Extramural research accounted for more than 80 percent of  NIH’s budget in fiscal year 2012. Twenty-four of  the 27 ICs fund extramural research projects, and these ICs make final  decisions on which extramural research projects to fund following a  standard peer review process.what NIH considers “unsolicited” research and research training projects  for which applications are submitted in response to broad funding  opportunity announcements that span the breadth of the NIH mission. Individual Institutes and Centers Set Their Own Research Priorities Using a Variety of Approaches, Including Strategic Planning, Annual Planning, and Review of Research Portfolios

Individual ICs at NIH set their own research priorities, and we found that  the five selected ICs we reviewed did so considering similar factors and  using various priority-setting approaches. Officials at all five of the ICs  stated that their mission and available appropriations inform priority  setting approaches. Some IC officials noted that because  the costs of potential research projects generally exceed the available  appropriation, the ICs generally must prioritize among research projects. In priority setting, IC officials also reported taking into consideration  scientific needs and opportunities, gaps in funded research, the burden of  disease in a population, and public health need, such as an emerging  public health threat that needs to be addressed, like influenza. Review and evaluation of research portfolio: Officials from the five  selected ICs we interviewed stated they conduct reviews of their research  portfolio to help ensure existing priorities reflect and align with current  scientific opportunities, research gaps, and emerging science. While the individual ICs set their own priorities, according to NIH officials,  the OD provides leadership to the ICs and helps coordinate priority  setting activities, especially for efforts that involve multiple ICs. NIH Funding Levels Varied Widely For Selected Categories of Research, Conditions, and Diseases Corresponding to the Leading Causes of Death and Chronic Conditions

In fiscal year 2012, NIH reported funding levels that ranged widely—from  $13 million for projects in one RCDC category to more than $5.6 billion for  another—for the 40 different RCDC categories we examined. NIH officials said that RCDC is the agency’s official system for reporting  research funding across the agency’s ICs and it provides a method for  reporting consistent information about NIH funding. Agency officials said that the system was not designed to be able to  estimate a total, non-duplicated amount of funding specific to a given  disease or condition because RCDC categories are neither mutually  exclusive nor exhaustive. Specifically:
Projects may be reported in multiple categories. For example, the category of  cancer includes other cancer categories, such as breast cancer, lung  cancer, or prostate cancer, and the research funding reported in each  of these categories will also be reported in the cancer research total. RCDC also does not capture  the funding for all diseases that NIH studies. Not all projects that NIH funds are included. Some ICs have their own systems that track and report funding within  their research portfolios. Of the five selected ICs we reviewed, two had  their own systems for tracking their funding. NCI maintains a publicly available website that communicates funding  decisions across the research supported by NCI. The system was  developed in 1998 and categorizes research into more than 40  specific cancer types, as well as almost 50 research topics that are  not disease-specific. Funding for individual projects may be separated  and reported in the NCI system by the specific types of cancers being  studied. NCI officials told us that they use the system to  report data to stakeholders, including Congress, and that the analyses  they conduct based on these data enhance NCI’s ability to plan and  monitor its scientific investment. The Department provided  technical comments, which we incorporated as appropriate. At that time, we will send copies to the Secretary of the  Department of Health and Human Services, the Director of the National  Institutes of Health, and other interested parties. See  table 4 for a list of the most prevalent chronic diseases and conditions for  adults identified by CDC. To determine the corresponding categories from the National Institutes of  Health’s (NIH) Research, Condition, and Disease Categorization system  (RCDC) for the diseases and conditions that are the leading causes of  death in the United States, the leading causes of death globally, and the  most prevalent chronic diseases and conditions in the United States, we  identified the International Classification of Diseases (ICD-10) codes  associated with each of these diseases and conditions and, using their  related descriptions, compared them with the RCDC category  descriptions.
Why GAO Did This Study

NIH is the nation's leader in sponsoring and conducting biomedical research. In fiscal year 2012, NIH had a budget of almost $31 billion, over 80 percent of which was used to fund extramural research that supports scientists and research personnel working at universities, medical schools, and other research institutions. Twenty-four of NIH's 27 ICs that support extramural research are focused on particular diseases, conditions, or research areas, and these ICs have their own appropriations. Decisions about which projects are funded are made by these individual ICs. NIH reports funding for 235 research, condition, and disease categories in RCDC.
GAO was asked to review NIH funding related to leading diseases and health conditions. GAO examined (1) how research priorities are set at NIH, and (2) NIH allocations of research funding across selected diseases and conditions. For five ICs—National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Allergy and Infectious Diseases; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of General Medical Sciences—GAO reviewed documents and interviewed IC officials about priority setting. GAO reviewed NIH fiscal year 2012 funding reported by RCDC for 40 research, condition, and disease categories related to the leading causes of death in the United States and globally, and the most prevalent chronic diseases and conditions in the United States.

What GAO Found

Individual institutes and centers (ICs) at the National Institutes of Health (NIH) set their own research priorities, and GAO found that the five selected ICs—awarding the largest amount of research funding—that it reviewed did so considering similar factors and using various priority-setting approaches. Agency officials stated that the ICs' mission and appropriations inform priority-setting approaches. Some IC officials noted that because the costs of potential research projects generally exceed the available appropriation, the ICs must prioritize among research projects. In priority setting, IC officials reported taking into consideration scientific needs and opportunities, gaps in funded research, the burden of disease in a population, and public health need, such as an emerging public health threat like influenza that needs to be addressed. While each IC GAO examined had its own approach for setting priorities, they all considered the input of stakeholders, including the scientific community, and used some similar strategies. All five ICs developed strategic plans, though the process varied by IC. Some ICs also used annual planning activities in various forms, which then guided funding opportunity announcements. All five ICs also conducted reviews and evaluations of their research portfolios to ensure that their priorities align with scientific opportunities, research gaps, and emerging science. In addition to these efforts at the IC level, agency officials told GAO that the NIH Office of the Director provides leadership and coordinates priority setting activities, especially for those activities that involve multiple ICs.
NIH reported funding levels that varied widely for the 40 different Research, Condition, and Disease Categorization system (RCDC) categories GAO examined that correspond to the leading causes of death and the most prevalent chronic conditions. For example, NIH reported actual fiscal year 2012 funding levels ranging from $13 million for projects in the fibromyalgia category to more than $5.6 billion for projects in the cancer category. Although these categories are part of NIH's RCDC, which is used to categorize the research activities across the agency, agency officials said that the system cannot estimate a total, non-duplicated amount of funding that is specific to a given disease or condition. This is because RCDC categories are neither mutually exclusive nor exhaustive. For example, projects may be included in multiple RCDC categories, some categories are related to each other and therefore some categories may also be included within another, and funding for all diseases is not captured in the system. While RCDC is NIH's official system for reporting research funding across the ICs, two of the five ICs that GAO reviewed—the National Cancer Institute (NCI) and the National Institute of Allergy and Infectious Diseases—had their own systems for tracking their funding, which allowed them to provide more detailed information than that available from RCDC. For example, NCI has a publicly available website that specifies funding for more than 40 specific cancer types as well as almost 50 research topics that are not disease-specific. Funding for individual projects may be separated for specific studies into those cancer types. According to officials, the system enhances NCI's ability to plan and monitor its scientific investment.
The Department of Health and Human Services provided technical comments, which GAO incorporated as appropriate.