Full Text NR-93-004

TUBERCULOSIS:  PREVENTION AND ADHERENCE INTERVENTIONS

NIH GUIDE, Volume 22, Number 11, March 19, 1993

RFA:  NR-93-004

P.T. 34

Keywords: 
  Pulmonary Diseases 
  Etiology 
  Disease Prevention+ 
  Treatment, Medical+ 


National Center for Nursing Research

Letter of Intent Receipt Date:  May 3, 1993
Application Receipt Date:  June 22, 1993

PURPOSE

The National Center for Nursing Research (NCNR) invites submissions of
research grant applications to investigate strategies to help persons
with or at risk of tuberculosis (TB) to understand the disease and its
etiology, methods of transmission and control, and the importance of
early and complete treatment.  The purpose of this request for
applications (RFA) is to develop and test interventions with a goal of
(1) minimizing TB exposure, (2) increasing awareness of signs and
symptoms of TB infection, or (3) promoting the correct use of
prophylaxis, treatment and respiratory precautions.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Tuberculosis:  Prevention and Adherence Interventions, is related to
the priority areas of immunization and infectious disease.  Potential
applicants may obtain a copy of the "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 202-783-3238).

ELIGIBILITY REQUIREMENTS

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 and local
governments, and eligible agencies of the Federal government.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
The total project period for an application submitted in response to
the present RFA may not exceed three years.  This RFA is a one-time
solicitation.  Future unsolicited competing continuation applications
will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.  Because
the nature and scope of the research proposed may vary, it is
anticipated that the size of the award will vary also.  The anticipated
average direct cost award per year will range from $150,000 to
$180,000.  The anticipated award date will be September 30, 1993.

FUNDS AVAILABLE

Approximately $500,000 in total costs for the first year will be
committed to specifically fund applications submitted in response to
this RFA.  It is anticipated that two to three applications will be
funded for a three year period.  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 purpose.

RESEARCH OBJECTIVES

Despite major advances in the understanding of the pathogenesis,
detection and treatment of tuberculosis, the number of reported cases
in the United States is increasing.  Mutation of the tubercle bacillus
resulting in multi-drug-resistant disease has created an alarming
dimension to this public health problem.  Social circumstances,
including increases in poverty, homelessness, substance abuse, and the
number of immunosuppressed HIV-infected individuals, have contributed
to the epidemic.  However, non-adherence with prescribed therapy and
inadequate education of health professionals, patients, and the
community also play an important role and are potentially amenable to
nursing intervention.

The goal of this initiative is to stimulate research testing nursing
interventions designed to increase awareness of tuberculosis risk,
prevention of transmission, and compliance with therapeutic regimens.

Examples of studies that would meet this objective include, but are not
limited to:

o  the development of innovative educational strategies using
biological and behavioral outcome measures to reach populations with
high disease prevalence

o  the development and testing of strategies that enable health
professionals to target efforts to address personal, social, or
cultural barriers to adherence

o  the testing of adherence interventions such as incentives, enablers,
or regimen strategies that promote correct use of prevention
precautions or treatment medications.

Of special concern with this initiative are the populations highly
vulnerable to tuberculosis: HIV infected, institutionalized, immigrant,
economically disadvantaged, and homeless persons.  The design and
implementation of the intervention strategies must address the unique
characteristics of the target population.  Data collection instruments
should be adapted to yield accurate and meaningful information tht will
enhance the understanding of the constraints and opportunities among
these vulnerable groups.

Nursing practice offers many opportunities for interaction with persons
at high risk for or infected with tuberculosis.  Nursing investigations
benefit from collaboration across disciplines, blending expertise from
the biological, clinical and social sciences.  Applications submitted
in response to this initiative should reflect the multidisciplinary
nature appropriate to the intervention being tested.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements 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.  For
foreign awards, the policy on inclusion of women applies fully; since
the definition of minority differs in other countries, the applicant
must discuss the relevance of research involving foreign population
groups to the United States' populations, including minorities.

If the required information is not contained within the application,
the application will be returned.

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

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

LETTER OF INTENT

Prospective applicants are asked to submit, by May 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 consultants, the 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

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/496-7441.

The RFA label available in the 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.

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
LETTER OF INTENT.

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 June 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed by NIH staff for
completeness and responsiveness.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NCNR staff will contact the
applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

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 noncompetitive 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 NCNR.  The second level of review will be provided by
the NCNR advisory council.

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

o  scientific and technical significance and originality of proposed
research

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.

AWARD CRITERIA

The anticipated date of award is September 30, 1993. 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.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
NCNR program staff welcome the opportunity to clarify any issues or
questions from potential applicants.

Direct inquiries regarding programmatic issues to:

June R. Lunney, Ph.D., R.N.
Acute and Chronic Illness Branch
National Center for Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 402-3290  (301/594-9606 after 03/25/93)

Direct inquiries regarding fiscal and administrative matters to:

Sally A. Nichols
Grants Management Officer
National Center for Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 496-0237 (301/594-9615 after 03/25/93)

AUTHORITY AND REGULATIONS

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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