Full Text HL-94-002

TUBERCULOSIS ACADEMIC AWARD

NIH GUIDE, Volume 22, Number 37, October 15, 1993

RFA:  HL-94-002

P.T.


Keywords: 


National Heart, Lung, and Blood Institute

Letter of Intent Receipt Date:  December 13, 1993
Application Receipt Date:  February 11, 1994

PURPOSE

The primary objective of this Request For Applications (RFA) is to
stimulate the development and/or improvement of the quality of
medical curricula, physician/patient/and community education, and
clinical practice for the prevention, management, and control of
Mycobacterial tuberculosis (TB) in the United States, with particular
emphasis on support of minority schools and minority individuals.

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 Academic Award, is related to the priority areas of
immunization and infectious diseases and HIV infection.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0) 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).

ELIGIBILITY REQUIREMENTS

Institutions

Applications may be submitted by domestic universities or schools of
medicine.

Although this announcement is not limited to minority institutions or
individuals, the intent of the program is to assure representation in
the program of minority medical schools and minority individuals,
with special emphasis on Black, Hispanic, Native American, Pacific
Islander and other ethnic or racial group members who have been found
to be underrepresented in biomedical or behavioral research
nationally.

Candidates

A candidate for an award must:

o  be an established physician and a medical faculty member in an
accredited school of medicine or osteopathy in the United States, its
territories or possessions;

o  have the unqualified support of the Dean and the educational
leadership at the institution and demonstrate knowledge and
commitment to medical education for medical students, physicians,
patients, and the public;

o  have sufficient clinical training, research, and teaching
experience in the control of TB to develop and implement a high
quality curriculum in TB encompassing current knowledge and methods
applicable to the control of tuberculosis in individuals of all ages
and to provide leadership in applied research in control of TB;

o  be a citizen or non-citizen national of the United States or have
been lawfully admitted to the United States for permanent residence
at the time of application; and

o  commit 30 to 50 percent effort for a five-year period.

Individuals who have held another NIH career development award (K
series) are eligible to apply for the Tuberculosis Academic Award.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA is part of the Academic Award Program (K07) of the National
Heart, Lung, and Blood Institute.  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  The total project period may not exceed five years
and is non-renewable.  It is anticipated that support for this
program will begin September 30, 1994.

FUNDS AVAILABLE

The estimated funds (total costs) for this fiscal year will be
$300,000.  It is anticipated that three to four grants will be
awarded each year for five years under this program.  The specific
number, however, will depend upon the merit and scope of the
applications received and the availability of funds.  It is the
intent of the program to assure representation of minority medical
schools and minority individuals, with special emphasis on Blacks,
Hispanics, Native Americans, and Pacific Islanders.

A maximum of $50,000 for the salary of the awardee, plus applicable
fringe benefits, a maximum of $20,000 for technical support, and
indirect costs not to exceed eight percent may be requested.

RESEARCH OBJECTIVES

Background

Despite major advances in our understanding of the pathogenesis,
detection and treatment of tuberculosis, nearly 28,000 cases have
been reported in the United States since 1984, the year when the
lowest number of cases were reported.  Currently, TB is spreading
rapidly, especially in some population groups.  From 1985 through
1990, the number of TB cases increased by 44 percent in the 25-44
year old age group.  There was a 12 percent increase among Asians, a
25 percent increase among non-Hispanic whites, a 55 percent increase
among blacks, and a 77 percent increase among Hispanics.  There is
also a high prevalence of TB among HIV infected patients.  It is
estimated that about 12 percent of all AIDS cases develop TB.
HIV-associated TB has occurred in virtually all age groups, both men
and women, all race/ethnic groups and in all HIV-transmission
categories, although the largest numbers of cases have occurred in
intravenous drug users and homosexual/bisexual men.

Other groups at high risk for TB include persons living or working in
group or institutional settings such as hospitals and correctional
facilities.  More recently, there have been outbreaks of multi-drug
resistant TB.  These outbreaks are a dramatic manifestation of
serious underlying problems in public and private efforts to control
TB.

Although considered "curable" since the development of effective
chemotherapy in 1950, the TB problem has not been dealt with
adequately.  This has been attributed to a lack of sufficient
awareness of the problem and inadequate resources, as well as
clinical management errors and patient nonadherence to treatment
regimens.  The management errors include failing to diagnose and
treat the cases in a timely manner, relying heavily on Isoniazide
(INH) therapy even in patients likely to have INH-resistant
organisms, using a single drug therapy, prescribing inappropriate
drug dosages, and failing to isolate patients appropriately with
infectious TB thereby missing opportunities to prevent the spread of
the disease.  Surveillance has often been slow or incomplete.
Noncompliance with treatment regimens for chronic diseases has been a
major problem with approximately 50 percent not taking their
medicine.  A study in 1988 in New York City reported 89 percent of
the patients at one hospital failed to complete therapy, more than
half failed to keep their first clinic appointment, and within twelve
months of discharge 27 percent of the patients had been readmitted at
least once with confirmed active TB.

The concept for this initiative originated with the Tuberculosis
Education Planning Committee convened by the NHLBI in December 1991,
which emphasized the need for increased efforts to educate health
care workers, patients, and the public on tuberculosis, and
recommended that public health officials identify populations and
geographic areas in the community where tuberculosis screening
programs should be intensified and conduct public education campaigns
targeted to high risk populations to encourage symptomatic patients
to seek prompt treatment.  In addition, in 1987 the Department of
Health and Human Services established an Advisory Committee (Council)
for the Elimination of TB (ACET), and in 1992 a "National Action Plan
to Combat Multidrug Resistant Tuberculosis" was published to
complement and supplement the "Strategic Plan for the Elimination of
Tuberculosis."  These plans indicate the urgency to improve the
control of TB in the United States.

In summary, TB is spreading in the U.S., despite major advances in
our ability to diagnose, treat, and prevent this disease, largely due
to inadequate education of health professionals, patients and their
families, and the community.

Objectives

The objectives of the Tuberculosis Academic Award are to:

o  encourage the development of high quality curricula in schools of
medicine that will significantly increase the opportunities for
students, house staff, and others, including practicing physicians,
to learn the principles and practice of preventing, managing, and
controlling TB;

o  develop and implement interdepartmental programs with common goals
and standardized diagnostic and therapeutic approaches;

o  promote communication among primary care and other specialists to
ensure appropriate control and treatment strategies;

o  encourage applied research in the control of TB;

o  promote the development of a faculty capable of providing
appropriate instruction in diagnosis and management of TB, with
special emphasis on minority faculty;

o  promote coordinated clinical approaches to the care of patients of
various ages and ethnic groups who have TB;

o  provide for outreach programs from medical centers to health
practitioners in the community to enhance optimal care, especially in
areas of high TB morbidity;

o  contribute to updating the knowledge and skills of practicing
physicians and other health care providers in the community;

o  enhance the awareness of health care providers of the unique
ethnic, cultural, socioeconomic, and medical dimensions of TB;

o  coordinate and collaborate with other community organizations to
control TB in areas with high incidence of TB;

o  facilitate an interchange of ideas and methods among awardees and
institutions;

o  contribute to public health efforts to control TB in the United
States; and

o  enhance the teaching of tuberculosis in minority medical schools
and promote TB education in the communities served by these
institutions.

Of particular interest are programs targeted to inner city
populations and to rural areas that may be in need of education about
tuberculosis and among physicians who are or who will be caring for
medically underserved populations.

Since this is a medical education program, funds may be requested for
technical support staff who have complementary expertise to the
principal investigator.  Such personnel may include medical
educators, curricula specialists, program evaluators, or other
specialists.

SPECIAL REQUIREMENTS

1.  Awardee Salary

The salary requested for the awardee must not exceed the actual
institutional salary rates for the effort devoted to the Academic
Award, and must not exceed $50,000 plus fringe benefits.  A candidate
must spend at least 30 percent time on this award.

An awardee may devote up to a total of 100 percent effort as an
Academic Awardee and as principal or participating investigator on
any other NIH-supported grant(s) or contract(s) and may receive
remuneration from such grant(s) or contract(s) accordingly.

An example of an investigator who receives the Academic Award at a
level of effort of 30 percent, who wishes to devote 60 percent of
effort to other Federally-sponsored research, and whose institutional
salary is $130,000 is as follows:

Academic Award             30 percent effort  $ 37,500*
Other Federally-supported
grants and contracts       60 percent effort  $ 75,000*
Total salary from Federal
sources                                       $112,500
Salary contribution from
grantee's institution                         $ 17,500
Total Salary                                  $130,000

*(based on the current ceiling of $125,000)

2.  Program Support

Technical support will be provided up to a maximum of $20,000 per
year for the following:

o  personnel other than the awardee if requested for the development,
implementation, and evaluation of the program. Salaries will be
allowable for technical and support staff and consultants, e.g.
educational and evaluation specialists.  Students stipends are
allowable for students conducting projects directly related to the
award;

o  equipment costs are not allowable;

o  consumable supplies essential to the proposed program;

o  funds for educational development to enable the awardee to develop
educational skills;

o  funds for travel for the Principal Investigator to meet with other
awardees and NHLBI staff to exchange ideas, to develop collaborative
projects, and to provide for some needed technical support.
(Awardees may be requested to meet as a group up to two times a year;
$2,000 should be allocated for this purpose.)

3.  Indirect Costs

Awards will be provided for the reimbursement of actual indirect
costs at a rate up to, but not exceeding, eight percent of the total
direct costs of each award, exclusive of tuition, fees, and
expenditures of equipment.

4.  Conditions of the Award

Institutions must provide documentation that the applicant would have
the necessary time and resources to implement the proposed plan.  In
some cases, it may be necessary for the applicant to be relieved of
some responsibilities for the five years of the grant award in order
to implement the proposed plan.

An Institution may apply for an award on behalf of a named individual
meeting the criteria for this award.  Awards will be limited to one
from each eligible school over the life of the award.  After the
first year, grants will be renewed for a maximum of four years on a
non-competitive basis depending upon progress being made in meeting
the program's objectives.  An annual report will be required that
summarizes activities relevant to curriculum development at the
institution and other elements of the program plan and outlines
future plans.  This report will serve as the principal basis for
renewal of the grant.

Awards may not be transferred from one institution to another.  If an
awardee moves to another institution, the award will continue at the
original institution only upon acceptance by the Division of Lung
Diseases of a suitable replacement proposed by the grantee
institution.  Such a replacement will not lengthen the overall term
of the award.

STUDY POPULATIONS

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

Although the TB Academic Award is not primarily a mechanism to
support research, some awardees may implement research as part of the
overall Academic Award Program.  If any clinical research is proposed
under the program, the policies of the NIH regarding inclusion of
women and minorities apply.

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 must 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 must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group and approximate percentages
should be included.  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
diseases, disorders or conditions, including but not limited to
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Programs involving educational strategies including the
effectiveness of such strategies, such as required by this program,
are considered human subject research.  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.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 13, 1993, a
letter of intent that includes 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 NHLBI 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:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548B
Bethesda, MD  20892
Telephone:  (301) 594-7452

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91).  Application kits are available at most
institutional offices of sponsored research and may be obtained from
the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD 20892, telephone (301) 594-7428.

The RFA label available in the PHS 398 (rev. 9/91) 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, "RFA: HL-94-002-L Tuberculosis Academic
Award" 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:

C. James Scheirer, Ph.D.
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Westwood Building, Room 548B
Bethesda, MD  20892

Applications must be received at both locations by February 11, 1994
to be assured of review in this competition.  If an application is
received after that date, it will be returned to the applicant
without review.  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, NHLBI staff will return the
application to the applicant.

The initial review may include a preliminary evaluation to determine
scientific merit relative to the other applications received in
response to this program announcement (triage); the NIH will remove
from further consideration applications judged to be noncompetitive
and promptly notify the Principal Investigator and the official
signing for the applicant organization.  Those applications judged to
be competitive will be further evaluated for scientific/technical
merit by the usual peer review procedures, including, if deemed
appropriate, an applicant interview in or near Bethesda at the
applicant's expense.  The initial review will be conducted by a
Special Emphasis Panel, managed by the Division of Extramural
Affairs, National Heart, Lung, and Blood Institute.  The secondary
review will be by the be by the National Heart, Lung, and Blood
Advisory Council.

Applications for this Tuberculosis Academic Award will be evaluated
in terms of the following criteria:

o  description of the magnitude of the tuberculosis problem and the
need for the program in the area to be served;

o  the overall merit of the proposed five-year plan for improving the
institution's interdepartmental curricula in tuberculosis control;

o  the qualifications and background of the candidate, including
experience in teaching, curriculum development, and administration in
a medical school, and planning and conduct of research;

o  the ability and commitment to work cooperatively with other
awardees to make innovative tuberculosis curricula, materials, and
programs available;

o  the institution's commitment to implement the proposed curriculum
and to maintain a program in education about tuberculosis control
after the termination of the award;

o  the significant involvement of appropriate disciplines in the
development, implementation, and evaluation of the program;

o  design and evaluation of educational interventions for health care
providers and for patients with tuberculosis in areas with high
incidence of TB;

o  plans for communication and cooperation between specialists in
adult and pediatric pulmonary medicine, infections, and community
medicine to ensure optimal treatment;

o  plans for collaborative projects with other organizations that
have responsibility for and interest in tuberculosis control, for
example, health departments, medical and nursing associations, and
voluntary health agencies;

o  plans for and availability of expertise to implement and evaluate
the proposed program, including strategies for both process and
impact evaluation;

o  the potential of the program for making an impact on the control
of tuberculosis among populations served;

o  the potential for replication or adaptation of the program at
other sites.

AWARD CRITERIA

The anticipated date of award is September 30, 1994.  Factors that
will be taken into consideration in making awards include the
scientific merit of the proposed program as evidenced by the priority
score and the availability of funds.  Subject to the availability of
necessary funds and consonant with the objectives of the Tuberculosis
Academic Award, the Division of Lung Diseases will provide funds for
a project period up to five years.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.  Applicants are urged to contact the program
administrator, listed below, as soon as they receive approval from
their institution to apply for this award.

Direct inquiries regarding programmatic issues to:

Joan M. Wolle, Ph.D., M.P.H.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
Westwood Building, Room 640
Bethesda, MD  20892
Telephone:  (301) 594-7466

Direct inquiries regarding fiscal matters to:

Raymond L. Zimmerman
Grants Operations Branch
National Heart, Lung, and Blood Institute
Westwood Building, Room 4A17
Bethesda, MD  20892
Telephone:  (301) 594-7420

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.838.  Grants are made under the authorization of
the Public Health Service Act, Title III, Section 301 (Public Law
78-410, as amended by Public Law 99-158, 42 US 241 and 285) and
administered under PHS grants policies and Federal Regulations 42 CAR
52 and 45 CAR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or to
a review by a Health Systems Agency.

.

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