Full Text NR-93-005


NIH Guide, Volume 22, Number 18, May 7, 1993

RFA:  NR-93-005

P.T. 34

  Biological Sciences 
  Biology, Molecular 

National Center for Nursing Research

Letter of Intent Receipt Date:  July 1, 1993
Application Receipt Date:  September 22, 1993


The National Center for Nursing Research (NCNR) invites applications to
develop or test innovative biological and molecular biological
techniques for solving nursing problems and answering nursing clinical
questions.  This small grants program will provide limited support for
meritorious research.  The goal of this Request for Applications (RFA)
is to generate significant findings so that nurse scientists can launch
into investigator-initiated nursing research using biological or
molecular technology.


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 RFA,
Small Grants Program for Nursing and Biology Interface, is related to
the priority area of physical activity, nutrition, and chronic
disabling conditions.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00473-1)
or"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).


The research proposed must utilize state-of-the-science biotechnology
and be an integral part of on-going research by a nurse scientist.  The
ongoing research must address a clinical issue relevant to the
advancement of the practice of nursing.  The applicant Principal
Investigator must have a Ph.D., or the equivalent, and an R.N. license.
If the applicant Principal Investigator is not actively involved in a
biological science or molecular biology laboratory, collaboration with
a biological or molecular biology scientist is required.  The purpose
of these requirements is to increase the number of beginning,
mid-career, and senior nurse researchers using state-of-the-science
biological and molecular technology to answer clinical nursing
questions.  Nurse scientists funded with Fiscal Year 1993 monies in
response to RFA NR-92-004 are ineligible.

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


This RFA will use the National Institute of Health (NIH) small grants
(R03) Program mechanism.  Responsibility for the planning, direction,
and execution of the proposed project will be solely that of the
applicant.  Awards will be administered under PHS grants policy as
stated in the Public Health Service Grants Policy Statement (October 1,


Approximately $200,000 in total costs will be committed to specifically
fund applications submitted in response to this RFA.  It is anticipated
that four applications will be funded for up to two years.  Each grant
is limited to $50,000 in total costs for the entire project period.
The Small Grants Program is a non-renewable award.  This level of
support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NCNR, awards pursuant to
this RFA are contingent upon the availability of funds for this



An important focus of nursing research in the improvement of patient
care is the interaction of biological/molecular factors associated with
acute and chronic illness, health promotion, and disease prevention.
This small grants program is designed to assist the integration of
advanced biological/molecular technology into nursing research and
clinical practice.

Recognizing the rapid changes that are taking place in the biological
and molecular sciences and the effect these changes will have on
nursing research and practice, the biological content of NCNR's
portfolio was analyzed.  A Nursing Biological Task Force recommended
strategies to integrate nursing research with state-of-the-art
biological science.  These recommendations were approved by the
National Advisory Council for Nursing Research (NACNR).  A long-range
plan for implementing the Task Force's recommendations includes
research, career development, and training initiatives to increase the
interface of biological sciences and molecular biology with nursing
research as a basis for clinical practice.  The first step of this plan
was to increase opportunities for research training and career
development in the biological sciences (PA-92-35, Training &
Development:  Nursing and Biology Interface).  The second step of this
plan targets research initiatives and its purpose is three-fold:  (1)
to facilitate the use of innovative biological and molecular biology
technology in nursing research; (2) to link the biological and
molecular underpinnings of nursing research and clinical practice in
specified areas of biomolecular clinical research; and (3) to
interweave nursing research and behavioral research with new areas of
biomolecular science, such as structural and molecular biology,
genetics, and immunology.

Subsequent to the announcement of RFA NR-92-04, Small Grants Program
for Nursing and Biology Interface, the Molecular Biology Nursing Task
Force convened to identify NCNR participation in the first objective of
the trans-NIH Strategic Plan, Critical Science and Technology.  Its
components include molecular medicine, biotechnology, molecular
immunology and vaccine development, structural biology, and cellular
and integrative biology.  Focusing on solving nursing problems and
answering clinical questions by using biological and molecular science,
task force members recommended NCNR participation in the Critical
Science and Technology objective: cellular and integrative biology,
molecular medicine (molecular biology), molecular immunology and
vaccine development, and bioengineering.  The Task Force and the NACNR
supported the opportunities available through NCNR to increase
training, career development, and research opportunities in the
interface between molecular biology and nursing research.

Targeted Aims

This RFA has two distinct aims:

1.  To stimulate nurse investigators to explore innovative,
state-of-the-science biological or molecular technology in order to
answer clinical questions and nursing problems.

2.  To facilitate use of state-of-the-science biomolecular techniques
by nurse researchers.  The validation of nursing practice by the
application of biological sciences and molecular biology to nursing
research requires investigators to have the ability to use new
techniques of structural and integrative biology, genetics, biophysics,
and immunology.

Example of Appropriate Biotechnology and Research Topics

Examples of biotechnology and topics appropriate to the objectives of
this solicitation include:

Biotechnology:  recombinant DNA, gene mapping and/or sequencing, signal
transduction, crystallographic analysis, peptide/protein modeling and
molecular dynamics simulation, in vitro or in vivo nuclear magnetic
resonance spectroscopy or imaging, positron emission tomography,
isotopic scanning, monoclonal antibodies, high pressure liquid/gas
chromatography, and spectrophotometry.


o  A nurse scientist who investigates interventions to treat pain might
be interested in measuring gene expression in the dorsal root ganglia,
in which the amount of messenger RNA changes after tissue and nerve

o  A nurse scientist who investigates interventions to treat and
prevent lead poisoning in school age children might be interested in
identifying blood cell markers as an immunological component of the
health assessment in this population.  The biotechnology might include
biological and biochemical cellular markers to identify lead poisoning.

o  A nurse scientist whose basic science research involves identifying
homeostatic mechanisms for regulating calcium ion concentration in
cardiac cells might choose to study the control of ionic flux in the
degeneration of cell function.

o  A nurse scientist whose clinical research is symptom management of
complications arising from type II diabetes and obesity might be
interested in the biochemical characterization of insulin resistance
seen in these disorders.  The R03 application might propose a study, in
collaboration with a molecular biologist, of insulin function at the
molecular level.

o  A nurse scientist whose clinical research is the quality of life
after organ transplantation might be interested in evaluating
immunologic indices of patient outcomes after bone marrow transplants.
The R03 application might propose as study, in collaboration with an
immunologist, of monoclonal antibodies produced by hybridomas in bone
marrow transplants.

Methodological Issues

A wide spectrum of research designs and analyses are acceptable under
this solicitation.  In preparing the application, the nurse
investigator must develop specific hypotheses or research questions
that apply biological or molecular technology to clinical nursing
research questions.



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis should be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are excluded
or inadequately represented in clinical research, particularly in
proposed population based studies, a clear compelling rationale should
be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the form PHS 398 (rev. 9/91) in
Sections 1-4 of the Research Plan AND summarized in Section 5, Human
Subjects. Applicants are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native
Americans, including American Indians or Alaskan Natives, Asian/Pacific
Islanders, Blacks, Hispanics). The rationale for studies on single
minority population groups should be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of disease,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants. If the
required information is not contained within the application, the
application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and reflected in assigning
the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants
or cooperative agreements that do not comply with these policies.


Prospective applicants are asked to submit, by July 1, 1993, a letter
of intent that includes a descriptive title of the proposed research,
the name, address, and telephone number of the Principal Investigator,
the identities of other key personnel and participating institutions,
and the number and title of the RFA in response to which the
application may be submitted.

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NCNR 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:

Ethel B. Jackson, D.D.S.
Office of Scientific Review
National Center for Nursing Research
Building 31, Room 5B25
Bethesda, MD  20892
Telephone:  (301) 496-0472
FAX:  (301) 480-4969


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone

The RFA label available in the PHS 398 application form must be affixed
to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that
it may not reach the review committee in time for review.  In addition,
the RFA title and number must be typed on line 2a of the face page of
the application form and the YES box must be marked.

The following supplemental instructions are given:

1.  Background and Significance:  The applicant must be explicit in
describing the interface of the chosen biological or molecular
technique with clinical nursing research questions.

2.  Progress Report/Preliminary Studies:  Since this award mechanism
intends to fund innovative technology, preliminary data are not

3.  Sections 1, 2, and 4 of the Research Plan (Specific Aims,
Background and Significance, and Research Design and Methods) are
limited to a total of 10 pages.

4.  Do not submit an Appendix.

Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to Dr. Ethel B. Jackson at the address listed under

If the applicant has an approved assurance covering the research, the
applicant should provide it with the application.  Certification of
Institutional Review Board (IRB) approval is required, if humans are
involved.  These reviews and approvals should occur prior to submission
of the application for award and the certifications should be submitted
with the application.  There is no 60 day grace period for RFAs.  If
humans will be subjects of the research at performance sites other than
the applicant organization, the applicant must identify, in the
application, the assurance status of each participant.  Failure to
provide required certifications in the application could result in
delay of an award.  Instructions regarding inclusion of human subjects
are given on pages 22-23 and 25-28 of PHS 398 (rev. 9/91).

Applications must be received by September 22, 1993.  If an application
is received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  The DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.


Upon receipt, applications will be reviewed by NCNR staff for
completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.

Applications may be triaged by an NCNR peer review group on the basis
of relative competitiveness.  The NIH will withdraw from further
competition those applications judged to be non-competitive for award
and notify the applicant Principal Investigator and institutional
official.  Those applications judged to be competitive will undergo
further scientific merit review.  Those applications that are complete
and responsive will be evaluated in accordance with the criteria stated
below for scientific/technical merit by an appropriate peer review
group convened by the NCNR.  The second level of review will be
provided by the NACNR.

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

o  scientific and technical significance and originality of proposed

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

o  qualifications and research experience of the Principal Investigator
and staff, particularly, but not exclusively, in the area of the
proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

o  the potential impact of the biological/molecular technique on
nursing research and its ability to strengthen a subsequent R01


The anticipated date of award is April 1994.  Decisions to make awards
are based on the scientific merit of the application reflected in the
priority score, availability of funds within the NCNR for this purpose,
and NCNR research program priorities.


Written and telephone inquiries concerning this RFA are encouraged and
should be directed to the following individuals. The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic and scientific issues to:

Hilary D. Sigmon, Ph.D., R.N.
Acute and Chronic Illness Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 594-7397
FAX:  (301) 594-7603

Direct inquiries regarding budgetary and administrative matters to:

Sally A. Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 594-7498
FAX:  (301) 594-7603


This program is described in the Catalog of Federal Domestic Assistance
No. 93.361, Nursing Research.  Awards are made under authorization of
the Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR
Part 74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.


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