National Institutes of Health,
Fiscal Years 2010 & 2011
This is the third National Institutes of Health (NIH) Biennial Report submitted under the requirement established by Section 104 of the NIH Reform Act (Pub. L. No. 109-482). Appendix A provides the language in the Reform Act that is relevant to this report, along with the language of two subsequent laws that supplement the provisions of the Reform Act—the Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) and the Newborn Screening Saves Lives Act of 2007 (Pub. L. No. 110-204). NIH’s goal is for the information in this report to serve as a useful reference for understanding NIH activities and operations and welcomes feedback on the report.
Chapter 1 opens with a statement from the Director of the NIH providing an assessment of the state of biomedical and behavioral research. It then describes NIH structure, policies, and procedures focusing on the operations of the extramural and intramural research programs, mechanisms for strategic planning (including the activities and processes of the Division of Program Coordination, Planning and Strategic Initiatives, and its management of the Common Fund), and various cross-cutting activities not covered in the chapters that follow, such as programs that provide the platform for discovery, including training and career development activities, and science literacy efforts.
Chapter 2 provides an overview of the NIH research portfolio. The topics covered include:
The chapter begins with a brief introduction that describes the full continuum of biomedical research at NIH. The research continuum begins with basic research, moves onto early or preclinical translational research, then goes into clinical research, proceeds to translational research, and ends with clinical and community practice. The path in the continuum is not strictly linear, because all steps of biomedical research can inform and relate to other areas.
The introduction is followed by a summary of the NIH research portfolio across all of the Institutes and Centers (ICs) and Office of the Director (OD) program offices. Specific examples are included in the summary, illustrating how NIH research at each stage of the continuum augments human knowledge and improves public health. Chapter 2 also describes how NIH ensures the uptake of research results by clinical practitioners and the public. Effective communication activities are another important facet of NIH’s mission. Targeted health communication plans and information campaigns that provide science-based information are essential to improving people’s health and saving lives. Chapter 2 concludes with NIH-funded research technologies, which provide innovative tools that are used within multiple steps in the continuum and often provide the means for an exchange of information.
Chapter 3 addresses NIH research activities from the perspective of diseases, disorders, and adverse health conditions. The topics covered include:
These topics, all categories specified in the NIH Reform Act of 2006 (see Appendix A), are grouped together in one chapter to address the intent of the statute, in terms of presenting information on diseases, disorders, and adverse health conditions in a standardized format. Each topic is addressed in a separate section.
Chapter 4 addresses certain NIH Centers of Excellence. Overall, NIH Centers of Excellence are diverse in focus, scope, and origin. The NIH Centers of Excellence described in this report are a subset—those established by statutory mandate. This chapter provides overviews, progress reports for the fiscal year (FY) 2010 and 2011 biennial period (covering programmatic and research activities and outcomes), recommendations, evaluation plans, and future directions for the six congressionally mandated NIH Centers of Excellence programs, which are described in the order of their establishment:
The Appendices present reference documents and supporting data. Appendix A provides a copy of the sections of the NIH Reform Act of 2006 (Pub. L. No. 109-482) that require this Biennial Report, as well as the relevant text from two subsequent laws that supplement the provisions of the Reform Act—the Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) and the Newborn Screening Saves Lives Act of 2007 (Pub. L. No. 110-204). Appendix B lists and provides links to the missions and strategic plans of the NIH ICs and the missions of the OD program offices. Appendix C provides the Common Fund Strategic Planning Report of 2011. Appendix D provides excerpts of Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research as required by the NIH Reform Act of 2006, in order to identify clinical research study populations and ensure the scientifically appropriate inclusion of individuals according to sex/gender, race, and ethnicity. Appendix E consists of data on the primary NIH research training program, the National Research Service Award program, the National Library of Medicine training programs, and NIH graduate medical education activities. Appendix F provides excerpts of the Report of the Advisory Committee on Research on Women’s Health, in order to include, by reference, that Biennial Report, within this one, as required by Section 486(d)(5) and Section 403 of the Public Health Service Act, 42 U.S.C. 283, which predate the reporting requirement established by the NIH Reform Act of 2006. Appendix G is provided in response to the mandate under SEC. 403 (a)(4)(C)(ii) of the Public Health Service Act to provide catalogs of disease registries and other data systems. Appendix H includes NIH funding levels for chronic diseases and organ systems. Appendix I contains a list of acronyms that are used in this Biennial Report.