Full Text AI-95-002

TROPICAL MEDICINE RESEARCH CENTERS

NIH GUIDE, Volume 23, Number 40, November 18, 1994

RFA:  AI-95-002

P.T. 04

Keywords: 
  0715151 
  Biomedical Research, Multidiscipl 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  December 19, 1994
Application Receipt:  May 16, 1995

PURPOSE

The Division of Microbiology and Infectious Diseases (DMID) of the
National Institute of Allergy and Infectious Diseases (NIAID) invites
applications for multiproject center grants from institutions in
geographic areas where tropical infectious diseases are endemic.
These centers of excellence, designated as Tropical Medicine Research
Centers (TMRCs), will conduct interdisciplinary research on parasitic
and other tropical infectious diseases, which will lead to the
development, evaluation and deployment of new and/or improved
intervention strategies to prevent and control these diseases.

The intent of the TMRC program is to bring together relevant
biomedical knowledge and technology to develop and evaluate new
approaches for the detection, prevention and treatment of infectious
diseases of recognized importance to the health of people living in
tropical countries.  It is envisioned that this program will enhance
opportunities for relevant experience in tropical disease research
and will promote scientific linkages and interaction between U.S. and
foreign investigators.  Each TMRC will be included as a component of
the NIAID's network of International Centers of Tropical Disease
Research (ICTDR).

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 Request
for Applications (RFA), Tropical Medicine Research Centers, is
related to the priority areas of immunization and infectious
diseases.  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 202-782-3238).

ELIGIBILITY REQUIREMENTS

Organizations and institutions with facilities in or near an area,
outside of the United States, where tropical diseases are endemic,
are eligible to apply for center grants under this RFA and the
research will be carried out in that area.  Applications may be
submitted by for-profit and non-profit organizations, public and
private institutions, such as universities, colleges, hospitals,
laboratories and government agencies in the host country.  To achieve
the goals identified in the application, subcontract or consortium
arrangements are permitted with other overseas institutions.

It will be necessary for each TMRC to demonstrate a working
relationship with the appropriate government organization in the host
country.  It may also be convenient to develop a collaborative
association with an organization such as Pan American Health
Organization or the World Health Organization.

Only institutions with strong ongoing research programs and resources
that can focus on a multidisciplinary approach on tropical infectious
diseases will be considered for TMRC support under the provisions of
this RFA.  Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The mechanism of support will be the specialized center (P50) grant.
This is a mechanism for the support of any phase of research
activities ranging from basic to more applied field and clinical
research and development aspects.  This research may require
ancillary activities such as protracted patient care necessary to
support the primary research and/or research and development effort.
The spectrum of activities comprises a multidisciplinary attack on a
specific disease entity or biomedical problem area.  Unless
specifically stated to the contrary herein, all policies and
requirements that normally govern the grant programs of the PHS will
apply.

The responsibility for leadership of each TMRC rests with the program
director (PD) who must possess demonstrated scientific and
administrative competence.  The PD should be located at and
affiliated with the institution at which the TMRC will reside.  The
PD must show a substantial commitment of time and effort to the
program and exercise leadership in the maintenance of its quality
control.  If desired, a U.S. Co-PD may be designated.

Each TMRC must consist of three or more scientifically meritorious
projects whose interrelationships will result in a greater
contribution to the program goals than if each project were pursued
individually.  There must be a unifying, well-defined goal or problem
area of research to which each project relates and contributes,
thereby producing a research environment that allows each research
effort to share the creative strengths of the others.  Each research
project included in the application must, as assessed by peer review,
stand on its own independent scientific merit, as well as complement
the other projects whenever feasible.  Each of the individual
projects within the TMRC should be under the leadership of an
established investigator who would be the principal investigator (PI)
for the specific project.  These multiple projects require the
participation of investigators in several disciplines with special
expertise in several areas of one discipline.  All investigators must
contribute to, and share in, the responsibilities of fulfilling the
objective of the TMRC.  Support for certain common resources (cores)
may also be requested.  Such resources (e.g., laboratory or clinical
service facilities) should be utilized by two or more projects within
the TMRC when such sharing facilitates the total research effort.

Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
requested period of support may not exceed five years.  At this time,
the NIAID is administratively limiting the duration of center grants
to four years; this administrative limitation may change in the
future.  These P50 applications should not request budgets in excess
of $550,000 total costs in the first year.  Currently, NIAID awards
no more than four percent annual inflationary increases for future
years.  It is the policy of the Public Health Service that indirect
costs will not be paid to organizations located outside of the
territorial limits of the United States.  The earliest anticipated
award date is April 1996.

FUNDS AVAILABLE

The estimated total funds available for the first year of support for
this RFA will be $1.6 million.  In fiscal year 1996, the NIAID plans
to fund approximately three center grants related to this RFA.  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 NIAID, awards pursuant to
this RFA are contingent upon the availability of funds for this
purpose.  Funding beyond the first and subsequent years of the grant
will be contingent upon satisfactory scientific progress during the
preceding years and availability of funds.  Satisfactory progress
will be assessed by NIAID staff, including their review of material
presented in annual reports.  At this time, the NIAID has not
determined whether or how this solicitation will be continued beyond
the present RFA.

RESEARCH OBJECTIVES

Background

Infectious diseases represent a tremendous public health threat for
people living in tropical and subtropical regions of the world and
are responsible for limiting individual productivity and
socioeconomic development.  It is estimated that 20 percent of the
world's population carries a helminthic parasite infection, and that
10 percent are infected with those parasites causing malaria,
schistosomiasis, filariasis, leishmaniasis or trypanosomiasis.
Enteric infections, caused by viruses, bacteria and protozoa, as well
as mycobacterial infections, especially leprosy and tuberculosis, are
responsible for immeasurable global morbidity and mortality.
Childhood mortality rates in tropical developing countries are at
least ten times higher than those in industrialized countries.  This
difference is to a large extent attributable to the prevalence of
diarrheal and acute respiratory diseases.

The magnitude of many tropical disease problems in endemic areas is
increasing, due to changing ecological patterns and to the failure of
currently available control measures, e.g., as a result of microbial
drug resistance.  Moreover, tropical diseases are of increasing
global concern as tourism, trade, business travel, immigration and
military activities extend the range of infectious agents and
invertebrate vectors.  An Institute of Medicine committee articulated
these issues in its report entitled Emerging Infections: Microbial
Threats to Health in the United States (National Academy Press,
Washington DC, 1992) and recommended the support of increased
research efforts on surveillance and applied disease control
strategies.  The report specifically identified expanding research
efforts on diagnostics, vaccines, antimicrobial drugs and vector
control.

Advances in biomedical technology are opening up exciting
possibilities for the development of vaccines, chemo- and
immunotherapeutics, and transmission control methodologies for all
the major tropical diseases.  For example, there are now multiple
defined antigens that have been shown to induce protective immunity
in laboratory animals, which require further preclinical and clinical
research to evaluate their vaccine potential.  In addition, the use
of cytokines as adjuvant therapy for infectious diseases is showing
great promise in animal models.  The need for sustained research
support in these areas has never been greater, especially for those
clinical and field efforts dependent upon access to populations of
pathogens, patients and invertebrate vectors.

The NIAID has long been the lead Federal agency for support of
research and training on tropical infectious diseases, funding the
development of new control strategies through a combination of
investigator-initiated grants and special Institute-initiated
programs designed to encourage more application-oriented work.  In
1991, NIAID established a competitive program to fund institutions,
in endemic areas, to carry out research on tropical diseases.  The
TMRC program was initiated to support the infrastructure and
expertise necessary to develop and assess new approaches to the
control of complex tropical infectious disease problems.  Currently
there are three TMRCs.

Scope of Research

The research to be supported by this RFA will focus on those
infectious diseases primarily endemic in or which profoundly impact
upon people living in the tropics.  Diseases of interest include, but
are not limited to, those resulting from infection with protozoa and
helminth parasites, enteric bacteria and viruses, mycobacteria and
arboviruses.  Emphasis is placed on those diseases for which recent
discoveries and developments, leading to new and/or improved control
strategies, require facilities and infrastructure for further testing
and evaluation in the field and in the clinic.  Studies of human
immunodeficiency virus (HIV) infections in developing countries are
supported by other NIAID activities, and will not be considered in
response to this solicitation.  Studies of the impact of HIV
infection on the clinical course and outcome of other tropical
diseases and on control programs for these diseases will, however, be
considered.

Each TMRC should organize a multidisciplinary research effort that
will bring together relevant biomedical knowledge and technology to
achieve a greater understanding of the world's tropical infectious
diseases and to develop and test new intervention strategies for
these diseases.  Relevant research activities for each TMRC may
include projects on clinical, epidemiological and field aspects of
tropical diseases as well as on supportive basic research areas
related to the biology of host-infectious agent interactions,
utilizing such disciplines as genetics, immunology, pharmacology,
bacteriology, virology, parasitology and medical entomology.  The
goals of the research projects should be the development and
evaluation of diagnostic tests, immunotherapeutic and
immunoprophylactic measures, chemotherapeutic and chemoprophylactic
methods, and vector control strategies as well as other approaches
that may be deployed as part of disease control programs relevant to
national control efforts on these diseases.

Projects may involve collaboration among investigators at several
institutions.  Consortium arrangements should follow the NIH Guide
outlined in "Guidelines for Establishing and Operating Consortium
Grants, January 1989."  These are available from the program staff
listed under INQUIRIES.

SPECIAL REQUIREMENTS

Research at the applicant institution in the endemic area will be
supported directly by NIAID.  Fiscal and administrative arrangements
for the transfer of funds and materials to the applicant institution
and for the management of these funds and materials must be described
in the application.  Travel, salaries and fringe benefits will be
subject to the applicant institution's rules and regulations.

Successful TMRCs will be designated as components of the NIAID
International Centers for Tropical Disease Research (ICTDR), which
constitutes a network of NIAID-supported activities in tropical
diseases (see Appendix).  Each TMRC program director will represent
his/her TMRC at the annual meeting of the ICTDR network organized by
NIAID.  These meetings will be held to share advances in tropical
disease research among the TMRC projects and other NIAID-supported
tropical disease research programs and activities, to discuss
research needs and opportunities in this arena, and to facilitate the
development of new collaborative protocols that may include multi-
center studies.  Provision should be made for the TMRC Program
Director to travel to the annual meetings of the NIAID ICTDR network
to be held in the Washington, DC area and generally lasting three
days.  Such anticipated travel costs should be identified in advance
and built into the budget of the TMRC application.  Other TMRC
personnel are encouraged, but not required, to attend the ICTDR
meetings, and travel support will be at their own discretion.

Applications must also include a Visiting Investigator component,
which should be described as a separate Core constituent.  Under the
terms of this Core, provision will be made by the TMRC for visiting
investigators to spend up to one year in residence to study tropical
disease problems of their own interest or participate in ongoing
programs of the TMRC.  This provision is intended to afford
opportunities for tropical disease research experience at the TMRC
primarily to U.S. scientists, although non-U.S. scientists may be
eligible as conditions permit.  The application should detail:  the
facilities available at the applicant institution to host visiting
investigators, the procedures to be used to advertise the program and
to recruit such visiting investigators, and the method by which their
research projects will be evaluated and approved.  Those selected
will require the approval of NIAID program staff.  Funds allotted to
the visiting investigator core should not exceed $50,000 per year to
cover the anticipated costs of travel, supplies, and salary.  Funds
initially designated for this core are restricted for this purpose
and cannot be rebudgeted to other programs within the Center.

Applicants must be aware of policies and procedures for the conduct
and oversight of clinical research studies and of clinical trials.
NIH defines all biomedical and behavioral research involving human
subjects as clinical research.  For the purposes of NIH policy, a
clinical trial is defined as a broadly based prospective phase III
clinical investigation that is designed to evaluate an experimental
intervention in comparison with a standard or control intervention or
to compare two or more existing treatments.  NIAID's Division of
Microbiology and Infectious Disease has developed guidelines for the
establishment, responsibilities and operating procedures of data
safety and monitoring boards (DSMBs) for clinical trials.  A copy of
these guidelines is available from Dr. Michael Gottlieb at the
address listed under INQUIRIES.  Applications must include details
for the implementation of these guidelines where relevant in the
proposed studies.

Recent advances in satellite remote sensing technology and in
computerized geographic information systems (GIS) have been applied
to the study of infectious diseases and their distribution.  These
tools have provided predictive data for such purposes as identifying
geographic areas where there is an increased risk of vector-borne
disease transmission. Investigators seeking to employ remote sensing
in their studies of tropical diseases should clearly indicate this
fact in the application.  In this regard, applicants should prepare a
separate budget indicating the funds and resources required for the
conduct of such studies.  This budget should be clearly identified
and should not be considered as part of the $550,000 limit indicated
above.  Applicants are strongly encouraged to contact Dr. Michael
Gottlieb at the address listed under INQUIRIES for more information
and assistance.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

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 new
provisions that are substantially different from the 1990 policies.

The NIH policy on inclusion of women in research conducted outside
the U.S. is the same as that for research conducted in the U.S.  With
regard, however, to the population of the foreign country, the
definition of the minority groups in foreign countries may be
different than in the U.S.  If there is a rationale for examining
subpopulation group differences within the foreign population,
investigators should consider designing their studies to accommodate
these differences.

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 28, 1994 (FR 59 14508-14513), and printed
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.  Investigators may obtain copies from these sources or
from Dr. Gottlieb at the address listed in INQUIRIES below, who may
also provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 19, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, and the number and title of this RFA.
Prospective applicants are also asked to submit a list of the key
investigators and their institution(s).  Although the letter of
intent is not required, is not binding, does not commit the sender to
submit an application, and does not enter into the review of
subsequent applications, the information that it contains allows
NIAID 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 Dr. Olivia Preble at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Applications are to be submitted on form PHS 398 (rev. 9/91), the
standard application form for research grants.  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, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301/435-0714.  Applicants
must adhere to the format and requirements specified in the PHS 398
application kit.  In addition, applicants for multicomponent grants
are strongly advised to read the information brochure "NIAID Program
Project Grants and Multiproject Cooperative Agreements," available
from Michael Gottlieb at the address listed under INQUIRIES.

For purposes of identification and processing, mark "YES" in item 2a
on the face page of the application and type in the RFA number
AI-95-002 and the title "TROPICAL MEDICINE RESEARCH CENTERS." The RFA
label available in the form PHS 398 must be affixed to the bottom of
the face page of the original 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.

The signed, typewritten original of the application, including the
Checklist, and three exact single-sided copies must be sent 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
and all five sets of appendices must also be sent to Dr. Olivia
Preble at the address listed under INQUIRIES.

To ensure their review, applications must be received by both the
Division of Research Grants and Dr. Olivia Preble by May 16, 1995.
Applications not received by May 16, 1995 will be considered non-
responsive and will be returned to the applicant without review.

Current NIH policy permits a component research project of a multi-
project grant application to be concurrently submitted as a
traditional individual research project (R01) application.  If,
following review, both the multi-project application and the R01
application are found to be in the fundable range, the investigator
must relinquish the R0l and will not have the option to withdraw from
the multi-project grant.  This is an NIH policy intended to preserve
the scientific integrity of a multi-project grant, which may be
seriously compromised if a strong component project(s) is removed
from the program.  Investigators wishing to participate in a multi-
project grant must be aware of this policy before making a commitment
to the Principal Investigator and awarding institution.

REVIEW CONSIDERATIONS

Review Procedures

Applications will be reviewed by DRG staff for completeness and by
NIAID staff to determine administrative and programmatic
responsiveness to this RFA.  Those judged to be incomplete or non-
responsive will be returned to the applicant without review.  Those
considered complete and responsive may be subjected to a triage
review by an NIAID peer review group to determine their scientific
merit relative to the other applications submitted in response to
this RFA.  The NIAID will withdraw from competition those
applications judged by the triage peer review group, before or during
the initial review group meeting, to be noncompetitive for award and
will so notify the applicant investigator and the institutional
business official.  For applications found non-competitive, summary
statements will be very brief and will generally contain unedited
reviewers' comments, indicating the major reason(s) for the non-
competitive rating.

Those applications judged to be competitive for award will be
reviewed for scientific and technical merit by a Review Committee
convened by the Division of Extramural Activities, NIAID.  The second
level of review will be provided by the National Advisory Allergy and
Infectious Diseases Council.

Review Criteria

The review criteria for P50 center grant applications are the same as
review criteria for large, multicomponent, interdisciplinary program
projects as outlined in the brochure, NIAID PROGRAM PROJECT GRANTS
AND MULTIPROJECT COOPERATIVE AGREEMENTS.

The distinguishing features of a multiproject center grant include:

o  A unifying well-defined goal or problem area of research to which
each project relates and contributes, thereby producing a research
environment that allows each research effort to share the creative
strengths of others.

o  A program director who possesses recognized scientific and
administrative competence; he/she must show a substantial commitment
of time and effort to the center and exercise leadership in its
quality control.

o  Each research project must, as assessed by peer review, stand on
its own independent scientific merit, as well as complement other
projects whenever feasible.

o  These multiple projects require the participation of established
investigators in several disciplines, or investigators with special
expertise in several areas of one discipline.  All investigators must
contribute to and share in the responsibilities of fulfilling the
center's objective.

In addition, the following criteria will be considered in the
scientific review of the application:

o  Relevance of research approach, design, and methodology to the
development and evaluation of intervention strategies for the control
of tropical diseases.

o  Adequacy of appropriate facilities for laboratory, field and
clinical studies.  In studies involving clinical trials, this
includes adequacy of procedures for the establishment and operation
of a DSMB.

o  Mechanisms proposed for the visiting investigator component.

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program needs and
balance, and the availability of funds.  It is the desire of NIAID to
fund a group of applications that together will provide a broad
spectrum of research opportunities for the development, evaluation
and deployment of intervention strategies for the control of tropical
infectious diseases.

INQUIRIES

Written, telephonic, and electronic inquiries concerning this RFA are
strongly encouraged.  The opportunity to clarify any issues or
questions from potential applicants is welcome.

Requests for the NIAID Information Brochure "NIAID Program Project
Grants and Multiproject Cooperative Agreements" and for the new "NIH
GUIDELINES FOR INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN
CLINICAL RESEARCH" as well as inquiries regarding programmatic issues
may be directed to:

Michael Gottlieb, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Solar Building, Room 3A12
6003 Executive Boulevard
Bethesda, MD  20892-7630
Telephone:  (301) 496-7115
FAX:  (301) 402-0804
Email:  mg35s@nih.gov

Direct inquiries regarding review issues, address the letter of
intent to, and mail two copies of the application and all five sets
of appendices to:

Olivia Preble, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C20
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-8208
FAX:  (301) 402-2638
Email:  op2t@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Leslie Marsden
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B35
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
Email:  leslie_marsden@exec.niaid.pc.niaid.nih.gov

Schedule

Letter of Intent Receipt Date:  December 19, 1994
Application Receipt Date:       May 16, 1995
Scientific Review Date:         October 1995
Advisory Council Date:          February 1996
Earliest Date of Award:         April 1996

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.856 - Microbiology and Infectious Diseases
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.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American
people.

.

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