Orientation for the Board of Scienti c Advisors

National Cancer Institute National Institutes of Health

March 2020 Bethesda, Maryland

National Cancer Institute National Institutes of Health Bethesda, Maryland

FOREWORD

Congratulations on your recent appointment to the Board of Scientific Advisors (BSA). As you join this distinguished panel, we could not be more honored to have you working with the National Cancer Institute (NCI).

The primary task of the BSA is to advise the Director of the NCI and the Director of each NCI Division/Office/Center on a wide variety of matters concerning scientific program policy as well as progress and future direction of extramural research programs of each of the Divisions. This includes the concept review of requests for applications for grants and cooperative agreements, and requests for proposals for research and development (R&D) contracts. This briefing document has been prepared to provide new members of the BSA with an overview of the mission, history, and activities of the National Institutes of Health (NIH) and the NCI.

The first section presents the NCI in the context of the total NIH organization. It includes budgetary information, cites current legislative statutes, and describes organizational structure, program disciplines, and mechanisms of funding used by the NCI. It also delineates the roles of those committees that advise the NCI in the conduct of its activities.

The second section describes the process used in the review of grant and cooperative agreement applications and contract proposals. It outlines the initial review procedures followed by the Center for Scientific Review (CSR) and the review groups of the NCI.

The subsequent three sections focus on the responsibilities of the BSA, including a summary of the BSA charter, selection of the appropriate award mechanism, and the NCI concept review process, including the role of the BSA. In previously held BSA Listens sessions in conjunction with NCI staff, the BSA played an important role in discussions held at national meetings. As a result, a summary of frequently asked questions from these past sessions has been provided in this orientation. Finally, a brief discussion of ethics and conflict of interest issues is included as a reference.

We are pleased to provide you with this BSA Orientation Book and hope you will refer to it often in fulfilling your responsibilities as a member of the BSA.

Paulette S. Gray, Ph.D. Director Division of Extramural Activities and Executive Secretary Board of Scientific Advisors National Cancer Institute

NCI Orientation for the Board of Scientific Advisors iii iv NCI Orientation for the Board of Scientific Advisors TABLE OF CONTENTS

Page NATIONAL CANCER ADVISORY BOARD FOREWORD ...... iii REVIEW...... 36 NCAB Responsibilities...... 36 HHS MISSION AND ORGANIZATION NCAB Meetings...... 36 THE NATIONAL INSTITUTES OF HEALTH.....1 AWARD OF GRANTS...... 37 Mission, Organization, and History...... 1. Selection for Funding...... 37 Overview of NIH History...... 1 Administrative/Business Review...... 37 THE NATIONAL CANCER INSTITUTE...... 8 Notice of Award...... 37 NCI Mission...... 8 NCI and the National Cancer Program...... 8 NCI BOARD OF SCIENTIFIC ADVISORS (BSA) NCI Legislative Authority...... 9 CHARTER SUMMARY Bypass Budget...... 9 AUTHORITY...... 39 NCI Organizational Structure...... 9. MEMBERSHIP AND DESIGNATION...... 39 Office of the Director...... 12 OBJECTIVES AND SCOPE OF ACTIVITIES...... 39 Extramural Divisions...... 14 DESCRIPTION OF DUTIES...... 39 Intramural Center and Division...... 15 ESTIMATED NUMBER AND NCI Advisory Committees...... 15 FREQUENCY OF MEETINGS...... 39 NCI Programs and Activities...... 17 BSA SUBCOMMITTEES...... 40 Research Programs...... 17 Resource Development...... 18 PRINCIPLES OF SELECTION OF AWARD NCI Funding Mechanisms...... 19 MECHANISMS IN EXTRAMURAL Grants...... 19 PROGRAMS I. Research Project Grants...... 19 DEFINITION OF NEED...... 41 II. Cancer Centers and Specialized GRANTS, CONTRACTS, AND Programs of Research Excellence...... 24 COOPERATIVE AGREEMENTS...... 41 III. Other Research Grants...... 25 POLICY...... 41 IV. Career Awards and Cancer I. Assistance – Grant or Cooperative Education...... 25 Agreement...... 41 V. Training (NRSA)...... 26 II. Acquisition – Contracts...... 41 Other Grant Mechanisms...... 27 OPEN AND CLOSED MEETINGS...... 42 Cooperative Agreements ...... 28 Solicitation of Grant Applications...... 29 BOARD OF SCIENTIFIC ADVISORS Contracts...... 30 CONCEPT REVIEW INTRODUCTION...... 43 PEER REVIEW CONCEPT CLEARANCE...... 43 INTRODUCTION...... 31 New Concepts...... 43 SUBMISSION OF GRANT APPLICATIONS...... 31 Reissued Concepts...... 44 ELECTRONIC SUBMISSION OF GRANT SPL & BSA Concept Approval Process...... 44 APPLICATIONS...... 32 BSA RESPONSIBILITIES...... 44 PROCESSING OF GRANT APPLICATIONS.....32 Concept Approval Process...... 44 Receipt and Review Assignment of Grant RFA Concept Review Criteria...... 45 Applications...... 32 R&D Contract Concept Review Criteria...... 46 Institute/Center (IC) and Program BSA DISCUSSION AND APPROVAL...... 47 Assignment...... 32 BSA ANNUAL RFA AND RFP CONCEPT INITIAL PEER REVIEW...... 32 REPORT...... 47 CSR Integrated Review Groups...... 32 NCI Review of Grant Applications...... 33 FREQUENTLY ASKED The Review Session...... 34 QUESTIONS AND ANSWERS Review Meeting Recommendations...... 34 INTRODUCTION...... 49 Summary Statements...... 35 GENERAL APPLICATION AND Post NCAB Meetings and Funding SUBMISSION ...... 49 Decisions...... 35 TRAINING...... 50 REVIEW OF CONTRACT PROPOSALS...... 35 CLINICAL RESEARCH...... 53

NCI Orientation for the Board of Scientific Advisors v PEER REVIEW...... 54 APPENDIX L. Example of RFA Reissuance BUDGET...... 56 Justification Letter...... 106 OTHER TOPICS...... 57 APPENDIX M. Example of Request for Proposal (RFP) Concept SUMMARY OF ETHICS RULES FOR Form and Justification...... 107 SPECIAL GOVERNMENT EMPLOYEES APPENDIX N. Acronyms...... 117 SERVING ON ADVISORY COMMITTEES APPENDIX O. Clinical Research and INTRODUCTION...... 58 Clinical Trials...... 124 GUIDE ON THE ETHICS RULES...... 61 APPENDIX P. Related Documents...... 125 APPENDIX Q. Websites of Interest...... 126 APPENDIX A. NCI Scientific Program Leadership Committee...... 73 EXHIBITS APPENDIX B. Overview of the Types of I. U.S. Department of Health and Human NIH Federal Advisory Services...... 2 Committees...... 75 II. NIH FY2016-2018 Funding...... 4 APPENDIX C. President’s Cancer Panel...... 76 III. National Institutes of Health...... 5 APPENDIX D. National Cancer Advisory IV. NIH Facilities Map...... 6 Board...... 77 V. The National Cancer Institute...... 10 APPENDIX E Board of Scientific Advisors...... 81 VI. NCI Funding History FY2008-2018...... 20 APPENDIX F. Board of Scientific Counse- VII. Research Funding for Various Research lors – Clinical Sciences and Areas...... 21 Epidemiology...... 84 VIII. Summary of NCI Obligations by APPENDIX G. Board of Scientific Counselors – Mechanism, FY2018...... 22 Basic Sciences...... 87 IX. RPG Awards by Activity Code, APPENDIX H. NCI Council of Research FY2009-2018; and Research Project Advocates...... 90 Grants and Dollars Awarded APPENDIX I. Clinical Trials and Transla- FY2009-2018...... 23 tional Research Advisory X. National Institutes of Health Grant Committee...... 91 Process...... 33 APPENDIX J. Frederick National Laboratory XI. NCI Contract Review Process ...... 37 Advisory Committee...... 94 XII. BSA Approved RFA Concept Set-Asides APPENDIX K. Example of Request for by Division/Office/Center...... 48 Application (RFA) Concept Form and Justification...... 97

vi NCI Orientation for the Board of Scientific Advisors HHS MISSION AND ORGANIZATION

The mission of the Department of Health and Hu- THE NATIONAL INSTITUTES man Services (HHS) is to enhance the health and well being of Americans by providing for effec- OF HEALTH tive health and human services and by fostering strong, sustained advances in the sciences under- Mission, Organization, and History lying medicine, public health, and social services. The HHS consists of the Office of the Secretary, NIH’s mission is to uncover new knowledge that which provides leadership; the Program Support will lead to better health for everyone. The NIH Center, which provides centralized administrative works toward that mission by conducting research support; and 12 operating divisions, which man- in its own laboratories; supporting the research age more than 300 health-related programs. These of non-Federal scientists in universities, medi- operating divisions are: cal schools, hospitals, and research institutions throughout the country and abroad; helping to Administration for Children and Families (ACF) train research investigators; and fostering com- munication of medical information. NIH’s budget Administration for Community Living (ACL) has grown from $300 in 1887, when the NIH was a one-room Laboratory of Hygiene, to $37.3 billion Agency for Healthcare Research and Quality in 2018 (see Exhibit II). The NIH is composed of (AHRQ) the Office of the Director, 20 Institutes, 6 Centers (four of which have funding authority), and the Agency for Toxic Substances and Disease National Library of Medicine; it has 75 build- Registry (ATSDR) ings located on more than 300 acres in Bethesda, Centers for Disease Control and Prevention Maryland. An organizational chart for the NIH is (CDC) presented in Exhibit III. Exhibit IV is a guide to the Bethesda campus. Centers for Medicare and Medicaid Services (CMS) [formerly the Health Care Financing Overview of NIH History Administration (HCFA)] NIH is a component of the Public Health Service Food and Drug Administration (FDA) (PHS) of HHS. The PHS traces its origin to “An Act for the Relief of Sick and Disabled Seamen” of Health Resources and Services Administration 1798 (Stat. L. 604), which authorized the establish- (HRSA) ment of marine hospitals for the care of American merchant seamen. In 1912, the Public Health and Indian Health Service (IHS) Marine Hospital Service became the Public Health National Institutes of Health (NIH) Service.

Program Support Center (PSC) The actual forerunner of the National Institutes of Health was established in 1887 as the Laboratory Substance Abuse and Mental Health Services of Hygiene, located at the Marine Hospital of Administration (SAMHSA) Staten Island, New York. In 1930, this laboratory was renamed the National Institute of Health. The ACF is responsible for temporary assistance The first of the present Institutes, the National to needy families; children’s welfare, care and Cancer Institute (NCI), was established in 1937 support; disabilities programs; and other ser- by an act of Congress. In 1938, the National vices. The ACL serves the elderly and people with Advisory Cancer Council approved the first disabilities. The CMS manages health insurance awards for research training fellowships in cancer programs, while the PSC provides products and research. In 1948, the National Heart Institute was services to the HHS and other Federal agencies. established, and the National Institute of Health The NIH, AHRQ, ATSDR, CDC, FDA, HRSA, IHS, became the National Institutes of Health (NIH). and SAMHSA are all devoted to public health During the years 1949-2001, NIH expanded to and compose the Public Health Service (PHS) (see include 27 Institutes and Centers. The current NIH Exhibit I). Institutes, in order of their establishment, are:

NCI Orientation for the Board of Scientific Advisors 1 ) (ACL Administration Assistant Secretary, for Community Living Exhibit I. U.S. Department of Health and Human Services

2 NCI Orientation for the Board of Scientific Advisors 1798 President John Adams signed “an Act 1937 Congress authorized the establish- for the relief of sick and disabled Sea- ment of the National Cancer Institute men,” which led to the establishment (NCI) and the awarding of research of the Marine Hospital Service. grants. Rocky Mountain Laboratory became part of the NIH. The National 1803 The first permanent Marine Hospital Advisory Cancer Council held its first was authorized to be built in Boston, meeting. Massachusetts. 1938 The NIH was moved to land donated 1836 The Library of the Office of Surgeon by Mr. and Mrs. Luke I. Wilson, lo- General of the Army was established. cated in Bethesda, Maryland. Corner- stone for Shannon Building was laid. 1870 President Grant signed a law estab- lishing a “Bureau of the U.S. Marine 1939 The Public Health Service (PHS) be- Hospital Service” within the Treasury came part of a newly created Federal Department. This Bureau, headed by Security Agency; until that time, it was a Supervising Surgeon (later Surgeon part of the Treasury Department. General), was given central control over the hospitals. 1946 The Division of Research Grants was established to process NIH grants and 1887 The Laboratory of Hygiene at the fellowships to non-Federal institutions Marine Hospital in Staten Island, New and scientists. (Originally established York, was established for research in as the Research Grants Office, it was cholera and other infectious diseases. renamed the Research Grants Division and, finally, the Division of Research 1891 The Laboratory of Hygiene was re- Grants.) designated the Hygienic Laboratory and moved from Staten Island to the 1948 The National Heart Institute was Marine Hospital Service headquarters authorized. Several laboratories (in- in Washington, DC. cluding Rocky Mountain Laboratory) were regrouped to form the National 1902 The Advisory Board for Hygienic Lab- Microbiological Institute. The Experi- oratory was established; later became mental Biology and Medicine Institute the National Advisory Health Coun- and the National Institute of Dental cil. Act of Congress changed name of Marine Hospital Service to the Public Research were established. The Na- Health and Marine Hospital Service. tional Institute of Health became the Hygienic Laboratory was authorized National Institutes of Health. by Congress to regulate laboratories that produced “biologicals.” The 1949 The Mental Hygiene Program of the Hygienic Laboratory was expanded PHS was transferred to the NIH and to four divisions: Bacteriology and expanded to become the National Pathology, Chemistry, Pharmacology, Institute of Mental Health. and Zoology. 1950 The “Omnibus Medical Research 1912 The Public Health and Marine Hospi- Act” authorized the establishment of tal Service was renamed Public Health the National Institute of Neurologi- Service (PHS). cal Diseases and Blindness, as well as the National Institute of Arthritis and 1922 The Library of the Office of Surgeon Metabolic Diseases. The latter ab- General was renamed Army Medical sorbed the Experimental Biology and Library. Medicine Institute.

1930 The Hygienic Laboratory was renamed 1953 The PHS became part of the newly the National Institute of Health (NIH). created Department of Health, Educa- Congress authorized construction of tion, and Welfare. The Clinical Center two buildings for the NIH and a sys- opened. tem of fellowships.

NCI Orientation for the Board of Scientific Advisors 3 Exhibit II. NIH FY2017-2019 Funding* 1955 The National Microbiological Institute was renamed National Institute of FUNDING (Dollars in Millions) Allergy and Infectious Diseases. The INSTITUTE/ Laboratory of Biologics Control was CENTER 2017 2018 2019 renamed the Division of Biologics Standards. The Division of Research NCI 5,689 5,964 6,144 Services was created.

NHLBI 3,207 3,383 3,488 1956 The Armed Forces Medical Library was renamed the National Library of NIDCR 426 448 461 Medicine (NLM) and placed in the PHS. NIDDK 2,010 2,120 2,180

NINDS 1,784 2,188 2,274 1957 The Center for Aging Research was established. NIAID 4,909 5,260 5,523 1958 The Division of General Medical NIGMS 2,651 2,785 2,873 Sciences was created. The Center for Aging Research was transferred from NICHD 1,380 1,452 1,506 the National Heart Institute to the NEI 733 772 797 Division of General Medical Sciences.

NIEHS 792 828 852 1961 The Center for Research in Child Health was established within the NIA 2,049 2,574 3,083 Division of General Medical Sciences.

NIAMS 558 586 605 1962 The NLM was moved to the NIH cam- pus. NIDCD 437 460 474

NIMH 1,601 1,755 1,870 1963 The Division of General Medical Sciences was renamed the National NIDA 1,091 1,384 1,420 Institute of General Medical Sciences (NIGMS). The National Institute of NIAAA 483 510 526 Child Health and Human Develop- ment (NICHD) was created. NINR 150 158 163

NHGRI 529 557 576 1966 The Division of Environmental Health Sciences was created. NIBIB 357 378 389 1967 The National Institute of Mental NIMHD 289 303 315 Health was separated from the NIH and became a separate bureau of the NCCIH 135 142 146 PHS. NCATS 706 742 806 1968 The John E. Fogarty International FIC 72 76 78 Center (FIC) for Advanced Study in the Health Sciences was created. The NLM 408 429 442 Bureau of Health Manpower and the NLM became part of the NIH. The Na- OD 1,730 1,926 2,118 tional Eye Institute (NEI) was created. The National Institute of Neurological B&F 129 129 200 Diseases and Blindness was renamed TOTAL 34,301 37,311 39,311 the National Institute of Neurological Diseases and Stroke.

*Source NIH Office of Budget, 2019.

4 NCI Orientation for the Board of Scientific Advisors the Director Immediate Office of Exhibit III. National Institutes of Health lanning, and Strategic er Eunice Kennedy Shriv es Initiativ Division of Program Coordination, P

NCI Orientation for the Board of Scientific Advisors 5 Exhibit IV. NIH Facilities Map

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46 18 Dr Gateway NIH Employee Parking ••Employee Pedestrian Entry

Building Key

Building 1 James Shannon Building (NIH Administration) Building 38 National Library of Medicine Building 10 Warren Grant Magnuson Clinical Center; Building 38A Lister Hill Mark Hatfield Clinical Research Center Building 40 Vaccine Research Center Building 11 Central Utility Plant Building 45 Natcher Building and Conference Center Building 13 Engineering Services Building 49 Sylvio Conte Building Building 14 Office of Research Facilities Building 50 Stokes Laboratories Building 16 Stone House Building 60 Mary Woodard Lasker Center Building 31 Claude D. Pepper Building (General Office Building) Building 62 The Children’s Inn at NIH Building 36 Lowell P. Weicker Building Blue, Parking Area

6 NCI Orientation for the Board of Scientific Advisors 1969 The Division of Environmental Health 1990 The National Center for Research Sciences was renamed the National Resources (NCRR) was created by Institute of Environmental Health consolidating the Division of Research Sciences (NIEHS). The National Heart Services and the Division of Research Institute was renamed the National Resources. Heart and Lung Institute. 1992 The National Institute on Alcohol 1972 The National Institute of Arthritis Abuse and Alcoholism (NIAAA), and Metabolic Diseases was renamed National Institute on Drug Abuse the National Institute of Arthritis, Me- (NIDA), and National Institute of tabolism, and Digestive Diseases. Mental Health (NIMH) were trans- ferred to the NIH from the Alcohol, 1974 The National Institute on Aging (NIA) Drug Abuse, and Mental Health Ad- was created. ministration.

1975 The National Institute of Neurological 1993 The National Center for Nursing Diseases and Stroke was renamed the Research was renamed the National National Institute of Neurological and Institute of Nursing Research (NINR). Communicative Disorders and Stroke (NINDS). 1995 The NIH was established as an HHS Operating Division, thereby elevating 1976 The National Heart and Lung Insti- it to report directly to the Secretary of tute was renamed the National Heart, HHS. Lung, and Blood Institute (NHLBI). 1997 The National Center for Human 1981 The National Institute of Arthritis, Genome Research was renamed the Metabolism, and Digestive Diseases National Human Genome Research was renamed the National Institute of Institute (NHGRI). Arthritis, Diabetes, and Digestive and Kidney Diseases (NIADDK). 1998 The Division of Research Grants was renamed the Center for Scientific Re- 1986 The National Institute of Arthritis, view. The National Center for Com- Diabetes, and Digestive and Kidney plementary and Alternative Medicine Diseases was renamed the National (NCCAM) was established. The Institute of Diabetes and Digestive and National Institute of Dental Research Kidney Diseases (NIDDK). The Na- was renamed the National Institute tional Institute of Arthritis and Muscu- of Dental and Craniofacial Research loskeletal and Skin Diseases (NIAMS) (NIDCR). was created. The Center for Nursing Research was transferred from the 2001 The National Center on Minority Health Resources and Services Ad- Health and Health Disparities was ministration (HRSA) and renamed the established. The National Institute of National Center for Nursing Research. Biomedical Imaging and Bioengineer- ing (NIBIB) was established. 1989 The National Institute on Deafness and Other Communication Disor- 2011 The National Center for Advancing ders (NIDCD) was established. The Translational Sciences (NCATS) was National Institute of Neurological established. and Communicative Disorders and Stroke was renamed the National 2012 NCI-Frederick was renamed the Fred- Institute of Neurological Disorders erick National Laboratory for Cancer and Stroke (NINDS). The National Research (FNLCR). Center for Human Genome Research was established. The National Center 2014 The National Center for Complemen- for Biotechnology Information was tary and Alternative Medicine became established within the NLM. the National Center for Complemen- tary and Integrative Health.

NCI Orientation for the Board of Scientific Advisors 7 THE NATIONAL CANCER The NCI supports a broad range of research to ex- pand scientific discovery at the molecular and cellu- INSTITUTE lar level, within a cell’s microenvironment, and in relation to human and environmental factors that NCI Mission influence cancer development and progression. Each year, almost 5,000 principal investigators The National Cancer Institute (NCI) is a compo- lead research projects that result in better ways to nent of the National Institutes of Health (NIH), combat cancer. Intramural research serves as a hub one of 11 operating divisions that compose the for new development through cutting-edge basic, Public Health Service (PHS) in the Department clinical, and epidemiological research. Extramural of Health and Human Services (HHS). The NCI, program experts provide guidance and oversight established under the National Cancer Act of 1937, for research conducted at universities, teaching is the Federal Government’s principal agency for hospitals, and other organizations. Proposals are cancer research and training. The National Cancer selected for funding by peer review, a rigorous Act of 1971 broadened the scope and responsibili- process by which scientific experts evaluate new ties of the NCI and created the National Cancer proposals and recommend the most scientifically Program. Over the years, legislative amendments meritorious for funding. In addition to direct have maintained the NCI authorities and responsi- research funding, the NCI offers the Nation’s bilities and added new information dissemination cancer scientists a variety of useful research tools mandates as well as a requirement to assess the and services: tissue samples, statistics on cancer incorporation of state-of-the-art cancer treatments incidence and mortality, bioinformatic tools for into clinical practice. analyzing data, databases of genetic information, and resources through NCI-supported Cancer The National Cancer Institute is committed to Centers, Centers of Research Excellence, and the dramatically lessening the impact of cancer. The Mouse Models of Human Cancer Consortium. NCI is the primary means of support for Ameri- ca’s cancer research enterprise, whether in its own The NCI also uses collaborative platforms and an laboratories or in our Nation’s research universi- interdisciplinary environment to promote transla- ties. The NCI is dedicated to the understanding, tional research and intervention development. Discov- diagnosis, treatment, and prevention of cancer ery of a new tool that first helps to understand the for all people. The NCI works toward this goal underlying mechanism of cancer may eventually by providing vision to the Nation and leadership be used to help diagnose it, and then may be fur- for both domestic and international NCI-funded ther developed to help treat it. For example, recent researchers. The NCI also works to ensure that advances in bioinformatics and the related explo- research results are applied in clinical practice sion of technology for genomics and proteomics and public heath related programs to reduce the research are dramatically accelerating the rate for burden of cancer for all populations. processing large amounts of information for can- cer screening and diagnosis. The largest collabora- Within this framework, NCI researchers work to tive research activity is the Clinical Trials Program more fully integrate discovery activities through for testing interventions for preventing cancer, interdisciplinary collaborations; accelerate de- diagnostic tools, and cancer treatments as well as velopment of interventions and new technology providing access as early as possible to all who can through translational research; and ensure the benefit. The NCI supports more than 2,900 clinical delivery of these interventions for application in trials a year, assisting more than 142,000 patients. the clinic and public health programs as state-of- the-art care for all those in need. The NCI research impacts the delivery of improved cancer interventions to cancer patients and those NCI and the National Cancer Program who care for them. Timely communication of NCI scientific findings help people make better As the leader of the National Cancer Program health choices and advise physicians about (NCP), the NCI provides vision and leadership treatment options that are more targeted and to the global cancer community. The NCI con- less invasive, resulting in fewer adverse side ducts and supports research, training, health effects. NCI researchers also seek the causes information dissemination, and other programs of disparities among underserved groups and with respect to the cause, diagnosis, prevention, gaps in quality cancer care, helping to translate and treatment of cancer, rehabilitation, and the research results into better health for groups at continuing care of cancer patients. Critical to the high risk for cancer, including cancer survivors success of its programs are collaborations and and the aging population. In addition, the NCI partnerships that further NCI’s progress in serving fosters partnerships with other agencies and cancer patients and those who care for them. organizations to accelerate the pace for moving

8 NCI Orientation for the Board of Scientific Advisors targeted drugs through the pipeline of discovery, successes, supporting the cancer research work- development, and delivery. force with the technologies and resources it needs, and ensuring that research discoveries are applied Information about NCI’s research and activities is to improve human health. This strategic plan is available through its public website, www.cancer. based on the authority and the responsibilities gov. entrusted to the Presidentially appointed NCI Director to coordinate the research activities of the NCI Legislative Authority NCI with the other parts/members of the NCP.

The NCI, established under the National Cancer In so doing, the Director is aided by the National Act of 1937, is the Federal Government’s principal Cancer Advisory Board (NCAB), a group com- agency for cancer research and training. The posed of scientists, medical personnel, and con- National Cancer Act of 1971 broadened the scope sumers from all sectors, public and private, of the and responsibilities of the NCI and created the cancer enterprise who possess the needed exper- National Cancer Program. Under the National tise and experience to help formulate a national Cancer Act of 1971, the Director of the NCI is agenda in cancer research. The NCAB meets with authorized to submit, directly to the President, a the President’s Cancer Panel (PCP) members, who professional judgment budget reflecting the full have ex officio seats on the Board, to facilitate trans- funding needs of the NCP. This budget is referred fer of PCP observations on the barriers to prog- to as the Bypass Budget. ress in the NCP and the development of possible solutions. Their deliberations are directly coordi- Bypass Budget nated with other government agencies through the participation of ex officio federal members The mandate to produce a “Bypass Budget” is a representing key agencies involved in executing special authority given to the NCI Director. The the NCP. For example, discussions at the NCAB Bypass Budget builds on research successes and meetings with ex officio members representing De- ensures that research discoveries are applied partment of Defense and Veterans Affairs health to improve human health, and allows the NCI care systems directly led to the availability of NCI Director to express to the President the plans and clinical trials through their health care systems. priorities of the NCI and the NCP, along with an Close coordination across agencies is critical in the indication of the associated costs. formulation of a strategic plan that takes advan- tage of the capabilities of each agency and the Each year, the NCI produces this document to constituencies it serves. reflect the professional judgment of the Nation’s top cancer experts about the realities of cancer The ability of the NCI and its partners to address research and control, and how much money could the initiatives in the Bypass Budget is a measure be spent wisely in the conduct of the entire pro- of the success of the NCP. In this way, the Bypass gram. Budget enables efficient strategic coordination of the NCP. The authority to produce the Bypass Budget has many benefits. The extensive strategic planning As part of the evaluation process, the Presiden- process that is used to develop the Bypass Budget tially appointed PCP is charged to review the builds on research successes, supporting the can- implementation of such plans and identify directly cer research workforce with the technologies and for the President and the Nation the extent of their resources it needs. In addition to being submitted success. to the President, this comprehensive research plan also is provided to Congress, and is used by the NCI Organizational Structure greater cancer research community, professional organizations, advisory groups, advocacy organi- The NCI’s current organizational structure can be zations, and public and private policymakers. As seen in Exhibit V. NCI’s Office of the Director serves a result, the Bypass Budget and its development as the focal point for the NCP, with advice from the serve as a planning process for the entire NCP, President’s Cancer Panel, the NCAB, the Board of outlining clearly the areas of highest priority. Scientific Counselors (BSC), and the Board of Sci- entific Advisors (BSA). The BSA gives final concept In addition to informing the President, the Bypass approval for extramural Requests for Applications Budget document also serves as the Institute’s (RFAs) and Requests for Proposals (RFPs), while strategic plan and has become a powerful com- the BSC conducts intramural laboratory and branch munication and priority setting tool used by reviews. The Director of the Institute, Dr. Norman constituents across the NCP. Updated each year, Sharpless, is assisted by Dr. Douglas R. Lowy, Prin- the plan provides a guide for building on research cipal Deputy Director, NCI; Dr. James Doroshow,

NCI Orientation for the Board of Scientific Advisors 9 The National Cancer Institute Exhibit V.

10 NCI Orientation for the Board of Scientific Advisors The National Cancer Institute (Continued) Exhibit V.

NCI Orientation for the Board of Scientific Advisors 11 Deputy Director, NCI; and Dr. Dinah Singer, Dep- disseminating information about cancer clinical tri- uty Director, NCI; and Ms. Donna Siegle, Acting als and funding opportunities. Executive Officer and Deputy Director for Office of Management, NCI. The Scientific Program Leader- Center to Reduce Cancer Health Disparities ship (SPL) Committee of the Institute (seeAppendix (CRCHD) A) includes the Director, Deputy Directors, Division The CRCHD is the keystone of NCI’s efforts to Directors, and other senior scientific staff. The SPL reduce the unequal burden of cancer in our soci- meets on a regular basis to discuss various matters ety. As the organizational focus for these efforts, of NCI policy, including but not limited to review the Center directs and supports initiatives that and approval of RFA and research and development advance the understanding of what causes health (R&D) contract concepts before review by the BSA; disparities. It also supports programs that develop review of program announcements; development and integrate effective interventions to reduce or of funding plans; grant payment by exceptions, etc. eliminate these disparities. The CRCHD, through NCI’s cancer research activities are monitored and its Diversity Training Branch (DTB), leads NCI’s administrated through several extramural and intra- efforts in the training of students and investiga- mural divisions, centers, and offices. tors from diverse populations who will be part of the next generation of competitive researchers in Office of the Director cancer and cancer health disparities research.

Examples of offices and centers within the Office Office of Advocacy Relations (OAR) of the Director include: The OAR engages the advocacy and NCI commu- nities in dialogue about cancer research oppor- NCI Center for Biomedical Informatics and Infor- tunities and priorities to advance progress and mation Technology (CBIIT) improve outcomes. The OAR (1) serves as the In- The NCI Center for Bioinformatics and Informa- stitute’s expert and central resource for advocacy tion Technology (CBIIT) helps speed scientific matters; (2) facilitates dynamic relationships and discovery and facilitates translational research collaborations to promote mutual goals; and (3) by building many types of tools and resources disseminates information and fosters understand- that enable information to be shared along the ing of key cancer issues and priorities. continuum from the scientific bench to the clinical bedside and back. The NCI CBIIT (1) coordinates Center for Strategic Scientific Initiatives (CSSI) and deploys informatics in support of NCI research The CSSI directs the planning, development, and initiatives; (2) provides all manner of informatics implementation of a number of strategic scientific support, including platforms, services, tools, and and technology initiatives and partnerships that data to NCI-supported research initiatives; emphasize innovation, transdisciplinary teams, (3) participates in the evaluation and prioritization and convergence of scientific disciplines to en- of NCI’s bioinformatics research portfolio; able progress against cancer. These programs (4) conducts or facilitates research that is required to also stress the development and application of fulfill NCI’s bioinformatics requirements; (5) serves advanced technologies, the synergy of large-scale as the focus for strategic planning to address NCI’s and individual initiated research, novel partner- expanding research initiative’s informatics needs; ships, and translation of discoveries into new (6) establishes bioinformatics technology standards interventions to detect, prevent, and treat cancer (both within and outside of the NCI); (7) commu- more effectively. nicates, coordinates, and establishes bioinformat- ics exchange standards; and (8) provides direct Several offices in CSSI are committed to accelerat- support to several NCI research programs, such ing the progress of cancer research through its as: the Cancer Genome Anatomy Project (CGAP), technology-driven initiatives, collaboration with the Mouse Models of Human Cancer Consortium other government programs, and engagement with (MMHCC), the Director’s Challenge: Towards a the private sector in the areas of nanotechnology, Molecular Classification of Cancer, and Clinical proteomics, cancer genomics, and biospecimen re- Trials. It also develops core infrastructure to sup- sources. By placing a heavy emphasis on advanced port the integration of these efforts. technology development, the NCI is accelerat- ing the creation and use of tools that are already Office of Communications and Public Liaison facilitating the translation of basic knowledge into (OCPL) clinical advances to benefit patients with a new gen- Supports the NCI by disseminating cancer research eration of molecularly based diagnostics and thera- findings; providing evidence-based information on peutics. Programs include: Alliance for Nanotech- cancer to the public, including patients, caregivers, nology in Cancer, Clinical Proteomic Technologies health professionals, researchers, advocates, the Initiative, Innovative Molecular Analysis Technolo- news media, and other stakeholders; and gies, and Provocative Questions Initiative.

12 NCI Orientation for the Board of Scientific Advisors Office of Cancer Centers (OCC) diagnosis, and treatment of cancer. To meet this Currently, the Office supports 71 NCI-designated goal, the CCG: cancer centers nationwide that are actively en- gaged in transdisciplinary research to reduce • Provides information, technology, methods, cancer incidence, morbidity, and mortality. The informatics tools, and reagents to serve the NCI-designated Cancer Centers designated as needs of the cancer research community. either Comprehensive Cancer Centers (51), Cancer • Manages the following research programs: Centers (13), or Basic Laboratory Cancer Centers the Cancer Genome Anatomy Project (CGAP), (7) are a major source of discovery of the nature the NIH Mammalian Gene Collection (MGC), of cancer and of the development of more effec- the Initiative for Chemical Genetics (ICG), tive approaches to cancer prevention, diagnosis, the Cancer Genome Atlas (TCGA), the Cancer and therapy. Comprehensive Cancer Centers also Genetic Markers of Susceptibility (CGEMS), deliver medical advances to patients and their and Therapeutically Applicable Research to families, educate health-care professionals and the Generate Effective Treatments (TARGET). public, and reach out to underserved populations. Cancer Centers are characterized by strong orga- Office of Biorepositories and Biospecimen Re- nizational capabilities, institutional commitment; search (OBBR) and trans-disciplinary, cancer-focused science; ex- The OBBR is responsible for coordinating and perienced scientific and administrative leadership; developing the Institute’s biospecimen resources and, state-of-the-art cancer research and patient and capabilities and ensuring that human bio- care facilities. specimens available for cancer research are of Center for Cancer Training (CCT) the highest quality. This is being accomplished The CCT is responsible for: (1) coordinating and through the development of a common bioreposi- providing research training and career develop- tory infrastructure that promotes resource sharing ment activities for fellows and trainees in NCI’s and team science to facilitate multi-institutional, laboratories, clinics, and other research groups; high throughput genomic and proteomic studies. (2) developing, coordinating, and implementing opportunities in support of cancer research train- Office of Budget and Finance (OBF) ing, career development, and education at institu- Advises the Office of the Director and other senior tions nationwide; and (3) identifying workforce staff on finance and personnel resource manage- needs in cancer research and adapting NCI’s train- ment to ensure fiscally responsible and efficient ing and career development programs and fund- operation of the NCI. ing opportunities to address these needs. Center for Global Cancer Research (CGCR) Coordinating Center for Clinical Trials (CCCT) The CGCR coordinates NCI’s worldwide activi- The CCCT is central to NCI’s efforts to accelerate ties in a number of arenas, including: liaison with the delivery of new tools into the clinic through foreign and international agencies and other U.S. its translational science and clinical trial enterpris- government agencies involved in global health; es. The CCCT facilitates collaborations that expe- coordination of cancer research activities under dite translational and clinical cancer research by: agreements between the United States and other countries; planning and implementation of inter- • Supporting the implementation of the Clini- national scientist exchange programs; sponsorship cal Trials Working Group and Translational of international workshops; and dissemination of Research Working Group recommendations; cancer information. • Facilitating prioritization of the NCI’s most important clinical trials by Scientific Steering Office of HIV and AIDS Malignancy (OHAM) Committees working with NCI clinical pro- The Office of HIV and AIDS Malignancy (1) coor- grams; dinates and works with the Divisions and other Offices to manage the portfolio of HIV/AIDS • Partnering with the NCI’s Center for Biomedi- and AIDS malignancy research within the NCI; cal Informatics and Information Technology (2) advises the NCI Director and other NCI man- (CBIIT) to establish the Clinical Trials Report- agers on issues related to research in HIV/AIDS ing Program (CTRP), a comprehensive data- and AIDS malignancies; (3) coordinates, helps base with current information on all NCI- prioritize, and facilitates the NCI research effort in funded clinical trials. HIV/AIDS and AIDS malignancies and works with NCI management to redirect the HIV/AIDS and Center for Cancer Genomics (CCG) AIDS malignancy research effort, as appropriate, The CCG is focused on understanding the mo- into the highest priority areas; (4) interfaces with lecular mechanisms of cancer, with the ultimate the NIH Office of AIDS Research (OAR) and other goal of improving the prevention, early detection, ICs regarding research in HIV/AIDS and AIDS

NCI Orientation for the Board of Scientific Advisors 13 malignancies in the NCI; and (5) directly manages NCI-Frederick facility “activities” such as the certain AIDS and AIDS malignancy research pro- Spring Research Festival; Take Your Child to Work grams, such as the AIDS and Cancer Specimen Re- Day; the Summer Student Seminar Series; Sum- source, the AIDS-Associated Malignancies Clinical mer Student Poster Day; the Housing Resources Trial Consortium (AMC), the NCI Component of List; speaker requests; and visits for students, the Centers for AIDS Research (CFARS), and the teachers, and other interested groups. NCI component of the Women’s Interagency HIV Study (WIHS). Extramural Divisions

Small Business Innovation Research (SBIR) The extramural research and research-related ac- Development Center tivities of the NCI are conducted by five divisions The SBIR Development Center serves as the NCI fo- under the supervision of the Office of the Director. cal point for the management of all Small Business The functions of the divisions and the major areas Innovation Research (SBIR) and Small Business of research and research support activities for Technology Transfer (STTR) Program activities, which each is responsible are: and implementation of pertinent legislation, rules and regulations and associated matters related to Division of Cancer Biology (DCB) the SBIR/STTR Program consisting of grant and The mission of the DCB is to ensure continuity and contractor awards and providing expertise, advice, stability in basic cancer research, while encourag- and services to applicants and NCI programs. ing and facilitating the emergence of new ideas, concepts, technologies, and possibilities. The DCB NCI-Frederick Office of Scientific Operations strives to achieve this goal by promoting a bal- The NCI-Frederick Office of Scientific Operations ance between the continued support of existing (1) oversees and manages scientific operations at research areas and selective support of emerging NCI-Frederick and serves as the Project Office for research areas. The DCB provides guidance, ad- the three main operation and support contracts at vice, funding information, and financial support to NCI-Frederick; (2) directs and develops advanced grantees and applicants. The DCB encourages the technologies that are made available to customers expansion of new research areas through a range of NCI-Frederick; (3) implements programmatic of initiatives and funding mechanisms. The scien- decisions approved by the NCI Director and the tific discoveries from this research base are critical Associate Director for NCI-Frederick to transition to the goal of the NCI since they form the intellec- new efforts to NCI-Frederick by developing con- tual and scientific foundation on which strategies tractual requirements and budgets, arranging for for the prevention, diagnosis, and treatment of needed space, and providing technical and project cancer are developed. (http://dcb.nci.nih.gov/) management advice to the Contracting Officer; (4) works closely with customers (including other Division of Cancer Control and Population NCI and NIH components, the Food and Drug Sciences (DCCPS) Administration, the Department of Defense, the The DCCPS aims to reduce the risk, incidence, Department of Agriculture, and the Department of and number of deaths from cancer, as well as to Homeland Security) and contractors to ensure that enhance the quality of life for cancer survivors. contractors understand customers’ needs and that This division conducts and supports an integrated the customers receive planned outcomes; (5) assists program of the highest quality genetic, epidemio- the NCI Associate Director for Frederick with the logic, behavioral, social, applied, and surveillance administrative and business operations of NCI- cancer research. DCCPS funded research aims to: Frederick; (6) assists the NCI Associate Director for (1) understand the causes and distribution of can- Frederick with planning and prioritizing of space cer in various populations, (2) support the devel- and the maintenance of all buildings and grounds; opment and implementation of effective interven- (7) monitors contractor performance, obtains tions, and (3) monitor and explain cancer trends customer satisfaction feedback, and provides this in all segments of the population. Central to these information to the Management Operations and activities is a process of synthesis and decision Support Branch for the Award Fee processes; making, which aids in evaluating what has been (8) tracks and reports funds received and costs learned, identifying new priorities and strategies, associated with all work performed at NCI- and effectively applying research discoveries to Frederick; (9) develops and manages educational, reduce the cancer burden at the population level. employee outreach, and public outreach pro- (http://dccps.nci.nih.gov) grams, including programs for K-12 students and internship opportunities for high school and Division of Cancer Treatment and Diagnosis undergraduate students; (10) coordinates the (DCTD) expansion of student/fellowship mentoring The DCTD attempts to identify and exploit the programs at NCI- Frederick; and (11) coordinates most promising areas of science and technology

14 NCI Orientation for the Board of Scientific Advisors and to initiate, enable, and conduct research that information to: (1) provide a basis for budget pro- will yield important new knowledge that is likely jections and (2) serve as a resource for the dissemi- to lead to better diagnostic or therapeutic interven- nation of information about cancer. (http://deainfo. tions in the various childhood and adult cancers. nci.nih.gov/funding.htm) The division administers grants, contracts, and cooperative agreements, and offers strategically Intramural Center and Division planned workshops and conferences with scien- tists, clinicians, and public and private partners. Center for Cancer Research (CCR) It also sponsors a vigorous program of in-house As the intramural component of the NCI, the CCR applied research linked to investigators and goals conducts basic, preclinical, and clinical investiga- in the extramural community. (http://dctd.cancer. tions at the Bethesda campus. The mission of the gov/) CCR is to reduce the burden of cancer through exploration, discovery, and translation. It provides Division of Cancer Prevention (DCP) a new forum for cancer research without scien- The DCP plans and conducts programs in basic tific, institutional, or administrative barriers. The and applied research and development, tech- Center is achieving this by conducting outstanding, nology transfer, demonstration, education, and cutting-edge, basic, preclinical, and clinical research information dissemination. DCP’s programs are on cancer and translating these discoveries into designed to: expedite the use of new information treatment and prevention. The overall goal is to relevant to the prevention, detection, and diagno- form a highly interactive, interdisciplinary group sis of cancer; expedite the use of new information of researchers who have access to technology and about pretreatment evaluation, treatment, rehabili- are able to participate in clinical investigations. The tation, and continuing care; plan, direct, and coor- CCR also maintains a foundation of investigator- dinate the support of research on cancer preven- initiated, independent research. CCR scientists tion at Cancer Centers and community hospitals, conduct innovative basic and clinical research and through organ systems programs; support aimed at discovering the causes and mechanisms cancer research training, clinical education, con- of cancer to improve the diagnosis, treatment, and tinuing education, and career development in can- prevention of cancer and other diseases. (http://ccr. cer prevention; coordinate program activities with nci.nih.gov/) other divisions, Institutes, and Federal and state agencies; and establish liaison with professional Division of Cancer Epidemiology and Genetics and voluntary health agencies, Cancer Centers, (DCEG) labor organizations, cancer organizations, and trade The DCEG is an intramural research program associations. (https://prevention.cancer.gov/) in which scientists conduct an international program of population-based studies to identify Division of Extramural Activities (DEA) environmental and genetic determinants of cancer. The mission and responsibilities of the DEA in In carrying out its mission, the DCEG is at the some way affect all extramural scientists receiving cutting edge of approaches to untangle complex research or training support from the NCI. The gene-environment and gene-gene interactions DEA coordinates the review of special initiatives, in cancer etiology. To conduct these studies, large grants, and contracts. It is involved in all investigators at all levels of their careers work aspects of grant development and tracking, from collaboratively to bring together a variety of the original conception of extramural research and scientific disciplines. http://dceg.cancer.gov/( ) training programs to follow-up after funds are dis- persed. In brief, the DEA was established to: pro- NCI Advisory Committees vide advice and guidance to potential applicants; receive and refer incoming grant applications to President’s Cancer Panel (PCP) appropriate programs within the NCI; provide the The President’s Cancer Panel (see Appendix C) is highest quality and most effective scientific peer an NCI Federal advisory committee that reports review and oversight of extramural research; coor- directly to the U.S. President on the activities of dinate and administer Federal advisory committee the National Cancer Program. The panel was activities related to the various aspects of the NCI established by the Public Health Service Act, as mission, such as the NCAB and BSA; establish and amended by the National Cancer Act (P.L. 92-218), disseminate extramural policies and procedures, and was chartered in accordance with the such as requirements for inclusion of certain Federal Advisory Committee Act (P.L. 92-463). populations in research, actions for ensuring The Panel consists of three members who are research integrity, or budgetary limitations for appointed by the President for terms of 3 years. grant applications; and track the NCI research One of the members is appointed by the President portfolio (more than 7,500 research and training as Chairperson of the Panel for a 1-year term. At awards) using consistent, budget-linked scientific least two members must be distinguished

NCI Orientation for the Board of Scientific Advisors 15 scientists or physicians, and the third may be a lay performance and productivity of each division, person. The panel, which meets at least four times including the staff scientists, through periodic site a year, is responsible for monitoring the devel- visits to intramural laboratories. It also offers ad- opment and execution of the National Cancer vice on the course of programs composing DCEG Program, evaluating its efficacy, making sugges- and CCR. tions for its improvement, and submitting periodic progress reports to the President. NCI Council of Research Advocates (NCRA) The NCRA (see Appendix H), formerly the Direc- National Cancer Advisory Board (NCAB) tor’s Consumers Liaison Group, provides advice The NCAB (see Appendix D) advises, assists, to the Director, NCI, with respect to promoting consults with, and makes recommendations to research outcomes that are in the best interest the Secretary of the HHS, and the Director of NCI, of cancer patients. To this end, the NCRA will regarding the activities carried out by and through conduct these activities with the intent to identify the Institute as well as policies regarding these new approaches, promote innovation, recognize activities. The NCAB may make recommendations unforeseen risks or barriers, and identify unin- regarding support grants and cooperative agree- tended consequences that could result from NCI ments, technical and scientific peer review, and decisions or actions. Additionally, the NCRA will functions pertaining to the NCI as described under provide insight into enhancing input, optimizing sections 405, 406, 413, and 414 of the PHS Act, as outreach, and promoting strong collaborations, all amended. with respect to non-scientist stakeholders.

The NCAB may implement procedures for ex- Clinical Trials and Translational Research pediting en bloc concurrence of Scientific Review Advisory Committee (CTAC) Group recommendations. Several members may The Committee (seeAppendix I) advises, assists, be selected by the Chair and/or Executive Secre- consults with, and makes recommendations to tary to provide en bloc concurrence on behalf of the the Director, NCI, NCI Deputy Directors, and Board. Only those applications that do not require the Director of each NCI Division on the NCI- individual consideration are included in this expe- supported national clinical trials enterprise to dited process. A report of the en bloc recommenda- build a strong scientific infrastructure by bringing tions is presented at each Board meeting. together a broadly developed and engaged coali- tion of stakeholders involved in the clinical trials Board of Scientific Advisors (BSA) process. This encompasses oversight of all trials The BSA (see Appendix E) advises NCI’s Director both extramural and intramural. The Committee and Deputy Directors, and the Director of each will provide broad scientific and programmatic NCI division, on a wide variety of matters. Topics advice on the investment of tax payer dollars in include scientific program policy and the progress clinical trials and supportive science. In addition, and future direction of each division’s extramu- the Committee makes recommendations regard- ral research programs. The BSA’s responsibilities ing the effectiveness of NCI’s translational re- include the evaluation of NCI awarded grants, search management and administration program, cooperative agreements, and contracts, as well as including needs and opportunities across disease concept review of those activities that it considers sites, patient populations, translational devel- to be meritorious and consistent with the Insti- opmental pathways, and the range of molecular tute’s programs. The advisory role of the Board mechanisms responsible for cancer development. is scientific and does not include deliberation on The Committee will advise on the appropriate matters of public policy. As necessary, the Board magnitude for dedicated translational research and its subcommittees may call upon special priorities and recommend allocation of transla- consultants, assemble ad hoc working groups, and tional research operations across organizational convene conferences, workshops, or other activi- units, programs, disease sites, populations, ties. developmental pathways, and molecular mecha- nisms. The Committee will ensure that appropri- Board of Scientific Counselors (BSC) ate emphasis is placed on rare cancers, medically The BSC (see Appendixes F and G) advises the underserved populations, and historically lower Directors of NCI’s Intramural Division of Cancer resourced pathways to clinical goals. The goal is Epidemiology and Genetics (DCEG) and Center to foster an open, collaborative system involving for Cancer Research (CCR) and the Director and all the critical stakeholders in the prioritization Deputy Directors of the NCI, on a wide variety of process bringing diverse institutions and indi- matters concerning scientific program policy and viduals together into an integrated and efficient, the progress and future direction of each of the but innovative and responsive effort, thus moving intramural research programs. The BSC evaluates therapies to patients.

16 NCI Orientation for the Board of Scientific Advisors Frederick National Laboratory Advisory Com- to Independence applications, and Subcommittee J mittee (FNLAC) reviews Career Development applications. The FNLAC (see Appendix I ) provides advice and makes recommendations to the Director, NCI, and the Associate Director, NCI-Frederick, NCI Programs and Activities on the optimal use of the NCI-Frederick facil- ity to rapidly meet the most urgent needs of the Research Programs Institute. The NCI facility in Frederick, Maryland, was established in 1972 as a Government-owned The Institute conducts and leads intensive work contractor-operated facility. In 1975, the facility to advance knowledge of cancer’s biology and pro- was designated as a Federally Funded Research cesses; to discover and develop new interventions; and Development Center (FFRDC) to provide a and to employ a bench-to-bedside approach that unique national resource for the development strives to rapidly make new treatments—our latest of new technologies and the translation of basic science—available to patients in the communities science discoveries into novel agents for the pre- where they live. Across these complex endeav- vention, diagnosis, and treatment of cancer and ors, the NCI works to foster the collaborations of acquired immune deficiency syndrome (AIDS). government, the private sector, and academia. In The FFRDC has been renamed as the Frederick addition to the broad range of both basic and ap- National Laboratory for Cancer Research plied laboratory and clinical programs that it sup- (FNLCR). ports, the NCI provides various research support services, including the development and distribu- As such, the FNLAC reviews the state of research tion of critical materials such as viruses, animals, at the FNLCR and makes recommendations to equipment, tissues, and standardized reference the Director, NCI, and the Associate Director, bibliographies. These activities are conducted NCI-Frederick, for the best use of its capabili- within the divisions and centers of the NCI, under ties and infrastructure. In addition, the FNLAC the supervision of the Office of the Director. will periodically review the existing portfolio of projects conducted at the FNLCR, evaluate pro- Cancer Causation ductivity, help determine which of these projects Cancer causation research concentrates on the should be continued at FNLCR or transitioned to events involved in the initiation and promotion other support mechanisms of support (i.e., grants, of cancer. It encompasses chemical and physical contracts, or cooperative agreements) and which carcinogenesis, biological carcinogenesis, epidemi- should be terminated. The FNLAC will help to ology, chemoprevention, and nutrition research. ensure that the operations at FNLCR are open, Studies in this area focus on external agents such transparent, and in the best interests of the NCI, as chemicals, radiation, fibers, and other particles, and the entire cancer research community. as well as viruses, parasitic infections, and host factors such as hormone levels, nutritional and im- Initial Review Group (IRG) munologic status, and the genetic endowment of The IRG advises the Director of the NCI, and the Director, Division of Extramural Activities, NCI, the individual. FY2018 cancer causation research on the scientific and technical merit of applications expenditures totaled about $1.32 billion, account- for grants for research, research training, research- ing for 22.3 percent of the total NCI budget. related grants and cooperative agreements, or contract proposals relating to scientific areas Detection and Diagnosis relevant to carcinogenesis, cancer biology and di- Detection and diagnosis research includes studies agnosis, Cancer Center administration, medicine, designed to improve diagnostic accuracy; provide radiological and surgical oncology, cancer chemo- better prognostic information to guide therapeutic therapy, cancer epidemiology, cancer prevention decisions; monitor the response to therapy more and control, cancer education, cancer information effectively; detect cancer at its earliest presenta- services, community outreach, cancer detection tion; and identify populations and individuals at and diagnosis, cancer treatment and restorative increased risk for the development of cancer. care, dentistry, nursing, public health, nutrition, education of health professionals, medical oncol- Areas of emphasis include: improvements in the ogy, surgery, radiotherapy, gynecologic oncology, detection and diagnosis of breast, cervical, uterine, pediatric oncology, pathology, and biostatistics. and prostate cancer; the transfer of molecular The IRG is composed of four chartered subcom- technologies from the laboratory to clinical mittees. Subcommittee A reviews Cancer Center practice; the identification of better prognostic Support grant (CCSG) applications. Subcommittee markers; increased availability of human tumor F reviews Institutional Training and Education samples with associated clinical information; and applications. Subcommittee I reviews Transition research to identify genetic alterations involved in

NCI Orientation for the Board of Scientific Advisors 17 tumor pathogenesis and behavior. FY2018 detec- the NCI, including information dissemination, epi- tion and diagnosis research expenditures totaled demiology, and cancer treatment. The four com- about $590 million, accounting for 10.0 percent of ponents are Cancer Prevention Research, Cancer the total NCI budget. Control Science, Early Detection and Community Oncology, and Cancer Surveillance. FY2018 Can- Treatment cer Prevention and Control Program expenditures Treatment research is composed of preclinical and totaled approximately $339 million, accounting for clinical research. Preclinical research focuses on 5.7 percent of the total NCI budget. the discovery of new antitumor agents and their development in preparation for testing in clinical Resource Development trials. These agents include both synthetic com- pounds and natural products. Clinical research Cancer Centers involves demonstrating the effectiveness of new The Cancer Centers Program consists of a group anticancer treatments through systematic testing of nationally recognized, geographically dispersed, in clinical trials. Phase I trials establish the maxi- individual institutions with outstanding scientific mum tolerated dose of a new agent; Phase II trials reputations. Each institution reflects particular re- examine its efficacy against a variety of cancers; search talents and special technological capabilities. and Phase III trials compare the new treatment In FY2018, there were 70 NCI-designated Cancer with the best standard therapy, in terms of im- Centers, which received a total of $313 million in proved survival and decreased toxicity. FY2018 support, accounting for 5.6 percent of the total treatment research expenditures totaled about NCI budget. $1.35 billion, accounting for 22.8 percent of The NCI uses the Cancer Center Support Grant the total NCI budget. (CCSG) mechanism (P30) to support centers that conduct research and outreach activities on Cancer Biology several different cancers. Cancer Centers are des- Cancer biology supports a broad spectrum of ignated as either comprehensive cancer centers, basic research on cancer and the body’s response cancer centers, or basic laboratory cancer centers. to cancer. Studies include investigations of cel- lular and molecular characteristics of tumor cells, Cancer Centers have developed in a number of interactions among cells within a tumor, and the different organizational settings. Some are inde- components of the host immune defense mecha- pendent institutional entities entirely dedicated to nisms. Cancer is the result of genetic damage that cancer research (free-standing centers); some have accumulates in stages. It is the goal of cancer biol- been formed as clearly identifiable entities within ogy to identify and explain the stepwise progres- academic institutions and promote interactive can- sion between the initiating event in the cell and cer research programs across departmental and/or final tumor development. FY2018 cancer biology college structures (matrix centers); and others expenditures totaled approximately $904 million, involve multiple institutions (consortium centers). accounting for 15.3 percent of the total NCI budget. The CCSG is intended to provide support to the Cancer Prevention and Control peer-reviewed research base of the Cancer Center The NCI conducts Cancer Prevention and Control within the larger institution. The CCSG supports basic and applied research through both intramu- the operational framework (infrastructure) of the ral and extramural mechanisms in all phases of center and partially pays for shared laboratory re- cancer prevention and control, as well as cancer sources and facilities. Research projects themselves surveillance. A key priority of this program is to are supported through the individual grants and develop strategies for the effective translation of contracts from the NIH and from a variety of other knowledge gained from prevention and control grant funding agencies and organizations. research into health promotion and disease pre- vention activities for the benefit of the public. An Specialized Programs of Research Excellence integrated system of basic research, clinical trials, The Specialized Programs of Research Excellence and applications research is in place and seeks to (SPOREs) are designed to stimulate translational promote cancer prevention and control activities research from the laboratory to clinical practice. across the country. SPOREs, which are funded under the P50 grant mechanism, focus on research in prevention, The Cancer Prevention and Control Program in- detection, diagnosis, and treatment for a single cludes four components and several subprograms, cancer site. These are awarded to institutions that many of which relate to other program activities of demonstrate the ability to perform significant

18 NCI Orientation for the Board of Scientific Advisors translational research. In FY2018, the SPORE mechanisms are three additional non-NRSA insti- Program expenditures totaled approximately tutional mechanisms (K12 and R25) and six indi- $116 million, accounting for 2.0 percent of the total vidual career development awards (K-series). The NCI budget. third function is the oversight and coordination of the NIH Loan Repayment Program. Research Comprehensive Minority Institution/Cancer Cen- Manpower Development expenditures in FY2018 ter Partnership totaled approximately $182 million, accounting for NCI’s Comprehensive Minority Institution/Cancer 3.1 percent of the total NCI budget. Center Partnership (U54) awards are cooperative agreements designed to establish comprehensive NCI Funding Mechanisms partnerships between the Minority Serving Institu- tion (MSI) and the NCI-designated Cancer Cen- The NCI supports cancer research, cancer con- ters. The partnership focuses on cancer research trol, and cancer support activities through an and one or more target areas in cancer research, extramural program of grants, cooperative agree- training and career development, education, or ments, and contracts, and through an intramural outreach activities designed to benefit racial program of in-house research. In accordance with and/or ethnic minority populations in the region NIH tradition, the Institute’s extramural programs the Cancer Center serves. The partnership also emphasize grant-supported, investigator-initiated creates a stable, long-term, collaborative relation- research projects, which are conducted at both ship between the MSI and NCI-designated Cancer nonprofit and for-profit institutions in the United Centers and raises awareness about problems and States and abroad. Research contracts are awarded issues relevant to the disproportionate rates of to both nonprofit and for-profit institutions. cancer incidence and mortality in minority Intramural funds support continuing investiga- populations. tions by NCI research scientists. The cooperative agreement mechanism, which is a cross between Research Manpower Development a grant and a contract, became available in 1979 The Cancer Training Branch (CTB) in the Center as an additional procurement mechanism. Annual for Cancer Training (CCT) manages the Institute’s appropriations from Congress provide the funds extramural research training, career development, for all research supported by the NCI. and education programs, and provides guidance to the extramural biomedical research community Exhibit VI illustrates the relationship between and administration of awards. This assures con- total NCI obligations and the grant, contract, and tinued development of well-trained investigators intramural/other components of the NCI budget in the basic, clinical, population, and behavioral from 2008 to 2018. Exhibit VII shows the 2013-2017 sciences, who are prepared to address problems in budgets for various disease research areas. Exhibit cancer biology, causation, prevention and control, VIII summarizes the FY2018 budget obligations by detection and diagnosis, treatment, and rehabili- mechanisms. Exhibit IX shows the RPG awards by tation. Operationally, the CTB has three func- activity code and presents the number of grants tions. The first is the management of NCI-funded awarded, the total dollars awarded, and the aver- grants in research training, career development, age cost of a grant for the period 2009-2018. and cancer education. The second function is the administration of the Ruth L. Kirschstein National Grants Research Service Award (NRSA) components (F32 and T32) of the CTB grant portfolio. The NRSA I. Research Project Grants program is the major mechanism for provid- ing long-term, stable support to a wide range of Research Project Grants, (RPGs) are awards for promising scientists and clinicians. Individual investigator-initiated research applications. Sev- awards are made directly to postdoctoral fellows eral types of awards are made in this category; (F32), and institutional awards (T32) are made to they vary in type of mechanism, type of appli- scientists who, together with a group of faculty- preceptors, administer a comprehensive train- cant, total amount of support, and length of time. ing program for pre- and postdoctoral trainees. FY2018 research project grant expenditures totaled CTB administers a research career development approximately $2.45 billion, accounting for program that supports the training of both scien- 41.3 percent of the total NCI budget. tists and research physicians during the first 3 to P01 Research Program Project Grant 5 years between receipt of a Ph.D., M.D., or other Research Program Project Grants (P01s) support professional degree and receipt of an individual, an integrated, multiproject research approach investigator-initiated award. Among the career

NCI Orientation for the Board of Scientific Advisors 19 Exhibit VI. NCI Funding History FY2008-2018*†

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Grants $3,145,011 $3,182,832 $3,289,368 $3,255,003 $3,236,947 $2,987,438 $3,055,661 $3,082,008 $3,163,531 $3,399,282 $3,696,412

Contracts 586,883 618,062 621,682 594,955 597,635 623,950 660,283 596,951 748,344 910,377 843,406

In-house 1,095,658 1,166,033 1,187,097 1,208,147 1,232,760 1,177,626 1,216,424 1,273,633 1,294,293 1,326,732 1,387,911

Total 4,827,552 4,966,927 5,098,147 5,058,105 5,067,342 4,789,014 4,932,368 4,952,592 5,206,168 5,636,391 5,927,729 Dollars in Thousands

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Fiscal Year *Includes FY2018 Cures-Moonshot funding. † Source: NCI Fact Book, FY2018. involving a number of independent investigators categorical program areas. Support generally is re- who share knowledge and common resources. A stricted, in terms of the level of support and time. P01 has a defined, central research focus involv- ing several disciplines or several aspects of one R33 Exploratory/Developmental Grant—Phase II discipline. Each individual project should contrib- Phase II Exploratory/Developmental Grants (R33s) ute or be directly related to the common theme of provide additional support to innovative, explor- the total research effort, thus forming a system of atory, and developmental research activities that research activities and projects directed toward a were initiated under the R21 mechanism. well-defined research program goal. R35 Outstanding Investigator Award (OIA) R01 Research Project Grant The OIA provides long-term support to experi- Research Project Grants (R01s) support a discrete, enced investigators with outstanding records of specified research project to be performed by the cancer research productivity who propose to con- named investigator(s) in an area representing his/ duct exceptional research. The OIA is intended to her specific interest and competencies. This is gen- allow investigators the opportunity to take greater erally referred to as a “traditional research project risks, be more adventurous in their lines of in- grant.” quiry, or take the time to develop new techniques. The OIA would allow an Institution to submit an R03 Small Research Grant application nominating an established Program Small Research Grants (R03s) provide research Director/Principal Investigator (PD/PI) for a 7-year support that is limited in time and amount, for grant. studies in categorical program areas. Small re- search grants provide flexibility and are generally R37 NCI Method to Extend Research in used to initiate studies for preliminary, short-term Time (MERIT) Award for Early Stage projects. These grants are nonrenewable. Investigators (ESI) The ESI MERIT allows eligible investigators the R21 Exploratory/Developmental Grant opportunity to obtain up to 7 years of support Exploratory/Developmental Grants (R21s) sup- in two segments, with the first being an initial port the development of new research activities in 5-year award and the second being based on an

20 NCI Orientation for the Board of Scientific Advisors Exhibit VII. Research Funding for Various Research Areas (Dollars in Millions)*

2013 2014 2015 2016 2017 Disease Area Actual Actual Actual Actual Actual†

Total NCI Budget 4,789.0 4,932.4 4,952.6 5,214.7 5,636.4

AIDS 261.6 269.9 269.6 266.4 249.0

Brain & CNS 176.8 180.4 204.8 196.3 219.8

Breast Cancer 559.2 528.5 543.6 522.6 545.1

Cervical Cancer 63.5 71.1 57.1 71.5 68.0

Clinical Trials 676.5 749.8 769.2 801.0 806.6

Colorectal Cancer 239.0 223.0 209.3 212.1 208.4

Head and Neck Cancers 40.6 57.1 60.2 58.9 63.6

Hodgkin Disease 14.7 15.4 13.6 12.8 13.0

Leukemia 235.3 236.7 246.9 241.0 250.5

Liver Cancer 64.5 60.0 70.3 75.7 72.7

Lung Cancer 287.6 254.1 255.8 283.9 320.6

Melanoma 122.7 126.2 132.8 142.9 153.2

Multiple Myeloma 45.5 46.6 48.9 52.1 60.7

Non-Hodgkin Lymphoma 113.9 118.0 122.4 116.7 119.5

Ovarian Cancer 101.0 91.5 92.8 95.6 109.8

Pancreatic Cancer 102.0 122.4 125.3 152.5 178.3

Prostate Cancer 256.3 217.8 228.9 241.0 233.0

Stomach Cancer 11.2 11.3 13.5 13.3 13.4

Uterine Cancer 17.9 15.5 13.0 16.8 17.5

*Source: Office of Budget and Finance, NCI, FY2018. † FY2017 funds include $300 million in Cures Act funding. opportunity for an extension of up to 2 addi- guidelines. Therefore, applicants are encouraged tional years, based on an expedited NCI review to propose a budget and project period that are of the accomplishments during the initial fund- appropriate for completion of their research proj- ing segment. By providing such an opportunity ect. Deviations from the guidelines must be well for longer term support to ESIs, the NCI intends justified. to give them flexibility and opportunity for creativity and innovation and additional time to R42 Small Business Technology Transfer (STTR) successfully launch their careers and to become Grant—Phase II more established before having to submit re- Phase II STTR Grants (R42s) support in-depth newal applications. development of cooperative research and develop- ment projects between research institutions and R41 Small Business Technology Transfer (STTR) small, domestic, for-profit organizations. They are Grant—Phase I limited in time and amount, and applicants must Phase I STTR Grants (R41s) support coopera- have established during phase I their project’s tive research and development projects between feasibility and potential for commercialization. research institutions and small, domestic, for- Generally, support for Phase II awards may not profit organizations. R41s are limited in time and exceed $500,000 for direct and indirect costs and amount and are used to establish the technical a fixed fee for a period normally not to exceed 2 merit and feasibility of ideas that have a potential years. Note: Phase II award levels and project peri- for commercialization. Generally, support for ods are statutory guidelines. Therefore, applicants Phase I STTR awards may not exceed $100,000 are encouraged to propose a budget and project for direct and indirect costs and a fixed fee for a period that are appropriate for completion of the period normally not to exceed 1 year. Note: Phase research project. Deviations from the guidelines I award levels and project periods are statutory must be well justified.

NCI Orientation for the Board of Scientific Advisors 21 Exhibit VIII. Summary of NCI Obligations by Mechanism, FY2018 (Whole Dollars)*†‡

% of Number Amount Total

RPGs Non-Competing 3,338 1,699,682,348 28.7% . Administrative Supplements 280 36,754,377 0.6% . Competing 1,162 571,221,786 9.6% . Subtotal, without SBIR/STTR Grants 4,500 2,307,658,511 38.9% . SBIR/STTR Grants 280 142,899,233 2.4% . Subtotal, RPGs 4,780 2,450,557,744 41.3% Centers & SPOREs Cancer Centers Grants-P20/P30 91 331,429,940 5.6% . SPOREs 55 115,829,834 2.0% . Other P50s/P20s 0 0 0.0% . Other Specialized Centers 92 178,315,713 3.0% . Subtotal, Centers 238 625,575,487 10.6% Other Research Career Program 0.0% . Post-Doc-Fellow Awards-K00 30 2,293,876 0.0% . Temin & Minority Mentored Awards-K01/K43 41 5,979,795 0.1% . Estab. Inv. Award-K05 5 444,131 0.2% . Preventive Oncology-K07 73 11,271,537 0.4% . Clinical Investigator-K08 113 20,858,368 0.2% . Clinical Oncology-K12 21 14,228,491 0.2% . Transitional Career Development-K22 58 10,304,211 0.0% . Mentored Patient Oriented RCDA-K23 13 2,165,733 0.0% . Mid-Career Invest. & Patient Orient. Res-K24 13 2,379,742 0.0% . Mentored Quant. Res Career-K25 6 847,484 0.1% . Pathway to Independence Awards-K99 59 7,564,148 1.3% . Subtotal, Career Program 432 78,337,516 1.3% . Cancer Education Program-R25 (including BD2K) 76 21,181,892 0.4% . Clinical Cooperative Groups-U10/UG1 101 255,340,505 4.3% . PreDoc PostDoc Transition Awards-F99 47 1,769,662 0.0% . Minority Biomedical Support-S06 0 97,802 0.0% . Research Pathway in Residency-R38 1 358,020 0.0% . Resource Grants-R24/U24/U2C 90 179,028,691 3.0% . Int’l Rsrch Training Grants Conference- D43/U2R 943,987 0.0% . Cooperative Conference Agreements-U13 2 9,000 0.0% . Conference Grants-R13 46 798,659 0.0% . Subtotal, Career and Other Research Grants 795 537,865,734 9.1% . Subtotal, Research Grants 5,813 3,613,998,965 61.0% NRSA Fellowships Trainees: 1,532 82,413,198 1.4%

R&D Contracts R&D Contracts 402 752,280,456 12.7% . SBIR Contracts 45 24,363,729 0.4% . NIH Management Fund/SSF Assessment 48,761,825 0.8% . Subtotal, Contracts 447 825,406,010 13.9% Intramural Research Program . 739,537,951 12.5% .. NIH Management Fund/SSF Assessment . 205,957,758 3.5% . . Subtotal, Intramural Research FTEs: 1,709 945,495,709 16.0% RMS Research Management and Support (RMS) . 340,686,109 5.7% . SBIR RMS . 0 0.0% . NIH Management Fund/SSF Assessment . 101,729,113 1.7% . Subtotal, RMS FTEs: 1,243 442,415,222 7.5% Buildings and Facilities 18,000,000 0.3%

*Total NCI FTEs: 2,952 $5,927,729,104 100.0%

*Excludes projects awarded with Stamp Out Breast Cancer funds as well as royalty income. †Includes FY2018 Cures-Moonshot Funding. ‡Source: NCI Fact Book, FY2018.

22 NCI Orientation for the Board of Scientific Advisors Exhibit IX. RPG Awards by Grant Activity Code, FY2009-2018*†‡§ (Dollars in Thousands)

SBIR/ R01 DP1 DP2 DP5 P01 R00 R37 U01 U19 UH2 R35 R50 UH3 UA5 UM1 UG3 R03 R21 R33 R15 R56 STTR TOTAL

No. 3,573 3 0 0 151 29 63 32 2 0 0 0 0 0 0 0 239 447 25 27 0 261 5,179 2009 $ 1,248,939 3,313 0 302,270 7,186 32,640 31,320 1,584 0 0 0 0 0 0 0 18,401 91,537 9,094 5,823 79 91,954 2,063,038

No. 3,655 5 1 0 140 55 61 43 1 0 0 0 0 0 0 0 181 415 16 24 0 207 5,079 2010 $ 1,323,673 6,021 2,512 0 280,531 13,665 31,498 36,209 1,252 0 0 0 0 0 0 0 14,195 83,950 5,583 7,539 8 85,669 2,092,729

No. 3,648 8 0 0 129 71 59 65 2 1 0 0 0 1 0 0 127 442 9 23 0 144 5,019 2011 $ 1,331,635 7,639 0 0 259,230 17,239 30,327 47,100 5,874 255 0 0 0 381 0 0 9,646 88,481 3,166 9,183 0 84,054 2,088,352

No. 3,526 7 2 0 122 76 48 84 1 1 0 0 0 0 5 0 172 439 3 19 0 190 5,021 2012 $ 1,318,483 7,289 4,584 0 243,599 18,531 23,972 53,457 1,031 100 0 0 0 0 13,467 0 13,132 86,384 1,182 7,772 0 77,355 2,075,295

No. 3,306 5 2 5 124 72 38 98 1 1 0 0 0 0 11 0 199 441 2 28 0 159 4,816 2013 $ 1,182,491 2,528 4,755 1,846 231,618 16,639 16,900 57,050 1,147 306 0 0 0 0 23,554 0 15,286 82,799 662 11,939 0 71,260 1,924,803

No. 3,085 4 3 6 109 84 25 131 2 1 0 0 0 0 15 0 194 551 0 23 0 217 4,814 2014 $ 1,166,410 4,024 7,489 2,318 211,171 19,652 11,391 72,618 3,421 194 0 0 433 0 29,649 0 15,078 102,958 0 9,875 0 81,841 1,939,623

No. 2,949 2 0 8 100 93 12 165 2 1 43 0 0 0 15 0 162 639 0 18 1 194 4,767 2015 $ 1,174,944 2,413 402 3,501 193,818 22,841 5,695 106,463 3,606 2,283 34,740 0 0 0 28,572 0 12,868 123,378 86 7,317 263 92,598 2,019,308

No. 2,883 2 0 11 94 93 6 148 2 6 77 34 0 0 14 0 114 585 0 22 2 202 4,666 2016 $ 1,194,861 3,021 220 4,818 173,358 22,620 2,649 100,206 3,027 1,678 71,418 5,674 432 0 26,106 0 9,057 113,327 0 9,315 560 101,478 2,068,869

No. 3,074 3 0 7 90 109 2 237 3 19 105 49 6 0 23 8 138 472 57 20 3 238 4,663 2017 $ 1,328,242 3,620 174 2,882 169,753 26,551 955 201,670 6,577 4,953 96,338 8,430 5,723 0 65,150 3,268 10,796 91,406 33,586 8,559 917 125,636 2,195,184

No. 3,092 2 1 6 85 103 66 285 2 7 125 63 21 0 33 11 149 382 45 20 2 280 4,780 2018 $ 1,375,890 2,388 2,711 2,494 165,529 24,704 30,163 243,522 5,087 1,408 118,267 10,559 11,275 0 110,404 5,574 12,227 74,013 17,863 8,951 602 142,899 2,366,530

Research Project Grants and Dollars Awarded FY2009-2018*†‡§

6,000 $500

5,000 $400

4,000 $300

3,000 No. Awards

$200 Average Cost 2,000

$100 1,000

0 $0 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

No. Awarded 5,179 5,079 5,019 5,021 4,816 4,814 4,767 4,666 4,663 4,780

$ in Millions $2,063 $2,093 $2,088 $2,075 $1,925 $1,940 $2,019 $2,069 $2,195 $2,367

Avg. Cost $ in Thousands $398.3 $412.0 $413.3 $399.7 $402.9 $403.0 $423.6 $443.4 $470.8 $495.1

* In 2011, NCI Awarded 1 UA5; it is not displayed but is included in the 2011 totals. † Excludes projects awarded with the Stamp Out Breast Cancer Funds and Program Evaluation. ‡ Includes FY2018 Cures-Moonshot funding. § Source: NCI Fact Book, FY2018.

NCI Orientation for the Board of Scientific Advisors 23 R43 Small Business Innovation Research (SBIR) Shannon Awards (R55s) provide a limited award Grant—Phase I to investigators to further develop, test, and refine Phase I SBIR Grants (R43s) support research ef- research techniques; perform secondary analysis of forts by for-profit, domestic, small businesses. The available data sets; test the feasibility of innovative objectives of this phase are to: (1) establish the and creative approaches; and conduct other discrete technical merit and feasibility of proposed re- projects that can demonstrate the investigator’s search or research and development (R&D) efforts, research capabilities and lend additional weight to and (2) evaluate the performance of the small his or her already meritorious application. business awardee organization prior to providing further Federal support in Phase II (R44). Gener- R56 High Priority, Short-Term Project Award ally, support for Phase I awards may not exceed Applicants do not submit requests for a High $100,000 for direct and indirect costs and a fixed Priority Award (R56). Instead, NCI program staff fee for a period normally not to exceed 6 months. nominate previously reviewed R01 applications Note: Phase I award levels and project periods are that are beyond the current NCI payline but, be- statutory guidelines. Therefore, applicants are en- cause of their merit, are eligible for funding. After couraged to propose a budget and project period each of the three review cycles per year, High that are appropriate for completion of the research Priority nominees are administratively reviewed project. Deviations from the guidelines must be by the NCI according to standard review criteria. well justified. The NCI then determines whether any awards are made from NCI funds. R44 Small Business Innovation Research (SBIR) Grant—Phase II High Priority Awards (R56s) provide limited, Phase II SBIR Grants (R44s) continue those R&D interim support to enable an applicant to gather efforts that were started in Phase I (R43). Awards additional data for revision of a new or compet- are based on the results of Phase I and the scien- ing renewal application. The R56 will assist early tific and technical merit and commercial potential career stage scientists trying to establish research of the Phase II application. Only Phase I awardees careers as well as more experienced scientists who are eligible for Phase II. Generally, support for just missed receiving funds. Phase II may not exceed $750,000 for direct and indirect costs and a fixed fee for a period nor- II. Cancer Centers and Specialized Programs of mally not to exceed 2 years. Note: Phase II award Research Excellence levels and project periods are statutory guidelines. Therefore, applicants are encouraged to propose The Cancer Centers, SPORE Program, and other a budget and project period that are appropriate specialized centers contain a great diversity of for completion of the research project. Deviations research approaches. In FY2018, expenditures from the guidelines must be well justified. totaled about $625 million, accounting for 10.6 percent of the total NCI budget. R50 Research Specialist Award The Research Specialist Award supports the devel- P20 Planning Grant opment of stable research career opportunities for Planning Grants (P20s) support planning for new exceptional scientists who want to pursue research programs, expansion or modification of existing within the context of an existing cancer research resources, and feasibility studies for new ap- program, but not serve as independent investiga- proaches. Such awards have been particularly tors. useful in the development of Cancer Centers and SPOREs but are no longer available for Cancer R55 James A. Shannon Director’s Award Centers. Applicants do not submit requests for Shannon P30 Cancer Center Support Grant Awards (R55). Instead, NCI program staff nomi- Cancer Center Support Grants (P30s) provide sup- nate previously reviewed R01 and R03 applica- port primarily for the research infrastructure tions that are beyond the current NCI payline but, of an active and unified Cancer Center, for the because of their merit, are eligible for funding. purpose of: consolidating and focusing cancer- After each of the three review cycles per year, related activities; increasing research productivity; Shannon Award nominees are administratively promoting shared use of research resources and reviewed by the NCI according to standard review improved quality control; stimulating and promot- criteria, then submitted to the Office of Extramural ing interdisciplinary and collaborative research; Research, NIH, for expedited review and concur- and increasing the rate at which research discover- rence prior to funding. ies are translated into medical developments.

24 NCI Orientation for the Board of Scientific Advisors P50 Specialized Center Grant time to devote to research and to act as mentors for Specialized Center Grants (P50s) support any part young investigators. NCI supports the Established of the full range of R&D, from very basic to clinical Investigator Award in Cancer Prevention, Control, activities. They also may support ancillary activi- Behavioral, and Population Sciences Research. ties, such as the protracted patient care that may be necessary while conducting primary research K07 Academic Career Award or R&D. The spectrum of activities comprises a Academic Career Awards (K07s) support more multidisciplinary attack on cancer. These grants junior candidates who are interested in developing differ from Program Project Grants in that they academic and research expertise in a specific area. usually are developed in response to an announce- They also support more senior individuals with ment of the programmatic needs of the NCI and acknowledged scientific expertise and leadership receive continuous attention from its staff. Centers skills who are interested in improving the curri- also may serve as regional or national resources cula and enhancing the research capability within for special research purposes. an academic institution. NCI supports the Cancer Prevention, Control, Behavioral and Population The Specialized Programs of Research Excellence Sciences Career Development Award. (SPORE) grant is one type of Specialized Center. The NCI SPORE is an organ system application, K08 Mentored Clinical Scientist Development which includes basic and clinical investigation, Award thus having a significant translational component. Mentored Clinical Scientist Development Awards (K08s) support the development of outstanding III. Other Research Grants clinical research scientists. These awards provide specialized study for clinically trained profession- Other research grants include the Research Career als who are committed to a career in research and Program and all other research grants not includ- have the potential to develop into independent ed in Research Project Grants, Research Centers, investigators. The NCI supports two K08 awards: and/or Cancer Prevention and Control, except the Mentored Clinical Scientist Development for National Research Service Awards. The NCI Award and the Mentored Clinical Scientist Devel- Research Career Program includes all “K” awards. opment Award to Promote Diversity. Other research grants also include the Clinical Cooperative Groups, Cancer Education Program K12 Mentored Clinical Scientist Development (R25), resource grants (R24/U24), conference Program Award grants, and Predoctoral to Postdoctoral Transition Mentored Clinical Scientist Development Program Fellow Awards (F99). In FY2018, other research Awards (K12s) help newly trained, appointed expenditures totaled approximately $537 million, clinicians gain independent research skills and accounting for 9.1 percent of the total NCI budget. experience in a fundamental science within the IV. Career Awards and Cancer Education framework of an interdisciplinary R&D program. NCI supports the Paul Calabresi Award for Clini- K01 Mentored Research Scientist Development cal Oncology. Award Mentored Research Scientist Development Awards K18 Career Enhancement Award for Stem Cell (K01s) provide support and “protected time” for Research an intensive, supervised career development ex- This program encourages investigators to obtain perience in the biomedical, behavioral, or clinical the training and career development they need to sciences leading to research independence. Some appropriately use stem cells in their research. It Institutes/Centers use the K01 to support individu- is intended to enable investigators to change the als who propose to train in a new field; for indi- direction of their research careers or to take time viduals who have had a hiatus in their research from their regular professional responsibilities to career; or to increase research workforce diversity. broaden their scientific background by acquiring The NCI supports the Mentored Research Scientist new research capabilities, specifically in the use of Development Award to Support Diversity. human or animal embryonic, adult, or cord blood stem cells. The award includes salary and support K05 Senior Scientist Award for career development costs. Senior Scientist Awards (K05s) support outstand- ing established scientists who have demonstrated K22 Career Transition Award a sustained, high level of productivity, research Career Transition Awards (K22s) help newly accomplishments, and contributions to research in trained basic or clinical investigators to develop the fields of cancer prevention, control, and popu- their independent research skills through a two- lation sciences. These awards provide protected phase program: an initial period involving an

NCI Orientation for the Board of Scientific Advisors 25 intramural appointment at the NIH and a final K99/R00 Howard Temin Pathway to Indepen- period of support at an extramural institution. dence Awards in Cancer Research The award is intended to enable the investigator Howard Temin Pathway to Independence Awards to establish a record of independent research to in Cancer Research (K99/R00) support highly sustain or promote a successful research career. promising, postdoctoral research scientists. The The NCI supports two K22 awards: the Scholars initial phase is followed by independent support Program and the Transition Career Development contingent on securing an independent research Award. The NCI Scholars Program provides an position. The goal of this award is to facilitate an opportunity for outstanding new investigators to investigator receiving an R01 award earlier in his/ begin independent research careers, intramurally, her research career. within the special environment of the NCI. It then enables awardees to continue their careers extra- V. Training (NRSA) murally at an institution of their choice, where they are appointed to junior faculty positions or The National Research Service Award (NRSA) is the equivalent. The NCI Transition Career Devel- the major mechanism providing long-term, stable opment Award is a fully portable mechanism that support to a wide range of promising scientists facilitates the professional advancement of talent- and research clinicians. FY2018 NRSA expendi- ed clinician cancer scientists, clinicians in patient- tures totaled approximately $82.4 million, account- oriented cancer research, and researchers in cancer ing for 1.8 percent of the NCI budget. prevention, control, and the population sciences. F31 Predoctoral Individual National Research K23 Mentored Patient-Oriented Research Career Service Award Development Award Predoctoral Individual National Research Service Mentored Patient-Oriented Research Career Awards (F31s) provide predoctoral individuals Development Awards (K23s) provide support with supervised research training in specified for the career development of investigators who health and health-related areas leading toward a focus their research endeavors on patient-oriented research degree (e.g., Ph.D.). research. The mechanism provides support for a period of supervised study and research to clini- F32 Postdoctoral Individual National Research cally trained professionals who have the potential Service Award to develop into productive clinical investigators in Postdoctoral Individual National Research Ser- patient-oriented research. vice Awards (F32s) provide postdoctoral research training to individuals to broaden their scientific K24 Mid-Career Investigator in Patient-Oriented background and extend their potential for research Research Award in specified, health-related areas. Mid-Career Investigator in Patient-Oriented Research Awards (K24s) provide clinicians the F33 National Research Service Award for Senior opportunity to dedicate time to patient-oriented Fellows research and to mentor other clinical investigators National Research Service Awards for Senior Fel- in patient-oriented research. lows (F33s) enable experienced scientists to take time away from their regular professional respon- K25 Mentored Quantitative Research Career sibilities to: make major changes in the direction Development Award of research careers; broaden scientific background; Mentored Quantitative Research Career Develop- acquire new research capabilities; enlarge com- ment Awards (K25s) support the career develop- mand of an allied research field; or increase capa- ment of investigators with quantitative scientific bilities to engage in health-related research. and engineering backgrounds outside of biology or medicine, who have made a commitment to F99/K00 Predoctoral to Postdoctoral Fellow Tran- focus their research endeavors on behavioral and sition Award biomedical research (basic or clinical). The F99/K00 award is intended for individuals who require 1-2 years to complete their Ph.D. K30 Institutional Curriculum Award dissertation research training (F99 phase) before Institutional Curriculum Awards (K30s) support transitioning to mentored postdoctoral research the development, conduct, and evaluation of cur- training (K00 phase). Consequently, applicants ricula that are designed to improve the quality of are expected to propose an individualized training for aspiring clinical investigators. research training plan for the next 1-2 years of dissertation research training and a plan for 3-4 years of mentored postdoctoral research and

26 NCI Orientation for the Board of Scientific Advisors career development activities that will prepare R24 Resource-Related Research Project them for independent cancer-focused research Resource-Related Research Project Grants (R24s) careers. support research projects that will enhance the ca- pability of resources to serve biomedical research. T32 Institutional National Research Service Award R25 Cancer Education Grant Institutional National Research Service Awards (T32s) Cancer Education Grants (R25s) provide support support training opportunities at the pre-doctoral or for educational activities including the development postdoctoral level at qualified institutions. Applicants and implementation of activities that complement must have the staff and facilities for the proposed and/or enhance the training of predoctoral or program. After the award is made, the institution’s postdoctoral candidates to meet the Nation’s training Program Director is responsible for selecting biomedical, behavioral, and clinical research the trainees and for administering the program. This needs. The NCI Cancer Education Grants Program program does not support residencies. (CEGP) is an institutional grant program aimed at developing and sustaining innovative educational D43 International Training Grants in curriculum-driven and research laboratory Epidemiology exposure approaches to train predoctoral and To improve and expand epidemiologic research postdoctoral candidates in cancer research settings and the utilization of epidemiology in clinical tri- that are highly interdisciplinary and collaborative als and prevention research in foreign countries and address the cause, diagnosis, prevention, through support of training programs for foreign treatment, rehabilitation, or the continuing care of health professionals, technicians, and other health cancer patients and the families of cancer patients. care workers. The CEGP awards (R25s) address a need that is not fulfilled adequately by any other grant mechanism DP1 NIH Director’s Pioneer Award (NDPA) available at the NIH. These awards are dedicated To support individuals who have the potential to areas of particular concern by the NCI. to make extraordinary contributions to medical research. The NIH Director’s Pioneer Award is not S06 Minority Biomedical Research Support renewable. (MBRS) Minority Biomedical Research Support Grants DP2 NIH Director’s New Innovator Awards (S06s) provide funds to strengthen the biomedical To support highly innovative research projects by research and research training capability of ethnic new investigators in all areas of biomedical and minority institutions, thus creating a more favor- behavioral research. able milieu for increasing the involvement of mi- nority faculty and students in biomedical research. DP5 NIH Director’s Early Indepencence Awards The DP5 NIH Director’s Early Independence S21 Research and Institutional Resources Health Awards provide an opportunity for exceptional Disparities Endowment Grants – Capacity Build- junior scientists to accelerate their entry into an ing independent research career by forgoing the tradi- To strengthen the research and training infrastruc- tional postdoctoral training period. ture of the institution, while addressing current and emerging needs in minority health and other Other Grant Mechanisms health disparities research. R13 Conference Grant SC1 Research Enhancement Award Conference Grants (R13s) support national or in- Individual investigator-initiated research projects ternational meetings, conferences, and workshops that are of value in promoting the goals of the aimed at developing researchers at minority- National Cancer Program. serving institutions (MSIs) to a stage where they can transition successfully to other extramural R15 Academic Research Enhancement Award support (R01 or equivalent). (AREA) Academic Research Enhancement Award (AREA) SC2 Pilot Research Project Grants (R15s) support small-scale research projects Individual investigator-initiated pilot research conducted by faculty in primarily baccalaureate projects for faculty at MSIs to generate preliminary degree-granting domestic institutions. Awards data for a more ambitious research project. are for up to $75,000 in direct costs (plus appli- cable indirect costs) for periods not to exceed 36 months.

NCI Orientation for the Board of Scientific Advisors 27 Cooperative Agreements staff involvement is intended to assist investiga- tors during performance of research activities, as The cooperative agreement is a mechanism to pro- defined in the terms and conditions of the award. vide funding assistance for a variety of activities. This mechanism can provide support for certain The Federal Grant and Cooperative Agreement basic, shared resources, which facilitate the total Act of 1977 authorized use of the cooperative research effort, including clinical components. agreement and formally defined the circumstances under which this mechanism is to be employed by U24 Resource-Related Research Project Coopera- Federal agencies. These instruments are used for tive Agreement situations in which an assistance relationship will Resource-Related Research Project Cooperative exist between the NCI and a recipient and sub- Agreements (U24s) support projects that help im- stantial programmatic involvement is anticipated. prove the capability of resources to serve biomedi- cal research. U01 Research Project Cooperative Agreement Research Project Cooperative Agreements (U01s) U43 Small Business Innovation Research (SBIR) support discrete, specified, circumscribed projects Cooperative Agreement—Phase I (see R43) to be performed by the named investigator(s) in Phase I SBIR Cooperative Agreements (U43s) sup- an area representing his/her specific interest and port finite projects to establish the technical merit competencies. This mechanism is utilized when and feasibility of R&D ideas that ultimately may substantial programmatic involvement is antici- lead to the development of commercial products pated between the NCI and the recipient. or services. This mechanism is utilized when an assistance relationship will exist between the NCI UG1 Clinical Research Cooperative Agreement and a recipient and in which substantial program- (Single Project) Clinical Research Cooperative matic involvement is anticipated. Cooperative Agreements (UG1s) support single project appli- agreement applications are considered only for cations conducting clinical evaluation of various the topics specifically listed in the current SBIR methods of therapy and/or prevention (in specific Omnibus Solicitation. Note: Phase I award levels and project periods are statutory guidelines. Ap- disease areas). The UG1 is the single-component plicants are encouraged to propose a budget and companion to the U10, which is used for multi- project period that are appropriate for completion project applications only. of the research project. Deviations from the guide- lines must be well justified. U10 Clinical Research Cooperative Agreement (Clinical Cooperative Groups) U44 Small Business Innovation Research (SBIR) Clinical Research Cooperative Agreements (U10s) Cooperative Agreement—Phase II (see U43 and support clinical evaluations of various methods R44) of therapy and/or prevention in specific disease Phase II SBIR Cooperative Agreements (U44s) areas. These represent cooperative programs support in-depth development of R&D ideas for between sponsoring institutions and participating which feasibility has been established in Phase I principal investigators, and usually are conducted (U43) and that are likely to result in commercial under established protocols. products or services. Note: Phase II award levels and project periods are statutory guidelines. Ap- U13 Conference Cooperative Agreement plicants are encouraged to propose a budget and Conference Cooperative Agreements (U13s) sup- project period that are appropriate for completion port international, national, or regional meetings, of the research project. Deviations from the guide- conferences, and workshops for which substantial lines must be well justified. programmatic NCI staff involvement is planned to assist the recipients. U54 Specialized Center—Cooperative Agreement Specialized Center Cooperative Agreements U19 Research Program Cooperative Agreement (U54s) support any part of the full range of R&D, Research Program Cooperative Agreements (U19s) from basic concepts to clinical applications. The support research programs that have multiple U54 may involve ancillary supportive activi- projects directed toward a specific major objective, ties, such as the provision of protracted patient basic theme, or program goal, requiring a broadly care during the primary research or R&D effort. based, multidisciplinary, and often long-term The spectrum of activities comprises a multidis- approach. Substantial Federal programmatic ciplinary attack on a specific disease entity or biomedical problem area. The U54s differ from

28 NCI Orientation for the Board of Scientific Advisors program projects in that they usually are devel- cannot be appropriately categorized into an avail- oped in response to an announcement of the pro- able single component activity code (e.g., clinical grammatic needs of an Institute or division and networks, research programs, or consortia). The subsequently receive continuous attention from components represent a variety of supporting its staff. Centers also may serve as regional or functions and are not independent of each com- national resources for special research purposes, ponent. Substantial Federal programmatic staff with funding staff helping to identify appropriate involvement is intended to assist investigators priority needs. At the NCI, U54s support compre- during performance of the research activities, as hensive partnerships between Minority Serving defined in the terms and conditions of the award. Institutions (MSIs) and the NCI-designated Cancer The performance period may extend up to 7 years Centers, for the benefit of both. These partnerships but only through the established deviation request focus on cancer research career development at process. ICs desiring to use this activity code for the MSI or cancer research plus one or more target programs greater than 5 years must receive areas in cancer research training. These partner- OPERA prior approval through the deviation ships also may focus on cancer research and target request process. areas in cancer education for, or cancer outreach to, minority communities. UM2 Program Project or Center With Complex Structure Cooperative Agreement U56 Exploratory Grant—Cooperative Agreement Cooperative agreements involving program proj- Exploratory Grant Cooperative Agreements (U56s) ects or centers with complicated structures that support planning for new programs, expansion or cannot be appropriately categorized into an avail- modification of existing resources, and develop- able multicomponent activity code (e.g., clinical ment of feasibility studies to explore the devel- networks, research programs or consortia. At least opment of interdisciplinary programs that offer one component must be UM1-like, supporting a potential solutions to problems of special signifi- variety of functions that are dependent on each cance to the mission of the NIH. These exploratory other and cannot be separated into distinct com- studies may lead to specialized or comprehensive ponents. Substantial Federal programmatic staff centers. Substantial Federal programmatic staff involvement is intended to assist investigators involvement is intended to assist investigators during performance of the research activities, as during the performance of the research activities, defined in the terms and conditions of the award. as defined in the terms and conditions of award. The performance period may extend up to 7 years but only through the established deviation request UH2 Exploratory/Developmental Cooperative process. Agreement—Phase I The Exploratory/Developmental Cooperative Solicitation of Grant Applications Agreement Phase I (UH2) provides support for the development of new research activities in categori- Electronic grant applications must be submitted cal program areas. (Support generally is restricted in response to a Funding Opportunity Announce- in level of support and in time.) ment (FOA) published on www.grants.gov or the NIH Guide for Grants and Contracts (https://grants. UH3 Exploratory/Developmental Cooperative nih.gov/funding/index.htm). “Investigator Initiat- Agreement—Phase II ed” or “unsolicited” applications are submitted to The UH3 provides a second phase for the sup- Parent Announcements that are mechanism (e.g. port for innovative exploratory and development R01, R21, R44, etc.) specific. In addition, the NCI research activities initiated under the UH2 mecha- may encourage the submission of grant applica- nism. Although only UH2 awardees are generally tions through the publication of additional FOAs eligible to apply for UH3 support, specific pro- using the following types of solicitations: gram initiatives may establish eligibility criteria under which applications could be accepted from Program Announcements (PAs) applicants demonstrating progress equivalent to PAs describe continuing, new, or expanded that expected under the UH2. program interests for which grant or cooperative agreement applications are invited. Applications UM1 Research Project With Complex Structure in response to PAs are reviewed in the same man- Cooperative Agreement ner as unsolicited grant applications (i.e., by char- Research Project With Complex Structure Cooper- tered peer review committees or Special Emphasis ative Agreements provide support for large-scale Panels (SEPs) of the Center for Scientific Review research activities with complicated structures that [CSR] or by the NCI).

NCI Orientation for the Board of Scientific Advisors 29 Program Announcements with Special and Contracting Officers. After award, the NCI is Receipt/Review (PARs) substantially involved in monitoring the project; PARs are program announcements that contain this may range from tight control to general sur- special receipt dates, referral guidelines, and veillance and support. Contracts may be used in review considerations and are reviewed either by support of either research or resource projects. In a CSR or by a specific Institute’s IRG or SEP with research contract, the NCI defines the specific area funds earmarked for the initiative. of research and may identify general approaches. Such a contract usually is used to stimulate work Requests for Applications (RFAs) in an area that has been neglected by the private RFAs are issued to invite grant or cooperative sector. agreement applications in a well-defined scientific area, to stimulate activity in NCI programmatic Loan Repayment Program (LRP) priority areas. Usually a single application receipt date is specified, and the announcement identifies The LRP was started in 1989 to recruit and retain the amount of funds earmarked for the initiative highly qualified professionals as AIDS research- and the number of awards likely to be funded. ers. Using the contract mechanism, this program Applications are evaluated before review for provides for repayment of up to $35,000 (princi- responsiveness to the RFA. Applications received pal and interest) of eligible, educational loans for in response to a particular RFA are reviewed by an qualified clinical and pediatric investigators, for appropriate NCI Special Emphasis Panel (SEP). each year of their research service. To be eligible, the awardee must agree to engage in clinical All PAs and RFAs are published in the NIH Guide or pediatric research for a minimum of 2 years. for Grants and Contracts (http://www.nih.gov/ Originally confined to intramural researchers, the grants/guide/index.html) and, when appropriate, LRP was expanded in 2002 to include extramural in scientific journals and periodicals. investigators.

Contracts L30 Clinical Research Loan Repayment Program The Clinical Research Loan Repayment Program is Research and Development Contracts for eligible investigators, in exchange for a 2-year commitment to clinical research. To participate in To stimulate scientific inquiry, direct it toward the program, individuals must hold an appropri- promising areas of current research, and solve spe- ate terminal degree from an accredited institu- cific research problems, the NCI awards research, tion, must conduct research for 20 hours per week development, demonstration, and support con- (based on a 40-hour week), and must conduct re- tracts to both nonprofit and commercial organiza- search that is supported by a domestic, nonprofit tions. The idea for a contract may be generated by institution or by a U.S. Government entity. the NCI program staff (usually the Project Officer), or it may originate from members of the scientific L40 Pediatric Research Loan Repayment Program community. The negotiated contract used by the The Pediatric Research Loan Repayment Program is NCI is awarded through a competitive process, in for eligible investigators, in exchange for a 2-year which bidders are judged on the basis of technical commitment to pediatric research. To participate (scientific merit), business, and cost factors. The in the program, individuals must hold an appro- responsibility for reviewing the technical merit priate terminal degree from an accredited institu- of proposals for R&D contracts is lodged in the tion, must conduct research for 20 hours per week Research Technology and Contract Review Branch (based on a 40-hour week), and must conduct re- (RTCRB), DEA, NCI. Review responsibility is search that is supported by a domestic, nonprofit separated from those responsibilities of the Project institution or by a U.S. Government entity.

30 NCI Orientation for the Board of Scientific Advisors PEER REVIEW

INTRODUCTION A board or council, hereafter referred to as board, is composed of both scientific and lay public rep- Because of the magnitude, diversity, and complex- resentatives who are selected for their expertise, ity of its research mission, as well as its pursuit of interest, or activity in matters related to the mis- excellence, the National Institutes of Health (NIH) sion of the specific Institute for which the board draws on a national pool of scientists actively or council serves. Board recommendations are engaged in research. These scientists advise the based not only on consideration of scientific merit NIH about how to select research projects based as judged by the CSR Integrated Review Groups on scientific merit. (IRGs) or the NCI Initial Review Group (IRG) or Special Emphasis Panel (SEP), but also on the As discussed in the previous section, the National relevance of the proposed study to an Institute’s Cancer Institute (NCI) supports research through programs and priorities. By statute, Congress three major mechanisms: investigator-initiated established the National Advisory Cancer Council projects, cooperative agreements for projects in as the National Cancer Advisory Board. which programmatic involvement between the NCI and a recipient is anticipated, and research The dual review system—which separates the and development (R&D) contracts for projects that scientific assessment of proposed projects from are undertaken in response to NCI Requests for policy decisions about scientific areas to be sup- Proposals (RFP). ported and the level of resources to be allocated— permits a more objective evaluation than would a The Board of Scientific Advisors (BSA) performs single level of peer review. It guarantees that the the review of concepts for special initiatives, NCI program staff will assess only the program- including both Requests for Applications (RFA) for matic aspects of an application, while the mem- grants and cooperative agreements and RFPs for bers of the scientific research community evaluate R&D contracts and master agreements. All under- the project’s technical merit. This dual system go peer review before funding decisions are made. provides the responsible NIH official with the best advice available regarding both scientific and The dual peer review system of the NIH consists societal values and needs. of two sequential levels of review, mandated by statute. Although the system already had been in The following describes the review of grant ap- effect for many years, the first or initial level of plications in detail. Review of contract proposals is peer review of research grant applications was described on pp. 35-36. formally mandated in 1974 by Section 475 of the Public Health Service Act. The review of grant applications by national boards/councils was SUBMISSION OF GRANT mandated by the National Cancer Act in 1937, and APPLICATIONS incorporated into the Public Health Service Act in 1944. In 1978, P.L. 95-224 authorized and directed Grants and cooperative agreement applications the use of cooperative agreements, which also are may be submitted by nonprofit and for-profit subject to peer review. organizations, institutions of higher education, hospitals, research foundations, governments and The National Cancer Advisory Board (NCAB) per- their agencies in response to Funding Opportu- forms the second level of review for NCI grants, as nity Announcements (FOA). An FOA is a publicly mandated by the National Cancer Act of 1937 and available document by which a Federal agency incorporated into the Public Health Service Act in makes known its intentions to award discretionary 1944. NCAB members bring to the grant review grants or cooperative agreements, usually as a re- process their knowledge in each of the relevant sult of competition for funds. FOAs may be known programmatic areas. They also are familiar with as Program Announcements, Requests for Appli- the NCI priorities and procedures and are aware cations, solicitations, or other names depending of the missions of the diverse Institutes in bio- on the agency and type of program. FOAs can be medical research as well as the health needs of the found at http://grants.nih.gov/grants/guide/ and in American people.

NCI Orientation for the Board of Scientific Advisors 31 the NIH Guide for Grants and Contracts. In addition, typical grants process from the date of receipt of the NIH and other HHS Agencies have developed applications through assignment of applications. omnibus Parent Announcements for common Within CSR’s Division of Receipt and Referral, grant mechanisms (e.g., R01, R03, R43, etc.) that referral officers, who are Health Scientist Adminis- have transitioned to electronic submission, for trators, determine the relevance of the applications use by applicants who wish to submit what were to NIH’s overall mission and assign each accept- formerly termed “unsolicited” or “investigator- able application to an appropriate CSR IRG or an initiated” applications. Institute for peer review. The choice of an IRG is based on the relevance of a proposed research The process of developing a grant application project to the review responsibilities of the IRG usually begins with the Principal Investigator members. Most NIH Institutes, including the NCI, (PI) who initiates the research data and prepares have established their own review units to review the application. The PI should work concurrently specialized grant applications of high program- with the authorized business official from his/ matic interest, such as those related to Cancer her institution to ensure that all of the application Control, Cancer Centers, Clinical Cooperative requirements are met. The PI accepts responsibil- Groups, National Research Service Awards, Clini- ity for the scientific conduct of the project and cal Cancer Education Programs, Program Projects, submission of progress and any other required and RFAs and special Program Announcements. reports. The applicant institution is in turn legally responsible and accountable to the NIH for the Institute/Center (IC) and Program performance and financial aspects of the grant- Assignment supported activity. CSR also assigns each application to an IC based on that Institute’s legislatively mandated program ELECTRONIC SUBMISSION OF responsibility using negotiated criteria (referral guidelines). If the subject matter of an applica- GRANT APPLICATIONS tion is pertinent to the missions of two Institutes, a dual assignment may be made. Then, the NCI NIH Transitions From Paper PHS398 Grant Ap- Referral Office refers all applications assigned to plication Submissions to Electronic Submission the NCI by CSR to one of the 50 NCI extramural Using the SF424 (R&R) Application research program areas. The NCI Referral Office The NIH transitioned from paper submission of staff assigns all incoming applications, tracks their grant applications to electronic submission via the review status, and distributes them to the appropri- Web portal of http://www.grants.gov, while simul- ate NCI Program Director. In FY2018, 16,236 grant taneously phasing out the PHS398 grant applica- applications were received for referral. tion form and re;lacing it with the SF424 [Research and Research-related (R&R)] application. INITIAL PEER REVIEW Applications must be submitted electronically through http://www.grants.gov. For additional CSR Integrated Review Groups information, please go to https://grants.nih.gov/ grants/submitapplication.htm. There are approximately 25 chartered IRGs distributed among the five review divisions PROCESSING OF GRANT within the CSR. Each IRG has 5 to 10 Scientific Review Groups (SRGs), or “study sections,” APPLICATIONS that review applications on specific topics (e.g., cell biology, clinical oncology, pathology, Receipt and Review Assignment of biochemistry, virology), regardless of the Grant Applications awarding NIH Institute assignment. There are approximately 180 regular study sections in the The referral section of the Center for Scientific 25 IRGs, plus 29 fellowship and 37 small business Review (CSR) serves as the central receipt point Special Emphasis Panels (SEPs). A listing of for all competing applications, including applica- IRGs and their study sections may be found at tions submitted in response to specifically targeted, the following website: http://public.csr.nih.gov/ pre-announced RFAs or program announcements StudySections/Pages/default.aspx. in areas of Institute interest. Exhibit X illustrates a

32 NCI Orientation for the Board of Scientific Advisors Exhibit X. National Institutes of Health Grant Process*

Generally, a study section is composed of 12 to 18 NCI Review of Grant Applications mostly non-Federal scientists who are selected on the basis of recognized competence in their respec- The NCI conducts its own initial review of certain tive research fields. In each of the three review specialized or complex cancer-oriented applica- cycles per year, a CSR study section may review tions, including Research Program Projects, Can- between 50 and 100 grant applications. cer Center Support Grants, Cooperative Clinical Research Grants, Conference Activities, Research Each study section is organized and managed by Demonstration and Dissemination Projects, an SRO—an NIH staff scientist who is the Des- SPOREs, SBIRs, and others. These reviews are ignated Federal Official (DFO) responsible for conducted by either NCI chartered or ad hoc SEP ensuring that the grant applications are reviewed peer review committees, which may includefrom in an impartial environment. SROs are respon- 15 to 80 reviewers. In FY2018, the DEA reviewed sible for overseeing the scientific peer review of 4,222 grant and cooperative agreement applica- applications. Their major responsibilities include tions, 414 Loan Repayments, and 105 SBIR contract managing study section meetings, nominating proposals. study section members, selecting ad hoc reviewers and site visitors, providing orientation for mem- Five branches are responsible for organizing, bers of review groups, explaining and interpreting managing, and reporting the scientific peer review the NIH review policies and procedures, manag- of applications for a wide variety of grant mecha- ing project site visits and study section meetings nisms: the Research Programs Review Branch and preparing Summary Statements. They also (RPRB), the Special Review Branch (SRB), the are responsible for attending advisory board or Resources and Training Review Branch (RTRB), council meetings to provide requested information Research Technology and Contract Review Branch in support of the peer review committee recom- (RTCRB), and the Program Coordination and mendations; communicating with program staff Referral Branch (PCRB). on review issues; and discussing review issues and policies with applicants. SROs do not have con- The RTRB has primary responsibility for review- tinuing programmatic, scientific, or fiscal responsi- ing applications for Cancer Centers, cancer training bilities for the applications after the scientific peer and career development, using four standing IRG review is completed. subcommittees. Cancer Centers reviews involve site

NCI Orientation for the Board of Scientific Advisors 33 visits with subsequent review by the appropriate his or her committee and obtains any additional parent committee. information necessary for the review from the principal investigators or applicant institutions. The RPRB has primary responsibility for review- Approximately 6 to 8 weeks before the meeting ing unsolicited P01s and applications for SPOREs date, the SRO assigns each application to three or (P50) in various disease sites with SEPs. The SRLB more members of the study section, who prepare is responsible for the review of most applications detailed critiques and lead the discussion of the submitted in response to the initiatives published application at the review meeting. Each member by the Institute, including RFAs and PAs. The reviews approximately 10 or more applications RTCRB is responsible for the review of SBIR/STTR in detail. In addition, every member is expected grant applications and Special Topics, technology- to read and comment on as many applications as related applications, and contract proposals submit- possible to be reviewed at the meeting. During ted in response to Requests for Proposals (RFP). All the three annual meetings, each of which lasts 1-2 of these reviews are conducted by SEPs or Techni- days, each study section reviews approximately cal Evaluation Panels (TEP) for contracts and in- 85 applications. clude the following types of mechanisms: P50, R03, U19, U54, U56, SBIRs (R43s and R44s), and STTRs The SRO is responsible for providing any informa- (R41s and R42s). For RFAs, the size and composition tion or materials necessary for the review, com- of the SEP is dependent on the research scope and municating with applicants, and providing the number of applications submitted in response to the appropriate I/C advisory board/council with an special initiative. The PCRB provides review support accurate record of the proceedings in the form of a for several grant applications, including conference detailed summary statement. At the review meet- grants (R13). ing, each assigned reviewer makes an initial rec- ommendation to the review group about the merit The various committees are responsible for advis- of each application. A discussion ensues, following ing the NCI Director and the NCAB concerning the which each member of the committee votes on the scientific and technical merit of grant applications application’s technical merit and assigns an overall assigned to the NCI for the initial review, which impact score. Scores are summed and averaged for addresses each application’s scientific merit in terms each application. of its discipline and the clinical implications of its re- search protocol. This review is conducted according The review meetings also are attended by staff to the established NIH procedures. With the excep- members of ICs to which applications have been tion of a parent committee used to review Cancer assigned, liaison members for certain other Federal Centers, Summary Statements are prepared in the agencies, and appropriate NIH staff. The review of same general format that is used by the CSR. applications is conducted in closed sessions, which are attended only by review committee members Once a grant application receives an NCI program and appropriate Institute staff. assignment, an NCI Program Director follows its progress through the review process and, if an Review Meeting Recommendations award is made, through the post-award period. For the duration of that project period, the Program At present, the possible recommendations by the Director is the contact point, negotiator, advisor, review committee are: scoring, not discussed and advocate for the principal investigator. This (ND), not recommended for further consider- individual evaluates the relevance of the research, ation (NR), or deferral (DF). If an application has considers the appropriateness of the appraisal by significant and substantial scientific merit, it is the study section, and makes recommendations to given an impact score from 1 to 9 and, in the case the NCAB regarding any need for special action in a of CSR-reviewed applications, a percentile ranking particular case. is calculated for the application. In the streamlined review process implemented at the NIH (particu- The Review Session larly for single-project applications), the reviewers identify but do not discuss or score applications IRGs (CSR study sections and NCI review that are not in the upper half of the applications committees) and SEPs meet from 1 to 3 months being reviewed by that committee for that round. before each meeting of the National Cancer For reviews of applications received in response Advisory Board (NCAB). Before the meeting, the to an RFA, the reviewers may be asked to identify SRO studies all of the applications assigned to the applications that are not in the upper half of

34 NCI Orientation for the Board of Scientific Advisors the group of applications under review. Review- or interactions with members of the scientific ers’ critiques of ND applications are provided as community. The relevance, priority, and need feedback to grant applicants. An application may for the anticipated project are assessed by NCI be designated Not Recommended for Further program staff, and the concept is subjected to a Consideration (NR) if it lacks significant and sub- series of internal clearances, including review by stantial merit; presents serious ethical problems the SPL of the NCI. Federal regulations (the 1974 in the protection of human subjects from research Amendments to the National Cancer Act and risks; or presents serious ethical problems in the Section 75 of the Public Health Service Act) require use of vertebrate animals, biohazards, and/or se- presolicitation peer review of the project concept lect agents. Applications designated as NR or ND before an RFP may be issued. NCI policy requires do not proceed to the second level of peer review concept review of all intra- and interagency (National Advisory Council/Board). An action for agreements, and all renewals and recompetitions scoring is equivalent to a recommendation that a of existing contracts and extensions of $100,000 or grant be awarded, provided that sufficient funds more for a 6-month or longer period. This review are available. is performed by the SPL Committee and BSA (new concepts and recompetitions with a change in Summary Statements scope).

Immediately after the IRG meeting, the SRO pre- Once a concept is approved and recommended to pares individual reports summarizing the recom- the Division Director, the Project Officer, consult- mendation for each application, called Summary ing with the Contracting Specialist in the NCI Statements. Before the NCAB meets, applicants Office of Acquisitions (OA), prepares a statement routinely are provided with copies of their own of work and evaluation criteria. The documents Summary Statements by accessing the document are incorporated into a Request for Contract using the NIH Electronic Research Administration Project Plan, which is the basis for the official RFP. Commons. This document then is presented to the division’s senior scientific and management staff for review, Post NCAB Meetings and Funding comment, and approval. A copy of the plan also is Decisions forwarded to the DEA to help verify the evaluation criteria and establish a timetable for the procure- After each NCAB meeting, NCI staff members ment process. The final version of the project plan meet to discuss and review the NCAB’s is incorporated into the RFP by the Contracting Of- recommendations. The NCI Scientific Program ficer, in conjunction with the Project Officer. RFPs Leadership (SPL) determines and approves the must be published in the Commerce Business Daily funding plans for all RFAs and other special and/or the NIH Guide for Grants and Contracts. Oc- initiatives. Applicants who will be funded are casionally, an RFP may receive wider distribution subsequently notified at the time of the award through publication in scientific journals. Propos- negotiation. Ideally, approximately 8 to 9 months als are received by the OA and are checked to be will have elapsed since the principal investigator sure they fulfill the RFP requirements and conform submitted the application. to Federal regulations.

REVIEW OF CONTRACT R&D proposals that are submitted by the private sector in response to an RFP are evaluated for PROPOSALS technical merit by ad hoc TEP review groups in a manner similar to that used for the peer review The NCAB has no direct involvement with the Re- of grant applications. The purpose of the techni- search and Development (R&D) contract program cal merit review is to obtain expert advice on the of the NCI; R&D contract concepts are reviewed qualifications of the offeror’s staff, the merit of the by the BSA. scientific/technical approaches, the sufficiency of staff and institutional experience, and the availabil- The contract solicitation process begins when an ity of equipment and facilities. A DEA RTCRB staff NCI program staff member (usually the individual member serves as the SRO for each contract review who will become the Project Officer) develops a committee. The SROs schedule review sessions, concept for a contract project through personal send proposals to committee members in advance initiative, discussion with advisory groups, of the sessions, and supervise the preparation of the consultation with others in the program, and/ contract review summary reports—brief synopses

NCI Orientation for the Board of Scientific Advisors 35 of the review sessions that contain the numerical 10 months from receipt of proposals to issuance scores (as required) and reflect the deliberations of an award. Exhibit XI portrays the NCI contract and considerations of the reviewers. review process.

In arriving at their recommendations, the TEP Following award, the NCI Project Officer performs peer review committee reviews each proposal. project surveillance, assisted by the OA. The OA is The results of its deliberations are documented by responsible for debriefing competitors. the NCI SRO, who makes the committee findings available to the Contracting Officer. At least three NATIONAL CANCER reviewers are assigned to report in depth on each contract proposal during the review meeting. ADVISORY BOARD REVIEW Proposals are reviewed for technical merit and rated for conformance to the evaluation criteria NCAB Responsibilities published in the RFP. If competitive, they are scored independently by each committee member, The NCAB is responsible for the final review of all based on the weighted review criteria in the RFP. grant applications referred to the NCI. The Board The individual scores are totaled and averaged to recommends to the Director of the NCI approval produce a technical merit score for each proposal. of meritorious grant applications. The NCAB Concurrently but independently, the OA evaluates appraises all grant applications with reference to proposals for business considerations. the needs of the Institute and the priorities of the National Cancer Program. The NCAB also per- Project Officers are the NCI program staff -mem forms the second-level review of all FDA grants bers who are responsible for developing and su- and cooperative agreements. pervising the contract projects. They attend review meetings to provide factual information, but are NCAB Meetings not permitted to make judgmental or evaluative comments. Representatives of the OA must attend The Board meets at the call of the Director of the the review sessions to provide guidance on policy NCI or the Chairperson, not less than four times and regulations. Review is conducted in accor- a year. Summary Statements are reviewed three dance with Federal conflict-of-interest regulations. times per year at regularly scheduled meetings. The December NCAB meeting is reserved for the Following the review session, the SRO forwards NCI intramural laboratory and extramural pro- the minutes containing the scores, ranking, and gram review. A joint NCAB/BSA meeting is held individual rating sheets to the Contracting Officer annually during the scheduled June meeting date. of the OA, who then convenes a Source Evaluation Group (SEG). This group usually consists of the NCAB meetings are open to the public when Project Officer and other program staff members, Summary Statements are not being discussed. who advise the Contracting Officer on the estab- Scheduled NCAB meeting dates are published in lishment of a competitive range, based on techni- the Federal Register (https://www.federalregister. cal merit scores, cost, and other considerations. gov), as required by HHS regulations. Attendance Occasionally, site visits are determined to be at the closed grant review sessions is limited to necessary subsequent to completion of the techni- Board members, SROs, the NCI Director, appro- cal review. priate NCI staff, and designated representatives of the Secretary of HHS. A quorum for conducting The Contracting Officer informs each offeror in the business will consist of a majority of the currently competitive range of the proposal’s deficiencies, appointed members. ambiguities, or other considerations, as identified by the reviewers or members of the SEG. Offerors Approximately 6 to 8 weeks before the NCAB are given an opportunity to make minor adjust- meeting, Summary Statements within the competi- ments in their proposals, which then are reviewed tive range for applications to be reviewed at the by the contracting and program staff, who serve as upcoming meeting are made available to all NCAB a Source Selection Group (SSG). The final deci- members via the NIH Electronic Council Book sion regarding award of a contract rests with the (ECB). This is a restricted access website that allows Contracting Officer who arranges for negotiations NCAB members to view all of the Summary State- with the prospective contractor with advice from ments, as well as the grant applications assigned the SSG. The total contracting cycle requires 9 to to them for review based on their areas of scientific

36 NCI Orientation for the Board of Scientific Advisors Exhibit XI. NCI Contract Review Process

Board of Scientific Advisors reviews concept of project. Project plan prepared Performance by Project Officer and monitored by Contracting Officer; Project Officer. copy forwarded to DEA for planning purposes.

Request for proposal Responsibility of (RFP) prepared by Contracting Officer. program staff and Office of Acquisitions and issued for publication.

Contract negotiations Proposals received by Office of by Office of Acquisitions Acquisitions. Contracting Officer.

Source selection from acceptable offerors by Source Evaluation/ Technical review of Selection Groups proposals by DEA based on scientific contract peer review and financial commi�ees. considerations.

interest. (Note: NCAB members are not given access Director of the NCI and NCI staff, based primarily to Summary Statements from their own institutions.) on IRG percentile/impact score ratings of scientific By the time the NCAB meets, approximately 3,500 merit, the Institute’s program objectives, avoidance Summary Statements will have been made available of duplicate effort, and other considerations. The to the Board members. As described in its Charter, a funding mechanisms are reevaluated prior to each key role of the NCAB is to “...advise, assist, consult grant review cycle and adjusted to the current level with, and make recommendations to the Secretary, of funds available and future funding. and the Director, National Cancer Institute, ...relat- ing to support of grants and cooperative agreements, Administrative/Business Review following technical and scientific peer review...” This important function is accomplished in the closed Following the NCAB grant review session, the session of the NCAB meeting by a committee of the NCI conducts an administrative/business review whole known as the Special Actions Subcommittee. of all applications selected for funding. Appli- cations are reviewed for compliance with NIH AWARD OF GRANTS policies and for necessary or desirable adjustments in the amounts and terms of the recommended Selection for Funding awards.

Many more grants are approved by the NCAB Notice of Award than can be financed from the NCI budget. Early in The list of applications selected for payment is the fiscal year, the NCI formulates funding guide- signed electronically by the NCI Program Director lines for its programs based on expected alloca- and the Division Director. The signed documents tions of funds, program requirements, and prior are forwarded to the Extramural Financial Data history. Final funding decisions are made by the Branch of the NCI, and the Grants Management

NCI Orientation for the Board of Scientific Advisors 37 Specialist negotiates the award if significant ad- awarded, the period of the grant, future years of justments are required prior to award. The funds support, and any special conditions or restrictions then are obligated and recorded in the NIH official under which the grant is awarded. accounting records. Congress must be alerted at least 45 hours be- For each application selected for payment, a fore the issuance of each new and renewed grant Notice of Award (NoA) is issued by the Grants award, so that the appropriate member of Con- Management Officer. NoAs are sent solely via gress may notify his or her constituents. If the e-mail to grantee organizations and are accessible award exceeds $1 million, 72 hours’ advance in the eRA Commons. The NoA contains the name notice is required, so that the White House may be and address of the grantee institution and the title informed. This requirement is fulfilled by forward- of the project. The NoA also names the principal ing a copy of the award notice to the NIH Office investigator(s) under whose direction the work of Congressional Liaison at the same time the ap- is to be carried out, the direct and indirect cost proval list is signed.

38 NCI Orientation for the Board of Scientific Advisors NCI BOARD OF SCIENTIFIC ADVISORS (BSA) CHARTER SUMMARY

AUTHORITY 5-year terms. A member may serve after the expi- ration of that member’s term until a successor has 42 U.S. C. 285a-2(b)(7), section 413(b)(7) of the taken office. A quorum for the conduct of busi- Public Health Service Act, as amended. The Na- ness by the full Board will consist of a majority of tional Cancer Institute Board of Scientific Advisors currently appointed members. (Board) is governed by the provisions of the Feder- al Advisory Committee Act, as amended (5 U.S.C. OBJECTIVES AND SCOPE app), which sets forth standards for the formation and use of advisory committees. OF ACTIVITIES

The Board will provide advice to the Director and MEMBERSHIP AND Deputy Director, National Cancer Institute (NCI), DESIGNATION and the Director of each NCI Division on a wide variety of matters concerning scientific program The Board will consist of 35 members, including policy, and progress and future direction of extra- the Chair, appointed by the Director, NCI, from mural research programs. authorities knowledgeable in the fields of labora- tory, clinical and biometric research, clinical cancer DESCRIPTION OF DUTIES treatment, cancer etiology, and cancer prevention and control, with emphasis on training and experi- The Board makes recommendations on research ence in the various disciplines and fields related to priorities conducted or supported by the Insti- scientific areas relevant to carcinogenesis, cancer tute. This includes the evaluation of NCI awarded biology and diagnosis, cancer center administra- grants, cooperative agreements and contracts and tion, medicine, radiological and surgical oncol- concept review of those activities which it consid- ogy, cancer chemotherapy, cancer epidemiology, ers meritorious and consistent with the Institute’s cancer prevention and control, cancer education, programs. The advisory role of the Board is scien- cancer information services, community outreach, tific and does not include deliberation on matters biological, chemical and physical carcinogen- of public policy. esis, DNA repair and effects, tumor biology and immunology, humoral and cellular immunity, hematopoiesis, cell differentiation and transforma- ESTIMATED NUMBER AND tion, oncogenes and growth factors, molecular and FREQUENCY OF MEETINGS structural biology and genetic regulation, viral oncology, vaccine development, transplantation, Meetings of the full Board will be held approxi- chemotherapy, clinical trial design, management mately 3 times within a fiscal year. Meetings and evaluation, pharmacology, drug develop- will be open to the public except as determined ment and developmental therapeutics, genetic and otherwise by the Secretary of Health and Human immunotherapies, pathology, diagnostic research Services (Secretary) in accordance with subsection and cytogenetics, biological response modifiers, (c) of section 552b of Title 5 U.S. C. Notice of all imaging, nutrition, survey research, epidemiology, meetings will be given to the public. In the event biostatistics, rehabilitation, psychology and be- a portion of a meeting is closed to the public, as havioral medicine, public health and community determined by the Secretary, in accordance with oncology, quality of life, pain management, cancer the Government in the Sunshine Act (5 U.S. C. detection and diagnosis, cancer treatment and 552b(c)) and the Federal Advisory Committee Act, restorative care, dentistry, nursing, public health, a report will be prepared which will contain, as nutrition, education of health professionals, medi- a minimum, a list of members and their business cal oncology, surgery, radiotherapy, gynecologic addresses, the Board’s functions, dates and places oncology, pediatric oncology, pathology, and of meetings, and a summary of the Board’s activi- biostatistics. All non-Federal members serve as ties and recommendations made during the fiscal Special Government Employees. Members and year. A copy of the report will be provided to the the Chair will be invited to serve for overlapping Department Committee Management Officer.

NCI Orientation for the Board of Scientific Advisors 39 BSA Continuous Submission BSA SUBCOMMITTEES

As part of NIH's continuing commitment to recog- To expedite the BSA’s work, ad hoc subcommittees nize outstanding service in the NIH peer review may be established to provide additional advice process and on NIH Advisory Groups, the NIH and oversight on specific topics or initiatives. For has implemented policy and procedures to allow example, The Childhood Cancer Therapeutically appointed members of NIH review and Advisory Applicable Research to Generate Effective Treat- Groups (i.e., BSA, NCAB, and FNLAC), with ments (TARGET) ad hoc subcommittee provides di- recent substantial service (six times in 18 months), rection of management on an initiative to support to submit their research grant applications (R01, the identification and validation of new therapeu- R21, or R34) on a continuous basis and to have tic targets to improve the outcome for childhood those applications undergo initial peer review in a cancers. timely manner.

40 NCI Orientation for the Board of Scientific Advisors PRINCIPLES OF SELECTION OF AWARD MECHANISMS IN EXTRAMURAL PROGRAMS

DEFINITION OF NEED assist a particular research development, train- ing, or related program activity conducted by a Through processes such as program oversight, recipient under specific legislation authorizing portfolio analysis, strategic planning, scientific such assistance. Under assistance mechanisms, the workshops, and occasionally Congressional man- NIH identifies general or specific program areas dates, scientific opportunities and/or unmet needs for support, and the performers define and imple- are defined which can best be addressed through ment the specific aims, objectives, and approaches extramural awards. The choice of award mecha- for their awarded project activities. nism is dictated by an analysis of the purpose, scope and objective of the research, along with A. Grants are appropriate when NIH staff has no consideration of a number of temporal, regulatory substantial programmatic involvement with and fiscal parameters. the recipients during performance of the as- sistance activities.

GRANTS, CONTRACTS, AND B. Cooperative agreements are appropriate as- COOPERATIVE AGREEMENTS sistance instruments when NIH staff has sub- stantial programmatic involvement with the The decision making process in selection of an recipients during performance of the activities. award mechanism to achieve an extramural objec- tive requires definition of several fundamental II. Acquisition – Contracts needs and interests of the Government: Contracts (also Master Agreements and Broad Area Announcements) shall be used for all ac- Choices to be considered include: quisition, i.e., when the NIH intends primarily to 1. Assistance vs. acquisition and procurement. obtain goods, services, research studies, surveys, 2. Specific set aside of funds vs. general encour- systems, or property for the direct benefit or use agement of a field. Are market incentives of the NIH or other Government agencies; these needed? agencies may, in turn, provide the end products or 3. Active vs. passive participation of Govern- results to non-Government parties, including the ment staff. general public. When acquisition is indicated, the 4. Urgency and one time only vs. extended need NIH may define specific problems or objectives and competition. in a Request for Proposals (RFP), asking offerors 5. Pool of eligible applicants. to submit their creative or innovative approaches 6. Extent of existing capabilities in extramural to the contemplated activities. The NIH may community. specify both the nature of and desired approaches 7. Availability of models and resources and du- to performing the activities, with the RFP then ration of project. requesting offerors to describe their capabilities to 8. Locus of review. accomplish the stated requirements.

A. Master Agreements – are a form of acquisition POLICY where the Government prequalifies a group of offerors with the requisite expertise and re- The NIH awarding units apply the following sources to perform stated types of research ac- criteria for selecting contract, cooperative agree- tivities, and then may without further review ment, and grant instruments to establish appropri- select from the pre-qualified group awardees ate relationships between the NIH and performer to conduct the pre-approved activities. organizations for the conduct of extramural R & D activities: B. Broad Agency Announcements – In some circumstances, in order to realize the maxi- I. Assistance – Grant or Cooperative mum competition possible pursuant to the Agreement Competition in Contracting Act of 1984, and Assistance mechanisms are appropriate when the to fulfill requirements for scientific study and NIH intends primarily to stimulate, support, or experimentation directed toward advancing

NCI Orientation for the Board of Scientific Advisors 41 the state of the art, or increasing knowledge avoid undue interference with NIH operations. In and/or understanding, the NIH will issue the those situations, participating reviewers and at- Broad Agency Announcements. tendees shall be notified in advance, that, under 42 CFR 52h.5(b) (3), dealing with conflict of interest, OPEN AND CLOSED they, their close relatives and professional associ- ates, and their organizations, will be ineligible to MEETINGS receive awards resulting from subsequent RFPs, and that the Procurement Integrity Act require- • Concept review meetings are generally open ments will apply. to the public. Persons who attend or partici- pate in meetings will be eligible to receive References: contract awards resulting from subsequent RFPs, unless other factors contravene. NIH Manual Chapter 1820 – Selection of Extramural Award Instrument – Grant, Cooperative Agreement, or • What happens if Concept Review occurs in Contract (Release date 2/22/85) Closed Session or gets too specific? NIH Manual Chapter 54513 – Management and Sessions that review specific details of projects or Procedures of National Advisory Councils and Boards RFPs, will be closed to the public, under authority in Their Review of Extramural Activities (Release of 45 CFR 11.5(a) (6) (ii) (c), to protect the free ex- date 2/7/12) change of advisory group members’ opinions and

42 NCI Orientation for the Board of Scientific Advisors BOARD OF SCIENTIFIC ADVISORS CONCEPT REVIEW

INTRODUCTION projects that procure research and supporting ser- vices to fulfill program objectives and are justified The National Cancer Institute (NCI) supports both by a strong scientific rationale and NCI research investigator-initiated research and large, directed priority. interdisciplinary and multidisciplinary programs as a comprehensive strategy to unravel the compo- As scientific opportunities are identified, it is criti- nents and complexities of multiple risk factors for cally important that the development, scientific re- cancer, understand specific types of cancer based view, and approval of RFA and RFP concepts be co- on their molecular characteristics, and develop ra- ordinated with budgetary planning. Furthermore, tionally designed interventions to prevent, detect, to implement new initiatives, the resources for new diagnose, and treat cancer and to predict patient and/or expanded activities will have to come from response to therapy. The issuance of Funding discontinuing support for specific ongoing activi- Opportunity Announcements (FOA) as Requests ties that either have achieved their goals or are no for Applications (RFA) is an important method for longer high programmatic priorities. Therefore, rapidly expanding new research areas that have the NCI must have a very thorough and stringent been identified as high priority areas for the NCI process for reviewing and approving all initiatives. or to implement new initiatives identified in the The NCI process for the development, approval, and NCI Strategic Plan and Bypass Budget (http://obf. issuance of RFAs is described below. cancer.gov/financial/plan.htm). CONCEPT CLEARANCE A Request for Applications (RFA) is defined as a formal statement that invites grant or cooperative A concept is an early planning stage in the devel- agreement applications in a well-defined scientific opment of a research initiative such as a Request area to accomplish specific program objectives. The for Application (RFA) or a Request for Proposal RFA indicates the estimated amount of funds set (RFP). Concept clearance includes review and aside for the competition, and submitted applica- approval by the NCI Executive Committee and tions usually are reviewed by the Institute that Director followed by BSA review. Each IC must issued the RFA. The development and issuance of document the clearance of RFA concepts, i.e., RFAs is required for a number of research activities, purpose, scope, and objectives. This clearance such as cooperative agreements, etc. For example, must include advice from the public and may be scientific initiatives requiring the development of obtained through, for example, consultation with large infrastructures or multidisciplinary teams to national advisory councils and advisory boards, address complex research questions and translate Congressional mandate, or workshops convened basic discoveries into the clinic often need coor- specifically for advisory purposes. One of the dination and access to additional resources that primary responsibilities of the BSA is the review is best accomplished through cooperative agree- and evaluation of concepts for RFAs and RFPs. If ments. a concept is developed into an official initiative, it will be published in the NIH Guide for Grants and Contracts or Requests for Proposals (RFPs) are Contracts. used when the principal purpose of the transac- tion is the acquisition of property or services to New Concepts support NCI-directed research activities. Funds are set aside for these institute-initiated research As scientific opportunities are identified through activities. RFP concepts for research and develop- NCI workshops, meetings, etc., program officials ment (R & D) contracts must be reviewed and ap- discuss new concepts with their Division/Office/ proved by the NCI Scientific Program Leadership Center (DOC) for further consideration and (SPL) Committee before formal concept review priority ranking. Multidisciplinary initiatives by the extramural Board of Scientific Advisors may require collaborations across DOCs to ensure (BSA). The NCI maximizes opportunities to sup- appropriate scientific oversight and guidance. port investigator-initiated research. To that end, The following points are considered in the the NCI uses contracts and master agreements for development of new concepts.

NCI Orientation for the Board of Scientific Advisors 43 • The selection of the appropriate funding R&D support contract renewals or RFPs for extra- instrument (i.e., grant, cooperative agree- mural programs that do not have a major change ment, contract) should be carefully considered in work scope are not required to undergo BSA including whether substantial programmatic review. The SPL reviews contract renewals and involvement is needed to coordinate or facili- determines whether BSA review is needed. tate the research effort. • Program staff should consider whether a SPL & BSA Concept Approval Process Program Announcement on the new scientific opportunity is sufficient to provide additional A Concept Review calendar coordinates SPL support. evaluation, budget planning, and presentation to • Other sources of funding should be explored the BSA three times per year. The approval pro- as part of the RFA or RFP concept develop- cess consists of review and approval by: ment process including co-sponsorship by • NCI Division/Office/Center Director; other NIH Institutes and Centers (ICs), foun- • Clinical Trials Operations Committee (clinical dations, and private industry. trials only); • Scientific Program Leadership Committee; and For approval of co-sponsorship for RFAs initiated • Board of Scientific Advisors. by other ICs, the SPL and the NCI Director may approve commitments of $2 million or less total BSA RESPONSIBILITIES costs per year. SPL and BSA approval is required for all commitments above $2 million total costs in The Board shall advise the Director, NCI, and any given year. the Director of each NCI Division/Office/Center Reissued Concepts on a wide variety of matters concerning scientific program policy, and progress and future direc- tion of extramural research programs of each of The reissuance of an RFA, including multi- the Divisions. The BSA’s responsibilities include disciplinary teams and large infrastructures, is the evaluation of NCI awarded grants, cooperative dependent on a thorough evaluation of their agreements, and contracts and concept review of accomplishments and continued need based upon those activities which it considers meritorious and evaluation plans included in the original RFA consistent with the Institute’s programs. The ad- Concept. visory role of the Board is scientific and does not include deliberation on matters of public policy. • Program staff should conduct an evaluation to ensure that the evaluation criteria and mile- Concept Approval Process stones set forth in the original concept and •

RFA document have been met. The evaluation The NCI BSA is charged with approving all RFAs will be an integral component of the consider- prior to issuance. These presentations are sched- ation of the requested reissuance. uled by the BSA Executive Secretary three times each year (http://deainfo.nci.nih.gov/advisory/bsa/ • For a large-scale infrastructure grant or bsa.htm). After SPL approval, the final Request for cooperative agreement (e.g., Early Detection Concept Approval Form and Concept Justifica- Research Network, etc.), an independent panel tion (see Appendixes K and L) will be submitted consisting of NCI and NIH staff members, electronically for distribution to the BSA members. NIH staff members, and/or extramural inves- In addition, the BSA Executive Secretary provides tigators should conduct a formal evaluation. BSA members with the guidelines entitled “NCI The review panel should be asked to provide Criteria for Use of RFA/RFP Mechanism.” an assessment of both the accomplishment of the funded investigators and where appropri- New Concept: The BSA Executive Secretary, ate (e.g. cooperative agreements) of the NCI in consultation with the BSA Chair, will select staff associated with the initiative. If the DOC BSA members to serve as the primary reviewers Director chooses to support reissuance, the for each concept. The BSA Executive Secretary report should be made available to the SPL and will provide program staff with the names of subsequently to the BSA. A scientific presenta- the assigned reviewers. It is the responsibility of tion and overview of the accomplishments of program staff to contact assigned reviewers and the grant or cooperative agreement is normally respond to any questions prior to the BSA presen- scheduled at the BSA meeting prior to the RFA tation. reissuance review.

44 NCI Orientation for the Board of Scientific Advisors Reissuance: In addition to the Concept Approval 3. Current Portfolio Analysis: Briefly describe Form and Concept Justification, the NCI Division/ current NCI/NIH grant and cooperative agree- Office/Center Director must prepare a Justifica- ment/application portfolio (and other related tion Memo in support of the pending re-issuance. projects) for the research area, specifically ad- The Justification Memo is attached to the concept dressing: a) funded (active) grants, contracts, and documentation and sent to the BSA members. A cooperative agreements; b) pending (scored) but BSA subcommittee (selected by the BSA Execu- unfunded grants; c) applications not scored; and tive Secretary and the BSA Chair) will be assigned d) any related research funded by other NIH Insti- to serve as the primary reviewers and determine tutes and/or Centers (ICs). Include the current and whether a full presentation to the BSA is needed at one previous fiscal year in the analysis. a teleconference scheduled by the Executive Secre- tary. The Justification Memo is an important docu- 4. Justification for Use of RFA Mechanism: In- ment in assisting the BSA subcommittee in making dicate why an RFA, and not another mechanism these determinations. The BSA subcommittee may (e.g., Program Announcement, contract), is needed request more detailed information from the NCI to foster and support the research area. Issues to staff for educational purposes. Subcommittee be considered include: decision options include: concur with reissuance a. need to STIMULATE SUBMISSION of addi- with no BSA presentation required; concur with tional applications in a high priority research reissuance with full presentation to the BSA; or do area (discuss the quality of pending applica- not concur with reissuance with full BSA presen- tions and indicate why the stimulation of ad- tation. Reviewer comments will be provided to ditional submissions by an RFA will increase program staff and NCI Division/Office/Center the scientific quality of applications or will be Directors by the BSA Executive Secretary so they more relevant to meeting this scientific oppor- may contact the reviewers prior to the meeting tunity than spontaneously submitted applica- as well as include a response in the BSA concept tions); presentation. b. need for INCREASED FUNDING (set-aside funds or exceptions) to encourage submission • RFA Concept Review Criteria of applications; c. need for SPECIAL REVIEW CRITERIA for The following criteria are intended to help NCI peer review (indicate why special criteria are staff, the SPL, and the BSA to determine whether needed); proposed RFAs are well justified. Please address d. need for SPECIAL REVIEW GROUP to review these points in preparing your justification. complex area (indicate why no existing CSR study section is adequate to the task); and 1. Background: e. need to create a NEW ORGANIZATIONAL New concept: STRUCTURE that cannot be adequately sup- a. Describe the new scientific opportunity and ported by investigator-initiated mechanisms why it should be considered a high priority that don’t require a set aside. (Indicate why.) for the NCI. b. Indicate how it was identified for additional 5. Justification of Use of Cooperative Agreement support (i.e., Congressional legislation, staff (if applicable): For Cooperative Agreements, ad- and/or scientific working group, etc.). dress the need for STAFF INVOLVEMENT that Reissuance: cannot be met by use of specific terms of award of a. Describe the continuing scientific need and/ R01s. What is the expected specific value added of or research area that requires reissuance of the involvement of NCI staff in the project? Discuss RFA. why the contract mechanism or traditional inves- b. Describe the specific accomplishments of this tigator-initiated mechanisms are not appropriate activity that have contributed to progress in based on the level of staff involvement. the field. For reissuance, describe interactions of staff 2. Purpose of the RFA: In the context of the cur- members with awardees during previous funding rent state of scientific knowledge in this area, what period and address the need for continuing staff is the RFA intended to achieve? (Note that the involvement. For “limited competition” RFAs, potential impact should be not only scientifically provide justification for the restriction of eligibility significant, but wide-ranging and clearly more to previous awardees. than one might achieve without this initiative.)

NCI Orientation for the Board of Scientific Advisors 45 6. Budget: Give the rationale for the requested c. The review panel should provide comments, level of funding and the number of grants to be suggestions, and/or recommendations regard- supported. All budget estimates should include to- ing the continued support, phase out, or tran- tal costs (direct plus F&A) for each year of support. sition to other support or investigator-initiated grant mechanisms of the various components 7. Evaluation: supported by the initiative. New concept: a. Provide a description of the evaluation criteria • R&D Contract Concept Review Criteria and metrics (as appropriate) that will be used to evaluate the accomplishments of the RFA The following review criteria should be applied initiative. to Request for Proposal concepts. Appendix M b. Provide examples of anticipated goals or mile- provides a sample form and justification for RFP stones that would be used to evaluate prog- concepts. ress. Reissuance: 1. Background: a. Provide the evaluation criteria established a. Describe the NCI organization level that this and approved in the original RFA Concept. activity will support. Address whether the anticipated/expected b. What is the scientific rationale and research outcomes, goals, and/or milestones were met priority for this initiative? How was it iden- by the RFA. tified? What constituencies support it/will b. Describe the specific accomplishments of this benefit from it? activity that have contributed to progress in c. Identify current related activities, and indicate the field, including clinical advances and/or how this initiative will complement or aug- advances with potential for clinical translation. ment any ongoing activities. Cite publications, inventions, patents, and/or collaborations. 2. Preliminary Data/Progress to Date: c. Was the initiative successful in increasing re- For new concepts, indicate any preliminary data search funding to this area/field and/or foster- supporting the need for and feasibility of addi- ing increased research efforts in the targeted tional efforts in this area. For recompetitions: area and/or achieving scientific advances? a. Provide specific examples of significant contri- d. Could the investigators continue the research butions to the field that have resulted from the activities supported by the RFA through other existing contract or master agreement activity. investigator-initiated mechanisms? Should Provide evaluation of success in accomplish- other mechanisms be considered for future ing RFP tasks. Include citations of publica- support? tions, inventions and patents resulting from For reissuance supporting large infrastructures: this activity. a. An independent panel consisting of NCI staff b. Justify with appropriate metrics whether the members, NIH staff members, and/or extra- results were or will be obtained, and if an mural investigators should conduct an evalu- acquisition/contract remains the appropriate ation of large-scale infrastructure grants or mechanism for conducting such work. cooperative agreements (e.g., Early Detection Research Network, etc.). The evaluation panel 3. Objectives/Scope: members should not be involved directly or For all concepts, indicate the planned objectives receive support from awards resulting from and scope of the project, and the intended out- the previous RFA issuance, but they should comes. For recompetitions, also indicate how these have sufficient familiarity with the research objectives have changed, if at all, based on previ- area to be able to assess the success of the ous progress and other new information in the activity. field. Discuss these objectives in the context of the b. The review should address the criteria out- NCI mission and the current state of knowledge in lined in the original Concept including the the field. accomplishment of milestones. The review panel should be asked to provide an assess- 4. Methods: ment of both the accomplishments of the Discuss the adequacy of the methodology to be funded investigators and where appropriate used in carrying out the activity (Federal Register (e.g., cooperative agreements), of the NCI staff Notice 1/05/2004 52h.11). associated with the initiative.

46 NCI Orientation for the Board of Scientific Advisors 5. Budget: • Deferral for additional information or modi- Give rationale for the requested level of funding. fications. Concept may be presented again For recompetitions, provide funding history of the at a future BSA meeting. Option to establish RFP, including level of support over entire budget subcommittee to work with staff. period, including modifications to the contract. (e.g., funding actions, exercise of options, changes, Decision Options for Reissuance: supplements, etc.) and the amount of any remain- A BSA subcommittee reviews reissuances by tele- ing funding increments and/or capacity currently conference prior to the BSA meeting where a final in the contract to cover the remaining performance decision and vote occur. Subcommittee decision period and closeout activities. options include: concur with reissuance with no BSA presentation required; concur with reissuance 6. Contract/Master Agreement Justification: with full presentation to the BSA; or do not concur Indicate why a contract or master agreement is with reissuance with full BSA presentation. appropriate relative to other mechanisms such as grants and cooperative agreements to accomplish Decision options by BSA include: the stated goals. Is the nature of the work for the • Concurrence. direct benefit of the government? For master agree- • Non-concurrence. ment, justify the need for this type of mechanism • Deferral for additional information or modi- as opposed to contracts. (Give specific reasons.) fications. Concept may be presented again at a future BSA meeting. Option to establish BSA DISCUSSION AND subcommittee to work with staff. APPROVAL BSA ANNUAL RFA AND RFP RFA Concept: CONCEPT REPORT In addressing the above issues, consider the actual need for set-asides and special reviews. The follow- The annual report on RFA concepts will be provid- ing questions are presented to stimulate thought. ed to the BSA at the November meeting. The re- • If exception funding were to be made avail- port includes a summary of all approved concepts able, would a Program Announcement (PA) reported by the date the concept was presented to with multiple receipt/submission dates be the Board and by the Division in which the con- more effective? cept originated. Also included in the report are: • If review were conducted by a special review 1. RFA grant funding and overall NCI grant group (CSR or NCI), would a PA be effective funding (e.g., no set aside)? 2. BSA-approved RFA concept set-asides by • Is there a need for a one time submission date Division (e.g., to coordinate review and funding of a 3. RFA allocation by concept area group of applications)? 4. NCI grant and RFA funding by concept area • Would an ongoing announcement with as a percentage of total NCI grants multiple receipt/submission dates indicate a 5. Listing of funded grants continuing NCI interest and allow for better 6. Abstracts of select funded grants also available preparation of applications? in hardcopy and electronic online formats

RFP Concept: As an example, Exhibit XII illustrates the percent- • Is there a significant need for direction by NCI age of the BSA approved RFA set aside for each staff? NCI Division/Office from 2014 through 2017. • Is there a need for a new organizational struc- ture that cannot be adequately organized or The report has been generated annually since the supported by other mechanisms? initial BSA request in 1999, to provide background information relevant to the concept review role Decision Options for New Concept: played by the BSA. A hardcopy and electronic ver- • Approval. BSA may suggest a modification in sion of the BSA Concept Review Report is provided the set aside or change in the RFA mechanism. to the BSA. • Disapproval.

NCI Orientation for the Board of Scientific Advisors 47 Exhibit XII. BSA Approved RFA Concept Set-Asides by Division/Office/Center

FY2015 FY2016

* OD-CSSI, OD-SBIRDC OD-OHAM * DCB, DCP DCB, DCCPS, 7% 5% 13% DCP, DCTD 7% DCB 33% * OD-CSSI, OD-CCG OD-CSSI 29% 15%

DCCPS OD-CCT 5% 11% * DCCPS, DCP DCTD 33% * DCCPS, OD-CCG DCTD, DCP, 17% * DCP, DCTD, 9% * DCCPS, DCEG DCB, DCTD DCTD, DCP, 5% OD-CSSI, 7% OD-CGCHR OD-CGC HR 1% 3%

FY2017 FY2018

OHAM * DCB, * OD-CRCHD, * OD-CSSI, DCB 1.5% DCB DCCPS,DCP * DCTD, DCTD DCCPS, DCP, DCTD * DCB, DCP, DCTD OD-SBIRDC 3.4% 1.6% OD-CRCHD 0.9% 1.8% DCCPS, 4.2% OD-CGCHR 0.7% DCB * DCTD, DCB * DCB, OD-CSSI 03% 15.8% OD-CCT 0.9% 0.9% 4.7% * DCCPS, DCCPS DCB DCTD DCP 7.7% 3.8% 10.3% 3.0% * DCP, DCB 0.9% * DCP, DCTD OD-CGCHR 69.9% 1.5% DCP 66.3% Legend:

DCB Division of Cancer Biology DCCPS Division of Cancer Control and Population Sciences DCP Division of Cancer Prevention DCEG Division of Cancer Epidemiology and Genetics DCTD Division of Cancer Treatment and Diagnosis OD-CCG Of ce of the Director - Center for Cancer Genomics OD-CCT Of ce of the Director - Center for Cancer Training OD-CGCHR Of ce of the Director - Center for Global Cancer Health Research OD-CRCHD Of ce of the Director - Center to Reduce Cancer Heath Disparities OD-OHAM Of ce of the Director - Of ce of HIV and AIDS Malignancy OD-CSSI Of ce of the Director - Center for Strategic Scienti c Initiatives OD-SBIRDC Of ce of the Director - Small Business Innovation Research Development Center

* Indicates co-funding among NCI Divisions/Of ces/Centers.

48 NCI Orientation for the Board of Scientific Advisors FREQUENTLY ASKED QUESTIONS AND ANSWERS

INTRODUCTION The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary The NCI sponsors sessions at national scientific meetings analysis of existing data; small, self-contained research to encourage communication with NCI senior staff and projects; and development of research methodology. BSA members. The attendees ask questions concerning Although the NCI does not accept applications from the the grant process and comment on other application and NIH R03 Parent announcement, a list of active R03 FOAs funding issues. The questions and answers below are published by the NCI can be found on the R03 Web page based on the most frequently asked questions from the (http://grants.nih.gov/grants/funding/r03.htm). research community. The R21 mechanism is intended to encourage new, explor- atory and developmental research projects by providing GENERAL APPLICATION AND support for the early stages of their development. Although SUBMISSION the NCI does not accept applications from the NIH R21 Parent announcement, a list of active R21 FOAs published Where can I find general information on the NIH by the NCI can be found on the R01/R21 Web page (http:// grants process? grants.nih.gov/grants/funding/r21.htm).

Everything You Wanted to Know About the NCI Grants Pro- Does the NCI support international research? cess describes how a grant is awarded and administered (http://www.cancer.gov/grants-training/grants-process). Yes. The NCI Office of International Affairs (OIA) (http://oia. cancer.gov/) coordinates the Institute’s worldwide activities, The NIH Office of Extramural Research provides in- including coordination of cancer research initiatives under formation on Grant Application Basics and the Grants agreements between the United States and other countries; Process Overview (http://grants.nih.gov/grants/oer.htm). planning and implementation of international scientist exchange programs; and sponsorship of international NCI Extramural Funding Opportunities provides links to workshops. Go to International Funding Opportunities for funding initiatives, applications, grant policies, and re- additional information (http://oia.cancer.gov/Programs/ search resources (http://deainfo.nci.nih.gov/funding.htm). Pages/programs-funding.aspx).

Where do I find information on the electronic grant Foreign institutions and international organizations are application process? also eligible to apply for research project grants, with the exception of Kirschstein-NRSA institutional research train- Go to the NIH Office of Extramural Research Web page ing grants, program project grants, center grants, resource on the Electronic Application Process for information on grants, SBIR/STTR grants, or construction grants. Informa- how to find a Funding Opportunity Announcement (FOA) tion on the grants process specific to foreign applicants is (https://grants.nih.gov/funding/index.htm and http:// located on Foreign Grant Information. grants.nih.gov/grants/submitapplication.htm, respective- ly) and download an application. Information is also pro- Go to the Fogarty International Center for information on vided about the preparation and submission of electronic trans-NIH international programs and training opportuni- applications. ties (http://www.fic.nih.gov/programs/training_grants/ index.htm). Are there mechanisms to support pilot projects? How does an investigator state their interest in a dual Yes. The small grant program (R03) and the exploratory/ assignment or cofunding in their grant application? developmental program (R21) (http://grants.nih.gov/ grants/funding/r03.htm and http://grants.nih.gov/grants/ If your research proposal is relevant to more than one funding/r21.htm, respectively) both support pilot or institute, you may request a primary assignment and one feasibility studies that can be carried out in a short time or more secondary assignments in your cover letter. To (2 years or less) with limited resources. ensure your research is appropriate for assignment to the NCI, contact the appropriate NCI program director prior to submission.

NCI Orientation for the Board of Scientific Advisors 49 Dual assignment, or assignment to more than one institute, The Cancer Therapy Evaluation Program has led the effort helps boost your funding chances by providing a backup. If to provide tools for participation in clinical trials, includ- the primary institute doesn’t fund it, the secondary institute ing the Clinical Data Update System (CDUS) (http://ctep. might or express interest in cofunding. cancer.gov/protocolDevelopment/electronic_applications/ cdus.htm) and the Adverse Event Expedited Reporting Are there special paylines for new investigators System (AdEERS) (https://ctep.cancer.gov/protocol and early stage investigators? Development/electronic_applications/adverse_events.htm).

Yes. The NCI establishes a special payline for new investi- The Office of Biorepositories and Biospecimen Research gators and early stage investigators (ESIs) that is normally (http://biospecimens.cancer.gov/default.asp) has released 5 percentile points above the R01 payline. Examples of the NCI Best Practices for Biospecimen Resources special paylines for new investigators set by NIH insti- (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_ tutes are available on the NIH New Investigators Program Practices_060507.pdf), which provides guiding principles website (http://grants.nih.gov/grants/new_ investigators/ for the collection of biospecimens and related patient index.htm). Go to the NCI Funding Policy Web page for data. information on the current NCI funding policies (https:// deainfo.nci.nih.gov/grantspolicies/FinalFundLtr.htm). Does the NCI support biomedical engineering and what initiatives are available for interdisciplinary In addition, new investigators and ESIs are more likely to research involving biomedical engineering? be funded through “exception funding” as a new investi- gator. Contact the program director listed on your sum- Yes. The NCI Center for Strategic Scientific Initiatives mary statement for more information. (http://cssi.cancer.gov/) coordinates the NCI technology- What can the NCI do to support integrated and driven initiatives in the areas of nanotechnology, pro- cross-disciplinary research? teomics, and cancer genomics. The Physical Sciences in On- cology initiative partners scientists in various non-biology Electronic applications allow more than one Principal disciplines with cancer biology. The Innovative Molecular Investigator (PI) (on individual research awards (http:// Analysis Technologies Program (http://innovation.cancer. grants.nih.gov/grants/multi_pi/). This presents a new and gov/) supports initiatives on the development of novel important opportunity for investigators seeking support technologies suitable for the molecular analysis of cancer, for projects or activities that require a “team science” including biomedical engineering approaches. approach. Paper applications also may use multiple PIs when the funding opportunity announcement specifically For training, the Mentored Quantitative Research allows them. Career Development Award (K25) (http://www.cancer. gov/grants-training/training/funding/K25) supports The NCI supports program project grants and special- investigators, with quantitative scientific and engineering ized centers focused on specific research areas that fund backgrounds outside of biology or medicine, who have integrated and cross-disciplinary research. For examples, made a commitment to focus their research on behavioral see the Specialized Programs for Research Excellence and biomedical research (basic or clinical). (SPORE) (http://trp.cancer.gov/), Integrative Cancer Biol- ogy Program (http://icbp.nci.nih.gov/), and the Centers of TRAINING Excellence in Cancer Communication Research (https:// cancercontrol.cancer.gov/brp/archive/ceccr/overview.html). Where can I find more information about The NIH Common Fund (http://commonfund.nih.gov/) fellowships and training and career awards? provides the opportunity for major initiatives to address gaps in biomedical research that no single institute at the Go to the NCI Training Career Development and Educa- NIH could tackle alone. Many of the new initiatives sup- tion page (http://www.cancer.gov/researchandfunding/ port integrated and crossdisciplinary research. training) or the Diversity Training Branch (DTB), Center to Reduce Cancer Health Disparities (CRCHD) (http:// Is the NCI working on bioinformatics and methods crchd.cancer.gov/diversity/diversity-index.html) for infor- to share data including data standards? mation on training and career development initiatives. To identify the appropriate Program Contact for your Yes. The NCI Center for Bioinformatics and Information area of interest, see the Cancer Training Branch’s Program Technology (CBIIT) (http://cbiit.nci.nih.gov/) leads the Contact List, the DTB, CRCHD Program Contact List, or effort to provide tools and resources that enable informa- contact the program director identified in the Program tion to be shared along the continuum from the scientific Announcement. bench to the clinic.

50 NCI Orientation for the Board of Scientific Advisors What does the NCI support for students The Mentored Clinical Scientist Development Award and investigators from diverse groups, from (http://www.cancer.gov/researchandfunding/training/ disadvantaged backgrounds, or with disabilities? K08) and Mentored Clinical Scientist Award to Promote Diversity (http://crchd.cancer.gov/diversity/cure-over Information on training and career development for view.html) use the NIH K08 grant mechanism to support individuals from racially and ethnically diverse and individuals with a clinical doctoral degree for an inten- medically underserved populations, including eligibil- sive, supervised research career development experience ity, is available on the CRCHD Training website (https:// in the fields of basic science, biomedical, behavioral, and/ www.cancer.gov/about-nci/organization/crchd/diversity- or translational research. training). The Pathway to Independence Award (K99/R00) (https:// Administrative supplements to existing grants can be researchtraining.nih.gov/programs/career-development/ provided to investigators who are seeking to support the K99-R00) assists postdoctoral investigators pursuing a training of individuals from underrepresented diverse research career in the biomedical sciences in transitioning groups, from disadvantaged backgrounds, or with dis- from a mentored postdoctoral position to a stable inde- abilities. For more information, see Research Supplements pendent research position. to Promote Diversity in Health Care Research (https:// grants.nih.gov/grants/guide/pa-files/pa-18-586.html). The NCI Transition Career Development Award (http:// www.cancer.gov/researchandfunding/training/K22) What opportunities are available for predoctoral and the NCI Transition Career Development Award to fellows to pursue in basic, translational, and Promote Diversity (https://www.cancer.gov/about-nci/ clinical careers? organization/crchd/funding-training-opportunities) use the K22 grant mechanism to support protected time for The NCI Ruth L. Kirschstein National Research Service clinicians, or equivalent, who are pursuing careers in Award (NRSA) for Individual Predoctoral Fellows (F31) basic science or in patient oriented research. (http://www.cancer.gov/grants-training/training/funding/ f31) award is to support promising doctoral candidates What NCI support mechanisms exist for young who will be performing dissertation research and training investigators in the area of cancer prevention, in scientific health-related fields relevant to the mission of control, behavioral, and population sciences the NCI during the tenure of the award. research?

The NCI Ruth L. Kirschstein National Research Service The NCI Cancer Prevention, Control, Behavioral and Awards (NRSA) for Individual Predoctoral MD/PhD Population Sciences Career Development Award (http:// Fellows and Other Dual Doctoral Degree Fellows www.cancer.gov/researchandfunding/training/K07) uses (F30) (http://www.cancer.gov/researchandfunding/ the developmental component of the K07 grant mecha- cancertraining/outsidenci/f30) award is to support nisms to support career development of postdoctoral promising predoctoral applicants who have the potential candidates or mentored junior faculty who are pursuing to become productive, independent, highly trained careers in cancer prevention, control, behavioral, and physician-scientists and other clinician-scientists, population sciences. including patient-oriented researchers in their scientific mission areas. Applicants are encouraged to submit The NCI Mentored Career Development Award to applications during the first 3 years of dual-degree Promote Diversity (K01) and the NCI Transition Career training to ensure that at least 1 year of graduate research Development Award to Promote Diversity (K22) (https:// training will remain at the time of award. www.cancer.gov/about-nci/organization/crchd/funding- training-opportunities) support the career development What opportunities are available for oncology of individuals from racially and ethnically diverse and fellows to pursue in basic or translational careers? medically underserved populations in the fields of cancer biology, etiology, pathogenesis, prevention, diagnosis, The Ruth L. Kirschstein Individual National Research and/or treatment. Service Award (NRSA) (http://www.cancer.gov/grants- training/training/funding/f32) uses the F32 grant mecha- The NCI Transition Career Development Award (http:// nism to support individuals with a doctoral degree (e.g., www.cancer.gov/researchandfunding/training/K22) and M.D., Ph.D., Dr.P.H.) for a 3-year period of supervised the NCI Transition Career Development Award to Pro- research experience to achieve independence. The Ruth L. mote Diversity (https://www.cancer.gov/about-nci/ Kirschstein National Research Service Award Institutional organization/crchd/funding-training-opportunities) use Training Grant for T32 programs is also available (http:// the K22 grant mechanism to support protected time for www.cancer.gov/researchandfunding/training/T32). newly independent investigators (e.g., Ph.D.s, Dr.P.H.s,

NCI Orientation for the Board of Scientific Advisors 51 M.D.s) to develop and receive support for their initial obtained is known. Finally, patient-oriented research is cancer-research programs in the prevention, control, be- research conducted with human subjects (or on material havioral, and population sciences. of human origin) for which an investigator (or colleague) interacts directly with human subjects. The NIH Established Investigator Award in Cancer Prevention, Control, Behavioral, and Population Sciences The NIH Mentored Patient-Oriented Research Career Research (http://www.cancer.gov/researchandfunding/ Development Award (http://www.cancer.gov/research training/K05) uses the K05 grant mechanism to provide andfunding/training/K23) and the NCI Mentored Pa- protected time to established investigators so that they tient-Oriented Research Career Development Award to can devote their time to conduct research and to mentor Promote Diversity (https://www.cancer.gov/about-nci/ junior investigators. organization/crchd/funding-training-opportunities) use the K23 grant mechanism to support the career develop- For specific funding initiatives, go to Division of Cancer ment of clinically trained professionals who have made a Prevention Funding and Grants (https://prevention. commitment to focus on patient-oriented research. cancer.gov/funding-and-grants) or Division of Cancer Control and Population Sciences Funding Opportunities The NIH Mentored Clinical Scientist Development Award (http://dccps.nci.nih.gov/funding.html). (http://www.cancer.gov/researchandfunding/training/ K08) and NCI Mentored Clinical Scientist Award to What type of support is available to transition Promote Diversity (https://www.cancer.gov/about-nci/ from postdoctoral positions to independent organization/crchd/funding-training-opportunities) use investigators? the NIH K08 grant mechanism to support individuals with clinical doctoral degrees who have made a The NCI Transition Career Development Award (http:// commitment to focus on laboratory-based basic science, www.cancer.gov/researchandfunding/training/K22) biomedical, behavioral, and/or translational research. and the NCI Transition Career Development Award to Promote Diversity (https://www.cancer.gov/about-nci/ The NCI Mentored Career Development Award to Pro- organization/crchd/funding-training-opportunities) use mote Diversity (https://www.cancer.gov/about-nci/ the K22 grant mechanism to support “protected time” organization/crchd/funding-training-opportunities) uses for newly independent investigators to develop and the NIH K01 grant mechanism to support the career receive support for their initial cancer-research programs. development of individuals with a doctoral degree in the This award is intended to facilitate the transition of fields of cancer biology, etiology, pathogenesis, preven- investigators from the mentored to the independent stage tion, diagnosis, and/or treatment. Applicants for this of their careers. It applies to clinicians (e.g., M.D.s and award are limited to individuals from racial and ethnic Doctoral level Oncology Nurses) who are pursuing basic minority groups; or with disabilities; or from disadvan- science careers; clinicians who are pursuing careers in taged backgrounds. patient-oriented research; and individuals (e.g., Ph.D.s, Dr.P.H.s, M.D.s) pursuing careers in the prevention, The NCI Transition Career Development Award (http:// control, and population sciences. www.cancer.gov/researchandfunding/training/K22) and the NCI Transition Career Development Award to Pro- The Pathway to Independence Award (K99/R00) (https:// mote Diversity (https://www.cancer.gov/about-nci/ researchtraining.nih.gov/programs/career-development/ organization/crchd/funding-training-opportunities) use K99-R00) provides up to 5 years of support, divided into the NIH K22 grant mechanism to support protected time two phases. Phase I provides 1 to 2 years of mentored for newly independent physician scientists who are pur- support under a K99 mechanism. Phase II provides up suing basic science or patient oriented research careers to to 3 years of independent research support under an R00 develop their first independent research program. mechanism. The NIH Mid-career Award in Patient-Oriented Research What NCI Career Development Awards exist for (https://researchtraining.nih.gov/programs/career- physician scientists interested in patient oriented development/K24) uses the NIH K24 grant mechanism to or clinical research? provide mid-career clinical investigators with protected time (1) for patient-oriented research and (2) to act as For the purpose of this question, the term “physician sci- mentors for junior clinical investigators. entists” includes clinicians pursuing careers in laboratory- based basic science as well as patient-oriented research. The NCI Paul Calabresi Career Development Award For Additionally, the term “clinical research” is research in Clinical Oncology (https://www.cancer.gov/grants- which the identity of the patients or the identity of the training/training/funding/K12) uses the K12 grant mecha- patients from whom cells or tissues under study are nism to support a research career development experience

52 NCI Orientation for the Board of Scientific Advisors for medical doctors and basic science researchers in the the policies and procedures for participants in clinical design, development, and implementation of hypothesis- trials of investigational agents sponsored by the NCI. based therapeutic cancer clinical trials. The Clinical Trials Support Unit (CTSU) (https://www. ctsu.org/) allows physicians who are not affiliated with a Does the NCI provide support for cancer cooperative group to enroll patients on NCI-sponsored education? clinical trials.

Yes. The NCI Cancer Research Education Grants Program The NCI Experimental Therapeutics (NExT) (https://next. (CREGP) (R25) provides support for educational activi- cancer.gov/) Program supports drug discovery and devel- ties, including the development and implementation of opment projects from preclinical development of an agent educational activities that complement and/or enhance the with a specific target through proof of concept clinical training of predoctoral or postdoctoral candidates to meet trials. Submission deadlines occur three times per year. the nation’s biomedical, behavioral, and clinical research needs. Applications should propose innovative, state- Contact the Division of Cancer Prevention (https:// of-the-art educational programs that address the cause, prevention.cancer.gov/clinical-trials) for information on diagnosis, prevention, or treatment of cancer; rehabilita- prevention clinical trials. Contact the Division of Cancer tion from cancer; or the continuing care of cancer patients Control and Population Sciences (http://dccps.nci.nih. and the families of cancer patients. (https://www.cancer. gov/) for information on behavior, clinical epidemiology gov/grants-training/training/funding/R25E) and genetics, survivorship, and outcomes research.

Are all training mechanisms restricted to U.S. Visit the NCI Clinical Trials (http://www.cancer.gov/ citizens or visa holders? clinicaltrials) website for information on NCI-sponsored clinical trials, clinical trial results, and education materials. Yes, with one exception: the Pathway to Independence Award (K99/R00) (https://researchtraining.nih.gov/ How can primary care physicians become involved programs/career-development/K99-R00). Otherwise, in primary and secondary prevention studies? you must be a U.S. citizen, a noncitizen national, or a permanent resident with a valid Alien Registration The NCI community Oncology Research Program Receipt Card (a “green card”) (http://grants.nih.gov/ (NCORP) (https://ncorp.cancer.gov), is a national network grants/glossary.htm) at the time of award. linking academic institutions with community primary care practitioners to facilitate the design and conduct of CLINICAL RESEARCH clinical trials to improve cancer prevention, http:// cancercontrol.cancer.gov/, cancer control, screening for Is there a source for information on the preparation early cancers, and post-treatment surveillance; and the of clinical research grant applications? delivery of cancer care and performance of comparative effectiveness research. NCORPs community-based ap- The Center for Scientific Review (CSR) has developed a proach builds on the scope and activities of NCI's website for Advice to Investigators Submitting Clinical previously supported community networks: the NCI Research Applications (https://grants.nih.gov/policy/ Community Clinical Oncology Program (CCOP) clinical-trials.htm). The website also contains links to (Community Clinical Oncology Programs, Minority- policies and institute contacts. Based Clinical Oncology Programs, Research Bases), administered by the NCI Division of Cancer Prevention See Conducting Clinical Trials (http://www.nci.nih.gov/ (http://prevention.cancer.gov/); and the NCI Community clinicaltrials/conducting/) for links to NCI clinical trials Cancer Centers Program (NCCCP), administered by the resources. NCI Division of Cancer Control and Population Sciences (http://cancercontrol.cancer.gov/). What resources and programs are available to assist clinicians in carrying out drug development Should the NCI support the development of and clinical research? clinical trial management tools that would allow researchers to access and use data to consider The Cancer Therapy Evaluation Program (CTEP) (http:// individual treatment, new trial designs, etc.? ctep.cancer.gov/) provides access to a wide variety of resources, including Clinical Investigator forms and The Coordinating Center for Clinical Trials (https://www. electronic applications for the standardization of trial cancer.gov/about-nci/organization/ccct) is leading the effort data collection and reporting, including common toxicity to establish a comprehensive database containing infor- criteria and common data elements. The Investigator’s mation on all NCI-funded clinical trials and translational Handbook (http://ctep.cancer.gov/investigatorResources/ research programs to facilitate better planning and manage- investigators_handbook.htm) provides information on ment across clinical trial venues.

NCI Orientation for the Board of Scientific Advisors 53 Since physicians are not aware of many clinical How do patient advocates participate in NCI’s trials, are there marketing tools to assist physicians research activities and programs? and patients? The NCI has established the Office of Advocacy Relations The NCI Clinical Trials website (http://www.cancer.gov/ (OAR) to integrate the perspective of people affected by clinicaltrials/) provides information on clinical trials, trial cancer into a wide range of NCI’s programs and activities, results, and education materials. The PDQ (Physician including peer review of clinical research. See the OAR Data Query) (http://www.cancer.gov/publications/pdq) Web page (https://www.cancer.gov/about-nci/ is NCI’s comprehensive cancer database on active clinical organization/oar) for more information. trials and includes peer-reviewed summaries. Clinical tri- als information on all NIH-sponsored clinical trials can be Is there a nomination process for the Clinical Trials accessed through the website (http://clinicaltrials.gov/). and Translational Research Advisory Committee (CTAC) membership? How is this committee The Cancer Information Service (CIS) educates the being constituted? public about cancer. Fact Sheets are available at the CIS website (http://www.cancer.gov/cancertopics/factsheet/ There is not a nomination process. The CTAC includes Information/CIS) and cancer information specialists current members from the major NCI boards/committees will answer questions at 1-800-4-CANCER. See the NCI and representatives from the appropriate clinical and Publications Locator (https://pubs.cancer.gov/ncipl/home. scientific areas. See the CTAC website for meeting sched- aspx?js=1) to view and order NCI publications. ule, minutes, and membership (http://deainfo.nci.nih.gov/ advisory/ctac/ctac.htm). The Clinical Trial Education Series (CTES) (https://pubs. cancer.gov/ncipl/detail.aspx?prodid=P921) is a group of 13 PEER REVIEW different educational materials (booklets, slides, videos) to target education and outreach for health professionals and Where can you find basic information about peer patients. review? Are NCI-supported human specimen banks See Grant Application Basics (http://grants.nih.gov/ available to investigators? grants/grant_basics.htm) and the Peer Review Process (http://grants.nih.gov/grants/peer_review_process.htm) Yes. The Specimen Resource Locator (https://specimens. for information. cancer.gov/) is a database to help researchers locate hu- man specimens (tissue, serum, DNA/RNA, other speci- The Center for Scientific Review also provides an mens) for cancer research. It includes tissue banks and overview on the Peer Review Process (http://public. tissue procurement systems with access to normal, benign csr.nih.gov/Pages/default.aspx) including a video of a precancerous, and cancerous human tissue from a variety study section meeting. Guidelines for Reviewers (https:// of organs. public.csr.nih.gov/ForReviewers) provides important information on the review criteria for grant applications In addition, the Office of Biorepositories and Biospecimen including guidelines for human subjects research and Research (OBBR) (http://biospecimens.cancer.gov/ specific grant mechanisms. default.asp) was established in 2005 to guide, coordinate, and develop the NCI’s biospecimen resources and How do you determine the best study section for capabilities. OBBR activities include establishment of the your application? Biospecimen Research Network (https://biospecimens. cancer.gov/about/researchnetwork/default.asp) and the On the NIH Center for Scientific Review (CSR) (http:// Biospecimen Research Database (https://brd.nci.nih.gov/ public.csr.nih.gov/StudySections/Pages/default.aspx) BRN/brnHome.seam), development of NCI Best Practices website, go to CSR Study Section Roster Index (http:// for Biospecimen Resources (http://biospecimens.cancer. www.csr.nih.gov/Committees/rosterindex.asp) to find gov/global/pdfs/NCI_Best_Practices_060507.pdf), and descriptions of the research areas for each study section sponsoring a series of Biospeciman Best Practices Forums and the study section membership. This information (http://biospecimens.cancer.gov/practices/forum/). can help you determine the appropriate study section. In many cases, there may be more than one study Contact staff in the Office of Biorepositories and Biospeci- section suitable for your grant application. It is highly men Research or Cancer Diagnosis Program for more recommended that you contact your NCI program information. director (https://www.cancer.gov/grants-training/grants- funding/contacts) or the study section Scientific Review

54 NCI Orientation for the Board of Scientific Advisors Officer (SRO), who can assist you in determining the best ing a continuous R01 applications submission process for study section. To request a specific study section and members of standing study sections (NOT-OD-17-042) institute assignment, include the information in your (http://grants.nih.gov/grants/guide/notice-files/NOT- cover letter. OD-17-042.html) and reviewers with recent substantial service (NOT-OD-17-042) (http://grants.nih.gov/grants/ Is there a way to shorten the review process so that guide/notice-files/NOT-OD-17-042.html). See Enhanc- investigators can receive the review outcome and ing Peer Review (http://enhancing-peer-review.nih.gov/ resubmit more rapidly? engage_the_bestreviewers.html) for more information on recommendations for recruiting the best reviewers. Beginning with the September/October 2007 study sec- tion meetings, new investigators now have the option of How can participation in peer review be increased? submitting a resubmission/amended R01 application for consecutive review cycles, saving 4 months. The summa- To address this problem and others, the NIH Director ry statements for qualifying applications will have an ex- called upon leaders from across the scientific commu- plicit note indicating eligibility for next cycle submission. nity and the NIH to join a trans-NIH effort to examine See NOT-OD-07-083 (http://grants1.nih.gov/grants/guide/ the two-level NIH peer review system with the goal notice-files/NOT-OD-07-083.html) for more information. of optimizing its efficiency and effectiveness. Informa- tion on their recommendations is available on the NIH How does the NIH ensure that peer review panels website, Enhancing Peer Review (http://enhancing-peer- have the appropriate expertise and experience review.nih.gov/). New policies include the expanded use and how can I ensure that my application gets an of teleconferences and virtual reviews. Standing study appropriate review? section members are now offered the option of serving a 4-year (three meetings a year) or 6-year (two meetings a Peer review is conducted by panels of reviewers with year) term. More flexibility is available through the use of broad expertise. These panels may include some ad hoc virtual reviews for some applications. review members with expertise in relevant areas of sci- ence. However, it is impossible to have experts in each In addition, the NIH has implemented an alternate plan grant application’s specific research area on study sec- for submission and review of research grant applications tions that review up to 120 applications. If you feel the from appointed members of chartered CSR study sections assigned study section does not have the appropriate and reviewers with recent substantial service to recognize expertise, contact the Scientific Review Officer (SRO) to their outstanding service and to minimize disincentives to discuss the general areas of expertise needed. You may study section service. See NOT-OD-17-042 (http://grants. also include this information in a cover letter with sub- nih.gov/grants/guide/notice-files/NOT-OD-17-042.html) mission of your application. for more information.

One of the Enhancing Peer Review at NIH recommenda- Summary statements do not clearly reflect the peer tions that have been instituted is the clustering of new review discussion, and review of resubmissions investigator and clinical applications in study sections. often focuses on new concerns rather than the previous critique. What is being done to recruit senior and experienced peer reviewers? In summary statements that are scored, a summary of discussion is included prior to the individual reviewer Scientific Review Officers strive to recruit senior and critiques to reflect the peer review discussion at the study experienced peer reviewers whenever possible. The section meeting. For resubmitted (amended) applications, majority of reviewers serving on CSR study sections are new reviewers in addition to previous reviewers are usu- successful peer reviewed investigators at the Associate ally assigned. They are instructed to review whether pre- Professor level or above. A description of “How Scientists vious concerns have been addressed as well as comment are Selected for Study Section Service” is provided on on any new concerns. Contact your program director to the CSR website. Training committees or ad hoc commit- discuss how to best respond to your summary statement. tees organized to review specific initiatives, such as RFAs (http://deainfo.nci.nih.gov/faqs-glossary.htm), may have There is concern that innovation in research is not junior investigators if the scientific area is a narrow re- adequately emphasized in peer review. search field and many of the senior experts have applied. The NIH Common Fund (formerly Roadmap) has created The NIH is striving to recruit experienced reviewers and new high risk research programs to encourage innovation, improve reviewer retention by providing reviewers more such as the NIH Director’s Pioneer Award (https://common flexibility regarding their tour of duty, and by institut- fund.nih.gov/pioneer), NIH Director’s New Innovator

NCI Orientation for the Board of Scientific Advisors 55 Award (https://commonfund.nih.gov/newinnovator), and How are funding decisions made? the Transformative Research Award Program (https:// commonfund.nih.gov/TRA). The NCI no longer publishes RPG paylines. Individual consideration of a broad range of competing applications In addition, many of the recommendations of the NIH will be the hallmark of NCI’s selection process. Peer re- report on “Enhancing Peer Review at NIH” encourage view evaluation of scientific merit will remain the primary reviewers to emphasize innovation rather than methodol- consideration in these funding decisions, which will be ogy in their reviews. See the NIH website, Enhancing Peer made by NCI Scientific Program Leaders (SPL) following Review (http://enhancing-peer-review.nih.gov/), for more discussions with Program Staff. The NCI SPL will give information and a timeline for implementation. special consideration to applications that fill a significant gap in the cancer research portfolio or propose an especial- How does the appeals process actually function? ly novel or promising scientific approach. Although there are no guaranteed paylines, the SPL does identify a per- The NIH has a formal process to resolve disagreements centile cutoff for R01s and R21s, then discusses additional between applicants and NIH review committees and/or applications for funding above the percentile. The NCI NIH staff concerning the referral (assignment) and review has a strong commitment to new investigators, including of applications. Note that disagreements are not neces- early stage investigators, and establishes a higher percen- sarily grounds for appeal. The NIH appeals policy and tile cutoff for these R01 applications. More information is process (http://grants.nih.gov/grants/guide/notice-files/ available at NCI Funding Policy (https://deainfo.nci.nih. NOT-OD-11-064.html) is described in the NIH Guide for gov/grantspolicies/FinalFundLtr.htm). Funding decisions Grants and Contracts. for Request for Applications (RFA) are determined by the set aside of funds available and the quality of the grant Before beginning the appeals process, the applicant is applications. strongly advised to speak with the NCI program director responsible for the application. The program director can How are funding decisions made for applications explain the options and their consequences and is often submitted in response to program announcements? in a position to help the applicant understand the study section’s recommendation. Appeal letters should be sub- The payline for R01 applications in response to PAs is mitted to the NCI program director. The NCI will make no different than if they are submitted in response to the the appeal letter together with the staff recommendation parent announcement. However, if the application is close available to the National Cancer Advisory Board (http:// to the payline, it may be eligible for funding by exception. deainfo.nci.nih.gov/advisory/ncab/ncab.htm) for the sec- Contact the program director listed on your summary ond level of review. statement for more information on “exception funding.”

Can administrative cuts be appealed? Is there a Where is information available on the funding process for restoration of administrative cuts? level in specific disease or research areas?

Administrative cuts cannot be appealed. If you find that The NCI reports how appropriated funds are spent in a you are unable to perform the research included in your number of different categories or classifications including grant application due to substantial administrative cuts, specific cancer sites, cancer types, and diseases related to contact your program director. The work scope of your cancer, as well as types of research mechanisms. See the research grant may be renegotiated or an administrative NCI Fact Book (http://obf.cancer.gov/financial/factbook. supplement may be considered in unusual circumstances. htm) for information on funding of disease categories as well as funding and success rates for grant mechanisms. BUDGET The NCI’s Funded Research Portfolio (https://funded What is the NCI Bypass Budget? research.cancer.gov/nciportfolio/) provides access to various NCI budget reports associated with research funding by research categories. It also provides the ability Each year, as mandated by the National Cancer Act of to search the database in various ways including a text 1971 (P.L. 92-218), the NCI prepares the NCI Bypass Bud- search of the project abstract and a search of the NIH get (http://obf.cancer.gov/financial/plan.htm), which de- research categories that are assigned to the projects by scribes continuing and new activities that take advantage extramural and intramural groups (http://fundedresearch. of new discoveries and opportunities and maximize the cancer.gov). use of NCI resources. This annual plan and budget pro- posal are provided directly to the President of the United The International Cancer Research Portfolio (https:// States for formulating the budget request to Congress. www.icrpartnership.org/) represents a searchable

56 NCI Orientation for the Board of Scientific Advisors database of information on cancer research awards of OTHER TOPICS the cancer funding organizations that comprise the International Cancer Research (ICR) Partners (https:// What products and services from the intramural www.icrpartnership.org/). program and NCI-Frederick are accessible to extramural investigators? The NIH report, Estimates of Funding for Various Dis- eases, Conditions and Research Areas (https://report.nih. Many NCI resources are available to extramural investi- gov/categorical_spending.aspx), includes funding levels gators including screening and production of compounds, for grants and contracts across the NIH by fiscal year. animal resources, genomic resources, and scientific computing resources. See NCI Research Resources (http:// Where can I find information on paylines and resresources.nci.nih.gov/) for more information. funding policies for the NCI? What is the NIH Common Fund? How are these Information on the current payline for R01 applications initiatives being coordinated and reviewed? and funding policies for competing and non-competing applications is available on the NCI Funding Policy The NIH Common Fund is an effort to transform the (https://deainfo.nci.nih.gov/grantspolicies/FinalFundLtr. Nation’s medical research capabilities and speed the htm) Web page. Information on NIH grant policies and movement of research discoveries from the bench to other policy resources is available on the Grants Policy the bedside. The Common Fund supports the series of and Guidance (http://grants.nih.gov/grants/policy/policy. transformative programs that were established under htm) Web page. the NIH Roadmap for Medical Research, as well as other non-Roadmap activities. Programs include the Where is information available on success rates, NIH Director’s Pioneer awards, New Innovator awards, including new investigator success rates? and Transformative Research Award Program. For complete information, visit the Common Fund (https:// See the NCI Fact Book (http://obf.cancer.gov/financial/ commonfund.nih.gov/) site. factbook.htm) for information on funding of disease categories as well as funding and success rates for grant The Division of Program Coordination, Planning, and mechanisms. The Research Portfolio Online Reporting Strategic Initiatives (DPCPSI) (https://dpcpsi.nih.gov/) is Tools (RePORT) website provides information on NIH responsible for managing the process by which trans-NIH success rates (http://report.nih.gov/index.aspx) by insti- initiatives are prioritized for consideration and evaluation tute, grant mechanism, medical school, application type, by both outside advisors and NIH leadership. and other categories. Who is the point of contact for nominations for RePORT also provides information on new investigator Boards or review committees? success rates and training and career development suc- cess rates (https://report.nih.gov/). Contact the Director, Division of Extramural Activities, NCI, if you are interested in volunteering for NCI peer review committees or Boards. For CSR peer review committees, go to “How to Become a CSR Reviewer” (https://public.csr.nih.gov/ForReviewers/ BecomeAReviewer/HowToApply) for information on reviewer qualifications and the CSR nomination process.

NCI Orientation for the Board of Scientific Advisors 57 SUMMARY OF ETHICS RULES FOR SPECIAL GOVERNMENT EMPLOYEES SERVING ON ADVISORY COMMITTEES

INTRODUCTION Concurrent Representation: While you are serv- ing, there are representational restrictions on As a special Government employee (SGE), you contacting the Government on behalf of another— are a Federal Government employee. As such, you for example, as an agent or attorney—with intent are covered by the executive branch ethics rules, to influence on a specific party matter that you are although in a somewhat less restrictive manner working on as an SGE. than regular Government employees. Post-Employment Representation: You cannot The Criminal Conflict of Interest “switch sides” in the private sector and represent Statutes 18 U.S.C. §§ 203, 205, 207, 208 back to the Government concerning the same spe- cific party matter—the same contract or grant, for Financial Conflicts: You are prohibited from example, that you worked on as an SGE. (Remem- participating personally and substantially in any ber also the restrictions resulting from employ- particular matter that directly and predictably ment negotiations that are covered by the financial affects your own financial interests or the financial conflict statute.) interests of certain other persons or organizations: your spouse, minor child, general partner, and Standards of Ethical Conduct outside organizations with which you serve 5 CFR Part 2635 as an officer, director, trustee, or employee, or with which you are negotiating for or have an You are prohibited from receiving compensation arrangement for future employment. If your for teaching, speaking, or writing about your duties would require you to participate in any Government duties or about any topic if the invita- particular matter that affects your financial tion to teach, speak, or write comes from a person interests, you have a conflict of interest which you substantially affected by the matters on which you will have to resolve. Of most concern are reviews of grant proposals or contract applications, or work as an SGE. However, you may teach courses similar funding decisions; recommendations or about general topics requiring multiple presenta- approvals of scientific studies, projects, clinical tions. trials, and new drug applications; and other actions that involve deliberation, decision, or You may not accept giftsoffered as a result of action affecting the legal rights of identified your advisory committee membership. In many parties. You might also be prohibited from circumstances, you may not participate as an ex- involvement in Particular Matters of General pert witness on any matter or proceeding that you Applicability. For example, recommendations of work on as an SGE. regulations, policies or standards that affect an industry, group of manufacturers, or health care Impartiality: You are prohibited from participat- providers. ing in a specific party matter where a reasonable person would question your impartiality—for ex- Divestiture: Sell or otherwise dispose of the finan- ample, conducting a review of a grant application cial interest that is creating the conflict. submitted by your mentor or someone with whom you have a close relationship— unless authorized Waiver: Get written approval from a senior of- by an agency designee to participate. ficial to continue with your work for the committee despite the conflict. Waivers can be Misuse of Position—Use of Public Office for granted where there is a pressing need for a par- Private Gain: This includes the misuse ticular individual’s services on the committee and of nonpublic information, government property, this outweighs the potential for conflict of interest. and official time. You may not use your Specific criteria must be met. This is considered a position to imply that the Committee endorses “general waiver” in that it only allows participa- your private activities or refer to your Government tion in matters that affect all institutions, or types position for your own private gain. of institutions, similarly.

58 NCI Orientation for the Board of Scientific Advisors Employment by, or Gifts from, Foreign Govern- Financial Conflicts of Interest ments: Committee member may be employed by Office of Government Ethics – OGE 450 a foreign government, which includes positions Form with foreign universities that are government operated. There are also statutory provisions Office of Government Ethics (OGE) 450 Form: restricting acceptance of gifts including awards, http://ethics.od.nih.gov/topics/450-info.htm educational scholarships, and travel expenses oc- curring outside the Unites States, but not on travel Financial Interests to be reported on the OGE 450 or honoraria for speaking engagement or employ- Form include: ment for consulting. • Stocks, stock options, bonds Lobbying: In their official capacities or as a group, • Sector funds (Waiver available for biotech/ committee members are prohibited from engaging health care sector funds up to aggregate value in any activity which directly or indirectly en- of $50,000) courages or directs any person or organization to lobby one or more members of Congress. You may • Earned income including salaries, fees, and/or appear for the purpose of informing or educating honoraria the public about a particular policy and you may • Limited partnerships and venture capital cor- communicate with members of Congress at their porations request. • Non-Federal research/training support • Invention rights and royalties Political Activities (Hatch Act): While on Govern- • Real estate, trades and businesses, and part- ment duty (unlike the other rules which always nership interests apply during your time of appointment), you • Speaking engagements and consultant work may not engage in partisan political activities, run for political office in a partisan election, or solicit SGEs report assets with a fair market value greater contributions from the public. For more informa- than $1,000 at the close of the reporting period, tion on political activity restrictions, please see the which produced income over $200. Office of Special Counsel website at www.osc.gov. Conflict of Interest and Ethics Websites Ethics for SGEs: Your Responsibilities as a Government Employee U.S. Office of Government Ethics Online training on Completing the OGE Form 450: • Complete the OGE-450 Financial Disclosure https://www.oge.gov/Web/oge.nsf/Resources/How+ Report and submit it for review. You should to+file+an+OGE+Confidential+Financial+Disclosure not attend meetings or participate in commit- +Form+(OGE+form+450) tee business until this form is submitted and reviewed. A Guide on the Ethics Rules That Apply to • Complete the HHS-697 Foreign Activities Advisory Committee Members Serving as Special Questionnaire and submit it for review. Government Employees: https://www2.oge.gov/ • If conflicts of interest are identified, work with web/oge.nsf/Education%20resources%20for%20 committee managers and ethics officials to Ethics%20Officials/7FB810D106E32FC985257F6B00 resolve them. 528843/$FILE/bkServeHonor.pdf?open • Complete a financial disclosure form 30 days prior to each Board meeting. Overview of the Ethics Rules for Special Govern- • Complete initial ethics orientation and yearly ethics training—you should have a basic ment Employees Serving on Advisory Commit- knowledge of the Standards of Ethical Con- tees: https://ofacp.od.nih.gov/ethics/index.asp duct and the Conflict of Interest Statutes. • Monitor changes in your circumstances that Ethics Rules for Advisory Committee Members might create new conflicts. and Other Individuals Appointed as Special Gov- • Be sure to contact your Designated Federal Of- ernment Employees (SGEs): https://ethics.od.nih. ficial (DFO) or ethics officials with any ques- gov/topics/SGE-Training-Oct-04.pdf tions. NIH Administrative Fact Sheet for Special Govern- Excerpted from: Overview of the Ethics Rules for Spe- ment Employees: http://ofacp.od.nih.gov/ cial Government Employees Serving on an Advisory Committee, U.S. Office of Government Ethics, NIH (see p. 61)

NCI Orientation for the Board of Scientific Advisors 59 Foreign Activities: NIH Ethics Program: http://ethics.od.nih.gov/ • U.S. Constitution Emoluments Clause: http:// default.htm ofacp.od.nih.gov/ethics/pdfs/EmolClause.pdf • Foreign Activities Questionnaire: https:// Bioethics Resources on the Web: https://bioethics. www.hhs.gov/sites/default/files/hhs-697-01- nih.gov/resources/index.shtml 23-17.pdf

Conflict of Interest and the Special Government Employee: http://ethics.od.nih.gov/topics/OGE- SGE.pdf

60 NCI Orientation for the Board of Scientific Advisors To Serve With Honor

A Guide on the Ethics Rules That Apply to Advisory Committee Members Serving as Special Government Employees

U.S. Office of Government Ethics www.usoge.gov March 2008

NCI Orientation for the Board of Scientific Advisors 61 1 Contents

3 Government Employee Status

4 Screening for Conflicts of Interest

5 Financial Disclosure Reports

6 Financial Conflicts of Interest

6 Financial Conflicts of Interest—Imputed Interests

7 Resolving Financial Conflicts of Interest

7 Considering Appearance Issues

8 Outside Consulting Work

8 Standards of Ethical Conduct Rules

10 Other Ethics Rules

10 Post-Employment Laws

10 Some Final Thoughts

12 SGE Game Plan for Peak Ethical Performance

62 NCI Orientation for the Board of Scientific Advisors questions or to point you in the right 3 To Serve With direction. They will help you even after your committee has finished its Honor work and your Government service A Game Plan for Success is done.

A Guide on the Ethics Rules Whether your time on a committee That Apply to Advisory Committee is short or long, understanding Members Serving as Special these basic ethics rules will make Government Employees your Government service more rewarding for you and for your ongratulations on becoming fellow committee members. a member of the Government’s advisory team! In your new C Government Employee committee position, you may be helping to shape public policy or Status making other contributions that impact important issues facing our country. I will be serving on a committee Your service on the committee will be only for a few days a year. Am I a a rewarding experience. But, while Government employee just because your membership has it rewards, it I am a member of an advisory also has its ethical obligations. Being committee? a member of the Government’s team means you’ll have to learn to play ot necessarily. However, by the Government’s ethics rules. if you have been given this These ethics rules help promote pamphlet by the agency public confidence and trust in our N sponsoring your advisory commit- Government and in the recommenda- tee, it’s likely that you are serving as tions that your committee will make a special Government employee to the Government. These rules will (SGE) 1 and are subject to the also help ensure that you serve the Government’s ethics rules. An Government and your committee agency official should determine honorably. your employment status and then inform you whether you are serving In this summary, you will learn more on an advisory committee in an about the ethics laws and rules that employee status. apply to your service as a member of a Federal advisory committee. We will highlight some of the ethics rules that are most likely to affect you during your Government service. After 1 An SGE is defined as an “officer or employee . . . who is retained, designated, appointed, or you’ve read this pamphlet, you may employed” by the Government to perform temporary want to learn more about specific duties, with or without compensation, for not more ethics rules. Agency ethics officials than 130 days during any period of 365 consecutive and committee management officials days. See Title 18, United States Code, Section are there to answer any of your 202(a).

NCI Orientation for the Board of Scientific Advisors 63 4 In general, your status will depend have on the commit- upon what role you will be expected tee. However, don’t to have on the committee. It is very ever begin your important for you and every member committee work of your committee to understand until you know your role on the committee before what your status is you even start your committee work. going to be If you have not been told, you should while serving ask a committee official or ethics on a committee. official to explain your status so you will know whether you are subject to any of the Government’s ethics rules. Screening for Conflicts of Interest If you are serving in an SGE status, you are considered a Government Is there anything that I should be employee. Your role as an employee doing to comply with the Government will be to provide your best judgment ethics rules before I begin my in committee matters that will be committee service? presented to you for discussion. As someone serving on a committee in es. You’ll need to get an an SGE status, you will be subject to “ethics checkup” before you most of the Government’s ethics Y begin your committee’s rules. Many of these rules will be work. We’ve all read press stories discussed in this pamphlet. about athletes having to pass a physical examination before they can Keep in mind that some committee start playing for a sports team. members may be regular Government One reason that employees. Other members may not teams require be serving as employees at all. These athletes to pass non-employee members may be such exams is to serving as representatives of outside make sure they organizations. Representative are able to members are not subject to the perform to the Government’s ethics rules because very best of their they are only on a committee to ability. In much the same way, the provide the views of outside interest Government wants to ensure that you groups or stakeholders. will be able to perform to the best of your ability when you begin working If you are ever unsure about your role on one of its advisory committee or status on an advisory committee, teams. talk to a committee or ethics official. In some cases, your committee Your best service is possible only appointment papers will say what when you are not affected by conflicts your status is and/or the role you will of interests or appearances of conflicts of interest. Conflicts of interest can arise if you have extensive outside

64 NCI Orientation for the Board of Scientific Advisors activities and financial holdings or benefit both you and your 5 other interests that relate to the committee’s work. An ethics subject matter of your committee checkup will protect you from service. An “ethics checkup” or a unintentionally violating ethics conflict of interest screening helps laws and rules. The ethics laws the Government ensure that your can sometimes carry very serious committee work is done in a manner penalties and fines if you violate that will uphold the Government’s them by allowing your conflicts to high ethical standards. go untreated. This exam will help the Government ensure that your advice is free from any actual or Financial Disclosure perceived conflicts of interest. Reports Your agency ethics official can tell What does an “ethics checkup” you more about the financial disclo- involve? Is this exam a one-time sure report, including the type of event? How will I know if I have report you will be required to fill passed this ethics checkup? out. Even after you have filed your report, you may want to sit down s with any physical exam, and talk to your ethics official about there is always a little bit of your report if you believe your A paperwork to fill out. In committee is going to work on a general, one of the first forms you matter that may affect one or more have to complete prior to beginning of your financial holdings. In some your committee work is a financial cases, a matter that would raise disclosure report. This report collects information about you, your spouse, and dependent children. You will have to fill this report out before you give any advice to the agency and in no event later than your first committee meeting. You will have to complete this report annually if you are reappointed.

As you know, no exam is ever complete without some amount of probing by the doctor. In much the concerns may not have been same way, ethics officials will probe apparent during your initial “ethics and look closely at your report to see checkup.” You should immediately if any of your financial interests or consult with an agency official about affiliations may raise any ethical this matter. Remember, an ethics flags. In some cases, they may have checkup is only as good as the to ask you additional questions information you provide to your about your finances. Keep in mind agency. that this checkup will ultimately

NCI Orientation for the Board of Scientific Advisors 65 6 Financial Conflicts of Financial Conflicts of Interest Interest—Imputed Interests I work for a pharmaceutical com- pany, and over the years have Would I still have a conflict of interest received a fair amount of stock in if I didn’t work for the pharmaceutical the company. What should I do if company or own any stock, but my the work of my advisory committee spouse owned stock in the company will affect my employer? that she bought through her broker?

enerally, you may not work es. The ethics laws treat the on a committee matter that financial interests of the G will affect your own, or following as if they were your employer’s, financial interest. Y your own financial interests: For example, let’s say you were serving on an advisory committee ❐ Your spouse; that is advising an agency on whether it should continue a health ❐ Your minor child; program that provides nutrition ❐ Your employer; information and free vitamins to children. The Government pur- ❐ Your general partner; chases some of the vitamins it ❐ An organization in which you distributes serve as officer, director, trustee, from your or general partner; or company. It would be a ❐ A person with whom you are conflict of negotiating or have an arrangement interest for you for prospective employment. to participate in committee matters So, if your spouse owned stock in the relating to the distri- pharmaceutical company described bution of the vitamins, because you above, you would still have the same both own stock in, and are em- conflict of interest concern described ployed by, a company that has a in the previous question. financial interest in the issue. Conflicts of interest concerns that are Whether you can be involved in not addressed can penalize you and committee matters that relate your committee’s work. Ethics generally to the agency’s nutrition officials or committee officials will program depends on how the work with you to make sure that you program will affect your company. can continue to do your committee The agency’s ethics official or work ethically and honorably. committee management official will advise you on how to proceed.

66 NCI Orientation for the Board of Scientific Advisors Resolving Financial ecause you serve the Govern- 7 Conflicts of Interests ment, you should always B conduct yourself in a manner What steps should I take to avoid that is above ethical reproach. So, violating the Government’s ethics even if there is no financial conflict rules if I have a conflict of interest? of interest, your outside relationships may at times raise questions in the here are several ways to avoid public’s mind about how fair you a conflict of interest while can be while working on a particular working on a committee committee matter. For example, T “appearance” concerns may arise matter. The most common way is simply not to work on a particular when you are asked to work on a committee matter if it raises a conflict committee matter that you know of interest for you. For example, in may affect a member of your house- the situations discussed above, to hold or your former employer or avoid what otherwise would be a client. In general, you should be conflict of interest because of your alert for situations where— financial interest in the pharmaceuti- ❐ cal company, you could simply not a former employer, participate in those committee matters ❐ a client of yours or your spouse, that would affect the financial inter- ❐ ests of the company. We call this a person or organization with remedy a recusal. which you have some kind of business or contract relation- If you have a conflict of interest, ship, or you should consult an ethics official ❐ your spouse’s employer because ethics regulations may resolve some of your conflicts of interests. For example, there are some exceptions that apply if the value of your stock is below a certain amount. Another exception may permit you to participate in matters affecting your non-Federal employer in certain cases.

Considering Appearance Issues

Am I required to do anything if I have an outside business relationship that is not a financial conflict of interest, but just looks bad for my committee?

NCI Orientation for the Board of Scientific Advisors 67 8 will be specifically affected by your you should always talk to an agency committee’s activities. In some cases, official if you are thinking about it may be appropriate for you not to representing a client before the work on a certain committee matter Government on a matter that involves because of appearance concerns. the subject matter of your committee’s work or the overall programs of the Because you are part of the agency that is sponsoring your Government’s team, you are never committee. alone in dealing with these kinds of appearance concerns. If you are not Standards of Ethical sure whether a potential situation Conduct Rules could raise an appearance problem, you should stop your work on that Are the conflict of interest laws the committee matter and contact your only ethics rules that I must know agency’s ethics official or committee before I start my work as a committee official to discuss your concerns. member? These officials can help you address possible appearance problems. here are a number of other important ethics rules that will guide your conduct while Outside Consulting Work T you are serving as an SGE. Most of these rules are part of “The Standards I have an outside consulting business of Ethical Conduct for Employees of that requires me to represent clients the Executive Branch (Standards of before the Government. Is this O.K.? Conduct).” As a committee member, n general, you may not represent you are expected to be aware of and another person, whether or not follow these basic ethics rules while you are compensated for the in Government service. Some of the I rules you should know include: representation, before a Federal agency or court in connection with a matter that you have worked on as an ❐ Don’t accept improper gifts. SGE. The types of representational Don’t ask for or accept gifts that services covered include written are given because of and oral communications, as well your committee as making physical appearances on position or that behalf of someone else with the come from intent to influence or persuade the certain “prohib- Government. ited sources.” For example, a Once you have served more than 60 company that does days as an SGE within the previous business with, or is regulated by, 365 days, you may not represent the agency that sponsors your anyone on any matter pending in the committee is a prohibited source. agency where you serve. Remember,

68 NCI Orientation for the Board of Scientific Advisors There are many exceptions to this ❐ Don’t accept compensation for 9 general rule. Find out more about teaching, speaking, and writing these gift exceptions by talking to related to your Government a committee or ethics official. duties. This restriction applies in narrow ❐ Don’t use public office for circumstances to SGEs. It does private gain. not apply at all if the compensa- For example, you may not use tion is for teaching university your committee position, title or courses. And it applies in very any authority associated with your limited cases if you are an SGE advisory committee to coerce or who is expected to serve less than induce a benefit for yourself or 60 days. If you intend to receive others.

❐ Don’t misuse Government information. If you get information that has not been made available to the general public, don’t use (or allow the improper use of) that nonpublic information to further any private interest, either your own or another’s. Contact a compensation for teaching, committee official or agency speaking, and writing that is ethics official if you have any related to the subject of your questions about whether you committee’s work, talk to may release certain types of an ethics official first so that you information. are sure the compensation is acceptable. ❐ Use Government property and time properly. ❐ Abide by expert witness rules. Always use Government property In general, you cannot be an only for authorized purposes. expert witness in a judicial or Government property includes administrative proceeding if you office supplies, telephones, participated as a Government computers, copiers and any other employee in the matter that is thing purchased with Government the subject of the proceeding. funds. Also, be sure to use Moreover, if you are appointed by your official time to carry out the President, serve on a commis- committee work. sion established by statute, or have served or are expected to serve more than 60 days in a

NCI Orientation for the Board of Scientific Advisors 69 10 period of 365 days, this bar Post-Employment Laws applies to any proceeding in which your employing agency Do any ethics rules apply to me after is a party or has a direct and my service on an advisory committee substantial interest. has ended?

The rules that govern service as es. Post-employment laws an expert witness can be very may limit the types of complex, so you should always communications you may get advice from an agency Y make back to the Government on ethics official before you agree behalf of another person. to serve as an expert. For example, you may be perma- nently barred by a criminal law from Other Ethics Rules representing anyone else before a Are there any ethics rules that may Federal agency or court on certain limit my political activities during matters (such as a contract, grant or my service on a committee? even an investigation) that you worked on while serving on an es, a law known as the advisory committee. Hatch Act limits certain political activities of There are some other restrictions that Y could apply to your post-Government Government employees, including SGEs when they are engaged in activities, depending on your agency committee work. The law has been and the function you served in on a substantially amended to allow most committee. Your agency’s ethics Government employees to engage official can help you to understand in many types of political activities. these and other post-employment However, you should check with rules, either before or after your your agency ethics official to ensure committee service ends. your activities comply with these laws. You may also want to check Some Final Thoughts the U.S. Office of Special Counsel’s website (the agency responsible he Government is very grateful for enforcing this law) for more for your dedicated service. information and guidance at TYour commitment in upholding www.osc.gov. the integrity of Government service before and even after your committee

70 NCI Orientation for the Board of Scientific Advisors service ends is important and will help In you need more information, please 11 maintain public confidence in the talk to a committee management Government’s decision making and in official or your agency ethics official. the quality of your committee’s work. Like a good coach, these individuals are there to help guide you into becoming the best committee member We hope this summary helps you to you can be — one that acts ethically understand how some of the Federal and responsibly before and after his ethics rules may apply to you as a or her service ends. In this way, you Federal advisory committee member can be proud of your service to the serving as an SGE. It is now up to Government and to your advisory you to ensure that you serve with committee team. honor by following this game plan for successful participation on the Government’s advisory team.

U.S. Office of Government Ethics www.usoge.gov March 2008

NCI Orientation for the Board of Scientific Advisors 71 12 SGE Game Plan for Peak Ethical Performance

Don’t ever begin your are found in the Standards 1 committee work until you of Conduct and in the know what your role or Conflict of Interest laws. status is on a committee. Talk to your agency ethics Always get an “ethics 6 official if you anticipate 2 checkup” before you begin doing some teaching, your committee work. speaking, or writing as an outside activity for Don’t work on a committee compensation or engaging 3 matter that will affect in representational activity your financial interests, before the Government. unless some exception allows you to do so. Understand the post- 7 employment rules either Always check with an ethics before or after your advisory 4 official if you have any committee service ends. concerns about an appearance of a conflict of interest. Remember that learning 8 more about the Government’s Improve “your game” by ethics rules will help ensure 5 becoming more familiar that you serve your committee with Government ethics honorably. rules, especially those that

72 NCI Orientation for the Board of Scientific Advisors APPENDIX A

NCI SCIENTIFIC PROGRAM LEADERSHIP COMMITTEE

Dr. Norman Sharpless Dr. Paulette Gray Director Director Division of Extramural Activities Dr. Douglas R. Lowy Principal Deputy Director Dr. Toby Hecht Deputy Director, Division of Cancer Treatment Dr. James Doroshow and Diagnosis Deputy Director for Clinical and Translational Research Dr. Sara Hook Director, Division of Cancer Treatment Associate Director and Diagnosis NCI at Frederick Office of Scientific Operations Dr. Dinah Singer Deputy Director for Scientific Strategy Dr. Tony Kerlavage and Development Acting Director, Center for Biomedical Informatics and Information Technology Dr. L. Michelle Bennett Director Mr. Patrick McCarey Center for Research Strategy Associate Director Finance and Legislation Dr. Oliver Bogler Director Dr. Glenn Merlino Center for Cancer Training Scientific Director for Basic Research Center for Cancer Research Dr. Stephen Chanock Director Dr. Tom Misteli Division of Cancer Epidemiology and Genetics Director Center for Cancer Research Dr. Henry Ciolino Director Dr. Sheila Prindiville Office of Cancer Centers Director Coordinating Center for Clinical Trials Dr. Robert Croyle Director Dr. Henry Rodriguez Division of Cancer Control and Population Acting Deputy Director Sciences Center for Strategic Scientific Initiatives

Dr. William Dahut Mr. Jeffrey Shilling Scientific Director of Clinical Research and Acting Chief Information Officer Clinical Director, Center for Cancer Research National Cancer Institute

Dr. Daniel Gallahan Ms. Donna Siegle Acting Director Executive Officer and Division of Cancer Biology Deputy Director for Office of Management

Mr. Peter Garrett Dr. Sanya Springfield Director Director Office of Communications and Public Liaison Center to Reduce Cancer Health Disparities

NCI Orientation for the Board of Scientific Advisors 73 Dr. Thomas M. Stackhouse Dr. Deborah Winn Director Acting Director Technology Transfer Center Division of Cancer Prevention

Dr. Louis M. Staudt Dr. Robert Yarchoan Director Director Center for Cancer Genomics Office of HIV and AIDS Malignancy

Mr. Michael Weingarten Dr. Maureen R. Johnson Director Executive Secretary SBIR Development Center

74 NCI Orientation for the Board of Scientific Advisors APPENDIX B OVERVIEW OF THE TYPES OF NIH FEDERAL ADVISORY COMMITTEES

• National Advisory Councils and Boards That is, in reviewing and evaluating the current Perform the second level peer review of research state of the science against what it is likely to be grant and cooperative agreement applications and in the future, the groups would look at the struc- offer advice on policy and program development. tures the NCI has and determine whether those structures are appropriate for the future and not • Program Advisory Committee an impediment to the furtherance of the science. Advise on specific research programs, and future The issuance of a written report is critical to gain a research needs and opportunities, and identify consensus that the altering of a structure either is and evaluate extramural initiatives. or is not necessary. The reports from the Review Groups will be presented to the NCAB and BSA • Boards of Scientific Counselors for discussion and comment, and referred to the Review and evaluate the research programs and Scientific Program Leadership (SPL) Committee investigators of the intramural laboratories. for follow-up and implementation.

• Initial Review Groups (IRGs) • Working Groups Provide scientific and technical merit review. This Working Groups are more fluid, responding to is the first level of peer review of research grant trans-divisional planning processes as reflected by applications and contract proposals. the Bypass Budget. In the Working Group concept, staff and the extramural community engage in a • Special Emphasis Panels (SEPs) free flowing forum type of discussion to identify Provide scientific review of extramural applica- high priority and promising scientific opportuni- tions, proposals, and concept reviews that have ties on the immediate horizon. No written report previously been performed through ad hoc groups. is envisioned. It is generally felt that the Working Provide scientific and technical merit review, Groups should have a limited life span (normally which is the first level of peer review of research 1 year unless circumstances dictate otherwise). The grant applications and contract proposals. Working Groups, unlike the Review Groups, will not get involved in the program structure of the In addition to NCI’s mandatory advisory Institute but rather are, in essence, “think tanks,” committees, the NCI also uses: Review with their memberships changing over time with Groups, Working Groups, Progress Review their major emphasis on the current state of the art Groups, etc. of the science and identifying resources needed for optimal coordination and future progress. The • Review Groups joint BSA/NCAB SPORE Evaluation Working Review Groups are programmatically oriented Group (https://deainfo.nci.nih.gov/advisory/bsa/ with a clear line of reporting accountability to the workGroup/index.htm), the NCAB Cancer Centers National Cancer Advisory Board (NCAB) and Working Group (https://deainfo.nci.nih.gov/ Board of Scientific Advisors (BSA). Review Groups advisory/ncab/workgroup/CancerCtrWG/report- are charged to examine the NCI programs and 13may14.pdf), and the CTAC Clinical Trials Infor- infrastructures to evaluate whether changes are matics Working Group (https://deainfo.nci.nih. necessary for the Institute to be in a position to gov/advisory/ctac/1117/1-CTIWGreport.pdf) are effectively guide and administer the needs of the examples of recent Working Groups, and reports. science in the foreseeable future.

NCI Orientation for the Board of Scientific Advisors 75 APPENDIX C PRESIDENT’S CANCER PANEL

Chair

John P. Williams, M.D., F.A.C.S. (2021)* Breast Cancer Surgeon Medical Director Breast Cancer School for Patients Clinical Professor Institute for Biohealth Innovation George Mason University Gainesville, VA

Members

Robert A. Ingram (2022)* General Partner Hatteras Venture Partners Durham, NC

Edith P. Mitchell, M.D., F.A.C.P., F.C.P.P. (2020)* Clinical Professor of Medicine and Medical Oncology Department of Medical Oncology Director, Center to Eliminate Cancer Disparities Associate Director, Diversity Affairs Sidney Kimmel Cancer Center Thomas Jefferson University Philadelphia, PA

Executive Secretary

Maureen R. Johnson, Ph.D. Special Assistant to the Director Office of the Director National Cancer Institute National Institutes of Health Bethesda, MD

______* Pending.

76 NCI Orientation for the Board of Scientific Advisors APPENDIX D

NATIONAL CANCER ADVISORY BOARD

Chair

Elizabeth M. Jaffee, M.D. 2018 Deputy Director The Sidney Kimmel Comprehensive Cancer Center The Dana and Albert “Cubby” Broccoli Professor of Oncology Co-Director, Skip Viragh Center for Pancreas Cancer Johns Hopkins University Baltimore, MD

Members David C. Christiani, M.D., M.P.H. 2018 Elkan Blout Professor of Environmental Peter C. Adamson, M.D. 2020 Genetics Chair, Children’s Oncology Group Departments of Environmental Health Alan R. Cohen Endowed Chair in Pediatrics and Environmental and Occupational The Children’s Hospital of Philadelphia Medicine and Epidemiology Philadelphia, PA Harvard School of Public Health Professor of Medicine Francis Ali-Osman, D.Sc. 2022 Harvard Medical School Margaret Harris and David Silverman Boston, MA Distinguished Professor of Neuro-Oncology Professor of Surgery Howard J. Fingert, M.D., F.A.C.P.* 2024 Professor of Pathology Consultant Duke University Medical Center Chestnut Hill, MA Durham, NC Judy E. Garber, M.D., M.P.H. 2018 Anna D. Barker, Ph.D.* 2024 Director Chief Strategy Officer Center for Cancer Genetics and Prevention Dana-Farber Cancer Institute Lawrence J. Ellison Institute Professor of Medicine for Transformative Medicine Harvard Medical School University of Southern California Boston, MA Beverly Hills, CA Lawrence O. Gostin, J.D. 2022 Deborah Watkins Bruner, R.N., Ph.D., University Professor F.A.A.N. 2020 Faculty Director, Founding Linda D. Robert W. Woodruff Chair of Nursing and Timothy J. O’Neill Professor Nell Hodgson Woodruff School of Nursing in Global Health Law Associate Director for Outcomes Research O’Neill Institute for National and Global Health Winship Cancer Institute Georgetown University Emory University Washington, DC Atlanta, GA Andrea A. Hayes-Jordan, M.D., F.A.C.S, 2024 Yuan Chang, M.D. 2020 F.A.A.P.* American Cancer Society Research Professor Byah Thompson Doxey Distinguished Distinguished Professor of Pathology Professor of Surgery UPCI Chair of Cancer Virology Division Chief, Pediatric Surgery University of Pittsburgh Cancer Institute Surgeon-in-Chief Pittsburgh, PA University of North Carolina Children’s Hospital ______Chapel Hill, NC * Pending.

NCI Orientation for the Board of Scientific Advisors 77 Scott W. Hiebert, Ph.D. 2022 Charles L. Sawyers, M.D. 2018 Hortense B. Ingram Chair in Caner Research Chairman Professor of Biochemistry Human Oncology and Pathogenesis Program Department of Biochemistry Memorial Sloan-Kettering Cancer Center Vanderbilt University School of Medicine Investigator Nashville, TN Howard Hughes Medical Institute Professor of Medicine Beth Y. Karlan, M.D. 2018 Weill-Cornell Medical College Director, Women’s Cancer Program New York, NY Samuel Oschin Comprehensive Cancer Institute Director of Obstetrics and Gynecology Margaret R. Spitz, M.D. 2022 Department of Obstetrics and Gynecology Professor Cedar-Sinai Medical Center Dan L. Duncan Cancer Center Professor, Obstetrics and Gynecology Baylor College of Medicine David Geffen School of Medicine Houston, TX University of California, Los Angeles Los Angeles, CA Susan Thomas Vadaparampil, Ph.D., 2024 M.P.H.* Timothy J. Ley, M.D. 2020 Vice Chair, Health Outcomes and Behavior Professor of Medicine and Genetics Associate Center Director Division of Oncology Community Outreach, Engagement, and Equity Washington University School of Medicine Moffitt Cancer Center St. Louis, MO Tampa, FL

Electra D. Paskett, Ph.D. 2022 Max S. Wicha, M.D. 2020 Marion N. Rowley Professor of Cancer Research Deputy Director of the Taubman Institute Director, Division of Cancer Prevention Distiguished Professor of Oncology and Control Professor, Internal Medicine Department of Internal Medicine Division of Hematology and Oncology College of Medicine University of Michigan The Ohio State University Ann Arbor, MI Columbus, OH Ex Officio Members Nancy J. Raab-Traub, Ph.D. 2022 Professor Robert S. Adler, J.D. Department of Microbiology and Immunology Acting Chairman School of Medicine U.S. Consumer Product Safety Commission Lineberger Comprehensive Cancer Center Bethesda, MD The University of North Carolina at Chapel Hill Chapel Hill, NC The Honorable Alex Azar, J.D. Secretary Mack Roach III, M.D., F.A.C.R., FASTRO 2018 U.S. Department of Health and Human Services Professor of Radiation Oncology Washington, DC and Urology Chair, Department of Radiation Oncology Francis S. Collins, M.D., Ph.D. University of California, San Francisco Director Helen Diller Family Comprehensive National Institutes of Health Cancer Center Bethesda, MD San Franscisco, CA The Honorable Mark T. Esper, Ph.D. Secretary of Defense The Pentagon Washington, DC

78 NCI Orientation for the Board of Scientific Advisors Stephen Hahn, M.D. Michael A. Babich, Ph.D. Commissioner Directorate for Epidemiology and Health U.S. Food and Drug Administration Sciences Silver Spring, MD U.S. Consumer Product Safety Commission Bethesda, MD John Howard, M.D., M.P.H., J.D., LL.M. (Ms. Ann Marie Buerkle, J.D.–CPSC) Director National Institute for Occupational Safety and Vincent J. Cogliano, Ph.D. Health Acting Director Washington, DC Integrated Risk Information System Program National Center for Environmental Assessment The Honorable Rick Perry Office of Research and Development Secretary U.S. Environmental Protection Agency Department of Energy Washington, DC Washington, DC (Andrew R. Wheeler, J.D.–EPA)

The Honorable Eugene Scalia, J.D. Michael Kelley, M.D., F.A.C.P. Secretary National Program Director for Oncology U.S. Department of Labor Veterans’ Health Administration Washington, DC U.S. Department of Veterans Affairs Washington, DC Robert A. Stone, M.D. (Robert A. Stone, M.D.–VA) Executive in Charge Veterans Health Administration Aubrey Miller, M.D., M.P.H. U.S. Department of Veterans Affairs Senior Medical Officer Washington, DC National Institute of Environmental Health Sciences Andrew R. Wheeler, J.D. National Institutes of Health Administrator Bethesda, MD U.S. Environmental Protection Agency (Richard Woychik, Ph.D.–NIEHS) Washington, DC Richard Pazdur, M.D., F.A.C.P. Richard Woychik, Ph.D. Director Acting Director Oncology Center of Excellence National Institute of Environmental Health U.S. Food and Drug Administration Sciences Silver Spring, MD National Toxicology Program (Stephen Hahn, M.D.–FDA) National Institutes of Health Research Triangle Park, NC Craig D. Shriver, M.D., F.A.C.S., COL., M.C. Director, John P. Murtha Cancer Center TBN Chief, General Surgery Science Advisor to the President Program Director, National Capital Consortium Director General Surgery Office of Science and Technology Policy Principal Investigator, Clinical Breast Care Project Executive Office of the President Professor of Surgery, Uniformed Services Washington, DC University Bethesda, MD Alternates to Ex Officio Members (The Honorable Mark T. Esper, Ph.D.–DOD)

Todd Anderson, Ph.D. Kerry Souza, Sc.D., M.P.H. Director, Biological Systems Science Division Epidemiologist Office of Biological and Environmental National Institute for Occupational Safety Research and Health Department of Energy Washington, DC Washington, DC (John Howard, M.D., M.P.H., J.D., LL.M.– (The Honorable Rick Perry–DOE) NIOSH)

NCI Orientation for the Board of Scientific Advisors 79 Lawrence A. Tabak, D.D.S., Ph.D. Executive Secretary Principal Deputy Director National Institutes of Health Paulette S. Gray, Ph.D. Bethesda, MD Director (Francis S. Collins, M.D., Ph.D.–NIH) Division of Extramural Activities National Cancer Institute, NIH Richard J. Thomas, M.D., M.P.H. Bethesda, MD Deputy Director Office of Occupational Medicine Acting Committee Management Officer OSHA/Department of Labor Washington, DC Ms. Joy Wiszneauckas (The Honorable R. Alexander Acosta, J.D.–DOL) Division of Extramural Activities National Cancer Institute, NIH TBN Bethesda, MD Office of Science and Technology Policy Executive Office of the President Washington, DC (TBN–OSTP)

80 NCI Orientation for the Board of Scientific Advisors APPENDIX E BOARD OF SCIENTIFIC ADVISORS

Chair

Dafna Bar-Sagi, Ph.D. 2021 Vice Dean for Science, Senior Vice President, and Chief Scientific Officer Professor, Department of Biochemistry and Molecular Pharmacology and Medicine NYU Langone Health New York University School of Medicine New York, NY

Members Otis W. Brawley, M.D., M.A.C.P., F.A.S.C.O., 2023 F.A.C.E. Kenneth C. Anderson, M.D., Ph.D. 2021 Bloomberg Distinguished Professor of Oncology Kraft Family Professor of Medicine and Epidemiology Harvard Medical School The Sidney Kimmel Comprehensive Cancer Center Director, Lebow Institute for Johns Hopkins University Myeloma Therapeutics Baltimore, MD Dana-Farber Cancer Institute Boston, MA Graham A. Colditz, M.D., Dr.P.H. 2019 Niess-Gain Professor of Surgery Michael John Becich, M.D., Ph.D. 2021 Professor of Medicine and Associate Director, Professor, Pathology Information Prevention and Control Sciences/Telecommunications, Alvin J. Siteman Cancer Center Clinical/Translational Deputy Director, Institute for Public Health Department of Biomedical Informatics Barnes Jewish Hospital University of Pittsburgh School Medicine Chief, Division of Public Health Sciences Pittsburgh, PA Department of Surgery Washington University School of Medicine Mary C. Beckerle, Ph.D. 2022 St. Louis, MO Jon M. Huntsman Presidential Endowed Chair Distinguished Professor of Biology Christopher M. Counter, Ph.D. 2021 CEO and Director, Huntsman Cancer Institute Professor and Associate Professor Associate Vice President of Cancer Affairs Department of Pharmacology and Cancer Biology The University of Utah Duke University School of Medicine Salt Lake City, UT Durham, NC

Melissa L. Bondy, Ph.D. 2021 Professor and Associate Director Department of Pediatrics Dan L. Duncan Cancer Center Baylor College of Medicine Houston, TX

NCI Orientation for the Board of Scientific Advisors 81 Carol E. Ferrans, Ph.D., R.N., F.A.A.N. 2020 Leslie L. Robison, Ph.D., M.P.H 2022 Professor and Associate Dean for Research Chairman Director, UIC Center of Excellence in Department of Epidemiology and Cancer Control Eliminating Health Disparities St. Jude Children’s Research Hospital Department of Biobehavioral Health Sciences Associate Director College of Nursing St. Jude Comprehensive Cancer Center University of Illinois at Chicago Memphis, TN Chicago, IL Martine F. Roussel (Sherr), Ph.D. 2020 Keith T. Flaherty, M.D. 2023 St. Jude Children’s Research’s Endowed Director Chair in Molecular Oncogenesis Henri and Belinda Termeer Center for Full Professor, Department of Molecular Sciences Targeted Therapy The University of Tennessee Director of Clinical Research Full Member Massachusetts General Hospital Cancer Center Department of Tumor Cell Biology Boston, MA St. Jude Children’s Research Hospital Memphis, TN Karen E. Knudsen, Ph.D. 2023 Hilary Koprowski Endowed Professor Robert D. Schreiber, Ph.D. 2021 Chair Alumni Endowed Professor of Pathology Department of Cancer Biology and Immunology Director Professor of Molecular Microbiology Sidney Kimmel Cancer Center Director, Washington University Center for Thomas Jefferson University Human Immunology and Immunotherapy Programs Philadelphia, PA Program Co-Leader, Tumor Immunology Siteman Comprehensive Cancer Center James V. Lacey, Jr., Ph.D., M.P.H. 2020 Washington University School of Medicine Director and Associate Professor St. Louis, MO Division of Cancer Etiology Department of Population Sciences Victoria L. Seewaldt, M.D. 2020 Beckman Research Institute Ruth Ziegler Professor City of Hope Chair, Department of Population Sciences Duarte, CA Beckman Research Institute City of Hope Michelle M. Le Beau, Ph.D. 2023 Duarte, CA Arthur and Marian Edelstein Professor of Medicine Director Kevin M. Shannon, M.D. 2020 University of Chicago Comprehensive Roma and Marvin Auerback Distinguished Cancer Center Professor in Molecular Oncology The University of Chicago American Cancer Society Research Professor Chicago, IL Department of Pediatrics University of California, San Francisco Sylvia Katina Plevritis, Ph.D. 2021 San Francisco, CA Professor Department of Radiology David Sidransky, M.D. 2022 Department of Biomedical Data Science Director Stanford University School of Medicine Head and Neck Cancer Research Stanford, CA Professor of Otolaryngology–Head and Neck Surgery W. Kimryn Rathmell, M.D., Ph.D. 2023 Department of Otolaryngology–Head Cornelius A. Craig Professor and Neck Surgery Department of Medicine Johns Hopkins University School of Medicine Director Baltimore, MD Division of Hematology and Oncology Vanderbilt University Medical Center Nashville, TN

82 NCI Orientation for the Board of Scientific Advisors Ian M. Thompson, Jr., M.D. 2021 Cheryl L. Willman, M.D. 2021 President The Maurice and Marguerite Liberman CHRISTUS Santa Rosa Medical Center Distinguished Chair in Cancer Research Hospital Director and CEO, University of New Mexico Texas Urology Group Comprehensive Cancer Center San Antonio, TX University of New Mexico Albuquerque, NM David A. Tuveson, Ph.D., M.D. 2021 Professor and Director Executive Secretary Cancer Center Cold Spring Harbor Laboratory Paulette S. Gray, Ph.D. Cold Spring Harbor, NY Director Division of Extramural Activities Robert H. Vonderheide, M.D. 2022 National Cancer Institute John H. Glick, M.D., Abramson Cancer Center’s National Institutes of Health Director Professor Bethesda, MD Professor of Medicine Perelman School of Medicine Director, Abramson Cancer Center University of Pennsylvania Philadelphia, PA

Eileen P. White, Ph.D. 2019 Distinguished Professor Department of Molecular Biology and Biochemestry Associate Director for Basic Science Rutgers Cancer Institute of New Jersey New Brunswick, NJ

NCI Orientation for the Board of Scientific Advisors 83 APPENDIX F

BOARD OF SCIENTIFIC COUNSELORS Clinical Sciences and Epidemiology Acting Chair

Raymond N. Dubois, Jr., M.D., Ph.D. 2021 Dean, College of Medicine Professor, Departments of Biochemistry and Medicine Medical University of South Carolina Charleston, SC

Members Nancy E. Davidson, M.D. 2022 Senior Vice President and Full Member Lynne V. Abruzzo, M.D., Ph.D. 2023 Clinical Research Division Professor Fred Hutchinson Cancer Research Center Department of Pathology President and Executive Director Division of Cytogenetics Seattle Cancer Care Alliance The Ohio State University Wexner Medical Center Head, Division of Medical Oncology Columbus, OH Department of Medicine University of Washington Rebecca A. Betensky, Ph.D. 2021 Seattle, WA Director, Biostatistics Program Professor, Department of Biostatistics Faith G. Davis, Ph.D. 2022 Harvard T. H. Chan School of Public Health Professor and Vice Dean Boston, MA School of Public Health University of Alberta Julie E. Buring, Sc.D. 2019 Edmonton, AB, Canada Professor of Medicine Harvard Medical School Mary L. Disis, M.D. 2022 Division of Preventive Medicine Director, Institute for Translational Health Brigham and Women’s Hospital Sciences Boston, MA Director, University of Washington Vaccine Institute John D. Carpten, Ph.D. 2021 Professor, Division of Oncology Professor and Chair Department of Medicine Department of Translational Genomics University of Washington Director, Institute of Translational Genomics Member, Clinical Research Division Keck School of Medicine Fred Hutchinson Cancer Research Center University of Southern California Seattle, WA Los Angeles, CA Gary D. Hammer, M.D., Ph.D. 2020 Arnab Chakravarti, M.D. 2022 Millie Schembechler Professor of Adrenal Professor and Chair, Department of Radiation Cancer Oncology Director, Endocrine Oncology Program Max Morehouse Chair of Cancer Research Director, Center for Organogenesis Director, Brain Tumor Program The University of Michigan Ohio State University Comprehensive Cancer Ann Arbor, MI Center Richard L. Solove Research Institute Arthur G. James Cancer Hospital Columbus, OH

84 NCI Orientation for the Board of Scientific Advisors Eric A. Klein, M.D. 2023 Joan H. Schiller, M.D. 2020 Andrew C. Novick Distinguished Professor Deputy Director for Clinical Investigation and Chair Invo Schar Cancer Institute Glickman Urological and Kidney Institute Falls Church, VA Cleveland Clinic Foundation Professor of Surgery Stephen M. Schwartz, Ph.D., M.P.H. 2020 Cleveland Clinic Lerner College of Medicine Member, Program in Epidemiology Cleveland, OH Division of Public Health Sciences Fred Hutchinson Cancer Research Center Steven K. Libutti, M.D. 2023 Professor, Department of Epidemiology Director, Rutgers Cancer Institute of New Jersey University of Washington Vice Chancellor for Cancer Programs Seattle, WA Rutgers Biomedical and Health Sciences Rutgers, The State University of New Jersey Virgil H. Simons 2023 New Brunswick, NJ Founder and President The Prostate Net, Inc. Patricia M. Lorusso, D.O. 2020 Sanford, NC Associate Director Innovative Medicine at Yale Cancer Center Vernon K. Sondak, M.D. 2021 Professor, Department of Medicine Chair Smilow Cancer Hospital at Yale-New Haven Department of Cutaneous Oncology Yale University Director of Surgical Education New Haven, CT H. Lee Moffitt Cancer Center & Research Institute Douglas G. McNeel, M.D., Ph.D.* 2023 Tampa, FL Professor of Medicine Division of Hematology-Oncology Ren Sun, Ph.D. 2020 University of Wisconsin Carbone Cancer Center Professor Madison, WI Department of Molecular and Medical Pharmacology Duane A. Mitchell, M.D., Ph.D. 2022 David Geffen School of Medicine Director, University of Florida Brain Tumor Professor, Department of Bioengineering Immunotherapy Program University of California, Los Angeles Associate Chair of Research Los Angeles, CA Phyllis Kottler Friedman Professor Department of Neurosurgery Mary Beth Terry, Ph.D. 2023 University of Florida Professor Gainesville, FL Department of Epidemiology Mailman School of Public Health Roman Perez-Soler, M.D. 2020 Columbia University Professor and Chairman New York, NY Department of Oncology Montefiore Medical Center Gail E. Tomlinson, M.D., Ph.D. 2021 Deputy Director, Albert Einstein Cancer Center Professor of Pediatrics Director, Division of Medical Oncology Greehey Distinguished Chair in Genetics Albert Einstein College of Medicine and Cancer Bronx, NY Division Chief, Pediatric Hematology- Oncology University of Texas Health Science Center at San Antonio San Antonio, TX

______* Pending.

NCI Orientation for the Board of Scientific Advisors 85 Sally W. Vernon, Ph.D. 2020 Executive Secretary Chair Department of Health Promotion and Behavioral Brian Wojcik, Ph.D. Sciences Institute Review Office Center for Health Promotion and Prevention Office of the Director Research National Cancer Institute Blair Justice, Ph.D. Professorship in Bethesda, MD Mind-Body Medicine and Public Health The University of Texas School of Public Health Houston, TX

86 NCI Orientation for the Board of Scientific Advisors APPENDIX G

BOARD OF SCIENTIFIC COUNSELORS Basic Sciences Chair

Martin McMahon, Ph.D. 2021 Cumming-Presidential Professor of Cancer Biology Department of Dermatology Senior Director for Preclinical Translation Huntsman Cancer Institute University of Utah Salt Lake City, UT

Members M. Luisa Iruela-Arispe, Ph.D. 2021 Professor and Vice-Chair Hashim M. Al-Hashimi, Ph.D. 2020 Department of Molecular, Cell, and James B. Duke Professor of Biochemistry Developmental Biology Director, Duke Center for RNA Biology Director, Molecular Biology Institute Professor, Department of Biochemistry and University of California, Los Angeles Chemistry Los Angeles, CA Duke University Medical Center Durham, NC Stephen C. Jameson, Ph.D. 2021 Professor Peter Cresswell, Ph.D., FRS 2020 Department of Laboratory Medicine Investigator, Howard Hughes Medical Institute and Pathology Eugene Higgins Professor Center for Immunology Department of Immunobiology University of Minnesota Medical Yale University School of Medicine School New Haven, CT Minneapolis, MN Sue Jinks-Robertson, Ph.D. 2020 Denise A. Galloway, Ph.D. 2020 Professor Associate Director Department of Molecular Genetics and Human Biology Division Microbiology Fred Hutchinson Cancer Research Center Duke University Medical Center Research Professor Durham, NC Department of Microbiology University of Washington Tracy L. Johnson., Ph.D. 2022 Seattle, WA Maria Rowera Ross Chair of Cell Biology Angela M. Gronenborn, Ph.D. 2020 and Biochemistry UPMC Rosalind Franklin Professor and Chair Professor Department of Structural Biology Department of Molecular, Cell, and Professor, Department of Bioengineering Developmental Biology Swanson School of Engineering Associate Dean for Inclusive Excellence Director, Pittsburgh Center for HIV Protein Division of Life Sciences Interactions University of California, Los Angeles University of Pittsburgh Los Angeles, CA Pittsburgh, PA

NCI Orientation for the Board of Scientific Advisors 87 Jonathan Karn, Ph.D. 2019 Mary Ann Osley, Ph.D. 2023 Reinberger Professor of Molecular Biology The Victor and Ruby Hanson Surface and Microbiology Professor in Cancer Epigenetics Director, CWRU/UH Center for AIDS Department of Molecular Genetics Research School of Medicine and Microbiology Case Western University The University of New Mexico Cleveland, OH Co-Director, Cancer Genetics, Epigenetics, and Genomics Program Mitchell Kroneberg, Ph.D. 2023 The University of New Mexico Cancer Center President and Chief Scientific Officer Albuquerque, NM La Jolla Institute for Allergy and Immunology San Diego, CA M. Celeste Simon, Ph.D. 2021 Professor, Department of Cell and Kit S. Lam, M.D., Ph.D. 2021 Developmental Biology Professor and Chair Scientific Director Department of Biochemistry and Molecular The Abramson Family Cancer Research Institute Medicine Perelman School of Medicine Professor, Division of Hematology and Oncology University of Pennsylvania UC Davis Comprehensive Cancer Center Philadelphia, PA University of California, Davis Sacramento, CA Erik J. Sontheimer, Ph.D. 2023 Professor Paul F. Lambert, Ph.D. 2022 RNA Therapeutics Institute Howard M. Temin Professor University of Massachusetts Medical School Chair Worcester, MA Department of Oncology Director Paul W. Spearman, M.D. 2020 McArdle Laboratory for Cancer Research Professor, Division Director and Vice Chair University of Wisconsin School of Medicine for Research and Public Health Department of Pediatrics Madison, WI Division of Infectious Diseases Emory University School of Medicine Anna K. Mapp, Ph.D. 2022 Atlanta, GA Edwin Vedejs Collegiate Professor of Chemistry Research Professor David W. Threadagill, Ph.D. 2021 Director, Cancer Biology Program University Distinguished Professor Life Sciences Institute University of Veterinary Pathobiology University of Michigan Department of Molecular and Cellular Ann Arbor, MI Medicine Texas A&M University Health Science Denise J. Montell, Ph.D. 2023 Center College Station, TX Robert and Patricia Duggan Professor Department of Molecular, Cellular, and JoAnn Trejo, Ph.D. 2023 Developmental Biology Professor and Vice Chair of Pharmacology University of California, Santa Barbara Associate Dean for Health Sciences Santa Barbara, CA Faculty Affairs Department of Pharmacology Alexandra C. Newton, Ph.D. 2021 School of Medicine Professor of Pharmacology University of California, San Diego Co-Director, Molecular Pharmacology Track La Jolla, CA University of California, San Diego La Jolla, CA

88 NCI Orientation for the Board of Scientific Advisors David L. Wiest, Ph.D. 2021 Executive Secretary Professor Immune Cell Development and Host Mehrdad Tondravi, Ph.D. Defense Program Chief Blood Cell Development and Cancer Institute Review Office Keystone Office of the Director Fox Chase Cancer Center National Cancer Institute Philadelphia, PA Bethesda, MD

NCI Orientation for the Board of Scientific Advisors 89 APPENDIX H

NCI COUNCIL OF RESEARCH ADVOCATES

Chair

Gregory H. Aune, M.D., Ph.D. 2019 Assistant Professor of Pediatrics The University of Texas Health Science Center San Antonio, TX

Members Danielle Leach, M.P.A. 2020 Director of Advocacy and Government Rick Bangs, M.B.A., PMP 2020 Relations Chair, SWOG Patient Advocate Committee St. Baldrick’s Foundation Rochester Hills, MI Huntington, MD

Mary Ann Battles, M.S. 2019 Jennifer W. Pegher 2021 Head, Clinical Quality and Compliance Executive Director Genentech/Roche Association of American Cancer Institutes South San Francisco, CA Pittsburgh, PA

Angelica Q. Davis 2021 Roberto A. Vargas, M.P.H. 2019 President Navigator Fight Colorectal Cancer Community Engagement and Health Policy Springfield, MO Program Clinical and Translational Sciences Institute Julie Fleshman, J.D., M.B.A. 2020 University of California San Francisco President and Executive Officer San Francisco, CA Pancreatic Cancer Action Network Manhattan Beach, CA Executive Secretary

Sue J. Friedman, D.V.M. 2019 Amy Williams Executive Director Acting Director Facing Our Risk of Cancer Empowered Office of Advocacy Relations Coral Springs, FL National Cancer Institute, NIH Bethesda, MD

90 NCI Orientation for the Board of Scientific Advisors APPENDIX I

CLINICAL TRIALS AND TRANSLATIONAL RESEARCH ADVISORY COMMITTEE (CTAC) Acting Chair

Patrick J. Loehrer, Sr., M.D. 2020 Director Melvin and Bren Simon Cancer Center Associate Dean for Cancer Research Indiana University School of Medicine Indianapolis, IN

Members Anne-Marie R. Langevin, M.D. 2021 Greehey Distinguished Chair in Pediatric Debra L. Barton, Ph.D., R.N., F.A.A.N. 2021 Oncology Mary Lou Willard French Professor Department of Pediatrics Hematology/ of Oncology Nursing Oncology University of Michigan School of Nursing The University of Texas Health Science Center Ann Arbor, MI at San Antonio San Antonio, TX Janet Ellen Dancey, M.D., F.R.C.P.C. 2021 Professor Lynn M. Matrisian, Ph.D., M.B.A. 2021 Department of Oncology Chief Research Officer Queen’s University Pancreatic Cancer Action Network Washington, DC Director, Canadian Cancer Trails Group Kingston, Ontario, Canada Neal J. Meropol, M.D. 2021 Vice President of Research Oncology Nancy E. Davidson, M.D. (BSC) 2022 Flatiron Health Senior Vice President, Director, and Full Member New York, NY Clinical Research Division Fred Hutchinson Cancer Research Center Augusto C. Ochoa, M.D. 2019 President and Executive Director Director Seattle Cancer Care Alliance Head Stanley S. Scott Cancer Center Division of Medical Oncology Professor Department of Medicine Department of Pediatrics University of Washington Louisiana State University Health Sciences Center Seattle, WA New Orleans, LA

Timothy J. Eberlein, M.D. 2020 Roman Perez-Soler, M.D. (BSC) 2020 Bixby Professor and Chairman Chairman Department of Surgery Department of Oncology Washington University School of Medicine Montefiore Medical Center in St. Louis Deputy Director St. Louis, MO Albert Einstein Cancer Center Director David M. Gershenson, M.D. 2020 Division of Medical Oncology Professor of Gynecology Albert Einstein College of Medicine Department of Gynecologic Oncology and Bronx, NY Reproductive Medicine Division of Surgery The University of Texas MD Anderson Cancer Center Houston, TX

NCI Orientation for the Board of Scientific Advisors 91 Gloria M. Petersen, Ph.D. 2019 Paulette S. Gray, Ph.D. Professor of Epidemiology Director Department of Education Administration Division of Extramural Activities Mayo Clinic College of Medicine National Cancer Institute Rochester, MN National Institutes of Health Bethesda, MD Steven T. Rosen, M.D., F.A.C.P. 2021 Provost & Chief Scientific Officer Michael J. Kelley, M.D., F.A.C.P. Director National Program Director for Oncology Comprehensive Cancer Center Veterans Health Administration and Beckman Research Institute U.S. Department of Veterans Affairs Irell & Manella Cancer Center Director’s Washington, DC Distinguished Chair City of Hope Comprehensive Cancer Center Anthony Kerlavage, Ph.D. Duarte, CA Director Center for Biomedical Informatics and Information Dan Theodorescu, M.D., Ph.D. 2020 Technology Professor and Director Office of the Director Department of Pharmacology and Urology National Cancer Institute University of Colorado Comprehensive National Institutes of Health Cancer Center Bethesda, MD Aurora, CO Richard Pazdur, M.D., F.A.C.P. Ex Officio Members Director Oncology Center of Excellence William Dahut, M.D. U.S. Food and Drug Administration Scientific Director of Clinical Research and Rockville, MD Clinical Director, Center for Cancer Research National Cancer Institute Executive Secretary National Institutes of Health Bethesda, MD Sheila A. Prindiville, M.D., M.P.H. Director James H. Doroshow, M.D. Coordinating Center for Clinical Trials Deputy Director for Clinical and Translational Office of the Director Research National Cancer Institute Director, Division of Cancer Treatment and National Institutes of Health Diagnosis Bethesda, MD National Cancer Institute National Institutes of Health Bethesda, MD

92 NCI Orientation for the Board of Scientific Advisors APPENDIX J FREDERICK NATIONAL LABORATORY ADVISORY COMMITTEE

Chair

Lawrence J. Marnett, Ph.D. 2021 Dean of Basic Sciences University Professor Mary Geddes Stahlman Professor of Cancer Research Professor of Biochemistry, Chemistry and Pharmacology Vanderbilt University School of Medicine Nashville, TN

Members Angela M. Gronenborn, Ph.D. (BSC3) 2020 UPMC Rosalind Franklin Professor and Chair Catherine M. Bollard, M.D. 2022 Department of Structural Biology Director, Center for Cancer and Immunology Professor, Department of Bioengineering Swanson Director, Program for Cell Enhancement and School of Engineering Technologies for Immunotherapy Director, Pittsburgh Center for HIV Protein Children’s Research Institute Interactions Children’s National Health System University of Pittsburgh Pittsburgh, PA Washington, DC Robert L. Grossman, Ph.D. 2021 Andrea Califano, Ph.D.* 2022 Director, Center for Data Intensive Science Clyde and Helen Wu Professor of Professor, Department of Medicine Chemical and Systems Biology University of Chicago Director, JP Sulzberger Columbia Genome Center Chicago, IL Associate Director for Bioinformatics Herbert Irving Comprehensive Cancer Center Klaus M. Hahn, Ph.D. 2020 Columbia University Thurman Professor of Pharmacology New York, NY Director, UNC-Olympus Imaging Center Department of Pharmacology Lisa M. Coussens, Ph.D. 2020 University of North Carolina at Chapel Hill Hildegard Lamfrom Chair in Basic Science Chapel Hill, NC Professor and Chair, Cell, Developmental and Cancer Biology David I. Hirsh, Ph.D. 2019 Associate Director for Basic Research Professor Knight Cancer Institute Department of Biochemistry and Molecular Oregon Health & Science University Biophysics Portland, OR College of Physicians & Surgeons Columbia University Kevin J. Cullen, M.D. 2020 New York, NY Director Marlene and Stewart Greenebaum Cancer Center Elizabeth M. Jaffee, M.D. (NCAB2) 2018 Professor of Medicine Deputy Director, The Sidney Kimmel University of Maryland School of Medicine Comprehensive Cancer Center Baltimore, MD The Dana and Albert Cubby Broccoli Professor of Oncology Raymond N. DuBois, Jr., M.D., Ph.D. (BSC4) 2021 Co-Director, Skip Viragh Center for Dean, College of Medicine Pancreas Cancer Professor, Departments of Biochemistry Johns Hopkins University Baltimore, MD and Medicine Medical University of South Carolina Charleston, SC ______* Pending.

NCI Orientation for the Board of Scientific Advisors 93 Nilsa C. Ramirez Milan, M.D., F.C.A.P. 2020 James H. Doroshow, M.D. Medical Director, Biopathology Center Deputy Director for Clinical and Translational Director, Autopsy Pathology Research Department of Pathology and Laboratory Director, Division of Cancer Treatment and Medicine Diagnosis Nationwide Children’s Hospital National Cancer Institute Professor of Clinical Pathology National Institutes of Health The Ohio State University College of Medicine Bethesda, MD Columbus, OH Paulette S. Gray, Ph.D. Patrick Nana-Sinkam, M.D. 2022 Director Professor of Medicine Division of Extramural Activities National Cancer Chair, Division of Pulmonary Disease Institute and Critical Care Medicine National Institutes of Health Virginia Commonwealth University Bethesda, MD Richmond, VA Sara Hook, Ph.D. Lincoln D. Stein, M.D., Ph.D. 2022 Associate Director Director, Informatics and Biological Computing Office of Scientific Operations Platform Frederick National Laboratory for Cancer Ontario Institute for Cancer Research Research Professor, Department of Molecular Genetics National Cancer Institute University of Toronto National Institutes of Health Toronto, Ontario, Canada Frederick, MD

Cheryl L. Willman, M.D. (BSA1) 2021 Anthony Kerlavage, Ph.D. Maurice and Marguerite Liberman Director, Center for Biomedical Distinguished Chair in Cancer Research Informatics and Information Technology Director and CEO, University of New Mexico National Cancer Institute Comprehensive Cancer Center University of National Institutes of Health New Mexico Albuquerque, NM Bethesda, MD Executive Secretary Tom Misteli, Ph.D. Caron A. Lyman, Ph.D. Director Chief, Research Programs Review Branch Center for Cancer Research Division of Extramural Activities National Cancer Institute National Cancer Institute National Institutes of Health National Institutes of Health Bethesda, MD Bethesda, MD Donna Siegle Representatives: Acting Deputy Director of Management and Executive Officer 1BSA Board of Scientific Advisors National Cancer Institute 2NCAB National Cancer Advisory Board National Institutes of Health 3BSC Board of Scientific Counselors— Bethesda, MD Basic Sciences 4BSC Board of Scientific Counselors—Clinical Dinah S. Singer, Ph.D. Sciences and Epidemiology Deputy Director for Scientific Strategy and Development Ex Officio Members National Cancer Institute National Institutes of Health Stephen J. Chanock, M.D. Bethesda, MD Director Division of Cancer Epidemiology & Genetics National Cancer Institute National Institutes of Health Bethesda, MD

94 NCI Orientation for the Board of Scientific Advisors APPENDIX K EXAMPLE OF REQUEST FOR APPLICATION (RFA) CONCEPT FORM AND JUSTIFICATION

Attachment I Date Prepared:__11/21/2008______

REQUEST FOR EC/BSA CONCEPT APPROVAL REQUESTS FOR APPLICATIONS (RFAs)/CONTRACTS (RFPs)

Title: Cancer Intervention and Surveillance Modeling Network

RFA _X__ Coop. Ag. __X__ RFP____ Activity Code (e.g.R01)__U01______

Limited Comp. _____ New ___ Reissue _X__

Division/Office/Center: Cancer Control Program Director: Eric J. Feuer, Ph.D. and Population Sciences Division/Office/Center Director: Robert Croyle, Ph.D. Division/Office/Center Co-sponsor(s): ______

Length of Award (Yrs.) ___5______Source of Funds: RPG _X__Control ___Centers____

Anticipated Award Date:_09/2010____ Other Res:______Construct _____ NRSA ______

RFAs (Set Aside): (single issuance only) Est. Number of Awards :_____6______

Amount of Set Aside 01 Est. Cost for Total Project Year:__$5.4M____ Period:___$29.4M______

Justification for Use of RFA/RFP New issuance: Mechanism: Are evaluation criteria included? ______Attached: ___X______Reissuance: Congressional Mandate:______Is the evaluation included? __Yes______Other: ______

revised: March 13, 2018

NCI Orientation for the Board of Scientific Advisors 95 1

Justification for Reissuance Cancer Intervention and Surveillance Modeling Network (CISNET)

I. Background

The Cancer Intervention and Surveillance Modeling Network (CISNET) is a consortium of NCI- sponsored investigators whose focus is to use modeling to improve our understanding of the impact of cancer control interventions (e.g., prevention, screening and treatment) on population trends in incidence and mortality. These models can be used to project future trends and aid in the development of optimal cancer control strategies. Currently, CISNET consists of four groups of grantees who focus on breast, prostate, colorectal, and lung cancers which utilize statistical simulation and other modeling approaches. The models incorporate data from randomized controlled trials, meta-analyses, observational studies, national surveys, and studies of practice patterns to evaluate the past and potential future impact of these interventions.

A. Continuing Scientific Need

There is a formidable and growing gap between the rapid pace of innovation in biomedicine and our ability to harness it to improve population health. While contemporary science has enabled the collection and analysis of health-related data from numerous sectors, enormous challenges remain to integrate various sources of information into optimal decision-making tools to inform public policy. Informed decisions regarding effective clinical and public health interventions for the four cancer sites in CISNET can have enormous impact because of their high incidence and mortality, and cancer control potential. Further public health challenges can be tackled by expanding work in this four cancer sites and by extending beyond these original four cancer sites.

Originally conceived as “virtual laboratories” performing in silico experiments of potential public health strategies, CISNET represents a quantum leap forward in the practice of modeling to inform clinical and policy decisions. Collaborative work on key questions promotes efficient collecting and sharing of the most important data resources, and critical evaluation of the strengths and weaknesses of each data sources. A systematic comparative modeling approach brings transparency to the modeling process. Providing results from a range of models, rather than a single estimate from one model, brings credibility to the process and reassures policy makers that the results are reproducible.

CISNET is committed to bringing the most sophisticated evidence based-planning tools to the areas of population health and public policy. CISNET models can translate evidence from randomized trials and epidemiological studies to the population setting by extrapolating evidence beyond study protocols to the general population accounting for actual usage in less controlled settings. Modeling real and hypothetical scenarios allows for the identification of key factors influencing outcomes and efficient cancer control strategies. The consortium’s work informs clinical practice and recommended guidelines by synthesizing existing, albeit often incomplete, information to model gaps in available knowledge. CISNET provides a suite of models that are able to meet the challenges of the increasing pace of scientific discovery and are poised to address emerging questions, and to determine the most efficient and cost-effective strategies for implementing technologies in the population. CISNET models can assist in determining which new technologies are the most promising when scaled up to the population level.

The research and accomplishments of CISNET to date have created a solid foundation that enables NCI and CISNET investigators and collaborating organizations to address a number of emerging cancer

96 NCI Orientation for the Board of Scientific Advisors NCI Orientation for the Board of Scientific Advisors 97 comparative

98 NCI Orientation for the Board of Scientific Advisors NCI Orientation for the Board of Scientific Advisors 99 100 NCI Orientation for the Board of Scientific Advisors 6

United States and Europe become available. For both prostate and lung cancer screening, substantial overdiagnosis and mortality benefits may coexist, complicating population-level recommendations. Trials in different countries are run under different protocols, and modeling may hold the key to translating results from one trial setting to another in order to reconcile putative differences. For example, the European Randomized Study of Screening for Prostate Cancer (ERSPC) is an “efficacy” trial with an established protocol for follow-up of abnormal results while the US PLCO trial is an “effectiveness” trial, with abnormal screening results provided to patient’s physicians, who determine further workup. CISNET will work to produce a more seamless link between trialists, modelers, and guideline-setting organizations.

Interactive policy-level decision-making tools: Development of interactive interfaces for models that will allow cancer control planners and policy makers to explore the impact of varying key parameters involved in their decision-making options. These tools will facilitate evidence-based decisions, while ensuring that they are understandable and relevant for the target audiences.

III. Current Portfolio Analysis

Besides CISNET there are very few grants in the NCI portfolio on population based disease modeling, and nothing else which employs the rigorous comparative modeling approach. The CISNET consortium has encouraged affiliate membership for those funded under a different mechanism, but who wish to join the collaborative activities for a particular cancer site. In addition to six grants by CISNET affiliate members, we could find only three other funded grants in population level cancer modeling (on HPV vaccination, economics of colon cancer screening, and radon policy for lung cancer control).

IV. Justification for the Use of the RFA Mechanism

The RFA mechanism will continue to greatly enhance the quality and quantity of work being conducted in this still relatively untapped but high priority area. It will provide assurance that the NCI's investment to date in building the capacity for comparative population modeling is capitalized in a timely and efficient manner. An RFA will continue to enunciate the Institute's interest in models of the population impact of cancer control interventions, by increasing the available funding specifically allocated to this area, and by assembling a special review group with appropriate specialized but multi-disciplinary expertise. The special review criteria encompassed in an RFA are necessary to ensure that grantees address the priority needs of the NCI in this area and that grantees are willing and able to collaborate with each other and with NCI staff. Other mechanisms, e.g. a Program Announcement with Review (PAR), would not allow for the level of scientific interactivity desired between the grantees and with NCI. The use of the cooperative agreement mechanism (see section V) will facilitate coordination and collaboration of this work, resulting in synergistic contributions to research progress in this area, and will produce research work that can inform national and local policy in the area of cancer control and surveillance.

V. Justification for the Use of the Cooperative Agreement Mechanism

CISNET will be continued to be funded through a cooperative agreement (U01) mechanism. A Cooperative Agreement Mechanism will make it possible to continue to have close collaboration between NCI staff and grantees, as well as among grantees. Collaboration will: (1) facilitate comparative analyses which improve the credibility of individual models, (2) allow modeling groups access to a broader array of data resources and multi-disciplinary expertise not readily found in any

NCI Orientation for the Board of Scientific Advisors 101 7

individual research center, and (3) provide a forum for discussions of validation and other methodologic issues across the consortium. Close collaboration and coordination with NCI staff is crucial because: (1) DCCPS has a federal-level function to respond to evolving surveillance and cancer control questions of national policy relevance, and can actively engage the consortium to help respond to these issues, (2) DCCPS has unique knowledge of and can help expedite access to a wide variety of data resources, and (3) the cooperative agreement mechanism will ensure substantive NCI involvement in attaining research goals and catalyzing collaborations both between consortium members and with outside groups seeking collaborations (who often come to NCI seeking assistance).

For each cancer site, we propose linked applications (each with approximately 2-5 models included), which will facilitate several goals of this reissuance, including: (1) group proposals will incorporate plans for joint collaborative analyses, rather than having to change plans after the grants are awarded, (2) the group as a whole would try to provide complete coverage of the new areas of model development (with each group specializing in certain areas), rather than each individual PI’s unrealistically trying to cover the entire range of new areas, (3) since the application process would allow PI’s to decide who they want to work with, it will reward those who are most cooperative, and (4) coordination of group activities would be built into the application, rather than having it funded separately. Coordination in the application phase will yield groups which have agreed upon areas for joint comparative analyses, and complementary areas of specialization. Groups can bring in specialized modeling expertise (e.g. multi- scale modelers, upstream modelers). Linked applications will designate one PI as the coordinator.

VI. Budget

We propose funding up to 6 cancer-site specific groups of linked applications averaging $900K total cost per year. The awards could be made for up to 5 years. In addition, in years 2-5 we are requesting $600K per year for discretionary core collaborative study funds that will be used to facilitate collaborations with organizations (either governmental or non-governmental) that bring timely cancer control issues to CISNET amenable to modeling (e.g. release of the PSA screening results from PLSO, with potential partnerships with trialists and the USPSTF). Funds will be used to pay for both the time of CISNET investigators, the time of collaborators, data acquisition and preparation costs, etc. These funds will be part of the coordinating PI’s budget, and will be allocated with agreement of the PI’s and the CISNET program director. Thus the total funding requested is:

FY2010 FY2011 FY2012 FY2013 FY2014 Grant funds $5.40M $5.40M $5.40M $5.40M $5.40M Core ______$0.60 M $0.60M $0.60M $0.60M Collaborative Study Funds Total $5.40M $6.00M $6.00M $6.00M $6.00M

The original CISNET RFA supported two phased in rounds of funding. In September 2010, CA-09-013 funded seven grants in breast cancer and one apiece in prostate and colorectal cancer. A second round, funded under CA-02-010 in August 2002, funded 5 grants in lung cancer as well as two additional grants for colorectal cancer and one in prostate cancer. The total amount of funding under these announcements was $13.1M. In September 2005, CA-05-018 funded 15 grants (3 prostate, 3 breast, 4 colorectal, and 5 lung), and the total amount of funding to date under this solicitation is $14.6M. While the first rounds of funding focused on model development, the second round has focused on applying the models to answer

102 NCI Orientation for the Board of Scientific Advisors 8

vital questions related to emerging cancer trends, the potential impact of interventions on future trends, and the identification of optimal strategies for reducing the cancer burden.

The CISNET grants have been run efficiently with an average annual budget of $0.25M total cost per awarded grant, and an average annual cost of between $3M and $4M for the entire consortium per year. With over 135 publications, CISNET participants continue to produce an exemplary publication track despite the increased time commitment of comparative modeling as opposed to single model publications. There has been a natural transition over the funding period from more technical modeling papers to papers focusing on model applications of the public health impact of interventions. Interdisciplinary expertise has been shared across the consortium, including specialized clinical and statistical expertise. The work of the consortium in facilitating evidence-based public health guidelines (e.g. ages to start and stop screening, periodicity of screening) has the potential to save billions of dollars in terms of health care costs because of the elimination of excessive testing with marginal benefit.

VII. Evaluation

An external review committee consisting of Dr. Alice Whittemore (Stanford University), Dr. Constantine Gatsonis (Brown University) and Dr. J. Sanford Schwartz (U. of Pennsylvania) have reviewed the accomplishments of CISNET to date, and indicated that the consortium has made major progress towards it primary goals. The report endorsed the areas for future research, suggested pilot projects as a way to incrementally gain experience in these new areas, and suggested evaluation of diagnostic tests as a fruitful area for modeling (which has been added). The report is attached.

In future evaluations of CISNET, the consortium should show evidence of:

x Providing an environment that is conducive to sharing modeling issues, discussing the strengths and limitation of various data sources, and collaboration. x Providing model transparency through standardized model documentation that can be displayed on the web, and encourages cross-model comparisons of model structure and assumptions. x Further development and utilization of multiple cohort population models that can describe the actual US population over time. x Engaging in collaborations with relevant trialists, researchers, and policy and guidelines setting organizations. x Providing assistance in facilitating the translation of medical research in the T1 to T4 schema in the areas identified in the “Purpose of the RFA” section above, and in other relevant areas. x Being responsive to emerging cancer control issues.

NCI Orientation for the Board of Scientific Advisors 103 APPENDIX L EXAMPLE OF RFA REISSUANCE JUSTIFICATION LETTER

104 NCI Orientation for the Board of Scientific Advisors APPENDIX M EXAMPLE OF REQUEST FOR PROPOSAL (RFP) CONCEPT FORM AND JUSTIFICATION

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NCI Orientation for the Board of Scientific Advisors 107 4 DISCOVERY ONGOING GENOME

TCGA and TARGET WIDE Datasets PROPOSED FUNDING OPPORTUNITY Mining of Databases and Publications

DNA, RNA Protein and epigenetic candidate candidate biomarkers biomarkers

Development of Reagents and Multiplex Assays FUTURE PLAN Assay optimization selectivity, specificity, and validation

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114 NCI Orientation for the Board of Scientific Advisors APPENDIX N ACRONYMS

FREQUENTLY USED NCI ACRONYMS CC Cancer Center ACRIN American College of Radiology CC Clinical Center Imaging Network CCCT Coordinating Center for Clinical ACSR AIDS and Cancer Specimen Trials Resource CCG Center for Cancer Genomics ACTNOW Accelerating Clinical Trials of Novel CCGs Clinical Cooperative Groups Oncologic Pathways CCNE Center of Cancer Nanotechnology AdEERS Adverse Event Expedited Reporting Excellence System CCOP Community Clinical Oncology AER Accelerated Executive Review Program AHRQ Agency for Healthcare Research and CCR Center for Cancer Research Quality CCSG Cancer Center Support Grant AIDS Acquired Immune Deficiency Syndrome CDC Centers for Disease Control and Prevention ARC Administrative Resource Center CDER Center for Drug Evaluation and AREA Academic Research Enhancement Research, FDA Award CDEs Common Data Elements ARRA American Recovery and Reinvestment Act CDRP Cancer Disparities Research Partnership Program ASSIST American Stop Smoking Intervention Study CECCR Centers of Excellence in Cancer Communication Research ATC Advanced Technology Radiation Therapy Clinical Trials Support CEPs Concept Evaluation Panels BAA Broad Agency Agreement CER Comparative Effectiveness Research BCERC Breast Cancer and the Environment CFR Code of Federal Regulations Research Centers CGs Cooperative Groups BCSC Breast Cancer Surveillance CGAP Cancer Genome Anatomy Project Consortium CGCR Center for Global Cancer Research BMTCTN Blood and Marrow Transplant CGEMS Cancer Genetic Markers of Clinical Trials Network Susceptibility BRDPI Biomedical Research and CGN Cancer Genetics Network Development Price Index CHP Consumer Health Profiles BRP Blue Ribbon Panel CHTN Cooperative Human Tissue BSA Board of Scientific Advisors Network BSC Board of Scientific Counselors CIBMTR Center for International Blood and caHUB Cancer Human Biobank Marrow Transplant Research caIMAGE Cancer Image database CIRB Central Institutional Review Board CAN Common Account Number CIS Cancer Information Service CanCORS Cancer Care Outcomes Research CISNET Cancer Intervention and and Surveillance Consortium Surveillance Modeling Network CanQual Cancer Quality of Care Measures CIT Center for Information Technology Project CLIA/CAP Clinical Laboratory Improvement CBER Center for Biologics Evaluation and Act and College of American Research, FDA Pathology

NCI Orientation for the Board of Scientific Advisors 115 CMO Committee Management Office EEO Equal Employment Opportunity CMS Centers for Medicare and Medicaid ER Extramural Research Services ERA Electronic Research Administration CNP Community Networks Program ERP Extramural Research Program CNPP Cancer Nanotechnology Platforms ESA Extramural Support Assistance Partnerships EXEC SEC Executive Secretary COI Conflict of Interest F&A Facilities and Administration COMMIT Community Intervention Trial for Smoking Cessation FACA Federal Advisory Committee Act Coop. Agr. Cooperative Agreement FAR Federal Acquisition Regulations CPTC Clinical Proteomic Technologies for FDA Food and Drug Administration Cancer FDP Federal Demonstration Partnership CPTI Clinical Proteomics Technologies FNLAC Frederick National Laboratory Initiative Advisory Committee CRADA Cooperative Research and FOA Funding Opportunity Development Agreement Announcement CRISP Computer Retrieval of Information FOIA Freedom of Information Act on Scientific Programs FR Federal Register CRN Cancer Research Network FTE Full-Time Equivalent CRP Cancer Research Portfolio FTTA Federal Technology Transfer Act CRTA Cancer Research Training Award FUS Focused Ultrasound CSO Common Scientific Outline FY Fiscal Year CSR Center for Scientific Review GAO Government Accountability Office CT spiral Computed Tomography GEI Genes and Environment Initiative CTAC Clinical and Translational Research GIS Advisory Committee Geographic Information System GMO CTROC Clinical and Translational Research Grants Management Officer Operations Committee GPRA Government Performance Review CTSU Clinical Trials Support Unit Act GSA CURE Continuing Umbrella of Research General Services Administration Experiences GWAS Genome Wide Association Studies DARPA Defense Advanced Research Projects HBCU Historically Black Colleges and Agency Universities DCIDE Development of Clinical Imaging HCFA Health Care Financing Drug Enhancers Administration DFO Designated Federal Official HHMI Howard Hughes Medical Institute DHHS Department of Health and Human HHS Department of Health and Human Services (now HHS) Services (replaces DHHS) DOD Department of Defense HINTS Health Information National Trends DOE Department of Energy Survey HIPAA DPCPSI Division of Program Coordination, Health Insurance Portability and Planning, and Strategic Initiatives Accountability Act HMO DSMB Data and Safety Monitoring Board Health Maintenance Organization HSA DSSC Disease-Specific Steering Committee Health Scientist Administrator IACUC eCIS online Cancer Information Service Institutional Animal Care and Use Committee EDRN Early Detection/Diagnosis Research IARC Network International Agency for Research on Cancer

116 NCI Orientation for the Board of Scientific Advisors IC Institute or Center NCATS National Center for Advancing IC CMO Institute/Center Committee Translational Sciences Management Office(r) NCBI National Cancer for Biotechnology ICBPs Integrative Cancer Biology Information Programs NCCCP NCI Community Cancer Centers ICMIC In Vivo Cellular and Molecular Program Imaging Centers NCDDGs National Cooperative Drug IDSC Investigational Drug Steering Discovery Groups Committee (CCCT) NCL Nanotechnology Characterization IHS Indian Health Service Laboratory IISAG Institute Information Systems NCORP NCI Clinical Oncology Research Advisory Group Program IMAT Innovative Molecular Analysis NCPB National Cancer Policy Board Technologies NCRA NCI Council of Research Advocates IND Investigational New Drug NCTN NCI National Clinical Trials IOM Institute of Medicine Network IPA Intergovernmental Personnel Act ND Not discussed IPR Intellectual Property Rights NEJM New England Journal of Medicine IR Intramural Research NGA Notice of Grant Award IRB Institutional Review Board NHIS National Health Interview Survey IRG Initial/Institutional Review Group NIH National Institutes of Health ITGs Informatics Technology Groups NIH GUIDE NIH Guide for Grants and Contracts (weekly Web publication) MARC Minority Access to Research Careers (NIH) NIOSH National Institute for Occupational Safety and Health MBCCOP Minority-Based Community Clinical Oncology Program NIST National Institute of Standards and Technology MBRS Minority Biomedical Research Support Program NLST National Lung Screening Trial mCGAP Mouse Cancer Genome Anatomy NQF National Quality Forum Project NRFC Not Recommended for Further MEO Most Efficient Organization Consideration MERIT Method to Extend Research in Time NRSA National Research Service Award Award (NIH, R37) NSF National Science Foundation MICCP Minority Institutions Cancer Center NTROI Network for Translational Research: Partnerships Optical Imaging MMHCC Mouse Models of Human Cancer OBC Operations and Biostatistics Center Consortium OBSSR Office of Behavioral and Social MR Magnetic Resonance Science Research MRI Magnetic Resonance Imaging OD Office of the Director MTDD Molecular Target Drug Discovery OEP Office of Extramural Policy MTL Molecular Targets Laboratory OER Office of Extramural Research (NIH) NAC National Advisory Council OFACP Office of Federal Advisory NASA National Aeronautics and Space Committee Policy (formerly NIH/ Administration CMO) NBN National Bio-specimen Network OGE Office of Government Ethics NCAB National Cancer Advisory Board OHRP Office for Human Research Protections

NCI Orientation for the Board of Scientific Advisors 117 OIG Office of the Inspector General PROMIS Patient-Reported Outcomes OLAW Office of Laboratory Animal Welfare Measurement Information System OMB Office of Management and Budget PSA Physician Scientist Award OPERA Office of Policy for Extramural QCCC Quality Cancer Care Committee Research Administration QOC Quality of Care OPM Office of Personnel Management QOL Quality of Life OPRR Office for Protection from Research R&D Research and Development Risks (Now OHRP) RAC Recombinant Activities Committee ORI Office of Research Integrity RAID Rapid Access to Intervention ORMH Office of Research on Minority Development Health (NIH) RAND Rapid Access to NCI Discovery ORWH Office of Research on Women’s RAPID Rapid Access to Preventive Health (NIH) Intervention Development OSTP Office of Science and Technology RCDC Research Condition and Disease Policy Categorization PA Program Announcement RCMI Research Centers in Minority PAC Program Advisory Committee Institutions PACCT Program for the Assessment of RFA Request for Application (Grants) Clinical Cancer Tests RFP Request for Proposal (Contracts) PAR Program Announcement Reviewed/ RM Roadmap Receipt RPG Research Project Grant PAS Program Announcement with Set- aside funds RWJ Robert Wood Johnson Foundation PBTC Pediatric Brain Tumor Consortium SAMHSA Substance Abuse and Mental Health Services Administration PCP President’s Cancer Panel SBIR Small Business Innovation Research PCPT Prostate Cancer Prevention Trial SEER Surveillance, Epidemiology, and PCOS Prostate Cancer Outcomes Study End Results PD Program Director/Project Director SEP Special Emphasis Panel PDQ Physicians Data Query SGE Special Government Employee PET Positron Emission Tomography SNAP Streamlined Noncompeting Award PHS Public Health Service Process PI Principal Investigator SoC Standards of Conduct PLANET Plan Link Act with Evidence-based SOW Statement of Work Tools SPIN Shared Pathology Informatics PLCO Prostate, Lung, Colorectal, and Network spiral Ovarian SPL Scientific Program Leadership PMA Premarket Application SPNs Special Population Networks PMI Precision Medicine Initiative SPORE Specialized Program of Research PNRP Patient Navigation Research Excellence Network SREA Scientific Review Evaluation Award PO Program Officer SRG Scientific Review Group POR Patient Oriented Research SRO Scientific Review Officer PRG Progress Review Group SSS Special Study Section PRODD Pilot Research to Overcome the STTR Small Business Technology Transfer Digital Divide TARGET Theapeutically Applicable Research PROG Peer Review Oversight Group to Generate Effective Treatments

118 NCI Orientation for the Board of Scientific Advisors TARP Tissue Array Research Program BBRB Basic BioBehavioral Research TCGA The Cancer Genome Atlas Branch TREC Transdisciplinary Research on BGCRG Breast and Gynecologic Cancer Energetics and Cancer Research Group TRIO Translating Research Into Improved BIP Biomedical Imaging Program Outcomes BOD Business Operations and TRWG Translational Research Working Development Group BPSRG Basic Prevention Science Research TTURCs Transdisciplinary Tobacco Use Group Research Centers BR Biological Resources VA Veterans Administration BRB Biometric Research Branch BRB Biological Resources Branch NCI ORGANIZATIONAL ACRONYMS BRB OC Biological Resources Branch Oversight Committee Division/Center(s): BRP Behavioral Research Program DCB Division of Cancer Biology CADRG Chemopreventive Agent DCCPS Division of Cancer Control and Development Research Group Population Sciences CBIIT Center for Biomedical Informatics DCEG Division of Cancer Etiology and and Information Technology Genetics CBRG Cancer Biomarkers Research Group DCP Division of Cancer Prevention CCB Cancer Centers Branch DCTD Division of Cancer Treatment and Diagnosis CCBB Cancer Cell Biology Branch DEA Division of Extramural Activities CCP Cancer Centers Program CCP Cancer Centers Program CDP Cancer Diagnosis Program CCR Center for Cancer Research CEB Cancer Etiology Branch CCT Center for Cancer Training cGAP Cancer Genome Atlas Project Office CRCHD Center to Reduce Cancer Health CGCB Clinical Grants and Contracts Disparities Branch CSSI Center for Strategic Scientific CIB Clinical Investigations Branch Initiatives CIHB Cancer Immunology and FNLCR Frederick National Laboratory for Hematology Branch Cancer Research CIP Cancer Imaging Program NCICB Center for Bioinformatics CIS Office of Cancer Information Service TTC Technology Transfer Center CMBB Comprehensive Minority SBIRDC Small Business Innovative Research Biomedical Branch Development Center COPTRG Community Oncology and Prevention Trials Research Group Programs/Offices/Branches: CROB Clinical Radiation Oncology Branch ACRB Applied Cancer Screening Research CSB Cancer Statistics Branch Branch CSSI Center for Strategic Scientific AERB Analytic Epidemiology Research Initiatives Branch CTB Cancer Training Branch AISB Applied Information Systems CTCP Branch Clinical Proteomic Technologies for Cancer AO Administration Operations CTEB Clinical and Translational ARC Administrative Resource Centers Epidemiology Branch ARP Applied Research Program

NCI Orientation for the Board of Scientific Advisors 119 CTEP Cancer Therapy Evaluation MTB Method and Technologies Branch Program NSRG Nutritional Science Research Group DCAB DNA and Chromosome Aberrations OA Office of Acquisitions Branch OAR Office of Advocacy Relations DIB Diagnostic Imaging Branch OBBR Office of Biorepositories and DRB Diagnostics Research Branch Biospecimens Research DRB Disparities Research Branch OBF Office of Budget and Finance DTP Development Therapeutics Program OCCAM Office of Cancer Complementary EDRG Early Detection Research Group and Alternative Medicine EFDB Extramural Financial Data Branch OCE Office of Communications and (Now OEFIA) Education EGRP Epidemiology and Genetics OCG Office of Cancer Genomics Research Program OCNR Office of Cancer Nanotechnology EO Ethics Office Research FMOSB Frederick Management Operations OCRP Office of Clinical Research and Support Branch Promotion GCOB Grants and Contracts Operations OCS Office of Cancer Survivorship Branch OCTR Office of Centers, Training and GOCRG Gastrointestinal and Other Cancer Resources Research Group OD Office of the Director HCIRB Health Communications and OEA Office of Extramural Applications Informatics Research Branch OEFIA Office of Extramural Finance and HPB Health Policy Branch Information Analysis (formerly HPRB Health Promotion Research Branch EFDB) HRMCB Human Resources Management and OESI Office of Education and Special Consulting Branch Initiatives HSEB Health Services and Economics OGA Office of Grants Administration Branch (formerly GAB) HSFB Host Susceptibility Factors Branch OGCR Office of Government and IDB Investigational Drug Branch Congressional Relations IGIB Image Guided Intervention Branch OGE Office of Government Ethics IRO Institute Review Office OHAM Office of HIV and AIDS Malignancy ISCS Information Systems and Computer OHRP Office of Human Research Services Protection ISTB Information Systems Technology OIA Office of International Affairs Branch OLACPD Office of Latin American Cancer ISWG Imaging Sciences Working Group Program Development ITDB Imaging Technology Development OM Office of Management Branch ORB Outcomes Research Branch LUACRG Lung and Upper Aerodigestive ORRPC Office of Referral Review and Cancer Research Group Program Coordination MAB Management Analysis Branch OSCB Organ Systems Coordinating MFRB Modifiable Risk Factors Branch Branch MIB Molecular Imaging Branch OTIR Office of Technology and Industrial Relations MRTB Molecular Radiation Therapeutics Branch OWH Office of Women’s Health PCRB Program Coordination and Referral Branch

120 NCI Orientation for the Board of Scientific Advisors PUCRG Prostate and Urologic Cancer FNIH Foundation for the National Research Group Institutes of Health RAEB Research Analysis and Evaluation NCATS National Center for Advancing Branch Translational Sciences RCAB Research Contracts and Acquisition NCCIH National Center for Complementary Branch and Integrative Health RDB Resources Development Branch NCI National Cancer Institute RDB Radiotherapy Development Branch NEI National Eye Institute REB Radiation Effects Branch NHGRI National Human Genome Research RFMMB Risk Factor Monitoring and Institute Methods Branch NHLBI National Heart, Lung and Blood RPRB Research Programs Review Branch Institute RRP Radiation Research Program NIA National Institute on Aging RTCRB Research Technology Contract NIAAA National Institute on Alcohol Abuse Review Branch and Alcoholism RTRB Resources and Training Review NIAID National Institute of Allergy and Branch Infectious Diseases SBMAB Structural Biology and Molecular NIAMS National Institute of Arthritis and Applications Branch Musculoskeletal and Skin Diseases SPL Scientific Program Leadership NIBIB National Institute of Biomedical Imaging and Bioengineering/ SRAB Statistical Research Application Biotechnology Branch NICHD National Institute of Child Health SRB Special Review Branch and Human Development SRP Surveillance Research Program NIDA National Institute on Drug Abuse STRIIC Strategic Technical Review and NIDCD National Institute on Deafness and Innovative Initiative Core Other Communication Disorders TBMB Tumor Biology and Metastasis NIDCR National Institute of Dental and Branch Craniofacial Research TCRB Tobacco Control Research Branch NIDDK National Institute of Diabetes and TDB Technology Development Branch Digestive and Kidney Diseases TDCB Technology Development and NIEHS National Institute of Environmental Commercialization Branch Health Sciences TRP Translational Research Program NIGMS National Institute of General Medical Sciences NIH ORGANIZATIONAL ACRONYMS NIH National Institutes of Health NIMH National Institute of Mental Health CC Clinical Center NIMHD National Institute on Minority CIT Center for Information Technology Health and Health Disparities CSR Center for Scientific Review NINDS National Institute of Neurological (formerly Division of Research Disorders and Stroke Grants) NINR National Institute for Nursing FIC John E. Fogarty International Center Research

NCI Orientation for the Board of Scientific Advisors 121 APPENDIX O CLINICAL RESEARCH AND CLINICAL TRIALS

Clinical Research: NIH defines human clinical re- • Phase I clinical trials are conducted to test a search as: (1) Patient-oriented research. Research new biomedical or behavioral intervention in conducted with human subjects (or on material a small group of people (e.g., 20-80) for the of human origin such as tissues, specimens, and first time to evaluate safety (e.g., determine a cognitive phenomena) for which an investigator safe dosage range, and identify side effects). (or colleague) directly interacts with human sub- jects. Excluded from this definition are in vitro • Phase II clinical trials are done to study the studies that utilize human tissues that cannot be biomedical or behavioral intervention in a linked to a living individual. Patient-oriented larger group of people (several hundred) to research includes: (a) mechanisms of human determine efficacy and to further evaluate its disease, (b) therapeutic interventions, (c) clinical safety. trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Out- • Phase III studies are conducted to study comes research and health services research. Note: the efficacy of the biomedical or behavioral Not considered clinical research by this definition intervention in large groups of human subjects is: research involving the collection or study of (from several hundred to several thousand) by existing data, documents, records, pathologi- comparing the intervention to other standard cal specimens, or diagnostic specimens, if these or experimental interventions as well as to sources are publicly available or if the informa- monitor adverse effects, and to collect infor- tion is recorded by the investigator in such a man- mation that will allow the interventions to be ner that subjects cannot be identified, directly or used safely. through identifiers linked to the subjects. • Phase IV studies are done after the interven- Clinical Trial: For purposes of reviewing ap- tion has been marketed. These studies are plications submitted to the NIH, a clinical trial is designed to monitor effectiveness of the ap- operationally defined as a prospective biomedical proved intervention in the general population or behavioral research study of human subjects and to collect information about any adverse that is designed to answer specific questions about effects associated with widespread use. biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known NIH-Defined Phase III Clinical Trial: For the drugs, treatments, or devices). purpose of the NIH Grants Policy Guidelines, an NIH-defined Phase III clinical trial is a broadly Clinical trials are used to determine whether new based prospective NIH-defined Phase III clinical biomedical or behavioral interventions are safe, investigation, usually involving several hun- efficacious, and effective. Clinical trials of experi- dred or more human subjects, for the purpose of mental drug, treatment, device, or behavioral evaluating an experimental intervention in com- intervention may proceed through the following parison with a standard or control intervention phases: or comparing two or more existing treatments. Often, the aim of such investigation is to provide • Phase 0 trials represent the earliest step in evidence leading to a scientific basis for consid- testing new treatments in humans. In a phase eration of a change in health policy or standard 0 trial, a very small dose of a chemical or of care. The definition includes pharmacologic, biologic agent is given to a small number of non-pharmacologic, and behavioral interven- people (approximately 10-15) to gather pre- tions given for disease prevention, prophylaxis, liminary information about how the agent is diagnosis, or therapy. Community trials and processed by the body (pharmacokinetics) and other population-based intervention trials also how the agent affects the body (pharmacody- are included. namics). Because the agents are given in such small amounts, no information is obtained about their safety or effectiveness in treating cancer.

122 NCI Orientation for the Board of Scientific Advisors APPENDIX P RELATED DOCUMENTS

Cancer DEA Annual Report http://www.cancer.gov http://deainfo.nci.nih.gov/aboutdea.htm

NCI Budget Fact Book NCI Grants Process: The Lifecycle of a Grant (2016) http://www.cancer.gov/about-nci/budget/fact- https://www.cancer.gov/grants-training/grants- book process/grants-process.pdf

Bypass Budgets NCI Office of Grants Administration http://plan.cancer.gov http://www.cancer.gov/about-nci/organization/ oga Cancer Centers http://cancercenters.cancer.gov Grants and Contracts https://www.cancer.gov/grants-training/grants- Clinical Trials funding/funding-opportunities http://www.cancer.gov/clinicaltrials Grant Mechanisms and Descriptions NCAB Orientation Book http://deainfo.nci.nih.gov/flash/awards.htm https://deainfo.nci.nih.gov/advisory/ncab/ OrientationBook.pdf NIH Policy Manual Chapters https://policymanual.nih.gov/ BSA Orientation Book https://deainfo.nci.nih.gov/advisory/bsa/ Center for Cancer Training OrientationBook/OrientationBook.pdf http://www.cancer.gov/grants-training/training/ about FNLAC Orientation Book https://deainfo.nci.nih.gov/advisory/fac/ Center for Scientific Review (CSR) Reviewer OrientationBook.pdf Resources https://public.csr.nih.gov/ForReviewers CTAC Member’s Manual https://deainfo.nci.nih.gov/advisory/ctac/ Surveillance OrientationBook.pdf http://seer.cancer.gov

NCI Division of Extramural Activities http://deainfo.nci.nih.gov

NCI Orientation for the Board of Scientific Advisors 123 APPENDIX Q WEBSITES OF INTEREST

DEA Websites Frederick National Laboratory Advisory Committee (FNLAC) charter, members, meeting DEA home page. Includes links to individual information. DEA Web Pages, the mission of the Division, and http://deainfo.nci.nih.gov/advisory/fac/fac.htm contact information for DEA staff. http://deainfo.nci.nih.gov Charter of the NCI Council of Research Advocates (NCRA); meeting schedules, agendas, minutes, and meeting summaries. http://deainfo.nci.nih.gov/advisory/ncra/ncra.htm

Charter of the Initial Review Group (IRG); subcommittee rosters. http://deainfo.nci.nih.gov/advisory/irg/irg.htm

Charter of the Special Emphasis Panel (SEP); rosters of recent meetings. http://deainfo.nci.nih.gov/advisory/sep/sep.htm

Links to grant-related NCI and NIH policies, such as guidelines on the inclusion of women and Links to the home pages of NCI’s advisory boards. minorities in clinical trials and instructions for http://deainfo.nci.nih.gov/advisory/boards.htm evaluating research involving human subjects. http://deainfo.nci.nih.gov/grantspolicies/index. President’s Cancer Panel (PCP) charter; meeting htm agendas and meeting minutes; annual reports. https://deainfo.nci.nih.gov/advisory/pcp/index. Comprehensive information about funding for htm cancer research; lists of active PAs and RFAs; grant policies and guidelines; downloadable application National Cancer Advisory Board (NCAB) charter; forms. rosters; meeting agendas, minutes, presentation http://deainfo.nci.nih.gov/funding.htm slides. http://deainfo.nci.nih.gov/advisory/ncab/ncab. Active PAs, with links to detailed descriptions. htm https://deais.nci.nih.gov/foastatus/?nt=P

Board of Scientific Advisors (BSA) charter; sub- Active RFAs, with links to detailed descriptions. committee rosters; meeting agendas, minutes, https://deais.nci.nih.gov/foastatus/? presentation slides. http://deainfo.nci.nih.gov/advisory/bsa/bsa.htm Grants Guidelines and Descriptions (descriptions of NCI funding mechanisms, with links to Pro- Charter of the Board of Scientific Counselors gram Announcements (PAs), RFAs, guidelines, (BSC), Clinical Sciences and Epidemiology. and supplemental materials). http://deainfo.nci.nih.gov/advisory/bsc/cse/ http://deainfo.nci.nih.gov/flash/awards.htm charter.pdf NCI Glossary of Terms. Charter of the Board of Scientific Counselors http://deais.nci.nih.gov/glossary (BSC), Basic Sciences. http://deainfo.nci.nih.gov/advisory/bsc/bs/ NCI Dictionary of Cancer Terms. charter.pdf https://www.cancer.gov/publications/ dictionaries/cancer-terms/ Clinical Trials and Translational Research Advi- sory Committee. http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm

124 NCI Orientation for the Board of Scientific Advisors NCI’s Funded Research Portfolio database Technology Transfer Center (TTC). The NCI TTC’s contains information about research grant and mission is to speed the progress of cancer research contract awards for the current and past 5 fiscal by encouraging development of new technologies years. Searchable by text words in abstracts and by and promoting scientific collaborations between Special Interest Category (SIC) and anatomic site the NCI and the private sector. codes. https://ttc.nci.nih.gov http://fundedresearch.cancer.gov The NCI Office of Advocacy Relations (OAR) uses NCI Websites a variety of methods to engage cancer research advocates in NCI activities. The NCI maintains numerous sites containing http://www.cancer.gov/about-nci/organization/ information about the Institute and its programs. oar All NCI websites, including those designed to provide cancer-related information to the general The Cancer Moonshot Initiative aims to make public and physicians, can be reached from the more therapies available to more patients, while NCI home page. also improving our ability to prevent cancer and https://www.cancer.gov detect it at an early stage. http://www.cancer.gov/research/key-initiatives/ Descriptions of NCI’s Divisions, Offices, and moonshot-cancer-initiative Centers. http://www.cancer.gov/aboutnci/organization NCI Cancer Information Websites

NCI’s website for the press, managed by the NCI Links to a wide variety of NCI’s Web-based Office of Media Relations; contains news and information resources for health professionals and information on cancer research and NCI programs the general public. and resources. http://www.cancer.gov/cancerinfo http://www.cancer.gov/newscenter A comprehensive resource for definitions of A wide variety of information sources on cancer-related terms, as well as links to additional obtaining funding for cancer research, including online dictionaries of medical and health-related assistance in applying for grants; descriptions of terms. NCI-sponsored research initiatives; review panel http://cancer.gov/dictionary rosters and schedules; training opportunities; and links to other funding resources. The NCI Contact Center, or Cancer Information http://deainfo.nci.nih.gov/funding.htm Service (CIS), is a free public service providing accurate, up-to-date, and reliable information The essentials of the NCI grants process are on cancer that is easy to understand. The available on this website. Cancer Information Specialists respond to calls http://www.cancer.gov/grants-training/grants- in English and Spanish and can be reached at process 1-800-4-CANCER (1-800-422-6237). Hearing- impaired callers with TTY equipment may call The Biorepositories and Biospecimens Research 1-800-332-8615. Branch is responsible for promoting a common http://www.cancer.gov/contact/contact-center biorepository infrastructure that promotes resource sharing and team science. The Cancer Trials website provides information http://biospecimens.cancer.gov/researchnetwork/ and news about cancer research studies. The site is default.asp designed to answer basic questions about clinical trials; provide resources for people considering Links to NCI’s partnerships with the cancer participating in clinical trials; help people learn research, advocacy, and support communities. what clinical trials are available; and publish http://www.cancer.gov/researchprograms/ current, accurate information about clinical trial partners results and advances in cancer care. http://www.cancer.gov/clinicaltrials

NCI Orientation for the Board of Scientific Advisors 125 The NCI Surveillance, Epidemiology, and End The Center for Information Technology (CIT) Results (SEER) Program is the most authoritative makes special NIH events, seminars, and lectures source of information on cancer incidence and available to viewers on the NIH network and survival in the United States. Information on the Internet from the NIH VideoCasting and more than 2.5 million cancer cases is included in Podcasting website. the SEER database, and approximately 160,000 http://videocast.nih.gov new cases are added each year within the SEER catchment areas. Information on Electronic Review of Grant http://seer.cancer.gov Applications. https://era.nih.gov/reviewer/index.cfm

NIH Websites Information on grants policy statements and National Institutes of Health home page. notices, grant awards and NIH appropriations, policy resources, and other guidance resources. http://www.nih.gov http://grants1.nih.gov/grants/policy/policy.htm National Institutes of Health Almanac. Information on Extramural Training Mechanisms. https://www.nih.gov/about-nih/what-we-do/nih- almanac http://grants.nih.gov/training/extramural.htm

NIH Research Portfolio Online Reporting Tool The NIH Event Calendar is a scheduling system (RePORT) provides access to reports, data, and for cancer-related scientific meetings and events. analyses of NIH research activities, including http://calendar.nih.gov information on NIH expenditures and the results The NIH Precision Medicine Initiative (PMI) of NIH-supported research. Cohort Program will seek to extend precision http://report.nih.gov medicine to all diseases by building a national Office of Federal Advisory Committee Policy research cohort of 1 million or more (OFACP). This site features downloadable U.S. participants. guidelines, reference tools, and training materials. https://www.nih.gov/precision-medicine- It also contains advisory committee membership initiative-cohort-program lists; laws, regulations, and policies related to PubMed comprises more than 29 million citations Federal advisory committees; and other resources. from Medline, life science journals, and online http://ofacp.od.nih.gov books. NIH Office of Extramural Research. Includes an https://www.ncbi.nlm.nih.gov/pubmed overview of the grants process. General Government-Related Websites http://grants.nih.gov/grants/oer.htm The official U.S. Government portal to 30 million NIH Guide to Grants and Contracts for NIH pages of Government information, services, and grants and funding opportunities. online transactions. USAGov offers a powerful https://grants.nih.gov/funding/searchguide/ search engine that searches every word of every index.html U.S. Government document. The site also features a topical index, options to contact Government NIH Center for Scientific Review. agencies, links to state and local agencies, and http://www.csr.nih.gov other tools, so the user does not have to know the Definitions of NIH Acronyms and Glossary. name of the agency to get needed information. http://grants.nih.gov/grants/glossary.htm https://www.usa.gov eRA Commons is an online interface where grant The Centers for Disease Control and Prevention. applicants and Federal staff at the NIH and grantee http://www.cdc.gov institutions can access and share administrative U.S. Food and Drug Administration. information relating to research grants. https://www.fda.gov http://commons.era.nih.gov/commons

126 NCI Orientation for the Board of Scientific Advisors An electronic version of this document can be viewed and downloaded from the Internet at http://deainfo.nci.nih.gov/advisory/bsa/OrientationBook/OrientationBook.pdf

NCI Orientation for the Board of Scientific Advisors 127 Orientation for the Board of Scienti c Advisors

National Cancer Institute National Institutes of Health

March 2020 Bethesda, Maryland