RFA-NR-04-002: NURSING RESEARCH CORE CENTER GRANTS (P30)

NURSING RESEARCH CORE CENTER GRANTS (P30)

RELEASE DATE: March 17, 2003

RFA: NR-04-002

National Institute of Nursing Research (NINR)
(http://www.ninr.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.361

LETTER OF INTENT RECEIPT DATE: July 15, 2003

APPLICATION RECEIPT DATE: August 15, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplemental Instructions
o Peer Review Process
o Review Criteria
o Additional Considerations
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Nursing Research (NINR) invites applications for
Nursing Research Center Core (P30) grants in key clinical and basic science
areas of nursing research that establish a scientific basis for the care of
individuals across the life span. The Core Center grants will provide the
infrastructure to centralize resources and facilities to support an active
center of excellence in a specific scientific area of inquiry that has a
strong base of research funding. By developing infrastructure components, a
number of established and independently funded investigators and their teams
will have the opportunity to enhance their collective productivity to a
greater degree than would be possible from each of their separately funded
projects.

RESEARCH OBJECTIVES

The National Institute of Nursing Research awarded competitive P30 Core
Centers in FY 1994 and FY 1999. This program has served as an important
mechanism for building and maintaining intellectual and physical resources
that serve as the infrastructure for synergism among researchers in a specific
area of scientific inquiry. Centers promote programs of research related to
NINR program areas, foster interdisciplinary/multidisciplinary research, and
provide an important mechanism to support the transition of research results
into clinical practice.

The success of the Core Center is greater when scientific and professional
personnel representing a variety of disciplines are willing to relate to and
collaborate with each other in order to facilitate the development of new
knowledge. The promotion of interdisciplinary/multidisciplinary research is a
valued component of the Core Centers program.

Applicants should select a scientific area of inquiry based on a conceptually
sound integration of currently funded projects in the research base. The link
to nursing practice issues within the Center should be explicit. Applications
should contain innovative ideas consistent with NINR's mission and use sound
methodologies.

Below are examples of research areas that impact NINR's future research
portfolio as outlined in the Strategic Planning for the 21st Century document:

o Chronic illness experiences, such as managing symptoms, avoiding
complications of disease and disability, supporting family caregivers,
promoting adherence and self-management activities, and promoting healthy
behaviors within the context of the chronic condition.

o Cultural and ethnic considerations in health and illness, including
culturally sensitive interventions to decrease health disparities among groups
by focusing upon health promotion activities and chronic illness management
strategies.

o End of life/palliative care research. NINR is currently the lead institute
at NIH for this area of research and is focusing on clinical management of
physical and psychological symptom management, communication, ethics and
clinical decision-making, caregiver support, and care delivery issues.

o Health promotion and disease prevention research, particularly as it relates
to lifestyle changes and health behavior maintenance across the lifespan.

o Implications of genetic advances, including reducing factors that increase
risk of disease, issues related to genetic screening, and subsequent gene
therapy techniques.

o Quality of life and quality of care, to include cost savings for the
patient, health care system, and society.

o Symptom management of illness and treatment, such as pain, cognitive
impairment, fatigue, nausea and vomiting, and sleep problems.

o Telehealth interventions and monitoring or other emerging technologies to
promote patient education and treatment.

Proposed scientific areas for this RFA are not limited to these specified
categories. In addition to these areas, applicants should note the research
program categories that describe NINR broad areas of interest. The categories
are listed at (http://www.ninr.nih.gov/ResearchAndFunding/DEA/OEP/AreasofscienceFile.htm).

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) Research Center
Core (P30) grant award mechanism. The purpose of this mechanism is to
support shared resources and facilities for a specific area of scientific
inquiry by a number of investigators who provide an
interdisciplinary/multidisciplinary approach to a joint research effort or
who focus on a common research problem. The Center is funded independently
from the currently funded projects but is integrated with them to provide
support. Responsibility for the planning, direction, and execution of the
proposed Center will be solely that of the applicant. The total project
period for an application submitted in response to this RFA may not exceed
five years. This RFA is a one-time solicitation. The earliest anticipated
award date is April 1, 2004.

This RFA uses just-in-time concepts.

FUNDS AVAILABLE

NINR intends to commit approximately $3.5 – 5.0 million in FY2004 to fund 8
to 12 new and/or competitive continuation grants in response to this RFA. An
applicant may request a project period of up to 5 years and a budget for
direct costs of up to $300,000 for the first year. Three (3) percent
escalation is permitted for the outyears. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size and duration of each award may also vary. Although
the financial plans of the NINR provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications. At this time, it
is not known if this RFA will be reissued.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has any of the following
characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic

Foreign institutions are not eligible for the Center program grants.

Institutions eligible for the Core Center grant are those at which there are
at least three (3) research projects funded by Department of Health and Human
Services (DHHS) grants from selected mechanisms (specifically, R01, R15, R18,
R21, P01, P50, or U01) or comparable peer reviewed research projects,
including those funded by state governments or private foundations. These
research projects should be directly related to the scientific area of the
proposed Center. Each of these projects in the research base must have at
least one (1) year of committed support remaining at the time of the Center
award, i.e., funding must continue through March 31, 2005 at a minimum. A
project that is in a no-cost extension phase does meet for this requirement.
At least three of the projects must be in the school of nursing. In addition,
it is strongly encouraged that institutions applying for a competing
continuation have at least one funded R01 type grant from another school
outside the nursing school, particularly if there is nursing involvement in
that grant. A larger number of NIH awards in the scientific area of inquiry
would strengthen an application. Institutions with Core Centers currently
funded by NINR may apply for a competing continuation. See COMPETING
CONTINUATION APPLICATIONS section below. An institution may not concurrently
apply for a P30 Core Center grant and a P20 Developmental Center grant. If
eligible under the above criteria, an institution with a currently funded NINR
P20 Partnership Center may submit an application for a P30 Core Center.

An applicant organization may submit only one (1) P30 application. Joint
applications will not be accepted from investigators at neighboring,
independent institutions, but subcontracts are allowed if their usage enhances
the development of the scientific area of inquiry and stays within the dollar
limits of the RFA.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

The Center must be an identifiable organizational unit within a department,
school, or college of nursing.

A Nursing Research Core Center grant benefits from an interdisciplinary
approach. When multiple organizations within an institution are represented in
the application, clear lines of authority and sanction by the appropriate
institutional officials must be specified.

Each applicant institution must name a Center Director who will be the key
figure in the administration and management of the Center grant. The Director
will be responsible for the organization and operation of the Center. The
Director should be experienced in conducting research and have demonstrated
ability to coordinate, integrate, and provide guidance in the establishment of
new programs in the scientific area of inquiry. The Director must make an
appropriate time commitment.

Funding is intended to support shared resources and facilities (core units)
that will enhance and extend the effectiveness of research at the applicant
institution.

CORES

A core is a shared central facility, such as a laboratory, service, or other
resource. Each core is directed by an investigator with substantial expertise
related to the core. Core facilities may be proposed that will enhance
productivity or in other ways benefit a group of investigators to accomplish
their stated goals. An important consideration is the degree to which core
facilities will be utilized by and benefit individual ongoing-funded projects
and Center investigators and will assist in the development of the scientific
area of inquiry. Each Center must have a minimum of three Cores, one of which
is the mandatory Administrative Core.

In a Core Center grant application, it is not sufficient for the applicant
merely to identify such centralized resources. Rather, it must be demonstrated
exactly how each core would augment or enhance the present capabilities of the
investigators and make new activities possible.

Administrative Core (Mandatory)

An Administrative Core is mandatory for all Core Centers. The Administrative
Core should manage the overall activities of the Center. This should include
the following:

1. A specified Director and Associate Director;
2. A description of the administrative structure; and
3. A general description of overall facilities and institutional commitment.

It is expected that the Core Center administrative structure will accomplish
the following:
1. coordinate and integrate the Core Center grant components and activities;
2. review the utilization of funds, including funds for pilot and feasibility
studies; and
3. provide information to the Core Center Director about the activities of
the Center's cores.

While the final administrative structure of the Core Center will, for the most
part, be left to the discretion of the applicant institution, NIH's experience
has demonstrated that the effective development of Center programs requires
interaction among the Director, the core leaders, the Principal Investigators
of research projects using the cores, appropriate institutional administrative
personnel and the staff of the awarding agency.

Each Core Center application should include funds for the Core Center
Director, Associate Director, and Business Official to travel to meetings in
Bethesda, Maryland in the second and fourth year of the award period.

An Executive Committee, consisting of the Associate Director and the PIs of
the cores and the Business Official, should be established to assist the
Director in making the scientific and administrative decisions relating to the
Center. In addition to coordination of the Core Center, the Director, with
his or her Executive Committee, will be responsible for allocation of Core
Center funds, the identification and selection of key personnel, and the
planning and evaluation of Core Center activities.

The complex nature of administrative requirements of the Core Centers will
necessitate the assistance of a person with business management expertise. It
is important that such an official be identified and directly involved with
the fiscal aspects of the Core Center application and grant. An appropriate
amount of this individual's time and effort should be committed for this
purpose. The institutional Business Official should be a member of the
Executive Committee. While budget formulation and planning will undoubtedly
begin with the Director in collaboration with the scientific staff, the
Business Official should be involved in the process and provide consultation
in matters of fiscal administration and evaluate such issues as equipment on
hand versus that requested for the core facilities. The Business Official
should attend the annual Director's meeting; funds may be requested in the
budget for this purpose.

An Advisory Committee should be established and composed of scientists from
within the college/university and at least two (2) scientists from outside the
college/university. This Committee may also be used in evaluating the overall
research programs of the Core Center, the effectiveness of communications
within the Core Center, and any other activities in which problems arise for
which expertise is required or desirable. If health disparities or emphasis
on culture and ethnicity is chosen as a core, it is highly suggested that
community representation be a part of the advisory committee.

The Advisory Committee should meet at least once annually. However, the nature
of its responsibilities may require ad hoc meetings at more frequent
intervals. A member of the NINR extramural program staff may attend
meetings as an observer. The outcome of the Advisory Committee review must be
part of the Core Center's annual report to the NINR.

Other Core Units (Two Mandatory)

The applicant must propose at least two additional cores that will promote
scientific accomplishments that are congruent with the research base and the
overall themes of the Center. Support is not allowed for cores that only
replace or centralize resources supported on individual project grants.

All cores must be well justified, conceptually linked to the scientific area
of inquiry, and clearly demonstrate how the shared resources will enable
investigators to conduct their independently funded research projects more
efficiently and/or more effectively.

Various types of other core units are acceptable. Examples of possible cores
that may be proposed include:

o Statistical Support Core: Provides centralized research equipment and
services as well as data management functions such as patient registry,
patient coordination, evaluation, clinical and laboratory data gathering, and
biometry or statistical data coordination. Assistance from computer experts,
biostatisticians, and other individuals who can assist or collaborate with the
participating investigators in conducting laboratory or applied clinical
research relevant to clinical practice and patient outcomes issues is
desirable.

o Biobehavioral or Biomedical/Genetic/Molecular Biology Core: Provides a
centralized laboratory, allowing the access to large scale equipment and/or
documentation of collaboration to use shared equipment, specialized personnel,
and other items necessary to conduct basic or applied research.

o Dissemination and Translation Core: Supports dissemination of research or
other results in the selected topical area into clinical practice by
facilitating the research training of staff in new skills and techniques as
well as enhancing the exchange and dissemination of information critical to
the scientific area of inquiry both within the Core Center and within the
broader scientific community.

o Health Disparities Core: Provides the expertise to facilitate research
focusing on health disparity research, defined as basic, clinical and
behavioral studies on health conditions including diseases, disorders, and
such other conditions that are unique to, more serious, or more prevalent in
sub-populations that are economically disadvantaged and medically underserved.
In addition to these last two categories, the special populations also include
racial and ethnic minority groups, generally defined as African Americans,
Hispanics, Native Americans, Alaska Natives, Hawaiian Islanders, and Asian
Pacific Islanders. Health disparities activities may stimulate research as
well as facilitate the development of current and future minority
investigators. If an emphasis on health disparities is chosen, it is
recommended that community representation be a part of the Advisory Committee.

Pilot/Feasibility Studies (Mandatory)

Pilot/feasibility studies are a mandatory component of the Core Center
application. These are intended to enable eligible investigators to explore
the feasibility of a concept within the scientific area of inquiry and to
amass sufficient data to pursue the research through other funding mechanisms.
They may be included in any proposed core, including the Administrative Core.
The budgets provide modest research support for a limited time (one year or
two years maximum with clear justification for the time length). Eligible
investigators include:

o An established investigator with no previous work in the scientific area of
the Center who will test the applicability of his/her expertise on a
conceptually related problem;

o A previously funded, beginning or mid-career investigator who would benefit
from additional pilot work to prepare for an R01-type study;

o A new investigator who has never been a Principal Investigator funded with a
DHHS research project grant (e.g., R01, R03, R15, R21, or P01).

Applications must propose a minimum of three (3) and a maximum of five (5)
pilot/feasibility studies to be carried out during the first year. A minimum
of three pilot/feasibility studies must be determined acceptable by the
reviewers. The application should describe the review and selection process
for the proposed pilot/feasibility proposals. The theoretical or conceptual
basis for the pilot and/or feasibility studies must be clearly explicated. An
interdisciplinary approach is encouraged to promote the collaboration of nurse
scientists with scientists of other disciplines as appropriate.

Each pilot/feasibility study is limited to 10 pages of description for the
Research Plan, Sections a. through d., and should delineate the question(s)
being asked, detail the procedures to be followed, and discuss how the data
will be analyzed. The application must indicate how the proposed
pilot/feasibility study fits within the scientific area of nursing inquiry
selected for the Center, and how the investigator satisfies the eligibility
criteria listed above.

Subsequent pilot/feasibility studies (a minimum of three (3) ongoing each
year) must be developed during the course of the award. A description of how
the pilot/feasibility studies were selected for this application and will be
reviewed and selected in the future must be provided. The review process may
be carried out by the Advisory Committee, by an ad hoc Review Committee, by a
mail review, or by a combination of these methods. It is recommended that the
Center Director utilize at least two (2) scientists with expertise relevant to
the scientific area of inquiry of the Center from outside the institution
during the review process.

Evaluation Plan

A plan for evaluating progress toward aims and/or goals of each core and the
overall Core Center is required. The evaluation must articulate how progress
has advanced the science based on the area of scientific inquiry chosen. This
plan should include the specific criteria and methods that will be used for
the evaluation.

The plan should specify the types of evaluation information that will be
submitted in the Center's annual progress reports. At a minimum, the
evaluation plan is to include numbers of publications by Core Center staff.

Competing Continuation Applications—Additional Requirements (P30)

In addition to all of the requirements noted above for the new P30 Center
application, the competing continuation application has two major requirements
listed below. The content for these areas may be integrated in the narrative,
but a summary of the rationale for a continuation must also be included.

Requirement 1 - Justification of the need for an additional 5-year period,
including but not limited to:

o Rationale for requesting continuation of the Core Center and how continuing
and new goals will be accomplished in the continuation grant.

o Evidence of increased research productivity in the school of nursing
directly attributable to the current Center.

o Specific accomplishments of the overall Center and the individual cores. If
the same cores are used, growth and development of accomplishments need to be
noted. If cores are changed, performance of previous cores and reason for the
change needs to be evident.

o Center research program accomplishments, such as, but not limited to, 1)
applications submitted and/or awarded and funding source, 2) publications, 3)
significant contributions of the Center pilot studies, 4) investigator
accomplishments, 5) number of new research awards since the funding of the
last competing application, and 6) products developed.

o Advances in the development of the science focus of the Center.

o Evidence of substantive collaborative activities within and across
institutional departments and disciplines as well as any external
collaborative activities.

Requirement 2 for those Core Centers that are requesting the SECOND competing
continuation – The application must demonstrate that the Center provides a
focal point to advance science in the selected area of research. It is
expected that long-standing Centers will have established strong ties to the
research community and are involved in mentoring research-developing
institutions.

Evidence of ongoing or newly proposed partnership(s) with other schools,
colleges, or departments of nursing, particularly minority-serving
institutions are required. Previously established partnerships may be used
to meet this requirement. However, the activities should be enhanced and
increased for this application. For those institutions that are proposing a
plan for a newly established partnership(s), evidence of meeting this
requirement needs to be provided in the first annual progress report if
funded.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:

o Direct your questions about scientific/research issues to:

Dr. Nell Armstrong
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-5973
FAX: (301) 480-8260
Email: armstrongn@nih.gov

o Direct your questions about peer review issues to:

Dr. John E. Richters
Office of Review
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
FAX: (301) 451-5645
Email: john_richters@nih.gov

o Direct your questions about financial or grants management matters to:

Ms. Cindy McDermott
Chief Grants Management Officer
National Institute of Nursing Research
6701 Democracy Boulevard, Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
FAX: (301) 402-4502
Email: cindy_mcdermott@nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows IC staff to estimate the potential review workload and plan
the review.

The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714,
Email: GrantsInfo@nih.gov.

The instructions for the Form PHS 398 do not entirely apply to the submission
of these P30 grant applications. Accordingly, applicants are strongly
encouraged to follow the SUPPLEMENTAL INSTRUCTIONS below, which have been
adapted to accommodate the PHS 398 and the special requirements of this RFA.
These instructions include all of the information that will be needed by the
peer reviewers of these applications.

SUPPLEMENTAL INSTRUCTIONS

1. Face Page: Use Form Page 1 as instructed in the PHS 398. On line 2, enter
the number and title of this RFA. Remember to affix the RFA label that comes
with the PHS 398 to the bottom of the Face Page.

2. Description, Performance Site(s) and Key Personnel: Use Form Page 2 of the
PHS 398 and follow the instructions provided in the PHS 398.

3. Table of Contents: Provide a detailed Table of Contents organized as
described below. This differs from Form Page 3 of the PHS 398.

Content Page Number

o Face Page
o Description, Performance Sites and Key Personnel
o Table of Contents, including List of all Tables and Figures
o Detailed Budget for Initial Budget Period (Cores and Pilot/Feasibility
Studies)
o Budget for Entire Proposed Project Period (Cores and Pilot/Feasibility
Studies)
o Budgets Pertaining to Consortium/Contractual Arrangements (if applicable)
o Budget Justification Pertaining to Consortium/Contractual Arrangements (if
applicable)
o Biographical Sketch of the Principal Investigator (Center Director)
o Biographical Sketches of All Professional Personnel and Pilot Investigators
o List of participating faculty/members of the Center
o Resources
o Overview of Center and Description of Research Base
o Administrative Core, Budget, and Budget Justification
o Mandatory Core #2, Budget, and Budget Justification
o Mandatory Core #3, Budget, and Budget Justification
o Optional Core(s), Budget, and Budget Justification
o References
o Letters of Support
o Pilot/Feasibility Study #1
o Pilot/Feasibility Study #2
o Pilot/Feasibility Study #3
o Pilot/Feasibility Study #4 (optional)
o Pilot/Feasibility Study #5 (optional)
o Consortium/Contractual Arrangements
o Checklist
o Appendix Material

4. Detailed Budget for Initial Budget Period: Use Form Page 4 of the PHS 398
application kit. This budget should include total direct costs of the Cores
and Pilot/Feasibility Studies.

5. Budget for Entire Proposed Project Period: Use Form Page 5 of the PHS 398
application kit. This budget should include total direct costs of the Cores
and Pilot/Feasibility Studies for all years requested. Future
pilot/feasibility studies to be identified should be budgeted as a block
under "Other Expenses" in the Pilot/Feasibility Studies Core.

6. Budgets Pertaining to Consortium/Contractual Arrangements: Use Form Pages
4 and 5. These budgets are included if consortium/contractual arrangements
are needed.

7. Budget Justification Pertaining to Consortium/Contractual Arrangements:
if applicable.

8. Biographical Sketch of Principal Investigator (Center Director): Use the
Biographical Sketch Format Page of the PHS 398 and follow the instructions in
the application kit.

9. Biographical Sketches of All Professional Personnel and Pilot
Investigators: Use the Biographical Sketch Format Page of the PHS 398 as
above. This section should include all professional personnel who are listed
with a percent effort, including consultants and members of the External
Advisory Committee. Biographical sketches are also required for those who
are listed in the research base. Arrange the biographical sketches
alphabetically. These pages should not be duplicated in the individual
component cores or pilots.

10. Complete List (or Table) of Participating Faculty/Members of the Center
and the External Advisory Committee: List members alphabetically by name and
include for each individual his/her degree, institution and department
affiliation or equivalent, and research or other interest (e.g., research
area, training, or education).

11. Resources: Using the Resources Format Page in the PHS 398 application
kit, describe the relevant resources.

12. Overview of the Center and Description of the Research Base: This
section is limited to 25 pages.

The Specific Aims should state concisely the scientific area of inquiry that
will serve as the focus for the Center, and the overall objectives of the
Center.

The Background and Significance section should include a critical review and
synthesis of relevant research, theory, and methods to establish the
scientific and public health significance of the proposed Center's objectives
as described under Specific Aims. It should also provide a detailed
rationale and justification for the proposed scientific area of inquiry with
emphasis on how the institution will benefit from the proposed Center. Plans
to develop productive collaborations among Center investigators should be
highlighted, and criteria for designating an investigator as a Center
participant (investigator) should be defined in terms of the responsibilities
and privileges associated with a Center investigator. The justification for
continuation of an existing Center should also be included in this section.

The Preliminary Studies section should provide a detailed description and
discussion of funded research projects that constitute the proposed Center's
Research Base, and indicate how these studies support the selected scientific
theme. It is helpful to present the Research Base studies in table format,
specifying for each funded study (a) the title and grant number, (b) funding
organization, (c) period of committed support, (d) direct costs for the
project period, (e) current year annual direct costs, (f) names and
institutional affiliations of the principal investigator and co-
investigators, and (g) principal investigator's percent of committed effort.
The Research Base studies and related resources should be described and
discussed in sufficient detail to support an evaluation of their (a)
relevance to the scientific area of inquiry, and (b) strengths and
limitations as a scientific foundation for pursuing the Specific Aims of the
proposed Center. Applicants may want to provide similar tables depicting
pending support for research projects related to the scientific area of
inquiry and current support for research projects unrelated to this theme.
The focus and interrelationships of ongoing research and research interests
for Center investigators should be documented.

The Overview should also include a description of the qualifications of the
Center Director.

13. Administrative Core:

Provide a Detailed Budget, a Budget for Entire Proposed Project Period, and
Budget Justification for the Administrative Core: Use Form Pages 4 and 5 of
the PHS 398 application kit. Future pilot/feasibility studies to be
identified should be budgeted for as a block under "Other Expenses" (on Form
page 5).

The narrative section is limited to 25 pages. Provide a detailed description
and discussion of the objectives, functions, organizational infrastructure,
administrative procedures, key personnel (including the Core Director), and
resources of the Administrative Core within the context of the overall
Center. The description should depict the relationships and lines of
authority by appropriate officials; committee structures and membership; and
plans for assistance of a business official for fiscal matters. A diagram of
the interactions to be fostered by the Center is useful in depicting proposed
interrelationships and collaborations among institutional resources. Provide
a general overall description of facilities and institutional commitment,
including letter(s) of institutional commitment, and if applicable, a letter
from the General Clinical Research Center Director. The composition and
functions of the External Advisory Committee should be delineated.

Also describe the criteria, methods, and other components of the
comprehensive evaluation plan for the Center.

14. Mandatory Cores #2 and 3: Provide information for the two mandatory
cores modeled after the instructions above.

15. Optional Core(s): Provide information for any optional core modeled
after the instructions above.

16. References: Follow the directions and instructions provided in the PHS
398 application kit.

17. Letters of Support: Provide letters of support.

18. Pilot/Feasibility Studies: For each proposed Pilot/Feasibility Study,
provide the information below.

o Description, Performance Site(s), and Key Personnel: Use PHS 398 Form
Page 2.
o Detailed Budget for the Pilot/Feasibility Study for the Initial Budget
Period: Use Form Page 4 of the PHS 398 application kit. If the
pilot/feasibility study is longer than one year in duration, also include
Form Page 5 of the PHS 398 application kit, Budget for Entire Proposed
Project Period.
o Budget Justification: Use PHS 398 Form Page 5. If the pilot/feasibility
study is longer than one year in duration, provide the requested direct costs
under Budget for Entire Proposed Project Period as well as Budget
Justification information.
o Justification of eligibility of the principal investigator according to
the stated criteria.
o Justification of the study as a pilot study (including where the project
could lead) and how the study fits into the Center's scientific area of
inquiry.
o Scientific proposal as outlined in PHS 398 (including justification for
core use if applicable): (10 pages maximum) See PHS 398 application kit,
Research Plan, sections a. through d.
o Information regarding human subjects or vertebrate animals as applicable.
o Literature cited.

19. Consortium/Contractual Arrangements: Follow the directions and
instructions provided in the PHS 398 application kit.

20. Checklist: Use Checklist Form Page in the PHS 398 application kit.

21. Appendix Material: Follow the directions and instructions provided in
the PHS 398 application kit.

22. Personal Data on Principal Investigator/Program Director: Use Personal
Data Form Page in the PHS 398 application kit.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. 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. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH: 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 be
sent to:

Dr. John E. Richters
Office of Review
National Institute of Nursing Research
6701 Democracy Blvd, Room 710, MSC 4870
Bethesda, MD 20892-4870

APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the applicant
without review.

Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.

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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While the
investigator may still benefit from the previous review, the RFA application
is not to state explicitly how.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by NINR.

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 NINR in accordance with the review criteria stated below. As
part of the initial merit review, all applications will:

o Receive a written critique
o 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
o Receive a second level review by the National Advisory Council for Nursing
Research.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to give careful consideration
of the information in the SPECIAL REQUIREMENTS section of the RFA and the
review criteria listed below in order to judge the likelihood that the
proposed Center will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.

Overall Center Grant Application

1. The overall scientific merit and the potential of the Center for making a
significant contribution to achieving the goals of NINR.
2. The scientific gain from linking the research projects in a Center grant,
i.e., the degree of interrelatedness and synergism among the components of
the Center.
3. The qualifications of the Center co-Directors and other key investigators
and the commitment of participating investigators to a common goal, to the
science focus, and to collaboration.
4. The adequacy of the available resources and the quality of and potential
for the research environment.
5. The commitment of the institution to the Center in terms of space,
resources, administrative authority, and other necessary support, e.g.,
donated faculty time, use of equipment, and the extent to which the Center is
recognized as a major element within the organizational structure of the
institution.
6. The plans for developmental activities, including recruitment and
expansion, insofar as these are justified by the proposed research program.
7. Evidence of the extent to which the planning, organization, structure,
and design of the proposed Center and activities reflect a genuine
collaboration within and across disciplines.
8. Appropriateness of the requested budget for the work proposed.

Research Base

1. Focus and depth of funded investigations that are currently in progress.
2. Presence of current and emerging collaborations and interactions among
investigators with common research interests within the area of scientific
inquiry, and among the investigators within the research base.
3. Impact that funded investigators have made in their respective fields, as
indicated by publications and other factors.
4. The qualifications, experience, and commitment of the Center
investigators responsible for the individual research projects, and their
willingness to collaborate with each other.
5. The appropriateness of the investigators as participants of the Center,
and whether their activities warrant core support.

Administrative Core

1. The adequacy of the Administrative Core to manage the overall activities
of the Center.
2. The appropriateness and relevance of the proposed Core and the modes of
operation, facilities, and potential for contribution to ongoing nursing
research.
3. Appropriate justification for the Core, including the duplication of
existing resources or services and anticipated future use of the Core.
4. The qualifications of the Director of the Administrative Core.
5. The adequacy of the multiple aspects related to the administrative
structure for the Center, including the provision of scientific and
administrative leadership for the Center; strategies to promote scientific
planning, interaction, implementation, and evaluation; and arrangements for
the fiscal management of the grant.
6. The proposed composition and functions of the Executive Committee to
support the proposed activities of the Center.
7. The proposed composition and function of the Advisory Committee to
support the proposed activities of the Center.
8. The appropriateness of the plan to evaluate Center activities and
outcomes.
9. The process for selecting the pilot/feasibility studies included in the
application.
10. The proposed process for reviewing and selecting future
pilot/feasibility studies.
11. The appropriateness and relevance of proposed Core activities to
facilitate successful pilot/feasibility studies.
12. Evidence of a strong commitment to, and plans to support, pilot
investigators in successful completion of their studies.

Other Individual Cores

1. The appropriateness and relevance of each proposed core and the modes of
operation, facilities, and potential for contribution to ongoing nursing
research.
2. The qualifications of the Director of each core.
3. The relevance and importance of the core to advance the scientific area
of inquiry.
4. Evidence of collaborative and/or interdisciplinary research. This is
particularly relevant for competing continuation Core Center applications.
5. The appropriateness of the justification for each core. Considerations
include the duplication of existing resources or services and anticipated
future use of each core.
6. The suitability of the facilities for the proposed research, including
the availability of required special resources.
7. The inclusion of community representation as part of the Advisory
Committee for the Health Disparities Core (if included).

Pilot/Feasibility Studies

1. The scientific merit of the research proposed and the importance of the
information sought to the mission of the NINR.
2. How well the pilot/feasibility study fits into the area of scientific
inquiry selected for the Center.
3. The justification for eligibility of the investigator(s) according to
criteria listed in the RFA.
4. The feasibility and promise of the proposed methods.
5. The innovativeness or originality of the proposed study.
6. The training, experience, and research competence of the investigator(s).
7. The suitability of the facilities for the proposed research, including
the availability of required special resources.
8. The appropriateness and justification of the requested budget for the
proposed work.
9. Provisions for the protection of human subjects and the humane care of
animals, and the appropriate inclusion of women, minorities, and children in
clinical research.
10. Adequacy of the Data and Safety Monitoring Plan for clinical trial pilot
studies.

Competing Continuations—Additional Review Criteria

1. The adequacy of the justification for the competing continuation.
2. The innovativeness and/or originality of the proposed competing
continuation.
3. The extent of the Center's accomplishments based on its goals.
4. The extent to which the new and continuing Center goals are likely to be
met.
5. The extent to which increased research intensity has resulted from the
current Core Center, and the potential for further development.
6. The progress of current Center investigators toward a program of
research.
7. The appropriateness and adequacy of existing collaborations in furthering
the goals and activities of the Center.
8. The extent to which advances have occurred in the development of the
science focus.
9. For Core Centers requesting a second competing continuation, the adequacy
and innovativeness of evidence or plans for mentoring research-developing
institutions in activities related to the scientific area of inquiry.

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL CONSIDERATIONS

DATA SHARING: The adequacy of the proposed plan to share data.

BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: July 15, 2003
Application Receipt Date: August 15, 2003
Peer Review Date: October 2003
Council Review: January 2004
Earliest Anticipated Start Date: April 1, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12,
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a
clear and compelling justification is provided indicating 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
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at http://grants.nih.gov/grants/funding/women_min/
guidelines_amended_10_2001.htm.The amended policy incorporates: the use
of an NIH definition of clinical research; updated racial and ethnic
categories in compliance with the new OMB standards; clarification of
language governing NIH-defined Phase III clinical trials consistent with the
new PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-defined
Phase III clinical trials that: a) all applications or proposals and/or
protocols must provide a description of plans to conduct analyses, as
appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must
report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy 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 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 is available at
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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