Full Text CA-93-034

DEVELOPMENTAL RESEARCH IN NATIVE PACIFIC POPULATIONS

NIH GUIDE, Volume 22, Number 25, July 16, 1993

RFA:  CA-93-034

P.T. 34, FB

Keywords: 
  Cancer/Carcinogenesis 
  Disease Control+ 
  Disease Prevention+ 


National Cancer Institute

Letter of Intent Receipt Date:  August 18, 1993
Application Receipt Date:  October 20, 1993

PURPOSE

The National Cancer Program is mandated to address the unique cancer
prevention, early detection, and treatment needs of all populations
within the U.S. and its territories.  An excerpt from the FY 1992
Committee on Appropriations to the U.S. Department of Health and
Human Services stated:

"The Committee also urges NCI to expand its efforts to develop an
appropriate response to the needs of American Samoans.  Access to
timely treatment intervention is especially important for this native
American population...."   (Senate Report No. 102-104, page 86)

Therefore, the Division of Cancer Prevention and Control (DCPC) of
the National Cancer Institute (NCI) invites applications from various
organizations for developmental studies that:  (1) assess cancer
control need, (2) determine barriers to cancer control, and/or (3)
validate intervention methods and assessment instruments in native
Pacific populations; i.e., American Samoans, Guamanians (Chamorros),
Palauians, and Northern Marianians.  This initiative will define the
cancer prevention and control needs of native Pacific populations and
those of similar ancestry located in the Pacific as well as the U.S.
mainland.

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), Developmental Research in Native Pacific
Populations, 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

Applications may be submitted by domestic (including U.S. Territorial
possessions) public and private, for-profit and non-profit
organizations serving native Pacific populations such as
universities, public health departments, voluntary organizations,
research centers, hospitals, consortia of health providers, units of
State and local governments and eligible agencies of the Federal
government.  Teams of applicants are encouraged.  Among a team of
applicants, one institution must be proposed as the lead institution
to serve as the applicant and to assume responsibility for the
conduct and administration of the project.  Note that awards will not
be made to foreign institutions and that applications from domestic
organizations may not include international components.

MECHANISM OF SUPPORT

The mechanism of support for this RFA will be the National Institutes
of Health (NIH) research project grant (R01).  Responsibility for the
planning, direction, and execution of the proposed research will be
solely that of the applicant.  In addition to the requirements 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, 1991.  This RFA
is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.  It is anticipated that four awards
will be made at approximately $300,000 total costs per year.

FUNDS AVAILABLE

Approximately $1.2 million in total costs per year for three years
will be set-aside to specifically fund applications that are
submitted in response to this RFA.  It is anticipated that up to four
awards will be made.  The total project period of these awards may
not exceed three years.  This level of support 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 a grant pursuant to this RFA is also
contingent upon the availability of funds for this purpose.

RESEARCH OBJECTIVES

Background

The National Cancer Program is mandated to address the unique cancer
prevention, early detection, and treatment needs of all populations
within the U.S. and its territories.  The cancer control objectives
for the nation are aimed at (1) reducing the cancer death rates for
all Americans and (2) eliminating differentials in cancer rates
between population segments.  The means to obtain these objectives
include the development and implementation of cancer control and
prevention strategies directed at the general U.S. population and
targeted initiatives directed at minority and medically underserved
populations that are differentially affected by cancer.  These
populations include those who experience high cancer
incidence/mortality rates or low survival rates, or who are
underserved in terms of cancer prevention and control programs that
include the native Pacific populations.

The paucity of data on effective cancer prevention and control
intervention methods in the target populations reflect both a dearth
of such programs and of validated instruments to evaluate their
effectiveness.  The need for the development of sensitive
intervention methods and assessment instruments has to be established
in many areas of health (e.g., mental health, cardiovascular
diseases) and other sectors (e.g., education).

In recent years, the Division of Cancer Prevention and Control (DCPC)
has carried out intervention research initiatives directed at the
American Indian/Alaska Native, Black, Native Hawaiian, and Hispanic
populations.  These experiences, combined with information gathered
through external working groups and experts in the cancer prevention
and control needs of minority and medically underserved populations
and extensive conversations with experienced investigators, has
clarified the need for Phase I and Phase II cancer control studies
for native Pacific populations.  It is clear that the concepts of
health and healing vary significantly, and this diversity is not
captured by a single design, method, or instrument.

Studies conducted under this RFA will seek to define cancer
prevention and control needs/services of the native Pacific
population segments (Phase I). Studies to test ways in which existing
intervention methods can be used or adapted for the target
populations (Phase II); studies of new methods designed to be
sensitive to the needs of the target populations (Phase II); and
methodologic research on validation of assessment instruments in
target populations (Phase II) are eligible for consideration under
the RFA.  This "developmental cancer control research" (Phase I and
Phase II) is absolutely essential to future development of cancer
prevention and control research for native Pacific populations.

The following definitions apply to this RFA:

1.  Native Pacific Populations -- The term "native Pacific
populations" refers to those population segments indigenous to the
Pacific region and/or populations of similar ancestry located within
the U.S. mainland, such as American Samoan populations.

2.  Cancer Control -- Cancer control is defined as the reduction of
cancer incidence, morbidity, and mortality through an orderly
sequence from research on interventions and their impact in defined
populations to the broad, systematic application of the research
results.

3.  Phases of Cancer Control -- Cancer control research studies are
classified in the five phases that represent the orderly progression
noted in the above definition:  (I) Hypothesis development; (II)
Intervention methods development and testing; (III) Controlled
intervention trials to establish cause and effect relationships; (IV)
Research in defined human populations; and (V) Demonstration and
implementation studies.

The research of interest in this RFA falls into either Phase I or
Phase II studies.  Hypothesis development (Phase I) studies should
focus on the assessment of cancer prevention and control needs in
communities or organizations within native Pacific populations, or
studies that identify barriers to cancer prevention and control
within these indigenous populations.  Methods development and testing
studies, Phase II, should focus on:  (1) validating the use of
existing intervention methods (e.g., dietary modification, health
services, tobacco cessation) as applied in the target populations
described above; (2) developing and pilot testing unique methods that
are sensitive to the needs of the target populations described above,
or (3) developing and validating assessment instruments to measure
the cancer control related needs of the target populations or for use
in evaluating the effectiveness of intervention methods in the target
populations.

It is the interest of this RFA that the projects should be
multidisciplinary in design.  Applicable disciplines may include
epidemiology, oncology, public health, pathology, health services
research, behavioral, and social sciences.  The research team should
include individuals with knowledge of the culture and language of the
native Pacific populations.

Because validation and intervention studies may depend on the review
of case records, investigators should assure in the application that
a mechanism to access pertinent records has been identified.

A.  Goals and Objectives

The goals of this program initiative are to identify cancer control
needs, to determine barriers to cancer control, and to validate
intervention methods and assessment instruments.  The objectives
relating to Phases I and II are described below:

Phase I Studies

1.  Assess cancer prevention and control needs/services in
communities with native Pacific populations.

2.  Identify barriers to cancer prevention and control in native
Pacific population communities.

Phase II Studies

1.  Validate the use of existing intervention methods (e.g., dietary
modification, health services, tobacco cessation) applied in the
target populations.

2.  Develop and pilot test unique intervention methods sensitive to
the needs of the target populations.

3.  Develop and validate assessment instruments (e.g., dietary
intake, risk factor surveys) to measure the cancer control related
needs of the target populations and to evaluate the effectiveness of
intervention methods in the target populations.

B.  Project Approach

It is important that applicants describe fully and in detail all
aspects of the proposed project in the application, including cancer
sites to be studied, the target population for which the research is
being conducted, available population data bases, hypotheses to be
considered, the planned intervention approaches, methods of
assessment and validation, and the overall research design approach
to the proposed study.  It is essential to select and justify in the
application, cancer sites on the basis of the significance in the
target population and the potential for reduction of mortality rates.
It is also essential that the population for which the study(ies)
will be carried out be specified and characterized using
population-based estimates of the demographic characteristics of the
target population.  All collaborative arrangements that are planned
should be described in detail, including areas of responsibility,
coordinating, decision-making authority, and financial relationships.
Letters of commitment from each participating organization should be
included in the application.

C.  Research Plan

The applicant should include a detailed protocol outlining the
proposed project methods for determining outcome effects.  The
protocol should detail the research project as conceived and should
provide the complete methodological approach to the problem under
investigation.  The design for the project should provide enough
information to determine an adequate "test" of the concepts, whether
validation or intervention outcomes.  It is important that the design
permits statistically valid results to be achieved within the period
of award.

D.  Options in Project Design

Applicants must choose from the three types of projects described
below:

o  Type One - Validation study of an existing intervention method for
use in a native Pacific population group.

o  Type Two - Develop and pilot test a "unique" intervention method
that is sensitive to the needs of the target population.

o  Type Three - Develop and validate needs assessment instruments or
assessment instruments that could be used to measure effectiveness of
cancer control methods in the target population.

Applicants must specify which type they have selected in the first
line of section 2(a), "Specific Aims", in the application.

E.  Time Schedule

A detailed time schedule should be presented in the application.
This schedule is important because it will provide the milestones
against which progress will be validated.

SPECIAL REQUIREMENTS

Awardees should include in the proposed budgets travel to the NCI for
up to two persons to attend two meetings of Principal Investigators
and NCI program staff to discuss such issues as the validation of
stated hypotheses, determination of population characteristics/size
relative to the intervention specified, research progress, and
results.  These meetings will be held approximately three months
prior to the scheduled completion of years 01 and 03, respectively.

Awardees should anticipate that NCI staff may conduct a site visit as
a part of program management in order to assure that projects are
proceeding according to the plans specified in the application.  This
anticipated site visit is not intended to reduce the requirements for
the customary detailed progress report in accordance with the
instructions appearing in form PHS 2590.

STUDY POPULATIONS

The targeted population intended under this RFA is the native Pacific
populations and those of similar ancestry located in the Pacific as
well as the U.S. mainland; i.e., American Samoans, Guamanians
(Chamorros), Palauians, and North Marianians.  Applicants responding
to this RFA are expected to successfully access a significant portion
of this population to decrease cancer incidence and mortality,
increase cancer survival, and increase the diagnosis of cancers at
earlier stages.

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH 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 and sample size appropriate for the scientific objectives of
the study.  This information should be included in the form PHS 398
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 Alaska
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 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 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 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.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 18, 1993, a
letter of intent that includes a descriptive title of the proposed
research, the name and address 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 is extremely helpful in planning for the review of
applications.  It allows NCI staff to estimate the potential review
workload and to avoid possible conflict of interest in the review.

In addition, if it appears that the potential applicant has
misunderstood the objectives of the RFA or opted for an inappropriate
funding mechanism, NCI staff will respond to such letters.  The NCI
would like to emphasize the benefits to the applicant and to staff of
having a Principal Investigator submit a letter of intent.  The
letter establishes communication between the potential applicant and
program staff initiating the RFA.  Program staff may be able to
assist prospective applicants in several areas, i.e., scientific
content and objectives of an application, size and focus of a
research program, organization of an application, and appropriate use
of core components and consultants.

The letter of intent is to be sent to:

George A. Alexander, M.D.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
6130 Executive Boulevard
Bethesda, MD  20892-4200
Telephone:  (301) 496-8589
FAX:  (301) 496-8675

APPLICATION PROCEDURES

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 and from the Office of
Grants Information Division of Research Grants, National Information
of Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892;
telephone 301/435-0714.

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 RFA title and number should 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, exact photocopies in one package to
the Division of Research Grants 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 the time of submission, two additional copies of the application
must also be sent to:

Ms. Toby Friedberg, Referral Officer
Division of Extramural Activities
National Cancer Institute
Westwood Building, Room 838
5333 Westbard Avenue
Bethesda, MD  20892

Applications must be received by January 25, 1993.  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 announcement 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 a substantial
revision of an application already reviewed, but the revised
application must include an introduction addressing the previous
critique.

REVIEW CONSIDERATIONS

Review Procedures

Upon receipt, applications will be reviewed (initially) by the DRG
for completeness.  Incomplete applications will be returned to the
applicant without further consideration.  Evaluation for
responsiveness to the RFA is an NCI program staff function.  If an
application is judged to be non-responsive, the applicant will be
contacted and given an opportunity to withdraw the application or
have it considered with other unsolicited applications received by
NIH in the next review cycle.  Questions concerning responsiveness to
the RFA may be directed to NCI program staff listed under INQUIRIES.

If the number of applications submitted is large compared to the
number of awards to be made, the NCI may conduct a preliminary
scientific peer review to eliminate those that are clearly not
competitive.  The NCI will remove from competition those applications
judged to be noncompetitive for award and notify the applicant and
institutional business official.

Those applications that are complete and responsive will be initially
evaluated in accordance with the review criteria stated below for
scientific/technical merit by an ad hoc review committee convened by
the Division of Extramural Activities, NCI.  The second level of
review will be provided by the National Cancer Advisory Board.

Responsiveness Criteria

Applicants must be responsive to this RFA in the sense of being
directed towards the attainment of the stated programmatic goals.
Five considerations are of paramount importance to this RFA:

1.  Descriptions of the cancer problem with justification for the
selection of specific cancer site(s) in terms of potential for
reduction of mortality rates, cancer control intervention strategy,
research method, procedures, analysis plans, and time schedule must
be clearly delineated.

2.  Studies must be limited to Phase I and/or Phase II only.

3.  Assurance of access to a community with characteristics
appropriate for the proposed intervention: written documentation must
be included.

4.  The target population must be a native Pacific population
indigenous to the U.S. Pacific territorial region, i.e., American
Samoa, Guam, Palau, Northern Marianas; or of similar ancestry located
in Hawaii and the U.S. mainland, i.e., American Samoans.

5.  Agreements with communities, organizations, agencies, or
institutions that are critical to ensure access to appropriate
records and to the implementation of the research plan must be
included.

Review Criteria

Each application will be reviewed on its own merit.  All applicants
must clearly define the target population and geographic location
where the program efforts will be demonstrated as well as the project
team's ability to access the target population.  All applicants
should include in the application a succinct discussion of previous
relevant efforts and plans to meet the terms of award.

Applicants are encouraged to submit and describe the approach that
they think would best meet the goals of this RFA and to identify
in-kind contributions and/or co-sponsors for specific personnel,
activities, and facilities.  Each application will be reviewed
according to the following criteria:

1.  Scientific merit of the research approach, design, and
methodology.

2.  Scientific and technical significance and originality of the
proposed research.

3.  Experience (research or clinical or service) and/or competence of
the Principal Investigator and staff.

4.  Adequacy of time (effort) that the Principal Investigator and
staff would devote to the proposed project.

5.  Characterization of the native Pacific population to be used
(cultural, spiritual or language considerations) in the proposed
project.

6.  Adequacy of the approaches to produce valid assessment
instruments for use in larger community intervention studies for
cancer control.

7.  Likelihood of intervention (Phase II studies) to be readily
accepted and feasible in terms of cost.

8.  Potential for generalizability of the findings and adaptability
of the intervention approaches and assessment instruments in other
communities with similar cancer control problems.

9.  Adequacy of the plans for inclusion of women.

The ad hoc review group will recommend an appropriate budget for each
approved application.

AWARD CRITERIA

The anticipated date of award is July 1, 1994.  Applicants will
compete for funding based on the quality and merit of the proposed
research study as determined by peer review, availability of funds,
and programmatic priorities, as well as geographic location.

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:

George A. Alexander, M.D.
Division of Cancer Prevention and Control
National Cancer Institute
Executive Plaza North, Room 240
Bethesda, MD  20892-4200
Telephone:  (301) 496-8589

Direct inquiries regarding fiscal issues to:

Crystal Elliott
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800 Ext. 19

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.399, Cancer Control Science Program.  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
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.

.

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