NCI Orientation for the National Cancer Advisory Board

101 Pages·2016·10.33 MB·English

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Orientation
for the National Cancer
Advisory Board

NCAB
U.S. Department of Health and Human Services
Public Health Service
National Institutes of Health
National Cancer Institute
Division of Extramural Activities

FOREWORD
Congratulations on your recent appointment to the National Cancer Advisory
Board (NCAB). Notably, the NCAB and the President’s Cancer Panel are the only
advisory bodies at either the National Institutes of Health or the Department of
Health and Human Services whose members are appointed by the President. As
you join this distinguished and historic panel, we could not be more honored to
have you working with the National Cancer Institute (NCI).
The primary task of the NCAB is to advise the Secretary of Health and Human
Services, the Director of the NCI, and ultimately the President of the United States
on a range of issues affecting the Nation’s cancer program and, specifically, NCI
operations. As a result of the National Cancer Act of 1971, the NCAB is required to
conduct second-level peer review of grant applications and cooperative agreements referred to the NCI
for funding. This briefing document has been prepared to provide new members of the NCAB 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. Attention also is given to the initiation of special actions by NCI staff
and the NCAB’s role in the overall process.
We are pleased to provide you with this NCAB Orientation Book and hope you will refer to it often in
fulfilling your responsibilities as a member of the NCAB.
Paulette S. Gray, Ph.D.
Director
Division of Extramural Activities
and
Executive Secretary
National Cancer Advisory Board
National Cancer Institute
NCI NCAB Orientation Book iii
iv NCI NCAB Orientation Book
TABLE OF CONTENTS

Page Page

FOREWORD ............................................................iii PROCESSING OF GRANT APPLICATIONS....32

Receipt and Assignment of Grant

HHS MISSION AND ORGANIZATION Applications........................................................32

THE NATIONAL INSTITUTES OF HEALTH ....1 Grant Application Identification

Mission, Organization, and History ..................1 Number ........................................................32

Overview of NIH History...................................1 Initial Peer Review.............................................34

THE NATIONAL CANCER INSTITUTE.............8 CSR Integrated Review Groups................34

NCI Mission..........................................................8 Selection of IRG Members ................................35

NCI and the National Cancer Program.....8 The Review Session ...........................................35

NCI Legislative Authority..................................9 Criteria for Evaluation .......................................36

Bypass Budget...............................................9 IRG Recommendations .....................................40

NCI Organizational Structure ..........................12 Impact Scores ......................................................40

Office of the Director ..................................12 Percentile Rank...................................................40

Extramural Divisions .................................15 Summary Statements .........................................41

Intramural Center and Division ...............16 Post NCAB Meetings and Funding

NCI Programs and Activities...........................16 Decisions .............................................................41

Research Programs .....................................16 Appeal of an IRG Recommendation ...............41

Resource Development ..............................17 Resubmission ..............................................41

NCI Funding Mechanisms...............................18 Project Site Visits .........................................41

Grants ...........................................................19 NCI INITIAL REVIEW .........................................45

I. Research Project Grants ........................19 NCI Referral of Grant Applications:

II. Cancer Centers and Specialized Program Assignment .........................................45

Programs of Research Excellence ........23 NCI Review of Grant Applications .................45

III. Other Research Grants .........................23 Selection of NCI Review Committee

IV. Career Awards and Cancer Members..............................................................46

Education................................................23 CSR/NCI Interface .............................................46

V. Training (NRSA) ....................................25 Review of Contract Proposals ..........................46

Other Grant Mechanisms ..........................25 NATIONAL CANCER ADVISORY

Cooperative Agreements...........................26 BOARD REVIEW...................................................48

Solicitation of Grant Applications ............28 NCAB Responsibilities......................................48

Contracts......................................................28 NCAB Legislative Authority ............................49

Research and Development NCAB Composition...........................................49

Contracts.................................................28 NCAB Meetings .................................................50

Loan Repayment Program ........................28 NCAB Subcommittees.......................................50

NCI Advisory Committees ...............................29 Special Actions Subcommittee .........................51

President’s Cancer Panel...............................29 Expedited Council Concurrence...............52

National Cancer Advisory Board.................29 Nonconcurrence ..........................................52

Board of Scientific Advisors ..........................29 Mail Ballots ..................................................53

Board of Scientific Counselors ......................29 Conflict of Interest .............................................53

NCI Council of Research Advocates ...........29 AWARD OF GRANTS...........................................53

Clinical Trials and Translational Selection for Funding........................................53

Research Advisory Committee .....................30 Administrative/Business Review.....................55

Frederick National Laboratory Advisory ...... Early Awards ......................................................55

Committee .......................................................30 Notice of Award .................................................55

Initial Review Group .....................................30 SPECIAL CONCERNS..........................................55

Conflict of Interest .............................................55

PEER REVIEW Confidentiality....................................................60

INTRODUCTION ..................................................31 Communication With Applicants ....................60

LEGAL BASIS FOR PEER REVIEW....................31 Freedom of Information and Privacy Acts .....60

ELECTRONIC SUBMISSION OF Research Involving Human Subjects ..............60

GRANT APPLICATIONS.....................................32

NCI NCAB Orientation Book v
Inclusion of Women and Minorities
EXHIBITS
as Subjects in Clinical Research .......................62
I. Department of Health and Human

Inclusion of Children as Participants
Services.............................................................2

in Research..........................................................62
II. NIH FY2012–2014 Funding............................4

Research Involving Animals ............................62
III. National Institutes of Health.........................5

Biohazardous Research .....................................63
IV. NIH Facilities Map..........................................6

REFERENCES ........................................................63
V. The National Cancer Institute.....................11

RECOMMENDED WEBSITES.............................63
VI. NCI Funding History....................................18

OTHER USEFUL WEBSITES ...............................64
VII. Research Funding for Various

Research Areas...............................................19

ABBREVIATIONS USED ......................................65
VIII. Summary of NCI Obligations

by Mechanism, FY2014.................................20

APPENDIX A. NCI Scientific Program
IX. RPG Awards by Grant Activity Code,
1
Leadership Committee ................70
FY2005–2014; and Research Project
1
APPENDIX B. President’s Cancer Panel.............72
Grants and Dollars Awarded
1
APPENDIX C. National Cancer Advisory
FY2005–2014...................................................21

Board..............................................73
X. The Grants Process From Receipt
1
APPENDIX D. Board of Scientific Advisors........77
to Award: Timeline .......................................33

APPENDIX E. Board of Scientific Counselors—
1 XI. IRGs Within CSR ...........................................34

Clinical Sciences and
XII. Receipt, Review, and Award Cycles...........37

Epidemiology................................80
XIII. Example of a Summary Statement..............42

APPENDIX F. Board of Scientific Counselors— XIV. NCI Contract Review Process .....................48

Basic Sciences................................83
XV. Grant Review Responsibilities of
APPENDIX G. NCI Council of Research the NCAB........................................................49

Advocates......................................86
XVI. Sample of an NCAB Mail Ballot..................54

APPENDIX H. Clinical Trials and
XVII. Sample Notice of a Grant Award ................56

Translational Research
XVIII. Sample Conflict of Interest

Advisory Committee....................87
Certification Statement .................................59

APPENDIX I. Frederick National Laboratory
...... XIX. The Freedom of Information and

Advisory Committee....................89
Privacy Acts....................................................61

APPENDIX J. Clinical Research and

Clinical Trials................................91

vi NCI NCAB Orientation Book
HHS MISSION AND ORGANIZATION

The mission of the Department of Health and agencies. The NIH, AHRQ, ATSDR, CDC, FDA,
Human Services (HHS) is to enhance the health and HRSA, IHS, and SAMHSA are all devoted to pub-
well being of Americans by providing for lic health and compose the Public Health Service
effective health and human services and by fostering (PHS) (see Exhibit I).
strong, sustained advances in the sciences underly-
ing medicine, public health, and social services. The
THE NATIONAL INSTITUTES
HHS consists of the Office of the Secretary, which
provides leadership; the Program Support Center, OF HEALTH
which provides centralized administrative support;
and 12 operating divisions, which manage more than
Mission, Organization, and History
300 health-related programs. These operating divi-
sions are:
NIH’s mission is to uncover new knowledge that
will lead to better health for everyone. The NIH
Administration for Children and Families (ACF)
works toward that mission by conducting research
in its own laboratories; supporting the research
Administration on Aging (AoA)
of non-Federal scientists in universities, medi-
cal schools, hospitals, and research institutions
Agency for Healthcare Research and Quality
throughout the country and abroad; helping to
(AHRQ)
train research investigators; and fostering com-
munication of medical information. NIH’s budget
Agency for Toxic Substances and Disease
has grown from $300 in 1887, when the NIH was a
Registry (ATSDR)
one-room Laboratory of Hygiene, to $30.1 billion
in 2014 (see Exhibit II). The NIH is composed of
Centers for Disease Control and Prevention
the Office of the Director, 20 Institutes, 6 Centers
(CDC)
(four of which have funding authority), and the
National Library of Medicine; it has 75 build-
Centers for Medicare and Medicaid Services
ings located on more than 300 acres in Bethesda,
(CMS) [formerly the Health Care Financing
Maryland. An organizational chart for the NIH is
Administration (HCFA)]
presented in Exhibit III. Exhibit IV is a guide to the
Bethesda campus.
Food and Drug Administration (FDA)
Overview of NIH History
Health Resources and Services Administration
(HRSA) NIH is a component of the Public Health Service
(PHS) of HHS. The PHS traces its origin to “An
Indian Health Service (IHS) Act for the Relief of Sick and Disabled Seamen” of
1798 (Stat. L. 604), which authorized the establish-
National Institutes of Health (NIH) ment of marine hospitals for the care of American
merchant seamen. In 1912, the Public Health and
Program Support Center (PSC) Marine Hospital Service became the Public Health
Service.
Substance Abuse and Mental Health Services
Administration (SAMHSA) The actual forerunner of the National Institutes
of Health was established in 1887 as the Labora-
The ACF is responsible for temporary assistance to tory of Hygiene, located at the Marine Hospital of
needy families; children’s welfare, care and sup- Staten Island, New York. In 1930, this laboratory
port; disabilities programs; and other services. The was renamed the National Institute of Health. The
AoA serves the elderly. The CMS manages health first of the present Institutes, the National Cancer
insurance programs, while the PSC provides prod- Institute (NCI), was established in 1937 by an act
ucts and services to the HHS and other Federal of Congress. In 1938, the National Advisory Cancer
NCI NCAB Orientation Book 1
2 Exhibit I. Department of Health and Human Services
Director, Chief of Staff
Intergovernmental Affairs, and
Secretary's Regional Representatives Executive Secretary
Assistant Secretary, Administrator,
Assistant Secretary Administration Agency for Toxic
General Counsel
for Health for Children and Substances and Disease
N Families (ACF) Registry (ATSDR)
C
I
N Assistant Secretary Chief Administrative Law
Commissioner,
C for Administration Assistant Secretary, Judge, Office of Medicare
A & Management Administration Food and Drug Hearings and Appeals
B Administration
on Aging (AoA)
O (FDA)
ri Director, Director,
e
n Program Support Center Office for Civil Rights
ta (PSC) Administrator, Administrator,
t Centers for Health Resources and
i
on Medicare & Medicaid Services Administration Director,
B Assistant Secretary Services (CMS) (HRSA) Center for Faith-Based
o for Resources and Community Initiatives
ok & Technology
Director,
Director,
Agency for Healthcare
Indian Health Service
Assistant Secretary Research and Quality Inspector General
(IHS)
for Planning (AHRQ)
& Evaluation
Director, Chair,
Director,
Assistant Secretary Centers for Departmental
National Institutes
for Preparedness Disease Control and Appeals Board
of Health (NIH)
and Response Prevention (CDC)
Director,
Administrator, Office of Global
Assistant Secretary
Substance Abuse and Health Affairs
for Legislation
Mental Health Services
Administration (SAMHSA)
National Coordinator,
Office of the National
Assistant Secretary
Coordinator for Health
for Public Affairs
Information Technology