CAMBRIDGE, Mass. (August 28, 2003) Despite the undeniable success of the National Institutes of Health as the world’s largest supporter of biomedical research and training, important organizational changes are needed at the agency for it to meet future challenges effectively, says a new report from the National Research Council (NRC) and Institute of Medicine (IOM) of the National Academies.In particular, changes are required to allow NIH to devote additional resources to innovative interdisciplinary research that reflects strategic objectives and cuts across all of the agency’s institutes and centers, said the committee that wrote the report.
Also, Congress should establish a formal process to review and act on specific proposals for changes in the number of NIH institutes and centers, which currently total 27. This process should be used to study two mergers favored by the committee: the combining of the National Institute on Drug Abuse with the National Institute on Alcohol Abuse and Alcoholism, and the National Institute of General Medical Sciences with the National Human Genome Research Institute.
Lydia Villa-Komaroff, vice president for research and chief operating officer at Whitehead Institute and a member of the NRC/IOM study committee, noted that an increasing number of institutes and centers have been added to NIH in recent decades, leading some officials to express concern that the agency has become too fragmented and unwieldy. Such concerns were one of the motivations that prompted Congress to request the Academies study. Another concern was whether the current organizational framework at NIH can accommodate the increasing pace of scientific advances. The committee noted, however, that it was not the first group of experts to look at this issue. In fact, a 1984 IOM report also recommended that a formal process be set up to review proposed organizational changes, though such a process was never put in place.
The wholesale consolidation of institutes and centers is not the best organizational step for NIH to take at this time for two key reasons, the new report says. First, the costs — mainly a lengthy, uncertain decision-making process involving parties that are unlikely to agree on how to proceed — would outweigh any benefits. Second, there are better ways to increase coordination and strategic focus, enhance responsiveness to emerging needs and foster development of a more innovative research portfolio — for example, by increasing the authority of the NIH director and giving NIH leadership more flexibility to make organizational changes, the committee said. It also called on Congress to fund a new program for special projects to be run out of the NIH director’s office.
“Despite our conclusion that widespread consolidation of the institutes and centers would be unwise now, we do not expect NIH’s organizational structure to remain frozen,” said committee chair Harold T. Shapiro, president emeritus and professor of economics and public affairs, Princeton University, Princeton, N.J. “We are convinced that many of the goals that might be achieved through large-scale consolidation could be achieved more rapidly and effectively through other organizational mechanisms.”
Although Congress must approve the creation or elimination of an institute, having a formal process in place would give NIH more flexibility to modify its structure as the situation warrants, the committee said. Congress should consider amending the legislation governing NIH to require that certain steps be taken before an NIH institute or center is added, closed or combined with another. Patient advocates, Congress, NIH advisory committees and the NIH Council of Public Representatives should be among the parties involved in this process, and public forums should be held. The process could be initiated by a congressional request or at the discretion of the NIH director.
The committee supported a merger between the drug- and alcohol-abuse institutes because the missions of the two organizations are nearly the same; also, there is a strong link between alcoholism and the use of illicit drugs, and many of the treatment options are similar. And since the National Human Genome Research Institute has successfully completed its main mission, it makes sense for it to merge with the National Institute of General Medical Sciences, which has a lead role in funding basic biomedical research.
In addition, NIH-sponsored clinical research — whether it takes place at NIH facilities or at outside hospitals — should be consolidated under a new entity called the National Center for Clinical Research and Research Resources, which would build upon the current National Center for Research Resources. This would improve collaboration and data sharing among clinical research programs, the committee said.
Given that much of today’s most important research requires the collaboration of experts from many disciplines, NIH needs new mechanisms for mobilizing and coordinating funding from several units for high-priority research that cuts across the purview of individual institutes and centers, the report says. To help achieve this, Congress should ask the NIH director to develop major crosscutting, or “trans-NIH,” research initiatives through periodic NIH-wide strategic planning, perhaps every two years. Congress should give the NIH director authority to require that each institute and center commit a certain percentage of its budget for participation in the trans-NIH initiatives chosen in the planning process. Five percent of the overall NIH budget could go toward new trans-NIH research in the first year, with the number growing to 10 percent or higher in four to five years, the committee said. Although co-sponsorship of projects by multiple institutes occurs now, it was not clear to the committee to what extent institutes currently collaborate from start to finish on projects.
For trans-NIH research to be effective, the position of NIH director will have to be strengthened, the committee added. The director will need a larger budget to plan for trans-NIH research and may need to be given the authority to reallocate earmarked funds in certain instances. Also, a “special project” program should be established in the director’s office to fund risky cutting-edge research that offers a high potential payoff for society in terms of cures or improved medical treatment. Congress should provide $100 million in new funding for the director’s special projects program the first year, with the annual budget eventually growing to as much as $1 billion.
The presidentially appointed NIH director should serve a six-year term unless removed sooner by the president, the committee said. Whether the director should serve a second and final six-year term should be determined after a review by outside experts and be based on the recommendation of the secretary of the U.S. Department of Health and Human Services, of which NIH is part. The committee noted that a longer term, like the six-year term served by the director of the National Science Foundation, may allow the NIH director to transcend changes in administration. The position of director currently has no set term.
Directors of NIH institutes and centers should be appointed to five-year terms with the option for a second and final five-year appointment, the committee said. Authority to hire and fire them should be transferred from the HHS secretary to the NIH director, who should review the performance of institute and center directors annually.
The special status granted to the National Cancer Institute by the National Cancer Act should be reconsidered, the committee said. Because the NCI director is appointed by the president and the institute’s budget is set without input from the NIH director, it is possible that an unnecessary rift may be created between the goals and leadership of NIH and those of NCI.
While the committee said the NIH director needs greater authority to direct crosscutting research, it expressed concern about efforts by HHS to consolidate or centralize management and administrative functions throughout the department as part of the “One HHS” initiative. The committee fears that some attempts to centralize or even outsource administrative tasks fail to appreciate how closely some of these functions, such as aspects of grants management, are tied to the scientific enterprise. Any consolidation efforts should be considered cautiously and only after careful study of circumstances unique to NIH, and in light of the agency’s proven success in carrying out its research and training mission. To improve administrative functions and facilities management within NIH, and to acquire and maintain new information technologies, Congress should increase funding for the research management and support budgets of each institute and center. These budgets have barely grown in the past decade despite considerable increases in the overall NIH budget.
The committee also took issue with the appointment process for the 140 NIH advisory committees. To avoid any perceived politicization of the committee appointment process, participation should be based solely on a person’s scientific or clinical expertise, or his or her involvement in relevant issues. And to achieve sufficient independence and avoid conflicts of interest, a substantial proportion of each institute’s advisory council should consist of people whose primary source of research support is derived from a different institute or center, or from outside NIH.
The study was mandated by Congress and sponsored by the National Institutes of Health. The National Research Council and Institute of Medicine are private, nonprofit organizations that provide science, technology and medical advice under a congressional charter. The Research Council is the principal operating agency of the National Academy of Sciences and National Academy of Engineering.
In addition to Villa-Komaroff, members of the Committee on the Organizational Structure of the National Institutes of Health included Chairman Harold Shapiro, Ph.D., President Emeritus and Professor of Economics and Public Affairs Department of Economics and Woodrow Wilson School of Public and International Affairs Princeton University Princeton, N.J.; Norman R. Augustine, M.S.E., Ph.D., Retired Chair and Chief Executive Officer, Lockheed Martin Corp., Bethesda, Md.; J. Michael Bishop, M.D., Chancellor, University of California, San Francisco; James Gavin, M.D., Ph.D., President Morehouse School of Medicine, Atlanta; Alfred Gilman, M.D., Ph.D., Professor and Chair, Department of Pharmacology, University of Texas Southwestern Medical Center, Dallas; Martha Hill, Ph.D., R.N., F.A.A.N., Dean and Professor, School of Nursing, Johns Hopkins University, Baltimore; Debra Lappin, J.D., President, Princeton Partners Ltd., Denver; Alan Leshner, Ph.D., Chief Executive Officer, American Association for the Advancement of Science, and Executive Publisher Science Magazine Washington, D.C.; Gilbert S. Omenn, M.D., Ph.D., Professor of Internal Medicine, Human Genetics, and Public Health University of Michigan Ann Arbor; Franklyn Prendergast, Ph.D., M.D., Director, Mayo Clinic Cancer Center, Rochester, Minn.; Stephen Ryan, M.D., Professor of Ophthalmology, and Dean, Keck Graduate School of Medicine, and Senior Vice President for Medical Care, University of Southern California, Los Angeles; Samuel Silverstein, M.D., John C. Dalton Professor and Chair, Department of Physiology and Cellular Biophysics, and Professor of Medicine Columbia University College of Physicians and Surgeons, New York City; Harold C. Slavkin, D.D.S., Dean, School of Dentistry, University of Southern California, Los Angeles; Judith Swain, M.D., Chair, Department of Medicine, Stanford University School of Medicine, Stanford, Calif.; Lydia Villa-Komaroff, Ph.D., Vice President for Research and Chief Operating Officer Whitehead Institute for Biomedical Research Cambridge, Mass.; Robert H. Waterman Jr., M.B.A , Founder and Chair, Waterman Group Inc., Hillsborough, Calif.; Myrl Weinberg, C.A.E., President, National Health Council, Washington, D.C.; Kenneth Wells, M.D., M.P.H., Professor-in-Residence of Psychiatry and Biobehavioral Sciences Neuropsychiatric Institute University of California, Los Angeles; Mary Woolley, M.A., President and Chief Executive Officer, Research!America, Alexandria, Va.; James Wyngaarden, M.D., Professor Emeritus, Duke University, Durham, N.C.; Tadataka Yamada, M.D., Chair, Research and Development, GlaxoSmithKline, King of Prussia, Pa.
Copies of “Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges” will be available in September from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu.
(Adapted from news releases of the National Academies news office)
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