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RESPONDING TO HEALTH NEEDS AND SCIENTIFIC OPPORTUNITY THE ORGANIZATIONAL STRUCTURE OF THE NATIONAL INSTITUTES OF HE: ALTH Report of a Study by a Committee of the INSTITUTE OF MEDICINE Division of Health Sciences Policy October 1984 National Academy Press Washington, D. C. 20418 .

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NOTICE: The project that is the sub ject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. The work on which this publication is based was performed pursuant to Contract No. N01-OD-3-2105 with the National Institutes of Health of the Department of Health and Human Services. Support for this project came from Evaluation Set-Aside funds (Section 513 of the PHS Act), Evaluation Project No. NIH-83-309. - 2101 Constitution Avenue, N.W. Washington, D.C. 20418 (202) 334-2352 Publication IOM-84-06

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INSTITUTE OF MEDICINE N^rioN^~ ~C^O~, Of 5ClNCS 2~0' co-srlrurio~ Cutout w^~ro-. o. c. 2044e rore,cx c. loosely. ~ 0 a.~.oc~r The Honorable Margaret it. Heckler Secretary Depertasnt of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 her Made0 Secretary: ac-tob.r 16, 1984 This report, Responding to Health Needs and Scientific O8~ortunitv: The Organizations Structure of the National Institutes of Health, is submitted in fulfillment of the request to the Institute of Medicine, National Academy of Sciences, to review the orgenisetional structure of the National Institutes of Health and to Hake recommendations of changes that sight better equip the institution to deal with the future expansion of scientific and technologic knowledge. It also was requested that criteria be developed by which proposals for the creation of new institutes or other Major structural changes could be evaluated . The report was prepared by a distinguished study committee headed by one of the country's most eminent scientist-states~n. The study committee and its excellent staff engaged in an intensive period of informing themselves in a var iety of ways which Ire discus ted in the report. Their task was greatly assisted by the Liaison co~itt" created at the NIB and chaired by ache Deputy Director, Dr. Too - e Malone. This committee was able to see that cats were made available to the study committee and to check descriptive "serial for factual accuracy. However, although they were important in making the study possible, they played no part in the study co~ittee's deliberations or in shaping i ts recommendations . The study committee chose to present their f indings and recommendations in a brief readable document. While this differs from the format of so" other repot ts, I suspect that the average reader will applaud this approach. Much of the documentation on which ehe s tudy committee based the it analys is and conclus ions is to be found in the appendices or in background mater isle available from the National Academy Preps. Some readers, particularly working scientists, may be disappointed that the report does not deal with some of the issues of special interest to them. These include concerns about peer review, relations between the intramural and extramural programs and var ions other managerial questions. As indicated in the report, the study committee was informed, in the course of their in~rcstigations, of son. problem and concerns in those areas. However, it was not within their ~ndatc

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The Honorable Margaret M. Heckler October 16, 1984 Page 2 to further investigate these issues and the Study commitee. itself felt that its attention was properly focused on the issues discusa~d in the report Among the recomb ndatione of the study committee is the proposed creation of a Health Science Board to advise the Secretary through the Assistant Secretary for Health on the desirability of any proposed change in the organizational structure of the health research program of the Public Health Service R actions have tanged fro. strong support to equally strong opposition for the idea. The criticien. have centered around the possibility that the board Might become politicized The study committee was not unmindful of the issues that have been raised but can to the conclusion that on balance the board would meet an important need The co aitte suggests ways to Minimize the likelihood of its becoming unduly political Furthermore questions were raised about whether or not in this instance the study committee had exceeded its charge because it proposes that the board be concerned with research throughout the PER and not only in the NIH Because many of the most important organizatione1 issues today involve the boundaries of the NIH Mission this reco~acndation is appropriate Although the study committee makes a number of suggestions for change they also comment on som of the strengths of the organization and above all what a tremendous resource the NIH has become for our country and indeed the world It is to be hoped that this report will be of assistance in preserving and strengthening this uniquely successful institution of our society as it faces a future of unparalled opportunity With kindest regards cc: James B. Wyngearden, M. D. Edward N. 8randt, Jr ., M. D. Frederick C. Robbine M ~

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CONTENTS committee Study Staf f and Acknowledgement. Pre face Pane 1 ~ Lis ison Cocci ttee Background Papers SU~QL1RY Organizat tonal E,rolut ion NIH and the Health Policy Environment Ensuring ~ Manageable Structure for NIH 1 . INTROI)UCrION The Hi ~ ~ ion o f N IN The Organizational Structure of NIH Recon~entse ions 2. ORGANIZATIONAL EVOLUTION Growth and Organizational Change Overal 1 NIH Appropriae ions Appropriations for the Affected Institutes The E f fee t on Sc fence and Management Responding to Needs and Opportunit ie. Sens ing the Need for Act ion Re search P land ing Range of Effective Responses The Bas is for Ma jar Organizat tonal Change A Process to Assess Proposed Organizational Changes Criteria to Assess Proposed Organizational Changes 3. NTH ANT) TlE HEALTH POLICY ENVIRONMENT The Need for Communication and Coordination The Scope of Health Research Governmental Patterns ant Prace ices The Hes 1 th Sc fence Board ~ Cont inued on next page ~ ALL LX X . . ~ Xt[L X,, ' . X,,` 3 4 8 9 10 10 11 12 14 16 18 18 19 20 20 21 24 24 24 25 26

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ENSURING A MANAGEABt.E STRUCTURE FOR NIH Overall Coordination and Accountability The Authority of the NIH Director Delegation of Authority to the Director Enhanced Budget Authority NTH Policy and Planning Counc it Structure of the Director's Office Clustering of Institutes Pub 1 ic and Sc iene i f ic Accountab i 1 ity Net ions1 Advisory Counc i Is Boards of Scientific Counselors Co~unicat ion Quality of Scientific Advice NOTES APPEND IDES A. Meetings and Contacts B. like Current Organizatione1 Structure of the NIH, Thomas 1). Morris - v~ 30 30 31 31 32 32 34 36 35 35 36 37 37 38 43 43 63

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INSTITUTE OF CHICANE Division of Healeh Sciences Policy Committee for a Stud, of the Organizational St ructure of the National Institutce of Health JAMES D. EBERT, Ph. D., Chair, Prceident, Carnegie Institution of Washington, and vice President. tiationet Acate~sy of Sciences, Wachingeon, D. C. STEVEN C. BEEPING, M.D., President, Purdue University, West Lafayette, Indiana BARUJ BENACER~, it. D., Pres itent , Oana-Farber Cancer Inst itute, Bos ton, Mas sachuse t es WILLIAM BEV0, Ph. D., Vice President and Director of Health Programs, The John D . and Catherine T. MacArthur Foundat ion, Chicago, I 1 linois STANLEY COHEN, Ph.D., Professor of Biochemistry, Vanderbilt University Schoo 1 o f Med ic ine, Nashvi 1 le. Tennes see MACLYN >2c CARTY, M . D ., Pro f e ~ sor Emer i e us, Roc ke fe l ~ ~ r Univers ity, New York, New York THOMAS D. MORRIS, Washington, D. C. GEORGE E. PACE, Ph.D., Vice President, Xerox Corporation, Palo Alto Research Center, Palo Alto, California DON K. PRICE, Professor, John F. Kennedy School of Government, Harvard University, Cambridge, Massachusetts DAVID S. SAXON, Ph.D., Chei.nnan of the Corporation, Massachusetts Institute of Technology, Cambridge, Massachusetts MARGERY W. SHAD, M.D., J.D., Director, Health Law Program, Health Law Institute, Houston, Texas HOWARD E. SI - ONS, JR., Ph.D., Vice President, Central Research and Development Department, E. 1. du Pone de Nemoure ~ Company, Inc., Wi lmington, De [aware V1L .

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SAMUEL O. THIER, M.D., Sterling Professor ant Chairman, of Internal Medicine, Yale University, Ncv Haven, Connecticut JOSEPH F. VOLICER, D.~.S., Ph.D., Distinguished Professor, University of Alabama in Birmingham, Birmingham, Alabe~ ADAM YARMOLINS KY, LL.B., of Counsel, Kominers, Fort, Schlefer ant Boye r ~ Wash ington ~ ~ e C - - V ~ L ~

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INSTITUTE 0E MEDICINE Pres ident Frederic k C. Robb ins, M. D . Division of Health Sciences Policy Barbara Fitner, Ph. O., Director St,,dV 51~ Michael A. Stoco, Ph.D., Study Director Stephen D. Nelson, Ph.D., Senior Professional Associate Pamela J. Saith, 8.S., Research Associate Cynthia J. Howe, 8.~., Research Assistant ltireille G. Mes ins, Administrac ive Secretary Talitha D. Evans, Senior Secretary Ac know ledgements The conenieeee appreciates the contributions of Any persons ant organizations who provided information throughout the study, afoot of whom are listed in Appendix A. we are especially grateful to the staff of NIH and the Department of Health and [lumen Services, including members of the special liaison committee chaired by Dr. Thong Malone, the project officer Kurt Habel, and many others who gave generously of their lime. Special thanks are due to the writers of case studies and other background papers used by the committee and panels, including Philip Caneelon, Philip Caper, Michael Duffy, Ruth Harris, Veronica Hill, Lorna Jaf fe, Betty Lockett, Laurel Radow, and Terri Schorz~n. We are especially grateful to Dr. Enriqueta Bond, Director of the Institute of Medicine' Division of Health Sciences Policy at the time the committee ' ~ charge was being defined and while the committee was getting underway, not only for her essential contributions at that time, but also for valuable assistance at every stage of our work. Finally, the Meyers of the committees and panels would like to express their appreciation to the capable and energetic project staff whose preparation and organization made the con~ittes's work possible. LX

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PREFACE The idea of ~ study of the organizational structure of the National Instieuees of Health (NIH) first arose while the Congress was considering the Health Research Act of 1982 Because of concern about the number of proposals to establish new institutes and make other organizational changes in NIH, a provision calling for a study by the Institute of Medicine was inserted in the bill For unrelated reasons, however, the bill never became law NIH and the Assistant Secretary for Health of the Department of Health ant Hum n Services realized the importance of such study for focusing the debate about organizational changes, and in the spring of 1983, contracted with the Institute of Medicine to establish the Com~ieeee for a Study of the Orgenizeeionet structure of the National Institutes of Health The committee has been asked to "~ckc an independent objective study of the organizational structure of the NIH and considering scientific developments and economic conditions reconmend the establishment of criteria (standards) to be met in determining the need for any substantial change in the organizational structure of the NIH," and (according to the contract) to perform the fol lowing three tasks 1. Analyzes of Organizational Evol Lion Conduct a thorough, systematic review of the agency's organiZatiOQat evolution and development. This analysis chalk include a review of the organization's development and an examination of the contributing factors involved in much development. The contractor shall also examine the present organizational structure and the underlying rationale for this structure. 2. Current Oreenizat ion Analys is Examine the present approach for those issues which cut across organizational ~ ines. The contractor shall examine the teas is for the current methods of handling such issues and develop alternative approaches for cons iderat ion. The rat ions le for ant implicceion within the current NIH structure of all approaches -(current and alternatives developed) shall be analyzed. 3. Study Recommendations Considering scientific developments and economic conditions, the contractor shall develop rationale and criteria to be met to determine the need for change, in any subs t ant is ~ manne r, in ~ he 0 rgan iza t ions ~ ~ ~ rue ture x

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of the NIH, and determine possible alternative organizational structures for the NlH. The committee consisted of IS individuals, appointed by the President of the Institute of Medicine (ION) with the concurrence of the President of the Nstione1 Academy of Sciences. The committee met six times in the course of 18 Loathe to He fine its tack, develop ~ study plan, analyze the issues, and make recommendations ~ liaison committee of NIH and Department of Health and Human Services officials helped the TOM committee fully define its charge and gain access to the necessary information ~ To gather information and develop preliminary recommendations, the committee established panels to explore (1) the effect of past organizational change. on the flow of funds into, ant the scope of research in, various disciplines ant research areas, and on the management and coordination of health research; (2) the current organizational structure of the NIH, and the way that this structure deals with scientific and management issues that cut across institute lines; ant (3) alternative means for goal setting, decision ~ kin', priority seeding, and budgeting that might suggest directions for organizational change A member of the main committee chaired each of these pancle, and the panels also included, in total, 17 additional people. The complete membership is liseed on the following pages. The reports of these panel. -have strongly influenced the deliberations of the main committee and many e cements have contributed to this report . lathe committee and the pane L~ relied upon a eerie. of activities de. igned to gather informal ion and opinions from a wit. range of interested parties. The committee held three publ ic meetings with representatives of pro fescional societies voluntary health associations and ocher concerned individuals. More than 135 persons participated in these meetings in Washington 0.C. Woods Hole Massachusee ts and Houston Texas . In addition the committee has received written convenes from 16~5 organizations and individuals. Connie tee Member and staff also interviewed soon 185 people to obtain a broad perspec t ive on health science policy issues; those interviewed include current and former NtH directors institute directors and other high officials of NIH; members of NIH advisory councils; secretaries assistant secretaries and ocher officials of the Department of Health and Human Services (and of Health Education and We [fare); ~~ rs of Congress and their staffs; and working scientists and representatives of the professional societies and voluntary health associations. A detailed list of meetings connecters and ineer~riew~ appears in Appendix A. x~

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These outreach activities have been extremely helpful in calling attention to critical orgenizatins1 issues rclevent to the committee' charge. They have also re~caled ~ number of concerns about NIH, especially about the ~nagemat of the peer review system and the intramural research program. The peer review system and the intramural program are both critical to ensuring NIH's continued success, and the concerns deserve the full attention of NIH ant the research community. For the most pare, the concerns that have been expressed relate to management and not organizatione1 issues, so arc beyond the committee' s charge. The organizational structure of the peer review system and the intermural program, on the other hand, are critical elements of NIH's success, and are addressed in the report ~ For siolilar reasons, the committee has not made ~ detailed study of t raining programs . lathe committee reaffirms, however' the critical importance of research training to the mission of NTH now and in the future. The panels also commissioned a series of case studies and background papers. These include seven case studies, reviewed by knowledgeable individuals, of new institutes and institutes that have experienced ocher major organizational changes; a statistical analysis of the relationship between organizational changes and research budgets; ant papers about the historical evolution of NIH's orgaoizeeionet structure, relations between NTH and Congress, and the organizational structure of foreign research agent ice . Sow of these papers are a~raitable from the National Academy Press; see page din. In addition, committee member Thomas Morris conducted a baseline a~anage~nt analysis of the current organizacional structures and practices at NIH. This analysis, which involved over 70 interviews and the review of many written documents, appears in Appendix B. Those readers who are not familiar with the current organizational structure of the NIN may find it helpful to read chis appendix before they read the win report. In addition, the con~ietec also reviewed many previous studies about NIH ~ for example the Wooldridge report ant the President' ~ Biomedical Research Panel; see page 29) ant other science policy ant management issues (for example' the reports of the Grace Conaiss ion and the White House Science Council's Federal Laboratory Review; see page 32~. Although the committee ant panels have tries to be as thorough as possible in gathering objective information about the structure ant functioning of NIH ant alternatives to the current structure, and in documenting the causes and effects of previous orgenizeeiona1 changes, much resins ~ Otter of judgment. In the end, the findings and recommendations in this report are the product of a synthesis of objective analyses, the informed opinion of a wide range of respondents, the members' own extensive experience, and thorough committee discussions. James 0. Ebere Cha irman x:~

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PANELS Panel on Historical Issues M*c~n~ Macon, M.D., Chair, Professor Emeritus, Rockefeller University, ttew York, New York MILDRED CON, Ph.D., Senior Member, Institute for Cancer Research, Ph i lade 1 ph is, Penney lvenis STEEN . LAYTON, Esq., Pierson, Bell and Oowd, Washington, D.C. ARNO G. t~TtJLSKY, M.D., Professor of Medicine and "netice, Director, Center for Inherited Diseases, Division of Helical Genetics, University of Washington School of - divine, Seattle, Wash ington RICWL= S. ROSS, M.D., Vice President for Medicine, Dean of the Hedica1 Faculty, The Johns Hopkins University School of Medicine, Balt imore, Mary lent ELMER STARTS , Ph. ~ ., Wash ington , ~ . C. STEPHEN P. STRICKI^ND, Ph. D., Vice Pres idene , Aspen Institute. for Humanistic Seudice, Washington, D.C. . Panel on Current Ornanizarinn SAMUEL 0. THIER, )1.~., Chair, Sterling Professor and Chin, Department of Internal Medicine, Yale University, New Haven, Connect icut BARBARA C . HANSEN , Ph. D., Assoc late V ice Pres item-Research , and Professor of Physiology and Psychology, Southern Illinois Uniters ity, Carbondale,. Illinois M. ALERED HAYNS , it. D., M. P. H., Pres ident and Dean, Char le ~ R. Drew Postgradu.ate Medical School, Los Angeles, California DAVID MECHANIC, Ph.D., University Professor and Dean, Faculty of Arts and Sc fences, Rutgers Univers ity, New Brunswick, New Jersey THO - S MOMIS, Washington, ~ . C . JOSEPH G. PERPICH, M.D., J.D., Vice President, Planning and Development, Meloy Laboratories, Inc. ~ Revlon Health Care Group' Springfield' Virginia . x~`

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LEON E. ROSEtlllERG, M.D., Dean, Ye1e University School of Medicine, New Haven, Connec e icon STENART WOW, H.~., Director, Totts Gap Medical Research Laboratories, Inc. ~ Bangor, Pennsylvania Pane 1 on Al ternae ices STEVEN C. PEERING, M. D., Chair , Pres ident , Purdue Univers icy , West Lafayette, Indiana TREOOORE COOPER, M.l)., Ph.D., Executive Vice President, The Upjohn Company, K8la~200 ~ Michigan ROBERT L. HILL, Pl,.l)., James B. Ouke Professor and Chairman, Department of Biochemisersr, Duke University Medical Center, Durham. North Carol ins GEORGE E. PARADE, M.D., Sterling Professor of Cell Biology, Yale University School of Medic ine, New Haven, Connecticut DAVID Z . ROBINSON, Ph. D., Execut ive Vice Pres ident , Carnegie Corporation of New York, New York, New York JOHN ~ . SLAUGHTER, Ph. D., Chance l lor , Unive ~ ~ i ty o f Mary land , Co 1 lege Park, Mary land Or

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L IAlSON COIQIITIEE THO - S E. MALONE, Ph.D., ~air, Deputy Director, National Institutes of Health CALVIN B. 8MDH1N, Jr., Associate Director for Administration, National Institutes of Health GI.ENNA M. CROOKS, Ph.D., Deputy Assistant Secretary for Health Planning and Evaluation, Department of Health and Huoun Services MICHAEL I. GOLDBERG, Ph. D., Associate Director of Program Planning ant Eva lust ion, Nat ions ~ Ins t i tu e es o f Hea ~ th WII~L"M H. GOLDWATER, Ph.D., Collaborative Programs Policy Officer, Office of Extramural Research and Training, National Instituees of Health ROBERT B. ALMS, Ph.D., Deputy Assistant Secretary for Planning ant E,raluseion/Health, Department of Health and Oman Services RUTH L. KIRSCHSTE IN, Direc tor, Nat tonal Institute ~ f General Medical Sc fences, National Institutes of Health CLAUDE LENFANT, M.D., Director, National Heart, Lung, and Blood Institute, National Institutes of Health MORTIMER B. t.IPSETT, Director, National Institute of Child Health and Human Development, National Institutes of Health Pro jec t Of f ice r KURT MABEL, Chief, Division of Program Analysis, Office of Program Planning and E'relustion, National Institutes of Health Consultants WILLLUf DANlORTH, ChanceIlor, Washington University, St . Louis, Missouri ARTHUR KORNBERG, Professor, Stanford University, Stanford, California ' x~

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BACKGROUND PAPERS 1. 2. Brief History of the Ocuelop~nt of the National Institutes of Health, by Stephen D. Nelson A Sundry of a Case Study of the National Cancer Inceitute, bar Pame Is J . Smi th 3. A Sundry of a Case Study of the National Eye Institute, by Pamela J. Smith 4. A Sugary of a Case Study of the Netionel Heare, Lung, and Stood Institute, by Stephen O. Nelson 5. 6. A Sundry of a Case Study of the National Institute on "in", by Pamela J. Smith A Sundry of a Case Study of the National Institute of Arthritis, Diabetes, and Digestive and Kidney Diseases, by Pamela J. Smith 7. A Summary of a Case Study of the National Institute of Environmental Health Sciences, by Panda J. Smith A Case Study of the National In~eitu:e of Mental Health, by Stephen O. Nelson Each of these papers is available from the National Acs,temy Press, Publication on Demand, 2101 Constitution Avenue N.W; Washington, D. C. 20418. ~ 202) 334-3313. xv: