Full Text TW-96-001
 
INTERNATIONAL TRAINING AND RESEARCH IN EMERGING INFECTIOUS DISEASES
 
NIH GUIDE, Volume 25, Number 12, April 19, 1996
 
RFA:  TW-96-001
 
P.T. 34

Keywords: 
  Infectious Diseases/Agents 
  Biomedical Research Training 
  Behavioral/Social Studies/Service 

 
Fogarty International Center
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  September 15, 1996
Application Receipt Date:  January 15, 1997
 
PURPOSE
 
A comprehensive strategy to address global emerging and re-emerging
infectious diseases (ERID) should include international training and
biomedical and behavioral research.  This strategy will strengthen
the capacity of scientists to understand and respond to outbreaks of
infectious diseases more effectively.
 
The definition of ERID is "new, re-emerging or drug-resistant
infections whose incidence in humans has increased within the past
two decades or whose incidence threatens to increase in the near
future" (Institute of Medicine, 1992).
 
The objectives of the International Training and Research in Emerging
Infectious Diseases (ITREID) Program are to:
 
o  Train laboratory scientists, clinicians, epidemiologists, social
scientists, and public health workers in developing countries and the
United States in emerging and re-emerging infectious disease
research, control and prevention strategies and their implementation
and evaluation; this will increase global infrastructure and capacity
for dealing with ERID.
 
o  Assist scientists from developing countries to contribute to
global emerging infectious diseases research efforts and advance
knowledge in support of national and international ERID policies.
 
o  Encourage and facilitate international collaboration on ERID
research, including the conduct of advanced in-country research.
 
o  As a result of the above, enhance domestic infectious diseases
research programs and improve the protection of the United States
population from ERID by early detection and response to epidemics
internationally and nationally.
 
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), International Training and Research in
Emerging Infectious Diseases, is related to the priority area of
emerging diseases.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
The grantee institution must be a U.S. non-profit private or public
institution capable of meeting the objectives in the RFA.
 
Applicant investigators (or co-investigators) must be either a U.S.
Principal Investigator of at least one relevant NIH-sponsored
research project grant (R-series) or a Project Director of an
NIH-sponsored center grant, program project grant or cooperative
agreement (P and U series) related to infectious diseases.  For
example, an award under the NIAID International Collaborations in
Infectious Diseases Research Program would satisfy the eligibility
requirements.  On submission of an application, at least eighteen
months of active research support must remain on the listed parent
grant(s) so that the parent grant will be funded during at least one
year of the proposed new grant award period.  The following
mechanisms alone do not meet the eligibility requirements: Center
Core Grants (P30), Shannon Awards (R55), and Small Grants (R03).
Investigators may request five years of support in anticipation that
a renewal application for the parent grant(s) will be submitted and
awarded.  Under certain circumstances, another award, such as an NIH
research contract will be considered as meeting the eligibility
requirements.  Though an existing international relationship would be
desirable to meet the eligibility requirements, this is not
absolutely necessary.
 
The application must demonstrate that the award is relevant to and
will enhance the activities of the NIH-supported parent grant(s), and
benefit the research needs and interests of the host countries, and
of participating scientists and health professionals.
 
Within allowable limits, research collaborations can include other
industrialized nations in addition to the U.S.
 
Questions about eligibility and partnerships with colleagues and
institutions in the U.S. and overseas should be referred to the
program staff listed under INQUIRIES.
Only one application will be allowed under this program
from each U.S. institution.
 
MECHANISM OF SUPPORT
 
This RFA will use the international training grants in epidemiology
(D43) mechanism.  The application should describe both training and
research objectives to be pursued in the United States and in the
cooperating developing nation(s) of Africa, Asia and the Pacific
region, the Middle East and Latin America including the Caribbean.
Applications may incorporate cooperative activities with scientists
from one or several developing countries or regions, based on the
training and research objectives of the program.  However, applicants
are encouraged to focus their efforts on a limited number of
countries.
 
Types Of Training:
 
Public health related training and research programs for foreign
scientists and health professionals may include the following
elements:
 
o  Participation in training of health workers in the diagnosis,
patient management, control, and prevention of disease and in
activities in support of field research;
 
o  Predoctoral training in research related to emerging infectious
diseases; academic courses (which may lead to a degree) will be
undertaken in the U.S. in disciplines which may include: laboratory,
epidemiologic and social science research as described above;
research projects may be undertaken either at the U.S. host
institution or preferentially, in the trainee's home country;
 
o  Postdoctoral training in laboratory procedures and research
projects and techniques related to emerging infectious diseases
research, to be conducted at the host U.S. institutions or in the
trainee's home country;
 
o  Participation in advanced in-country research training conducted
by U.S. faculty in the host country and also short-term in-country
training for foreign scientists and health professionals in the host
country; and
 
As part of the application, the applicant institution must describe
recruitment and selection procedures for the foreign pre- and
post-doctoral scientists.
 
Major Research Themes
 
The areas of research addressed by this ITREID program would include
the following major research themes.  These are exclusive of HIV/AIDS
international training and research areas that are addressed by other
granting mechanisms, particularly the FIC/NIH AIDS International
Training and Research Program and the NIAID/NIH HIV Network (HIVNET)
program:
 
o  Emerging and re-emerging viruses particularly hemorrhagic fevers
occurring in the geographic areas emphasized above; including Ebola
virus and other filoviruses, dengue, yellow fever, Lassa fever and
other arena viruses,
 
o  Parasitic infections; including malaria and leishmaniasis;
 
o  Bacterial diseases; including cholera, plague, meningitis,
tuberculosis, leptospirosis, lyme disease, group A streptococcus,
diphtheria, pertussis, and shigella.
 
o  Other viral diseases of local, national and international
importance; including, but not limited to, Hantaviruses, rotavirus,
rabies,.
 
o  Cross cutting themes such as microbial resistance to drugs
 
Special recommendations for infectious diseases training and research
would address the following categories; these are examples, and
programs are not limited to these topics.
 
Training Categories
 
A.  Epidemiologic research
 
o  The clinical presentation, transmission patterns and risk factors
for transmitting and/or becoming infected with infectious diseases
o  The natural history of infectious diseases
o  The development and testing for effectiveness of intervention
strategies for limiting the spread of new diseases and preventing and
controlling resurgent diseases
o  Studies to identify patterns and host factors associated with the
development of drug resistance
o  New epidemiologic and statistical methods, including the
development of predictive models for the occurrence and spread of
epidemics and the use of geographical information systems
o  Improvement of surveillance tools, including computer programs for
reporting and data management
o  Environmental and ecologic factors that influence the population
biology of insects, rodent vectors and other animal (or unknown)
vectors.
 
B.  Laboratory research
 
o  Fundamental aspects of microbial physiology, genetics, and
biochemistry
o  Pathogenesis and pathology
o  Human immune response
o  Development and standardization of diagnostic tests
o  Development of drugs
o  Development of vaccines
o  Development of vector control interventions
o  Methods for monitoring drug resistance
o  Cellular and molecular factors that accelerate the development of
drug resistance and methods for limiting those factors
o  Environmental and climatic factors that influence temperature, the
quality and distribution of water and the population biology of
insect and rodent vectors
 
C.  Social science research:
 
o  Human behavior and demographics as they relate to the causes and
control of infectious diseases, including the development of drug
resistance
o  Economic assessments of the cost-effectiveness of different
surveillance and response strategies
 
Training Programs would:
 
o  Strengthen interdisciplinary training programs and scientific
exchanges within the United States in the area of infectious diseases
and emerging infections;
 
o  Enhance and increase international research capacity and training
programs in infectious diseases;
 
o  Encourage networking among international research and public
health communities that support surveillance and response actions for
emerging diseases; and
 
o  Support the World Health Organization initiative to improve
detection, response to and understanding of ERID.
 
Allowable Costs
 
Eligible costs include: travel and subsistence related to research
and training conducted at a foreign site; support for short and
long-term training of pre- and postdoctoral scientists and health
professionals from developing nations; provision of research supplies
and materials to the foreign site in support of joint activities; and
limited support for relevant activities with institutions in
industrialized nations that would provide scientific contributions.
 
The following cost categories are eligible for reimbursement under
this program.  The stipends and allowances are maximums and
applicants are encouraged to design the most cost-effective programs:
 
For foreign scientists from developing nations:
 
- Living allowance (stipend) comparable to scientist's professional
level and compatible with established NIH guidelines, but not to
exceed $45,000 per annum while undergoing training or conducting
research in the U.S.;
 
- Stipend, if necessary and justified, to cover the added time for
scientists to conduct in-country research if not paid for by the home
institution at a level comparable to that received by similar
professionals in-country, but also not to exceed $45,000 per annum;
 
- Tuition and fees at the U.S. university;
 
- Round trip economy class air fare between the U.S. and home country
(via U.S. air carrier);
 
- Allowance for the grantee institution of up to $600 monthly per
scientist to cover health insurance, travel to scientific meetings,
and incidental research expenses;
 
- Additional research support of up to $15,000 per person to support
training-related research or advanced research training in the
developing country (the program director is expected to ensure that
projects submitted for this funding are peer reviewed by the U.S.
institution);
 
For U.S. scientists affiliated with grantee institution:
 
- Economy class travel (via U.S. carrier) and per diem for the
program director and U.S. faculty colleagues to provide guidance to
trainees conducting related field studies or advanced research
training in their home countries;
 
- Economy class travel (via U.S. carrier) and per diem for U.S.
faculty presenting short-term courses in the foreign country;
 
- Longer-term support (travel, per diem and pro-rated salary, up to
10 percent of annual salary or $10,000, whichever is less) to enable
U.S. faculty to conduct advanced research training activities
in-country;
 
For administrative expenses:
 
- Administrative expenses at the U.S. institution (secretarial
expenses, etc.) not to exceed 10 percent of the direct costs of this
award.  These expenses must be exclusively for this training and
research proposal.  It is expected that the portion of salary for the
program director for the purpose of administering this award will be
provided for under the parent grant(s) associated with this proposal;
 
For related activities with other industrialized nations:
 
- Support for travel and subsistence of U.S. or foreign
investigator(s), and the exchange of data, materials and supplies,
not to exceed 10 percent of direct costs of this award unless prior
approval is secured from the FIC.  As a condition of this special
expenditure, the applicant must indicate that some form of
cost-sharing will be provided by the counterpart institution in an
industrialized nation.
 
Requests for an administrative supplemental budget will be considered
for increases of up to 20 percent of funded levels in a given budget
year.  These funds may be requested to meet special needs and take
advantage of unusual opportunities.  Such requests will be reviewed
by FIC program staff in consultation with NIAID and support will
depend upon availability of funds.
 
The grantee institution may request an indirect cost allowance based
on 8 percent of the total allowable direct costs, exclusive of
tuition and related fees and expenditures for equipment.  Applicants
should assume a budget increase of four percent per year for each
succeeding year.
 
The anticipated date of award will be before September 30, 1997.
 
FUNDS AVAILABLE
 
An estimated total of $500,000 is available for this program.
International Training and Research in Emerging Infectious Diseases
awards (D-43) will be available to U.S. investigators at a funding
level not to exceed $150,000 per year in total costs (direct and
indirect) for the first year, for a maximum of five years.  It is
anticipated that three to four awards will be made, with an estimated
total of $500,000 available for the entire program in the first year,
with no single award exceeding $150,000 (in total costs).
 
RESEARCH OBJECTIVES
 
Outbreaks of newly identified infectious diseases in humans and
animals have occurred with increasing frequency worldwide over the
past two decades.  During the same period there has been a
re-emergence of infectious diseases that had been in abeyance, for
which control and prevention measures have become ineffective.  The
reasons for the emergence of infectious diseases are complex and are
tied to biologic properties of the organisms, behavior of human
populations, and environmental changes.  As a global community
becomes a reality, the dangers of disease importation to all
countries, linked mainly to immigration (legal and illegal) and
international air travel, have increased.
 
The objectives of the research supported by the International
Training and Research in Emerging Infectious Diseases Program
(ITREID) grants are consistent with those championed by the National
Academy of Sciences, Institute of Medicine Report "Emerging
Infections: Microbial Threats to Health in the United States" (1992),
and the Report of the National Science and Technology Council,
Committee on International Science, Engineering, and Technology,
Working Group on Emerging and Re-emerging Infectious Diseases,
"Infectious Disease-A Global Health Threat" (1995).
 
The geographic emphasis of this program will be primarily on
developing countries in Africa, Asia and the Pacific Region, the
Middle East, and Latin America including the Caribbean, but may also
include other areas when well justified; for example, projects in the
former Soviet Union and Eastern European regions will be considered.
 
SPECIAL REQUIREMENTS
 
Before any funds may be expended on in-country research, the grantee
institution must show evidence of formal approval from responsible
authorities at the collaborating institution and the host government.
These approvals should be included in the application.
 
As part of proposed training programs, the applicants must describe
the training in the responsible conduct of research, consistent with
NIH policy (NIH Guide for Grants and Contracts, Volume 21, Number 43,
November 27, 1992) to be part of the program.  An award will not be
made unless such a description is included in the proposal.
 
Protection of Human Subjects and Laboratory Animals:
 
Applicable provisions for the protection of human research subjects
and laboratory animals in research and training activities must be
met in both domestic and foreign settings.  Title 45 CFR, Part 46,
provides guidelines concerning Department of Health and Human
Services regulations for the protection of human subjects and the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals.  These are available from the Office for Protection from
Research Risks, National Institutes of Health, 6100 Executive
Boulevard, Rockville, Maryland 20852.
 
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
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (59 FR 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 28, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by September 15, 1996, 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 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 a subsequent application, the information that it contains allows
NIH staff to estimate the potential review workload and avoid
conflict of interest in the review as well as to provide important
information to prospective applicants.
 
The letter of intent is to be sent to:
 
Dr. Joel Breman
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  ASKNIH@odrockm1.od.nih.gov; and from the program
administrator listed under INQUIRIES.
 
The RFA label available in the PHS 398 (rev. 5/95) 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 2 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
6701 ROCKLEDGE DRIVE, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for overnight/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Mr. Allan W. Czarra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 3C28
Rockville, MD  20852
 
Applications must be received by January 15, 1997.  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 RFA 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 for completeness by DRG
and responsiveness by the FIC, NIAID and other collaborating
institutions.  Incomplete applications will be returned to the
applicant without further consideration.  If the application is not
responsive to the RFA, the application will be returned to the
applicant without review.  Applications that are complete and
responsive to the RFA will be evaluated for scientific and technical
merit by a peer review group convened by the NIAID in accordance with
the review criteria stated below.  As part of the initial merit
review, all applications will 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 applications under
review, will be discussed, assigned a priority score, and receive a
second level review by the FIC Advisory Board.
 
Review criteria include those generally applicable to research
training programs and research:
 
o  Past training and research record for both the program and
designated preceptors in terms of the rate at which former trainees
establish independent and productive research careers;
 
o  Past training and research record in terms of the success of
former trainees in obtaining individual awards such as fellowships,
career awards and research grants for further development;
 
o  Objectives, design and direction of the training and research
program;
 
o  Training environment including the institutional commitment, the
quality of the facilities and the availability of research support;
 
o  Caliber of preceptors as researchers including the institutional
commitment, the quality of the facilities, and the availability of
research support;
 
o  Recruitment and selection plans for appointees and the
availability of high quality candidates;
 
o  The record of the research training program in retaining health
professional postdoctoral trainees for at least two years in research
training or other research activities; and
 
o  When appropriate, the concomitant training of health-professional
postdoctorates (e.g. , individuals with the M.D., D.O., D.D.S.) with
basic science postdoctorates (e.g., individuals with a Ph.D., Sc.D.)
will receive special consideration.
 
Where specific research protocols are proposed, additional review
criteria, applicable to research grants, will be as follows:
 
o  Scientific, technical or medical 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 the resources necessary to perform the research;
 
o  Appropriateness of the proposed budget and duration in relation to
the proposed research;
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
 
Additional factors to be considered in the scientific evaluation of
each application include the likelihood that the applicant
institution can meet the objectives stated in this RFA and
specifically:
 
o  The expected public health and scientific contributions of the
proposed activity;
 
o  The strength of the research program in health sciences related to
the proposed research and training;
 
o  Quality of teaching and research facilities and resources of the
U.S. institution, as well as the cooperating institution(s) in other
countries including documentation of previous international
collaboration with developing country scientists and institutions;
 
o  Previous training experience at the pre- and postdoctoral levels
and success in maintaining collaboration with former trainees;
 
o  Demonstrated capacity or potential to provide advanced in-country
research or technical training; and
 
o  Demonstrated capacity or potential to conduct future emerging
diseases related research projects with collaborating scientists and
institutions from developing nations.
 
AWARD CRITERIA
 
The most important factor to be considered in making funding
decisions will be the quality of the proposed project as determined
by peer review.
 
In addition, FIC, in consultation with NIAID and other ICDs and
collaborators will make every effort to ensure a reasonable balance
of basic, clinical and epidemiologic research training, as well as a
geographic distribution among developing nations of Asia and the
Pacific region, Africa, the Middle East and Latin America including
the Caribbean.  The number and amount of the awards made under this
program will depend upon the availability of funds;
cost-effectiveness of activities will be one of the factors
considered in making funding decisions.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome
and prospective applicants are strongly encouraged to discuss their
proposals with program staff prior to submission.
 
Inquiries regarding programmatic issues to:
 
Dr. Joel Breman
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-2056
Email:  jbreman@nih.gov
 
Inquiries regarding fiscal matters to:
 
Ms. Silvia Mandes
Division of International Training and Research
Fogarty International Center
National Institutes of Health
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  mandess@ficod.fic.nih.gov
 
AUTHORITY AND REGULATIONS
 
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 to Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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