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5. Enhancing NIH's Ability to Respond to New Challenges
Pages 83-102

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From page 83...
... For example, Congress has created most additional units with their own budgets and decision- making authorities, which constrains the ability of the NIH director to influence the decisions and choices made by individual institutes and centers and makes the scientific leadership and management of NIH as a whole extremely challenging. The Committee's view of those complexities was governed by the desire to be of practical assistance to all those who wish NIH to continue as an effective, indeed outstanding, organization, and it proceeded on the premise that its task included assessing the organizational configuration of NIH and the key processes and authorities that play roles in NIH-wide decision-making.
From page 84...
... In this chapter, the Committee focuses on: planning and implementation of trans-NIH initiatives, which require more authority and resources for the director; development of a new mechanism to address high-risk research; and improvement in the NIH intramural research program's ability to move quickly and flexibly to meet urgent new needs and to work more collaboratively with the extramural research community. THE AUTHORITIES OF THE DIRECTOR AND TRANS-NIH INITIATIVES Despite the enormous success of NIH, and in part because of that success, the changing world of biomedical science and the stewardship of this great enterprise require increased attention to a number of critical scientific and health issues that no institute or center can address alone.
From page 85...
... Furthermore, there is no formal mandate for NIH to identify, plan, and implement such cross-cutting strategic initiatives. In particular, the Committee believes that the difficulties encountered in initiat~ng trans-NIH initiatives have been one reason why in the past some groups have called for new free-standing organizational units, which in turn has led to the proliferation witnessed over the past few decades.
From page 86...
... Proteomics, already cited by NIH Director Zerhouni as a critical enabling technology for discovery in the Roadmap, is another current example. Multiple institutes are independently holding workshops and considering or issuing Requests for Applications at a time when concerted trans-NIH work on the assessment of existing and emerging technology platforms and database formats utilizing reference specimens, could help to advance the whole field and guide NIH-supported studies.
From page 87...
... A relatively new and path-breaking attempt at trans-NIH science is the consolidation of the intramural programs of the neuroscience-related institutes in the newly constructed Porter Center on the Bethesda campus. Other cooperative attempts, such as the NIH Pain Research Consortium although well intended have started and faltered over many years because funding generally has not been available and research programs are dependent on the willingness of individual institutes to fund specific projects (IOM, 2003b)
From page 88...
... However, as the work involved in these initiatives is performed, the Committee expects that at least some elements of the work will spin off into new components in the portfolios of many of the ICs that become part of their regular research agendas. In addition, many activities covered by existing grants and programs are likely to be relevant to some strategic initiative topics, and could become part of IC participation in the trans-NIH initiatives if the NIH director's review confirms their appropriateness for inclusion.
From page 89...
... The director of NIH should be formally charged by Congress to lead a transNIH planning process to identify major cross-cutting 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.
From page 90...
... If all existing programs continue to enjoy the highest priority there will likely be resistance in the early years of the initiative by institutes that claim difficulty in meeting their commitments while still offering some new grants. As a result the NIH director will have to exert superb and compelling leadership to withstand requests to release "escrowed" funds from trans-NIH projects.
From page 91...
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From page 92...
... Because of the tight budget for OD Operations, when unforeseen needs surface, as has happened recently with the development of stem cell research policies and harmonizing the rules for human subjects protection, OD is likely to have to "pass the hat" to the ICs to gather the additional resources needed. The Committee believes that the director should be given either a more adequate budget to support OD's management roles or greater discretionary authority to reprogram funding from earmarked components of the OD budget when necessary to meet emerging needs.
From page 93...
... The current steep decline in the growth rate of the NIH budget proposed in the President's FY 2004 budget may make it even less likely that high-risk proposals will be funded. The DARPA approach specifically seeks high-risk research and expects failures a marked difference from the NIH study sections or the consensus approach 93
From page 94...
... In 1981, both NIH and NSF turned down a request from Leroy Hood and colleagues at Caltech for funding to automate DNA sequencing. The Caltech researchers subsequently obtained funding from the Weingart Institute instead, and by 1984 had made sufficient progress in prototype development to win NSF funding.
From page 95...
... The proposed Director's Special Projects Program at NIH would, like DARPA, be designed to foster the conduct of innovative, high-risk research. Research initially funded through the program that generates useful results would be handed off after 3-5 years for further development and funding through the standard NIH peerreview mechanisms of the ICs.
From page 96...
... In addition, to allow for appropriate peer review, review panels specifically charged with selection of high-risk, high potential return projects could be constituted outside the standard peer review mechanisms to assist the program managers in selecting projects for funding. The Committee believes that such a program will have its best chance to succeed if Congress provides new funding.
From page 97...
... But one might equally wonder whether the repeated calls for review reflect a continuing concern about the quality of programs and performance and a lack of response to criticism and recommendations. The IRP has faced persistent difficulties, including problems with recruitment and retention of senior scientists, expansion of a postdoctoral training program of uncertain and uneven quality, cumbersome administrative requirements, inadequately funded congressional and administrative mandates, and deteriorating facilities, in particular in the Clinical Center.
From page 98...
... In its many recommendations to the NIH director, the EAC concluded that the problems plaguing the IRP, unless addressed, "may destine it to a mediocre future." The committee identified many areas of concern: The review process for tenured scientists and scientific directors, The review process for appointment to tenure, Postdoctoral training, Administrative issues affecting recruitment and retention, NIH-private sector collaborations, The process for allocating funds between the extramural and intramural programs, and Renewal of the Clinical Center. The EAC recommended that each institute be subjected to an individual review along lines proposed by the EAC.
From page 99...
... The criteria used for the assessment included alignment with the NIH and Clinical Center missions, the extent to which the protocol represented cutting-edge science, whether the Clinical Center environment was uniquely appropriate for the study, whether the protocol addressed a national public health emergency, the importance of the protocol for training, whether the protocol was crucial to the institute's research program, whether the protocol was likely to contribute to patient care or patient comfort, and whether the protocol attempted to improve the efficiency or cost effectiveness of patient care. Some of the findings of the assessment such as that only half of the protocols of NCI's Division of Cancer Therapy, the largest user of the Clinical Center, received excellent or good rankings led to the identification of programs that were candidates for being phased out.
From page 100...
... It should be reiterated that the Director's Special Projects Program proposed above should be open to ideas from IRP scientists. The Committee agrees that another important aspect of the IRP is that it is capable of moving quickly and flexibly to meet urgent new needs.
From page 101...
... The public process for evaluating proposals to create organizational units described in Chapter 4 should also be applied to programmatic offices in the OD. Finally, to enhance the quality and innovative nature of NIH's portfolio, the Committee proposes a variety of adjustments in intramural research and the creation of a new program in OD to promote high-risk, high-payoff research.
From page 102...
... The Committee's view of those complexities was governed by the desire to be of some practical assistance to all who wish NIH to continue to be an effective - indeed, outstanding organization. Thus, the Committee proceeded on the premise that its task included assessing the organizational configuration of NTH ant!


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