Justification of Estimates for Appropriations Committees, FY2009, Vol. V, Office
of the Director, pp. OD-12 to OD-27
[ =1].

accessible, stable, permanent, and searchable electronic archive of life science
literature, one separate from publishers’ databases. A large number of journals
already routinely deposit material in PMC, and generally make all of their published
articles available. Many scientists with NIH grants, however, may publish the results
of their research in journals that do not contribute articles to PMC.
In February 2005, NIH announced a new Public Access Policy
[], formally called the Policy on Enhancing Public Access
to Archived Publications Resulting from NIH-Funded Research.38 The policy
requested each NIH-funded investigator to submit an electronic version of a final,
peer-reviewed manuscript to NLM’s existing PubMed Central database at the time
the article was accepted for publication in a journal. NIH encouraged authors to
make manuscripts available to other researchers and the public immediately after they
have been published, but the policy allowed a delay in releasing articles of up to 12
NIH listed the following three goals as an answer to the question, “Why should
there be a public resource of published peer-reviewed research findings of
NIH-funded research?”:
!creating a stable archive of peer-reviewed research publications
resulting from NIH-funded research to ensure the permanent
preservation of these vital published research findings;
!securing a searchable compendium of these peer-reviewed research
publications that the NIH and its awardees can use to manage more
efficiently and to understand better their research portfolios, monitor
scientific productivity, and ultimately, help set research priorities;
!making published results of NIH-funded research more readily
accessible to the public, health care providers, educators, and
NIH implemented the policy in May 2005, when it activated a manuscript
submission system for authors to deposit articles. Participation was voluntary, in
deference to publishers’ concerns about the loss of their proprietary content. As time
went on, however, the rate of submission to the system continued to be very low, and
there began to be calls to make the submission of manuscripts mandatory. The
FY2007 House Labor-HHS-ED Appropriations bill (H.R. 5647) included such a
provision, although the Senate bill of that year did not. Both committees included
report language commending NLM for developing PubMed Central. They
encouraged NLM to work with health sciences librarians and the medical library
community on issues related to copyright, fair use, peer review, and classification of
information on PubMed Central.

38 “Policy on Enhancing Public Access to Archived Publications Resulting from NIH-
Funded Research,” NIH Guide for Grants and Contracts, February 3, 2005, available at
[ -OD-05-022.html ].
39 NIH, Office of Extramural Research, “Questions and Answers: NIH Public Access
Policy,” February 24, 2005.

The FY2008 appropriation made the policy mandatory. NIH released its revised
policy statement on January 11, 2008, with an effective date of April 7, 2008, saying:
“In accordance with Division G, Title II, Section 218 of PL 110-161 (Consolidated
Appropriations Act, 2008), the NIH voluntary Public Access Policy
(NOT-OD-05-022) is now mandatory. The law states: ‘The Director of the National
Institutes of Health shall require that all investigators funded by the NIH submit or
have submitted for them to the National Library of Medicine’s PubMed Central an
electronic version of their final, peer-reviewed manuscripts upon acceptance for
publication, to be made publicly available no later than 12 months after the official
date of publication: Provided, That the NIH shall implement the public access policy
in a manner consistent with copyright law.’”40
NIH estimates that there are approximately 80,000 articles published each year
that arise from NIH funds.41 At a public meeting held March 20, 2008, to hear
comments on the new policy, Dr. Zerhouni is reported as saying that if the policy
remained voluntary, about 64,000 new research articles arising from NIH funds
would not be available to the public each year.42
Ethics Regulations for NIH Employees Regarding Conflicts of
Interest. In late 2003, investigations by the Los Angeles Times indicated that some
NIH scientists were earning outside income (including stock options in some cases)
from consulting arrangements with drug and biotech companies.43 Earlier that year,
questions had been raised about some top NIH scientists receiving honoraria for
giving lectures at institutions that received NIH funding. Many of these
arrangements were technically allowed under ethics rules that were in place at the
time. Nonetheless, NIH Director Elias Zerhouni wrote to senior NIH staff in
November 2003:
Recently Congress and the media have been scrutinizing the implementation of
ethics rules at the NIH. They are reviewing a wide range of activities that are
allowed under Federal regulations, including lecture awards, outside activities,
consultant arrangements, and financial holdings. Care must be taken to ensure
that we continue to adhere to strict ethical practices and that we avoid the
perception of conflicts of interest, even in situations where remuneration or44

awards are considered permissible.
40 NIH, Office of Extramural Research, “Revised Policy on Enhancing Public Access to
Archived Publications Resulting from NIH-Funded Research,” Notice number
NOT-OD-08-033, January 11, 2008
[ -OD-08-033.html ].
41 NIH, “Public Access Frequently Asked Questions,” January 11, 2008
42 NIH, Office of Extramural Research, “NIH Hears Public Access Comments,” NIH Nexus,
March 2008 [].
43 David Willman wrote a series of articles for the Times over a number of months. The first
was “Stealth Merger: Drug Companies and Government Medical Research,” Los Angeles
Times, December 7, 2003, p. A1.
44 Elias A. Zerhouni, “Awards, Travel, and Official Duty and Outside Activity Approvals,”

More studies and hearings on ethics policies, and investigations of individual
cases, both by NIH and by Congress, ensued during 2004 and 2005.45 Several dozen
NIH scientists who had not complied with reporting requirements were disciplined.
In February 2005, to supplement existing ethics regulations, HHS published a new
rule focusing on outside activities, financial holdings, and awards for all NIH
employees, not just for scientists.46 Published as an interim final rule with a request
for comments, the regulation strictly limited interactions with pharmaceutical and
biotechnology companies, grantee research institutions, and other entities, as well as
investments in such companies for many NIH staff and their families. The rule was
meant to create a substantially expanded system of oversight of employee activities
to preserve the trust of the public in NIH. It was recognized, however, that the rule
could have adverse impacts on recruitment and retention of employees, and that
revisions of the rules might be desirable, especially for staff whose jobs did not
involve decisions over research policies.
The final revised regulation, published in August 2005, covered reporting of
certain financial interests, stock divestiture, outside activities, and awards.47
According to an NIH press release:
Three principles guided the crafting of the rules: (1) The public must be assured
that research decisions made at NIH are based on scientific evidence and not by
inappropriate influences; (2) Senior management and people who play an
important role in research decisions must meet a higher standard of disclosure
and divestiture than people who are not decision-makers; and (3) To advance the
science and stay on the cutting edge of research, NIH employees must be allowed
interaction with professional associations, participation in public health48
activities, and genuine teaching opportunities.
Implementation of the ethics rules has largely quelled concern over new
infractions. As a followup, NIH did some surveys and assessments of the impact of
the rules on current employees, as well as on individuals who had left the agency or
were potential employees. Some of the results of that process are posted at
[], but no definitive trends
were apparent.

44 (...continued)
memo to IC Directors and OD Senior Staff, November 20, 2003
[ /nov2003/11202003drze rhounime mo.pdf].
45 Many pertinent documents can be found on NIH’s “Conflict of Interest Information and
Resources” web page [].
46 U.S. Department of Health and Human Services, “Supplemental Standards of Ethical
Conduct and Financial Disclosure Requirements for Employees of the Department of Health
and Human Services,” 70 Federal Register 5543-5565, February 3, 2005.
47 U.S. Department of Health and Human Services, “Supplemental Standards of Ethical
Conduct and Financial Disclosure Requirements for Employees of the Department of Health
and Human Services,” 70 Federal Register 51559-51574, August 31, 2005.
48 NIH Office of the Director, “NIH Announces Final Ethics Rules,” press release, August

25, 2005 [].

Also of ongoing concern to NIH and the public is the possibility that research
results will be biased because of financial conflicts of interest (FCOI) on the part of
extramural grantees. Regulations setting forth requirements for researchers and their
institutions are longstanding, but NIH recognizes that increasingly complex financial
arrangements involving scientists are becoming more common, and might threaten
objectivity in research. Reminders of the policies and answers to frequently asked
questions are available to researchers and peer reviewers on the website of the Office
of Extramural Research, at [].
Selected NIH Online Resources
NIH Home Page [].
!health information [];
!websites of the Office of the Director and each Institute and Center
[] ;
!general information on grants [];
!grants searchable by topic [
generat e_screen] ;
!grants searchable by recipient [
!overview of the peer review system [
!background on NIH [], including
organization and historical and legislative chronologies in the NIH
Almanac []; and
!current news and medical research issues pages.
NIH Budget [].
!Presidents’ budget requests;
!budget justification documents prepared for the Appropriations
!appropriations history;
!estimates of NIH spending (FY2004-FY2009) on about 210 specific
diseases, conditions, and research areas (note that these are estimates
of research activity, not set-asides by NIH or line items from
Congress) [];
!information on the Biomedical Research and Development Price
Index (BRDPI) and other measures of inflation, including tables
[ h ttp://] .
Legislation Affecting NIH [].
!The NIH Office of Legislative Policy and Analysis (OLPA) in the
Office of the Director produces and compiles summaries of major

legislative issues relevant to NIH, and tracks pending legislation,
public laws, and hearings.
!OLPA serves as the congressional liaison office for NIH (301-


Table 4. Components of NIH, with History and Scope
Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
tional Cancer InstituteNCI1937 — National Cancer Institute ActAll aspects of cancer — cause,$4,805

417D,(P.L. 75-244).diagnosis, prevention, treatment,

285a-101944 — under the PHS Act of 1944 (P.L.rehabilitation, and continuing care of

78-410), NCI became a division of thepatients.

National Institute of Health.
NHLBI1948 — National Heart Act (P.L. 80-655):Diseases of the heart, blood vessels,$2,922
iki/CRS-RL33695ood Institute National Heart Institute.lungs, and blood; sleep disorders; and
g/w425,1969 — National Heart and Lungblood resources management.
s.or285b-8 Institute.
leak1976 — NHLBI.
://wiki DentalNIDCR1948 — National Dental Research ActOral, dental, and craniofacial diseases$390
httpacial Research (P.L. 80-755): National Institute of Dentaland disorders.

1998 — NIDCR.

ute of DiabetesNIDDK1950 — Omnibus Medical Research ActDiabetes, endocrinology, metabolic$1,857

gestive and Kidney(P.L. 81-692): National Institute ofdiseases; digestive diseases, nutrition;
seasesArthritis and Metabolic Diseases.kidney, urologic, hematologic

434A,1972 — National Institute of Arthritis,diseases.

285c-9Metabolism, and Digestive Diseases.

1981 — National Institute of Arthritis,

Diabetes, and Digestive and Kidney

1985 — NIDDK.

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
NINDS1950 — Omnibus Medical Research ActConvulsive, neuromuscular,$1,544
(P.L. 81-692): National Institute ofdemyelinating, and dementing
roke Neurological Diseases and Blindness.disorders; fundamental neurosciences;

460,1968 — National Institute of Neurologicalstroke, trauma.

-285j-3Diseases and Stroke.
1975 — National Institute of Neurological
and Communicative Disorders and Stroke.

1988 — NINDS.

iki/CRS-RL33695 AllergyNIAID1955 — established under authority ofAllergic, immunologic, and infectious$4,266
g/wectious DiseasesOmnibus Medical Research Act (P.L. 81-diseases.
s.or447B, 692).
://wiki GeneralNIGMS1962 — PHS Act Amendment (P.L. 87-Research and research training in basic$1,936
http838) authorized the Surgeon General tobiomedical sciences (cellular and
establish an institute for general (basic)molecular biology, genetics,
biomedical sciences.pharmacology, physiology). Special

1963 — NIGMS created in thefocus on minority researchers.

Department of Health, Education, and
Welfare (HEW).
ChildNICHD1962 — PHS Act Amendment (P.L. 87-Reproductive biology; population$1,255

838) authorized the Surgeon General toissues; embryonic development;

velopment establish an institute for research on childmaternal, child, and family health;

452G,health and human development.medical rehabilitation.

-285g-101963 — NICHD created in HEW.

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
NEI1968 — National Eye InstituteEye diseases, visual disorders, visual$667
456,Establishment Act (P.L. 90-489)function, preservation of sight, health

285i-1(functions formerly in the institute forproblems of the visually impaired.

neurological diseases and blindness).
NIEHS1969 — The NIH Division ofInterrelationships of environmental$720
vironmental HealthEnvironmental Health Sciencesfactors, individual genetic
ences (located in Research(established by the Surgeon General insusceptibility, and age as they affect
iangle Park, NC)1965) was elevated to institute status byhealth.
iki/CRS-RL33695463A,the Secretary of HEW.
g/wl -285l -1
s.orNIA1974 — Research on Aging Act of 1974Biomedical, social, and behavioral$1,047
leak445J,(P.L. 93-296).research on the aging process;
://wiki285e-11diseases, problems, and needs of the
http aged.
e of ArthritisNIAMS1986 — Established under authority of theArthritis; bone, joint, connective tissue$509
oskeletal and SkinHealth Research Extension Act of 1985and muscle disorders; skin diseases.
seases(P.L. 99-158). For earlier history, see


nessNIDCD1988 — National Deafness and OtherDisorders of hearing, balance, smell,$394

ther CommunicationCommunication Disorders Act of 1988taste, voice, speech, and language.
sorders(P.L. 100-553) (functions formerly in the
464F,institute for neurological and
-285m-6communicative disorders and stroke).

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
NursingNINR1986 — National Center for NursingAcute and chronic illness, health$137
search Research established under authority ofpromotion/disease prevention, nursing
-464Y,the Health Research Extension Act ofsystems, clinical therapeutics.

285q-31985 (P.L. 99-158).

1993 — NINR.

ute on AlcoholNIAAA1970 — Comprehensive Alcohol AbuseCauses of alcoholism, how alcohol$436
coholismand Alcoholism Prevention, Treatment,damages the body, prevention and

464J,and Rehabilitation Act (P.L. 91-616)treatment strategies.

iki/CRS-RL33695285n-2established NIAAA within NIMH in PHS.
g/w1974 — moved to Alcohol, Drug Abuse,
s.orand Mental Health Administration
leak(ADAMHA) (P.L. 93-282).
1992 — moved to NIH
://wiki(P.L. 102-321).
NIDA1974 — established under authority ofSocial, biological, behavioral, and$1,001

Drug Abuse Office and Treatment Act ofneuro-scientific bases of drug abuse
464P,1972 (P.L. 92-255).and addiction; causes, prevention, and

285o-41974 — moved to ADAMHAtreatment strategies.

(P.L. 93-282).

1992 — moved to NIH (P.L. 102-321).

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
MentalNIMH1949 — established under authority ofBrain research, mental illness, and$1,405
National Mental Health Act of 1946mental health.

464U,(P.L. 79-487).

285p-31967 — transferred out of NIH to PHS

1974 — moved to ADAMHA (P.L. 93-


1992 — moved back to NIH
(P.L. 102-321).
g/wtional Human GenomeNHGRI1989 — National Center for HumanChromosome mapping, DNA$487
s.orsearch InstituteGenome Research (NCHGR) established.sequencing, database development,
leak1993 — NCHGR authorizedethical/legal/social implications of
(P.L. 103-43).genetics research.
://wiki1997 — elevated to institute by the HHS
http Secretary.
2007 — name officially changed in the
PHS Act from NCHGR to NHGRI (P.L.


NIBIB2000 — NIBIB Establishment Act (P.L.Research, training and coordination in$299

omedical Imaging and106-580).biomedical imaging, bioengineering
oengineering and related technologies and
,modalities, including biomaterials and

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
tional Center for ResearchNCRR1970 — Division of Research ResourcesExtramural and intramural research$1,149
sources (DRR) moved to NIH from PHS.resources and technologies: general

481C,1990 — NCRR created by merging DRRclinical research centers, computers,

287a-4and Division of Research Servicesinstrument systems, animal resources
(statutory authority in NIH Revitalizationand facilities, nonmammalian research
Act of 1993, P.L. 103-43).models.
orNCCAM1992 — Office of Alternative MedicineIdentifies, evaluates, and researches$122
(OAM) created in OD.unconventional health care practices.
iki/CRS-RL33695ternative Medicine1993 — OAM authorized (P.L. 103-43).
g/w1999 — NCCAM created
s.or21(P.L. 105-277).
leakNCMHD1990 — Office of Research on MinorityResearch, training, and coordination on$200
://wikiHealth (ORMH) created by NIH in OD.minority health conditions and
http485H,1993 — ORMH authorizedpopulations with health disparities.

31-287c-34(P.L. 103-43).

2000 — NCMHD created
(P.L. 106-525).
ogarty InternationalFIC1968 — established by HEW.Focal point for NIH’s international$67

nter for Advanced Study in1985 — established in lawcollaboration activities and scientific
(P.L. 99-158).exchanges; provides leadership in
global health.

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
MedicineNLM1836 — established as the Library of theCollects, organizes, and makes$329

478A,Office of the Surgeon General of theavailable biomedical information;

286dArmy, later Army Medical Librarysponsors programs to improve U.S.

(1922), Armed Forces Medical Librarymedical library services.
(1952), and NLM under PHS (1956, NLM
Act, P.L. 84-941).

1968 — moved to NIH.

fice of the Director OD1930 — Ransdell Act (P.L. 71-251)Overall NIH leadership, and liaison$1,109
iki/CRS-RL33695created the National Institute of Health.with HHS. Includes special offices for
g/wresearch on AIDS, women’s health,
s.orbehavioral and social sciences, and
leakdisease prevention (including rare
diseases and dietary supplements).
httpildings and FacilitiesB&FFirst separate appropriation FY1970.Provides for the design, construction,$119
improvement, and repair of NIH
clinical and laboratory buildings.
tal for appropriated$29,171
ing a separate appropriation (funded by taps from appropriated accounts listed above)
H Clinical CenterCC1944 — authorized by the PHS Act (P.L.NIH’s hospital and outpatient facility($361)

78-410).for clinical research.

1953 — first patient admitted.

nter for Scientific ReviewCSR1946 — Division of Research GrantsReceives, assigns, and reviews($105)

created.research and training grant

1997 — reorganized and renamed CSR.applications.

Institute/CenterFY2008 program
tatutory Authority in PublicAcronymWhen and How Established;Major Research Focuslevel
Health Service Act and U.S.Chronology of Name Changes($ millions)
Code)(details, Table 2)
nter for InformationCIT1964 — Division of Computer ResearchProvides, coordinates, and manages($39)
and Technology (DCRT) established.information technology for NIH;
1998 — CIT formed (DCRT combinedresearch to advance computational
with other offices).science.
: NIH Almanac, 2006-2007 []. Budget figures from NIH FY2009 Budget Justification, vol. I, pp. TD-1 and SI-8