Attachment 4 REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 DEFENSE ACTIVITIES OF THE NATIONAL INSTITUTES OF HEALTH (1950 - 1952) May 13, 1952 REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 DEFENSE ACTIVITIES OF THE NATIONAL INSTITUTES OF HEALTH (1950-1952) I. Introduction - Early Evaluation of Policy Governing N.I.H. Action While the N.I.H had considered what its role with respect to National defense might be as international tension increased after World War II, no definite planning was done until after the Korean action began. In July, 1950, the Director of the National Institutes of health met with Directors of the constituent Institutes to consider what the policy and action of this research organization should be with respect to defense related activities. Subsequent developments can best be assessed by consideration of the document quoted below, which indicate the major assumptions made early in the period of accelerated defense activity. It will be noted that some of these assumptions were later modified, but they state explicitly how the problems of conversion to defense were viewed by the top staff of the N.I.H. when the problem of the relationship of the research program of N.I.H. to defense became a matter of practical rather than theoretical importance. The document in question, which is the minutes of a meeting in July 25, 1950 between the Director of N.I.H. and his Institute Directors, reads as follows: 1. Role of Public Health Services It is recognized that the Service will be called upon in defense emergency to serve as the Federal health and medical agency responsible for (a) civilian welfare and (b) medical research of direct military value. It was agreed that the Service should appraise its research and manpower resources in terms of projects of (a) direct military usefulness, (b) convertibility to defense and (c) manpower terms available for conversion. The Research Planning Council has already undertaken a rough inventory along lines which will be REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 2 distributed to all research units this work for comment, clarification and addition. B. Intramural Research at NIH 1. It was agreed that, in addition to a statement of current research, all Institutions should analyze research and manpower to determine what facilities (including manpower, space, budget) are (a) immediately convertible to military and civil defense (b) standby, convertible as required in accordance with mobilization schedules and (c) basic operations, consisting of (a) statutory functions and (2) fundamental research, to be continued as long as possible. 2. It was recognized in this connection that changes in direction of intramural research were limited mainly by personnel and space and that consequently more money could not be too efficiently utilized to expand research and that emphasis would have to be given to (a) new orientation of research programs a pressures grew and (b) extramural research. It was generally felt, with respect to intramural research, that NIH should take the lead in explaining to the military and central planning organizations what contributions and advice it could best provide and what fundamental research it considered essential. 3. With respect to the clinical Center, the consensus was of extreme importance to achieve completion, with due respect to its role as a military research and civilian medical center, as required. Accordingly, there was agreement that the Center would, as far as personnel and facilities permitted, (a) undertake research problems addressed to it by the military and (b) serve as a civilian or military casualty hospital in event of mobilization. 4. Rotations with military and overall planning research bodies in the field of health and medical research were adjudged extremely important REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 3 It was agreed that the defense programs and policies of NIH should be made known to the Research and Development Board, the Interdepartmental Committee on Research and Development and to he NSRB as soon as formulated and that liaison be established to keep NIH ILLEGIBLE of defense needs. 5. Relations with Advisory Councils were similarly adjudged important, and it was agreed that they be informed of such developments and that perhaps one day of the next meeting of the Joint Councils be devoted to these matters, particularly with respect to implications on grant policy. 6. Budget implications required (a) determinations of the basic program needs in event of Budget Bureau request (as anticipated) for retrenchment recommendations and (b) needs for conversion. With respect to the latter, it was suggested that (a) "B" budget specifications be developed for special defense projects which could be expanded intramurally, such as blood, burn, shock and radiation research, with due regard to space and manpower limits and (b) that generally, that NIH agrees that its money would be converted, as needed, along with space and men, except that additional funds would be required for emergency conversions. C. Extramural Research 1. It was agreed that current grants should immediately be analyzed on the same basis as intramural projects, to complete the picture. 2. It was felt that greatest expansion should and could be made via grants and that applications should be classified as having military and civilian defense implications. 3. It was suggested alternatively that (a) defense projects should be handled by a contract mechanism rather than the present grants system since these required coordination, control and additional overhead support or (b) REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 4 (preferably) that insofar as possible, the present grant system be used. With respect to the latter alternative, it was felt that study section and Council ILLEGIBLE be advised of defense needs and encouraged to stimulate defense projects. It was felt that each section and Council, approved individually, could be kept advised of NIH policy and would agree to permit NIH to review applications rejected or deferred by determine whether any of these should be activated in addition to those approved on grounds now applied. It was felt that emphasis in all instances would be on selecting high-caliber men who would be a credit to the research proposed. 4. When and as research which could best be stimulated by NIH, because of contacts, familiarity with field or other reasons, had to partake of contract specifications, it was felt that the military should be approached to develop joint contract with NIH, so as not to interfere with the regular grant mechanism. 5. It was suggested that a staff member take up with Council and study section members the matter of security clearances to enable select groups to handle defense projects expeditiously. 6. It was agreed that, at all events, basic research should continue to be supported and that training, teaching and other grant activities essential to civilian defense be discussed with RDB and NSRB along with the possibility of fluid grants during the emergency period to sustain such work at medical schools. These problems tie in with general selective service- manpower policies in the light of decreasing reservoirs of skilled talent. 7. Budget implications indicated increases in grant funds since it is to be expected that conversion of extramural research could not be as rapid or controlled as intramural research and new defense research under stimulation would require more money. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 5 8. Grants for purposes other than research, mainly, training, control and construction should be discussed with Advisory Councils and others, such as the American Association of Medical Colleges with respect to conversion problems." Extended discussions followed this first general meeting. From these discussions several basic policies were worked out. Some of these were modifications of the principles laid down earlier and some simply expanded the judgements reached earlier. The following document prepared on August 7, 1950 as a summary of more extended staff discussions indicates how the plans for defenses related activities evolved: "N.I.H DEFENSE PLANNING" 1. Duration of the Emergency Plans will be set on the assumption that instrumental tension will continue for so indefinite number of years with alternating periods of relative quiet and crises, and with the possibility of total war. The execution of plans will depend on the course of events. Current action will be that judged appropriate for partial mobilization. 2. Prices and Wage Increases and Shortages There will be a gradual general increase in prices and wages and a gradually increasing list of scarce goods. Substitute materials may be necessary in the late stages of construction and in equipping the Clinical Center. The possibility of establishing priorities among research projects for equipment that may be scarce (electronic equipment, for example) is foreseen, but such priorities need not be set now. 3. Maintenance of Basic Research Proceeding on the assumption that international tension may continue for years, basic research will be strengthened. An expanded basic medical REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 6 research programs at this time is the best means of providing the fundamental knowledge exploitable through applied research in the future. A wholesale shift to civil defense and military defense involving sharp changes in individuals research plans would jeopardize the most effective applied research in the future. This principle will be applied to the intramural program, and to all grant programs. The scale of basic research will be reviewed periodically, with emphasis upon basic research decreasing as the urgency of findings immediately applicable to civilian defense and to combat increases. 4. Limited Immediate Expansion of Defense Research N.I.H. is, however, increasing emphasis upon current research applicable with little or no change to civilian defense and military medical problems. These areas include research related to such areas as psychiatric screening of inductees, combat psychoneuroses, biological warfare, blood and blood substitutes, shock, radiation injury and thermal burns. Specific plans for space, manpower and money for projects in those areas are being prepared. Upon completion, they will be discussed with other Bureaus and modified, if necessary, to integrate them most effectively. 5. Identification of Convertible research The total research program of N.I.H. is being reviewed to identify manpower, projects or areas of research convertible to defense or military medicine if more extensive military operations seem more imminent. These will include such investigations as the interrelationships of stress and adrenal function, nutritional requirements and studies of ropal function. Specific plans for conversion of personnel to such projects will be made, with timing contingent upon unpredictable developments. Institute organizational lines will be ignored when necessary to build the most effective research teams. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 7 6. Revision of Intramural Programs to Save Money and Source Materials All programs are being reviewed to identify research, services or construction specifications that can be modified, curtailed or stopped to save money and source materials. For example, acquisition of a ILLEGIBLE Van de ILLEGIBLE generator costing about $1 million has been indefinitely postponed. 7. Relationships with Armed Forces and Research Policy Groups N.I.H. staff relationships, formal and informal, with the medical departments of the armed forces (including R.H.B.), and N.S.R.B., N.R.C., A.K.C., the Red Cross and other groups in the medical research field will be made closer to ensure that N.I.H. policies and actions are consistent with the plans of the groups responsible for civilian defense and for military operations. In the general field of research on medical problems of civilian defense, N.I.H. ILLEGIBLE on the assumption that the Public Health Service carries a major responsibility and that it should not ILLEGIBLE requests or directions from either agencies before initiating work. In the field of research related to military medicine (as far as the problems are distinct from those of civilian defense), N.I.H. will initiate or expand work in areas that may become critical without awaiting reports from the armed forces. Expanded research in the field of tropical medicine ILLEGIBLE ILLEGIBLE this category. When the armed forces wish N.I.H. personnel to work on problems of direct interest to the armed forces, N.I.H. will urge effective action to ensure that the armed forces utilize research teams at N.I.H. to the greatest practicable extent, rather than to recruit N.I.H. personnel for work in other laboratories on the same or closely related projects. N.I.H. will within limits set by manpower, funds and facilities, accepted armed forces personnel for specialized training. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 8 8. Overburden of the Research Grant Program The general principle of relating the degree of conversion to the degree of general mobilization will be followed for the grant as well as the intramural program. As a means of assessing the relevance of the current grant program to medical problems of civilian defense and military operations, the content of projects and the fields of interest of investigators are being reviewed. Specifically, these guide lines to the content of research grants will be followed: (a) A large ILLEGIBLE of basic research not obviously directed to defense applications will be sustained. A substantial decline in Public Health Service support of basic medical research at this time would be interpreted as repudiation by the Federal government of the policy of sustaining fundamental studies. (b) Within limits set by the scale of continuing fundamental research, preference will be given to how applications having implications for civilian defense and military medicine, provided the investigations are competent. (c) Investigators whose interests, competence and current work are closely allied to medical research problems of high defense priority will be approached to determine their willingness to re-align their work. (d) N.I.H. will initiate a limited number of projects to be done in non-governmental institutions with varying degrees of participations and direction by N.I.H. personnel. The nature and magnitude of the projects falling into each of the above categories cannot be determined at this time. Procedurally, these steps will be followed: REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 9 (a) All the policies outlined in this statement, revised as may be required by changing circumstances, will be presented to all councils at the next meetings for discussion and possible modification. Council members will be asked to assist in explaining the policy to their institutions and their colleagues. Under some circumstances, defense research proposed for non- Federal institutions may be discussed with Councils rather than study sections. (b) The appropriate study sections will be apprised by the appropriate scientific personnel of N.I.H. of the nature of defense related work which N.I.H. wishes to stimulate in non- Federal establishments. Their advice will be sought on the most promising approach to the general problems presented to them and on the personnel best qualified to undertake such research. They will be asked to assist in framing and guiding research projects and in committing personnel to undertake the work. They will be asked to advice on the core of basic research, not directly related to defense problems which should be retained. (c) Special consultants of the highest attainable caliber will be secured on an official or unofficial basis to discuss specific research problems. (d) Research will be supported through contract only when the degree of central direction and control is such that the grant mechanism is inappropriate. When used, the form of contract will be simple. (f) Policies with respect to financing of research grants, including overhead allowances will be reviewed to ensure that these policies contribute to achievement of the objectives of the grants in the defense situational. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 10 9. Training and Teaching Grants and Fellowships. The experience of the last war made it clear that ILLEGIBLE rather than stabilization or ILLEGIBLE of medical training and teaching activities is appropriate until the manpower demands of the armed forces can be met only by a ruthless ILLEGIBLE on all non-military uses of manpower. 10. Construction Grants Liquidation each provided for fiscal year 1951 will be used to complete projects for which awards have already been made whether construction has actually begun or not. No contract authority for construction grants will be requested in the 1952 budget, but relatively small amounts of liquidation each may be required. 11. The Clinical Center N.I.H. considers the Clinical Center as a potential defense installation. It will be available for large scale clinical- laboratory investigations of medical problems important to civilian defenses and ILLEGIBLE. Conversion of work done in the Clinical Center will be considered -- together with all other intramural research -- in the light of the urgency of the civil defense or military medical problems. The Clinical Center should be rushed to completion as a major facility in the event of attack upon the Washington area. 12. Personnel Policies Research manpower will be increasingly difficult to obtain as the demands of the armed forces increase for military manpower and for research by civilians on problems of military importance. This factor, added to either pressing reasons for securing high grade talent, makes continuing efforts to recruit key scientific personnel a high priority objective of N.I.H. during the next few months. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 11 Postponement of return to active duty of personnel with active reserve commissions will be based upon the policies of the Department of Defense relating to critically ILLEGIBLE skills. Policy with respect to ILLEGIBLE of retaining employees with inactive reserve commissions who cannot be placed remains to be met. Deferment of induction for personnel without reserve commissions will be requested if they have scarce skills and are not replaceable. As the role of N.I.H. in the defense area is clarified, employee will be urged to remain at N.I.H. if their work is related to defense. 13. Publicity Publicity should reflect the policies outlined above. The case for maintaining basic research should not be ignored because the position of the Public Health Service will influence the nature of medical research over the next few years. Public relations activities of N.I.H. will be reviewed to determine the degree of relationship of each area of activity to the defense program. The nature and degree of redirection of effort is being worked out." While these general principles here by and large remained as the basis for N.I.H. defenses activities the actual application of the principles to both the internal work of the laboratories and to the grant program was complicated by a number of factors. II. Practical Problems Encountered in Adjusting N.I.H. Activities to Defense Needs A. Indefinite Status of N.I.H. as a Defense Agency While there was general recognition throughout the executive branch of government that the Public Health Service possessed unique facilities, REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 12 personnel and relationships that were critically important for a National defense program, neither the Public Health Services nor the N.I.H. as a component of the Public Health Service, were clearly and unequivocally designated as defense agencies. This situation both made judgments of the N.I.H. as to how rapidly and how extensively it should convert its research to defense needs, and created difficulties in carrying out general decisions once they were made. The importance of the psychological factor should not be underestimated since the task of a laboratory director in changing the nature of the activities of his research staff rests, in large part, upon his ability to motivate his staff. In the absence of a research director, such extensive conversion of research would have been difficult. In retrospect, it appears that extremely extensive conversion of the existing program would not, as a matter of fact, have contributed to the National defense. Hence, the indecision and wavering which seem to characterize not only policies relating to N.I.H., but policies relating to the scope and urgency of the defense effort of the nation as a whole, may well have been the atmosphere best designed to secure the degree of conversion that, in retrospect, appears to have been most appropriate. B. Inherent Limitations on the Flexibility of a Research Organization. At any given time any research laboratory is composed of a given staff working upon a set of problems. The extent to which, and the rapidity of which the work progress of a laboratory or a set of laboratories can be altered is limited. The primary limitation is the training, experience and interests of the research staff. When extremely urgent problems in the field of medicine and related sciences must be resolved existing work can be dropped and new work undertaken. In an extreme emergency people with sound REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 13 general training and extensive experience can be set to work on problems quite remote from their field of specialization. The consequences of such a change, however, are the disruption of the long range program of the laboratory and the investigator and, in all probability, some decrease in the effectiveness of the new program. The difficult problem that has faced the NIH throughout the period of semi-mobilization has been to judge how extensive conversion should be in the light of the urgency of the National situation. The general policy that has been arrived at has been roughly consistent with the major decisions taken for the economy as a whole. The production effort, for example, has not been an all out effort. The civil defense effort has not been at a maximum. Economic controls have been fairly loose. In concrete terms general decision at NIH has been to select defense related research which is (1) obviously of the utmost urgency to the Nation, (2) the type of investigation to which the talents of existing staff can be profitably turned; (3) areas of research which hold promise of general scientific productivity as well as promise of providing specific answer to defense problems. C. Indefinite Duration of the Emergency as a Factor Affecting Defense Related Research at NIH Careful consideration of defense related defense at NIH has led to the conclusion that the National defense would not be best promoted during a period of long semi-mobilization by conversion of the staff to specific applied problems of immediate importance to the Armed Forces. The Armed Forces have their own research installations and contract authority to handle such problems. Medical and related research will, over the long run, contribute REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 14 most effectively to National defense if a substantial portion of the Nation's talent and facilities continue to be devoted to basic problems. Such a policy at this stage has the further advantage of sustaining a reservoir of personnel, equipment and facilities that can be turned to immediate problems of defense in the event of an all out war. This line of reasoning has played an important part in determining the nature and degree of the shift of NIH research activities to defense related work. D. Dispersion v. Maintenance of NIH Staff as a Research Unit During World War II there was an extensive reshuffling of research personnel from existing laboratories to newly established research organizations. This was true not only in medicine and related fields but in all areas of research. Postwar consideration of the effects of this policy by those who controlled scientific strategy in this Country during World War II has led to a firm consensus that every effort should be made to utilize research groups in existing organizations, and to minimize the establishment of new organizations for research. The NIH has, therefore, adopted the policy that the contribution of the staff to defense work will be made primarily by their efforts at NIH, revised as may be necessary to take account of defense needs. In exceptional circumstances, however, individual scientists may be detailed or transferred to other research organizations when it is clear that their acceptance is such that they can contribute more effectively as part of another research group. E. The Characteristics of the Research Grant Program as a Special Problem The same major considerations that have governed the defense activities of NIH laboratories themselves have applied to the Research Grants Program. The reasoning outlined in the internal memorandum quoted above, REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 15 in addition to the general applicability of the factor mentioned in this section, have led to a firm decision not to put pressure upon universities, to shift in any wholesale manner into defense research. F. Practical Budget Problems In any given fiscal year the NIH has a given sum of money available from Congressional appropriations and a general understanding with the Congress as to how these funds will be expended. In the absence of a National crisis this understanding with Congress sets limits upon the extent to which the research program can be shifted to ends that have not been explained to the Congress. During the period under consideration, proposals for medical research that might be undertaken by NIH were offered by a number of groups in general terms. Both the National Security Resources Board and Civil Defense Administration, for example, suggested that NIH undertake certain general areas of research. The first agency, however, was a planning group, and the second had very limited funds. Hence, compliance with these requests would have necessitated cancellation or postponement of some research in progress at NIH in favor of that proposed by other agencies. the discussion below indicates how these requests were verified and the extent to which existing programs were revised. ILLEGIBLE. The very practical problem of financing defense related defense has played an important role in NIH decisions during the period under consideration. G. Security Classification When any laboratory undertakes an extensive research program directly related to National defense, it is quite probable that some or all of the work must be kept secret. The NIH, out of concern for the productivity of its staff, has attempted to minimize the areas of secrecy by keeping to a minimum the areas of work which involve classified information. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 16 The hampering effects of secrecy on scientific output must be constantly assessed against the urgency of getting classified work done. The position of the NIH has been that the urgency of the National situation has not been such as to warrant large scale staff concentration upon classified problems of interest to the military forces and the Atomic Energy Commission. R. Secrecy The questions that have thus far been discussed were a matter of major concern to those responsible or NIH policy over a period of several months. They were not answered all at one time, but rather, as an accumulation of impressions and judgments. There follows in the section below, a description of the substance of major NIH defense related research programs. An examination of these will indicate how the generalizations that have been outlined were applied to specific problems. III. Major Defense Related Research Activities of NIH A. Malaria Investigations Resulting From the "Police" Action in Korea 1. Nature of Study As a result of the Korean situation a Subcommittee on Malaria of the Committee on Medical Research of the National Research Council, convened on 29 December 1950 for the purpose of deciding whether additional research on the therapy of malaria was needed. It was decided at that time to ask the Public Health Service (NIH) to undertake an evaluation of the curative potentialities of certain 8-amino-quinolines. As a consequence of this request, the Public Health Service set-up facilities for carrying out this request in the Federal Penitentiary at Atlanta, Georgia in cooperation with the Department of Justice, and the Army; operations began April 24, 1951. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 17 Our responsibility was to infect and treat 200 volunteers, these to be divided into six equal groups, using four drugs and six dosage regimens. By December 30, the 200 men had been infected and most of the observations had been completed. The rest of the project up to January 1 was approximately $60,000. Personnel consisted of two medical officers, one chief nurse, one nurse, one technician, three Army corpsmen and the Army technicians. Early this year we were requested to continue the project with three objectives: 1. Continuation of studies begun in 1951. 2. Carry out tolerability studies on a new drug ILLEGIBLE (50-63) 3. Carry out resistance studies. In this work we will use the same staff and will probably spend in the neighborhood of $40,000. The Public Health Service makes a further contribution to these studies in that the mosquitoes for infecting the volunteers must be raised and infected by Dr. Jeffery at Milledgeville, Georgia. The Army pays the salary of one technician in Dr. Jeffrey's laboratory. 2. General Considerations Relating in the Malaria Investigations The "why" of this study is fairly obvious. While the anti- malarial drugs used during World War II were suppressive, postwar developments disclosed new drugs which might cure, rather than suppress malaria. Since it seemed quite probable that large numbers of American troops would be in areas where malaria is endemic, a rapid test of these drugs was clearly ILLEGIBLE. As to the "how" of this area of research, two points are particularly significant. The first is, that the decision to undertake the study was the result of the consensus of highly informed medical authorities REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 18 many of whom are not associated with NIH. The second point is that the actual conduct of the study, including financing, has involved cooperation between NIH, the Federal Bureau of Prisons of the Department of Justice, and the Department of the Army. B. Hepatitis Studies 1. Nature of the Study The Public Health Service hepatitis program was initiated following an ad hoc meeting on December 6, 1950, under the aegis of the Committee on Sterilization of Blood and Blood Derivative of the Hematology Study Section of the National Institutes of Health. Dr. Joseph Stokes, Jr. acted as chairman. It was unanimously agreed at this meeting that in view of the importance of the serum hepatitis question to the National Blood Program and because of the nature of the data on which requirements for ultraviolet irradiation were based that a strong recommendation be made to the Public Health Service that it undertake at the National Institutes of Health at the National Institutes of Health a study of serum hepatitis virus in human blood and blood derivatives. Preliminary negotiations indicated the feasibility of carrying out this study within the laboratory of Biological Control with the cooperation of the Laboratory of Infectious Diseases of the NIH, which was already carrying on a study of infectious hepatitis, and the United States Department of Justice, Bureau of Prisons, which indicated that arrangements could be made for access to human volunteers. Dr. Oliphan, who had done some of the original work on irradiation and who was present at the December meeting agreed to head the project. Dr. Oliphan reported for duty on February 5, 1951, and actual work was initiated in May 1951, primarily to investigate methods of sterilizing blood products with respect to the virus homologous serum hepatitis but in addition to develop any other information which might be helpful in solving the hepatitis problem such as epidemiological studies among persons receiving irradiated plasma and to carry out human irradiation studies with the virus of infectious hepatitis. As the results of the first ultraviolet irradiation experiment, reported below, began to manifest themselves, it was apparent that all the human volunteer resources at the disposal of the project were needed to investigate methods of sterilizing blood derivatives. For this reason it was decided that some of the original work upon which the requirements for the irradiation of plasma had been based be repeated and that the proposed epidemiological studies not be pursued. Since this time a more limited though promising epidemiological study along these lines has been instituted elsewhere in the Laboratory of Biologies Control. The program was expanded in October 1951 to include a nutritional study aimed at determining the effect of a high protein diet on recovery in cases of hepatitis. Volunteers developing hepatitis in the course of the present program were considered to be particularly suitable for this purpose because of the opportunity of early treatment. Facilities and Resources Apart from the support provided by the Armed Forces Epidemiological Board the project has at its disposal the following facilities and resources: 1. Access to the facilities of the Laboratory of Biologies Control and of the National Microbiological Institute. 2. Through the Laboratory of Biologies Control to all agencies and laboratories engaged in the processing of blood and blood products for interstate commerce and for the National Blood Program. 3. Through arrangements with the Bureau of Prisons, Department of Justice and with the cooperation of the Prison Medical Service (staffed by Public REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 20 Health Service officers) the project has access to volunteers in the following institutions: United States Penitentiary, Lewisburg, Pennsylvania, United states Penitentiary, McNeil Island, Washington, Federal Correctional Institution, Ashland, Kentucky. Space has been set aside for use of this project in the hospitals of the first two institutions. This is particularly suitable for the serum hepatitis patients. In the institution at Ashland, Kentucky, a portion of the quarters normally reserved for admission and orientation has been set aside and is suited to the infectious hepatitis studies. It is estimated that approximately 80 to 100 volunteers will be available at any one time in each of the penitentiaries mentioned, and that 18 volunteers will be continuously available at Ashland. 2. General Considerations Relating to the Hepatitis Study Both the "why" and "how" of this study are essentially similar to the malaria investigations. One additional point, however, is worth making. Personnel had to be shifted to build the research team that was considered necessary for this undertaking. Regrouping of personnel in shifts and duties is a major practical problem encountered when a research organization changes its program extensively. C. Sectional Research Program in Microbiology 1. Nature of the Study The Sectional Research Program in Microbiology of the Public Health Service has two major objectives. It is a plan to encourage and support original research by independent investigators in problems of infectious diseases of man which may be important in national defense. Secondly, it is a plan to develop more definite collaboration between research centers engaged in these investigations and the official health agencies which have REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 21 the basic responsibility for the control of communicable diseases. Although the Public Health Services at the present time has no direct responsibility in defense against biological warfare, it seems appropriate that we ILLEGIBLE to encourage the expansion of microbiological research along these lines and the strengthening of these relationships. From the viewpoint of modern public health as well as National defense there is a great need for intensified research leading to better diagnostic, immunizing, epidemiologic, and therapeutic procedures in infectious diseases. There must be more fundamental as well as developmental work directed toward a solution of these problems. Some of the essential lines of investigation are: 1. Methods for faster and more accurate identification of disease agents. 2. Simpler methods for the detection of antibodies. 3. Methods for immunization after exposure to infectious agents. 4. Methods for treatment after similar exposure. 5. Treatment for certain virus diseases for which therapy is now ILLEGIBLE. 6. Better general immunization with more effective and lasting protection. 7. Better methods of epidemiologic investigations. The development of these aspects of investigation will require expanded work in research centers already working on similar problems, and a continuous and sustained program of research over a period of years. In order to utilize fully the knowledge gained through these efforts and to capitalize on the skills of the investigators it will be necessary to encourage better means of communication between the research workers and the official health agencies and a closer relationship between investigation of infectious disease outbreaks in the field and the laboratory facilities for specific diagnosis. The stimulation of investigations of these problems in infectious diseases should develop an increasing number of investigators ILLEGIBLE REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 22 ILLEGIBLE ILLEGIBLE and accurate diagnosis of infectious disease and expert in prophylactic and therapeutic procedures. This group will constitute an important resource in National defense not only in the results of their investigations, but in their abilities to assist official health agencies in a National emergency. These laboratories should be available to official health agencies for expert assistance in the event their services are necessary. In order to encourage investigations in all parts of the United States and make these laboratories resources available where they may be immediately needed, the pattern of the Influenza Study Program in the United States has been followed. The Influenza Study Program was originated in 1948 to improve the specific diagnosis and reporting of influenza and to study recently isolated ILLEGIBLE, and was organized on the basis of location of laboratories, specific abilities and interests. The Sectional Research Program, twelve outstanding investigators in various parts of the United States, including six already operating in the Influenza Study Program, have been invited to work with other scientists in their vicinity in the implementation of this Program. As not ILLEGIBLE, three of those coordinating laboratories are State Health Department laboratories, two are Public Health Services laboratories, and seven are located in universities. Associated with each of these laboratories will be from five to ten nearby participating laboratories located in universities, State Health Departments, hospitals, or research institutions. These laboratories have been selected to cover broad fields of interest in microbiology and in general these are laboratories in each section which have specialized interest in microbiology and in general there are laboratories in each section which have specialized REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 23 interest in virus, ILLEGIBLE, mycotic, exotic bacterial, and veterinary diseases to ILLEGIBLE to man. While no one laboratory necessarily need be expert in all of these diseases, an effort has been made to include at lest one laboratory specially interested in each of these types of disease in each geographic section. Participating laboratories may request support for their research activities from Research Grant fund of the NIH. These investigations can be independently pursued by the grantee under principles already established by the Division of Research Grants of the NIH. An ad hoc committee composed of the twelve coordinators and representatives of the military services, the Bureau of Animal Industry, and the PHS will review applications for grants and recommend awards. However, as a part of this program the research laboratories will no be asked to do routine diagnostic work which can be performed by State or municipal heath department laboratories. They will not participate in public health administration or be asked to become an operational part of a public health organization. Their time and energy must be kept free to devote to research and only in unusual circumstances or at their own request should they be called upon by official agencies for expert aid. In addition to such relationships as now exist between laboratories and health agencies, the directors of the coordinating laboratories will inform the PHS Regional Medical Directors in regard to the specialized participating laboratories in their section and transmit appropriate and pertinent information to them. Regional Medical Directors will make this information available to the health officers of the States in their Regions. The whole program will REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 24 be coordinated in the National Microbiological Institute of the NIH. While the arrangement has been set up in geographic sections, these lines are not strict and requests, of course, may be made of any laboratory which is ILLEGIBLE to render assistance. The Communicable Disease Center at the PHS has established a program to strengthen epidemiologic and laboratory service through State Health Departments and to train epidemiologists by the assignment of medical officers directly to certain State Health Departments and Public Health Service field stations. These officers will be on call to investigate outbreaks of disease in any state in the United States through the regular procedure of the communicable Disease Center and the State Health Departments. Their investigations may be supported on request by such services as the participating laboratories of the Sectional Research Program are willing and able to provide. Such a program of research collaboration and technical aid may provide service that will develop into a usable part of a civil defense operating program in the field of biological warfare. If this happens, the conditions under which services will be made a part of a civil defense operating program will be determined by the Federal Civil Defense Administration or by such agencies as it may stipulate and by the participating laboratories. This program should bring beneficial results not only in better preparation for National defense but also in improved methods for normal public health activities and particularly in reciprocal collaboration between research centers and official health agencies. 2. General Considerations Relating to Sectional Research Programs in Microbiology The Sectional Research Program is described in some detail because it is a key study in the manner in which the Research Grants Program REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 25 can be utilized effectively and without improper pressure upon independent investigators to further defense related research. The research program outlined above is a specific example of the manner in which the NIH believes that basic research should be promoted in order to provide information of fundamental importance to National defense. This program is also a specific example of the manner in which the NIH can contribute to the appropriate kind and degree of mobilization of scientific talent in the field of microbiology in the absence of a statutory mandate. The practical problem encountered was that Civil Defense Administration sorely needed this activity, but during the period under consideration it did not have the professional contacts, a full regional organization, technical headquarters ILLEGIBLE, nor funds. Hence, the actual planning and operation of the activity ILLEGIBLE upon NIH. B. Blood and Blood Fraction Research Program 1. Nature of the Study With the Korean invasion, a greatly intensified medical research program to develop more effective means for collecting, preserving and using blood and its fractions and more knowledge of the medical value of the various components of blood became a matter of first priority. The priority importance of this program can be stated simply. In event of a toxic bombing or large scale attacks on U.S. cities by ordinary bombs, a large proportion of deaths both civilian and military, would come from shock, from burns and from hemorrhage. Plasma and plasma substitutes are essential, but in addition many thousands of cases would require whole blood. Whole blood can be preserved for only a few weeks. It therefore cannot be stockpiled. Moreover, sufficient donors, trained personnel or physical facilities for immediate blood replacement would not be available during the confusion of a major catastrophe. Therefore, REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 26 research into the entire problem of blood-collection, preservation and fractionation, and the effects of blood fractions and blood substitutes on various types of injury -- immediately become a matter of supreme importance. The total research problem was so complex and the number of governmental and other agencies with a direct interest in the problem was so numerous, that the actual formulation of a research program that would best deal with the acute problem was an undertaking of some difficulty. Some of the organizations with an interest in the problem included the American National Red Cross, the National Research Council, the Federal Civil Defense Administration, the Department of Agriculture, the Department of Defense, the National Bureau of Standards, the National Security Resources Board, various independent blood banks and State agencies and universities and other research centers. The entire problem was made more difficult by the fact that the research program had to integrate with a complicated National program for recruitment of voluntary blood donors, blood collection activities and the allocation of blood. Representatives of the NIH and of the PHS participated in the extended conversations which preceded the actual establishment of a research program. It was finally decided that the NIH would allocate $600,000 from the Center, Health and general research grant funds. A technical committee of scientists was set up to advise on the scientific aspects of the program. This group set the general area of emphasis for the blood research program. Since other sources of funds for blood research were available a major problem was to determine who the program of the NIH could be most effective as part of a wide program. As an example of the types of decisions which had to be made, it was REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 27 concluded early in the development of the program that few grants in the field of plasma substitutes would be made since the National Research Council was supporting a great deal of work in this general area. The final outcome of the research program fell into three parts: In the first category of basic research, emphasis was placed on the separation, purification, storage and use of the various formed elements of the blood which can not be substitutes for whole blood. Among the formed elements, red cells, responsible for carrying oxygen throughout the body, can now be separated and preserved for only a short time. Preservation of these cells for much longer periods is necessary before stockpiling can become feasible. The separation and preservation of the blood's white cells (to combat infection) and platelets (for blood coagulation) are almost equally urgent research problems according to Dr. ILLEGIBLE. The second major category, developmental research, consistent of technical experiments designed to develop improved methods for blood collection. The Committee for Research and Development headed by Dr. Charles ILLEGIBLE ILLEGIBLE of Ohio State University was allocated $215,765 of the currently available funds for use in the field of developmental research. This sum was given used to adapt results of test-tube research to large scale production of blood fractions. Emphasis was placed on the development of special equipment, such as centrifuges, refrigeration equipment, plastic equipment such as transfusion kits as substitutes for glass or metal which usually damage the separated elements of the blood, and on mobile processing equipment. In the third major category, clinical research, PHS funds will be used to support research which seeks to determine as rapidly as possible the REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 28 relative effectiveness of the formed elements, whole blood and blood substitutes in the treatment of burn, shock and radiation injury. After consideration of work proposed and work in progress in various universities throughout the country, grants were made to some twenty principal investigators to carry on various aspects of the program. Since the Federal Civil Defense Administration has expanded its budget the temporary expedience of financing the blood research program from NIH funds has been abandoned and the work will henceforth be financed by FCDA, with transfer of funds from NIH for disbursement to the various investigators. The current level of support from NIH funds -- F.Y. 1952 -- is $800,000 as compared with the level of $600,000 for F.Y. 1951. In F.Y. 1952, moreover, the entire program was carried as a part of the budget of the National Heart Institute. As all of the aspects of the National blood program, including not only research, but the other factors mentioned above, went into operation the need for some classification of responsibilities became evident. This was done in a Presidential memorandum of December 30, 1951, and through a statement of policy issued by the Office of Defense Mobilization on February 18, 1952, under the general authority of the Presidential memorandum. The portion of the office of Defense statement relating to research is as follows: Research on Blood and Related Problems 1. A committee on blood and related problems shall be established in the National Research Council for the purpose of: a. service as a clearing house for the exchange of information related to research on blood, blood derivatives, and plasma expanders; REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 29 b. formulating, stimulating, and evaluating programs of research in the blood, plasma, blood derivatives, and plasma expanders field, and c. making recommendations on the basis of the facts established to the various agencies involved in the operation of the National Blood Program. 2. This committee shall be composed of experts in the blood field with liaison representatives from the Department of Defense, Federal Civil Defense Administration, American National Red Cross,the Office of Defense Mobilization, the United States Public Health Service, the Food and Drug Administration, and other agencies concerned with these problems. 3. Scientific problems in the field of blood requiring investigation shall be referred to the National Research Council committee by using or by administrative agencies, such as the Department of Defense, the American National Red Cross, the Federal Civil Defense Administration, the United States Public Health Service, the Food and Drug Administration or by groups affiliated with the National Research Council committee on blood and related problems through membership representation. 4. The National Research Council shall keep the Office of Defense Mobilization informed of the progress of its work on blood and related problems. 5. Funds shall be provided for the work of the National Research Council Committee on Blood and Related Problems by participating agencies in accordance with established practices." 2. General Considerations Relating to the Blood Research Program The Blood research program is a primary example of the manner in which a Federal medical research grants program can be deliberately adopted to meet some urgent National need without coercing or unduly influencing the scientific decisions of individuals investigators and groups of investigators. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 30 Over the long run, as a guide to administrators, this may prove to be the most important single aspect of the blood research program. In common with the studies described above, the evaluation of the blood program indicates the extensive set of negotiations that appear necessary when a research bank involving the interests of a large number of groups is undertaken. E. Radiation Research 1. Nature of the Study The significance of research relating to the biologic effects of ionizing radiation need not be elaborated. The NIH has approached this problem administratively in three ways: 1. The investigations of a team that has been interested for a number of years in the effect of ionizing radiation upon individual cells and upon specific body functions has been expanded. This expansion has been, in part, financed by the Atomic Energy Commission. It is worth noting that in this case the work already in progress was precisely the type of a study which was felt by the Atomic Energy Commission to be necessary as a segment of the studies called for by the possibility of an atomic attack. Finally, it is worth pointing out that these investigations are not classified. This is an indication that with careful selection a substantial volume of research bearing directly upon defense can be undertaken without moving into the "secret" area. 2. A second major activity of the NIH relating to radiation research has been participation in the medical and biological aspects of atomic bomb tests. A large share of the expanse of this activity has been borne by the Armed Forces Special Weapons Project. The substance of this work is classified. 3. A third segment of radiation research has been undertaken under the REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 31 research grants program. This area of investigation relate to the effect of ionizing radiation upon primates. No study of the effects of heavy doses of radiation can be finally conclusive until detailed studies are made with human beings as subjects, controlled experimentation of this nature being clearly impossible. Monkeys, however, can be studied within a fair degree, with the hope that the effects observed in them may be translatable to human beings. Such an investigation has been designed with the cooperation of the Atomic Energy Commission and the Armed Forces, with the assistance of advise both from the National Cancer council and from technical groups. As is the case under the blood program, the actual experiments are conducted by selected investigators in university research centers. 2. General Consideration The radiation research program of the NIH is an example of the use of three devices to facilitate defense related research - - continuation and intensification of work already in progress, diversion of NIH personnel in studies of the utmost importance in relation to atomic warfare, and stimulation of a planned program of research in universities through financial support provided under the research grants program. 1Dr. John W. Oliphant, principal investigator since the initiation of these studies, died unexpectedly on January 10, 1952. Dr. Roderick Morray, formerly Asst. Chief, Laboratory of Biologics Control, NIH, has been in charge since January 15, 1952. CVKidd:ab May 12, 1952 REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 32 IV. Administrative Questions Within the Federal Security Agency Bearing Upon Defense Related Research at the National Institutes of Health The evaluation of defense related research at NIH cannot be fully understood simply by a description of evaluation of policies within the NIH as a single operating entity, by a description of the relationships between NIH and other governmental and non-governmental agencies, or by a description of the why and how of defense related research. There remains the significant impact of the place of NIH as a constituent part of the Public Health Service and of the place of the PHS as a component of the ILLEGIBLE. A. Coordination of NIH Defense Related Research with Other Research Activities of the PHS By far the most significant set of relationships that had to be resolved in framing the internal NIH research program in relation to defense were those concerned with investigations of airborne disease agents. When the police action in Korea was undertaken, four PHS laboratories were engaged in work bearing upon this area. The first was the development of means of collecting air samples that would make identification of disease agents easier, quicker and more precise. The second was identification of substance found in the air and, the third was assessment of the significance of airborne disease agents as a source of human disease. This research had been undertaken not specifically in relation to defense problems, but as an element of the continuing research program of the PHS. The question immediately arose as to whether this program was of the appropriate size and nature called for in the light of the emergency, and whether the allocation of research functions among units of the PHS was appropriate. The question was approached both from the administrative and the technical level. REPRODUCED AT THE NATIONAL ARCHIVES DECLASSIFIED E 0 10501 BY BF NARS DATE 6-29-93 33 At the administrative level conferences among representatives of the Bureau of State ILLEGIBLE and the NIH were held to block out in general terms the areas of research that would be covered by the various laboratories. The specific research units concerned were the National Microbiological Institute of the NIH, and the Communicable Disease Center, the Environmental Health Center and the Division of Occupational Health of the ILLEGIBLE. It was decided that the NMI would concentrate its efforts upon basic medical research relating to such matters as the basic factors influencing the susceptibility of humans to airborne disease agents to the ultimate characteristics of the agents themselves and to new means of preventing and treating clinical illness. The Environmental Health Center would engage primarily in highly technical research to develop devises designed to improve the efficiency of collection of microorganisms from the air. The Division of Occupational Health would center its efforts on the study of chemical contaminants of air or reasons for their presence and means for preventing and dispersal or removing them. The Communicable Disease Center would center its attention upon epidemiological studies and upon the development of means of improving the speed and accuracy of reports upon the ILLEGIBLE of airborne diseases. An understanding was reached that these would be the focus of each of the research units but that they would not be construed as prohibiting relatively minor undertakings in areas outside the scope of the responsibility of each research unit. At the technical level the problem of coordination was approached through a thorough technical symposium attended by the principal investigators engaged in work relating to airborne pathogens. This conference was held at the Environmental Health Center at Cincinnati, Ohio on July 12 and 13, 1951.