and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
COOPERATIVE PLANNING GRANT FOR CANCER DISPARITIES RESEARCH PARTNERSHIP PROGRAM
Release Date: August 28, 2002
RFA: CA-03-018 - (Reissued as RFA-CA-09-502)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
Letter of Intent Receipt Date: February 20, 2003
Application Receipt Date: March 20, 2003
This RFA is a reissue of CA-02-002, which was published in the NIH Guide on
October 19, 2001.
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE
The National Cancer Institute (NCI) invites cooperative planning grant
applications (using the U56 mechanism) in an effort to strengthen the national
cancer program by developing models to reduce significant negative
consequences of cancer disparities seen in certain U.S. populations. This
grant will support the planning, development and conduct of radiation oncology
clinical research trials in institutions that care for a disproportionate
number of medically underserved, low income, ethnic and minority populations
but have not been traditionally involved in NCI-sponsored research. The grant
will also support the planning, development and implementation of nurturing
partnerships between applicant institutions and committed and experienced
institutions actively involved in NCI-sponsored cancer research. All
approaches to planning are encouraged, as long as they address the following
essential features: a focus on cancer disparities, radiation oncology clinical
research, institutional commitment, organizational capabilities, facilities,
and interdisciplinary coordination and collaboration. At this time, NCI
anticipates issuing another RFA for the establishment of additional Cancer
Disparities Research Partnerships in fiscal year 2003.
RESEARCH OBJECTIVES
Background
The burden of cancer is not borne equally by all population groups in the
United States. Twenty-nine years have passed since the War on Cancer was
initiated, and during this period, the disparities in cancer incidence and
mortality in segments of the U.S. population have continued to rise. The
unequal burden is exemplified by differences in cancer morbidity and mortality
as a function of gender, ethnicity and socioeconomic status. Men are about
50% more likely than women to die from cancer. The incidence of colon and
rectum, and lung and bronchus cancers in Alaska Natives and African American
men and women is higher than that of other ethnic groups. Death rates from
prostate cancer among African American men are almost twice those of white
men. The incidence of cervical cancer in Hispanic women has been consistently
higher at all ages than for other women, although African American women have
the highest rate of dying from cervical cancer. Five-year survival rates by
selective sites among populations experiencing the negative consequences of
health disparities in the U.S. (e.g., African Americans, Asians, Pacific
Islanders, Hispanics, Latinos, Native Indians, native Alaskans, and/or those
of low socioeconomic status) are lower than the 5-year survival rates of the
rest of the population. The cancer mortality rates for lung, trachea,
bronchus, and pleura for minority males and females differ widely when
measured by state economic area. Examples of geographical differences are
seen in a pattern of excessive prostate cancer among African American males in
the Southeastern U.S., particularly in rural areas. High rates of esophageal
cancer in the District of Columbia and in the Coastal area of South Carolina
appear to be related to alcohol consumption, tobacco use and dietary
deficiencies. Persons of low socioeconomic status generally have higher cancer
death rates than persons of higher socioeconomic status.
The significant negative consequences of cancer-related health disparities are
also reflected in risk behaviors and health service utilization. These
include higher rates of smoking among some populations (e.g. American
Indians), strikingly higher rates of obesity among African Americans and
Hispanics, and related dietary practices. Similarly, differentials have been
documented by age, income, education, and race/ethnicity in these health
practices as well as in cancer screening and treatment. Data confirm lower
rates of cancer screening and early detection, differential treatment
patterns, and greater frequency of a number of chronic diseases with similar
risk profiles to cancer. These and many other factors contribute to more
advanced disease at diagnosis, lower survival, and higher cancer death rates
among certain population groups.
Objectives and Scope
Health care institutions providing cancer services to a disproportionate
number of medically underserved, low income and/or minority populations,
whether urban or rural, are not often linked to the national cancer research
enterprise as effectively as they could be and often struggle to maintain
state-of-the-art cancer care. As a result, radiation oncologists in these
institutions have difficulty in starting, developing, and sustaining research
programs either independently or collaboratively. Thus, the populations
primarily served by these institutions, largely minority, ethnic, and/or low
income, do not readily benefit from the rapid progress being made in cancer
research in radiation oncology, and may bear an unequal burden of disease as a
result. The populations targeted by this cooperative planning grant tend to
access the health care system in the advanced stages of their disease and,
because of this, radiation oncology usually represents a major treatment
alternative. Therefore, the field of radiation oncology offers a unique
opportunity to explore ways to reduce the significant negative consequences of
cancer-related health disparities due to its technological base, the facility
of application, and as an entry platform for inclusion of medical and surgical
oncology research. These institutions, when provided the necessary resources
and mentoring and supportive partnership with an experienced and committed
research institution, represent an opportunity for conducting and/or expanding
participation in clinical trials developed for radiation oncology and combined
modality therapy as well as cultural and social-related research important to
the understanding of cancer-related health disparities.
The low involvement of health care institutions in cancer research that
predominantly serve populations who experience the worst consequences of
cancer-related health disparities must be addressed. The increased
involvement of these institutions is necessary in order to develop a stronger
national cancer research effort aimed at understanding the disparities of
cancer incidence and mortality in those populations. This cooperative
planning effort is dedicated to developing stable, long-term radiation
oncology clinical research trials programs and partnerships to increase the
participation of applicant institutions in the nation"s cancer research
enterprise. Members of the Cancer Disparities Research Partnership (CDRP)
would be expected to combine their expertise in working with affected
populations to develop outreach programs that effectively reach individuals
and physicians and that increase the recruitment and retention of target
populations into clinical trials and prevention protocols.
The four overall objectives and scope of this Request For Applications (RFA)
are to solicit cooperative planning grants that would: 1) build and stabilize
independent and collaborative clinical research capabilities of institutions
providing radiation oncology care to populations experiencing the negative
consequences of cancer-related health disparities, 2) increase the number of
clinical scientists engaged in radiation oncology research by providing access
to and participation in clinical trials with the target populations, 3)
improve the effectiveness of the applicant institution and its partner
institution in developing and sustaining activities focused on radiation
oncology clinical research trials and mortality and morbidity in cancer among
the target populations, continuing past the life of this grant, and 4)
establish priorities for and initiate stable, long-term collaborations and
partnerships that will strengthen competitive cancer research, research
training and career development, education and outreach capabilities at both
the applicant institution and the partner institution that address problems
and issues relevant to the disproportionate cancer incidence and mortality.
The most significant components of a U56 Cancer Disparities Research
Partnership application are: 1) a thorough description and implementation plan
of the proposed radiation oncology clinical trials research effort that must
address the negative consequences of cancer disparities in the population
served with the inclusion of examples of pilot clinical trials research
projects, and 2) the articulation of the steps to be taken with potential
partner institutions during the first year of the award to develop a
comprehensive and supportive partnership relationship and the subsequent
implementation of that plan over the remaining life of the grant with the
selected partner. The expectation is that successful Cancer Disparities
Research Partnership projects will ultimately be competitively funded grants
(e.g., R03, R01, project on a P01, project on a P50).
The National Cancer Institute is strongly committed to reducing cancer-related
health disparities across the cancer control continuum from prevention to end-
of-life. The NCI"s Strategic Plan to Reduce Health Disparities can be viewed
at http://www3.cancer.gov/announcements/healthdisp.html. The Institute
supports research to understand the complex causes of disparities in cancer
risk, incidence, and mortality, including socioeconomic, cultural,
environmental, institutional, behavioral, biological factors, and other
contributing factors seen in the health care delivery system. The overall
goal is to understand the causes of health disparities and to develop
effective interventions to eliminate these disparities that result in
significant negative outcomes. More research is needed that specifically
addresses these and other cancer disparities if these trends are to be reduced
and brought into balance with the rest of the population. Information about
cancer incidence and mortality rates in different U.S. sub-populations can be
obtained at the following website address: http://www.nci.nih.gov/atlasplus/.
MECHANISM OF SUPPORT
The RFA will use NIH U56 award mechanism. As an applicant you will be solely
responsible for planning, directing, and executing the proposed project. This
RFA is a one-time solicitation. The anticipated award date is September 20,
2003.
The NIH U56 is a cooperative agreement in which the Principal Investigator
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with NIH staff being actively involves as
a partner with the Principal Investigator as described under the section
"Cooperative Agreement Terms and Conditions of Award."
At this time the NCI anticipates that there will not be a renewed competition
after 5 years. If the NCI does not continue the program, awardees may submit
grant applications through the usual investigator-initiated grants program.
FUNDS AVAILABLE
The NCI plans to commit approximately $ 2.8 million in direct costs in FY 2003
to fund up to four new grants in response to this RFA. Any applicant may
request a project period of up to five years and an annual budget for direct
costs of up to $400,000 per year over five years, excluding one-time capital
costs expended in the first year. Because the nature and scope of research
and partnerships may vary, it is anticipated that the size of each award will
also vary. Although the financial plans of NCI provide for support of this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications. The
total project period for applications submitted in response to this RFA may
not exceed five years. The anticipated award date is September 20, 2003.
ELIGIBILITY REQUIREMENTS
Applications will only be accepted from health care institutions accredited by
the Joint Commission on Accreditation of Health Organizations or free-standing
cancer centers accredited by a nationally recognized accrediting body such as
the American College of Radiology, either in the United States or in
territories under U.S. jurisdiction, which have Letters of Commitment from
potential partners that are NCI-designated Cancer Centers, RTOG participating
institutions or other NCI-sponsored cooperative group participating
institutions that wish to develop comprehensive partnerships with the
applicant institution. Each Cancer Center or cooperative group participating
partner institution is limited to no more than one Cancer Disparities Research
Partnership (U56) planning grant application.
The applicant institution must be the primary provider of radiation oncology
care to one or more populations identified with cancer-related health
disparities (e.g., African Americans, Asians, Hispanics, Latinos, Native
Americans, Alaskan Natives, Native Hawaiians, Pacific Islanders and/or those
with low socioeconomic status as defined by the Federal poverty level or the
state-defined level, if lower) at a percentage greater than the state average
of that population according to the 2000 U.S. Census Bureau statistics, and
have a greater cancer incidence and/or mortality than the national average
according to NCI data.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institutions to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
o The applicant institution must have the necessary facilities to provide
radiation oncology services according to current standards, such as three
dimensional treatment planning and CT simulation.
o The applicant institution must have a level of professional expertise that
includes one or more board certified radiation oncologists and physics support
at one or more full-time (40 hours) Ph.D. or MS level.
o The percentage of one or more of the target populations (e.g., African
Americans, Asians, Hispanics, Latinos, Native Americans, Alaskan Natives,
Native Hawaiians, Pacific Islanders and/or those with low socioeconomic
status) served by the applicant institution must be greater than the state
average of that population according to the 2000 U.S. Census Bureau
statistics, and have a greater cancer incidence and/or mortality than the
national average according to NCI data.
o The applicant institution must be a primary provider of care for the
population group(s) identified in the bullet above according to the respective
State Department of Health statistics.
o If the applicant institution currently receives NCI research funding, it
cannot exceed $100,000 annually.
o If currently participating in NCI-sponsored clinical trials, the applicant
institution"s accrual level must be 1% or less of the cancer patient base to
qualify.
o The applicant must submit base line metrics with the application as
described in the Supplemental Application Guidelines.
o The applicant institution must identify a Co-PI from each of the proposed
partner institutions.
o Any new project/program and shared resources for development in response to
this RFA must not overlap in purpose and intent with existing
projects/programs and shared resources funded at the applicant institution by
the NCI Cancer Center Support Grant, National Center for Research Resources
Infrastructure Grants, National Institute of General Medical Sciences Minority
Biomedical Research Support Grant or any other peer reviewed funded program.
o All recipients of CDRP U56 Planning Grant Awards will be expected to
participate in an annual meeting sponsored by the Radiation Research Program
(RRP) of the NCI. Travel funds for this purpose should be included in the
grant application from the applicant institution.
o Once a CDRP U56 grant is funded, specific guidelines for non-competing
renewal applications will be provided to the grantee.
The following terms and conditions will be incorporated into the award
statement and provided to the Principal Investigator(s) as well as the
institutional official at the time of the award.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The administrative and funding instrument used for this program is a
cooperative agreement (U56), an "assistance" mechanism (rather than an
"acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance of
the activity. Under the cooperative agreement, the NIH purpose is to support
and/or stimulate the recipient"s activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is not to
assume direction, prime responsibility, or a dominant role in the activity.
Consistent with this concept, the dominant role and prime responsibility for
the activity resides with the awardee(s) for the project as a whole, although
specific tasks and activities in carrying out the studies will be shared among
the awardees and the NCI/RRP Program Scientist, as described below.
1. Awardee Rights and Responsibilities
a. Awardees have primary authorities and responsibilities for the project as a
whole, including defining objectives and approaches, planning, implementing,
clinical trials development, participant recruitment and follow-up, data
collection, quality control, interim data and safety monitoring, analysis and
interpretation, preparation of publications, as well as collaboration with
their partner and other awardees, and with assistance from NCI/RRP Program
staff.
b. Awardees will be required to participate on and follow the advice and
recommendation of the Program Steering Committee, in meeting the intent of the
initiative.
c. Each partnership should plan regular meetings (no less than monthly) to
discuss the progress and directions of its activities to insure that the
necessary interactions are taking place.
d. The Principal Investigator, Co-Investigators, and other designated
investigators will attend an Annual Meeting to be organized by NCI staff in
Washington D.C.
e. Each partnership will submit annual progress reports to the NCI that
describe the activities and accomplishments during the previous funding period
as part of the Non-Competing Continuation Renewal.
f. Awardees will retain custody of and have primary rights to the data
developed under these awards, subject to Government rights of access
consistent with current HHS, PHS, and NIH policies and agree to the
appropriate sharing of methods and data among collaborating institutions.
2. NCI Staff Responsibilities
The NCI/RRP Program Scientist will have substantial scientific-programmatic
involvement during the conduct of this activity, through technical assistance,
advice and coordination above and beyond normal program stewardship for
grants. The NCI/RRP Program Scientist will have substantial involvement in
assisting the awardee in the development of partnerships, identifying new
areas of opportunity, recommending mid-course corrections on an annual basis
and generally ensuring that the U56 CDRP remains focused on the intent of this
initiative. The NCI/RRP Program Scientist will be involved in the following
ways:
a. Serve as a voting member on the Program Steering Committee, and, as
determined by that committee, its subcommittees.
b. Work closely with individual investigators and partners to facilitate
successful collaborations.
c. Facilitate access to fiscal and intellectual resources provided by NCI,
NIH, RRP, industry, private foundations and federal funding agencies.
e. Provide assistance in reviewing and commenting on all major transitional
changes of the awardee or partner institution"s activities prior to
implementation to assure consistency with the goals of this RFA.
f. Help reprogram efforts, including options to modify clinical research
projects/programs when they are not making headway relative to the time-line
for achieving the objectives of the RFA.
g. Monitor institutional commitments and resources to ensure that the
partnership receives the maximum chance of stabilization and success.
h. Organize and make final decisions on the agenda for an annual workshop that
engages all of the partnerships and other participants as needed. This meeting
will be held for all funded investigators to share progress and research
insights that may benefit all of the projects.
i. Call additional meetings/workshops of the participants to address emerging
areas of high priority to the NCI and/or the problems of high cancer incidence
and mortality in populations experiencing cancer disparities.
An NCI Program Director from the staff of the NCI Radiation Research Program
(RRP) will provide the normal level of grant stewardship and monitoring and
generally ensure that the U56 CDRP grant efforts remains focused on the intent
of this initiative.
3. Collaborative Responsibilities
A Program Steering Committee (PSC) will be composed of the Principal
Investigator from the applicant institution, who is the Principal Investigator
for the award, the Co-Investigator from the institution that was selected as
the partner, and the NCI/RRP Program Scientist. The Principal Investigator
from the awardee institution, the co-investigator from the partner institution
and the NCI/RRP Program Scientist will each have one vote. The chairperson,
who will be someone other than the NCI/RRP Program Scientist, will be selected
by the PSC. The PSC will meet a minimum of twice a year to review and resolve
operational and implementation issues and propose recommendations for
establishing or changing priorities. The PSC"s recommendations, in the form of
a written annual report, are to be submitted to the leaders of the applicant
institution and the partner institution, the Board of Scientific Advisors"
Program Advisory Committee and to the NCI.
The Program Advisory Committee (PAC) will be composed of three members of the
NCI Board of Scientific Advisors and the RRP Program Director as an Ad Hoc
member. The Program Advisory Committee will serve as the primary advisory
board of the overall grant program with the responsibility to provide advice
and make recommendations that include but are not limited to changing
priorities and directions or identifying areas of new opportunity. The
recommendations are to be used by the principal investigators in guiding and
directing the development of the CDRP program. After appropriate discussions,
the awardee generally will be expected to accept and implement the
recommendations of the PAC, in those situations where the recommendations are
not feasible to implement, the Principal Investigator of the applicant
institution must provide a thorough explanation and rationale to the PAC.
Subcommittees may be established or external advisors may be called upon to
provide appropriate advice, as the PSC or PAC deems appropriate. NCI/RRP staff
will serve on subcommittees, as the PSC or PAC deems appropriate.
An annual meeting of all Principal Investigators, the members of the Program
Advisory Committee, the RRP Program Scientist and other experts as necessary
will be held to review and discuss individual progress and that of the overall
CDRP Program.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipient and the NCI/RRP may be brought to
arbitration. An arbitration panel will be composed of three members -- one
selected by the Program Steering Committee (with the NCI/RRP member not
voting), or by the individual awardee in the event of an individual
disagreement, a second member selected by the NCI, and the third member
selected by the two prior selected members. This special arbitration procedure
in no way affects the awardee"s right to appeal an adverse action that is
otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50,
Subpart D and HHS regulation at 45 CFR Part 16.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grant management
issues.
Direct inquiries regarding programmatic issue to:
Frank Govern, Ph.D.
Deputy Chief, Radiation Oncology Sciences Program
National Cancer Institute
Executive Plaza North, 6015A
6130 Executive Blvd, MSC 7440
Bethesda, MD 20892-7440
Telephone: (301) 496-6111
Fax: (301) 480-5785
Email: governfr@mail.nih.gov
Or
Norman Coleman, M.D.
Chief, Radiation Oncology Sciences Program
National Cancer Institute, DCTD, RRP
Executive Plaza North, 6015A
6130 Executive Blvd, MSC 7440
Bethesda, MD 20892-7440
Telephone: (301) 496-6111
Fax: (301) 480-5785
Email: ccoleman@mail.nih.gov
Direct inquiries regarding review issues to:
Referral Officer
Division of Extramural Activities
6116 Executive Boulevard, Room 8109, MSC 8239
Rockville, MD 20852 (express service)
Bethesda, MD 20892-8236
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: ncidearefof-r@mail.nih.gov
Direct inquiries regarding fiscal or budget matters to:
Eileen M. Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Blvd.
EPS - 243
Bethesda, MD 20892
Telephone (301) 496-8626
Fax: (301) 496-8601
Email: natolie@gab.nci.nih.gov
LETTER OF INTENT
Prospective applicant institutions are asked to submit a letter of intent
(LOI) that includes the following information
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Proposed participating institutions
o Number and title of the RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allow NCI staff to estimate the potential review workload and plan
the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to:
Frank Govern, Ph.D.
Deputy Chief, Radiation Oncology Sciences Program
National Cancer Institute
Executive Plaza North, 6015A
6130 Executive Blvd, MSC 7440
Bethesda, MD 20892-7440
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 grant application instructions
and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone 301/435-0714,
Email: GrantsInfo@nih.gov.
The application research plan should address the following elements:
1. The objectives and scope of the RFA,
2. Detailed information addressing the ELIGIBILITY REQUIREMENTS Section of the
RFA,
3. Detailed information addressing the SPECIAL REQUIREMENTS Section of the
RFA,
4. History and background of cancer activities as described in No. 1, Metrics
Evaluation Plan of the Supplemental Application Guidelines,
5. Information in response to No. 2,3, and 4, General Information of the
Supplemental Application Guidelines,
6. Partnership Plan (see Partnership Plan, Supplemental Application
Guidelines),
7. Pilot and Feasibility Studies Examples (see Examples of Pilot Clinical
Trials Research Projects, Supplemental Application Guidelines),
8. Budgets for each year over the course of the grant award (see CDRP
Allowable Costs, Supplemental Application Guidelines).
SUPPLEMENTAL APPLICATION GUIDELINES
The NCI has Supplemental Application Guidelines for this RFA that have been
added due to the unique aspects of this U56 CDRP RFA. The Supplemental
Application Guidelines reside on the Radiation Research Program"s Website:
http://www3.cancer.gov/rrp/supguide.html.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number
must be typed on line 2 of the face page of the application form and the YES
box must be marked. The RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed, photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must also
be sent to:
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8109, MSC-8329
Rockville, MD 20852 (express courier)
Bethesda, MD 20892-8329
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE
WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries
(i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html. This
change in practice is effective immediately. This policy is similar to and
consistent with the policy for applications addressed to Centers for Scientific
Review as published in the NIH Guide
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of this RFA. If an application is received
after that date, it will be returned to the applicant without review. The
Center for Scientific Review (CSR) will not accept any application in
response to this announcement that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. The CSR will not accept any application that is essentially the
same as one already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such an
application must include an Introduction addressing the previous critique.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NCI program staff.
Incomplete applications will be returned to the applicant without further
consideration. Applications that are complete and responsive to the RFA will
be evaluated for scientific and technical merit by an appropriate peer review
group convened by the Division of Extramural Activities (DEA) at NCI in
accordance with the review criteria stated below. As part of the initial merit
review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications under
review, will be discussed, assigned a priority score
o Those that receive a priority score will undergo a second level review by
the National Cancer Advisory Board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In the
written comments, reviewers will be asked to discuss the following aspects of
your application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The scientific
review group will address and consider each of these in assigning your
application"s overall score, weighing them as appropriate for each
application. Each of these criteria will be addressed and considered by the
reviewers in assigning the overall score weighting them as appropriate for
each application. Your application does not need to be strong in all
categories to be judged likely to have a major scientific impact and thus
deserve a high priority score. For example, you may propose to carry out
important work that by its nature is not innovative but is essential to move a
field forward.
1. Significance. Does this application bring together sufficient expertise to
address an important cancer-related health disparities problem? Particularly
significant, what will be the effect of these studies on addressing cancer-
related health disparities? If the aims of the application are achieved, how
will the collaborative undertaking advance scientific knowledge?
2. Approach. Are the conceptual framework, design, methods and analyses
adequately developed, well integrated, and appropriate to the aims of the
application? Do letters of commitment support the priorities and objectives
of the plan for the collaborative partnership? Does the application
demonstrate the ability to achieve a comprehensive partnership plan with one
of the interested parties within the one-year develop period? Does the
application convincingly demonstrate that these commitments will be stable and
long lasting? Does the application exhibit the necessary strength for
implementing radiation oncology clinical research trials? Does the applicant
provide evidence about the adequacy of the resources (e.g., discretionary
resources, space, faculty positions, and protected time for research?
3. Innovation. Are the approaches or methods original and innovative? Does the
project challenge existing paradigms or develop new methodologies or
technologies?
4. Investigator. Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigators and other researchers (if any)? Are the
qualifications and experience of the collaborating investigators adequate to
provide strong programmatic (e.g., scientific) and administrative leadership?
Are the qualifications and experience of other key personnel of the applicant
and the interested partners adequate to successfully plan for and achieve the
objectives of this planning effort?
5. Environment. Does the scientific environment in which the work will be
done contribute to the probability of success? Does the proposed work take
advantage of the unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional support?
How would resource/infrastructure provide long-term stability to the
activities of the partnership?
ADDITIONAL REVIEW CRITERIA
In addition to the above criteria, the initial review group will also examine:
o the scientific merit of the proposed pilot projects,
o the appropriateness of proposed project budget and duration,
o the adequacy of plans to include both genders, minorities (and their
subgroups), and children as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects,
o the provisions for the protection of human participants,
o the safety of the research environment,
o the adequacy of the Data and Safety Monitoring Program to be in place prior
to the start of patient protocol activity,
o the adequacy of the proposed plan to share data.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt: February 20, 2003
Application Receipt Date: March 20, 2003
Peer Review Date: May/June, 2003
Review by NCAB Advisory Board: September, 2003
Earliest Anticipated Award Date: September 20, 2003
AWARD CRITERIA
Applications recommended by the National Cancer Advisory Board will be
considered for award based upon the following:
o the scientific merit (as determined by peer review)
o the availability of funds
o the geographical location
o the programmatic priorities
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Clinical trials
supported or performed by NCI require special consideration. The method and
degree of monitoring should be commensurate with the degree of risk involved
in participation and the size and complexity of the clinical trial. Monitoring
exists on a continuum from monitoring by the principal investigator/project
manager or NCI program staff to a Data and Safety Monitoring Board (DSMB).
These monitoring activities are distinct from the requirement for study review
and approval by the Institutional Review Board (IRB). For details about the
Policy of the NCI for Data Safety Monitoring of Clinical Trials see
http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II
clinical trials, investigators must submit a general description of the data
and safety monitoring plan as part of the research application. See NIH Guide
Notice on "Further Guidance on a Data and Safety Monitoring for Phase I and II
Trials" for additional information:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
Information concerning essential elements of data
safety monitoring plan for clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided that the
inclusion is inappropriate with respect to the health of the subjects or the
purpose of the research. This policy results from the NIH Revitalization Act
of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research – Amended, October, 2001," published in the NIH Guide for
Grants and Contract on October 9, 2001.
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html, a
complete copy of the updated guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research, updated racial and ethnic categories in compliance with the new OMB
standards, clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398, and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require that: a) all applications and proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable, and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted and supported
by the NIH, unless that are scientific and ethical reasons not to include
them. This policy applies to all initial (Type I) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as participants in
Research Involving Human Subjects that is available at:
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research is now available online at http://cme.nci.nih.gov/.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force or effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the applications should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subject procedures given the potential for wider
use of data collected under this award.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This RFA is related to the priority areas
of cancer and health disparities. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.398, Cancer Research Manpower and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public
Health Service Act as amended, (42 USC 241 and 284) and administered under NIH
grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74
and 92.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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