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lated to this, and I believe determining this, is the need for program funding at levels unprecedented in more conventional biomedical research and the certain indication of a broad growth potential for each activity.

Before a major "biomedical development” program is mounted by the Federal Government, specific reassurances are needed on these points:

(1) That the science base for the program is adequate,

(2) that necessary management skills are on hand, and organizational arrangements permit effective deployment of these skills,

(3) that the resources to carry forward the program will not be made available in adequate amount unless the Federal Govern

ment provides them. I would also say that:

(4) each such program should be funded separately, on its own merits, and

(5) each effort should be scaled realistically in terms of the unusually high funding levels that will be required to draw in the necessary quality of contractor competence, both in engineering

and management. In summary, there is indeed need for additional Federal attention in the field of biomedical development and application. But this attention must take into account the quite different challenge and needs in the several applications areas just described. I would add that current concepts of acceptable budget levels permit little of such proposed activities. I see little to be gained and tragic loss were we to disassemble ongoing research of a fundamental and applied nature in order to take advantage of the developmental possibilities we perceive.

Your second question was:

What means are employed by your Department to establish research priorities and long-range research plans?

If I limit the scope of my answer to the NIH—which seems appropriate in this instance I would say that these are established by institute directors for their respective program areas, drawing principally on advice from the planning activities of their staffs and the counterpart planning of their National Advisory Council. I cannot stress too strongly that a prime essential of the planning process must

a be centered in the fulltime activity of the staff of an institute. Given this, there then emerges a special role for the Council and for special disease- and problem-oriented committees. The operations of a National Advisory Council afford a mechanism for examining opportunities and the direction of program effort by a group of professionals not involved in the execution of the effort. National Advisory Councils typically include a number of outstanding nongovernmental scientists who have won distinction in relevant research areas, also lay members distinguished in some area of public affairs, and, finally, liaison members from other Federal agencies with major health activities. In earlier years, much Council effort was devoted to the detailed review of individual grant applications for program relevance. As the increasing volume of grant applications has made grant-by-grant review less feasible and less meaningful, it has been possible to shift the emphasis of Council activity to the broad considerations of program planning and evaluation. These changes have also been reflected

in the character of institute staffs and organization, that is, in the development of staff capability for program planning and analysis.

I addition, several new advisory mechanisms have been establishedor are in the process of being established—at the NIH which contribute to the overall process of longer range planning. These include:

(1) The Advisory Committee to the Director, NIH, which performs for total NIH program a somewhat analagous function as to that performed by individual National Advisory Councils for their respective institutes. As the apparatus of this committee develops, it will increasingly be concerned with a consideration of long-range program direction and emphasis and consequently in the deployment of resources. The membership of this committee encompasses outstanding individuals in the fields of medicine, the physical and social sciences, and public affairs.

(2) A structure of disease or specific problem-oriented committees is being set up throughout NIH programs, with membership drawn from outstanding experts in relevant areas. A number of these have been in effective operation for some time so that we are aware of both the potential and limitations of such groups. Each institute may have as many of these committees as are needed to cover its major disease or disciplinary concerns. Committee responsibility for its assigned area includes examining and reporting on “the state of the art," and identifying gaps in present support as well as a reas warranting increased program

attention. Backing up both the Council and committee deliberations, and the decisionmaking apparatus in each institute, is a framework of planning officials and supporting staff, aided by computer resources for program analysis, which performs advisory and evaluation functions across all program areas.

A new mechanism worth noting is the program-planning-budgeting system established at the direction of the Bureau of the Budget to cover HEW and other major agency programs. The intent here is to establish a system to provide for more informed program decisionmaking and to assess the course and effectiveness of alternative program approaches. This would be useful indeed. But much of our activity is not amenable to such an analytic approach-at least as presently worked out—and the conventional budget approach seems more meaningful for the time being. Be that as it may, we are committed to the effort, and the mechanism does have a longer range promise if the techniques can be so modified as to aline them with problems of a real world.

Your third question was:

llow do you evaluate and maintain a continuing examination of ongoing projects and programs?

I have already cited the role here of National Advisory Councils, of special advisory committees that relate to definable portions of institute programs, the activities of institute and division planning and program staff, and the still embryonic planning-programing-budgeting system. I would add these points:

(1) All NIH research and training projects that are planned to continue over a period of years become subject to a built-in review process which periodically assesses the quality, direction, and productivity

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of effort as a prerequisite to extension of funding. Such continuing assessments involve the same type of peer group evaluations as applied to initial approval of the grant application.

(2) Expert reviews by ad hoc advisory groups are periodically established to assess progress in particular program areas warranting attention for one reason or another. An example of this would be the Richardson committee review of the cancer chemotherapy program.

(3) NIH programs as a whole have also received a series of largescale reviews over time, beginning with the Long committee in 1956, and extending through the Bayne-Jones, the Jones, the Wooldridge, the Kistiakowsky, and the Ruina studies. Few Federal programs have been as extensively reviewed and evaluated as the biomedical research and training programs of the National Institutes of Health. With your permission, Senator Harris, I would be very glad to insert in the record a listing of such studies for the information of the committee.

Senator HARRIS. Without objection, that will be included in the record at this point.

EXHIBIT 3

LIST OF REVISIONS OF NIH BIOMEDICAL RESEARCH AND TRAINING PROGRAMS

STUDIES OF THE NATIONAL INSTITUTES OF HEALTH

1955: Medical Research Activities of the Department of Health, Education,

and Welfare. Report of the Special Committe on Medical Research Appointed by the National Science Foundation at the Request of the Secretary of Health,

Education, and Welfare (the “Long Report”) 1958: “The Advancement of Medical Research and Education.” Final Report

of the Secretary's Consultants on Medical Research and Education (the

"Bayne-Jones Report") 1960 : “Federal Support of Medical Research." Report of the Consultants on Medi

cal Research to the Subcommittee on the Departments of Labor and Health, Education, and Welfare, Senate Committee on Appropriations (the "Jones

Report") 1964: "Federal Support of Basic Research in Institutions of Higher Learning."

Report of the Committee on Science and Public Policy, National Academy of

Sciences (the "Kistiakowsky Report") 1965: "Biomedical Science and Its Administration-A Study of the National

Institutes of Health." Report to the President of the NIH Study Committee

(the “Wooldridge Report”) 1966: "Report of the Secretary's Advisory Committee on the Management of

NIH Research Contracts and Grants” (the "Ruina Report”)
Dr. SHANNON. Your fourth question was:

What means does your Department use to maintain adequate communication with scientists and engineers in the field of biomedical development and applications, as well as with medical practitioners and hospitals? Are they odegriate?

I will break my discussion of communications problems into several parts:

(1) Taking the least troublesome aspect first-scientist-to-scientist communications, I would say that we do rather well here. You must appreciate that in biomedicine (unlike the defense area) there is a completely open scientific literature; also a well-developed structure of scientist-to-scientist communication through professional scientific journals of all kinds, and through seminars, conferences, and symposia. Add to this the effective interaction provided for laboratory and clinical research, clinical training, and health care by major university medical centers, and you will appreciate why I am reasonably well satisfied—though not complacent-about this area of communications.

(2) Communication between scientists, the health practitioners, and their hospitals is much less adequate than between scientists and scientists. While the scientific literature is open in theory to health practioners, its value for communication in this area is limited. Few practioners can spare the time from their patients to read and absorb the quantity of literature required. Furthermore, the rapid advance of science limits the duration of knowledge acquired in the formal train. ing process. Therefore, special devices are required to meet this problem. As I mentioned before, many departmental programs aim at closing this science-practice communications gap. The regional medical program—with its emphasis on continuing education for physicians and the establishment of operating links between university medical centers and the community health scene—is one of the more promising of these. A similar function is served by the community mental health centers program. Many other community-oriented, disease control, demonstration, and health services programs of the Public Health Service are having an impact in this problem area.

In the final analysis, there is needed a formal system of continuing education that makes information available to the practitioner in a systematic and convenient fashion. I am personally convinced that such a system, even if established, will not be generally used unless professional involvement such as periodic measurement of professional capability is built into the patient-care system.

(3) Communications between scientists and engineers represent a second area of inadequacy. Relatively few ongoing programs are directed to closing this communications gap--for the practical but disturbing reason that there are all too few engineers working in the biosciences or contiguous areas. However, the bioengineering centers program in the Division of Research Facilities and Resources and support of research and training in bioengineering by the National Institute of General Medical Sciences will contribute to progress in this area. At this point in time, the progress will be dollar limited and consequently slow.

Your fifth question was:

What procedures do you em ploy to translate results of biomedical research into actual treatment and care of patients ?

The organization of American medicine is such that improvement in the delivery of health services cannot be directly brought about by the NIH or any other Federal agency. The treatment and care of patients is, in the United States, a private function with, of course, the exception of care for Federal beneficiaries such as veterans. Consequently, Federal programs work through public or private agencies that relate to the medical care scene. In this system, the university medical center provides the setting for the transfer of research findings in biomedicine, by means of the ready access to new knowledge, and the skills, techniques, and other resources needed to apply them. To the extent that the NIH has had a major impact on the university medical center, likewise we have had an impact on this transferral process. No other area of science has a natural theater, as it were, for the transmission of the fruits of research comparable to the university center in biomedicine.

The regional medical programs is the focus for NIH interest and concern in improving the delivery of health services. The British medical journal, Lancet, aptly captured the significance of the regional medical programs in calling them “An American Catalyst. In this catalytic role, this regional approach to health relationships must cause such diverse elements as medical schools, health professional organizations, individual physicians, hospitals, voluntary organization, and business and community planners to react together in a way which will promote, at the community level, the same high quality of medical care now available at our university centers of medical excellence.

One key element in the effort to translate research findings into improved patient care has emerged from the evolving regional medical programs. The practicing physician is the core of our system of health care, and his continuing education and retraining in modern medical precepts is crucial to the higher quality patient care which the regional medical programs has as a goal for the Nation. The regional medical programs can also provide some of the special diagnostic and therapeutic resources needed at the community level as more physicians require these complex new procedures in day-to-day practice. A general increase in professional sophistication can reduce significantly the toll of death and disability from disease.

Your final question was:

What further steps might be taken by Government agencies to bring about more biomedical development without diminishing basic research and without disorienting institutions involved in basic research?

I believe that we in the Federal Government need only adhere to certain commonsense precepts:

(1) The first imperative is to be certain that the science base for a proposed development effort has been carefully assessed by those most competent to judge these matters, and has in fact been found adequate. Another prerequisite is to be certain that the problem to be attacked is a major one; for a lesser problem would not warrant the heavy allocation of resources that may be required. Some very promising areas are research on containment, on the automation of clinical laboratory procedures, on centrifugation techniques, on models of complex biological systems, and on the computerization of hospital systems of drug dispensing, patient monitoring, and recordkeeping.

(2) A second set of requirements has to do with funding for developmental programs. If major new programs of this type are to be mounted without diminishing basic research and without disorienting institutions involved in basic research," the new program must be funded on the basis of its own merits, and not as a substitute for the essential base of continuing scientific activity out of which emerge the developmental opportunities. Furthermore, the costs involved in the successful mounting and conduct of development programs must be recognized as high. Costs must, therefore, be projected realistically at levels that assure the entrance of very competent professionals into the area of activity if the objectives are to be attained and these in a reasonable time.

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