Full Text CA-93-04


NIH GUIDE, Volume 21, Number 39, October 30, 1992

RFA:  CA-93-04

P.T. 34

  Disease Prevention+ 

National Cancer Institute

Letter of Intent Receipt Date:  November 1, 1992
Application Receipt Date:  January 19, 1993


The Division of Cancer Prevention and Control, National Cancer
Institute (NCI), invites Interactive Research Project Grants (IRPGs;
see NIH Guide, Vol. 21, No. 1, January 10, 1992), to encourage and
facilitate formal interdisciplinary collaborations through the
coordinated submission of related research project applications that
share a common research focus relevant to nutrition and cancer
prevention but do not require extensive shared physical resources or
core functions.

Complex questions in nutrition and cancer prevention research often
require investigative efforts that extend beyond the level practical
in a single project, or that require a mixture of technical
approaches beyond the means of a single investigator.  The perceived
merit of individual research project (R01) applications sometimes may
be limited by the lack of a comprehensive, interdisciplinary
approach, or by limitations in resident technical expertise.  There
also may be areas of investigation that are under-represented in
applications because they cannot effectively be exploited without a
collaborative effort, yet local opportunities for such interactions
are not available.

The objectives of this Request for Applications (RFA) for IRPGs are:
(1) to increase the investigator-initiated pool of quality
applications in the area of nutrition and cancer research and (2) to
stimulate an intermediate level of interdisciplinary collaborative
efforts to build stronger research bridges between nutritional
science and the disciplines that relate closely to basic and clinical
research for the development and evaluation of new approaches to
nutrition and cancer prevention research.

A minimum of three independent investigators with related research
objectives are encouraged to submit concurrent, collaborative, cross-
referenced individual research project grant applications (R01) that
share a common research focus.  Applications may be submitted from
either a single institution or a consortium of institutions.
Applications will be reviewed independently for scientific merit.
Meritorious applications will be considered for funding both as
independent awards and in the context of the overall proposed

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  In such a case, a letter of agreement from
either the GCRC program director or principal investigator could be
included with the application.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Interactive Research Project Grants for Nutrition and Cancer
Prevention, is related to the priority area of cancer prevention.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-783-3238).


Domestic and foreign non-profit and for-profit organizations and
institutions, governments and their agencies, are eligible to apply.
Applications may be submitted from a single institution or may
include arrangement with several institutions if appropriate.
Applications from or involving minority institutions, individuals,
and women are encouraged.

Each application will be considered on its own merit as an individual
research project.  Therefore, applicants for IRPGs MAY NOT
concurrently submit R01 applications that represent significant
duplication of the efforts described in the applicant's IRPG.  In
this regard, it should be noted that the NCI will consider funding
meritorious individual IRPG applications if it is not possible to
fund the IRPG package as a whole.  Concurrent submission of program
project (P01) applications that request support for essentially
similar work is prohibited.


Support of this program will be by the research project (R01) grant.
Applicants will be responsible for the planning, direction and
execution of the proposed projects.  The total project period for
applications submitted in response to the present RFA should not
exceed five years.

This is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-
initiated applications and be reviewed according to customary peer


Approximately $2.5 million in total costs per year for up to five
years will be committed to specifically fund applications that are
submitted in response to this RFA.  It is anticipated that six to
nine awards will be made.  This level of support is dependent on the
receipt of a sufficient number of applications of high scientific
merit.  Although this program is provided for in the financial plans
of the NCI, awards pursuant to this RFA are contingent upon the
availability of funds for this purpose.


A.  Background

Historically, the NCI has relied on multi-component awards, such as
program projects (P01) and Cancer Center Support grants (P30), to
encourage interdisciplinary collaborations in areas requiring
integration and central direction of basic and clinical research
components.  A hallmark of such awards is the provision for extensive
core facilities/resources to support the common research efforts of
the program and appointment of a program director to manage the
overall effort.

For many nutrition and cancer prevention research areas it may be
more appropriate to consider an intermediate level of collaboration,
less extensive than that described above, but beyond that practical
for single projects.  For such intellectually driven collaborative
efforts, the exchange of data, materials, and ideas, rather than
shared physical resources or central oversight, is the primary
requirement.  The concept of IRPGs put forth in this RFA aims to
address and facilitate this class of research activities.  Typically,
the IRPG approach will be suited to many basic research questions in
cancer prevention, as well as research to develop and apply
innovative technology and to evaluate intervention strategies in
individuals and target subpopulations.  The IRPG mechanism is also
well suited for conducting a series of short-term controlled clinical
and/or metabolic and related correlative laboratory studies.

Use of the IRPG mechanism will benefit applicants by establishing a
larger framework of reference for the proposed work, by facilitating
formal collaborations tailored to achieving research objectives, by
providing a record of independently acquired awards credited to each
funded investigator, and by allowing retention of research autonomy
by the named Principal Investigator (PI) on each of the interactive
grants.  Each grantee will have the ability to submit on his/her own
behalf competing supplements as appropriate to incorporate promising
new directions of research as they evolve.  The freedom to establish
collaborations at separate sites, and the improved transferability of
awards made to individual Principal Investigators, also are
significant benefits. In contrast, translational research programs
that span a variety of disciplines and programs that require
extensive ties to co-located core resources would continue to be
served best by traditional multi-component program award mechanisms.

The NCI encourages qualified investigators to develop and submit
concurrently coordinated research project applications that address
areas of relevance to nutrition and cancer prevention to which the
interactive research project concept may be applied.  Applications
submitted as a package should be tightly focused and the interactions
and benefits of the proposed linkages should be made explicit as
explained in the section on "SPECIAL INSTRUCTIONS FOR IRPG

B.  Research Areas of Interest

Representative areas of particular interest for this RFA focus on
innovative research approaches for the development, evaluation and/or
application of specific methodologies for elucidating the mechanisms
of action and quantification of the role of diet and dietary
components in cancer prevention.

Several examples of research areas relevant to nutrition and cancer
prevention in which the IRPG concept may be applied are as follows:

o  Metabolic effectors of dietary origin.  Basic science projects may
be combined that integrate multiple aspects of dietary factors that
modulate signal transduction, DNA repair, antioxidants, hormonal
regulation and gene regulation.

o  Interaction of diet and dietary components with drugs, hormones,
metabolites and genes - synergistic and antagonistic effects.

o  Development of new and better methods to quantify dietary intake
in individuals.

o  Further identification and evaluation of overall dietary patterns,
foods and food constituents that alter cancer risk and elucidation of
their mechanisms of action.

o  Identification of markers of dietary exposure and early indicators
of risk.

o  Quantification of optimal ranges of dietary constituents that
affect cancer risk.

o  Social behavioral research to identify motivation factors and
barriers to changing food habits.

o  Nutrition as one component of healthy lifestyle modification.
Studies of fundamental relationships between diet, nutrition and
cancer and behavioral change affiliated with modification.

Prospective applicants are encouraged to explore other areas of
potential for the Interactive Research Project Grant mechanism with
the NCI Program Director.

The overall goal is to provide more definitive data for developing
quantitative dietary guidance and translation into optimal and
desirable eating patterns and food choices that have the potential
for a substantial reduction in the risk of diet-related cancers in
the general population.



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements will be required to include minorities and
women in study populations so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition
under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders
and conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information should be included in the Form PHS 398
in Sections 1-4 of the Research Plan AND summarized in Section 5,
Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every
effort should be made to include human tissue from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including

If the required information is not contained within the application,
the application may be returned, or may be deferred until additional
information can be provided.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.


Prospective applicants are asked to submit by November 24, 1992, a
letter of intent that includes a descriptive title of the proposed
research, the name and address of the Principal Investigator, the
names of other key personnel, the participating institutions, and the
number and title of the RFA in response to which the application is
being submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, it is requested
in order to provide an indication of the number and scope of
applications to be reviewed.

The letter of intent is to be sent to:

Carolyn K. Clifford, Ph.D.
Diet and Cancer Branch
National Cancer Institute
Division of Cancer Prevention and Control
Executive Plaza North, Suite 212
Bethesda, MD  20892-6130
Telephone:  (301) 496-8573
FAX:  (301) 402-0553


General Instructions

The research grant application form PHS-398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda,
Maryland 20892; and from the NCI Program Director named below.

The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page.  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 title of the application, "Interactive Research Project Grants
for Nutrition and Cancer Prevention", and the RFA number, CA-93-04,
should be typed on line 2a of the face page of the application form.

Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package to
the Division of Research Grants (DRG) at the address listed below.
The photocopies must be clear and single sided.

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 828
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by January 19, 1993.  If an application
is received after that date, it will be returned.  If the application
submitted in response to this RFA is substantially similar to a grant
application already submitted to the NIH for review, but has not yet
been reviewed, the applicant will be asked to withdraw either the
pending application or the new one.  Simultaneous submission of
identical applications will not be allowed, nor will essentially
identical applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this RFA
that is essentially identical to one that has already been reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

Special Instructions for IRPG Applications

One Principal Investigator from the IRPG group MUST be identified as
the "Program Coordinator", and should be cited in all applications on
Page 2 of form PHS 398 (rev. 9/91).  Individual investigators may
request funds for the time and effort contributed toward the
coordination of the overall research and for collaborative resource

To facilitate referral, all applications submitted under the IRPG
mechanism MUST be as a single package.  Each application MUST be
complete in itself, with all appropriate approvals, budgets and
signatures.  A cover letter MUST accompany the package identifying
all principal investigators and project titles that are a part of the
combined submission.  The letter should be firmly attached to the
face page of the top application.  Each application MUST be
identified by checking "yes" on line 2 of the PHS 398 face page and
citing this RFA, "Interactive Research Project Grants for Nutrition
and Cancer Prevention".

The use of the IRPG mechanism should be mentioned briefly in form PHS
398 (rev. 9/91), Sections 1-4 of the Research Plan.  The goal of the
collaborative efforts MUST be identified in the specific aims of each
application, with the major rationale and explanation for the use of
the IRPG mechanism to be given in Section 7, Consultants/
Collaborators.  A complete list of applications in the IRPG should be
provided in Section 7, as well as an indication of the specific
collaborations to be established for the individual application under

Requests for limited shared resources, if any, should be
proportionally budgeted in each application based on anticipated use,
with a full explanation given in the budget.  Personnel Time and
Effort requests for management of shared resources are allowable.
Where consortium arrangements between independent institutions are
proposed that would make transfer of funds for required new equipment
impractical, the entire equipment request may be budgeted by the
responsible laboratory.  This should be clearly justified.

All PHS and NIH grant policies will apply to applications received in
response to this RFA.


Upon receipt, applications will be reviewed by the DRG for
completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the program requirements and criteria stated in the
RFA is an NCI program staff function.  Questions concerning the
responsiveness of proposed research to the RFA should be directed to
the Program Director indicated in the Letter of Intent Section.

If the number of applications is large compared to the number of
awards to be made, the NCI may conduct a preliminary scientific peer
review to eliminate those applications that are clearly not
competitive.  The NCI will remove from competition those applications
judged to be noncompetitive for award to notify the applicant and
institutional business official.  Those applications judged to be
both competitive and responsive will be further evaluated according
to the review criteria stated below for scientific and technical
merit by an appropriate peer review group convened by the Division of
Extramural Activities, NCI.  The second level of review by the
National Cancer Advisory Board considers the special needs of the NCI
and the priorities of National Cancer Program.

The following factors will be considered in evaluating the scientific
merit of each response to this RFA:

o  Scientific, technical or medical significance and originality of
the proposed research;

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed studies;

o  Adequacy of plans for coordination of the overall research and for
collaborative resource activities;

o  Availability of resources necessary to perform the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research.

For each application that is given a priority score, the review group
will assign an adjectival descriptor that reflects the extent and
effectiveness of its collaboration(s) with other applications
included in the IRPG.  This assessment will be documented in a brief
administrative note in the summary statement to assist the NCI in
making final decisions on each application in the context of the
overall IRPG.


The anticipated date of award is September 30, 1993.


Written and telephone inquiries concerning the objectives and scope
of this RFA, and inquiries about whether or not specific proposed
research would be responsive are encouraged and may be directed to
the Program Director listed below.  The program staff welcome the
opportunity to clarify any issues or questions from potential

Direct inquiries regarding programmatic issues to:

Carolyn K. Clifford, Ph.D.
Program Director, Diet and Cancer Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Suite 212
Bethesda, MD  20892-6130
Telephone:  (301) 496-8573
FAX:  (301) 402-0553

Direct inquiries regarding fiscal matters to:

Eileen Natoli
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard
Executive Plaza South, Room 243
Rockville, MD  20852
Telephone:  (301) 496-7800 Ext.56


This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control.  Awards will be made under the
authority of the Public Health Services Act, Title IV, Section 301
(Public Law 78-410,;42 U.S.C. 241 and Section 412, as amended by
Public Law 99-518, 42 U.S.C 258a-1); and administered under PHS
grants policies and Federal regulations 42 CFR Part 52 and 45 CFR
Part 74. This program is not subject to the intergovernmental review
requirements of Executive Order 12732 or Health Systems Agency


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