NATIONAL 

INSTITUTES OF 

HEALTH

Kidney Disease 

Research Funding 

and Priority Setting

Report to Congressional Requesters

December 2016

GAO-17-121

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-17-121, a report to 

congressional requesters

December 2016

NATIONAL INSTITUTES OF HEALTH

Kidney Disease Research Funding and Priority 

Setting

What GAO Found

The National Institutes of Health (NIH), within the Department of Health and 

Human Services, is the primary federal agency that conducts biomedical 

research on kidney disease, as well as various other diseases and conditions. 

NIH’s budget—$30 billion in fiscal year 2015—mostly funds extramural research 

that supports research personnel working at universities, medical schools, and 

other institutions. The National Institute of Diabetes and Digestive and Kidney 

Diseases (NIDDK)—one of NIH’s 27 institutes and centers (IC)—has primary 

responsibility for kidney disease research. NIH funding for biomedical research 

on kidney disease in fiscal year 2015 was approximately $564 million—an 

increase of 2.7 percent from fiscal year 2014. NIDDK provided the majority (60 

percent) of this funding, supporting a broad range of projects, such as chronic 

kidney disease, end-stage renal disease (ESRD) treatment, and kidney donation. 

GAO also reviewed NIH research funding levels for other diseases and 

conditions in the United States—those that are associated with high mortality or 

are among the most prevalent chronic conditions. GAO found that funding for 

fiscal year 2015 varied widely among these diseases and conditions—for 

example, from $28 million for emphysema to nearly $5.4 billion for cancer. This 

variation in funding reflects a range of factors, including each IC’s mission, 

budget, and research priorities. 

NIDDK obtains input from the broader kidney care community to develop its 

research priorities. To develop funding announcements that target high-priority 

research areas, NIDDK considers the kidney care community’s input in the 

context of its ongoing work and its knowledge of the current state of kidney 

disease research. NIDDK’s process for obtaining input from the kidney care 

community is iterative by design to help ensure that the institute’s research 

priorities evolve to reflect the latest research developments and needs of the 

kidney care community. 

NIDDK’s Methods for Obtaining Input from Stakeholders to Set Research Priorities

Representatives from six private kidney care groups GAO interviewed generally 

agreed with NIDDK’s kidney disease research priorities; however, some of the 

groups’ members identified kidney disease topic areas they believe warrant more

attention from NIDDK, such as a lack of kidney disease awareness in the general 

public. NIDDK agreed with this and other topics raised by the groups, and 

pointed out a variety of ongoing NIDDK programs that address these topics.

The Department of Health and Human Services provided technical comments, 

which GAO incorporated as appropriate.

View GAO-17-121. For more information, 

contact Elizabeth H. Curda at (202) 512-7114 

or curdae@gao.gov.

Why GAO Did This Study

An estimated 17 percent of U.S. adults

have chronic kidney disease—the most 

common form of kidney disease—a 

condition in which the kidneys are 

damaged and cannot filter blood 

sufficiently, causing waste from the 

blood to remain in the body. Kidney 

disease patients may progress to 

ESRD, a condition of kidney failure, 

which can cause death without dialysis 

or kidney transplant. In 2013, the 

Medicare program—which pays for 

ESRD treatment—spent $30.9 billion 

to treat approximately 530,000 

patients. Given the high cost of kidney 

disease in terms of health 

consequences and federal spending, 

GAO was asked to examine how the 

federal government funds and 

prioritizes kidney disease research. 

This report describes (1) the level of 

NIH funding for biomedical research on 

kidney disease, and for other leading 

diseases and conditions; and (2) how 

NIDDK sets priorities for kidney 

disease research.

To describe NIH funding for research 

on kidney disease and other diseases 

and conditions, GAO selected leading 

diseases and conditions (based on 

mortality and prevalence) and 

analyzed their levels of research 

funding based on NIH data for fiscal 

year 2015. To describe how NIDDK 

sets priorities for kidney disease 

research, GAO reviewed documents—

including those on research portfolios 

and strategic planning—from NIDDK, 

NIH, and other relevant federal 

agencies. Also, GAO interviewed 

agency officials and private kidney 

care groups representing a broad 

range of perspectives.
Page i GAO-17-121 Kidney Disease Research Funding

Letter 1

Background 4

NIH Funding for Kidney Disease Research Totaled $564 Million in 

Fiscal Year 2015; Funding Levels Varied across Leading 

Diseases and Conditions 7

NIDDK Obtains Input from the Broader Kidney Care Community to 

Develop its Research Priorities 11

Agency Comments 15

Appendix I Leading Diseases and Conditions and their Corresponding National 

Institutes of Health Research Categories 17

Appendix II Federal Funding for Kidney Disease Biomedical Research by 

Agencies Other than the National Institutes of Health 23

Appendix III The Kidney Research National Dialogue 26

Appendix IV GAO Contact and Staff Acknowledgments 28

Tables

Table 1: National Institutes of Health (NIH) Research Funding for 

Leading Diseases and Conditions in the United States, 

Fiscal Year 2015 9

Table 2: Diseases and Conditions with High Mortality in the United 

States in 2014 17

Table 3: Chronic Diseases and Conditions with High Prevalence in 

the United States 20

Table 4: Diseases and Conditions with High Mortality or High 

Prevalence and Corresponding Research, Condition, and 

Disease Categorization System Categories 21

Contents
Page ii GAO-17-121 Kidney Disease Research Funding

Figures

Figure 1: Funding for Kidney Disease Research by National 

Institutes of Health (NIH) Institutes and Centers, Fiscal 

Year 2015 8

Figure 2: National Institute of Diabetes Digestive and Kidney 

Diseases’ (NIDDK) Process to Develop Research 

Priorities 12

Abbreviations

CDC Centers for Disease Control and Prevention

DOD Department of Defense

ESRD end-stage renal disease

FDA Food and Drug Administration

IC institutes and centers

ICD-10 International Classification of Diseases, Tenth Revision

KHI Kidney Health Initiative

KICC Kidney Interagency Coordinating Committee

KRND Kidney Research National Dialogue

NHANES National Health and Nutrition Examination Survey

NHIS National Health Interview Survey

NIDDK National Institute of Diabetes and Digestive and Kidney

Diseases

NIH National Institutes of Health

OASH Office of the Assistant Secretary of Health

RCDC Research, Condition, and Disease Categorization system

VA Department of Veterans Affairs

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

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Page 1 GAO-17-121 Kidney Disease Research Funding

441 G St. N.W.

Washington, DC 20548

December 19, 2016

The Honorable Barbara Comstock

Chairwoman

Subcommittee on Research and Technology

Committee on Science, Space, and Technology

House of Representatives

The Honorable Benjamin Cardin

United States Senate

The Honorable Bill Nelson

United States Senate

The Honorable Tom Marino

House of Representatives

An estimated 17 percent of U.S. adults have chronic kidney disease—the 

most common form of kidney disease—a condition in which the kidneys 

are damaged and cannot filter blood sufficiently, causing waste from the 

blood to remain in the body.1 Kidney disease disproportionately affects 

older, minority, and low-income individuals, and is often associated with 

other health conditions, including heart disease. Diabetes and 

hypertension—significant health problems in the United States—are the 

leading causes of kidney disease. Individuals who have kidney disease 

are at risk of progressing to end-stage renal disease (ESRD), a condition 

of kidney failure, which causes death without dialysis or a kidney 

transplant. Due to the scarcity of kidneys for transplants, treatment of 

ESRD typically involves dialysis treatment for 3 to 4 hours, three times 

per week, at a facility outside the home, and can significantly diminish 

patients’ quality of life. Most individuals with ESRD are eligible for 

 1

Centers for Disease Control and Prevention, National Health and Nutrition Examination 

Survey, 2013-2014, accessed October 14, 2016, 

https://nccd.cdc.gov/CKD/detail.aspx?Qnum=Q372. This estimate does not include endstage renal disease, the final stage of chronic kidney disease.

Letter
Page 2 GAO-17-121 Kidney Disease Research Funding

Medicare regardless of age.2 In 2013, the Medicare program spent $30.9 

billion to treat approximately 530,000 individuals with ESRD.3

The National Institutes of Health (NIH), an agency of the Department of 

Health and Human Services, is the primary source of federal funding for 

biomedical research on kidney disease and various other diseases and 

conditions.4 Within NIH, the National Institute of Diabetes and Digestive 

and Kidney Diseases (NIDDK) is the institute with primary responsibility 

for setting research priorities that guide the allocation of research funding 

for kidney disease. Given the high cost of kidney disease in terms of 

health consequences and spending, you asked us to examine how the 

level of federal funding for kidney disease research compares to funding 

for other diseases and conditions, and how the federal government sets 

priorities for kidney disease research funding. In this report, we describe

1. the level of NIH funding for biomedical research on kidney disease, 

and other leading diseases and conditions; and

2. how NIDDK sets priorities for kidney disease research.

To describe NIH funding levels for biomedical research on kidney disease 

and other leading diseases and conditions, we first identified diseases 

and conditions with a high disease burden in the United States relative to 

other conditions based on data from the Centers for Disease Control and 

Prevention (CDC). Specifically, we analyzed CDC’s national survey data, 

and interviewed CDC officials to identify conditions that had high 

mortality, or were chronic conditions with high prevalence, or both. We 

then matched the diseases and conditions we identified with fiscal year 

2015 data—the most current available—from NIH’s Research, Condition, 

and Disease Categorization (RCDC) system, which categorizes NIH 

research projects (and associated funding) into categories that 

 2

Most individuals diagnosed with ESRD are eligible to receive Medicare benefits under 

Medicare Part A, Part B, and Part D. 42 U.S.C. §§ 426-1(a), 1395w-101(a)(3)(A).

3

National Institutes of Health, National Institute of Diabetes and Digestive and Kidney 

Diseases, United States Renal Data System, 2015 USRDS Annual Data Report: 

Epidemiology of Kidney Disease in the United States, (Bethesda, Md.: 2015).

4

For the purposes of this report, the term research refers to biomedical research, which 

consists of (1) basic research, which involves laboratory studies that provide the 

foundation for clinical research; (2) clinical research, which includes patient-oriented 

research, epidemiologic and behavioral studies, and outcomes and health services 

research; and (3) translational research, which can involve enhancing the adoption of 

clinical best practices in the community. 
Page 3 GAO-17-121 Kidney Disease Research Funding

correspond to diseases and conditions. We confirmed the 

appropriateness of these matches with NIH officials, and clarified any 

differences in definition between the diseases and conditions and the 

associated RCDC categories. (See app. I for a more detailed description 

of our methodology.) To assess the reliability of the data used in our 

analysis, we interviewed knowledgeable NIH and CDC officials, and 

reviewed documentation about the data sources and methods for 

collecting the data. We determined that the data were sufficiently reliable 

for the purposes of our reporting objectives. Given our focus on kidney 

disease research funding, we also reviewed documentation and 

interviewed officials from non-NIH federal agencies that are part of the 

Kidney Interagency Coordinating Committee (KICC) and fund biomedical 

research related to kidney disease: Agency for Healthcare Research and 

Quality, CDC, Department of Defense, Food and Drug Administration, 

and Department of Veterans Affairs.5 (See app. II for a summary of nonNIH kidney disease biomedical research activities and associated 

funding.)

To describe how NIDDK sets priorities for kidney disease research, we 

reviewed documentation relevant to its priority setting efforts and 

interviewed NIDDK officials about their processes. To understand how 

NIDDK officials work with other federal agencies engaged in kidney 

disease research, we interviewed officials from the KICC agencies that 

fund or conduct biomedical research and attended two KICC meetings in 

March and June of 2016. We also interviewed officials from the three NIH 

institutes that fund most of the kidney-related research after NIDDK: the 

National Heart, Lung, and Blood Institute, the National Institute of Allergy 

and Infectious Diseases, and the National Cancer Institute. To gain 

insight into the extent to which NIDDK’s priorities align with those of the 

kidney care community, we obtained the perspective of six private kidney 

care groups representing professional societies, patient advocacy groups, 

dialysis providers, and other kidney-care industries. We selected these 

six groups because, together, they represent a broad range of 

perspectives within the kidney care community. However, our summary of 

these groups’ views of NIDDK’s kidney disease research priorities cannot 

be generalized to the entire private kidney care community.

 5

KICC, which is led by NIDDK, also includes representatives from Centers for Medicare & 

Medicaid Services, Health Resources and Services Administration, and Indian Health 

Service.
Page 4 GAO-17-121 Kidney Disease Research Funding

We conducted this performance audit from February 2016 to December 

2016 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

The kidneys are the body’s filtration system that removes waste and extra 

fluid from the blood. Further, the kidneys maintain electrolyte stability, 

help to control blood pressure, and produce hormones to keep the body 

and blood healthy. Kidney disease occurs when the kidneys become 

damaged and can no longer filter blood like they should, often due to 

diabetes or high blood pressure—the most common causes of kidney 

disease.6 For most people, kidney disease unfolds slowly over many 

years and often has no signs or symptoms until the disease is very 

advanced, such that less than 15 percent of people in the late stages of 

kidney disease are aware of their disease.7 However, early detection is 

possible through blood and urine tests, which can delay or prevent the 

progression of kidney disease. Treatment may include, for example, 

taking medicines to manage high blood pressure to protect the kidneys. 

However, even with treatment, kidney disease usually cannot be cured. 

Instead, it may get worse over time leading to kidney failure, or ESRD, 

which may lead to death without dialysis treatment or a kidney transplant. 

While anyone can develop kidney disease, regardless of age or race, 

African Americans, Hispanics, and Native Americans are at high risk for 

ESRD, due, in part, to high rates of diabetes and high blood pressure in 

these communities. Medicare provides health coverage for most 

individuals with ESRD, regardless of their age. Medicare spending on 

treatment for individuals with ESRD has almost doubled in recent years—

from $16.2 billion in 2003 to $30.9 billion in 2013—as the number of 

 6

Additional risk factors for developing kidney disease are cardiovascular (heart and blood 

vessel) disease and a family history of kidney failure.

7

Centers for Disease Control and Prevention, Chronic Kidney Disease Surveillance 

System—United States, accessed October 18, 2016, http://www.cdc.gov/ckd.

Background

Kidney Disease
Page 5 GAO-17-121 Kidney Disease Research Funding

Medicare beneficiaries with this condition and annual Medicare spending 

per person have increased.8

NIH—which had a total budget of $30 billion in fiscal year 2015—is 

comprised of the Office of the Director, and 27 institutes and centers (IC) 

that focus on specific diseases, particular organs, or stages in life, such 

as childhood or old age. Twenty-four of the 27 ICs receive specific

appropriations to support, plan, and manage their research programs. 

Within NIDDK, the Division of Kidney, Urologic, and Hematologic 

Diseases researches diseases of the kidney and also focuses on the 

fields of urology and hematology.9 Specifically, the division’s areas of 

kidney research include chronic kidney disease, ESRD, cystic kidney 

disease, acute kidney injury, and kidney donation.10 NIDDK’s budget in 

fiscal year 2015 was $1.75 billion, of which $430 million (25 percent) was 

allocated to the division.

NIDDK and the other ICs accomplish their missions primarily through 

extramural research conducted by scientists and research personnel 

working at universities, medical schools, and other research institutions.11

Most extramural research funding is provided for investigator-initiated 

research projects for which researchers submit applications in response 

to broad funding opportunity announcements that span the breadth of 

NIH’s mission. In addition to the broad investigator research 

 8

United States Renal Data System. 2015 USRDS Annual Data Report: Epidemiology of 

Kidney Disease in the United States. These dollar amounts are in nominal dollars. After 

adjusting for inflation using the Gross Domestic Product index, Medicare spending on 

treatment for individuals with ESRD increased by about 55 percent from 2003 to 2013, 

from $20.5 billion to $31.8 billion (in constant 2015 dollars).

9

Urology is the medical specialty concerned with the urinary system in both males and 

females, and the genital organs in the male. Hematology is the medical specialty dealing 

with the blood and blood-forming tissues. The other NIDDK divisions and offices include 

the Division of Diabetes, Endocrinology, and Metabolic Diseases; and the Division of 

Digestive Diseases and Nutrition.

10Cystic kidney disease is generally an inherited disease that causes clusters of noncancerous cysts to develop, primarily within the kidney, which can lead to a variety of 

serious complications, including kidney failure.

11NIH scientists and labs also conduct intramural research through NIH’s intramural 

research program, although that efforts accounts for approximately 11 percent of NIH’s 

total budget. The individual ICs also have intramural research programs, but the size, 

structure, and activities of the programs vary greatly.

NIH Institutes and Centers 

and Their Research 

Activities
Page 6 GAO-17-121 Kidney Disease Research Funding

announcements, ICs issue more narrowly scoped solicitations for 

research targeting specific areas.

All extramural research project applications follow NIH’s process of peer 

review, which was established by law, and includes two sequential levels 

of review.12 The first level involves panels of non-governmental experts to 

assess the scientific merit of the proposed science, and the second level 

involves panels of non-governmental experts and leaders of non-science 

fields, including patient advocates, that, in addition to scientific merit, 

consider the IC’s mission and strategic plan goals, public health needs, 

scientific opportunities, and the balance of the IC’s research across its 

various divisions and centers.

In January 2007, Congress directed NIH to establish an electronic system 

to categorize the research grants and activities of the Office of the 

Director and the ICs.13 In response, NIH implemented RCDC in February 

2008, which reports on the amount of NIH funding in a given fiscal year 

associated with one or more categories of diseases, conditions, or 

research areas. RCDC reports publicly on 265 of these categories. To 

assign an NIH project to the appropriate categories, RCDC uses a 

computer-based text-mining tool that recognizes words and phrases in 

project descriptions. Projects may fall into one or more RCDC categories. 

For example, a study on how diabetes leads to kidney disease would be 

listed in the “diabetes” and “kidney disease” categories. The system 

includes reporting tools that can be used to generate publically available, 

 12See 42 U.S.C. §§ 282(b)(9) (the Director of NIH must ensure that NIH research 

undergoes peer review and advisory council review); 289a(a) (peer review); 289a-1(a)(2) 

(advisory council review).

13National Institutes of Health Reform Act of 2006, Pub. L. No. 109-482, § 104, 120 Stat. 

3675, 3689 (2007) (adding § 402B to the Public Health Service Act, codified at 42 U.S.C. 

§ 282b). The House committee of reference indicated that this language was intended to 

address a recommendation made in an Institute of Medicine report to standardize data 

and information management systems by creating a comprehensive electronic reporting 

system that would catalogue all of the research activities of the NIH in a standardized 

format. H. Rep. No. 109-687, at 4–5 (2006), referring to Institute of Medicine, Responding 

to Health Needs and Scientific Opportunity: The Organizational Structure of the National 

Institutes of Health, (Washington, D.C.; Oct. 16, 1984).

NIH’s System for 

Categorizing Research 

Funding
Page 7 GAO-17-121 Kidney Disease Research Funding

web-based reports on total funding amounts for the research projects 

related to each RCDC category.14

NIH funding for biomedical research related to kidney disease totaled 

approximately $564 million for 1,493 projects in fiscal year 2015—an 

increase of 2.7 percent from fiscal year 2014.15 NIDDK provided the 

majority (60 percent) of this funding; other ICs provided the remaining 40 

percent of funding. In NIDDK, the average research project award was 

about $345,000, and ranged from approximately $27,120 for the smallest 

to $28.5 million for the largest. (See fig. 1.)

 14RCDC tracks projects funded by three different types of NIH funding: extramural 

research grants, research and development contracts, and intramural research conducted 

in NIH’s own laboratories and clinics. Information on funding totals and projects within 

each category is available on the NIH website. See Estimates of Funding for Various 

Research, Condition, and Disease Categories, accessed October 18, 2016,

http://www.report.nih.gov/categorical_spending.aspx.

15All amounts are based on data from NIH’s RCDC system. NIH funding for kidney 

disease research was $551 million in fiscal year 2013 and $556 million in fiscal year 2012.

NIH Funding for 

Kidney Disease 

Research Totaled 

$564 Million in Fiscal 

Year 2015; Funding 

Levels Varied across 

Leading Diseases 

and Conditions
Page 8 GAO-17-121 Kidney Disease Research Funding

Figure 1: Funding for Kidney Disease Research by National Institutes of Health (NIH) Institutes and Centers, Fiscal Year 2015

The kidney disease projects funded by each IC reflect their different 

missions. As the lead NIH institute for kidney disease, NIDDK funds a 

broad kidney disease research portfolio, while the other ICs fund kidney 

disease research in more specific areas that relate to their missions. For 

example, one component of the National Heart, Lung, and Blood 

Institute’s mission is heart health, and as noted earlier, heart disease can 

be a cause of kidney disease. Therefore, that institute funds research that 

examines how kidney disease impacts cardiovascular health. Similarly,

the National Institute of Allergy and Infectious Diseases fulfills its 

mission—to study immunology and infectious diseases—through kidney 

disease research that primarily addresses how a patient’s immune 

system responds to a kidney transplant, as well as the negative impacts 

of chronic-autoimmune diseases on long-term kidney health. Although 

NIH is the primary federal agency involved in biomedical research on 

kidney disease, there are other federal agencies that conduct and fund 

research in this area. Appendix II describes these agencies’ kidney 

disease research efforts.
Page 9 GAO-17-121 Kidney Disease Research Funding

To provide context for the level of NIH research funding for kidney 

disease, we also analyzed NIH funding levels for other leading diseases 

and conditions in the United States—those that had high mortality, were 

among the most prevalent chronic conditions, or both.16 The RCDC 

categories corresponding to these leading diseases and conditions, which 

are shown in table 1, are neither mutually exclusive nor exhaustive. 

Categories do not exist for all diseases and conditions, and NIH officials 

said that a project may be included in, on average, six RCDC categories. 

For example, a $1 million project on “depression in older men with 

diabetes” could be placed into each of four categories: (1) depression ($1 

million), (2) aging ($1 million), (3) mental health ($1 million), and (4) 

diabetes ($1 million). Therefore, while RCDC produces a complete list of 

the funded projects included within a category, it is not designed to 

produce non-overlapping assignment of projects or fractions of projects to 

categories. In fiscal year 2015, NIH research funding varied across the 

categories corresponding to the diseases and conditions in our analysis, 

from $8 million for fibromyalgia to nearly $5.4 billion for cancer. (See table 

1.)

Table 1: National Institutes of Health (NIH) Research Funding for Leading Diseases 

and Conditions in the United States, Fiscal Year 2015

Research, Condition, and Disease 

Categorization (RCDC) system categories 

corresponding to leading diseases and 

conditions in the United Statesa

Fiscal year 2015 NIH research 

funding ($ millions)b

Alzheimer’s disease $589

Arthritis 214

Asthma 281

Cancer (all types)c 5,389

Colo-rectal cancer 309

Childhood leukemia 155

Lung cancer 349

Lymphoma 270

Cardiovascular 1,991

Chronic liver disease and cirrhosis 295

 16Chronic conditions are generally defined as those that last a year or more, require 

ongoing medical attention, and/or limit activities of daily living. We focus on chronic 

conditions since chronic kidney disease is the most common form of kidney disease. See 

appendix 1 for more detail on our methods for identifying leading diseases and conditions 

for our analysis.
Page 10 GAO-17-121 Kidney Disease Research Funding

Research, Condition, and Disease 

Categorization (RCDC) system categories 

corresponding to leading diseases and 

conditions in the United Statesa

Fiscal year 2015 NIH research 

funding ($ millions)b

Chronic obstructive pulmonary disease 97

Dental/oral and craniofacial disease 493

Diabetes 1,010

Emphysema 28

Fibromyalgia 8

Heart disease 1,262

Heart disease – coronary 426

Hypertension 214

Injury (total) accidents/adverse effects 399

Kidney diseased 564

Lupus 90

Obesity 900

Pneumonia and influenza 384

Pneumonia 112

Stroke 288

Suicide 46

Source: GAO analysis of NIH data. | GAO-17-121

Notes: Leading diseases and conditions were selected based on whether they had (1) high mortality; 

(2) were chronic conditions with high prevalence; or both. We identified disease and conditions with 

high mortality from: Kenneth D. Kochanek, Sherry L. Murphy, Jiaquan Xu, and Betzaida Tejada-Vera, 

National Center for Health Statistics, Deaths: Final Data for 2014, National Vital Statistics Reports, 

vol. 65, no. 4 (June 16, 2016). We selected prevalent chronic conditions based on data from the 

National Center for Health Statistics within the Centers for Disease Control and Prevention.

a

There were three conditions in our analysis that did not have a corresponding RCDC category and 

therefore are excluded from this table: chronic joint symptoms, hyperlipidemia (high cholesterol), and 

non-transport accidents.

b

RCDC categories are neither mutually exclusive nor exhaustive, and categories do not exist for all 

diseases. According to NIH officials, a project may be included in, on average, six RCDC categories. 

Therefore, it is not possible to add the totals for each category in the table above to determine the 

grand total of research funding across all of those categories.

c

The category of “Cancer (all types)” includes more subcategories of the disease than the ones listed 

here.

d

The kidney disease category includes conditions and diseases beyond chronic and acute kidney 

disease, such as kidney cancer.

The variation in research funding across the RCDC categories in table 1 

reflects a range of factors, including differences in each IC’s mission, 

congressional appropriations, and research priorities. An IC’s 

appropriation sets the amount of funding available for the given fiscal 

year. Furthermore, appropriations may include mandated spending for a 

specific disease, as is the case, for example, for type I diabetes. 
Page 11 GAO-17-121 Kidney Disease Research Funding

Research priorities can affect the amount of funding devoted to the study 

of a particular disease. We previously reported that ICs considered a 

variety of factors when setting research priorities and NIH officials

confirmed that this is still the case.17 The factors ICs consider when 

setting research priorities include

• scientific needs and opportunities—identifying those research areas 

that have advanced such that additional research funding could yield 

a breakthrough;

• gaps in funded research and investment, such as diseases that may 

attract limited private sector research funding;

• burden of disease—the impact of a health problem—on a population, 

as measured by indicators such as prevalence, mortality, and impact 

on quality of life; and

• public health needs, such as an emerging public health threat that 

needs to be addressed, like the Zika virus.

NIDDK works with the broader kidney care community to develop its 

kidney disease research priorities by using a web-based forum, hosting a 

variety of meetings for kidney disease stakeholders, and by assessing its 

research portfolio. NIDDK considers the community’s input in the context 

of the institute’s ongoing work and its knowledge of the current state of 

kidney disease research to develop funding announcements that target 

high-priority research areas that are not being adequately addressed. 

According to NIDDK officials, NIDDK’s process for obtaining input from 

the kidney care and scientific communities, and developing research 

priorities is iterative by design to help ensure that the institute’s priorities 

evolve to reflect the latest research developments and needs of the

communities. (See fig. 2.)

 17See GAO, National Institutes of Health: Research Priority Setting, and Funding 

Allocations across Selected Diseases and Conditions, GAO-14-246 (Washington, D.C.: 

March 31, 2014).

NIDDK Obtains Input 

from the Broader 

Kidney Care 

Community to 

Develop its Research 

Priorities
Page 12 GAO-17-121 Kidney Disease Research Funding

Figure 2: National Institute of Diabetes and Digestive and Kidney Diseases’ (NIDDK) Process to Develop Research Priorities

a

NIDDK’s stakeholders include its advisory council, government agencies, scientific researchers, and 

kidney care organizations.

NIDDK established and maintains the Kidney Research National Dialogue 

(KRND)—an open, interactive, web-based forum—to obtain input from

the kidney care research community. The KRND began in 2010 by 

allowing participants to submit, comment on, and prioritize potential 

kidney disease research objectives for the kidney care and research 

community and to be supported by NIDDK through workshops and 

initiatives. (See app. III for more information on the KRND.) With the help 

of established researchers in the kidney disease field, NIDDK staff 

reviewed and distilled the KRND submissions into kidney disease 

research priorities that address a variety of topic areas such as improving 

therapies for chronic kidney disease, promoting human studies to better 
Page 13 GAO-17-121 Kidney Disease Research Funding

understand kidney function, and advancing dialysis technology and 

research.18

In addition to the KRND, NIDDK officials stated that the institute obtains 

input for its research priorities by meeting with its advisory council, federal 

agencies involved in kidney disease research, scientific researchers, and 

private kidney care organizations.

• NIDDK advisory council: According to NIDDK officials, an NIDDK 

advisory council member with expertise in kidney disease research 

annually presents NIDDK officials with what he or she views, based 

on clinical or research experience, as the most pressing kidney 

disease research priorities.19 In addition, council members help shape 

the research priorities by peer reviewing research proposals.

• Federal agencies: Through the KICC, representatives of the federal 

agencies involved in kidney disease research meet twice per year to 

present and discuss information on their agencies’ respective kidney 

disease-related programs and activities. The KICC agencies also 

discuss a specific kidney disease topic at each meeting, such as 

improving access to kidney transplantation, chronic kidney disease 

awareness, and determining gaps in kidney disease research.20

• Scientific researchers: NIDDK’s Division of Kidney, Urologic, and 

Hematologic Diseases hosts four to six scientific kidney disease 

meetings every year, according to NIDDK officials. These meetings 

are largely attended by scientific researchers and also by private 

kidney care organizations, pharmaceutical industry members, and 

officials from other federal agencies. Past meeting topics have 

focused on a variety of areas as they relate to kidney disease, 

 18See, for example: J. V. Bonventre et al., “The Kidney Research National Dialogue: 

Gearing Up to Move Forward,” Clinical Journal of the American Society of Nephrology, 

vol. 9, no. 10 (October 2014); F. Kaskel et al., “Improving CKD therapies and care: a 

National Dialogue,” Clinical Journal of the American Society of Nephrology, vol. 9, no. 4 

(April 2014); and D. E. Kohan et al., “Propagating the Nephrology Research Workforce: A 

Kidney Research National Dialogue Training Commentary,” Clinical Journal of the 

American Society of Nephrology, vol. 9, no. 6 (June 2014).

19Members of NIDDK’s advisory council are drawn from the scientific community and 

public, meet together three times per year, and act as liaisons between the research 

communities they represent and NIDDK.

20As noted earlier, we observed KICC meetings in March and June 2016.
Page 14 GAO-17-121 Kidney Disease Research Funding

including clinical trials, health information technology, and precision 

medicine.21

• Kidney care organizations: Throughout the year, NIDDK meets with 

kidney care organizations that represent different factions of the 

kidney care community (e.g., patient and provider organizations, and 

professional societies) to discuss their kidney disease research 

priorities. For example, of the six private kidney care organizations we 

interviewed, five reported that they meet with NIDDK individually or in 

the company of other private organizations on at least an annual 

basis.

In addition to the stakeholder meetings, NIDDK officials told us that they 

annually assess the institute’s research portfolio—including investigator 

research projects—to identify research gaps. NIDDK then uses the input 

obtained through the portfolio review, the KRND, and stakeholder 

meetings to develop targeted funding announcements for NIDDK 

research initiatives. For example, for one NIDDK research initiative—the 

Kidney Precision Medicine Project—NIDDK officials expect to issue $33 

million in grant funding between fiscal years 2017 and 2021 to increase 

research related to acquiring and studying human kidney tissues. The 

lack of research on human kidney samples was highlighted in the KRND, 

suggested by an advisory council member at an advisory council meeting, 

and discussed at two scientific research meetings.22

Representatives from six private kidney care groups we interviewed 

generally agreed with NIDDK’s kidney disease research priorities as 

published in the KRND; however, all of the organizations’ representatives 

identified kidney disease topic areas that they said warranted increased 

emphasis by NIDDK. For instance, representatives from four of the six 

groups we interviewed expressed concern over a lack of kidney disease 

awareness in the general public. To mitigate this, representatives from 

one group recommended additional research on identifying at-risk 

populations that would benefit from kidney disease screenings. In 

addition, some of representatives noted that additional outreach and 

 21According to NIH, precision medicine is an emerging approach for disease treatment 

and prevention that takes into account individual variability in genes, environment, and 

lifestyle for each person.

22A KRND published summary stated the need for increased efforts to procure highquality human biological samples that would be widely available to research communities. 

See J. V. Bonventre et al., “The Kidney Research National Dialogue: Gearing Up to Move 

Forward,” Clinical Journal of the American Society of Nephrology, vol. 9, no. 10 (October 

2014).
Page 15 GAO-17-121 Kidney Disease Research Funding

research is needed to reduce the disparities associated with ESRD. 

Specifically, rates of ESRD are 3.4 times higher in African Americans and 

1.5 times higher in Hispanics than in whites.23 NIDDK officials agreed that 

improving kidney disease awareness and reducing kidney disease 

disparities were important issues, and pointed out a variety of ongoing 

NIDDK programs related to these topics. For example, NIDDK 

established the National Kidney Disease Education Program to raise 

awareness and reduce disparities through a variety of efforts directed at 

communities at high risk for kidney disease, patients, and professionals 

working in the primary care setting. NIDDK officials also said that 

NIDDK’s Kidney Sundays program is intended to address both kidney 

disease awareness and disparities. Specifically, Kidney Sundays provides 

kidney disease information to African Americans by raising awareness 

within churches about the risks of kidney disease and the importance of 

being tested for kidney disease.24 According to NIDDK officials, 134 

churches across 25 states participated in Kidney Sundays in 2016.

We provided a draft of this product to the Department of Health and 

Human Services. The department provided us with technical comments, 

which we incorporated as appropriate.

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to relevant congressional 

committees and other interested parties. In addition, this report is also 

available at no charge on the GAO website at http://www.gao.gov.

If you or your staffs have any questions about this report, please contact 

me at (202) 512-7114 or curdae@gao.gov. Contact points for our Offices 

of Congressional Relations and Public Affairs are on the last page of this 

 23National Institutes of Health, A Summary Report: National Kidney Disease Education 

Program, (Bethesda, Md.: January 2014).

24For more information on Kidney Sundays, see https://www.niddk.nih.gov/healthinformation/health-communication-programs/nkdep/a-z/Documents/kidney-sundaystoolkit-508.pdf (accessed October 21, 2016).

Agency Comments
Page 16 GAO-17-121 Kidney Disease Research Funding

report. GAO staff who made major contributions to this report are listed in 

appendix IV.

Elizabeth H. Curda

Acting Director, Health Care
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 17 GAO-17-121 Kidney Disease Research Funding

To determine the leading diseases and conditions for our analysis of 

National Institutes of Health (NIH) research funding, we identified 

diseases and conditions that had high mortality, were chronic conditions 

with high prevalence, or both. To inform our selection, we examined 

results from national surveys conducted by the National Center for Health 

Statistics, within the Centers for Disease Control and Prevention (CDC), 

interviewed CDC officials, and examined related GAO work. To identify 

diseases and conditions with high mortality, we used the CDC’s National 

Vital Statistics Report on mortality list for 2014, the most current data 

available.1 These data are based on nationwide, standardized reporting 

using the International Classification of Diseases, Tenth Revision (ICD10) system, which provides the rules used to code and classify primary 

and contributing causes of death, as well as the selection of the 

underlying cause of death on death certificates. When mortality data were 

reported for disease subcategories, we included the disease subcategory 

in our analysis when it exceeded 42,773 deaths, which was the number 

for the 10th leading cause of death (suicide).2 For instance, three 

subcategories of cancer each caused at least 42,773 deaths in 2014, as 

shown in table 2.

Table 2: Diseases and Conditions with High Mortality in the United States in 2014 

Rank Diseases and conditions Number of 

deaths

1 Diseases of heart (heart disease) 614,348 

Ischemic heart diseases (coronary artery disease) 364,593

2 Malignant neoplasms (cancers) 591,699 

Malignant neoplasms of trachea, bronchus and lung 155,610

Malignant neoplasms of lymphoid, hematopoietic and 

related tissue 

57,536

Malignant neoplasms of colon, rectum and anus 52,234

3 Chronic lower respiratory diseases 147,101 

4 Accidents (unintentional injuries) 136,053 

Non-transport accidents 98,114

5 Cerebrovascular diseases (stroke) 133,103 

 1

Kenneth D. Kochanek, Sherry L. Murphy, Jiaquan Xu, and Betzaida Tejada-Vera, 

National Center for Health Statistics, Deaths: Final Data for 2014, National Vital Statistics 

Reports, vol. 65, no. 4 (June 16, 2016).

2

We did not include subcategories that were nonspecific to a disease, such as “all other 

heart diseases.”

Appendix I: Leading Diseases and 

Conditions and their Corresponding National 

Institutes of Health Research Categories
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 18 GAO-17-121 Kidney Disease Research Funding

Rank Diseases and conditions Number of 

deaths

6 Alzheimer’s disease 93,541 

7 Diabetes mellitus (diabetes) 76,488 

8 Influenza and pneumonia 55,227 

Pneumonia 50,622

9 Nephritis, nephrotic syndrome and nephrosis (kidney disease) 48,146 

Renal failure 47,364

10 Intentional self-harm (suicide) 42,773 

Source: GAO analysis of data from the National Center for Health Statistics within the Centers for Disease Control and Prevention. | 

GAO-17-121

Note: The diseases and conditions that are ranked above were the 10 leading causes of death in the 

United States in 2014. See Kenneth D. Kochanek, Sherry L. Murphy, Jiaquan Xu, and Betzaida 

Tejada-Vera, National Center for Health Statistics, Deaths: Final Data for 2014, National Vital 

Statistics Reports, vol. 65, no. 4 (June 30, 2016). We included subcategories of these diseases and 

conditions in the table above when they were associated with high mortality, which we defined as 

exceeding 42,773 deaths—the number for the 10th leading cause of death (suicide).

To identify a list of prevalent chronic conditions, we first identified a peerreviewed paper authored by researchers at CDC (among other 

institutions) that identifies a list of 20 chronic conditions that are likely to 

be among the most prevalent.3 This paper—which we refer to as “the 

OASH list,” because the work was led by a working group within the 

Department of Health and Human Services’ Office of the Assistant 

Secretary of Health (OASH)—was particularly well-suited for our work 

due to several factors. Among these are that it includes a precise 

definition of chronic illnesses: “conditions that last a year or more and 

require ongoing medical attention and/or limit activities of daily living 

(such as physical medical conditions, behavioral health problems, and 

developmental disabilities).” In addition, the authors applied a clear 

methodology in identifying their list of chronic conditions from three 

sources: (1) the Centers for Medicare & Medicaid Services’ Chronic 

Condition Data Warehouse; (2) the list of “Priority Conditions” identified 

by the Agency for Healthcare Research and Quality’s Effective Health 

Care Program; and (3) the Robert Wood Johnson Foundation chart book 

Chronic Care: Making the Case for Ongoing Care. Though our list of 

chronic conditions was primarily based on the OASH list, we compared it 

with CDC’s leading causes of death list and the list of most prevalent 

 3

Goodman RA, Posner SF, Huang ES, Parekh AK, Koh HK. Defining and Measuring 

Chronic Conditions: Imperatives for Research, Policy, Program, and Practice, Preventing 

Chronic Disease, vol. 10 (April 25, 2013), accessed November 1, 2016, 

http://dx.doi.org/10.5888/pcd10.120239).
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 19 GAO-17-121 Kidney Disease Research Funding

chronic conditions that CDC provided GAO in 2013.4 If a condition was 

listed on the leading cause of death list or the 2013 list from CDC, but 

was not present on the OASH list, we added it to our total list of 

conditions to ensure that we did not omit any key chronic conditions.5

This process resulted in a list of 35 leading chronic diseases and 

conditions for which we requested prevalence estimates from CDC.

We requested the most recently available prevalence estimates for the 35 

conditions from one or both of two CDC surveys: the National Health 

Interview Survey (NHIS) or the National Health and Nutrition Examination 

Survey (NHANES).6 NHIS contains data collected through personal 

household interviews on a broad range of health topics. NHANES is 

designed to assess the health and nutritional status of adults and children 

in the United States, and combines interviews with clinical information—a 

physical examination and laboratory tests. We used NHANES as the 

basis for the prevalence estimate for a given condition, because NHANES 

includes clinical information, which would capture diagnosed and 

undiagnosed conditions. When NHANES data for a condition were limited 

to the interview (self-reported) or not available for the 2013-2014 time 

period, we relied on the data from NHIS. We obtained prevalence 

estimates for adults in the United States for 25 of the 35 conditions.7 We 

included in our analysis the 10 chronic conditions with the highest 

estimated prevalence rate. (See table 3.)

 4

This list was provided to GAO for a previous engagement. See GAO-14-246.

5

In cases where the team identified potential overlap between conditions we (1) compared 

the ICD-10 codes underlying the disease or condition names on the prevalence and 

causes of death lists, (2) determined which items were unique, and (3) removed those 

items that were duplicates.

6

To improve the accuracy of prevalence estimates for certain conditions, estimates were 

based on more than one year of survey data, as noted in table 3.

7

We obtained prevalence data from CDC for 23 conditions. For 2 additional conditions—

those related to substance use or mental health—we obtained prevalence estimates from 

the Substance Abuse and Mental Health Services Administration’s National Survey on 

Drug Use and Health. For the remaining 10 conditions, we were unable to obtain 

prevalence data from either CDC or other sources.
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 20 GAO-17-121 Kidney Disease Research Funding

Table 3: Chronic Diseases and Conditions with High Prevalence in the United 

States 

Disease/condition Percentage of adults 

(18 and over) with 

condition

Data source

(Year(s))

1. Obesity 36.5 National Health and Nutrition 

Examination Survey (NHANES)

2011-2014c

2. Hypertension 31.3 NHANES

2011-2014d

3. Chronic joint symptoms 28.7 National Health Interview Survey 

(NHIS)

2014e

4. Untreated dental caries 25.5a NHANES

2011-2012f

5. Arthritis 22.5 NHIS

2014e

6. Chronic Kidney Disease 16.9b NHANES

2013-2014g

7. Diabetes (all 

nongestational)

12.6a NHANES

2011-2014f

8. Diseases of the heart 11.5 NHIS

2014e

9. Hyperlipidemia (high 

cholesterol)

11.1 NHANES

2013-2014f

10. Malignant neoplasms 

(cancers)

8.5 NHIS

2014e

Source: GAO analysis of data from the National Center for Health Statistics within the Centers for Disease Control and Prevention | 

GAO-17-121

Notes: We identified prevalent chronic conditions by collecting information from multiple CDC data 

sources, including a peer-reviewed paper authored by CDC researchers and national data on leading 

causes of death. This process resulted in a list of 35 leading chronic diseases and conditions for 

which we requested prevalence data from CDC. We then identified the 10 most prevalent chronic 

conditions. The specific CDC sources for the prevalence rates are noted above.

a

Data are for adults age 20 and over.

b

This prevalence estimate does not include end-stage renal disease, the final stage of chronic kidney 

disease.

c

Ogden CL et al., Prevalence of obesity among adults and youth: United States, 2011-2014, NCHS 

data brief, no 219 (Hyattsville, Md.: National Center for Health Statistics, 2015).

d

SS Yoon et al., Hypertension prevalence and control among adults: United States, 2011-2014, 

NCHS data brief, no 220 (Hyattsville, Md.: National Center for Health Statistics, 2015).

e

NHIS Summary Health Statistics, 2014. Available at http://www.cdc.gov/nchs/nhis/SHS/tables.htm

(accessed October 28, 2016).

f

National Center for Health Statistics, Health, United States, 2015: With Special Feature on Racial 

and Ethnic Disparities (Hyattsville, Md.: 2016).
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 21 GAO-17-121 Kidney Disease Research Funding

g

Centers for Disease Control and Prevention, Chronic Kidney Disease Surveillance System—United 

States, accessed October 26, 2016, http://nccd.cdc.gov/CKD/.

For the diseases and conditions included in our analysis, we identified the 

corresponding categories from NIH’s Research, Condition, and Disease 

Categorization (RCDC) system, which categorizes NIH research projects 

(and associated funding). First, we reviewed the ICD-10 codes associated 

with each of these diseases and conditions. We then identified the RCDC 

categories that corresponded to the list of diseases and conditions. We 

confirmed the appropriateness of these matches with NIH officials, and 

clarified any differences in definition between the diseases and 

conditions, and the associated RCDC categories. Table 4 contains a 

crosswalk between these categories and the disease and conditions in 

our analysis. To assess the reliability of the data used in our analysis, we 

interviewed knowledgeable NIH and CDC officials, and reviewed 

documentation about the data sources and methods for collecting the 

data. We determined that the data were sufficiently reliable for the 

purposes of our reporting objectives.

Table 4: Diseases and Conditions with High Mortality or High Prevalence and Corresponding Research, Condition, and 

Disease Categorization System Categories

Diseases and conditions High 

mortality

High 

prevalence

Research, Condition, and Disease 

Categorization (RCDC) system categories

Accidents (unintentional injuries) X Injury (total) accidents/adverse effects

Alzheimer’s disease X Alzheimer’s disease

Arthritis X Arthritis; lupus; fibromyalgia 

Cerebrovascular diseases (stroke) X Strokea

Chronic joint symptoms X No RCDC match

Chronic lower respiratory diseases X Asthma; chronic obstructive pulmonary 

disease; emphysema

Diabetes mellitus (diabetes) X X Diabetes

Diseases of heart (heart disease) X X Heart disease; cardiovascular

Hyperlipidemia (high cholesterol) X No RCDC match

Hypertension X Hypertension

Influenza and pneumonia X Pneumonia and influenza

Intentional self-harm (suicide) X Suicide

Ischemic heart diseases (coronary artery disease) X Heart disease – coronary heart diseasea

Chronic kidney disease X Kidney disease

Malignant neoplasms (cancer) X X Cancer

Malignant neoplasms of colon, rectum and anus X Colo-rectal cancer
Appendix I: Leading Diseases and Conditions 

and their Corresponding National Institutes of 

Health Research Categories

Page 22 GAO-17-121 Kidney Disease Research Funding

Diseases and conditions High 

mortality

High 

prevalence

Research, Condition, and Disease 

Categorization (RCDC) system categories

Malignant neoplasms of lymphoid, hematopoietic 

and related tissue 

X Lymphoma; childhood leukemia

Malignant neoplasms of trachea, bronchus and 

lung 

X Lung cancer

Nephritis, nephrotic syndrome and nephrosis 

(kidney disease)

X Kidney disease

Non-transport accidents X No RCDC match

Obesity X Obesity

Pneumonia X Pneumonia

Renal failure X Kidney disease

Untreated dental caries X Dental/oral and craniofacial diseaseb

Source: GAO analysis of data from the National Center for Health Statistics within the Centers for Disease Control and Prevention, and data from the National Institutes of Health. | GAO-17-121

a

NIH noted that while this RCDC category was the closest match, it is narrower than the disease or 

condition it was selected to represent.

b

NIH noted that while this RCDC category was the closest match, it is broader than the disease or 

condition it was selected to represent.
Appendix II: Federal Funding for Kidney 

Disease Biomedical Research by Agencies 

Other than the National Institutes of Health

Page 23 GAO-17-121 Kidney Disease Research Funding

The following is a summary of biomedical research on kidney disease 

conducted by federal agencies outside the National Institutes of Health 

(NIH): specifically, agencies that are part of the Kidney Interagency 

Coordinating Committee (KICC), as well as the Patient-Centered 

Outcomes Research Institute (PCORI).1 For the purposes of this report, 

we defined biomedical research as consisting of (1) basic research, which 

involves laboratory studies that provide the foundation for clinical 

research; (2) clinical research, which includes patient-oriented research, 

epidemiologic and behavioral studies, and outcomes and health services 

research; and (3) translational research, which can involve enhancing the 

adoption of clinical best practices in the community.2 Where available, we 

also provide information on funding associated with these kidney disease 

research activities.3

• Department of Defense (DOD). DOD supports biomedical research on 

kidney disease primarily through the Peer Reviewed Medical 

Research Program, which funds research of high scientific merit and 

direct relevance to military health, across a wide array of topic areas 

directed by Congress.4 Two of the topic areas in fiscal year 2015 were 

directly related to kidney disease: focal segmental 

glomerulosclerosis—a disease in which scar tissue develops on the 

parts of the kidneys that filter waste out of the blood; and polycystic 

kidney disease—an inherited disorder in which clusters of cysts 

 1

KICC is led by the National Institute of Diabetes and Digestive and Kidney Diseases 

(NIDDK), and consists of representatives of federal agencies involved in chronic kidney 

disease programs and activities. While not a federal agency, PCORI is a federally funded, 

nonprofit nongovernmental organization that was authorized in 2010 by the Patient 

Protection and Affordable Care Act to improve patient care and outcomes through patientcentered comparative clinical effectiveness research. 

2

Rubio et al., Defining Translational Research: Implications for Training, (NIH-PA Author 

Manuscript), Academy of Medicine, vol. 85(3) (March 2010). 

3 We determined that the following agencies, which are part of the KICC, did not conduct 

biomedical research on kidney disease at the time of our analysis: Centers for Medicare & 

Medicaid Services, Health Resources and Services Administration, and Indian Health 

Services.

4

In addition to the Peer Reviewed Medical Research Program, DOD also supports 

research on kidney disease as it relates to the tuberous sclerosis complex—a rare genetic 

disease that causes noncancerous (benign) tumors to grow in many parts of the body. 

According to DOD, in fiscal year 2015, DOD funded one kidney-related tuberous sclerosis 

complex research project in the amount of $240,000. 

Appendix II: Federal Funding for Kidney 

Disease Biomedical Research by Agencies 

Other than the National Institutes of Health
Appendix II: Federal Funding for Kidney 

Disease Biomedical Research by Agencies 

Other than the National Institutes of Health

Page 24 GAO-17-121 Kidney Disease Research Funding

develop primarily within the kidneys.5 According to DOD, the agency 

funded eight research projects related to kidney disease within these 

two topic areas in the amount of $7.1 million in fiscal year 2015. In 

addition, the agency funded two fiscal year 2015 kidney diseaserelated research projects under the topic areas of cardiovascular 

health and lupus in the amount of $2.8 million.6

• Department of Health and Human Services.

• Agency for Healthcare Research and Quality (AHRQ). As part of 

its mission to improve the safety and quality of health care, AHRQ 

funds extramural research grants to study chronic kidney disease 

in areas such as patient safety and disease management, and 

assessment in patients with multiple chronic conditions. According 

to ARHQ officials, in fiscal year 2015, ARHQ provided new or 

ongoing funding to four kidney disease research projects in the 

amount of $1.3 million.

• Centers for Disease Control and Prevention (CDC). CDC 

conducts numerous epidemiologic studies to determine risk 

factors for the incidence and progression of chronic kidney 

disease, and to research the burden of the disease in both the 

general and specific populations. In addition, CDC’s Chronic 

Kidney Disease Initiative includes a website that provides 

information on the disease’s burden and risk factors. Lastly, CDC 

is also collaborating with NIDDK to investigate using new kidney 

disease markers to diagnose early kidney function decline. 

According to CDC officials, the agency obligated approximately $2 

million in fiscal year 2015 for kidney disease activities, including 

biomedical research.

• Food and Drug Administration (FDA). FDA is currently in year 

three of a 5-year renewable grant to the Kidney Health Initiative 

(KHI). Founded in 2012, the KHI is a public-private partnership 

between FDA and the American Society of Nephrology. Through a 

collaboration with over 75 member organizations—such as patient 

organizations, pharmaceutical and biotechnology companies, 

dialysis providers, and government agencies—the KHI aims to (1) 

 5

According to DOD officials, additional topic areas indirectly relate to kidney disease, such 

as diabetes. A full list of the fiscal year 2016 topic areas, as well as previous years’ topic 

areas, can be found at http://cdmrp.army.mil/prmrp/topicareas/topicareas.shtml (accessed 

November 1, 2016). 

6

Lupus is a chronic inflammatory disease that can affect many different body systems, 

including the kidneys.
Appendix II: Federal Funding for Kidney 

Disease Biomedical Research by Agencies 

Other than the National Institutes of Health

Page 25 GAO-17-121 Kidney Disease Research Funding

advance scientific understanding of the kidney health and patient 

safety implications of new and existing medical products, and to 

(2) foster development of therapies for diseases that affect the 

kidneys. For instance, one of KHI’s current research projects 

seeks to clarify clinical trial endpoints for dialysis vascular access 

trials.7 Though FDA does not direct its grant to specific KHI 

projects, FDA representatives participate on KHI’s board of 

directors and can thereby influence research project funding 

decisions. According to FDA officials, in fiscal year 2015, FDA 

provided KHI with $500,000.

• Department of Veterans Affairs (VA). In fiscal year 2015, VA 

supported 107 kidney disease intramural research projects.8 For 

example, a past VA study found that patients who took part in a 

screening and education program for kidney disease before being 

diagnosed with the disease were better prepared to live with the 

disease and had significantly lower death rates than those who had 

not taken part in the program. In addition, VA recently issued 

guidelines (jointly developed with DOD), for the management of 

chronic kidney disease. According to VA officials, the total VA 

biomedical research budget in fiscal year 2015 was $589 million, of 

which about $20.9 million was for kidney disease research.

• PCORI. PCORI’s Board of Governors approved three extramural 

research projects related to kidney disease in fiscal year 2015 for 

funding totaling $14 million.

 7

A vascular access site is a surgically created vein or catheter through which blood flows 

from a patient’s body through tubing to a dialysis machine during the dialysis process.

8

All of VA’s biomedical research is intramural—conducted by VA investigators in VA 

facilities. 
Appendix III: The Kidney Research National 

Dialogue

Page 26 GAO-17-121 Kidney Disease Research Funding

The National Institute of Diabetes and Digestive and Kidney Diseases 

(NIDDK) established the Kidney Research National Dialogue (KRND) to 

help inform its research priorities by obtaining input from the kidney care 

research community. The KRND consists of three phases.

• Phase 1 (2010—2013): KRND was an interactive, web-based forum 

that allowed participants to submit, comment on, and prioritize 

potential kidney disease research priorities. Participants were asked 

to categorize their ideas into 12 topic areas, such as chronic kidney 

disease, acute kidney injury, and end stage renal disease. According 

to NIDDK’s website, the KRND had over 1,600 participants from more 

than 30 countries.

• Phase 2 of the KRND (2011—2014): NIDDK invited research experts 

to participate in one of 12 topic-specific working groups. Each group 

was charged with fully assessing the postings from phase 1 of the 

KRND, identifying research gaps, and developing a potential strategy 

for moving the field forward. Each working group published their 

priority recommendations in the Clinical Journal of American Society 

of Nephrology.1 The groups’ papers covered the following 12 topics:

1. Overview of the KRND

2. Diabetic Nephropathy2

3. Acute Kidney Injury

4. Defining Kidney Biology to Understand Renal Disease

5. Dialysis Therapies

6. Improving Chronic Kidney Disease Therapies and Care

7. Propagating the Nephrology Research Workforce

8. Pediatric Kidney Disease: Tracking Onset and Improving Clinical 

Outcomes

9. Glomerular Disease3

 1

For full narratives on each phase 1 topic area and links to the phase 2 papers, see 

https://www.niddk.nih.gov/about-niddk/offices-divisions/division-kidney-urologichematologic-diseases/kidney-research-national-dialogue/Pages/kidney-research-nationaldialogue.aspx (accessed September 20, 2016).

2

Diabetic nephropathy—kidney disease caused by long-standing diabetes—is the largest 

single cause of end stage renal disease in the United States.

Appendix III: The Kidney Research National 

Dialogue
Appendix III: The Kidney Research National 

Dialogue

Page 27 GAO-17-121 Kidney Disease Research Funding

10. Filling the Holes in Cystic Kidney Disease Research4

11. Translational Research to Improve Chronic Kidney Disease Outcomes

12. The KRND: Gearing Up to Move Forward

• Phase 3 (2014—present): NIDDK officials continue to seek comments 

on the priorities articulated in the 12 topic papers through comments 

on PubMed Commons (an NIH-funded open, web-based platform). 

NIDDK officials told us that, to date, they have not received any 

comments.

 3

Glomerular disease occurs when the glomeruli—the microscopic blood vessel filters in 

the kidneys that help to filter waste and extra fluid from the blood—are damaged, thereby 

causing kidney failure.

4

Cystic kidney disease is generally an inherited disease that causes clusters of noncancerous cysts to develop, primarily within the kidney, which can lead to a variety of 

serious complications, including kidney failure.
Appendix IV: GAO Contact and Staff 

Acknowledgments

Page 28 GAO-17-121 Kidney Disease Research Funding

Elizabeth H. Curda, (202) 512-7114 or curdae@gao.gov

In addition to the contact named above, Will Black (Assistant Director), 

Kristeen McLain (Analyst-in-Charge), Jesse Elrod, and Alison Smith 

made key contributions to this report. Also contributing were Hayden 

Huang, Drew Long, Yesook Merrill, Vikki Porter, and Emily Wilson.

Appendix IV: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(100620)
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Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-4400, 

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Washington, DC 20548

Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, DC 20548

James-Christian Blockwood, Managing Director, spel@gao.gov, (202) 512-4707

U.S. Government Accountability Office, 441 G Street NW, Room 7814, 

Washington, DC 20548

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