Director's Council of Public Representatives
Activities and ReportsReport on the Organizational Structure and Management of the NIHReport to the Director of the National Institutes of Health on the Organizational Structure and Management of the NIH from the Council of Public RepresentativesDecember 2, 2002 Council of Public Representatives:
Letter from Dr. Zerhouni Harold T. Shapiro, Ph.D. Dear Dr. Shapiro: At the request of the National Institutes of Health (NIH) council of Public Representatives (COPR), I am forwarding the enclosed report as prepared by the Council. The independent conclusions and recommendations in this report regarding the organizational structure and management of the NIH cover a range of topics specifically from the public perspective. As you may be aware, the COPR is a forum for discussing issues affecting the broad development of agency policy, programs, and research goals and for advising the NIH Director on these matters. It also advises and assists the NIH Director to enhance public participation in NIH activities, to increase public understanding of the NIH, and to bring important matters of public interest forward for discussion in public settings. The COPR membership comprises a variety of backgrounds, cultures, and geographic origins; its twenty-one members all share a vital interest in the work of the NIH. I trust you and the committee will find this report helpful in your deliberations. Sincerely, Elias A. Zerhouni, MD CC: Enclosure INTRODUCTION The Council of Public Representatives (COPR) was created as the public voice of the American people, in the broadest and least encumbered sense, to the Director of the National Institutes of Health (NIH). This report, stimulated in part by a study underway by the Institute of Medicine (IOM), is a piece of the ongoing dialogue on how the NIH can best manage biomedical research on behalf of all Americans. The American public supports NIH research with its wallets and by putting their very bodies on the line to make clinical trials possible. They will continue to do so only if they trust that research and the people who conduct it. Maintaining and enhancing that essential trust requires constant, diligent work on the part of the NIH that is based upon five key principles:
In this report we use these five principles to analyze aspects of the structure and function of the NIH that may be considered by the IOM committee. We believe they are integral to guiding any reorganization. We also offer recommendations for the NIH Director to consider in conjunction with the IOM committee report. An appendix contains additional thoughts and recommendations that are important for the Director to consider. KEY POINTS
In sum, the goal in changing the existing framework of the NIH should be to create mechanisms that embrace and are responsive to all constituencies, including the American public, as partners in the research process; that facilitate collaborative interactions between those partners; and that are more open to change and new ideas. PROLIFERATION OF INSTITUTES AND CENTERS The proliferation of Institutes and Centers has occurred primarily through two mechanisms: one arising from a perceived need on the part of the NIH, as with the National Human Genome Research Institute, and the other as a consequence of the NIH being seen as insufficiently responsive to specific constituencies, as was the case with the National Center for Complementary and Alternative Medicine. This also holds true for the formation and establishment of the Council of Public Representatives (COPR). The greater administrative burden of those added structures can be a legitimate cost of including valid constituent interests that may arise from time to time. However, we remain generally skeptical of the need to create additional Institutes and Centers. Although a consolidation or clustering of some existing structures has a certain logic, one must also consider the internal and political costs associated with such activity and choose priorities wisely. What might initially seem logical or rational on paper often does not remain so when one examines the details. Organizational rationality should not be an end in itself. Rather, the purpose of any reorganizations should be to significantly improve functionality and/or reduce administrative costs. Because the nature of research and "known truths" is constantly changing, so too the framework within which to conduct that research must be flexible and evolving. Furthermore, not only is disease complex, so too are patients. Even a "simple" disease often can initiate a cascade of increased risks for other afflictions. The comorbid patient is the rule, not the exception. The public realizes the limitations of treating disease and demands that the focus of treatment be on the whole patient, not his or her parts. Research must reflect that demand. There is value in having overlapping and redundant responsibilities, particularly in a process such as research, where both goals and the paths to those goals often are not yet fully known. It is one way of reducing the risks of orthodoxy, where a single approach and set of gatekeepers can preclude support for differing approaches. It also can induce some degree of competition, which often is a good thing. Creation of the Office of AIDS Research is a useful case study in how to manage structural change. Former NIH Director Harold Varmus has written of it as "a compromise to avoid an especially contentious fusion of AIDS programs into a full-fledged Institute." It was, in his eyes, at least a partial success in reining in the further proliferation of Institutes. An important factor in that outcome was the decision by AIDS activist, historically one of the most potent advocacy communities and then at the peak of its influence, not to seek such an Institute. Much of the reason why is that the NIH, particularly through the leadership of Anthony Fauci, mad extraordinary and groundbreaking efforts to include the affected community as partners in shaping the research agenda. Community leaders had a stake in the process, bought into the outcome, and felt no need to carve out a special Institute. Recommendations:
OFFICE OF THE DIRECTOR Biomedical research today is moving in the direction of a multidisciplinary approach to discovery, in part because of increasingly sophisticated research tools and computational power are giving us the ability to handle the complexity of large data sets and to integrate them in ways that are orders of magnitude greater than they were even a decade ago. This central fact of contemporary biomedical research supports the idea of greater role for the Office of the Director at the NIH. That office, unlike every other one at the NIH, uniquely has the broad responsibility of advancing health-not a specific disease, or approach, or organ, but the overall health and well-being of the American public. It should be given the resources necessary to fulfill that mandate. We do not mean to suggest a centralized or directed approach to research; that would be antithetical to the principles at the core of the NIH since its founding. Rather, we seek to equip the Director with the tools necessary to facilitate and integrate research on a trans-NIH basis, so that he may truly be first among equals. The budget of the Office of the Director has not kept pace with the growth in the overall NIH budget, even while it has take on added responsibilities. Over the last decade, the total NIH budget has increased by 125%, whereas the Director's budget has increased only by 88%. It has shrunk from 0.4% to 0.3% of the total budget. Recommendation:
Research Leadership: One option in strengthening the hand of the Director is to give that Office more money that can be awarded on a discretionary basis to shifting priorities and emerging opportunities across all of the NIH. We encourage that to some extent, through we wish to avoid creation of a parallel administrative bureaucracy (and pressures for funding) that might arise from placing extraordinarily large sums in the Office. We believe another mechanism offers equal or greater opportunity to promote better-integrated research and enhance the authority of the Director. It would encourage Institutes and Centers to pursue research that the Director has identified as NIH priorities. It would not give the Director and absolute veto over trans-Institute research, which still could be conducted with other funds, but it would help to direct a portion of their funding toward centrally defined priorities. Recommendation:
We believe the commitment to such trans-Institute programs should be significant. Some have suggested that the floor be 20% of the total budget, but we are not prepared at this point to offer any guidance on budgetary targets. Administrative Consolidation: The larger Institutes generally have a critical mass to efficiently carry out most administrative functions. It is clear that many of the smaller Institutes and Centers do not have those scales of operations. Certain functions could more rationally be carried out on a centralized basis. We recognize that NIH has already carried out many of these efforts and we support them. Data Systems and Nomenclature: The promise of enhanced health based on knowledge of the human genome ultimately will require huge data sets for maximum understanding of those complex interactions. That will not be achieved through single studies but through the integration of data from vast numbers of studies. Failure to implement standardization, and even delay in doing so, carries a price that is measured in deferred development of therapy, increased risk in clinical trials, and patient deaths. The recent development of harmonized mechanisms of reporting serious adverse events in gene transfer trials, which the NIH and the Food and Drug Administration are implementing, is a useful model for broader application. Recommendation:
Communications: The NIH devotes tremendous resources to and effectively communicates with researchers through the peer review process and the conduct of scientific meetings. It is much less effective in communicating with other partners in the research process, most notably the general public, in part because it devotes few resources to those tasks. There are exceptions to this. For example, the National Library of Medicine has made a concerted effort to create resources that are accessible to the general public. As a result, its web site has become one of the most credible and most visited health sites in the world. Reorganization must improve the nature, quality, and mechanisms of communication with the American public so that the public and patients can become truly informed, active, and equal partners in fulfilling the NIH mission of improving health. Unfortunately, the NIH has seldom proactively and effectively reached out to the broad American public through the medium of television. It is the single most important vehicle in contemporary America for reaching both a broad audience and underserved minority populations. Even the largest Institutes would be hard pressed to exploit this media potential on their own in a cost effective manner. The smaller Institutes and Centers cannot even dream of utilizing television. Recommendation:
Clinical Trials: Public concern is that some Institutes and Centers have insufficient capacity to carry out the large-scale clinical trials in areas of their responsibility that are necessary to improve the nation's health. This is particularly true when it comes to data safety monitoring and other functions of patient protection. Recommendation:
Education and Training: The NIH has invested heavily in education and training in research. Perhaps best known are post-doctoral fellowships. But the span of activity is much broader; it includes promoting state-of-the-art standards of care for medical practitioners through the Office of Medical Application of Research, stimulating public school students to consider a career in biomedical research, and recent educational initiatives to strengthen patient protections in clinical trials. One element that is missing is investment in the education and training of the public to better serve their role as a partner in the research process. Recommendation:
FUTURE STEPS COPR recognizes that the structure and management of NIH is a continuing matter that will be revisited periodically. We anticipate making further comments after reviewing the forthcoming IOM report and we will continue to evaluate all NIH operations in light of the five principles articulated in this document. APPENDIX NIH Staffing Levels The NIH budget has increased from $4 billion to $27 billion over the last 20 years. The absolute numbers of grants has increased by 40%; the value of the average grant has increased three-fold, to $375,000; and the complexity of research has increased enormously. However, staffing levels (full-time employees) at the NIH have increased by only about 20%. This state of affairs raises the very real possibility that the NIH is understaffed to best administer its program responsibilities. Peer review can act as one kind of check on poor allocation of resources, but program review also is necessary. That cannot occur if program officers are stretched too thin and have neither the time nor the resources for adequate site visits and interactions with grantees. Of equal or greater importance to good stewardship of the expenditure of public resources is the role that NIH program officers can play in facilitating interaction between grant recipients. They can be catalysts, stimulating a "cross-pollination" of ideas and collaborations in what otherwise might be more isolated nodes of research activity. Crossing the boundaries of disciplines and of geography is increasingly important. This facilitator role of NIH program administrators often is not given the recognition and support that it merits. An internal examination by the NIH, while useful, will always carry the perception of being self-serving. Staffing levels need to be examined by a body that is perceived by all to be objective. Recommendation:
Research = Growth We recognize that health is an important and vibrant part of the nation's economy-about 14% of gross domestic product by most estimates. Medical centers have long been engines of local and regional economic growth. So it is no surprise that biotechnology is seen as not only the cutting edge of the next generation of improvements in human health, but also as important for the economic life of the communities that house or hope to house such operations. This has created political pressures to direct NIH funding for Centers of Excellence and other large-scale investments in biomedical research to locations other than what standards of "the best science" might indicate. We are not so naïve as to think that these pressures can be eliminated entirely, nor in many ways should they be. However, we believe that these opportunities should be leveraged to the greatest extent possible to build partnerships and attract additional resources to biomedical research. Recommendation:
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