Full Text PA-97-047
NIH GUIDE, Volume 26, Number 9, March 21, 1997
PA NUMBER:  PA-97-047
P.T. 34

  Biology, Molecular 
  Ethics/Values in Science & Technol 

National Institute of Nursing Research
The National Institute of Nursing Research (NINR) is committed to
answering relevant clinical questions by interfacing genetics with
nursing research.  These studies, which emerge from nursing
questions, will move basic science from the bench to the bedside as
nursing practice is validated through research. To assist NINR in
identifying unique research and research training opportunities in
the field of genetics, NINR convened a science workgroup in the
spring of 1996, entitled, "Opportunities in Genetics Research."
Participants were basic and clinical scientists from multiple
disciplines. This program announcement is an outgrowth of this
workgroup and is NINR's second step in linking nurse scientists with
genetic research.
Genetics offers many opportunities for nursing research, ranging from
basic biological and behavioral investigations to clinical and
population studies.  In turn, nurse researchers offer a unique
perspective and special expertise that is not otherwise found in
genetics research.  Specific topics of interest to nursing research
that have immediate application to genetic studies include the role
of biopsychosocial factors in health and illness, managing and
diagnosing cardinal symptoms of chronic conditions, holistic and
community approaches, cognitive decision making and learning styles,
family education and counseling, risk behaviors and risk reduction,
health promotion and disease prevention, and rehabilitation.  With an
emphasis in an integrated, whole-person approach, researchers can
provide valuable insight across the continuum of nursing
interventions, from genetic counseling and testing to the care and
rehabilitation of patients with chronic illness. In these roles,
nurse researchers and molecular biology/genome scientists are an
essential component of multidisciplinary research teams.
Genetic research can be a major force for stimulating collaboration
among nurse researchers  because it is related to all areas of
nursing science.  As a relatively new area of study for nursing
research, genetics also offers scientists a special opportunity for
initiating multidisciplinary efforts to develop important
contributions to nursing and genetics research. Nurse researchers are
encouraged to stimulate genetics research by organizing cooperative
relationships with researchers in other disciplines, "piggybacking"
nursing research components onto existing or new studies, and/or
sharing expertise on various aspects of genetics research at
collegial gatherings.  Nursing research can contribute to basic
studies of biological, environmental, and behavioral linkages, the
genetic determination of physiological responses, and applied studies
aimed at translating basic science results into health care
management and delivery.  Nurse researchers are especially well
positioned for fostering the necessary connection between basic and
applied studies through the development and implementation of
improved strategies for managing illness.
The multidisciplinary collaboration of  basic and clinical scientists
involved in genetics research is especially important in order to
solve biobehavioral problems.  A cadre of nurse scientists and
genetic researchers is key in translating research findings from
biobehavioral research to clinical practice.  Participation of nurse
scientists in genetics research will further reinforce the benefits
of multidisciplinary research.
The purpose of this Program Announcement (PA)  is to integrate
genetics and nursing research. Currently funded PHS-funded
investigators with at least two years remaining on their research
grants are eligible.  Nurse researchers are encouraged to collaborate
with an ethicist, geneticist, molecular biologist, or an equivalent
professional trained in genetic research.  Likewise, PHS-funded
genetic researchers in fields of ethics, genetics, molecular biology,
or equivalent fields are encouraged to collaborate with a nurse
researcher.  Collaborations and consortia promoting the cross-
fertilization of  ideas are welcome.  In such cases, each
participant's contribution should be identified and well-integrated
into the overall design.
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 PA,
Combining Nursing with Genetics Research, is related to the priority
areas of heart disease, chronic disabling conditions, and clinical
prevention services.  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).
Applications may be submitted by domestic and foreign for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State or local
governments, and eligible agencies of the Federal government.
Applications from women, ethnic minorities and persons with
disabilities are encouraged.
The research mechanism that supports additional funds for an expanded
scope of work is the competing supplement. The competing supplement
application should be submitted to request support for a significant
expansion of a currently funded research project (R01) research
project's scope.  Applications will be accepted only from individuals
who currently hold NIH R01 grants with at least two years of support
remaining at the time of submission.
Policies that govern the research grants programs of the NIH will
This PA emphasizes the ongoing commitment of the NINR to support
cross-cutting areas of opportunity for nurse researchers.  Nurse
researchers can make a significant contribution to clinical practice
by addressing the gaps and opportunities in genetics research.
Possible areas of investigation include the gene-environment-
behavioral interface, biopsychosocial and neuroimmunological markers,
basic research, biopsychosocial intervention and counseling,
cognitive models of patients' decision making, new approaches to
health care delivery, and strategies for primary care providers.
Specific areas of interest include, but are not limited to the
following topics:
o  gene-environmental-behavioral interface
o  interventions to delay the symptoms or onset of chronic conditions
o  modify an individual's genetic predisposition to illness
o  improve treatment and management programs for patients with
chronic conditions
o  decision making process of patients and families to
consent/decline genetic testing/therapy
o  biopsychosocial and neuroimmunological markers
o  identify/isolate disease markers and risk factors in at-risk
individuals and families to decrease symptoms and treat/diagnose
o  monitoring the development and progression of conditions to assess
patient's adherence to treatment and management
o  implement genetic, biopsychosocial or neuroimmunological markers
to predict the development of chronic conditions
o  biopsychosocial intervention and counseling related to genetic
o  identify outcome measures for quantifying the effectiveness of
interventions for individuals with chronic illness
o  prescribe optimum timing and methods of conveying genetic
information to individuals, particularly children
o  approaches to predict the development of chronic conditions in
susceptible individuals and families
o  cognitive models of patients' decision making
o  determine the cognitive mechanism, experiential and cultural
reasons by which individuals and families make decisions
o  design/test interventions for assisting patients in assessing
their risk reduction, satisfaction, and quality of life in relation
to decisions made before and after genetic testing
o  determine the behaviors necessary for patients to comprehend
genetic information and change health practices resulting from this
information, particularly for patients with chronic illnesses
The introduction to the competing supplement application should
provide an overall description of the nature of the supplement and
how it will influence the specific aims, research design, and methods
of the current grant. The applicant should be explicit in describing
the interface of the chosen genetic research topic with the currently
funded clinical research grant. Since the intent of this program
announcement is to fund a genetic research competing supplement to an
ongoing funded application by a researcher, preliminary data of the
supplement's research question are not required. However,
substantiation of the methodology and the research design should be
appropriate to the nature of the project proposed and the disciplines
involved.  Interdisciplinary, collaborative projects between nurse
researchers, genome scientists, mental health researchers, genetics
specialists, and/or ethicists are particularly encouraged.
The competing supplement application should be submitted to request
support to significantly expand the currently funded research
project's scope by incorporating a clearly articulated component of
genetics or nursing research.  Applications for competing supplements
are not appropriate when the sole purpose is to restore the Initial
Review Group (IRG)-recommended level awards that were
administratively reduced by the funding agency.  A competing
supplement application will not be awarded until after the original
application has been awarded, and may not extend beyond the term of
the current grant.  Any budgetary changes for the remainder of the
project period of the current grant should be discussed under the
budget justification.  The body of the competing supplement
application should contain sufficient information from the original
grant application to allow evaluation of the proposed supplement in
relation to the goals of the original application.  If the competing
supplement application relates to a specific line of investigation
presented in the original application that was not recommended for
approval by the IRG, then the applicant must respond to the
criticisms in the prior summary statement, and substantial revisions
must be clearly evident and summarized in the introduction.
Preliminary Studies/Progress Report. A progress report is required
for competing supplement applications.  The beginning and ending
dates for the period covered since the project was last reviewed
competitively should be included in the competing supplement
For this PA, a ceiling of $50,000 direct costs per year may be
requested.  It is anticipated that a competing supplement could
request $50,000 for the first-year to be used to support a
geneticist, molecular biologist, ethicist, nurse researcher, or other
personnel and for other project costs, such as the purchase of
specialized equipment.  Future year escalation of direct costs may
not exceed three percent per year.
Because this is a competing supplement application, the detailed
requests for the initial budget period should show only those items
for which additional funds are requested.
The ending date of the competing supplement's first budget period
should coincide with the ending date of the budget period of the
currently funded grant that is to be supplemented, regardless of the
competing supplement's beginning date.  Amounts for first year budget
periods of less than 12 months should be prorated at a rate
proportional to the actual time requested. When requesting competing
supplement funds for the future years of  the currently funded grant,
make the future years' budget periods coincide with those of the
currently funded grant.
Grant funds may be used for expenses clearly related and necessary to
conduct the proposed research, including both direct costs and
allowable indirect costs. Grant funds may not be used to create a
treatment, rehabilitation or other service program.
It is the policy of the NIH that women and members of minority groups
and their subpopulations 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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.
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 20, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994. Program staff may also provide additional relevant
information concerning the policy.
All applications involving human subjects should describe, in detail,
plans for the protection of the rights and interests of any
individual and/or family involved in any clinical testing protocol.
Specific plans for recruitment of subjects should be clearly
summarized. Any plans for sharing of data and storage of DNA samples
for other purposes must be outlined. While it is foreseeable that
there may be some research situations in which it would be
appropriate to involve minors as subjects, studies proposing to
perform gene-based risk assessments involving minors have the
potential to result in a "greater than minimal risk," and thus
applicants need to explicitly address any potential benefits and
risks to minor subjects, in whom such testing would be carried out.
Applicants proposing to carry out clinical protocols should review
the Protecting Human Research Subjects: Institutional Review Board
Guidebook, Chapter 5, Section H, Human Genetic Research [1993, Office
of Protection from Research Risks (OPRR), NIH]. If funded, applicants
may wish to consider applying for a Certificate of Confidentiality
from the Department of Health and Human Services in order to attempt
to provide further protection for research subjects.
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  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, email:
This PA is for a competing supplement.  Follow the instructions
specified in the standard PHS 398 application instructions for a
competing supplement.
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC program director or principal investigator should be included
with the application.
To identify the application as a response to this PA, check "Yes" on
item 2 of page 1 of the application and enter "PA-97-047,
Opportunities in Genetics and Nursing Research."
Submit a signed, typewritten original of the application and five
signed, exact photocopies, in one package to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications will be reviewed for
scientific and technical merit in accordance with the standard NIH
peer review procedures. Following scientific-technical review, the
applications will receive a second-level review by the appropriate
national advisory council.
Review Criteria
Competing supplement applications will be reviewed by the Division of
Research Grants.  The following review criteria will apply:
o  scientific, technical, scholarly or medical significance and
originality of proposed research;
o  appropriateness and adequacy of the experimental or scholarly
approach and methodology proposed to carry out the research;
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
o  availability of the resources necessary to perform the research;
o  evidence that the competing supplement contains a genetic or
nursing research component as an extension of currently funded
research; and
o  appropriateness of the proposed budget and duration in relation to
the proposed research.
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
Applications will compete for available funds with all other approved
applications assigned to NINR.  The following criteria will be
considered in making funding decisions:
o  quality of the proposed project as determined by peer review;
o  availability of funds;
o  potential impact of the proposed project to provide insight into,
or solutions to, critical clinical, ethical, and social issues that
link nursing and genetic research;
o  balance among funded projects to address high priority areas.
In order for the NIH to fund applications from foreign institutions,
the application must meet the following three criteria: (1) The
proposed project must have special relevance to the mission and
objectives of the awarding organization and have the potential to
advance knowledge that will benefit the United States; (2) The
project must present special opportunities for furthering research
programs through the use of unusual talent resources, populations, or
environmental conditions in other countries which are not readily
available in the United States or which provide augmentation of
existing U.S. resources; and (3) The foreign grant application must
be in the upper half of the research grant priority scores. Because
most of the ethical and social issues which are the focus of this
announcement are intrinsically specific to the U.S. cultural and
social context, it is not anticipated that applications from foreign
institutions will be able to meet all three criteria cited.  However,
i t is anticipated that U.S. collaborations with foreign
investigators and subcontracts to foreign institutions could meet all
Inquiries concerning this program announcement are encouraged.  The
opportunity to clarify any issues or questions from potential
applicants are welcome.
Direct inquires regarding programmatic issues to:
Hilary D. Sigmon, Ph.D., R.N.
National Institute of Nursing Research
Building 45, Room 3AN-18, MSC 6300
Bethesda, MD  20892-6300
Telephone:  (301) 594-5970
FAX: (301) 480-8260
Email: hsigmon@ep.ninr.nih.gov
Direct inquiries regarding fiscal matters to:
Mr. Jeff Carow
Grants Management Office
National Institute of Nursing Research
Building 45, Room 3AN-24, MSC 63016
Bethesda, MD  20892-6300
Telephone:  (301) 594-6869
FAX: (301) 480-8256
Email:  jcarow@ep.ninr.nih.gov
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 parts 52, and 45 CFR Parts 74 and 92. The program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards will be
administered under PHS grants policy as stated in the PHS Grants
Policy Statement (April 1, 1994).
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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