TROPICAL MEDICINE RESEARCH CENTERS
Release Date: January 24, 2000
RFA: AI-00-009 (This RFA has been reissued and modified, see RFA-AI-06-006)
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: May 1, 2000
Application Receipt: June 27, 2000
APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE
PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC
INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS.
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH) invites applications for
multiproject center grants from institutions in geographic areas where
tropical infectious diseases are endemic. It is the NIAID's objective
to develop a flexible tropical disease research network that can be
responsive to emerging scientific needs and challenges in the field of
tropical infectious diseases. The purpose of the Tropical Medicine
Research Centers (TMRCs) program is to support high quality centers for
research that will lead to or result in prevention, amelioration,
and/or treatment of tropical infectious diseases and thus improve the
health and quality of life of individuals in endemic areas. 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 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," 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 2010" at
http://odphp.osophs.dhhs.gov/pubs/hp2000
ELIGIBILITY REQUIREMENTS
Non US and non-European organizations and institutions located in the
tropics in or near an area endemic for tropical infections are eligible
to apply. 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
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 the Pan American Health
Organization or the World Health Organization.
Only institutions with strong ongoing research programs 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 grant (P50).
This mechanism supports all phases of research ranging from basic and
developmental aspects to applied field and clinical research. 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 NIH 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 is expected
to contribute at least 40% effort to the program and exercise
leadership in program development and integration, quality control,
administration, and scientific collaboration within the program. If
desired, an U.S. Co-PD may be designated. Participation of a US
investigator is not a requirement of the program.
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 project to benefit from 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.
Each of the individual projects within the TMRC will be under the
leadership of an established, non-US or non-European, investigator who
will be the principal investigator (PI) for the specific project.
Principal investigators are expected to expend at least 25% effort on
their individual projects. All investigators must contribute to, and
share in, the responsibilities of fulfilling the objectives of the
TMRC. To enhance the individual projects as well as the program goals
it is envisioned that each TMRC, under the direction of the Program
Director, will schedule regular bi-weekly or monthly meetings to foster
scientific cooperation and collaboration. Common shared resources
e.g., laboratory or clinical service facilities will be requested as
cores. Such cores should be utilized by two or more projects within
the TMRC. In addition provision for an administrative core with
detailed arrangements for financial management is a requirement of the
RFA.
Responsibility for the planning, direction, and execution of the
proposed research plan will be solely that of the applicant. The total
requested period of support may not exceed five years. These P50
applications should not request budgets in excess of $600,000 total
costs per year. It is the policy of the NIH that facilities and
administrative (F&A) costs will not be paid to organizations located
outside of the territorial limits of the United States. The earliest
anticipated award date is June 2001.
FUNDS AVAILABLE
The estimated total funds available for the first year of support for
this RFA will be $1.75 million. In fiscal year 2001, 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 review of material presented in
annual reports and at a required annual reverse site visit. 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. Infectious diseases remain a major cause of death in
developing countries. 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. Greater than 70% of
deaths in children less than five years of age and greater than 40% of
deaths in developing countries are due to infectious and parasitic
infections. Enteric infections, caused by viruses, bacteria and
protozoa, including mycobacterial infections such as leprosy, are
responsible for immeasurable global morbidity and mortality. Childhood
mortality rates in tropical developing countries are five 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 morbidity and mortality of many tropical disease problems in
endemic areas are increasing, due to changing ecological patterns
leading to an increase in incidence and prevalence as well as new
pathogens, drug resistance, and failure of currently available control
measures. 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.
Many fundamental questions about host pathogen interaction remain
unanswered. Moreover, advances in biomedical technology and genomics
have opened up exciting possibilities for the development of vaccines,
chemo- and immuno- therapeutics, and transmission control methodologies
for all the major tropical diseases. The need for sustained research
support in these areas persists, especially for those clinical and
field efforts dependent upon access to populations of pathogens,
patients and invertebrate vectors. To address these needs the NIAID
initiated the competitive TMRC program in 1991. Currently there are
three TMRCs.
Scope of Research
Projects to be supported by this RFA will focus on infectious diseases
primarily endemic in or profoundly impacting people living in the
tropics and emphasize research requiring access to human, pathogen, and
vector populations. Diseases of interest include, but are not limited
to, those resulting from infection with protozoa and helminth
parasites, enteric bacteria and viruses, arboviruses, and bacterial
meningitis. Emphasis is placed on those diseases for which recent
discoveries and developments require facilities and infrastructure for
further testing and evaluation in the field and in the clinic. Studies
focusing on human immunodeficiency virus (HIV) infections and
tuberculosis in developing countries are supported by other NIAID
activities, and will not be considered in response to this
solicitation.
Each TMRC should bring together relevant biomedical knowledge,
technology, and expertise in tropical infectious diseases with the
ultimate goal to develop and test new diagnostic and intervention
strategies. The TMRC program is intended to support research requiring
access to populations. Relevant research activities include projects
on clinical, epidemiological and field aspects of tropical diseases as
well as supportive basic research related to the biology of host-
infectious agent interactions. Relevant disciplines include but are
not limited to genetics, immunology, pharmacology, bacteriology,
virology, parasitology, clinical science, and medical entomology. The
goals of the research projects should support the development and
evaluation of diagnostic tests, immunotherapeutic and
immunoprophylactic measures, chemotherapeutic and chemoprophylactic
methods, and vector and other control strategies that may be deployed
as part of national control efforts.
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 detail in the application under a required administrative core.
Applications should budget approximately $50,000 for the
administrative/fiscal core that should focus on financial management
and accounting. Fiscal core funds can be utilized to purchase the
appropriate hardware and software for required accounting procedures.
Applicants must work with a U.S. University or the NIAID in the
administrative core, as funds must be first distributed to a United
States Bank. The NIAID Grants Management Office must approve final
arrangements before an award is made and will be available to answer
inquiries regarding these arrangements (see Inquires). An initial start
up meeting of the TMRC program directors will be required early in year
one at the time of the 2001 ICTDR network meeting to convey information
on NIH requirements for human subject research and fiscal arrangements.
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. 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. Each TMRC will have a
required annual reverse site visit at the NIH in Bethesda. Thus,
provision should be made for the TMRC Program Director to make two
trips to Bethesda each year. 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 the discretion
of the TMRC.
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 or other members of the ICTDR network.
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 re-budgeted to other
programs within the Center. The TMRC Program Director is expected to
include plans for the visiting scientist in his/her annual reverse site
visit at the NIAID.
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. All human subject research is subject to the
NIAID’s terms of award requirements (see appendix), which include
requirements for protocol review, safety and site monitoring. Clinical
protocols involving human subjects will be reviewed at two stages of
development, early (during the concept stage) and later close to
protocol completion, for: scientific content, design, safety,
feasibility, statistical and regulatory issues such as adverse
experience reporting mechanisms and informed consent.
All TMRC protocol documents for clinical trials should, at minimum,
include the following sections: an introduction, including background
and rationale; a statement of the study objectives; criteria for
selection of subjects, and enrollment procedures; clinical and
laboratory evaluations to be performed; plans for data management,
collection, and monitoring, and for reporting of adverse events; a
complete description of the study treatment; and statistical
considerations, including general design issues, endpoints, sample
size, accrual and power, monitoring and analysis, and stopping rules.
An ICTDR Data Safety and Monitoring Board, to be selected and overseen
by NIAID, will monitor all Phase III TMRC clinical trials. All phase I
and II clinical trails will be monitored by interim monitoring boards
that will be established jointly by NIAID program staff and the TMRC
team.
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 sub-populations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear, compelling rationale, and justification are provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research", published in the Federal Register of
March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and
Contracts, Vol. 23, No. 11, March 18, 1994 which is available via the
WWW at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS
IN RESEARCH INVOLVING HUMAN SUBJECTS:
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects" that was published
in the NIH Guide for Grants and Contracts, March 6, 1998, and which is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may obtain copies from these sources or from Elizabeth
Higgs, (listed in INQUIRIES below) who may also provide additional
relevant information concerning the policy.
LETTER OF INTENT
Prospective applicants are asked to submit, by the date listed on the
face page of this RFA, 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). The information in the letter
of intent allows NIAID staff to estimate the potential review workload
and to avoidance conflict of interest in the review. The letter of
intent is neither required nor binding. It does not commit the sender
to submit an application, nor does it enter into the review.
All potential applicants are encouraged to contact Dr. Elizabeth Higgs
listed under INQUIREIES to discuss intended projects.
The letter of intent is to be sent to Dr. Peter Jackson at the address
listed under INQUIRIES.
APPLICATION PROCEDURES
Applicants for P50 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants. Application kits are available at most
institutional offices of sponsored research and 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: GrantsInfo@nih.gov. Applications are
also available on the World Wide Web at
http://grants.nih.gov/grants/forms.htm.
For purposes of identification and processing, item 2a on the face page
of the application must be marked "YES" and the RFA number "AI-00-009"
and the words "TROPICAL MEDICINE RESEARCH CENTERS" must be typed in.
The RFA label and line 2 of the application should both indicate the
RFA number. The RFA label must be affixed to the bottom of the face
page. 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified
to allow for this change. Please note this is in pdf format.
Applications must be received by the Receipt Date listed on the face
page of this RFA. Applications that are not received as a single
package on the receipt date or that do not conform to the instructions
contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and
superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR
APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive
and will be returned to the applicant.
It is highly recommended that the appropriate NIAID program contact be
consulted before submitting the letter of intent and during the early
stages of preparation of the application. (See program contact under
INQUIRIES).
Submit a signed, typewritten original of the application, including the
checklist, and three signed, exact, single-sided photocopies, in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express mail or courier service)
At the time of submission, two additional exact copies of the grant
application and all five sets of any appendix material must be sent to
Dr. Peter Jackson at the address listed under INQUIRIES.
Concurrent submission of an R01 and a Component Project of a Multi-
project Application: 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 R01 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.
SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS
RFA
Applicants for P50 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
The brochure presents specific instructions for sections of the PHS 398
(rev. 4/98) application form that should be completed differently than
usual. For all other items in the application, follow the usual
instructions in the PHS 398 REVIEW CONSIDERATIONS
Review Procedures
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIAID. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIAID in accordance with the review criteria
stated below. As part of the initial merit review, a process will be
used by which applications receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under
review, will be discussed, and assigned a priority score. A 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 40% 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
prevention, treatment, and control of tropical diseases.
o Major emphasis on research requiring access to human, pathogen, and
vector populations.
o Adequacy of administrative and financial core.
o Adequacy of appropriate facilities for laboratory, field and
clinical studies.
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:
Dr. Elizabeth S. Higgs
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, MSC 7630
Bethesda, MD 20892-7630
Telephone: (301) 496-7115
FAX: (301) 402-0804
Email: eh63a@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:
Dr. Peter Jackson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2154 MSC 7616
Bethesda, MD 20892-7616
Telephone: (301) 496-8426
FAX: (301) 402-2638
Email: pj8v@nih.gov
(Fed-Ex Mailings use: Bethesda, MD 20817-7613)
Direct inquiries regarding fiscal matters to:
Ms. Lesia Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive
Bethesda, MD 20892-7610
Telephone: (301) 402-6581
Email: lnorwood@niaid.nih.gov
Schedule
Letter of Intent Receipt Date: May 1, 2000
Application Receipt Date: June 27, 2000
Scientific Review Date: October, 2000
Advisory Council Date: February, 2001
Earliest Date of Award: June, 2001
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,
Sections 301 and 405 as amended (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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