SPECIAL POPULATIONS NETWORKS FOR CANCER AWARENESS RESEARCH AND TRAINING

Release Date:  March 23, 1999

RFA:  CA-99-003 (see reissuance RFA-CA-05-012)

P.T.

National Cancer Institute

Letter of Intent Receipt Date:  June 11, 1999
Application Receipt Date:  July 16, 1999

PURPOSE

The National Cancer Institute (NCI), Office of Special Populations Research
(OSPR), invites applications for cooperative agreement awards from eligible
institutions to develop and implement a variety of community-based cancer control
and prevention activities.  The major goal is to establish a robust and
sustainable infrastructure to promote cancer awareness within minority and
medically underserved communities, and to launch from these more research and
cancer control activities aimed at specific population subgroups.  Examples of
cancer awareness activities appropriate for this project include health fairs,
lectures to community groups, healthy cooking workshops, campaigns to encourage
cancer screening, and the establishment of survivor support groups.  Other key
activities involve facilitating collaborative interactions among academic
institutions with substantial minority student enrollments, cancer research
centers, clinical cooperative groups, and NCI funded independent researchers.

An informational session for those investigators planning to submit applications
in response to this RFA will be held on Monday, April 12, 1999 from 12:00 p.m.
to 4:00 p.m. in Room 6C6, Building 31 on the Bethesda campus of the National
Institutes of Health.  Representatives from the NCI's extramural research
programs, Grants Administration Branch, and Division of Extramural Activities
will be available to provide information and to answer questions relevant to
applications responding to this RFA.  Transcripts will be available upon request
for investigators who are unable to attend.  Investigators who plan to attend
should contact the NCI program staff member listed under INQUIRIES by April 5,
1999 to confirm their attendance and to obtain further information regarding the
site of the meeting.

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),
Special Populations Networks for Cancer Awareness Research and Training, 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 Summary
Report: Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800),
or at http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic organizations, public and private, such
as colleges, universities, hospitals, medical/nursing and sociological
associations, biomedical research centers, and eligible agencies or units of
federal, state, and local governments.  Applications are encouraged from the
existing Leadership Initiatives projects (Appalachia, Black, and Hispanic), and
from Asian American, Pacific Islander, Native American and other population
subgroups throughout the country that focus on America's minority and underserved
populations.  Applicants should have a history of involvement with the community
and have qualified staff to direct the program.  Collaborative applications are
encouraged.  Among collaborators, one must be designated as the lead applicant
and assume responsibility for the project.  Organizations that must rely
primarily on consultants to conduct the project are ineligible.  Foreign
organizations are not eligible and domestic organizations may not include
international components.

MECHANISM OF SUPPORT

The administrative and funding instrument to be used for this program will be a
cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH scientific and/or programmatic
involvement with the awardee is anticipated during performance of the activity. 
Under the cooperative agreement, the NCI purpose is to support and/or stimulate
the recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Details of the
responsibilities, relationships and governance of the study to be funded under
cooperative agreement(s) are discussed later in this document under the section
"Terms and Conditions of Award."

The total project period may not exceed five years.  The anticipated award date
is March 1, 2000.  Because the nature and scope of the research proposed in
response to this RFA may vary, the sizes of awards may vary also.  Although this
program is provided for in the financial plans of the National Cancer Institute,
awards pursuant to this RFA are contingent upon the availability of funds for
this purpose.  This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all investigator-initiated R01
applications and be reviewed according to the customary peer review procedures.

FUNDS AVAILABLE

Approximately $6 million will be available per year for five years to fund
several large, multi-site projects at approximately $1.4 million total costs each
(direct and indirect), and a series of small, single-site projects at up to $350
thousand total costs each.

RESEARCH OBJECTIVES

Background

This RFA builds upon the series of "Leadership Initiatives on Cancer" launched
in 1989 as part of NCI's response to the disproportionate burden of cancer on
minority and medically underserved populations.  This issue was identified as
important for NCI to address by the National Cancer Advisory Board.  The focus
was on cancer awareness and related activities, and aimed at reducing cancer
incidence and mortality, increasing cancer survival, and improving access to
health care within the targeted populations.  First was the National Black
Leadership Initiative on Cancer, implemented in 1989.  The Appalachia Leadership
Initiative on Cancer and the National Hispanic Leadership Initiative on Cancer
followed in 1992.  There are currently seven Leadership Initiative cooperative
agreement awards comprising both large and small-scale projects.

It is expected that this project, the "Special Populations Networks for Cancer
Awareness Research and Training"(hereafter referred to as the Networks), will
lead to increased community understanding of cancer research and that the
resulting infrastructure and educational efforts will result in more effective
recruitment to NCI-sponsored clinical trials.  Another crucial aim is to increase
the probability that community-based minority researchers with good ideas will
establish linkages and receive the infrastructure support they need to help them
compete successfully for peer-reviewed research support.  The Networks will
provide for improved community channels to access NCI resources so that research
can be focused on issues that affect minorities and the underserved, and improved
health promotion efforts can be developed that respect cultural traditions.  It
is also expected that a salutary by-product of the networks will be enhanced
input from the community to NCI, so that their perceived needs can be heard and
research projects be designed to address those needs.

Applicants are encouraged to propose either large or small-scale projects
comprising, for example, several regions or a single tribal nation.

Objectives and Scope

The specific goals of the Special Populations Networks include the following:

1.  Infrastructure-building by the awardees.  Collaborative relationships are to
be established with relevant entities such as the Cancer Information Service
(CIS) and NCI-funded Cancer Centers; other government agencies such as the
Centers for Disease Control and Prevention (CDC), Health Care Finance
Administration (HCFA) and the Office of Minority Health (OMH); voluntary
organizations such as the American Cancer Society (ACS), and grass-roots
community groups, programs, and coalitions.  The relationships are to foster
cancer awareness activities and should be formalized by the joint preparation of
project plans describing the elements of the relationship and the activities to
be conducted.

2.  Establishment of academic and/or clinical partnerships between the awardee
and cooperating institutions to support enhanced minority accrual to clinical
trials and to promote participation of minority scientists in research.

3.  Promotion of training opportunities, including mini-sabbaticals, for minority
researchers and students, and enhancing awareness and utilization of training
opportunities.  Awareness of NCI training opportunities could be enhanced by
establishment of informational links with the Comprehensive Minority Biomedical
Branch (CMBB) and the Cancer Training Branch.  Utilization rates of NCI training
opportunities will be tracked annually with the assistance of the CMBB.

4.  Planning and instituting collaborative developmental projects with relevant
NCI Divisions and research partners, including Cancer Centers, Cooperative
Groups, academic institutions, and community groups.  Using additional
developmental funds, each awardee may initiate one to four pilot projects per
year following review, approval and prioritization of applications by the
awardee's steering committee.

5.  Developing with research partners competing grant applications stemming from
the pilot projects. Success here would be measured by the awarding of an NIH
grant to one or more of the research partners.

Project Design

The project involves three phases.  Activities initiated during each phase
continue for the entire award period.  Successful applicants who were awardees
in the Leadership Initiatives may, pending NCI approval, begin by launching
Phases I and II concurrently, while new awardees are expected to need time before
initiating Phase II.  Applicants proposing to implement Phase II must provide
evidence that they have met the criteria provided later in this document under
the section entitled "Timetable."

This RFA anticipates the possibility that issues involving the
underrepresentation of minority scientists and research infrastructure at
minority institutions may not be priority issues for certain Asian American,
Appalachian, and other minority/medically underserved populations.  Accordingly,
applicants serving such populations may propose alternative community-based
activities for Phases II and III that are tailored to address specific cancer
prevention and control needs regarded as more relevant to their targeted
communities.  Activities proposed might include, for example, efforts aimed at
addressing barriers (i.e., low literacy and/or the inability to communicate
effectively in other than one's native language) that are known to limit or
prevent one's understanding of health issues or their access to cancer/health
care.  Such applicants must provide clear and compelling justification/data in
support of their proposed activity.  (See "Application Procedures")

Phase I (Year 1) Infrastructure-Capacity Building

This phase is aimed at establishing and maintaining a continuum of cancer
awareness and education activities while organizing and building a community
infrastructure for research participation.  Awardees are to begin linking with
government and non-government entities, as well as community groups and
coalitions, to develop joint project plans for pursuing cancer awareness and
education goals.  They should also begin establishing viable working
relationships with major research organizations, such as  NCI Cancer Centers
and/or Clinical Cooperative Groups, or with NCI-funded independent researchers,
and develop joint research project plans for implementation during Phase II.

Awardees are encouraged to partner with the Centers for Disease Control and
Prevention (CDC), Health Care Finance Administration (HCFA), DHHS Office of
Minority Health (OMH), and other Federal and State health units, utilizing their
health resource programs to develop and implement culturally competent health
promotion activities at the community level.  Examples of activities that may be
conducted include seminars, workshops, and campaigns that address such issues as
the benefits of mammography and the Pap test, screening for colorectal cancer, 
presenting scientifically accurate cancer control messages relative to diet and
physical activity, smoking, and the pros and cons of prostate cancer screening. 
Supported activities may also  include efforts that identify and bridge gaps
between culture and cancer services, and programs that complement or improve upon
existing programs.

Phase II (Years 2&3) Establishment of Academic/Clinical Partnerships

This phase involves the establishment of formal clinical/academic partnerships
between Networks awardees and Cancer Centers, academic institutions and Clinical
Cooperative Groups, and collaborations with NCI Divisions such as the Division
of Cancer Prevention and the Division of Cancer Control and Population Sciences. 
These partnerships have three purposes:

1.  To enlist the community partners in efforts to enhance minority accrual to
clinical treatment and prevention trials.  Such efforts might include, for
example, lectures to relevant audiences in the community and arranging working
relationships and linkages between community groups and research organizations
such as cancer centers and cooperative groups.

2.  To enhance training opportunities for minority scientists.  Efforts in this
regard include taking advantage of training opportunities offered by NCI (e.g.,
the Comprehensive Minority Biomedical Branch) or other appropriate organizations. 
Indicators of progress would include (a) the awardee's identification of junior
minority researchers and students participating in the networks and facilitating
their pursuit of further training assignments in cancer control and related
areas, and (b) the arrangement of short-term training assignments (3-6 weeks
duration) for minority researchers of all levels in cancer prevention and control
programs of the NCI and at NCI-funded cancer centers. (See "Collaborative
Responsibilities", item b.)

3.  To facilitate planning and pursuit of pilot projects in collaboration with
research partners. During this phase awardees may submit requests for separate
developmental funds to support one to four such projects, at a maximum of $50,000
each per year.  It is anticipated that the pilot projects will lead to the
development of grant applications for new and innovative research projects during
Phase III.

Phase III (Years 4&5) Development of Grant Applications with Partners

This phase emphasizes the functioning of the partnerships, now fully operational
and actively engaged in a suitable spectrum of pilot projects involving the
community.  The partnerships should now be capable of sustaining the
infrastructure from which multiple independent investigator-initiated research
projects (R01s) in cancer control can be launched.  Awardees are expected to
develop grant applications based on results from the pilot projects begun during
Phase II.  Said grant applications shall be developed and submitted independently
of the Networks and its funds will not be authorized for grant application
preparation.  Applications will be peer-reviewed according to usual NIH
procedures for investigator-initiated research projects.  Activities initiated
in Phases I and II also continue throughout Phase III.

Project Evaluation

Awardees shall evaluate their projects using success indicators such as the
number, type, size, and leaders of activities conducted; observable increases in
the number of persons visiting clinics who are linguistically disadvantaged or
have low levels of literacy; the overall effectiveness of cancer awareness
activities generated by the programs; the number and effectiveness of
partnerships established and descriptions of their contributions.  Measures for
research activities developed should include the numbers of minority researchers
trained and the number of research grant applications submitted versus the number
of those funded.  Following are additional questions that should be addressed as
Phase III nears completion:  How well did the project achieve its stated goals? 
What explains the effectiveness of the project?  How much of what was
accomplished directly resulted from project activities?  What about the project
is reproducible or translatable into other settings?   To what extent did the
community assume project ownership for continuation?  Although project outcomes
will be tabulated during Phase III, it is important that awardees incorporate
measurements of these outcomes during the entire course of the project.

Timetable

Awards that result from this RFA will begin March 1, 2000 and continue for up to
five years contingent upon the recommendation of peer review, the awardee's
sustained performance in carrying out all aspects of the project, and
availability of funds.

To proceed from Phase I (Year 1) to Phase II, awardees will have established a
robust working relationship with at least one major research organization to
implement a research project or protocol within the targeted population, and to
proceed from Phase II (Years 2&3) to Phase III awardees and their research
partners will have completed at least one pilot project within the targeted
population.

Progress for all phases will be assessed by a special panel of cancer control
experts assembled by NCI.  Panel members shall include the director of the NCI
Office of Special Populations Research; the NCI Associate Director for Special
Projects, and two representatives each from the NCI Board of Scientific Advisors
and the National Cancer Advisory Board.

Budget and Related Issues

Each application must reflect careful planning to ensure that the allocation of
project funds for administrative costs are reasonably proportional to the costs
for regional/local programming.  Cost containment over the entire five-year
project period is an important aspect of program management.

SPECIAL REQUIREMENTS

Each application must identify a "Research Director" to assist in leading the
project.  This individual, who may also be the application's principal
investigator, must have an established track record in cancer control,
prevention, and/or public health, and a record of research publications in peer
reviewed journals.  This individual must also have competence in addressing the
cultural traditions and nuances of the targeted population.  If other than the
PI, the research director also serves as a member of the project's steering
committee and, as applicable, the regional advisory committee.

Applications should include a description of the steering committee and, if
applicable, any regional advisory committee(s).

Applications must include a plan that describes how the institution/organization,
if awarded, will draw upon the expertise of the Cancer Information Service (CIS),
utilizing and modifying, as appropriate, their health promotional and educational
materials.

Applications proposing alternative activities (See under Section "Project
Design") for Phases II and III must include scientifically-based justification
and detailed descriptions of how those activities will complement the required
cancer awareness and community capacity building activities.

Applications must also include a detailed description of the process by which
pilot project applications will be reviewed, approved, and prioritized by the
project's steering committee.

This RFA recognizes that the structure and function of the NCI and the mechanisms
by which it supports cancer research are not well understood by many individuals
outside the Institute.  To help make the NCI and cancer control research more
transparent, employees and key volunteers in all funded institutions will be
encouraged to attend an NCI-sponsored Cancer Control Academy, to be held at NCI,
early in the first year of funding.  The Academy will be a three-day course
organized and taught by cancer control scientists from the NCI, CDC, and the
extramural community and will include cancer advocates.  The target audience will
be the awardee institution's employees and volunteers, some of whom will be
medical professionals.  The Academy's curriculum will include a series of
didactic lectures on cancer, cancer control research, and research funding.  It
is anticipated that the course syllabus will be a useful resource for some years
for graduates of the Academy.  The Academy will begin with a pretest to assess
knowledge of cancer control issues and a post-test which will allow for
assessment of the Academy's impact.  Awardees should factor into their budgets
travel costs and related expenses for this event.

Project Organization

Applicants are encouraged to propose an organizational structure with staffing
that maximizes project effectiveness while minimizing costs.  For example,
applicants may consider focusing their efforts on those cancer sites and/or
geographical areas where cancer rates are higher in lieu of attempting to cover
all cancer sites and/or targeting an entire region.  Historically, projects
similar to the Networks have typically operated large projects with a structure
that included the PI and 2-3 full-time positions in the primary office or
coordinating center, and 2-3 full-time positions plus, in the case of the NBLIC,
a volunteer part-time leader at each regional site.  Small-scale projects have
typically included the PI and 2-3 full-time positions.

Applications proposing large, multi-site (consortium) projects should discuss the
rationale for their choice of each regional site, and should document their
ability to recruit a sufficient number of minority and/or underserved
participants within each region.  Each regional site must be able to interact
effectively with the coordinating center.  All applicants should discuss their
capability to participate in key aspects of the Networks, and state their
willingness to follow the joint project plans that will be agreed upon during
Phase I.  In addition, the budget for each regional site must conform to the
consortium approach used by all such NIH applications (see 398 instructions).

Project Steering Committee

Each awardee shall establish and maintain a steering committee to set policy,
provide overall guidance and direction, and provide support for project-sponsored
activities.  Membership shall include the Project PI, NCI Program Director,
Regional PIs, and others.  It is strongly recommended that at least one-third of
the steering committee's membership include individuals with expertise in
scientific disciplines such as epidemiology, biostatistics, public
health/education, sociology, medicine, nursing, etc.  Other members may include
leaders in various disciplines such as business, media, and information systems
technology.

Regional Advisory Committee

Awardees with large, multi-site projects may, in addition to the project steering
committee, allow their regional sites to organize regional advisory committees. 
The Regional PI shall serve as chairperson of this committee and as its
representative on the project Steering Committee.  The NCI Program Director does
not serve as a member of this committee.  Like the project Steering Committee,
it is strongly recommended that at least one-third of the regional committee's
membership include individuals with expertise in scientific disciplines such as
epidemiology, biostatistics, public health/education, sociology, medicine,
nursing, etc.

The following terms and conditions will be incorporated into the award statement
and provided to the Principal Investigator(s) as well as the institutional
official at the time of award.

Terms and Conditions of Award

These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration Regulations
at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration
policy statements.

The administrative and funding instrument used for this program is a cooperative
agreement (U01), an "assistance" mechanism (rather than an "acquisition"
mechanism) in which substantial NIH scientific and/or programmatic involvement
with the awardee is anticipated during performance of the activity.  Under the
cooperative agreement, the NCI purpose is to support and/or stimulate the
recipient's activity by involvement in and otherwise working jointly with the
award recipient in a partner role, but it is not to assume direction, prime
responsibility, or a dominant role in the activity.  Consistent with this
concept, the dominant role and prime responsibility for the activity resides with
the awardee(s) for the project as a whole, although specific tasks and activities
in carrying out the studies will be shared among the awardees and the NCI Program
Director.

1.  Awardee Rights and Responsibilities

a.  Awardees have primary authorities and responsibilities to define objectives
and approaches, and to plan, conduct, analyze, and publish results,
interpretations, and conclusions of their projects.

b.  Establish and maintain a project steering committee.  The role and
responsibilities of the steering committee are described later under
"Collaborative Responsibilities."

c.  If appropriate, awardees with large, multi-site projects may, in addition to
the project steering committee, allow their regional sites to organize regional
advisory committees.  The Regional PI shall serve as chairperson of this
committee and as its representative on the Project Steering Committee.  The NCI
Program Director does not serve as a member of this committee.  The regional
advisory committee functions in an advisory role to the steering committee, and
as liaison between the steering committee and the community.  This committee
works to ensure that the decisions and recommendations of the steering committee
are effectively adapted to regional settings; to assist in the development and
implementation of regionally-initiated activities, identify and encourage
minority junior researchers and students, interface with regional CIS partners,
and ensure community support for project activities.

d.  Request separate funding for pilot projects; seek approval of the steering
committee for key cancer awareness activities and pilot projects.  Funds awarded
as a result of this RFA may not be used for pilot projects.  Any disagreement
that may arise on scientific/programmatic matters (within the scope of the
award), between award recipients and the NCI may be brought to arbitration.  See
"Arbitration" below.

e.  Establish and maintain collaborative relationships with the NCI Cancer
Information Service (required) and relevant community organizations and groups;
apprise the NCI Program Director and the CIS Outreach Coordinator of the need for
specialized printed materials and media messages.

f.  Seek technical assistance from CIS in the development of locally developed
anti-cancer messages that are consistent with NCI guidelines.  Funds awarded as
a result of this RFA may not be used for print or broadcast media materials that
have not been jointly approved by the CIS representative and the NCI Program
Director.

g.  Retain custody of and have primary rights to the data developed under these
awards, subject to Government rights of access consistent with current HHS, PHS,
and NIH policies.

h.  Provide semi-annual progress reports and additional information as requested
by the NCI Program Director.  In addition to descriptions of past activities and
their results, the report due at the end of each funding period should include
a detailed plan for implementing the next phase (e.g., at the end of year 1 going
from Phase I to II, and at the end of year 2 going from Phase II to III).

2.  NCI Staff Responsibilities

The NCI Program Director will have substantial scientific-programmatic
involvement during conduct of this activity, through technical assistance, advice
and coordination above and beyond normal program stewardship for grants, as
described below.

a.  Assist awardees with planning and establishing priorities; approve the
awardees' project plans prior to their implementation of Phase I activities.

b.  Determine whether an awardee planned community activity is consistent with
NCI guidelines.

c.  Confer with awardees regarding staffing needs; must concur in the hiring or
replacement of key program personnel.  Key personnel are defined as, and should
be limited to, individuals who contribute in a substantive way to the scientific
development or execution of the project, whether or not salaries are requested. 
(See PHS 398, pages 2, 11.)

d.  Coordinate activities with other federal agencies, e.g., the Centers for
Disease Control and Prevention (CDC), Health Care Finance Administration (HCFA),
and the DHHS Office of Minority Health (OMH); broker interactions between NCI and
awardees as necessary to provide technical assistance and guidance in specialty
areas, and to arrange short-term training assignments for minority researchers.

e.  Serve as a member of the steering committees for both large, multi-site
projects, and small-scale, single-site projects; convene special meetings and ad
hoc groups to address NCI priority issues.

The NCI reserves the right to terminate or curtail the project (or an individual
award) in the event of substantial shortfall in performance of the requirements
for any single Phase or key activities of the project.

3.  Collaborative Responsibilities

a.  The awardee shall collaborate with the NCI Program Director to establish and
maintain for their project a steering committee whose role is as a governing
body, appropriately comprised of scientists and community figures, to set policy,
provide overall guidance and direction, and provide support for project-sponsored
activities.  Membership shall include the Project PI, the NCI Program Director,
Regional PIs, and others with expertise in relevant scientific or other
disciplines.  Responsibilities of the steering committee include reviewing and
ensuring the scientific soundness of project plans, guiding the development and
implementation of population-specific cancer control and prevention activities,
approving joint and pilot project plans, prioritizing project needs, promoting
collaborations, and facilitating interactions between NCI, the partners, and the
populations.  The PI shall serve as chairperson of the steering committee and be
responsible for selection of the other members.  The decisions and
recommendations of the steering committee shall be binding and take precedence
over those of the regional advisory committees.  Awardees and the NCI Program
Director shall jointly plan the schedule and agenda for each meeting.

b.  The awardee and the NCI Program Director will collaborate to develop and
implement an  annual summit - where awardees may discuss the progress of their
projects and learn more about NCI resources/priorities, and where junior
researchers, accompanied by their mentors, can tout their developmental progress
and showcase their research projects via verbal presentations and/or poster
sessions.  This activity is intended to highlight the awardee's progress towards
accomplishment of a core requirement under Phase II.  (See Phase II,
"Establishment of Academic/Clinical Partnerships", item 2).

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters (within the
scope of the award), between award recipients and the NCI may be brought to
arbitration.  An arbitration panel will be composed of three members - one
selected by the steering committee (with NCI members not voting) or by the
individual awardee in the event of an individual disagreement, a second member
selected by NCI, and the third member selected by the two prior selected members.
This special arbitration procedure in no way affects the awardee's right to
appeal an adverse action that is otherwise appealable in accordance with the PHS
regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

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
sub populations 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
policy results from the NIH Revitalization Act of 1993.

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 in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

Investigators may also obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not to
include them.  This policy applies to all initial (Type 1) applications submitted
for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by June 11, 1999, a letter of intent
that includes a descriptive title of the proposed research, name, address, and
telephone number of the principal investigator, identities of other key personnel
and participating institutions, and 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 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 the program staff listed under
INQUIRIES by the letter of intent receipt date listed in the heading of this RFA.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these cooperative agreements.  Applications kits are available at most
institutional offices of sponsored research and may be obtained from the Division
of Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
E-mail: [email protected].  For those applicants with internet access, the 398
kit may be found at https://grants.nih.gov/grants/forms.htm

Additional Materials to Include in the Application

1.  An overall project plan with its component parts (program plan, management
plan, and evaluation plan; a plan for reviewing, approving, and prioritizing
pilot projects by the project steering committee.

2.  A summary of the applicant institution's experience with community-based
health awareness activities, and detailed descriptions of the facilities reserved
for the project..

3.  Official letters of commitment and support from independent researchers and
community-based groups/organizations/coalitions defining their intended roles and
responsibilities in the project, and formal documents (Memoranda of Understanding
(MOUs), Letters of Agreement (LOA) from research organizations such as cancer
centers, cooperative groups, other Federal agencies, etc., defining their
involvement with the awardee institution.

4.  Budget justification for each 12-month performance period for a total of five
years of funding.  In addition to the project's routine travel needs, budget
estimates should include travel costs for appropriate key staff to participate
in meetings at NCI offices in the Bethesda/Rockville, Maryland area.  One trip
will be required per year.  The purpose of the trip in year 1 is for
participation in the NCI Cancer Control Academy, and the trip in each of the
subsequent years is for participation in the annual summit mentioned previously
under "Collaborative Responsibilities."

5.  Applications proposing alternative activities for Phases II and III must
include a sound rationale as to why the activities outlined in this RFA are not
regarded as priority activities for the targeted population; a detailed statement
on the relevance of the proposed activities to the population, and  descriptions
of how those activities will complement the required cancer awareness and
capacity building activities of Phase I.  (See "Review Criteria")

6.  Applications proposing large, multi-site (consortium) projects should discuss
the rationale for their choice of each regional site, and should document their
ability to recruit a sufficient number of minority and/or underserved
participants within each region.  Each regional site must be able to interact
effectively with the coordinating center.  All applicants should discuss their
capability to participate in key aspects of the project, and state their
willingness to follow the joint project plans that will be agreed upon during
Phase I.

The RFA label available in the PHS 398 (rev.4/98) 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 2 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:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

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

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD  20892-7399
Rockville, MD  20850 (for express/courier service)

Applications must be received by July 16, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review  (CSR) 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 CSR 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 such an application must follow the guidance in the PHS Form 398
application instructions for the preparation of revised applications, including
an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NCI.  Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.  Applications that
are complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NCI in
accordance with the review criteria stated below.  As part of the initial merit
review, a process will be used by the initial review group in which applications
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 the
applications under review, will be discussed and assigned a priority score, and
receive a second level review by the National Cancer Advisory Board.

Review Criteria

Applicants are encouraged to submit and describe their own ideas about how best
to meet the goals of the cooperative project and their specific plans, and are
expected to address issues identified under SPECIAL REQUIREMENTS of the RFA.  The
review group will assess the scientific merit of the plans and related factors,
including:

1.  The scientific, technical, or demographic significance and originality of the
proposed project;

2.  The appropriateness and adequacy of the approach and methodology proposed to
carry out the project;

3.  The qualifications and experience of the Principal Investigator and staff,
particularly, but not exclusively, in the area of the proposed project;

4.  The availability of the resources necessary to perform project activities;

5.  The appropriateness of the proposed budget and duration in relation to the
proposed project;

6.  The viability of the applicant's formal linkage(s) with academic institutions
and direct channels of access to senior researchers and substantial numbers of
minority and underserved students; the extent to which the applicant can
facilitate quality training assignments and developmental research projects for
junior researchers;

7.  The reasonableness of the proposed budget relative to the proposed
activities, particularly the allocation ratio of funds retained for
administrative costs and those for local programming;

8.  The merit and feasibility of any alternative activities proposed for Phases
II and III, and adequacy of descriptions provided on how those activities fit
into the overall program;

9.  The appropriateness of methods and demonstrated willingness to work as part
of the cooperative project and with the NCI Program Director.

10.  The potential for applicant effectiveness in reaching even the most
difficult-to-access segments of the community.

11.  The adequacy of plans to develop and initiate pilot projects and their
relevance to special populations, if applicant proposes to implement Phases I and
II in the first year.

12.  The appropriateness of the evaluation methodology proposed relative to the
type of program activity.

The initial review group will also examine the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion; the provisions for the protection of
human and animal subjects; and the safety of the research environment.

AWARD CRITERIA

Applications recommended by the National Cancer Advisory Board will be considered
for award based upon (a) scientific and technical merit; (b) program balance,
including in this instance, sufficient compatibility of features to make a
successful collaborative program a reasonable likelihood; and (c) availability
of funds.  Priority consideration shall be afforded applications from
institutions that are geographically located in minority and/or underserved
communities and those proposing to establish cancer awareness and capacity
building programs in geographical areas where cancer trends are on the rise or
where rates exceed the national average.

SCHEDULE

Pre Application Conference        April 12, 1999
Letter of Intent Receipt Date:    June 11, 1999
Application Receipt Date:         July 16, 1999
Review by NCAB Advisory Board:    February 2000
Earliest Anticipated Start Date:  March 1, 2000

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:

Mr. Frank E. Jackson
Office of Special Populations Research
National Cancer Institute
Executive Plaza South, Room 320
Bethesda, MD  20892
Telephone:  (301) 496-8589
Fax: (301) 435-9225
Email: [email protected]

Direct inquiries regarding review issues to:

Ms. Toby Friedberg
Referral Officer, Division of Extramural Activities
National Cancer Institute
Executive Plaza North, Room 636
Bethesda MD 20892-7399
(for express courier delivery)
Rockville, MD 20850
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Jennifer Edwards
Grants Management Specialist
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
Bethesda, MD  20892
Telephone:  (301) 496-7800, Ext. 257
Fax: (301) 496-8601
Email: [email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.399 and 93.393.  Awards are made under authorization of the Public Health
Service Act, as amended the sections 301 and 405, 42 USC 241 and 284) and
administered under PHS grants policies and Federal Regulations 42 CFR Parts 52
and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. 
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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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)