Full Text CA-93-027


NIH GUIDE, Volume 22, Number 21, June 11, 1993

RFA:  CA-93-027

P.T. 34, FF

  Clinical Medicine, General 
  Treatment, Medical+ 

National Cancer Institute

Letter of Intent Receipt Date:  July 14, 1993
Application Receipt Date:  September 22, 1993


The Comprehensive Minority Biomedical Program (CMBP), Division of
Extramural Activities (DEA), National Cancer Institute (NCI), invites
research grant applications from interested investigators with access
to large or predominantly minority populations to promote minority
group participation in cancer research with a special focus on cancer
control research.  Support provided by this initiative would broaden
the operational base of each institution by:

1.  Expanding cancer control and prevention efforts in early
detection, prevention, screening, pre-treatment evaluation,
treatment, continuation care, and rehabilitation;

2.  Increasing the involvement of minority population primary care
providers early in the course of clinical treatment research;

3.  Promoting the involvement in treatment research at the
institutional level with a focus on the development of treatment
protocols for cancers that have a high incidence in minorities;

4.  Supporting programs involving diet and nutrition cancer control
research activities;

5.  Coordinating the contributions of investigators from various
relevant disciplines, psychology and nutrition; and

6.  Promoting the inclusion of minority individuals at  all levels in
the conduct of the research with the increased recruitment of
minority scientists into the  research base of the institution as an
expected outcome.


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), Minority Enhancement Awards, 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).


Applications may be submitted by domestic for-profit and non- profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of state and local governments, and
eligible agencies of the federal government.  Applications from
minority individuals and women are encouraged. Institutions are
eligible if they can demonstrate the following:

1.  Broad research capabilities in cancer prevention, cancer control
and cancer treatment as evidenced by significant research support in
these areas.  This would include past and current examples of ability
to design and implement strong clinical trials research programs.

2.  An organizational infrastructure that promotes and sustains a
strong interdisciplinary, interactive cancer research environment
which links basic research effectively to research in patient and
populations settings (e.g., NCI-designated Comprehensive Cancer

3.  Clear access to large numbers of minorities who are
representative of the minority populations in the communities and/or
regions associated with the institution.

4.  Demonstrated capability to work with minority populations in a
research setting within communities and/or regions.

Applicants who do not adequately meet the above eligibility
requirements of this initiative may have their applications returned.
Thus, the NCI strongly encourages applicants to communicate with the
appropriate NCI program official before submitting a letter of intent
(see INQUIRIES section).


This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  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.  Generally, future unsolicited
competitive continuation applications will compete with all
investigator-initiated applications and be reviewed by the Division
of Research Grants (DRG).  However, should the NCI determine that
there is a sufficient continuing program need, a request for
competitive continuation applications will be announced.  Only
recipients of awards under this RFA will be eligible to apply.   The
average amount of direct costs expected per award is 200,000.


Funding in the amount of $1,600,000 in total costs has been set aside
for the first year to specifically fund applications which are
submitted in response to this RFA.  It is anticipated that six awards
will be made.  This funding level is dependent on the receipt of
sufficient number of applications of high scientific merit.  The
total project period for applications submitted in response to the
present RFA may not exceed three years.  The earliest feasible start
date for the initial awards will be April 1, 1994.  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.


The NCI is committed to reducing the cancer mortality disparity
between disadvantaged populations, which include African Americans,
Hispanics and Native Americans, and the general population.  One
approach to achieving this objective is through the NCI DEA CMBP,
which is committed to providing support to institutions for
increasing their efforts to broaden minority involvement in programs
developing the latest and most effective measures in cancer
prevention, cancer control, and clinical treatment research.  One
primary goal is the delivery of state-of-the-art cancer prevention
and control as well as treatment modalities to underserved and
minority populations.

Cancer survival statistics verify that certain segments of the
population, African Americans for example, have substantially lower
cancer survival rates than that of American Whites with the same
disease.  By targeting minority populations with the highest
mortality in different regions of the country, it is hoped that this
initiative will have significant impact on minority population cancer
survival.  This initiative is to encourage institutions to develop
research programs in cancer prevention, cancer control and cancer
treatment that will specifically benefit minority populations.

General research objectives within the scope of this initiative
include, but are not limited to, smoking behavior in minority youth;
studies of communication strategies for presenting information to
minorities about cancer and its prevention; investigations of patient
perspectives of cancer risks; the design and evaluation of
interventions to minimize and prevent distress of minority patients
with cancer; the development of pilot studies for minority clinical
prevention trials; and psychosocial studies and perception of cancer
risk in minorities.

Specific research strategies include:

1.  Targeting and facilitating the involvement of minority
populations in cancer control research.

2.  Investigating the impact of cancer therapy and control advances
on minorities in community medical practice settings.

3.  Increasing the involvement of minority primary health care
providers and other specialists in treatment and other cancer control
research, thereby providing both educational opportunities for health
providers and facilitating interchange of information about current
advances in cancer control research.

4.  Increasing the number of underserved patients entered into
clinical cancer treatment protocols.

5.  Delivery of state-of-the-art cancer treatment to underserved
minority populations.

6.  Significantly impacting minority population cancer treatment and



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are 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 must be placed on the need for inclusion of
minorities and women in studies 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 must 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 must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) 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 must
be provided.

For the purpose of this policy, clinical research is defined as 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 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 population is inadequate, it will be
considered a scientific weakness or deficiency in the study design
and 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


Prospective applicants are asked to submit, by July 14, 1993, 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. Lemuel Evans at the address
listed under INQUIRIES.


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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
(301) 710-0267; and from the NCI Program Director named below.

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 RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.

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:

NCI Referral Office
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda, MD  20892

Applications must be received by September 22, 1993.  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


Upon receipt, applications will be reviewed for completeness by DRG
and for responsiveness by the NCI Program Staff.  Incomplete
applications will be returned to the applicant without further
consideration.  If the application is 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 on the basis of relative
competitiveness.  The NIH will withdraw from further competition
those applications judged to be non-competitive for award and notify
the applicant Principal Investigator and institutional official.
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 NCI.  The second level of review will be
provided by the National Cancer Advisory Board.

Review criteria for RFAs are generally the same as those for
unsolicited research grant applications.

o  Extent to which the proposed research plan addresses the goals and
objectives of the RFA;

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

o  Availability of the resources necessary to perform the research;

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


The earliest anticipated date of award is April 1, 1994.  The
following will be considered for making funding decisions:

o  quality of the proposed research project as determined by peer
o  availability of funds
o  program balance among research areas
o  geographical distribution of awards


Written and telephone inquiries concerning the objectives and scope
of this RFA or inquiries about whether or not specific proposed
research would be responsive are encouraged and may be directed to:

Dr. Lemuel Evans
Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 620
Bethesda, MD  20892
Telephone:  (301) 496-7344
FAX:  (301)  496-7911

For information regarding budgetary/administrative issues related to
this RFA, contact:

Ms. Carolyn Mason
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD 20892
Telephone:  (301) 496-7800, Extension 59


This program is described in the Catalog of Federal Domestic
Assistance, Number 93.399, Cancer Control.  Awards are made under the
authorization of the Public Health Service Act, Title V, 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 Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.


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