The Search for a “Better Way:” Reauthorization of the National Institutes of Health Elias A. Zerhouni, M.D., Director, NIH July 19, 2005 House Energy and Commerce Committee

Section 301 of the PHS Act – “The Secretary shall conduct in the Service and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man...” National Institutes of Health Mission of NIH The NIH is the primary Federal agency for conducting and supporting medical research

Public Health Service Act Key Authorities for NIH  Prioritizes Research Through Organizational Structure  Mandates Biomedical Research  Provides Grant-making Authority  Mandates Peer Review  Mandates Training  Mandates Dissemination of Information  Mandates Human Subjects Protections  Mandates the Solicitation of Public Advice

“While the NIH is to be celebrated, success alone does not answer fully the question of whether there is a better way to proceed, particularly as one faces a future where the world of biomedical science is being rapidly transformed in virtually all its dimensions.” Institute of Medicine Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges (2003)

National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Library of Medicine The View of the NIH on March 17, 2005 A Larger and More Complex Organization than Ever A Larger and More Complex Organization than Ever National Cancer Institute National Institute on Aging National Heart Lung and Blood Institute National Eye Institute Clinical CenterCenter for Scientific Review Center for Information Technology National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research John E. Fogarty Center for Advanced Study in the Health Sciences National Center for Complementary and Alternative Medicine National Center for Minority Health and Health Disparities National Center for Research Resources National Institute of Nursing Research National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Allergy and Infectious Disease National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse National Institute of Biomedical Imaging and Bioengineering National Human Genome Research Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Child Health and Human Development Office of the Director Program Offices Office of Research on Women’s Health Office of AIDS Research Office of Behavioral and Social Sciences Research Office of Disease Prevention OD Deputy and Associate Directors Administrative Offices Advisory Committee to the Director

Office of the Director Program Offices Office of Research on Women’s Health Office of AIDS Research Office of Behavioral and Social Sciences Research Office of Disease Prevention John E. Fogarty Center for Advanced Study in the Health Sciences National Library of Medicine Clinical CenterCenter for Scientific Review OD Deputy and Associate Directors Administrative Offices Center for Information Technology National Center for Complementary and Alternative Medicine National Center for Minority Health and Health Disparities National Center for Research Resources National Human Genome Research Institute National Institute of Environmental Health Sciences National Institute of General Medical Sciences National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering Advisory Committee to the Director The Committee’s Conceptual Framework for NIH DiseaseOrgan Life Stage 15 Institutes that Support Research Specific to a Disease, Organ, or Life Stage

Office of the Director Program Offices Office of Research on Women’s Health Office of AIDS Research Office of Behavioral and Social Sciences Research Office of Disease Prevention OD Deputy and Associate Directors Administrative Offices Advisory Committee to the Director 9 Institutes and Centers that Support Research that Applies to All Diseases, Organs or Life stages 5 Program Coordination Offices The Committee’s Conceptual Framework for NIH DiseaseOrgan Life Stage 15 Institutes that Support Research Specific to a Disease, Organ, or Life Stage Basic Science Basic Training Clinical/Translational Science Cross-cutting Issues Emerging Disciplines

Advisory Committee to the Director OD Deputy and Associate Directors Administrative Offices OD Division of Program Coordination, Planning, and Strategic Initiatives DiseaseOrgan Life Stage Includes the 5 Specific Program Coordination Offices Which Will Continue Their Roles The Committee’s Conceptual Framework for NIH Basic Science Basic Training Clinical/Translational Science Cross-cutting Issues Emerging Disciplines

Advisory Committee to the Director OD Deputy and Associate Directors Administrative Offices Institutes that support Research specific to A Disease, Organ, or Life Stage Institutes that support Research that applies to All Diseases, Organs or Life stages The Committee’s Conceptual Framework for NIH OD Division of Program Coordination, Planning, and Strategic Initiatives

OD Division of Program Coordination, Planning, and Strategic Initiatives  Formalize the ad hoc priority-setting process that has led to recent trans-NIH research initiatives  Accelerate the progress we have already made  Involves entire NIH NIH Roadmap for Medical Research Image © Time magazine, June 2004 FY 2004 FY 2005 FY 2006  Involves 19 Institutes and Centers  Involves 15 Institutes and Centers NIH Neuroscience Blueprint NIH Strategic Plan for Obesity Research

 Consistent analysis and streamlined reporting  Prospective analysis of emerging areas of scientific opportunities, rising public health challenges, or knowledge gaps that would benefit from additional research  In conjunction with ICs, identifies areas that require strategic coordination across multiple ICs  Launches initiatives that are beyond the purview or resources of any one IC but need to be undertaken by NIH as a whole OD Division of Program Coordination, Planning, and Strategic Initiatives

Recommendation 4: Enhance and Increase Trans-NIH Strategic Planning and Funding a.The director of NIH should be formally charged by Congress to lead a trans-NIH planning process to identify major crosscutting issues and their associated research and training opportunities and to generate a small number of major multi-year, but time limited, research programs. The process should be conducted periodically—perhaps every 2 years—and should involve substantial input from the scientific community and the public. b. The director of NIH should present the scientific rationale for trans-NIH budgeting to the relevant committees of Congress, including a proposed target for investment in trans-NIH initiatives across all institutes. For example, an average target of 5% of overall NIH funding in the first year, growing to 10% or more over 4-5 years, may be appropriate. c. The appropriations committees should annually review budget justifications and testimony from the NIH director and from individual IC directors about the participation of each unit in the planned trans-NIH initiatives and the portion of their budgets so directed. Congress should include budget targets in the appropriations report language. The Committee recommends beginning with 5% of the overall NIH budget. d. To ensure that each IC uses the target proportion of its budget for trans-NIH initiatives of its choosing, that proportion of the annual appropriation to each unit should be treated as “in escrow” until the NIH director affirms that the unit has committed to its expenditure for the identified trans-NIH initiatives. e. The President should include in the budget request, and Congress should include in the NIH appropriation for OD, funds to support an appropriate number of additional full-time staff to conduct the trans-NIH planning process and “jump-start” the initiatives that emerge from this process.

 Does not supplant or dictate IC-specific plans or investigator or IC-initiated programs  Institutionalize a mechanism for allocating a percentage of the total NIH budget for greater synergy on a prospective basis with proper consultation and oversight  “A common fund for common needs” in an era of interdisciplinary, collaborative, and converging science OD Division of Program Coordination, Planning, and Strategic Initiatives

 Higher level of coordination, not centralization  Input from NIH Institutes and Centers, outside Scientists, Public  Assess:  Public Health Landscape  Scientific Landscape  NIH Portfolio  Allow NIH to be nimble, dynamic, and responsive to scientific demands Science Public Health Trans-NIH Research OD Division of Program Coordination, Planning, and Strategic Initiatives

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