More than a year ago, the House Appropriations Committee placed the Intramural Research Program squarely at a crossroads. In its fiscal year 1994 report, the committee insisted that NIH perform a critical evaluation of the quality, appropriateness, size, and cost of the IRP, in order to inform decisions on which way to take the program, how best to allocate resources between the IRP and extramural programs, and what to do about the deteriorating infrastructure of the Clinical Center. This evaluation took nine months and was performed by the External Advisory Committee of the NIH Director's Advisory Committee. Committee members, led by Paul Marks of Memorial Sloan Kettering Cancer Center and Gail Cassell of the University of Alabama at Birmingham, reviewed reams of data carefully assembled by a hardworking internal committee. The result was a 69-page draft report, now available from Lab/Section Chiefs and Scientific Directors. Below, we reprint the Executive Summary and major recommendations from the report, and on page 2, Michael Gottesman, Acting Deputy Director for Intramural Research, comments and invites responses to the report.

EXECUTIVE SUMMARY

The intramural research program (IRP) of the National Institutes of Health (NIH) has been among the most distinguished biomedical research establishments in the world. The research achievements and the record of "graduates" of the NIH intramural program are matched by few biomedical research institutions. The NIH Clinical Center, a 450-bed hospital, is one of the world's largest hospitals devoted solely to clinical research. It has been a unique and invaluable resource for the direct clinical application of new knowledge derived from basic research. Despite this distinguished past, changes in the national biomedical research environment have led Congress and others to question the quality, appropriateness, size, and cost of the NIH intramural program.

The IRP is one of two components of NIH. The other is the extramural research program (ERP), which supports research at universities and other research institutions throughout the country. The IRP accounts for about 11% of the total NIH budget.

The External Advisory Committee has concluded that unless addressed, problems identified in this report -- and several previous reports -- may condemn the NIH IRP to a mediocre future. Several factors are increasing the pressure on the NIH budget, both extramural and intramural. On the one hand are the rapidly expanding opportunities to significantly increase basic biomedical knowledge, accompanied by enhanced capabilities for translating such knowledge into clinical application. On the other hand are rising costs of biomedical research. These forces are leading to a new reality in the extramural research community. Research judged to be "good," "very good," or even "excellent" is no longer funded. Funding of new grants is at an all-time low of about 15 percent of submitted proposals.

The NIH IRP is also facing its own difficulties. Over the past decade, the IRP has experienced 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 a deteriorating facility infrastructure -- in particular, the Clinical Center.

Concerns about the health of the NIH IRP contributed, in part, to the establishment of the External Advisory Committee. Specifically, the fiscal year (FY) 1994 House Appropriations Committee Report directed the new Director of NIH "to review carefully the roles, size, and cost of the intramural program [IRP], and its relationship to the extramural research program, and indicated that NIH must put together a process "for allocating resources to and among its intramural programs based on a thoughtful analysis of these issues."

Recent congressional concern has focused on three issues with respect to the IRP: 1) whether the level of quality across the IRP continues to place it among the best institutions; 2) whether the allocation of resources to the IRP relative to the ERP can be justified based on rigorous considerations of quality and the importance of the research questions addressed in the IRP; and 3) given the high cost of the needed renewal of the physical facilities of NIH, particularly the Clinical Center, what new and renewed facilities are required to ensure high-quality research and productivity in the future.

The IRP has a fragmented federated structure with inadequate processes for oversight by NIH's Office of the Director. Each institute, center, and division has a different legislative history and mandate from Congress, and each institute's intramural program differs with respect to goals, scope, absolute size, and allocation of funding between extramural and intramural research. This complex structure for the administration and conduct of research has both strengths and weaknesses. Although it has contributed to a research establishment of great diversity and vitality, it has led to an administrative structure that in the present environment of constrained resources, frequently hinders effective management of the IRP. This Balkanization of the IRP has contributed to unevenness in quality, quality control, and productivity.

At least three previous advisory committees have made recommendations for improving the IRP, some of which have been implemented but many of which have been ignored. This may be attributed in part to systemic problems that transcend NIH and require major administrative or legislative remedies and in part to resistance to change within a large institution.

The IRP possesses several unique characteristics that set it apart from the extramural research program. These include relatively long-term and stable funding of research programs, availability of the Clinical Center's patients and facilities, few or no distractions from research for scientists, and a primarily retrospective rather than prospective review process for determining scientific quality and the funding of research. It must be emphasized that a strong ERP requires a strong IRP, and quality -- not necessarily uniqueness -- should be of the highest priority in determining support for the intramural research program. Those with the responsibility to make decisions must use a rigorous approach to evaluate quality in terms of personnel, training, management, and priority of the research program.

Periodic, objective, unbiased peer review is crucial to the long-term excellence of all scientific institutions, including NIH's IRP. Science progresses, and scientists must respond. The review process can be positive when it calls attention to deficiencies in time for them to be corrected. When improvement is not adequate, a review provides reliable justification for shifting resources from unproductive to more productive scientists. Every effort must be made to put in place personnel systems that facilitate recruitment of outstanding people and provide for termination of individuals whose research programs are of inadequate quality or are not sufficiently productive.

The challenge of "reinventing" the IRP requires that NIH rethink some of its practices regarding 1) appointing and promoting scientists NIH-wide, 2) recruiting and retaining outstanding scientists, 3) invigorating postdoctoral training programs that transcend institute lines, 4) using patient and research facilities in the Clinical Center, 5) instituting efficient management and review practices that are more responsive to the needs of the research enterprise, and 6) exploring opportunities for increased collaboration with the extramural community, including industrial and academic laboratories.

The recommendations contained in this report aim to create more uniform and consistent processes for setting priorities and ensuring quality across the NIH IRP. Although each institute should retain a level of autonomy in its research programs, more centralized control of the process for ensuring quality is desperately needed.

To enhance quality control, the External Advisory Committee makes several recommendations related to review of quality and productivity of scientists, scientific directors, and training programs. It is unlikely that the NIH intramural budget will increase significantly beyond the cost of inflation in the foreseeable future. The need to renovate the Clinical Center is also likely to drain funds from the operating budget of the intramural research program. One way to make room for new investigators will be to reclaim resources from those investigators whose research is no longer productive. This report outlines mechanisms to use in achieving the goal of redirecting intramural research resources to the most productive programs, thereby improving accountability and freeing resources for new recruitment and new initiatives and for renewing the Clinical Center.

MAJOR RECOMMENDATIONS

The Extramural Advisory Committee makes the following major recommendations. Additional recommendations and justification and methods for implementing the recommendations are presented in the body of the report.

1. To improve the processes by which Senior Scientists and Scientific Directors are reviewed, the External Advisory Committee recommends that a standing Advisory Committee to the Deputy Director for Intramural Research be formed that would be composed mainly of the Chairs of the external Boards of Scientific Counselors of each institute, center, and division. This committee should be charged to provide ongoing review of the processes of quality control across NIH. The committee should be chaired by the Deputy Director for Intramural Research (DDIR).

2. To improve quality review, the committee recommends that the selection and appointment process be altered for the Boards of Scientific Counselors to ensure expert, arm-length membership; that the process by which Boards of Scientific Counselors review the programs of intramural scientists be made more explicit; and that the criteria used to evaluate Scientific Directors be made more rigorous.

3. To ensure a strong tenure system that provides the intramural research program with creative and productive scientists, an NIH-wide Tenure Committee, advisory to the DDIR and composed of 12 to 16 tenured scientists serving staggered terms, should be established to review and recommend for approval (or rejection) all potential appointments to tenured and tenure-track positions. Recommendations for appointments to the tenure track should be made by each institute, center, and division through its existing processes, then forwarded to the Tenure Committee with all appropriate documentary support. Once the Tenure Committee is in place, it should no longer be necessary for the NIH Board of Scientific Directors to review or approve tenure decisions.

4. To improve the intramural training program, the independence and career development of trainees should be emphasized. Trainees should be encouraged to seek positions outside NIH after a two- to four-year program so that space and resources are continuously provided for recruitment of new trainees.

5. To provide ethnic diversity in the intramural training programs, there should be better linkage with NIH-funded extramural programs, including the NIH Minority Access to Research Careers and the Minority Biomedical Research Support undergraduate programs, and with the Short-Term Training Program for physicians. The intramural program should also increase the number of physician scientists from underrepresented minority groups by increasing research experiences for minority medical students.

6. An annual, prospective planning process should be conducted by each institute, center, and division to determine the allocation of resources to the intramural and extramural programs. The process should be outlined in a written document and reviewed, approved, and monitored by the NIH Director and the NIH Advisory Committee to the Director. Extensive consultation with the extramural research community should be part of this process. The overall NIH scientific mission should be assessed and allocation decisions should be made on the basis of scientific excellence and opportunity. The total IRP budget for institutes, centers, and divisions (ICDs) should not exceed the current rate of 11.3 percent of the total NIH budget. This percentage should be reviewed and appropriately adjusted through the prospective planning process, following full implementation of the recommendations that emerge from the quality review of the intramural program as outlined in recommendation number 1. It is anticipated that implementation of this process of quality assurance may require 3 to 4 years.

7. The procedures for procurement and staff travel should be streamlined and improved, as should the procedures for appointing technical and scientific staff as part of the process of "reinventing government." NIH could serve as a model for developing and testing novel procedures to make the procurement process efficient and responsive to research needs while simultaneously ensuring the integrity of federal expenditures.

8. To ensure that the NIH intramural program is fulfilling its mandate to facilitate technology transfer, NIH should broadly communicate in a clear and precise manner the scope, purpose, definition, and processes of implementing and monitoring Cooperative Research and Development Agreements (CRADAs).

9. To renew the Clinical Center, there should be a phased program starting with a 250-bed Clinical Center Hospital and followed by a modular approach to construction and renovation of research laboratories. Funds recovered from phasing out weaker intramural research programs should be used to the extent possible to fund renewal of the Clinical Center. However, recognizing the likelihood that these funds will not be adequate to meet the costs of renewal of the Clinical Center, the External Advisory Committee recommends that additional funds be allocated by Congress for this purpose. Funds must not be diverted from the ERP to the IRP for renewal of the Clinical Center.

10. If, on renewal of the Clinical Center, inpatient nursing units and laboratory research space become available in excess of the needs of the ongoing programs of the Clinical Center, then establishing priority for the use of such space should be at the discretion of the Director of NIH, with the understanding that priority should be given to programs currently housed off the Bethesda campus (both clinical facilities and research laboratories). Such consolidation of NIH intramural programs should facilitate quality control and could reduce costs.

11. Recognizing that it is not within the authority of the Director of NIH to change the current classification of the intramural research program as an administrative expense, the committee strongly believes that it should not be classified in this manner. Such a classification leads to budgetary procedures that are not rationally related to the scientific process and that do not support the goal of achieving the highest quality and productivity of the intramural research program.