Subject: NIH GUIDE - RFA CA-92-04 - V21(03) 01/24/92
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Fri, 24 Jan 92 08:20 EST

Hi Paul,
   Please post to the NIH LIstserver as:
      RFACA-92-04.920124
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA CA9204 CA-92-04 P1O1 *****************************************
 
CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANT PROGRAM
 
RFA:  RFA CA-92-04
 
P.T. 34; K.W. 0715035, 0795003, 0745027, 0745035, 0710095, 0404000
 
National Cancer Institute
 
Application Receipt Date:  May 6, 1992
 
PURPOSE
 
The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI) invites Small Research Grant (R03)
applications from interested investigators.  This program is designed
to aid and facilitate the growth of a nationwide cohort of scientists
with a high level of research expertise in the field of human cancer
control intervention research.
 
New and experienced investigators in relevant fields and disciplines
(e.g., disease prevention and control, medicine, public health,
health promotion, epidemiology, social work, nursing research,
nutrition, health policy, health services research, and behavioral
sciences such as social psychology, health education, sociology, and
community organization) may apply for small grants to test ideas or
do pilot studies.
 
This Request for Applications (RFA) is a modified reissuance of RFA
CA-89-09.  The six prior Small Grant RFAs have resulted in 89 awards.
 
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 and Control Research Small Grant Program, 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 "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).
 
ELIGIBILITY REQUIREMENTS
 
Investigators are eligible to apply for a small grant to support
research on a cancer control topic if they are interested in
conducting exploratory studies in cancer control research.  Eligible
applicants include established researchers, new investigators,
qualified staff of public health departments and collaborating
agencies, and predoctoral investigators currently enrolled in an
accredited doctoral degree program.  Applications from minority
individuals and women are encouraged.  Non-profit and for-profit
organizations and institutions, governments and their agencies, and
occasionally individuals, are eligible to apply.
 
The only INELIGIBLE applicants are:
 
1.  Individuals who are or have previously been a Principal
Investigator
on an NCI-funded CANCER CONTROL grant or contract for more than TWO
years;
 
2.  previous recipients (Principal Investigators) of a DCPC Small
Grant;
 
3.  foreign institutions.
 
Small grant research support may NOT be used to supplement research
projects currently supported by Federal or non-Federal funds or to
provide interim support of projects under review by the Public Health
Service.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the National Institutes of
Health (NIH) small grant (R03) program.  Applicants will be
responsible for the planning, direction, and execution of the
proposed project.  Except as otherwise stated in this RFA, awards
will be administered under PHS grants policy as stated in the Public
Health Service Grants Policy Statement, DHHS Publication No. (OASH)
90-50,000, revised October 1, 1990.
 
This RFA is a one-time solicitation.  The total project period for
applications submitted in response to the present RFA may not exceed
two years.  The earliest possible beginning date will be March 1,
1993.  Small grants are not renewable.
 
FUNDS AVAILABLE
 
Approximately $500,000 in total costs for two years will be committed
to fund applications that are submitted in response to this RFA.
Direct costs up to $50,000 for the two-year time period are allowed.
It is anticipated that up to seven 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.
 
RESEARCH OBJECTIVES
 
The Cancer Prevention and Control Research Small Grants Award is
designed to encourage investigators from a variety of academic,
scientific, and public health disciplines to apply their skills to
scientific investigations in the field of human cancer control
intervention research.  The research may occur in a variety of
settings, such as communities, schools, health departments, and work
sites.  These investigators will become part of the new nationwide
group of scientists pursuing cancer control research goals.
 
RESEARCH APPROACHES
 
Within this small grant program, investigators may choose any of the
full range of scientific approaches in their work.  Many studies and
research designs may contribute to the design, implementation, or
evaluation of future phase III-V studies, e.g., descriptive baseline
surveys, testing, modification and validation of surveys or program
materials for use in the proposed population groups, and testing of
recruitment or compliance procedures for participants.
 
Investigators must address the specific aims and hypotheses,
background and significance of the proposed work, results of any
preliminary studies, experimental design and methods including any
relevant theoretical concepts that underlie the research, human
subjects involvement and protection, and relevant literature (see
instructions in the grant application).
 
PROGRAM AREAS OF INTEREST
 
The NCI has established a goal and a set of objectives for achieving
a 50 percent reduction in the cancer mortality rate by the Year 2000
(Greenwald, P, Sondik, EJ. Cancer Control Objectives For the Nation:
1985-2000. NCI Monograph No. 2, 1986).  In keeping with this goal and
objectives, the following cancer control program areas are
appropriate for HUMAN INTERVENTION research grant applications:
 
o  Prevention (chemoprevention, diet and nutrition intervention
studies)
 
o  Screening and early detection, e.g., pilot studies of new methods;
application of the "NCI Guidelines For Early Detection".  In the area
of breast screening and detection, studies of breast self-examination
as a single modality will not be accepted.
 
o  Cancer control sciences (studies to change current behaviors
and/or institute new behaviors or health promotion interventions
effective in reducing incidence, morbidity, or mortality from
cancer).
 
o  Smoking prevention and cessation pilot studies targeted at
improving utilization of current technologies in target populations
or organizations are encouraged.  Minor enhancements of existing
technology are not encouraged.
 
o  Applications research in modifying, feasibility testing, and
adopting proven, state-of-the-art intervention programs and
strategies from other research projects (e.g., screening, smoking
prevention) for use in special populations, State and local health
agencies, or other organizational and community settings.
 
In addition, planning, epidemiologic, and survey studies aimed at
developing cancer control operations research and evaluation studies
are appropriate for human intervention research grant applications.
 
o  Community oncology (improving the application of patient
management and continuing care research advances into community
settings).
 
o  Applied epidemiology studies (using epidemiologic methods to
determine the association between exposure to an INTERVENTION and its
impact on disease) are acceptable within the above program areas.
 
ALTHOUGH THE SPECIFIC STUDY PROPOSED MAY ATTEMPT TO OBTAIN ONLY
PRELIMINARY DATA AND/OR CONDUCT PILOT STUDIES IN SUPPORT OF A FUTURE,
MORE DETAILED PHASE III-V STUDY, IT IS IMPORTANT THAT A LONG-TERM
HUMAN CANCER CONTROL HYPOTHESIS AND SUPPORTING SCIENTIFIC
JUSTIFICATION BE PRESENTED.
 
EXCLUSIONS
 
Studies to determine the efficacy of chemotherapy, surgery,
radiotherapy, and other primary treatment interventions are not
considered cancer control research under this RFA.  Other laboratory
animal studies are not allowed.
 
STUDY POPULATIONS
 
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 sample size appropriate for the scientific objectives of the
study.  This information should be included in the form PHS 398 in
Section 2, A-D of the Research Plan and summarized in Section 2, E,
Human Subjects.  Applicants/offerors 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 limited to clinical
trials.
 
The usual NIH 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 tissues 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.
 
If the required information is not contained within the application,
the application will be returned.
 
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 or cooperative agreements that do not comply with these
policies.
 
REVIEW PROCEDURES AND CRITERIA
 
Upon receipt, applications will be reviewed by 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.  Applications that are judged nonresponsive will be
returned to the applicant, but may be submitted as investigator-
initiated research applications at the next receipt date.  Questions
concerning the responsiveness of the proposed research to the RFA may
be directed to program staff listed in INQUIRIES below.
 
In cases where the number of applications is large compared to the
number of awards to be made, the NIH may conduct a preliminary
scientific peer review (triage) to eliminate those applications that
are clearly not competitive.  The NIH will administratively withdraw
from competition those applications judged to be noncompetitive and
notify the applicant and institutional business official.
 
Responsive applications will be reviewed for scientific and technical
merit by a multidisciplinary committee convened by the NCI consisting
primarily of non-Federal technical, intervention, and scientific
experts in relevant disciplines, such as cancer control, medicine,
oncology, nursing research, public health, epidemiology,
biostatistics, behavioral and social sciences (psychology, health
education, sociology), community intervention, health policy, and
health services research.
 
REVIEW CRITERIA
 
Applications will be evaluated subject to the following criteria:
 
o  The scientific/technical merit of the research, including
originality, feasibility, adequacy of design, plans for analyses and
evaluation of data, and soundness of the research plan.
 
o  The quality of the Principal Investigator's research training,
intervention experience, and potential for contribution as an
investigator in the field of cancer control intervention research.
 
o  The adequacy of resources and facilities, and the supportive
nature of the research environment.
 
The review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.  Final decision will be made by the DCPC NCI on
the basis of the initial review and the availability of funds.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (revised 9/91) must be
used in applying for these grants.  These forms are available at most
institutional business offices; from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, Room 449,
Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892,
telephone 301/496-7441; 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 and the RFA number must be typed on line
2 of the face page of the application form.
 
Submit a signed, typewritten original of the application, including
the Checklist, and four signed, exact photocopies in one package to
the DRG at the address 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, send two additional copies of the application
to:
 
REFERRAL OFFICER
Division of Extramural Activities
National Cancer Institute
Room 848, Westwood Building
5333 Westbard Avenue
Bethesda, MD  20892**
 
**IF AN EXPRESS COURIER SERVICE IS USED FOR DELIVERY, USE ZIP CODE
20816.
 
Applications must be received by May 6, 1992.  If an application is
received after that date, it will be administratively withdrawn and
returned to the applicant.  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.
 
The following additional page limitations (typewritten,
single-spaced) apply to sections 1 and 2 (pages 12-22) of the PHS-398
application:
 
Section 2:  Research Plan (14 pages total; a suggested page
distribution is as follows):
 
o  Specific Aims - one page.  Clearly state the cancer control
hypothesis and intervention to be studied.
 
o  Significance -  one page.
 
o  Progress Report & Preliminary Studies - if applicable, two pages.
 
o  Experimental Design and Methods - ten pages.
 
Following the research plan, include the discussion of human subjects
and the literature cited.  Appendices are acceptable.  These page
limitations and others in the PHS 398 application instructions must
be observed or the application will be returned to the applicant.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify questions on specific proposed research
from potential applicants is welcome.  Direct inquiries regarding
programmatic issues to:
 
Sherry L. Mills, M.D., M.P.H.
Program Director, Prevention and Control Extramural Research Branch
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 320
Bethesda, MD  20892
Telephone:  (301) 496-8520
 
Direct inquiries regarding fiscal matters to:
 
Katharine Schulze
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 ext. 16
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.399.  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.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.