Full Text CA-96-013
 
TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL
 
NIH GUIDE, Volume 25, Number 14, May 3, 1996
 
RFA:  CA-96-013
 
P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Disease Prevention+ 
  Disease Control+ 

 
National Cancer Institute
 
Letter of Intent Receipt Date:  June 11, 1996
Application Receipt Date:  August 8, 1996
 
PURPOSE
 
The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI), invites research project grant (R01)
applications from new prevention and control investigators for the
conduct of studies translating phase I (hypothesis development) and
II (methods development) basic, epidemiological, and clinical
research into new approaches for the prevention and control of
cancer.
 
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 Request
for Applications (RFA), Translational Investigator Grants for Cancer
Prevention and Control, is related to the priority area of cancer.
Potential applicants may obtain a copy of "Health People 2000" (Full
Report:  Stock No. 017-001-00474-01 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 amd private entities such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government.
Foreign institutions are ineligible to apply.  Racial/ethnic minority
individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
 
The principal investigator (PI) must have a doctoral degree and be
working independently, but at the beginning stages of his or her
research career in the areas of translational prevention and control
research.  An important principle to remember is that the more
extensive the prior independent research experience, regardless of
funding source, the greater likelihood there will be diminished
priority for award. Applicants also must identify a senior
collaborator from whom they will receive guidance regarding the
proposed research.  Senior collaborators are encouraged to provide
sufficient input into the research proposed prior to grant
submission.  The investigator's senior collaborator will be required
to outline specific plans for providing guidance to the candidate
with respect to development and execution of the research plan.  The
collaborator should be an experienced investigator in cancer
prevention and control who is willing to devote time and effort to
ensure that acceptable standards for the research are met.
 
MECHANISM OF SUPPORT
 
This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  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 this RFA may not exceed four years.
 
The total direct cost for the four year period may not exceed
$500,000. The direct cost in any budget period may not exceed
$150,000. The anticipated award date is April 1997.
 
Awards and level of support depend on 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 contingent upon the continuing availability
of funds for this purpose.
 
This RFA is a one-time solicitation for FY 97.  Future unsolicited
competing applications will compete with all investigator-initiated
applications and be reviewed according to customary peer review
procedures unless additional re-issuances are required.
 
FUNDS AVAILABLE
 
Approximately $1.5 million, per year, in total costs for four years
will be committed to fund applications that are submitted in response
to this RFA.  It is anticipated that eight new individual awards will
be made.
 
RESEARCH OBJECTIVES
 
Background and Rationale
 
The DCPC supports research with an emphasis on studies to identify,
evaluate, and implement techniques and approaches for the primary,
secondary, and tertiary prevention of cancer.  Those studies may
focus on specific cancers, such as breast or prostate, or more
general areas of prevention research such as studies to change
current behaviors and/or develop new behaviors effective in reducing
incidence, morbidity or mortality from cancer (e.g., smoking, diet,
early detection), or studies to improve application of patient
management, pain, or symptom management and rehabilitation
principles.
 
There is, however, ongoing concern over the declining number of
investigators entering and remaining in academic research related to
cancer prevention and control.  These investigators are a critical
component in translating phase I and phase II prevention and control
research from epidemiological studies, the laboratory, and the clinic
to broader venues such as physician practices, HMOs, and communities.
These investigators must maintain a broad perspective and knowledge
concerning epidemiology and clinical and basic sciences, while
developing new delivery and intervention approaches that are
hypothesis driven.  They are highly interactive with basic, clinical,
and epidemiological researchers in related disciplines.  This
translational investigator is considered distinct from the
investigator who has a Ph.D. or equivalent training and concentrates
on basic or epidemiological research, or the M.D. clinician who
participates in cancer research by entering patients on clinical
trials.
 
Investigators who do not have the publication or research track
record in cancer prevention and control translational research are
usually not competitive for R01 grant support.  Thus, very few
prevention and control research applications are submitted by these
investigators.  DCPC would like to reverse this trend and encourage
new prevention and control investigators in the conduct of
translational research.
 
Objectives
 
The objective of this initiative is to support new cancer prevention
and control investigators in the conduct of interventions and trials
which translate phase I and II research into new means of preventing
particular cancers or improving survival from cancers.  Investigators
are urged especially to address the more difficult prevention and
control challenges, including the most common malignancies in adults
(e.g., breast, lung, colon, prostate) and risk factors (e.g., tobacco
use, diet and nutrition, early detection, environmental exposures).
Investigators must clearly demonstrate that the research is
translational.  The term RtranslationalS used here refers to the
science of implementing or applying the results of basic, clinical or
epidemiological research into prevention and control clinical and
public health practice.
 
Project Description
 
DCPC encourages qualified prevention and control investigators to
develop R01 grant applications for the conduct of intervention
studies translating phase I and II epidemiological, basic, and
clinical research into new approaches for the prevention and control
of cancer.   Examples of translational research include controlled
interventions to increase and improve smoking cessation counseling by
physicians, or maximize utilization of breast, cervical and
colorectal screening; trials addressing behavioral and psychosocial
consequences of genetic screening for cancer; studies to determine
the relative effectiveness of behavioral interventions to reduce side
effects of cancer treatments, such as anxiety or nausea; controlled
feeding studies to improve understanding of the bioavailability of
vitamins and minerals administered in different forms (e.g., tablets,
fruits).
 
Grant applications must include trials and interventions involving
human subjects and be designed to ultimately reduce the incidence
of particular cancers or improve cancer survival. The trials and
interventions must have a strong rationale and be based upon phase
I and II research which support the underlying hypotheses.  New
intervention trials employing such channels as appropriate dietary
regimens, pharmacologic agents, or behavioral or psychosocial
change mechanisms, whether used as a single agent/modality or in
combination, are appropriate.  The research plan should be focused
on the trial or intervention proposed.  It is expected that at
least 30 percent effort will be committed to the research project by
the
Principal Investigator.
 
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 subpopulations 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 provisions that are
substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects
should read the "NIH Guidelines For Inclusion of Women and
Minorities as Subjects in Clinical Research," which have been
published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and reprinted in the NIH Guide for Grants and Contracts,
Volume 23, Number 11, March 18, 1994.
 
Investigators also may obtain copies of the policy from the
program staff listed under INQUIRIES.  Program staff may also
provide additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by June 11, 1996, 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 the 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:
 
Helen Meissner, Sc.M.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 232D MSC 7330
6130 Executive Boulevard
Bethesda, MD  20892-7330
Rockville, MD  20852 (for exprexx/courier service)
Telephone:  (301) 496-8520
FAX:  (301) 496-8675
Email:  meissneh@dcpceps.nci.nih.gov
 
APPLICATION PROCEDURES
 
A. Method of Applying
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  These forms are available at most institutional
offices of sponsored research; from the Office of Extramural Outreach
and Information Resources, National Institutes of Health, 6701
Rockledge Drive MSC 7910, Bethesda, MD 20892-7910 telephone
301/435-0714, email: asknih@odrockm1.od.nih.gov; and from the program
administrator listed under INQUIRIES.
 
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 in
Section 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.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier services)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Mrs. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
6130 Executive Boulevard
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)
 
Applications must be received by August 8, 1996.  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.
 
B. Application Requirements
 
The application must include the following documentation to be
considered for review:
 
o  A letter of support from the PI's senior collaborator outlining
specific plans for providing guidance to the candidate with respect
to development and execution of the research plan.  A description of
intended commitment of the institution to the project for the four
year period also should be included.
 
o  A draft of any protocols involved must be included in the
Appendix. Documentation of the status of Human Subjects and IRB
approval should also be included.
 
o  Documentation for the composition of the proposed study population
in terms of gender and racial/ethnic group, together with a rationale
for its choice, must be included in the Human Subjects section.
 
o  Applications responding to this RFA should include one round trip,
2 day meeting to Bethesda in each year's budget.
 
C. Pre-application Conference
 
The National Cancer Institute intends to sponsor a pre-application
conference for anyone interested in responding to this RFA,
Translational Investigator Grants for Cancer Prevention and Control.
Issues to be addressed during the conference will include application
and review procedures, program goals and objectives, and award
criteria.  Time will be allotted for questions and answers.
Participation in the conference is optional and is not a requirement
of this RFA.
 
The pre-application conference will be held Wednesday, May 29, 1996
from 9:00 a.m to 4:00 p.m., at the Natcher Conference Center located
on the National Institutes of Health (NIH) campus in Bethesda,
Maryland (9000 Rockville Pike, Building 45, LL Room D).  Parking is
very limited and all visitors must park in areas marked for visitors
only.  As these spaces go very quickly, we urge anyone planning to
drive to the conference to arrive by 8:00 a.m.  A Metro stop, Medical
Center, is conveniently located on the NIH campus and is about a 7 to
10 minute walk from the Natcher Conference Center.  All travel costs
and arrangements are the responsibility of the investigator.
 
Contact Veronica Chollett at (301) 435-2837, if you are planning to
attend the pre-application conference.  Conference material and
information will be made available to anyone interested, including
those who cannot attend.  If you cannot attend, but would like to
receive copies of information & transcripts from the conference,
contact Ms. Chollett.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the National Cancer Institute.  Incomplete
and/or non-responsive applications will be returned to the applicant
without further consideration.  Those applications judged to be
competitive will undergo further scientific merit review.  Those
applications that are complete and responsive will be evaluated in
accordance with the criteria stated below for scientific/technical
merit by an appropriate peer review group convened by the Division of
Extramural Activities, NCI.
 
As part of the initial 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 of review by the
National Cancer Advisory Board.
 
Review Criteria include, but are not limited to:
 
o  scientific and technical significance and originality of proposed
research;
 
o  extent to which proposed research clearly translates basic,
epidemiological and clinical research into cancer prevention and
control applications;
 
o evidence of familiarity with and understanding of relevant research
literature as it relates to cancer prevention and control;
 
o  appropriateness and adequacy of the experimental design and
methodology, including appropriateness of control and comparison
groups, reliability and validity of instruments to assess key
variables, methods to identify and minimize biases and threats to
validity, and specification of statistical power and sample sizes;
 
o  qualifications and relevant research experience of the Principal
Investigator and collaborating scientists, including the senior
collaborator, particularly in the area of the proposed research;
 
o  potential contribution of the project to diffuse cancer prevention
and control research into clinical and public health practice;
 
o  availability of the resources necessary to perform the research;
 
o  evidence that appropriate steps have been taken to insure the
protection of human subjects; and
 
o  adequacy of plans to include both genders 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 review group will critically examine the submitted budget and
will recommend an appropriate budget and period of support for each
approved application.
 
AWARD CRITERIA
 
Applications found to have significant and substantial merit will be
considered for funding by the following:
 
o  priority score
o  availability of funds
o  programmatic priorities
 
Preference will also be given to clinical investigators who are new
to cancer prevention and control translational research.
 
INQUIRIES
 
Written and telephone 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:
 
Helen Meissner, Sc.M.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 232D MSC 7330
6130 Executive Boulevard
Bethesda, MD  20892-7330
Rockville, MD  20852 (for exprexx/courier service)
Telephone:  (301) 496-8520
FAX:  (301) 496-8675
Email:  meissneh@dcpceps.nci.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Tanya Terrell Collier
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard
Bethesda, MD  20892
Telephone: (301) 496-7800, 247.
 
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 Services 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 Part 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 and contract 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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