Full Text CA-94-017

TRANSLATIONAL INVESTIGATOR GRANTS FOR CANCER PREVENTION AND CONTROL

NIH GUIDE, Volume 23, Number 17, May 6, 1994

RFA:  CA-94-017

P.T. 34

Keywords: 
  Cancer/Carcinogenesis 
  Epidemiology 
  Disease Prevention+ 
  Disease Control+ 


National Cancer Institute

Letter of Intent Receipt Date:  June 15, 1994
Application Receipt Date:  September 23, 1994

PURPOSE

The Division of Cancer Prevention and Control (DCPC) of the National
Cancer Institute (NCI), invites research grant applications from
investigators new to this area of research, who are in the early
stages of their career, to conduct 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. 017-001-00474-0) or "Health 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

Applications may be submitted by domestic, non-profit and for-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state or local governments, and
eligible agencies of the Federal government.  Applications from
minority and women investigators are encouraged.

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.

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 the present 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 July 1, 1995.

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 95.  However, the NCI has
plans to re-issue this RFA for funding in FY 1996 and 1997.  Future
unsolicited competing continuation 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 the application of patient
management, pain, or symptom management and rehabilitation
principles.

There is concern about 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, Health Maintenance Organizations
(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.

Usually, investigators who do not have the publication or research
track record in cancer prevention and control translational research
are not competitive for R01 grant support.  Thus, very few prevention
and control research applications are submitted by these
investigators.  The DCPC would like to reverse this trend and
encourage prevention and control investigators new to the area of the
conduct of translational research.

Objectives

The objective of this initiative is to encourage qualified cancer
prevention and control investigators to develop grant applications to
conduct interventions and trials that 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).

Project Description

The DCPC encourages qualified prevention and control investigators to
develop R01 research grant applications to conduct 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
feeding studies to improve understanding of the bioavailability of
vitamins and minerals administered in different forms (e.g., tablets,
fruits); controlled interventions to increase and improve smoking
cessation counseling, or breast, cervical and colorectal screening by
physicians; and studies to determine the relative effectiveness of
behavioral interventions to reduce side effects of cancer treatments,
such as anxiety or nausea.

Research grant applications submitted in response to this RFA 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 that
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.  Laboratory studies to monitor patients or to study the
mechanism of action of agents may be included as appropriate.  It is
expected that at least 30 percent effort will be committed to the
research project by the Principal Investigator.

STUDY POPULATIONS

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 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 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 15, 1994, 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 Dr. Helen Meissner at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Method of Applying

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  These forms are available at most institutional
offices of sponsored research and may be obtained from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone (301) 435-0714.

The RFA label available in the PHS 398 (rev. 9/91) 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 title and number of this RFA must be
typed in Section 2a on the face page of the application form and the
YES box must be marked

All requirements including those with regard to type, size, page
limitations, and appendix material must be followed or the
application 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
Westwood Building, Room 240
Bethesda, MD  20892**

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

Mrs. Toby Friedberg
Referral Office
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda, MD  20892

Applications must be received by September 23, 1994.  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.

Application Requirements

The application must include the following documentation to be
considered for review:

o  A letter or memorandum from a department head or dean must be
included that addresses the eligibility of the proposed principal
investigator to independently lead a research project at the
applicant institution and a description of the institution's intended
commitment to the project for the four year period.

o  A draft of any protocols involved must be included in the
Appendix.  Documentation of the status of Human Subjects and IRB
approval must also be included.

o  Documentation of the gender and racial/ethnic group composition of
the proposed study population, together with a rationale for its
choice, must be included in the Human Subjects section.

o  Provision for one two-day meeting to Bethesda must be included in
each year's budget.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the
DRG and responsiveness by the NCI.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is complete but not responsive to the RFA, NCI staff will
contact the applicant to determine whether to return the application
to the applicant or submit it for review in competition with
unsolicited applications at the next review cycle.

Applications may receive a preliminary scientific peer review
(triage) by an NCI peer review group for relative competitiveness.
The NIH will withdraw from further consideration those applications
judged to be noncompetitive for award and will notify the Principal
Investigator and institutional office.  Those applications judged to
be competitive will undergo further scientific merit review in
accordance with the criteria stated below by an appropriate peer
review group convened by the Division of Extramural Activities, NCI.
The second level of review will be by the National Cancer Advisory
Board.

Review Criteria are:

o  scientific/technical significance and originality of proposed
research;

o  extent to which the proposed research clearly translates basic,
epidemiological and clinical research into cancer prevention and
control applications;

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

o  qualifications and relevant research experience of the Principal
Investigator and collaborating scientists

o  availability of the resources necessary to perform the research;

o  evidence that appropriate steps have been taken to ensure the
protection of human subjects; and

o  evidence of compliance with NIH policies regarding the inclusion
of women and minorities in research study populations.

The review group will examine the details of the proposed budget and
recommend an appropriate budget and period of support for each
application recommended for further consideration.

AWARD CRITERIA

The anticipated date of award is July 1, 1995

Applications found to have significant and substantial scientific
merit will be considered for funding based on priority score,
availability of funds, and programmatic priorities.

In addition, preference will 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 and address the letter
of intent to:

Helen Meissner, Sc.M.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 330
Bethesda, MD  20892
Telephone:  (301) 496-8520
FAX:  (301) 402-8520

Direct inquiries regarding fiscal matters to:

Robert E. Hawkins
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800,  ext. 213

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 HHS policies and grant regulations.  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.
This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

.

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