Full Text CA-95-018

CANCER PREVENTION RESEARCH UNITS

NIH GUIDE, Volume 24, Number 32, September 1, 1995

RFA:  CA-95-018

P.T.  34

Keywords: 
  Cancer/Carcinogenesis 
  Disease Prevention+ 
  Health Promotion 
  Biomedical Research, Multidiscipl 
  Health and Safety Education 


National Cancer Institute

Letter of Intent Receipt Date:  October 3, 1995
Application Receipt Date:  December 8, 1995

PURPOSE

The Cancer Control Science Program within the Division of Cancer
Prevention and Control (DCPC) of the National Cancer Institute (NCI),
seeks to stimulate the establishment of programs in primary and
secondary cancer prevention, health promotion and prevention services
research.  The objective of this Request For Applications (RFA) is to
reestablish efforts to develop a group of multidisciplinary cancer
prevention research programs as a national long-term resource in
cancer prevention and control research.

These programs, entitled Cancer Prevention Research Units (CPRUs),
will conduct primary and secondary prevention, health promotion, and
preventive services research aimed at (1) developing new intervention
approaches in all areas of cancer prevention and/or (2) applying
proven or state-of-the-science interventions in tobacco control,
nutrition, and screening identified in Healthy People 2000: National
Health Promotion and Disease Prevention Objectives.

The CPRU should foster a multidisciplinary environment of scientists
interacting closely within the research program.  These can include
experienced investigators in relevant fields and disciplines, such as
disease prevention and control, medicine, public health, health
education, health promotion, epidemiology, nutrition sciences, health
policy and economics, health services research, behavioral and social
sciences, community organization, communications, and biostatistics.

Additionally, the CPRU Program is intended to hasten the
establishment of high quality multidisciplinary research programs,
and will be supported by the NCI Program Project Grant (P01)
mechanism.  Traditionally, the program project approach has resulted
in the development of long-term research programs investigating
important research problems, has fostered interdisciplinary and
inter-institutional collaborations, and has led to new insights and
progress in meeting research goals.  The intent of this RFA is to
achieve the same results in cancer prevention and control research.

HEALTHY PEOPLE 2000

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,
Cancer Prevention Research Units (CPRU), is related to the priority
area of cancer.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017-001-00474-0 or Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic, non-profit and for-profit
organizations, public and private entities such as universities,
colleges, hospitals, laboratories, units of state and local
governments.  Applications from minority and women investigators are
encouraged.  Foreign institutions are ineligible to apply.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.  Any
of the three current NCI-funded CPRU P01 grantee institutions (Fred
Hutchinson Comprehensive Cancer Center, University of Minnesota,
University of Rhode Island) are ineligible to apply.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Research
program project grant mechanism (P01).  The CPRU must consist of a
minimum of three projects.  P01 grant applications must comply with
Guidelines for Program Project Grant of the National Cancer
Institute, which have been revised in 1995.  Copies can be obtained
from the program director listed below.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  The total project period for
applications submitted in response to the present RFA may not exceed
five years.  The anticipated award date is August 1, 1996.  This is a
one-time solicitation.  Future unsolicited competing continuation
applications will compete with the investigator-initiated
applications and will be reviewed according to customary NIH peer
review procedures.

FUNDS AVAILABLE

Approximately $5 million, per year, in total costs for five years
will be committed to specifically fund applications which are
submitted in response to this RFA.  It is anticipated that up to four
awards will be made.  This funding level 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, the award of grants pursuant to this RFA is also contingent upon
the availability of funds for this purpose.  Funds for each CPRU will
be capped at $1.25 million total annual costs.

RESEARCH OBJECTIVES

The CPRU Program is an attempt to stimulate the rapid establishment
of long-term programs in cancer primary and secondary prevention,
health promotion and prevention services research.  These CPRUs must
focus on problem- or program oriented cancer prevention research
studies, will require long-term support and involve multidisciplinary
participation, and, for cancer control Phase IV ad V studies, need to
have access to defined populations in order to measure the population
impact of any cancer control activities.

The CPRU concept envisions a multidisciplinary environment of
scientists interacting closely in the research program. These are
experienced investigators in relevant fields and disciplines, such as
disease prevention and control, medicine, public health, health
education, health promotion, epidemiology, nutrition, nutrition
sciences, early detection, chemoprevention, health policy and
economics, health services research, behavioral and social sciences,
community organization, communications, and biostatistics.  Linkages
between occupational and environmental exposure and cancer control
will strongly be encouraged.

It is not necessarily the intent of this RFA to create a CPRU in a
location where a critical mass of resources and qualified
investigators does not exist, but rather to redirect, focus, and
recruit institutions - such as cancer centers - already having highly
competent investigators into cancer prevention and control research.
At present, there exists a shortage of comparable research units
which are devoted to cancer prevention.

a.  Themes

The CPRU requires a major program theme to focus the research effort
and form the basis for multidisciplinary and inter-institutional
collaboration and synergism. Themes previously used in large cancer
prevention and control program project grants have varied, from
single cancer site (e.g., breast cancer prevention and control), to
risk factor focus (e.g., tobacco reduction in a managed care
setting), to intervention focus (e.g., adherence to cancer control
regimens).

b.  Developmental Projects

Peer-reviewed developmental, pilot, or feasibility projects are
permitted and encouraged in the CPRU.  These short-term projects
(usually 1-2 years) are particularly appropriate in conjunction with
long-term prevention intervention studies in communities or other
settings as a means to continually test new ideas, improve
procedures, ensure rapid integration into ongoing studies, and allow
a means to endure successful and optimal completion of major program
project objectives.  Occasionally, projects may be renewable with
appropriate justification and scientific merit review by an
institutional process.

These projects are analogous to the variety of short-term experiments
that a laboratory scientist can conduct in following up new leads
rapidly as findings emerge from in-vitro studies within the general
program theme of the grant.

c.  Components of a Cancer Prevention Research Unit

The CPRU should include the following components or elements:

o  A qualified leader with an appropriate time commitment;

o  A multidisciplinary group of prevention oriented scientists who
can conduct this type of research;

o  A rationale for why the CPRU method is appropriate for the
intended research program;

o  An emphasis on cancer prevention or health promotion and
prevention services research as noted above;

o  One major, specific research theme to focus the CPRU efforts, and
at least three research projects within the theme area;

o  Specific, although optional, developmental projects for up to 15
percent of the total costs of the CPRU;

o  Research or administrative core units or shared resources
necessary to more efficiently conduct the research program. These are
optional; and

o  Evidence of collaborative arrangements with the appropriate
organizations or population groups necessary to conduct the studies

In summary, investigators, especially in the nation's cancer centers,
are encouraged to form multidisciplinary, collaborative teams to
address research issues of critical importance to cancer prevention
and control.  These teams should focus on a single theme and may
consider developmental research projects as part of their overall
response and research

DCPC supports research with an emphasis on studies to identify,
evaluate, and implement techniques and approaches for primary and
secondary prevention of cancer.  Those studies may include specific
cancers such as breast or more general areas of prevention research
such as cancer prevention and screening among special populations,
chemoprevention, tobacco prevention among children and adolescents,
diet and nutrition, and early detection.  The CPRU should focus on
problem- or program-oriented cancer prevention research studies and
involve multidisciplinary participation.

Investigators may choose from the full range of scientific
approaches.  Many Phase II studies may contribute to the design,
implementation, or evaluation of future Phase III-V studies, e.g.,
validation of surveys or program materials for use in the proposed
population groups, testing of recruitment or compliance procedures
for participants, or testing of biochemical or dietary methods for
objectively monitoring participation in studies.  The proposed
research may occur in a variety of settings ranging from the
laboratory to communities, schools, health departments, managed care
organizations, and worksites.

The Cancer Control Science Program supports the development and
testing of primary and secondary intervention strategies to modify
personal, social, and life-style factors known to contribute to the
development and/or increased risk of cancer.  This research includes
the health promotion sciences, special population studies, and
applications research, as well as implementation studies for proven
technologies such as breast and cervical screening.  Research on
cost-effective health services is encouraged, since it impacts on
obtaining optimal application of the interventions in community
settings.  Interventions aimed at reducing cancer incidence related
to smoking and tobacco use is also emphasized (e.g., Phase IV and V
research in achieving the goals of the Year 2000 for smoking).

Linkages between laboratory research and applied cancer prevention
and control research are encouraged, i.e. laboratory research in
support of these prevention studies.  Basic laboratory research
without this linkage will be deemed non-responsive to the RFA.

Investigators must address the specific aims and hypotheses, the
background and significance of the proposed work, results of any
preliminary studies, experimental design and methods, any theoretical
concepts that underlie the intervention research, human subjects
involvement and protection, and relevant literature.

SPECIAL REQUIREMENTS

Applicants will be expected to present a budget for the overall
projects for five years.  Up to 15 percent of the CPRU total costs
may be devoted to two to three developmental/pilot projects.
Initially these projects will be reviewed by the NCI initial review
group according to the criteria listed under the REVIEW
CONSIDERATIONS section of this RFA.  Renewal or follow-on
developmental projects will be funded pending appropriate
justification and scientific merit review by an institutional
process.  For future years, institutionally reviewed new
developmental projects awarded under the parent grant must have the
prior approval of the NCI Program Director.

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
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research," which was reprinted in the Federal
Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting
errors in the earlier publication, and reprinted in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by October 3, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of this RFA in response to
which the application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains allows NCI staff to estimate the potential review
workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Sherry Mills, M.D., M.P.H.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Suite 330
6130 Executive Boulevard, MSC 7346
Bethesda, MD  20892-7346
Telephone:  (301) 496-8520
FAX:  (301) 402-0816
Email:  [email protected]

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research or may be obtained from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC
7762, Bethesda, MD 20892-7762, telephone (301) 710-0267.

The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
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.  All requirements with regard to type, size, page
limitations, appendix material, etc., must be followed or
applications will be returned without review.

The completed application and three copies must be sent or delivered
to:

Division of Research Grants
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 be sent to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Suite 636
6130 Executive Boulevard -  MSC 7405
Bethesda, MD  20892-7405 (if using U.S. Postal Service)
Rockville, MD  20852 (If hand delivered or delivery service)

Applications must be received by December 8, 1995.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NCI.  Incomplete applications will be
returned to the applicant without further consideration.  If NCI
staff find that the application is not responsive to the RFA, it will
be returned without further consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by convened in
accordance with NIH peer review procedures.  As part of the initial
merit review, all applications will receive a written critique and
undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications
under review, will be discussed, assigned a priority score, and
receive a second level review by the National Cancer Advisory Board.

Review criteria for P01 grant applications are contained within the
Guidelines for Program Project Grant of the National Cancer
Institute, which have been revised in 1995 and may be obtained from
the program director listed under INQUIRIES.  Review criteria for
developmental projects include, but are not limited to:

1.  scientific and technical significance and originality of proposed
research;

2.  appropriateness and adequacy of the experimental design and
methodology proposed to carry out the research;

3.  qualifications and research experience of the Principal
Investigators and staff, particularly, but not exclusively, in the
area of the proposed research;

4.  availability of the resources necessary to perform the research;

5.  appropriateness of the proposed budget and duration in relation
to the proposed research

6.  o  adequacy of plans to include both sexes and minorities and
their subgroups as appropriate for the scientific goals of the
research.  Plans for the recruitment and retention of subjects will
also be evaluated.

The initial review group will critically examine the submitted budget
and will recommend an appropriate budget and period of support.  They
will also examine the provisions for the protection of human and
animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of women and
Minorities as subjects in Clinical Research.

AWARD CRITERIA

Applications found to have significant and substantial merit will be
considered for funding by the following criteria:

o  Scientific merit as determined by peer review
o  Availability of funds
o  Programmatic priorities

INQUIRIES

Inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential
applicants is welcome.

Direct inquiries regarding programmatic issues to:

Sherry Mills, M.D., M.P.H.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Suite 330
6130 Executive Boulevard - MSC 7346
Bethesda, MD  20892-7346
Telephone:  (301) 496-8520
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Marian Focke
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Suite 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, ext. 246

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and administered under PHS grants policies and Federal
Regulations 42 CFR 52 and 45 CFR Part 74 and 92. This program is not
subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-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.

.

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