REPORT TO THE COMMITTEE ON LABOR AND PUBLIC WELFARE UNITED STATES SENATE Administration Of Contracts And Grants For Cancer’ Research 80164031(21 National Institutes of Health Department of Health, Education, and Welfare BY THE COMPTROLLER GENERAL OF THE UNITED STATES H 5,1971 COMPTROLLER GENELAL OF-THE UNlTED STATES WASHINGTON DC 20548 B- 164031(2) Dear Mr Chairman This 1s our report on the admrnlstratlon of contracts and grants for cancer research by the National Institutes of Health, Department of Health, Education, and Welfare Our review was made pursuant to a request dated September 25, 1970, from the former Chairman of the Committee on Labor and Public Wel- fare, United States Senate, to assist and complement the work of the Committee’s Special Staff on Cancer Research Smce we believe that the contents of this report will be of interest to the Congress and to others concerned with can- cer research, we have arranged with the former Committee Chairman to make further dlstrlbutlon of the report Sincerely yours, Comptroller General of the United States The Honorable Harrison A Wllllams, Jr Chairman, Committee on Labor and Public Welfare United States Senate 50TH ANNIVERSARY 1921- 1971 l . COMPTROLLER GENERAL'S REPORT ADMIMISTRATION OF CONTRACTSAND TO THE COMMITTEE ON GRANTSFOR CANCERRESEARCH LABORANDPUBLICWELFARE National Institutes of Health UNITEDSTATESSENATE Department of Health, Education, and Welfare B-164031(2) DIGEST ------ WHYTHEREVIEWWASMADE The Chairman of the Senate Committee on Labor and Public Welfare (here- Inafter referred to as the Senate Committee) asked the General Account- lng Office (GAO) to assist and complement the work of a special staff established by the Senate Committee to study cancer research. GAO examined into the admlnlstratlon of the cancer research program within the Department of Health, Education, and Welfare (HEW), the Na- tional Institutes of Health, and the National Cancer Institute, lnclud- ing the methods and procedures used for processing, reviewing, and ap- proving contracts and grants for cancer research. The National Cancer Institute conducts and supports cancer research through (1) research at the National Cancer Institute's laboratories and cllnlcs, (2) contracts for research, and (3) grants-In-ald for research proJects The National Cancer Institute received an approprlatlon of $181 million in fiscal year 1970. It awarded 333 research contracts for $49 7 million and 1,782 research grants for $71.4 million A committee of consultants appointed by the Senate Committee to study the cancer problem estimated that the program it recommended would re- quire annual Federal expenditures for cancer research of $800 mtllton to $1 billion by 1976 FINDINGSAND CONCLUSIONS The present system of administering and funding National Cancer Instl- tute research has resulted in delays in the approvals and funding of contracts and grants. GAOwas told by the Director of the National Can- cer Institute and some officials at research lnstltutlons receiving grants that --the lnltlatlon of some research proJects was made uncertain because of the lnab-rllty of some research Institutions to provide private funding until final approval and funding was received from the Na- tional Cancer Institute and Tear Sheet MARCH 523-71 1 --such delays could cause problems for the instltutlons In attract- ing and retain1 ng qualified researchers (See p. 30 > Approval Delags The 333 contracts awarded during fiscal year 1970 for cancer research required an average of about 7 months for review and approval. Approxi- mately l-l/2 months of that time was the result of what GAO believes were unnecessary duplicative reviews by the National Instl tutes of Health and the National Cancer Institute (See p 21 ) Specifically, the reviews of contract proposals by the National Institutes of Health-- including the qualifications of the proposed contractors, the work specifications, and the amounts of the proposed contracts--duplicate steps in the National Cancer Ins-h tute review (See p 23 ) Although the Secretary of HEWdelegated contract authority to the Direr- tor of the National Institutes of Health, he did not delegate such au- thority to the National Cancer Institute. GAO believes that much delay could be eliminated if the National Cancer Institute program managers were granted research-contracting authority. Research grants during calendar year 1970 required an average of about 8 months for review and approval A ssgniflcant portion of thx pro- cesslng time occurs because the study sectlons which review grant appll catTons for sclentlfic merit and the National Advisory Cancer Council which recommends approval of grant applications each meet only three times a year. (See p. 25 > : An appllcatlon submltted after the deadline for review at one of the three meetings of the applicable study sectlon would require from 3 to 8 months before it could be consIdered at the next study section meet- trig. The National Advisory Cancer Council was establ lshed tn compliance with the Public Health Service Act The study sectlons were establlshed by the National Institutes of Health to provide an Independent peer review of the scientific merit of all applications to the National Institutes of Health for research grant funds. The study sections are made up of eminent scientists knowledgeable about research in specific areas. In general , all research grant appllcatlons must go through the same rev view process, including a study section evaluation, and all must receive Council approval (See p. 27 ) GAO does not question the meritSh;f ex- ternal sclentlflc reviews of applications for research grants present system, however, results in significant delays. (See p 28 ) Approximately 45 percent of the 1,182 grants awarded -rn fiscal year 19X+$ by the National Cancer Institute were for less than $30,000 each. (See p. 27 ) To expedite approval of grant appllcatlons involving moderate amounts, GAO belleves that HEW should consider authorlzlng program man- agers to award grants up to a specified amount without review by study sect3ons Fundwq Delays Action on the National Cancer Institute funding request must wait each year until the entlre HEW appropnatlon bill IS enacted Cancer research proJects, usually from 3 to 5 years in length, are funded annually \ (See p 30 ) During each of the past 6 fiscal years, the HEWapproprlatlons were not approved by the beginning of the fiscal year in which the funds were to be used Such approval has been delayed from 2 to 8 months. Although ongoing research grants and contracts are funded under a Joint congressional resolution making contlnulng approprlatlons for a fiscal year pending approval of approprlatlons for that year, the National Can- cer Instl tute cannot effectively plan for research, particularly new programs and proJects, until the National Cancer Institute appropnatlon request IS approved and the total funds appropriated are known GAO believes that the Congress should consider authorizing appropriations for the National Cancer Institute to be available for the next fiscal year following the usual budget year. This type of advance fundlng has been authorized for certain other programs, including aid to educationally deprived children under title I of the Elementary and Secondary Education Act of 1965 (See p. 31 ) RECOMk'ENDAIPIOiW OR SUGGESTIONS The Secretary of HEW should authorize the National Cancer Institute pro- gram managers to --negotiate research contracts (see p 24) and --award grants up to a specified dollar llmlt without review by study sections (See p. 29 ) AGENCY ACTIONSAND UNRESOLVED ISSUES The Secretary of HEW stated that action was being taken to extend research-contracting authority to the National Cancer Institute (See p 24 ) The Secretary said that HEW planned to evaluate the grant re- view system with a view toward strengthening and expediting the revlew process He said that the evaluation would include conslderatlon of granting authority to the National Cancer Institute program managers to award grants up to a speclfled dollar 11m1t without review by study sec- tions (See p 29 > Tear - Sheet -- The Secretary stated that, although funding delays are of considerable lnconvenlence and concern to researchers and research institutions, at the present time the Department did not have any data that lndlcated any serious d-csruptl on to research or any s~gnlflcant or widespread problems for research lnstltutlons (See p 31 ) He stated also that the delays in approprlatlon approvals could be a slgnlflcant deterrent to lnltlatlon of the new and sizable cancer pro- gram levels vlsuallzed by the consultants to the Senate Committee The Secretary advlsed GAO that delays in fundIng had emanated most often from the recent practice followed by both the Congress and the executive branch of establishing annual spending ceilings He said that the ef- fect of these spending ceilings on the tjmlng of grant funding was to de- lay awards of new grants until a spending plan had been developed for the entire fiscal year, which was very difficult to do until appropria- tion and expenditure llmttatlons were known He said also that the re- sult was that typically HEW did not fund new proJects until well into the fiscal year and that this sltuatlon would exist whether or not the grants were advance funded GAO recognizes that HEWmust develop an annual spending plan based upon various expenditure control llmltatlons; however, it seems to GAO that it would not be desirable to delay financing most new proJects until ap- propriation and expenditure llmltatlons for the year are known GAO belleves that, to optimize the Government's research investment, particularly in view of the adverse effect that delays in funding can have on new research programs and proJects, consideration should be g;ven to the advance-funding mechanism as a means to plan and program research more effectively In GAO's opinion, advance funding would enable the National Cancer In- stitute to make awards on the basis of the amount appropriated for the year covered by the advance funding and would facilitate more timely financing of new programs and proJects, rather than limit awards for re- search to the amounts authorized by a Joint resolution making continuing appropriations, which generally provides appropriations up to the prior year's level. MATTERS FORCONSIDERATION BY TBE CONGRESS The Congress may wish to consider the enactment of leglslatlon authonz- In the case of the Nati onal Cancer Institute, the making of appro- $&ons to be available for the next fiscal year following the usual budget year (See p. 34 ) 4 Contents Page DIGEST 1 CHAPTER 1 INTRODUCTION 5 Establishment and functions of NatIonal Cancer Institute r 9 2 ADMINISTRATION OF CANCER RESEARCHBY THE NATIONAL CANCER INSTITUTE 16 Utilization of review committees for decislonmaklng 17 Process used for reviewing and approv- ing contracts for cancer research 21 Recommendation to the Secretary of Health, Education, and Welfare 24 Process used for reviewing and approv- ing grants for cancer research 25 Recommendation to the Secretary of Health, Education, and Welfare 29 Delays in funding cancer research program 30 Matter for consideration by the Congress 34 3 SCOPE OF REVIEW 35 APPENDIX I Letter dated September 25, 1970, from the Chairman, Committee on Labor and Public Welfare, United States Senate 39 II Letter dated January 21, 1971, from the Secretary, Department of Health, Educa- tion, and Welfare, to the General I Accounting Office 40 III Report of the National Panel of Consultants on the Conquest of Cancer 44 APPENDIX Page IV Division of Research Grants, Natlonal In- statutes of Health, list of study sec- tlons as of July 1, 1970 57 ABBREVIATIONS GAO General Accounting Office HEW Department of Health, Education, and Welfare NC1 National Cancer Institute NIH National Institutes of Health COMPTROLLER GENERAL'S REPORT ADMINISTRATION OF CONTRACTSAND TO THECOMMITTEE ON GRANTSFOR CANCERRESEARCH LABORANDPUBLICWELFARE NatIonal Instl tutes of Health UNITEDSTATESSENATE Department of Health, Education, and Welfare B-164031(2) DIGEST -em--- WHYTHEREVIEWWASMADE The Chalman of the Senate Committee on Labor and Public Welfare (here- inafter referred to as the Senate Committee) asked the General Account- lng Office (GAO) to assist and complement the work of a special staff established by the Senate Conunattee to study cancer research, GAO examined into the admlnlstratlon of the cancer research rogram wIthin the Department of Health, Education, and Welfare (HEWY the Na- tlonal Institutes of Health, and the National Cancer Institut& lnclud- lng the methods and procedures used for processing, reviewing, and ap- proving contracts and grants for cancer research. The National Cancer Institute conducts and supports cancer research through (1) research at the National Cancer Institute’s laboratories and cltnlcs, (2) contracts for research, and (3) grants-in-aid for research proJects. The National Cancer Institute received an appropriation of $181 mllllon ln fiscal year 1970. It awarded 333 research contracts for $49.7 million and 1,182 research grants for $71.4 mllllon. A committee of consultants appointed by the Senate Committee to study the cancer problem estimated that the program tt recommended would re- quire annual Federal expenditures for cancer research of $800 mtlllon to $1 bllllon by 1976. FINDINGSANDCONCLUSIONS The present system of admlnlsterang and funding National Cancer Insti- tute research has resulted in delays ln the approvals and fundlng of contracts and grants. GAOwas told by the Director of the National Can- cer Institute and some offlclals at research lnstltutlons recelvlng grants that --the lnltlatlon of some research proJects was made uncertain because of the inability of some research lnstltutlons to provide private funding until final approval and fundlng was received from the Na- tlonal Cancer Institute and --such delays could cause problems for t",e 7nstTtut707s ln attract- Ing and retalnlrlg quaIlfled researcherq See pa 30 ) The 333 contracts awarded during fiscal year 7970 for cancer research required an average of about 7 months for review dl?CIapproval. Approxl- mately l-l/Z months of that time was the result of what GAO belleves were unnecessary dupllcatlve reviews by the National Institutes of Health and the National Cancer Institute. (See p 27 ) Speclflcally, the reviews of contract proposals by the National Institutes of Health-- including the quallflcatlons of the proposed contractors, the work specifications, and the amounts of the proposed contracts--duplicate steps In the National Cancer Institute review (See p 23.) Although the Secretary of HEWdelegated contract authority to the Dlrec- tor of the National Institutes of Health, he did not delegate such au- thority to the National Cancer Institute. GAO believes that much delay could be eliminated if the NatIonal Cancer Institute program managers were granted research-contracting authority Research grants during calendar year 1970 required an average of about 8 months for review and approval A slgnlflcant portlon of this pro- cesslng time occurs because the study sections which review grant apple- catlons for sclentlflc merit and the NatIonal Advisory Cancer Council which recommends approval of grant appllcat~ons each meet only three times a year. (See p 25 ) An appllcatlon submitted after the deadline for review at one of the three meetings of the applicable study section would require from 3 to 8 months before It could be considered at the next study sectIon meet- ing. The National Advisory Cancer Council was established in compliance with the Public Health Sermce Act. The study sections were establIshed by the National Institutes of Health to provide an Independent peer yevlew of the scientific merit of all applications to the National Institutes of Health for research grant funds. The study sections are made up of eminent sclenttsts knowledgeable about research ln specific areas. In general , all research grant appllcatlons must go through the same re- view process, including a stud section evaluation, and all must receive Council approval. (See p, 27. J GAO does not question the merits of ex- ternal sclentlfic reviews of appllcatlons for research grants. The present system, however, results in significant delays. (See p. 28 ) Approxtmately 45 percent of the 1,182 grants awarded tn fiscal year 1970 by the NatIonal Cancer Institute were for less than $30,000 each. (See p. 27.) To expedite approval of grant appltcatlons ~nvolv~rg moderate amounts) GAObe1leves that HEWshould consider authorizing program man- agers to award grants up to a specified amount without review by study sections. Fundmg Dehys Action on the National Cancer Instl tute funding request must wait each year until the entire HEW appropriation bill 1s enacted. Cancer research proJects, usually from 3 to 5 years in length, are funded annually (See p 30 ) During each of the past 6 fiscal years, the HEW appropnatlons were not approved by the beginning of the fiscal year ln which the funds were to be used Such approval has been delayed from 2 to 8 months. Although ongolng research grants and contracts are funded under a Joint congressional resolution making contlnulng approprlatlons for a fiscal year pending approval of appropriations for that year, the National Can- cer Institute cannot effectively plan for research, particularly new programs and proJects , unto 1 the National Cancer Institute appropriation request 1s approved and the total funds appropriated are known. GAO believes that the Congress should consider authorizing appropriations for the National Cancer Institute to be available for the next fiscal year follow-ing the usual budget year. This type of advance funding has been authorized for certain other programs, including aid to educatlonally deprived children under title I of the Elementary and Secondary Education Act of 1965 (See p. 31.) RECOMMENDATIONS OR SUGGESTIONS The Secretary of HEW should authorize the National Cancer Institute pro- gram managers to --negotiate research contracts (see p. 24) and --award grants up to a specified dollar llmlt without review by study sections (See p. 29 > AGENCYACTIONS AND UNIESOLVEDISSUES The Secretary of HEWstated that action was being taken to extend research-contracting authority to the National Cancer Institute (See p 24 ) The Secretary said that HEWplanned to evaluate the grant re- view system with a view toward strengthening and expediting the review process He said that the evaluation would include conslderatlon of granting authority to the National Cancer Institute program managers to award grants up to a specified dollar llnnt without review by study sec- tions (Seep 29) 3 The Secretary stated that, although fundIng delays are of considerable lnconvenlence and concern to researchers and research lnst~tutlons, at the present time the Department did not have any data that lndlcated any serious dlsruptlon to research or any s?gn~f~cant or wIdespread problems for research lnstltutions (See p 31 ) He stated also that the delays in approprlatlon approvals could be a slgnlflcant deterrent to lnttiatlon of the new and sizable cancer pro- gram levels vlsuallzed by the consultants to the Senate Committee The Secretary advised GAO that delays in funding had emanated most often from the recent practice followed by both the Congress and the executive branch of establlshlng annual spending celllngs. He said that the ef- fect of these spending celllngs on the tlmtng of grant funding was to de- lay awards of new grants until a spending plan had been developed for the entire fiscal year, which was very chfflcult to do until approprla- tion and expenditure llmltatlons were known. He said also that the re- sult was that typically HEWdid not fund new proJects until well into the fiscal year and that this sltuatlon would exist whether or not the grants were advance funded. GAO recognizes that HEWmust develop an annual spending plan based upon various expenditure control limitations, however, It seems to GAO that It would not be desirable to delay financing most new proJects until ap- propriation and expenditure limitations for the year are known GAO believes that, to optimize the Government's research investment, particularly tn view of the adverse effect that delays in funding can have on new research programs and proJects, consideration should be given to the advance-funding mechanism as a means to plan and program research more effectively In GAO's opinion, advance funding would enable the National Cancer In- stitute to make awards on the basis of the amount appropriated for the year covered by the advance fundlng and would facilitate more timely financing of new programs and proJects, rather than limit awards for re- search to the amounts authorized by a Joint resolution making continuing approprlatlons, which generally provides appropriations up to the prior year's level MATTERS FORCONSIDERATION BY THECONGRESS The Congress may wish to consider the enactment of legislation authonz- II-I the case of the National Cancer Institute, the making of appro- ~~~~tlons to be available for the next fiscal year following the usual budget year. (See p. 34.) 4 CHAPTER1 INTRODUCTION Pursuant to a request dated September 25, 1970, from the Chairman, Committee on labor and Public Welfare, United States Senate, and to subsequent discussions with the Com- mittee's special staff on cancer research, the General Ac- countzng Office has reviewed selected aspects of the admin- istration of the cancer program of the National Cancer In- stitute (NC11 of the National Institutes of Health (NIH), Department of Health, Education, and Welfare (HEW). Our re- view was made to assist and complement the work of the Sen- ate Committeets dpecial staff on cancer research. A copy of the Chairman's request is Included as appendix I. On April 27, 1970, the Senate passed Senate Resolution 376, authorizing the Senate Committee, with the assistance of an advisory committee, to report to the Senate on (1) the present status of scientific knowledge with respect to the causes of cancer and Its treatment, cure, and elimination, (2) the prospect of success in such endeavors, and (3) mea- sures necessary or desirable to facilitate success at the earliest possible time. Pursuant to this resolution, a committee of consultants on the conquest of cancer, composed of 13 eminent laymen and 13 eminent scientists, was established in June 1970 as the advisory committee to assist the Senate CommIttee with the new study on cancer and was asked to submit its report and recommendations at the earliest practicable date. On July 15, 1970, the House of Representatives passed Concurrent Resolution 675, later passed on August 28, 1970, by the Senate, expressing the unanimous sense of the Con- gress that "the conquest of cancer is a national crusadtil and that "the Congress should appropriate the necessary funds so that the citizens of this land and all other lands may be delivered from the greatest medical scourge in history." On June 29, 1970, the committee of consultants held its first meeting, Since that time the committee of consultants has met 10 full days, subcommittees have met many additional days,and the written or verbal testimony of 289 witnesses 5 and advisors has been considered. On November 25, 1970, the committee of consultants submitted its report and recommen- dations to the Chairman of the Senate Committee. In the foreword to the report of the committee of con- sultants, the Chairman of the Senate Committee stated that: "After months of intensive and diligent effort, this Panel has prepared the attached report, 'A National Program for the Conquest of Cancer.' The report LS dedicated to the proposition, ex- pressed in a recent Concurrent Resolution of the Congress, that the conquest of cancer should be a national crusade. The recommendations are bold and far reaching. They call for a new agency, whose sole mission is the conquest of cancer. They call for adequate resources of man- power, facilities and funds to do the job in ac- cordance with the provlslons of a coordinated national program plan." The committee of consultants estimated that the program that it recommendedwould require annual appropriations for cancer research of $800 million to $1 billion by 1976, A copy of the report is included as appendix III. Cancer is one of the maJor disease problems facing this nation. The American Cancer Society estimated that during 1970 about 330 thousand Americans would die from cancer. Estimated cancer mortality rates by State per 100,000 popu- lation for 1970 are shown on the map on page 7, and cancer mortality rates around the world for 1962 and 1963 are shown on the graph on page 8. The map shows a considerable range in the incidence of cancer-caused deaths among the several states. The graph, which shows cancer mortality rates per 100,000 population in 24 countries in 1962 and 1963, shows the United States as ranking 18th for males and 19th for females, Studies are being made concerning the relationship of the environment to cancer all over the world. On December 4, 1970, the Chairman of the Senate Commit- tee introduced Senate bill 4564 in the Senate, which called for essentially the action recommendedby the committee of \ 6 i J 7 CANCER AROUND THE WORLD AGE-ADJUSTED DEATH RATES FOR SELECTED CANCER SITES IN VARIOUS COUNTRIES, 1962- 63 MALE FEMALE 0 50 100 150 200 0 50 100 150 200 I I I I I DENMARK 1 CHILE _ 1 AUSTRIA I GERMANY, F R 1 SCO-fLAND 1 BELGIUM 1 ISRAEL 1 FRANCE NETHERLANDS SOUTH AFRICA I ENGLAND b WALES I IRELAND _ 1 NE” ZEALAND k...n CANADA I NEWZEALAND I NORTH IRELAND 1 SWEDEN I 1 SWITZERLAND CANADA FINLAND NORTH IRELAND UNITED STATES 1-1 FRANCE I-, JAPAN UNITED STATES AUSTRALIA NORWAY SWEDEN ITALY NORWAY AUSTRALIA JAPAN POd:1:: Fs , , 0 50 100 150 200 RATE PER 100,000 POPULATION SOURCE PREPAREDBYGAO consultants. On January 25, 1971, a similar bill was lntro- duced as Senate bill 34 in the current Congress. In fulfilling the request of the Senate Commlttee, we examined into the HEW-NIH-NCI organlzatlonal structure and the methods and procedures used for processing, revrewing, and approving contracts and grants for cancer research. The scope of our review 1s described on page 35. ESTABLISHMENT AND FUNCTIONS OF NATIONAL CANCER INSTITUTE NC1 operates wrthin the framework of the HEW-NIH or- ganization and, accordingly, IS sublect to and must be re- sponsive to HEW-NIH policies, procedures, and requirements. The chart on page 10 illustrates the overall HEW-NIH-NC1 or- ganlzatlon as of January 1, 1971. In terms of Federal expenditures, HEW is the largest Government entity other than the Department of Defense. HEW had 102,500 employees as of June 30, 1970, and in fiscal year 1970 made estimated expenditures, lncludlng those made from trust funds admlnlstered by the Social Security Adminlstra- tion, of $52.7 bllllon. HEW is, among other things, the Government's prlnclpal medlcal research organization. NC1 was established In 1937. Part A, Title IV, of the Public Health Service Act (42 U.S.C. 281), authorizes the Secretary of HEW, through NCI, to conduct and support re- search relating to the cause, diagnosis, and treatment of cancer by directly performlng such research in-house and by awarding grants-in-aid and contracts to research lnstltutlons for performing research proJects In the field of cancer. The Public Health Service Act also established a National Advisory Cancer Council, which 1s a body of 12 members ap- pointed by the Secretary of HEW and three ex officio Gov- ernment members, to review and recommend appropriate action on applications for grants-in-aid and to recommend general policy and programs. During fiscal year 1970, NC1 employees totaled about 1,400. The NC1 admlnlstrative work force as of September 30, 1970, consisted of about 260 persons and represented about 19 percent of the total 1,400 NC1 employees. The remainder of 9 ORGANiZATlON OF SELECTED OFflCESILF THE DEPARTMENT OF HEALTH, EDUCATKMAklfI Vt'ELFARE NATIOMALD4STlTUTESDi- tiU,LTH, I\f!D NATlOMALCANCERINSTITUTE the employees perform principally research and research support activities. This administrative force does not in- clude the various NC1 advisory and review committees or NI% appointed study sections. Administrative services are also furnished by NIH to the NC1 program. For example, the NIH Research Contracts Branch is Involved in the negotiation of NC1 contracts, and NIH offices-- such as the associate directors' offices for Extramural Research and Training, Program Planning and Eval- uation, Direct Research, Clinical Care Administration, and Administration--provide administrative services. Presently NCI conducts, fosters, and supports studies of the occurrence and distribution of cancer and laboratory and clinical research on the cause, prevent-Ion, and methods of diagnosis and treatment of cancer through four major or- ganizational components--Extramural Activities, Etiology, Chemotherapy, and General Laboratories and Clinics. Two of these organizational components--Etiology and Chemotherapy-- are referred to as collaborative research programs in that they consist of both in-house and contract research, An as- sociate director is in charge of extramural activities. The other three malor organizational components are each headed by a scientific director. The Office of the Associate Director for Extramural Ac- tivities plans and directs NCI's grant-supported activities and recommends NC1 policies relating to the administratlon of grant and contract programs. This Office also develops and coordinates plans, reviews, and criteria for the imple- mentation of NC1 grants and research contracts; evaluates the effectiveness of grant-supported activities; and advises NCI's Director, the National Advisory Cancer Council, and other scientific advisory bodies of grant and contract ac- tivities and developments., The Office of the Scientific Director for Etiology is charged with the responsibility for the major share of NCI's collaborative research on cancer causation and preventlon. Its investigations are aimed at finding means to prevent human cancers and encompass studies of the cancer risks to defined human and animal populations. Investigations are also dlrected toward identifying viral and chemical 11 cancer-causmg agents and the means by which these agents produce alterations in living systems. The program involves collaboration with investigators in industry, universities, and other research institutions in this country and abroad, The Office of the Scientific Director for Chemotherapy plans, directs, and coordinates NCI's integrated cancer chemotherapy activities, including intramural laboratory and clinical studies, contracted research, and research con- ducted in cooperation with other Federal agencies. The chemotherapy program is concerned with finding the best methods of treating cancer through the screening, testing, and clinical evaluation of drugs. The Office of the Scientific Director for General Lab- oratories and Clinics has general responsibility for the planning and direction of all In-house laboratory and clin- ical studies, other than the research performed in-house by the Offices of Scientific Director of Etiology or Chemother- apy. General laboratories and clinics provide broad re- search support for the various scientific disciplines gen- erating knowledge basic to the advancement of cancer re- search. The chart on page 14 shows the NC1 appropriations from 1960 through 1970. The fiscal year 1970 appropriation1 by program for NC1 is shown on the chart on page15, and the fiscal year 1970 estimated funds obligated by each of the four major organizational components of NC1 and the Office of the Director, NCI, are shown below. 'The amount in the chart on page 15 was subsequently cut back by $9.6 millron to comply with section 410 of the Labor-HEW Appropriation Act for fiscal year 1970 (Pub. L. 91-204, March 5, 1970). The amount appropriated less the cut back plus net transfers in, totaling $0.6 million from other NIH appropriations, equals the $181.3 million of funds obligated. 12 Estimated obligated funds for fiscal year 1970 (millions) Extramural Activities $ 95.3 Collaborative research: Etiology 40.0 Chemotherapy 26.1 General Laboratories and Clinics 18.8 Office of the Director 1.1 Total $181.3 NATIONAL CANCER IPaSFlTUTE APPROPRIATIONS 1960 - 1970 DOLLARS IN MI1 LIONS 200 F- 163 a 110 100 90 80 70 60 50 40 30 20 10 0 67 68 69 70 FISCAL YEAR fLzl ; ’ GRANTS Q - CONTRACTS DiRECT OTHER DIRECT OPERATION OPERATIONS *$14 6 MILLION FOR CANCER CONTROL HOW APPROPRIATFD ELSEWHERE SOURCE FACT BOOK, NCI, REVISED MARCI-I 1970 NATIONAL CANCER INSTITUTE 1970 APPROPRIATION BY PROGRAM $190,362,500 $1,573,000 ; REVIEW AND APPROVAL $9 601,000 i GENERAL LABS I’ $8 517,900 AND CLINICS ; I , ETIOLOGY CHEMICAL AND $27,807,000 ,’ ENVIRONMENTAL CARCINOGENESIS 5:x ,a CANCER THERAPY ,, 45% ‘, I’ I $21,913,500 146% i t , ETIOLOGY-VIRUS $1,6OO,OOO LUNG CANCER 115; . $2 873 000 $3,130,090 ETIOLOGY-DEMOGRAPHY BREAST CANCER A AND OTHER -4 $1,608,000 15%r ALL OTHER DIRECT &@ ACTIVITIES $1.466.000 w-- 8%---. i310rinETRY EPIDEMIOLOGY L AND FIELD STUDIES --. $16,315,000 48% Lo $9 178.000 FELLOWSHIPS ---8 6%- -- REIMBURSEMENT TO AND TRAINING -- 6% MANAGEMENT FUND 1% $1-036 000 \ PROGRAM DIRECTION \ ‘\ $250,000 RESEARCH DEVELOPMENT .ABLE AND RADIATION THERAPY $76 657 000 UNPROGRAMMED RESEARCH PROJECTS TOTAL RESEARCH GRANTS SUPPORT GRANTS SOURCE FACT BOOK, NCI, REVISED MARCH 1970 $83,495,000 CHAPTER2 ADMINISTRATION OF CANCERRESEARCH BY THE NATIONALCANCERINSTITUTE The present system of administering NC1 research and the method of funding the research has resulted in signifi- cant delays in approving and funding contracts and grants for cancer research. NIH awarded 333 cancer research contracts, totaling $49.7 million, during fiscal year 1970. These contracts re- quired an average of about 7 months for review and approval. About 1% months of this review and approval time was the result of what we believe were unnecessary duplicative re- views by NIH and NCI, During calendar year 1970 the revrew and approval pro- cess for appllcatlons for research grants required an average of about 8 months. This processing time was due, to a large extent, to the fact that both the study sections which must review grant applications and the National Advisory Cancer Council which must approve grant applicatrons met only three times annually for recommending grant approvals. During each of the past 6 fiscal years, the HEW appro- priatlons were not approved by the beginning of the fiscal year in which the funds were to be used. The delays of such approvals, which ranged from 2 to 8 months, hlndered effec- tive planning for research, p articularly for new programs and projects. We were told by the Director, NCI, and by some grantee offlclals at research lnstltutlons that, because of the in- ability of some research institutions to provide interim private funding until final approval and funding 1s received from NCI, the lnltlatlon of some research projects was made uncertain. 16 UTILIZATION OF REVIEW COMMITTEES FOR DECISIONMAKING There are 25 committees or groups, with approximately 279 members, which advise and assrst NC1 in the management of the cancer program. NIH has 47 study sections, with about 700 persons who are primarily nonfederally employed persons, which review the research grant applications of all institutes, lncludlng NCI, for scientific merit within the broad fields of medicine and public health. Each grant ap- plication, however, is reviewed by only one study section. The National Advisory Cancer Council was established in compliance with the Public Health Service Act. The various study sections were established by NIH to provide an inde- pendent peer review of the sclentlflc merit of all appllca- tlons to NIH for research grant funds. The study sections are made up of eminent scientists knowledgeable about re- search in specific areas. The chart on page 18 illustrates the review and advisory groups which have responsibilities for cancer programs. The study sections, depending on the specific research area in- volved, review NC1 research grant applications. Also, three committees review NC1 research grant applications, three committees review NC1 training-grant appllcatlons, 15 com- mittees advise or assist in the management of NC1 collabora- tive research, including contract research, two committees advise on NC1 laboratory and clinical research, and two groups (the Natronal Advisory Cancer Council and the Sclen- tlflc Directorate) advise on the overall program. The review and advisory groups' members are selected primarily from outside the Government and represent leading medical or sclentlflc authorities in the study, diagnosis, or treatment of cancer and in specialized areas of health- related research, fundamental sciences, or medical sciences. Several of the committees have NIH or NC1 employees repre- sented on the committees, and a few committees are com- prised entirely of NIH or NC1 employees. The chart on page 20 illustrates the organizational and administrative arrangements within HEW, including the advl- sory and review groups, relating to the etiology program. I 17 NATIONAL CANCER INSTITUTE REVIEW AND ADVISORY COMMITTEES AND FISCAL YEAR 1970 OBLIGATIONS BY PROGRAM AREA 47 STUDY SECTIONS FOR REVIEW OF i RESEARCH GRANTS OF NCI AND OTHER 3 COMMITTEES REVIEW APPLICATIONS NIH INSTITUTES AND ASSIST IN MANAGEMENT OF CERTAIN MULTI-DISCIPLINARY GRANT PROGRAMS STUDY SECTIONS ARE BASED ON VARIOUS DISCIPLINES TOTAL OF 52 MEMBERS EACH SECTION HAS AN AVERAGE OF 15 MEMBERS RESEARCH RECOMMENDATIONS TO $81 0 MILLION DIRECTOR, NIH, ON ALL GRANT APPLICATIONS GRANT APPLICATIONS RECOMMENDS ON MATTERS RELATING TO NC1 PRO GRAMS AND ACTIVITIES $14 4 MILLION TOTAL OF 12 MEMBERS ICE OF THE MAKES REVIEWS AND RECOMMENDATIONS ON NC PLANNING, POLICY AND PERSONNEL SCIENTIFIC CONTENT AND 5 COMMITTEES TO ADVISE AND/OR ASSIST IN MANAGEMENT OF SPECIFIC PROGRAMS TOTAL OF 43 MEMBERS SOURCE PREPARED BY GAO I The Sclentlfrc Director for Etiology receives advice directly from four committees and indirectly from two com- mittees. In addition to receiving direction from the Set- retary of HEW through normal channels, the Director, NCI, receives policy direction or program advice from several staff organizations within HEW-NIH. Both the Deputy Assls- tant Secretary, Research and Development, HEW, and the As- a sociate Director for Direct Research, NIH, have policy and program guidance responslbllitles for the etrology program. In the area of contracting, a number of internal and external groups are involved. The Assistant Secretary, Comptroller, HEW, and the Assistant Secretary for Admlnlstra- tron, HEW, establish overall financial and admrnistrative policy for contracting. The Research Contracts Branch under the Associate Director for Adminlstratlon, NIX, performs ad- ministrative review and negotiation of contracts. Scien- tific review of etiology research contracts 1s the responsi- bility of eight contract review committees made up of NC1 and NIH employees and non-Government consultants. 19 ORGANIZATIONALAND ADMINISTRATIVEARRANGEOENTS ON THE NATIONAL CANCERINSTITUTE'SETIOLOGYPROGRAM STAFF .="NcTIOHS LINE FUNCTIONS PROCESSUSED FOR REVIEWING AND AJ?PROVINGCONTRACTSFOR CANCER RESEARCH In recent years NC1 has made extensive use of research contracts in Its collaborative research programs. Of 1ts $181 million of fiscal year 1970 obligations, NC1 awarded 333 research contracts for $49.7 million. The 333 contracts required an average of about 7 months for review and approval. Approximately l-l/Z months of that time was the result of what we believe were unnecessary du- plicative reviews by NPH and NCI. The contractor selection and proposal review process commences with an NCI scientist's proposal to establish a specific project under contract support and ends upon award of a contract. Contract proposals are reviewed by the ap- propriate scientific review committee. The review covers the scientific aspects of the proposal and the propriety of the selection of the contractor. Each review committee is responsible for the review of contract proposals relating to a given type or phase of scientific research. The process of contract development and award can be divided into two phases: the development of a project and the preaward procedures leading up to the award of a con- tract. The program scientific director, a program scientific coordinator (project officer or project orlgrnator), and an NC1 program contract specialist determine that a proposed project is relevant to their established program. Then a recommendation is developed on the source of potential con- tractors and on the scope of the work to be solicited. Ap- proval of the scientific director for the program area is then obtained to proceed with the contract selection and proposal review process. The schedule on page 22 shows that it takes an average of about 7 months of processing time from advertising to the award of a contract when the contractor selection in- volves multiple solicitation of prospective contractors. The processing time is broken down by steps, and the number of days required for each step and the cumulative days at each step are shown. 21 After advertrsJng and obtalnrng the proposals, the NC1 proJect officer and contract specrallst make a pxllmlnary screening of all proposals to eliminate those which are not responsive to the requirements of the project or which are otherwise unacceptable. Schedule of ProcesslngTlme for NC1 Research Con&acts from Inltlatron to Award Days cumu- per lative Step step days Procedure 1 30 30 Advertlsrna the effort--1nrtratron of a research con- tract normally consists of advertlslng the scope and obJectIves of the proposed prolect and requesting Interested contractors to submit resumes of their qualrflcatlons rather than proposals for the effort. Thus period rncludes the time when the Grants and Research Contracts Operatrons Branch receives word from the speclfx program offrcrals to advertise through the time when the program offrcrals advise the Contracts Operations Branch on which of the re- sumes received merrt request for proposals. 2 21 51 Obtalnlnc pronosals and forwardlnp them to nropram offlclals. 3 34 85 Contractor selectron (when multrple solicitation 1s Involved)--Prellmrnary screenrng by prolect officer and contract specrallst. Evaluation by an ad hoc group of the proposals received on a proJect and its recommendatron of one of these proposals. 4 28 113 Review of proposal by program offlcrals. 5 14 127 Preparatxon of revleT' committee "pac'~aae", by the Contracts Operation Branch--Delrvered 1 week prior to committee meetrng 6 14 141 Contract review corn&tee review--Allows 1 week to revxew "packages" and 1 week to prepare mrnutes. 7 14 155 Preparation of flnal review commrttee "package" by the Contracts OneratIon Branch 8 18 173 Review by final review committee. 9 4 177 -oval by NC1 Director PrPparats of propram memo to NIH. 10 47 224 /Negotratlon of contract by NIH. of contract Work begins. 22 The In-depth review by the program officials (step 4 on pe 22) involves both the scientific and the admlnlstra- tive aspects of the proposal, such as the capabilIty of the contractor, the type of contract proposed, the proposed budget of the contractor, and a check for scientific dupli- cation of effort. The method of reviewing prospective contracts for can- cer research had its inception in the early days of the che- motherapy program, which was initiated in 1955. At that time it was believed that a review system similar to the study section-National Advisory Cancer Council concept used m reviewing grants was needed. Chemotherapy panels (com- posed of outside consultants) and the Chemotherapy Review Board (composed of the chairmen of the panels plus some members of the National Advisory Cancer Council) were es- tablished. As time went on, however, difficulty was expe- rienced in recruiting outside consultants with no appearance of conflicts of interest. As a result, a system was estab- lished in which preaward reviews were made first by standing program committees comprised of NC1 staff and then by the Scientific Directorate. Subsequently, early in 1965 Congress gave considera- tion to adding to the HEW appropriation bill a requirement that the National Advisory Cancer Council review each con- tract before award. As a compromise, it was agreed that NC1 periodically would provide the National Advisory Cancer Council with information regarding the plans for and status of the contractual program. This procedure is still being used, After the Director, NCI, approves the contract propos- als, the Research Contracts Branch In the Office of the Associate Dlrector for Administration, NIH, negotiates and finalizes the contracts. The Secretary, HEW, has formally delegated contracting authority to the Director, NIH, who in turn has delegated this authorrty to certain NIH offl- cials but not to any NC1 officials. Contract negotiations by NIH take approximately l-1/2 months and duplicate several of the review steps pre- viously taken by NCI. Specifically, the reviews of contract proposals by the NIH contracting officers--including the 23 quallficatlons of the proposed contractors, the work spec- lficatlons, and the amounts of the proposed contracts-- duplrcate certain work m steps 3, 4, and 6 of the NC1 re- view 1.n the schedule shown on page 22. Conclusion We believe that about l-1/2 months of the -/-month pe- riod required to review and approve an NC1 research contract consisted of an unnecessary duplication of review by NIH and NCI. We believe also that much of the l-1/2 months could be eliminated if NIH gave research-contracting author- ity to NC1 program managers. Recommendation to the Secretary of HEW Accordingly, we recommend that the Secretary of HEW authorize NC1 program managers to negotiate research con- tracts. In his comments dated January 21, 1971 (see app. II), on a draft of this report, the Secretary of HEW stated that action was being taken to extend research-contracting au- thority to NCI. The Secretary noted that HEW studies had recommended decentralization of research-contracting author- ity to NC1 and other NIH components which have a large vol- ume of research contracts. 24 PROCESSUSED FOR REVIEWING AND APPROVING GRANTS FOR CANCER RESEARCH In fiscal year 1970 NCI awarded 1,182 research grants amounting to $71.4 million. The research grant review and approval process, which is summarized rn the chart on page 26, took an average of about 8 months during calendar year 1970. A significant portion of this processing time occurs because the study sections that review grant applications and the National Advisory Cancer Council that recommends approval of grant applications each meet only three times a year. All applications, regardless of amounts involved or complexity, are held for some period of time, the amount of time depending upon when the applicable study sections and the National Advisory Cancer Council will meet. Inherent in such a review process is a certain amount of time when most applications are Just waiting for the next step without being processed. For example, as indicated below, an application for a new project submitted between February 2 and the June 1 deadline for submission of an ap- plication would take from 3 to 8 months to reach the study section review. It would then have a 6- to lo-week wait be- ., fore consideration by the National Advisory Cancer Council. The National Advisory Cancer Council meets three times annually to consider grant applications. The frequency of its meetings determines, to a great extent, the timing of the grant review process. The following table illustrates key dates in the grant review process for fiscal year 1969 Council meetings. Deadline for sub- mission of appli- cation to NIH: Renewal &Y 1 Sept. 1 Jan. 1 New and supple- mental June1 Oct. 1 Feb. 1 Period of study sec- Aug. 28 to Jan, 5 to Apr. 12 to tions meetings Sept. 29 Feb. 1 %Y 3 Period of National Advisory Cancer Nov. 18 to Mar. 10 to June 16 to Council meetings Nov. 20 Mar. 12 June18 25 f In reply to a GAO suggestion in a draft of this report that meetings of study sections and the National Advisory Cancer Council be scheduled more frequently, the Secretary * of HEW stated that there was a serious danger that an in- crease in the frequency of these meetings would jeopardize the ability of NIH to obtain the kind of expert advice needed to ensure the quality of its programs. He said that the eminent scientists involved would be most reluctant to commit significant additional time away from their schools and laboratories and that, in any case, the time saved by addltlonal meetings would be minimal. (See app. II.> In general, all research grant applications, regardless of the complexity of the project or the amount of funds re- quested, must go through the same review process and there- fore require approximately the same overall processing time. In fiscal year 1970 NC1 awarded 1,182 research grants totaling about $71.4 million, Grants of under $30,000 each made up 45 percent of the number of grants and about 12 per- cent of the dollar amount. Amount of Percent of Percent of individual grant total number total amount award of grants awarded of grants awarded $ 0 to $ 9,999 13 1 10,000 to 19,999 13 3 20,000 to 29,999 19 - !z Total 45 12 In excess of $30,000 Total The review process for grant applications starts with .i the Division of Research Grants of NIH, which is the central 1 h receiving point -for - all grant applications. The Dlvlsion - _ * designates, on the basis of program relevance, the institute to which applications are referred and assigns the appllca- tions for scientific review to one of the study sections which are organized along scientific discipline lines. (See app. IV.) 27 IO ensure scientific excellence rn the revrew of grant proposals, NIH and NC1 use study sectlons made up of such experts as sclentlsts, educators, and others in the scien- tfflc area of the research covered by the grant application being consrdered The responsrbillty of the study sectlons and the special review committees reviewing NC1 grant pro- posals includes determining the sclentrflc merit of the pro- posed research. Prrorrties are established by these groups on the basis of scientific merit. The grant appllcatlons relevant to cancer, along with the study sections evaluations, are forwarded to the Na- tional Advisory Cancer Council. About 400 to 500 applica- tions are considered at each meeting. The National Advisory Cancer Council usually has approved the study sections' rec- ommendatrons without any material change. The proposals recommended by the National Advisory Cancer Council with the highest priorltles are funded within the lrmitations of available appropriations. All applications to be funded are sent to NCI's busi- ness staff, which reviews the funding level In the appllca- tlon for reasonableness of the amounts involved. c0unc11 recommendations are used as a guideline. The remaining ap- plications are grouped into two categories, those which may be funded later If sufficient money is available and those not to be funded. During fiscal year 1970 the chance of not obtaining funds for newly approved projects for cancer re- search was about 50 percent. Conclusion We do not question the concept or the merits of scien- tific reviews by outside committees in approving research proposals for the purpose of setting priorities on the basis of scientific merit. However, the fact that the system of review and approval of proposals for research projects has reached the point at which proposals for NC1 grants take an average of about 8 months to process raises the question of whether the present system should be continued. We believe that, unless some measures are taken to streamline and ex- pedite the review and approval process, the problem of de- lays In the review and approval process probably would be made worse if the substantial increases in the amount of 28 cancer research recommended by the committee of consultants are appropriated by the Congress. Recommendation to the Secretary of HEW Accordingly, we recommend that the Secretary of HEW authorize the NCI program managers to award grants up to a specified dollar limit without review by study sections but with the review and recommendations of the National Advisory Cancer Council. In commenting on this matter, the Secretary of HEW in- formed us that the Department planned to review all aspects of the grant review system with a view toward strengthening and expediting the review process. He also stated that the Department's evaluation of the grant review system would include consideration of granting authority to NC1 program managers to award grants up to a specified dollar limit without review by study sections. (See app. II.) 29 DELAYS IN FUNDING CANCER RESEARCHPROGRAM Because the NC1 budget 1s part of the HEW budget, ac- tion on NC1 funding requests must wart until the entrre HEW appropriation bill 1s enacted. Cancer research projects, usually from 3 to 5 years in length, are funded annually. Although ongoing research grants and contracts are funded under a Joint congressronal resolution making continuing appropriations for a fiscal year pending approval of appro- priations for that year, NC1 cannot effectrvely plan for re- search, particularly new programs and projects, until the NC1 approprlatlon request is approved and the total funds approprrated are known. The Director, NCI, and some grantee officials advised us that, because of the lnablllty of some research rnstrtu- tlons to provide Interim private funding until final approval and funding 1s received from NCI, the initration of some re- search proJects was made uncertain. Also, the Drrector, NCI, and the grantee officials informed us that such delays could cause problems for research lnstrtutlons In attractrng and retaining qualified researchers. Effect of HEW budget process on fundrng cancer research Each of the 10 institutes at NIH has separate approprr- ations, and each must be considered during the budget pro- cess by various levels wlthrn HEW and the Executive Office of the President, as well as by the approprratlon committees of Congress. For example, In fiscal year 1970 HEW had a total of 88 approprlatlon requests to prepare and justify. Conslderatlon of the HEW approprratlon request takes sub- stantial time each year, as shown below by the dates of en- actment for the past 6 years. Budget delay Date of from June 30 Fiscal year enactment (months) 1966 8-31-65 1967 ll- 7-66 1968 ll- 8-67 1969 10-11-68 1970 3- 5-70 1971 l-11-71 30 Although NC1 has a separate appropriation, the NC1 bud- get is consolidated with the NIH budget and included in the overall HEW budget, so that the NC1 budget must compete with all other HEW research and health, education, and welfare programs. The budgetary process takes 24 months and is pre- sented in the chart on page 32. Many scientific researchers depend primarily upon NC1 for research funds, Research experiments talce several years to perform; therefore grants generally are awarded for pe- riods ranging from 3 to 5 years, subject to annual fundmg. About a year prior to the expiration of the grant award, the researcher must begin the application process anew to fi- nance a new experiment or series of experiments or a contin- uation of the prior experiment that was not completed within the estimated time,, Officials of some research institutions informed us that they were unable to fund new projects for ' periods of time because of delays in Federal appropriations. HEW's comments and our evaluation We believe that, to minimize the effect of the substan- tial time delays in obtaining appropriations and funding for NC1 grants and contracts each year, the possibility of adopt- ing the practice of authorizing advance funding should be considered by the Congress. This can be accomplished through authorizing and malting appropriations to be available for the next fiscal year following the usual budget year. This type of advance funding was authorized by title I of the Elementary and Secondary Education Act of 1965, as amended, for the program of aid to educationally deprived children and by the Economic Opportunity Amendments of 1969, The Secretary of HEW advised us that, at the present time, despite delays in the funding of new grants and con- tracts, HEW did not have any data that indicated any serious disruption to research under the funding mechanism and that HEW was not aware of any significant or widespread problems encountered by research institutions in attracting qualified staff. He stated that funding delays were a considerable inconvenience and concern to the research institutions and to individual investigators, not only U-I the cancer program but also throughout the programs admlnistered by HEW. The Secretary concluded that the delays in appropriation 31 NATIONAL CANCER INSTITUTE BUDGETPROCESS OFFICE OF MNAW&NJ AND PHASE NM HEW HOUSE SENATE PRESIDENT IA” FE8 l RELIYI”*RT YIRCR EsnY*TE APRIL MAT JUNE JUL” FOrWAL I”0 E,TIMATE IEPT OFFlCEOP WANAGWEnt OCT WOV w L 8”DGET t3 COHGREssIO”*L DEC. ,“snFIC*nOI( J&n FORMAL PE*RIHG*on FE8 COHGRESSONAL MARCH APRIL JUSlIFIUllON APRIL *PPRQPRI*nOll THRU I BUDGET DEL EXECUT,O” I approvals could be a significant deterrent to initiation of the new and sizable cancer program levels visualized by the consultants to the Senate Committee. Also, the Secretary of HEW advised us that delays in funding had emanated most often from the recent practice followed by both the Congress and the executive branch of establishing annual spending ceilings. For example, in re- gard to the fiscal year 1970 appropriations, funds were withheld from HEW by the Office of Management and Budget to keep 1970 Federal outlays within the overall budget estl- mate for the year, and funds were also withheld as a re- sult of limitations placed by the Congress on the expendl- ture of appropriations. The Secretary stated that the effect of these spending ceilings on the timing of grant funding was to delay awards of new grants until a spending plan had been developed for the entire fiscal year, which was very difficult to do until appropriation and expenditure limitations were known. He also said that the result was that typically HEW did not fund new projects until well into the fiscal year and that this situation would exist whether or not the grants were advance funded. We recognize that HEW must develop an annual spending plan based upon various expenditure control limitations; however, it seems to us that it would not be desirable to delay financing most new projects until appropriation and expenditure limitations for the year are known. We believe that it would be desirable to begin financing new projects as soon as possible after the beginning of each fiscal year wIthin the authority of either a joint congressional resolu- tion making continuing appropriations for the fiscal year which generally limits appropriations to the prior years level, or advance funding. In either case provision could I be made to hold back a reasonable amount of funds to cover any estimated expenditure limitations that might be imposed subsequently. We believe that, to optimize the Government's invest- ment in terms of both facllltres and the sclentlflc knowl- edge accumulated by professional researchers, particularly in view of the adverse effect which delays in funding can 33 have on the lmplementatlon of new research programs and proJ- ects, conslderatron should be given to the advance-fundlng mechanism as a means to plan and program research more effec- tively. In our opinion, advance fundlng would enable NC1 to make awards on the basis of the amount appropriated for the year covered by the advance fundlng and would facllltate more timely planning and flnanclng of new programs and proJ- ects, rather than llmlt awards for research to the amounts authorized by a Joint resolution making contlnulng approprla- tions Matter for conslderatlon by the Congress. In consrderatlon of the foregoing observations concern- ing the problems of funding cancer research, the Congress may wish to consider the enactment of leglslatlon authorlz- ix, in the case of NCI, the making of approprlatlons to be available for the next fiscal year following the usual bud- get year. 34 CHAPTER3 SCOPE OF REVIEW Our review was directed toward obtarnlng rnformatlon concerning the organlzatronal and adminrstratlve problems associated with implementing a large-scale, mission-oriented program to conquer cancer wlthrn the present structure of NIH, as expressed to us In a letter dated September 25, 1970, from the Chairman of the Senate Commrttee on Labor and Public Welfare. Our review also was concerned with the use of grants and contracts rn financing cancer research, Our review was accomplished through dlscusslons with offrclals of NIH, NCI, and various grantee institutions and through the use of available records and documents relating to the administration of research contracts and grants, the organization and administration of HEW-NIH-NCI, and the HEW budget process. 35 APPENDIXES 37 APPENDIX I September 25, 1970 Honorable Elmer B. Staats Comptroller General of the United States General Accountltlg Office 441 G Street - Washington, D.C. 20548 Dear General Staats Pursuant to Senate Resolution 376 (copy enclosed), a Special Staff of the Senate CommIttee on Labor and Public Welfare 1s conducting a study of our current efforts In cancer research to deterrmne the best way to Implement a maJor national effort to conquer cancer. The problems associated mth lmplementlng a large scale, mission-oriented program mthm the present structure of the National Institutes of Health must be examined m considerable detail. It 1s my understanding that your staff has been resident m NIH for a considerable period of tune and therefore has background and experience that can be very helpful to the Special Senate Staff I further understand that our staffs have dLscussed the problem and agree that your people should be able to contribute m an important way to this effort. It 1s therefore requested that the General Accounting Office provide such assistance as you consder appropriate to the Special Staff on Cancer of the Senate Comzzttee on Labor and Public Welfare in developing background and support for Its report on implementing a maJor effort on cancer. It would be patilcularly helpful if prelunlnary lnformatlon could be made avallable before the end of October 1970 with a final report submItted by the end of the year. Please be assured of w personal appreciation for any asszstance you may give in this matter. mclosure RWY/mmb 39 APPENDIXIL Page 1 THE SECRETARY Or riEALTH EDUCATION AN” WELFARE WAZHINGTON D C 20201 JAN 21 1971 Mr. Dean K. Crowther Assistant Director Umted States General Accounting Office W ashmgton, D. C. 20548 Dear Mr. Crowther: Thank you for the opportumty to comment on the draft report of the Comptroller General’s Review of Selected Aspects of Admlmstratlon of Cancer Research. This draft report examines the organlzatlonal structure of the Department of Health, Education, and Welfare (HEW), the National Institutes of Health (NIH), and the National Cancer Institute (NCI) relatmg to the adrmmstratlon of the cancer research program, and the method and procedures used for processmgJ, revlewlng and approvmg grants and contracts for cancer research; and considers alternative approaches to such methods and procedures. The basic alrn of the report appears to be the ldentlflcatlon of problems of orgamzatlon and processes that rmght mnhlblt or deter the proper adrnmlstratlon of a cancer research program of a much larger size or that recommended by the Commlttee of Consultants appolnted by the Committee on Labor and Public Welfare. The report’s fmdmg 1s that slgnlhcant delays In approving and funding grants and contracts for cancer research are caused by long delays In Congressional approval of HEW fiscal year budgets and by problems in the Internal review and approval procedures. Because of the delays “the lnltlatlon of some research proJects was uncertain.. . and that GAO was told that the delays can cause problems to research mstltutlons m attrackng and retamlng quaIlfled researchers.” We assume that the delays In funding of grants and contracts as noted by the GAO, applies to new programs and appllcatlons smce all on-gomg grants and contracts are funded under a contlnulng resolution pendmg approval of appropriations. 40 APPENDIXII Page 2 Page 2 - Mr. Dean K. Crowther At the present time, despite delays U-Lthe fundmg of new grants and contracts we have no data that mdlcate any serious dlsruptlon to re- search conducted under these mechanisms nor are we aware of any slgnlflcant or wldespread problems encountered by research lnstltu- tlons 1~1attractmg quallfled staff. We are, of course, aware that fundmg delays of new grants and contracts are a considerable mconvenlence and concern to the research mstltutlons and lndlvldual inves tzgators, not only in the Cancer program, but throughout the programs admlnlstered by this Department Every effort has and will continue to be made to m’mlwL1ze the mconvenlence and problems involved. However, the delay in approprlatlon approvals could be a slgnlflcant deterrent to mltlatlon of the new and sizable Cancer program levels vlsualleed by the Consultants to the Committee In our view, the funding delays m the awards of grants and contracts are caused prlmarlly by events outside the control of this Department, such as the lag m approval of annual budgets as mentloned m the report. The delays caused by Office of the Secretary-Office of the Director, National Institutes of Health-Natlonal Cancer Institute internal review and approval procedures are mmlmal. As outlmed further In this letter, the speed-up of the processes involved may do damage to the sclentrflc review necessary to fund only research proJects of high sclentlhc merit without achlevmg slgnlficant time s avlngs . The followmg are the Department’s comments on the recommendations cited m the report. For convenience, the response to each 1s listed directly below the recommendation, as follows: 1. Provide for more frequent meetings of NIH study sections and the National Cancer Advisory Council to mmlmlze approval delays. There IS a serious danger that an increase m the frequency of NIH study section and council meetings would Jeopardize the ablllty of the NIH to obtain the kind of expert advice needed to assure the quality of Its programs. The eminent sclentlsts mvolved would be most reluctant to commit slgmflcant addltlonal time away from their schools and laboratorxes. In any case, the time saved by addltlonal meetings would be mmlmal. 41 APPENDIXII Page 3 Page 3 - Mr. Dean K Crowther 2 Grant authority to NCI program managers to award grants up to a speclfled dollar limit without review by study sections. We ~111 include conslderatlon of this idea m our future evaluations of the proJect grant review system. We are planning to review all aspects of this system with a view toward strengthening it In a number of areas, mcludmg expedltmg the process. 3. Grant authority to NC1 program managers to negotiate contracts, Studies conducted by my office have recommended decentrall- zatlon of research contracting authority to NC1 and other NIH components which have a large volume of research contracts Steps are being taken to effect this recommendation. 4 Congress consider leglslatlon authorlzmg, In the case of NCI, the makmg of approprlatlons for the fiscal year next followmg the usual budget year. We doubt that this recommendation goes to the true source of the problem. We believe that delays m funding have emanated most often from the recent practice followed by both the Congress and the Executive Branch of establlshmg annual spending cellmgs The effect of these celhngs on the tlmmg of grant fundmg 1s to delay new awards until a spendmg plan has been developed for the exre fiscal year. Thus 1s very dlfflcult to do until final approprlatlons are known. The result has been that typlcally we do not fund new proJects until well into the fiscal year Ths sltuatlon would exist whether or not the grants were forward funded. We believe that as we gam experience with the execution of expenditure control devices we can overcome the Impact on the tlmmg of grant awards. On the other hand, there IS not much that we can do to speed-up the approprlatlon process. 42 APPENDIXII Page 4 Page 4 - Mr. Dean K. Crowther in summary8 the real problem lies xn the fact that approprla- tlon actlon has been occurrmg later and later with each fiscal year. This, coupled wxth the requirements for expenditure controls, has occasioned the problem wzth which both the Department and your report are concerned. We trust that these comments will be helpful in your reporting to the Commzttee Chairman. Smcerely, Secretary 43 APPENDIXIII Page 1 Dlst Congress CONXITTEE PRINT 2a SESSION NATIONAL PROGRAM FOR THE CONQUEST OF CANCER REPORT OF THE NATIONAL PANEL OF CONSULTANTS ON THE CONQUEST OF CANCER AUTHORIZED BY S Res 376 (Agreed to by Senate April 27, 1970) PREPARED FOR THE COMMITTEE ON LABOR AND PUBLIC WELFARE UNITED STATES SENATE NOVEMBER 1970 PART 1 Printed for the use of the Committee on Labor and Pubhc Welfare U S GOVERNMENT PRINTING OFFICE 5!2-532 WASHINGTON 1970 44 APPENDIXIII Page 2 COMMITTEE ON LABOR AND PUBLIC WELFARE RALPH YARBOROUGH Texas, Chawman JENNINGS RANDOLPH West VlrSlnis JACOB K JAVITS, New York HARRISON A WILLIAMS, JR , New Jersey WINSTON L PROUTY, Vermont CLAIBORNE PELL, Rhode Island PETER H DOMINICK, Colorado EDWARD M KENNEDY, Massachusetts GEORGE MURPHY, Cahfomis GAYLORD NELSON, Wisconsin RICHARD S SCHWEIKE R, Penm) lvanfa WALTER E MONDALE, M.mnes~ta WILLIAM B SAKBE, Ohlo THOMAS li EAGLETON, Mmoun ALAN CRANSTON, Calffornm HAROLD E HUGHES, Iowa ADLAI E STEVENSON III, Ihnois ROBERT 0 HARRIS, St@ Dmctor GENE E GODLEY, &nerd Counsel ROY H =LENSON, Mtnonly Staf Dzrector EUQENE MIPFELMAN. Mtnorztg Counsel 45 APPENDIXIII Page 3 COMMITTEE OF CONSULTANTS ON CANCER (Appended Pursuant to S Res 376) BENNO C SCHMIDT, Chawman Dr SIDNEYFARBER, Cochaarman I W ABLL Dr HENRYS KAPLAN WILLIAM McC BLAIR, Jl I)r MATHILDI- KRIM ELMER BOBST MI-~ M41ty WI LLS LAWRENCE Dr JOSEPH BURCHFNAL Dr JOSHU I LFDLRBLRG Dr R LEF CLARK EMIL MU~Y Dr PAUL B CORNFLY MICHAI LJ O'NEILL EMERSON FOOTE JUR~L R PARTFN G KEITH FUNSTON LAURANCI b ROCK~FILLER Dr SOLOMON GARB I)1 JONATHAN E RHOADS Mrs ANNAROSENRERGHOFFMAN Dr HYROID P RUSCH Dr JAMESF HOLLAND 1)~ WCNDILL G ~COIT Dr WILLIAM B HUTCHINSON LPI\ W\SSl RMQN STAFF OF TBC COMMITTEE Robert F Sweek, Dwector Carl M Flxlnan, Deputy Dwector Mrs Helena Cur&, Speczal Assastant John A Grnnes, Edatord Darector 46 APPENDIXIII Page 4 Foreword US SENATE, COMMITTEE ON I&lOR AND PURLI WELFARE, November 27, 1970 Cancer 1s a disease which can be conquered Our advances m the field of cancer research have brought us to the verge of important and excltmg developments m the early detection and control of this dlead disease; but as a nation we have not put forth the effort necessary to exploit the full potential of these gams, nor have we made the proper effort to ascertain what addltlonal avenues of research should be opened In March of this year, I mtroduced a resolution supported by 53 of my colleagues m the Senate, calling for a completely new study of can- cer, cancer research, and the cause and cure of cancer The Intent of tins resolution IS to make the conquest of cancer a natlonal goal of the hlgh- est pnorlty The resolution authormed the Comrmttee on Labor and Public Wel- fare to study cancer research activities It specifically charged the com- mittee to “examme, mvestlgate, and make a complete study of anv and all matters pertammg to (1) the present status and extent of sclentlfic research conducted by governmental and nongovernmental agencies to ascertain the causes and develop means for the treatment, cme and elnmnatlon of cancer, (2) the prospect for success m such endeavors, and (3) means and measures necessary or desirable to facllltate success m such endeavors at the earliest possible time ” As a result of this resolution a Panel of Consultants on the Conquest of Cancer, composed of 13 emment laymen and 13 emment sclentlsts, was established to assist the Comrmttee with the new study on cancer After months of mtenslve and dIllgent effort, this Panel has plepared the attached report, (‘A Natlonal Program for the Conquest of Cancer ” The report 1s dedicated to the proposltlon, expressed m a recent Con- current Resolution of the Congress, that the conquest of cancel shonld be a national crusade The recommendations are bold and far reaching Thev call for a new agency, whose sale IIusslon 1s the conquest of can- cer They call for adequate resources of manpower, facllltles and funds to do the Job m accordance w&h the provlslons of a coordmated na- tlonal program lan The recommendations, along with the supportmg findings, are spef led out 111detail m the attached report I mtend to introduce m this session of Congress major leg&atlon to nnplement these recommendations and I therefore commend this re- port to the committee and to the Senate for early conslderatlon a RALPH W YARROROUQR, C'hazmmn tv 44 APPENDIXIII Page 5 Letter of Transmittal NEW YORK, N Y , November .%5,1870 Hon RALPH W YARBOROUGH, Ch%rm,un, Comzttee on Labor and Publtc Welfare, US Senate, Wadmgton, D C DEAR Mi CHAIRMAN I am pleased to present heremth the report and recommendations of the Comnuttee of Consultants on Cancer appomted pursuant to Senate Resolution 376 Part I of the report sets forth m 12 brief paragraphs a summary of the cancer problem, the areas of special promise which offer unusual opportumtles for mtensl- fied effort, and the recommendations of the comrmttee Part II of the report sets forth the sclentlfic and medical background m more detail For the convenience of your committee, this part of the report IS also preceded by a summary of the sclentlfic material Of the $250,000 appropriated by the Senate for this study, you will be pleased to learn that we have comnntted or spent only approx- lmately $75,000 This has been possible because of the generous con- tllbutlon of time and effort of many persons who would not have been available at all on a rennbursement basis, but who, because of their dedlcatlon to the goals of this study, have given most gen- erously of their time and talents These included not only members of the committee, but several hundred members of the sclenttic com- mumty whose lives are devoted m a large measure to work related to the conquest of cancer I would hke to express my personal appreclatlon to the members of the comrmttee, not only for their splendid cooperation and 100- percent dedlcatlon to our task, but more particularly for the unprec- edented hours of work which they have devoted wlthout reservation The sclentlfic and professional members of the committee have borne by far the largest burden of the work of our CommnXee, and no group could have given more unselfishly of their time and talent The com- mittee 1s most appreclatlve to the members of the sclentlfic commumty, mcludmg those at the National Cancer Institute, and to the members of our staff for the mformatlon, views, and suggestions which they have so generously made available to the committee The committee was most fortunate m the diverse views and back- grounds represented, and m such a group one would not expect nor did we have unanimous agreement on all POIJ&, However, there has been unammous commitment to the obJectlve of the study as set forth m the Senate resolution Out of our dlscusslons and differences we have been able to crystalhze a consensus TIM report represents that consensus The committee 1s unammously of the view th&, the conquest of cancer 1s a reallstlc goal If an effective national program along the lines recommended m the report IS promptly mltlated and relentlessly pursued Respectfully, BENNO C SCHMIDT, CWmrnmn (VII) 48 APPENDIXIII Page 6 ANATl[O~AkPROGRAMFORTWECON&UEST OF CANCER INTPODUCTION On April 27,19’70, the Senate passed Senate Resolution 376 author- 1Zln~ the Senate CommnXee on Label and Pubhc Welfare, with the as- s&&e of an advisory committee, to rep01 t to the Senate on (1) the present status of sclentlfic knowledge with respect to the causes of cancer and its treatment, cure, and ellmmatlon, (2) the prospect of success m such endeavors, and (3) measures necessary or desirable to facilitate success at the earliest possible time Pursuant to that resolu- tlon, the Committee of Consultants was designated m June 1970, and was asked to subrmt its report and recommendations at the earllest practicable date On July 15, 1970, the House of Representatives passed Concurrent Resolution 675, later passed by the Senate, expressmg the unanimous sense of the Congress that “the conquest of cancer IS a national cru sade” and that “the Congress should appropriate the necessary funds so that the cltlzens of this land and all other lands may be delivered from the greatest medical scourge m history ” On June 29, 1970, the Committee of Consultants held Its first meet- ing Smee that tune the Committee has met 10 full days, subcommittees have met many addltlonal days and the wrrtten or verbal testnnony of 289 rmtnesses and advlsors has been consldered The Committee 1s pleased to present herewith its report and recommendatmns SUNMARY AND RECOMMENDATIONS 1 Cancer IS the No 1 health concern of the American people A poll conducted m 1966 showed that 62 percent of the public feared cancer more than any other disease Of the 200 ml&on Americans alive today, 50 mllllon ~111 develop cancer at present rates of mcldence, and 34 m&on wdl die of this pamful and o&n ugly disease, If better methods of prevention and treatment are not discovered About one- half of cancer deaths occur before the age of 65, and cancer causes more deaths among children under age 15 than any other disease Over 16 percent of all deaths m the United States are caused by cancer, makmg it by a wide margin our second greatest killer (after cardiovascular diseases) Cancer often St&es as harshly at human dignity as at human hfe, and more often than not it represents financial catastrophe for the farmly m whch It strikes 2 The amount spent on cancer research IS grossly madequate today For every man, woman, and child m the United States, we spent m 1969 $410 on national defense, $125 on the war m Vietnam, $19 on the space program, $19 on foreign aid and only $0 89 on cancer re- search Cancer deaths last year were 8 times the number of lives lost m 6 years m Vietnam, 51/z times the number k&d m automobile accl- (1) 49 APPENDIXIII Page 7 2 dents, and gleater than the number of Americans lL~lled m battle m all 4 J cals of Wolld War II Given the sel~ousne~s 01 the cancer problem to the health and morale of our society, this allocation of national pllolltles seems open to serious question In addltlon to the poignancy of the disease, and the death and suffering that it causes, the econonuc loss is staggering, with estimates of its costs to the Nation rmnmg as Hugh as $15 bllllon pel year, of which some $3 to $5 bllhon represents direct care and treatment costs and the balance 1sloss of earnmg power and productlvlty 3 The mcldence of cancer 1sIncreasing This IS partly due to the fact that a greater number of our cltlzens are reachmg more advanced ages, where cancer strikes more frequent1 , but It 1s also due to the sharp increase m lung cancer, undoubte B ly attributable to the air pollution m certain environments and most Importantly to the self- pollution of those who smoke cigarettes It IS estimated that if the 4mencan people stopped smoking cigarettes this alone would ehml- nate about 15 percent of all cancer deaths 4 The nature of cancer IS not yet fully known We know that human cancers are caused by certain chemicals, by certain types of radiation, and probably by viruses The precise mechanisms by which these car- cmogenlc agents cause, or mtelact to cause, cancer 1s not known, and 1 el y little 1s known about the natural defense mechamsms that prevent cancer m some cases and not m others A great deal more must be learned about chemical carcinogens, radiation, and viruses, and how they work We must also learn more about what takes place at the cellular level when cancer occurs There 1s very strong suggestive e\ I- dence that viruses cause some human cancers, but which viruses, how they are transmitted, and how they operate are unknown It 1s errone- ous to thmk of cancer as a smgle disease with a single cause that will be sublect to a single form of m-ununlzatlon (as m the case of poho) or a single cm e Cancer comprises many diseases and results from a vallety of caUses that R 111have to be dealt with m a variety of ways However, as our knonledge IS expanded, more and more cancers ml11 become prel entable or curable 5 The cure rate for cancer IS gradually lmprovmg In 1930 we were able to cure only about one case In five, today we cule one case m three, and it 1s estmlated that the cure rate could be brought close to one m two by a better appllcatlon of knowledge which exists today, 1 e detectlon at an earlier stage through the more widespread use of exlstmg techniques (such as the Papamcolaou test for women and mammography) , coupled with an extension to all cltlzens of the same quality of dlagnosls and treatment now available at the best treatment centers There are three methods for curmg cancer today surgery, ladlatlon therapy, and chemothera Often two or even three of these methods are used m combmatttlon firome types of cancer are far more curable than others For example, early breast cancer treated by sur- gery, cancel of the cervix by radlatlon or surgery, and chonocarcl- noma and Rurkltt’s tumor by chemotherapy, are among those most susceptible to cure today Treatment techmques are lmprovmg mark- edlv, particularly m radlatlon therapy and chemotherapy, and more widespread avallabll$ of the best quality detection and treatment will give us more and mole cures However, it 1s still true that those cancers which dlssemmate lapidly are seldom curable today, and this represents a major gap m our exrstmg knowledge Where we stand today m our knowledge of the causes, nature, prevention, dlagno=s, APPENDIXIII Page 8 3 treatment, and control of cancer IS set forth m detail m part II of this repo1t 6 There Ease been malor advances m the fundamental hnonl~lpc of cancer m the past decade, and these advances m knon ledge lid\ e opened up far more promlsmg areas for mtenslve mvestlgatlon than ha\c ever heretofore exlsted These areas of special promise must be explored with tlgor, if we are to exploit the great opportunltles that lie before us They are examined m detail m part II of this report Among the areas of special promise which must be aggressllel? pursued are (a) The ldentlficatlon and stud) of the chemxal, phvslcal, and other environmental factors that cause cancel (food additives, am pollutants, Industrial hazards, radmtlon, and other carcinogens) , (b ) Viruses causing cancer (what viruses cause cancer, how are thev transmitted, and how do they act) , (P) CM1 and turn01 biology (mcludmg cell surface phenomena, molecular functions, dlfferentlattlon and genlc expression, controls of cell dlvlslon, mechanisms of metastasis, nutritional require- ments and other biological factors) , (d) Immunologv (host resistance agamst cancer, its nature, causes and therapeutic use) , (e) Epldemlology (the variables III cancer mcldence and types stemmmg from geographic. social, economic, nutrltlonal, occupa- tional, and constltutlonal differences) (f) Cancer prevention (more effective utilization of existmg knowledge and mtenslfied research on preventive measures) , (g) Dlagnosls (the development of new and Improved dlag- nostic techniques) , (h) Chemotherapy (the development of new and better drugs and Improvement m their uses) , (2) RadIotherapy (development of new and better techniques and apparatus for radiation therapy) , (1) Surgery (the best techniques m cancer surgerv coupled with earlier diagnosis must be made generally avaIlable 111 order to further increase the cure of cancer Better rehabdltatlon tech- niques must be further developed and utlllzed to return the cancer patient to an active and full life) , (h) Combmatlons of treatment modahtles (Improvement m treatment results bv better comblnatlons of surgery, radiotherapy, chemotherapy, and nnmunotherapy) ‘7 A natlonal program for the conquest of cancer 1s now essential If we are to exploit effectively the great opportunltles which are pre- sented as a result of recent advances m our knowledge However, such a program will require three malor mgredlents that are not present today First, effective admmlstratlon with clearly defined authoxltv and responslblllty , Second, the development of a comprehensive national plan for a coherent and systematic attack on the vastly complex problems of cancer Such a plan would mclude not only programmatic re- search where that 1s appropriate, but also major segments of much more loosely coordmated research where plans camlot be define- tively laid out nor long-range obJectives clearly spectied , and Third, the necessary financial resources APPENDIX III Page 9 4 11 t 4c present time there 1s no cooldmated national program or ljrcl_;r km plan The Xatlonal Cancer Instltute has done excellent work l&elf and has supported grants and contracts m the scientific com- mullIt whlrh hare resulted m much outstandmg work, but the over- all research eftort IS frdgmented and, for the most part, unccordmated The effort m cancer should now be ex anded and mtenstied under an effectlre admmlstratlon charged wit % developmg and executmg a comprehensive nataonal plan for the conquest of cancer at the earllest possible time The three foregoing elements are considered separately m more detail 111the succeeding paragraphs 8,9, and 10 8 Admtnzstrafwn -An effective major assault on can< el 1eqmres an admmlstratlr e setup which can efficlentlg admmlstel the coherent program that 1s reqmred m this formidable and complex sccrentlfic field Such a setup Q 111not be easy to achieve wlthm the Federal Gob - ernment The effecter e nnplementatlon of such a program will reqmre a slmpllficatlon of orgamzatlonal arrangements and a drastic reduc- tlon m the nunlbel of people mvolved m admmlstratlve decisions This tape of straight-lme organlzatlonal efficlpncy does not exist today m the National Cancel Institute, the Nattlonal Institutes of Health, or the Department of Health, Education, and Welfare Obxqously, flom man\ standpoints It can be argued that any cancer program should be m the Department of Health, Education, and Welfnxe and indeed that It should be m the National Institutes of Health Honever, there IS real doubt whether the kind of organlzattlon that IS rymred for this program can m fact be achieved wlthm the Nallonal Institutes of Health OI wlthm the Department of Health, Education, and Wel- falc ,4part from the question of whether It can be done, there 1s also the questlon of whether it would be wise to reqmre the Secretary of Health, Education, and Welfare to attempt to give cancer the prlonty necessary to carry out the congressional mandate m a department charged with the multiple health and other responabllltles of that Department in the past Then the Federal Government has desired to give top pllorltg to a malor scientific prolect of the magmtude of that mvolved m the conquest of cancer, It has on occasion, w&h conslderable success, gl\en the responslblllty for the proJect to an independent agency Such an agencv provides a degtee of independence m management, plan- nmg, budget presentation, and assessment of progress which IS d&cult if not lmposslble to achieve m a large government department Ac- cordmgly, if the Congress and the admmlstratlon are truly committed to making the conquest of cancer a “national crusade”, as expressed in the conrurrent resolution of the Congress It IS the view of the Com- mlttee that a X’atlonal Cancer Authorlty should be estabhshed whose mlsslon 15 defined by statute to be the conquest of cancer at the earllest possible time A.11 the functions, personnel, faclhtles, appropnatlons, programs, and authoxltles of the National Cancer Institute should be tlansfrrred to the Natlonal Cancer Authority The Authollty should be headed by an ,4dmmlstrator appomted by the President with the adI ice and consent of the Senate, and he should report directly to the President and present 111sbudgets and programs to the Con ress In considering the feaslbllltt of an independent agency, x5 should f >eborne m mmd that we are talking about a major sclentlfic program and, as pomted out m subsequent paragr a phs, not the delivery of patrpnt cnle generall, m cancer cases The only patlent care mvolvcd m tins plo- gram will be that associated w1t11 clmxal research and trachxg and the development and demonstlatlon of improved methods III fhe d+ 52 APPENDIXIII Page 10 5 h\ery of patlen t care undertaken as a part of the comprehenslve 1)’ ograni plan The powers of such a National Cancer Authority should be very broadly defined m order to accomplish a mlsslon of this complexity It would not be useful to attempt to enumerate here all the powers that such an Authority should have and m the wrltmg of the unple- mentmg leglslatlon, the Committee belleves that the powers should be broadly defined and not enumerated However, the followmg are lllustratlve of the kmds of powers which the Natlonal Cancer Author- lty will have to be able to exercise m order to carry out a comprehen- sive program of the type envisaged (a) The power to enter mto prnne contracts with authority m the prime contractor to enter mto subcontracts, (6) The power to commit avallable funds until expended rather than on a year-to-year basis, (c) The power to authorize exceptions to exlstmg regulations, whele necessary, to permit the use of expernnental drugs, blo- loglcals, and devices m cancer research, (d) The power to establish or support the large-scale productlon of speclallzed blologcal materials for cancer research, such as viruses, cell cultures, ammals, and the hke, as well as the power to set standards of safety and care for those using such materials, (e) The ower to support research outslde the United States by highly qua Ytied foreign nationals, collaborative research mvolv- mg Amencan and foreign participants, and trammg of Amencan sclentlsts abroad and foreign sclentlsts m the Umted States, to the extent that such actlvltles ml1 promote the accomphshment of the mrsslon The Committee believes that cancer research offers a particularly fruitful field for collaboration with other nations, m- cludmg those nations with whom present cooperation IS lmnted but with whom greater collaboration 1sdesired , ( f) T%e power to fund by loan, grant, contract, or otherwise any facllltles or programs, or to take such other actions, as may be required for the accomplishment of the nusslon 9 Progrurn p2an. -A compreheneve national plan for the conquest of cancer should be developed as promptly as possible The develop- ment of a coherent overall program plan should mclude the followmg features (a) The present research actlvltles now bemg carried forward under the National Cancer InstnWe should m no way be nnpeded or mter- rupted while plans are being made for the expansion, mtenslficatlon, and coordmatlon of the cancer research program, (6) Exlstmg research facllltles and manpower should be used as promptly as possible for the accelerated exploltatlon of the opportum- ties m the areas of special promise There 1s substantial unused capa- city m this country today that should be utlhzed m order to attract and retam the manpower that IS needed It 1s a myth that we could not spend effectively on cancer verv much more than 1s now being spent The fact that Federal sup ort for cancer research has leveled off smce 1967 and that, due to m 2 atlon, the actual amount of work done has decreased has created a serious gap between what we are domg now and what we could and should be domg m cancer research It IS estl- mated that current expenditures could be doubled wlthm the frame- work of the exlstmg faclhtles and manpower potential of this country 53 APPENDIX III Page 11 6 today, exclusive of the great mduqtrlal research capablllty m tlus field which should be brought to bear on an appreciable scale m high pnor- lty areas to which this type of capablllty 1s particularly suIted (c) Exlstmg cancer centers should be strengthen and addltlonal can- cer centers m different palts of the country should be created The solution of the cancer problem lends itself to a multldlsclpllnary eff art, where teams of highly quahfied speclahsts are avallable to interact on problems of research, both chmcal and nonclmlcal, teachmng, dlag- noses, preventive programs, and the development of Improved methods m the delivery of patlent care, mcludmg rehabllltatlon Among those who work m the cancer field, there 1s great emphasis on the advantages of cmtlcal mass-a crltlcal mass of sclentlsts and physlclans commltted to the cooperatlve solution of the cancer problem, of research fac&tles, of patients, and of financial and other resources This IS snnply another way of saymg that the complehenslve cancer center offers the best orgamzatlonal structure for the expanded attack on cancer In addition to the few comprehensive cancer centers that exist 111the United States today, there are a number of other mstltutlons wbch combme all or most of the capabllltles for a multldlsclplmary effort m cancer These could serve as a base for the creation of addltlonal centers The new centers should have appropriate geographic dlstrlbutlon and should, wherever possible, be created where a nucleus of sclentlfic, professional and managemal personnel already exists and preferably where a um- verslty or a medical school afiillatlon exists or 1s planned In the creation of new cancer centers, manpower lmutatlons should be taken mto account, and new centers should not be created where there would be a dllutlon m the effectiveness of exlstmg centers which would offset any gam from the new center There should be a reallstlc opelatmg plan for each new center which assures the sclentlfic and managemal commitment and ablllty necessary to the creation and op- eration of a successful center It should be emphasized that the strengthemng of exlstmg cancer centers and the creation of new cancer centers does not mean that under this program general responslbllltv should be undertaken for the care of the Nation’s cancer patients The dellvery of patient care m cancer cases 1s a part of the general roblem of the delivery of patient care and should be so dealt with 2 owever, this mhlbltlon must not prevent the cancer centers from mcludmg such patient care faclll- ties as are necessary for clmlcal research and teachmg and for the de- velopment and demonstration of the best methods of treatment m cancer cases (d) The cancer centers should also serve as admnnstratlve coordma- tors of those programs which require reeonal coordmatlon Such cen- ters should support and assist clmlcs and commumty medlcal centers m their own geographic areas m order to assure the wldespread use of the best available methods for early detectlon and treatment of cancer They should also serve to collect data useful m the preventlon and cure of cancer, mcludmg patient follow-up mformatlon, and be responsible for the dlssemmatlon of mformatlon, both at the lay and professional levels, that 1s useful m the prevention, diagnosis and cure of cancer The effective dlssemmatlon and utlllzatlon of such mfor- mation is a most im ortant part of any natlonal plan to conquer cancer (e) A national p Ban of the type envisaged must take account of the manpower requirements for this effort There 1s a cntlcal need for 54 APPENDIXIII Page 12 7 trammg and career opportunltles for young sclentlsts, physlclans, and other personnel m this program We must reaffirm to young mvestlga- tors our confidence m the future of American science and m our na- tional dedlcatlon to success m the conquest of cancer A manpower program m this field should include trammv stipends, redoctoral fel- lowshlps for particularly prornismg candlaates, post croctoral fellow- ships for brllhant mvestlgators, and career posltlons where appro- priate through career mltlatlon awards, career development awards, and semor career awards (f) A national plan for the conquest of cancer should provide for the generous use of grants as well as contracts and other methods of fundmg Thele should be mcreased emphasis on the grants mechanism m order to stmmlate contmued independent exploration, particularly m those areas where knowledge 1s not su%clently mature for a co- ordinated program amed at reachmg defined obJectlves (4) A comprehenslve natlonal program reqmres optnnum commu- mcatlon and centrallyed banks of mformatlon There must be an accu- rate and prompt mformatlon flow m both dlrectlons This will call for mtegrated data processmg, storage, and retrieval m order to ratlonallze the declslon-making and to make mformatlon avallable when and where needed As mdlcated abole, the centers can be mlpor- tant foci m both the collection and dlssemmatlon of this mformatlon (h’) A cooldmated national program plan should, to the greatest possible extent, be generated bT the voluntarv productive mtelactlon and joint plannmg of the sclentlsts who will be responsible for domp the work The program should not be the result of the happenstance of a multitude of random declstons mdependently al rived at An mte- elated and coherent plan resultmg from the lomt effort of representa tlve sclentlsts who will be responsible for its execution 1s fundamentallv dlffelent from the hierarchical lmposltlon or dnectlon of a research program from abot e However, the effective use of collective plannmg does not mean that centralized admmlstratlon or management of re- sources should be sacrificed 10 Ix”ulz&ng -The Committee estimates that a coordmated national program aimed at the conquest of cancer at the earllest possible time, as envisaged by the concurrent resolution of the Congress, would re- quire an appropriation in fiscal 1972 of approximately $400 mllllon Thereafter, the cost of the program nould increase at the rate of ap- proximately $100 to $150 million per year, reachmg a level of $800 mGon to $1 bllllon m 1976 These sums are not large m terms of our natIona resources or of the human suffermg and economic loss attllbut- able to cancer A program of the type helem recommended IS so nnpol - tant to the American people and to the world that we feel that the amounts called for should be provided even If tbs necessitates the ralsmg of addltlonal revenues It 1s of utmost nnportance that the financing of this program not result m cutbacks m other health programs 11 Nutzonal Cancer Advzsory Board -Both the public and the scl- entlfic commumtv must be effectively represented m this effort, and must have a part m its plannmg as well as its execution To this end, a National Cancer Advisory Board should be created with 18 members, nme of whom are dlstmgulshed sclentlsts and doctors m the field of cancer, and nme of whom are dlstmgmshed laymen The members should serve for a term of 6 years with the terms of one-third of the APPENDIXIII Page 13 8 men&21 9 clplnng e’ el v Q d years Members of the Board should be appomtc(l b\ the Prcndent of the United States with the advice and consent of the Senate The Ghan-man of the Board should be elected by the members and should selve for a term of 2 years The Board should meet not 1~~sthan once each quarter and its function should be to advlse and ~~~1stthe Satlonal Cancer Authority and its Admmlstrator m the development and e\ecutlon of the procram The Admmlstrntor should be an eu-officlclo member of the Board The Board should have statu- tory responslblllty for the approval of each year’s program plan and budget, but the responslbllltv for admmlstermg the program should rest with the Admmlstrator The Board should have full mvestlpatory powers and should be required to report once each year to the Presl- dent and the Congress on the progress of the National Cancer Author- ity m the accomphshment of Its mlsslon This Board should supersede the presently exlstmg National Advisory Cancer Council, and the members of that Council should serve as addltlonal members of the Natlonal Cancer Bdvlsory Board for the duration of their present terms 12 Cancer 1s an Implacable foe and the difficulty of ehmmatmg It as a ma-jar disease must not be underestimated A top prlorlty commlt- ment by the Congress, the President, and the American people 1s required If we are to mount and sustam an assault on cancer of the magnitude envisaged by Senate Resolution 3’76 and the concurrent resolution of the Congress Such a commitment mvolves a recognltlon not only of the difficulty and complexlt of cancer but also of the time and resources required to attack it e2 ectlvely While It IS probably unreallstlc at this tune to talk about the total elumnatlon of cancer within a short period of time or to expect a smgle vaccme or cure that will eradicate the disease completely, the progress that has been made m the past decade rovldes a strong basis for the belief that an accel- erated and mtensl Hed assault on cancer at this tune ~111 produce ex- traordmary rewards The Committee IS unanimously of the view that an effective national program for the conquest of cancer should be promptly mlhated and relentlessly pursued 0 APPENDIX IV Page 1 DIVISION OF RESEARCHGRANTS NATIONAL INSTITUTES OF HEALTH LIST OF STUDY SECTIONS AS OF JULY 1, 1970 1. Allergy and Immunology Study Section 2. Applied Physiology Study Section 3. Arthritis and Metabolic Diseases Program-Project Commit- tee 4. Bacteriology and Mycology Study Section 5. Biochemistry Study Section 6. Biomedical Communications Study Section 7 Biophysics and Biophysical Chemistry A Study Section 8. Biophysics and Biophysxal Chemistry B Study Section 9. Cardiovascular A Study Section 10. Cardiovascular B Study Sectlon 11. Cell Biology Study Section 12. Communicative Sciences Study Section 13. Computer and Biomathematical Sciences Study Sectron 14. Dental Study Section 15. Developmental Behavioral Sciences Study Section 16. Endocrinology Study Section 17. Epidemiology and Disease Control Study Section 18. Experimental Psychology Study Section 19, General Medicine A Study Section 20. General Medicine B Study Section 21. Genetics Study Section 22. Hematology Study Section 23. History of the Life Sciences Study Section 24. Human Embryology and Development Study Section 25. Immunobiology Study Section 26. Medicinal Chemistry A Study Section 27. Medicinal Chemistry B Study Section 28. Metabolism Study Sectron 29. Microbial Chemistry Study Section 30. Molecular Biology Study Section 31. Neurology A Study Section 32. Neurology B Study Section 33. Nutrition Study Section 34. Pathology A Study Section 35. Pathology B Study Section 36. Pharmacology A Study Section 37. Pharmacology B Study Section 57 APPENDIX IV Page 2 38. Physiological Chemistry Study Sectron 39. Physiology Study Sectlon 40. Radlatlon Study Sectlon 41. Reproductive Biology Study Section 42. Surgery A Study Sectron 43. Surgery B Study Sectlon 44. Toxicology Study Section 45. Tropical Medicine and Parasitology Study SectIon 46. Virology Study Section 47. Visual Sciences Study Section 58 APPENDIX IV Page 2 38. Physiological Chemstry Study Sectron 39. Physiology Study Sectmn 40. Radiation Study Section 41. Reproductive Brology Study Section 42. Surgery A Study Section 43. Surgery B Study Section 44. Toxicology Study SectIon 45. Tropical Medicine and Parasitology Study Sectmn 46. Virology Study Section 47. Visual Sciences Study Section 58
Administration of Contracts and Grants for Cancer Research
Published by the Government Accountability Office on 1971-03-05.
Below is a raw (and likely hideous) rendition of the original report. (PDF)