Full Text TW-98-002
 
AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM
 
NIH GUIDE, Volume 26, Number 31, September 19, 1997
 
RFA:   TW-98-002
 
P.T.


Keywords: 

 
Fogarty International Center
 
Letter of Intent Receipt Date: October 15, 1997
Application Receipt Date:  February 18, 1998
 
PURPOSE
 
The Fogarty International Center (FIC), National Institutes of Health
(NIH), invites applications from non-profit private or public U.S.
institutions with interest in working with foreign colleagues to
build global HIV/AIDS research capacity and thereby help to prevent
HIV transmission through development of HIV/AIDS international
training and research programs for foreign health scientists,
clinicians, and allied health workers in collaboration with U.S
scientists in developing countries, including emerging democracies in
Eastern Europe and Latin America.  This announcement is for the third
five-year funding cycle for the AIDS International Training and
Research Program (AITRP).  Both new and competing renewal
applications for this D43 program are welcome.
 
Prevention, through biomedical or behavioral approaches, is critical
to stop the global spread of HIV/AIDS.  International collaboration
can greatly enhance HIV/AIDS prevention efforts, but to be fully
effective, prevention research in other countries must involve
scientists and health professionals from these countries who are
familiar with the unique local and cultural factors contributing to
the epidemic in their countries, and should also be fully endorsed by
their governments.
 
A major goal of this program is to train developing country
scientists to address more effectively the AIDS epidemic through
research.  This training program will help to:  (1) establish
critical biomedical and behavioral science expertise in developing
countries affected by HIV/AIDS; (2) facilitate new prevention
research efforts which supplement or complement NIH and other U.S.
AIDS research; (3) establish long-term cooperative relationships
between U.S. and foreign research groups; and (4) support cooperation
between U.S. academic research centers and foreign scientists.
Collaborations supported through this effort will help to facilitate
the conduct of scientifically valid and ethically sound HIV/AIDS
prevention, technology testing and research.
 
Funds will be awarded to provide training in the various scientific
disciplines required to conduct HIV/AIDS research in accordance with
the stated objectives for the program.  Applicants are strongly
encouraged to relate training to ongoing prevention research efforts
in developing countries supported by NIH and other organizations.
 
In October, 1996, the FIC convened a panel of scientists to conduct a
comprehensive review of the AITRP program.  The present announcement
reflects most of the recommendations of the panel as described in
their report.  In addition, the recommendations from the NIH AIDS
Research Program Evaluation Task Force, contained in the "Levine"
Report, contributed to this Request for Applications (RFA).  For
example, the need to develop a coordinated and comprehensive
Prevention Science Agenda that includes and combines biomedical,
behavioral, and social interventions was underscored.  Applicants are
encouraged to request copies of both of these documents from the FIC.
This RFA also reflects guidance of other NIH components, including
the Office of AIDS Research (OAR), the National Institute of Allergy
and Infectious Diseases (NIAID), the National Institute of Child
Health and Human Development (NICHD), the National Cancer Institute
(NCI), the National Institute of Dental Research (NIDR), the National
Institute on Drug Abuse (NIDA), and the National Institute of Mental
Health (NIMH).  The FY 1999 NIH Plan for HIV-Related Research,
available from the FIC, describes the range of prevention research
encompassed within the "Levine" report and emphasizes the importance
of international cooperation and multidisciplinary prevention
research to combat the global spread of HIV/AIDS.
 
The FIC AITRP program review noted that the program has become an
important component of global research on AIDS and related diseases
and that, by integrating research and research training, and by its
inherent flexibility, the AITRP is adding significant value to the
human resource capability for research and disease prevention in
developing countries. This RFA refocuses AITRP from an emphasis on
epidemiology to prevention research involving multiple disciplines,
which will require a broader research perspective.  Accordingly, the
overall focus of prevention research training in the new FIC AITRP
should be multidisciplinary.
 
Based upon the review of the AIDS International Training and Research
Programs (AITRP), the FIC has adopted the following mission and goal
statement for the next funding cycle of the AITRP.
 
"The mission of the AITRP is to train international health
professionals in research on prevention of HIV infection."
 
The interpretation of this mission statement, in the context of the
overall AITRP review, is broad, encompassing not only prevention of
HIV transmission and infection, but also prevention of progression of
HIV infection to AIDS, which may reduce the likelihood of HIV
transmission by infected individuals.  AITRP, by strengthening
research and public health capacity in developing countries, will
help to: o  prevent HIV-uninfected persons from becoming HIV-
infected; o  prevent HIV-infected persons from transmitting HIV to
uninfected persons (including prevention of mother-to-child
transmission); and o  prevent HIV disease progression in infected
individuals which, as noted above, may also help to further reduce
the spread of HIV.
 
Five specific goals are to:
 
o  Encourage development of genuine collaboration and equal
partnerships between investigators in different countries;
o  Assist developing countries achieve independent capacity to
conduct their own research and training;
o  Encourage independent local research on HIV prevention;
o  Assist NIH institutes to conduct their research missions related
to HIV; and
o  Stimulate multidisciplinary cooperation.
Applicants are strongly encouraged to propose multidisciplinary
training in one or more areas in each of the two broad fields of
biomedical and behavioral research, in addition to a core component
of data management and analysis.  Biomedical research areas may
include basic science, clinical science, epidemiology (as a subset of
prevention research), behavioral change, and vaccine research.
Behavioral research areas may include the social sciences, behavioral
change, economics, policy issues, etc.  Data management and analysis
includes protocol development, biostatistics, data collection
procedures, and quality control.
The research focus of the AITRP will remain HIV/AIDS.  This includes
specific HIV-related co-factors, namely opportunistic infections,
STDs, TB, and HIV-associated reproductive health issues but only
insofar as they specifically relate to HIV/AIDS.
 
This program will continue to emphasize support for trainees from,
and training activities in, the developing countries of Africa, Latin
America and the Caribbean, Asia and the Pacific region.  The program
will also accommodate trainees from, and training activities in,
countries of Central and Eastern Europe and the former Soviet Union.
However, AITRP is not expected to necessarily be active in all
countries with significant HIV incidence or prevalence.  Rather, the
demonstrated capacity and/or potential to achieve sustained research
and training efforts within a country will be the priority.  In this
regard, research capacity is built in large part by participation in
research and thus AITRP programs are strongly encouraged to link
training with NIH-supported and other research programs in common
countries in such a manner that training and research mutually
reinforce each other.  The emphasis in AITRP will be depth, not
breadth; that is, programs which focus on a relatively few sites or
countries would have a greater impact than those which dilute their
resources across many countries.
 
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, "AIDS International Training and Research Program
(AITRP)," is related to the priority of HIV infections.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 Summary Report: Stock No. 017-001-0473-1)
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., nonprofit private or public
institution capable of meeting the objectives in this RFA.
 
The previous FIC epidemiology (D43) and postdoctoral (T22) training
programs related to AIDS have now been combined into this new D43
program with an emphasis on prevention.  However, only one D43
application will be allowed under this program from each U.S.
institution.  Thus, existing postdoctoral programs are not eligible
to apply as free-standing postdoctoral programs, but will be provided
two-year phaseout funding.  Postdoctoral training, however, can be
included as part of the new AITRP.
 
The three newly awarded epidemiology (D43) programs initiated during
the second funding cycle (1993) can apply for this competition, but
have the option of a two-year administrative extension in which case
they can reapply during a recompetition planned two-years later for
another five-year funding cycle.  Any programs which opt for this
two-year extension must provide a revised workplan indicating how
they are refocusing their program to achieve the multidisciplinary
prevention research goals of this RFA.  This revised workplan should
be submitted in lieu of a letter of intent by October 15, 1997.
These modifications are being made to establish a staggered AITRP
funding cycle in order to achieve greater flexibility as recommended
in the AITRP program review.
 
MECHANISM OF SUPPORT
 
Grants will be made as D43 awards for a total project period of five
years.  Continued support during this period depends on satisfactory
performance as judged by annual progress reports; site visits and
meetings of program directors; indicators such as career progress of
trainees (e.g., positions occupied, first author publications,
presentations, research undertaken and research awards received); and
impact on developing national capacity for research and prevention.
 
FUNDS AVAILABLE
 
Approximately $6,500,000 (total costs) will be allocated to this
program in FY 1998, availability of funds permitting, resulting in an
estimated twelve awards, depending upon the quality of approved
applications.  The development of new programs is a time consuming
process.  As a result, while the total (direct and indirect) cost per
grant for the first year must not exceed $600,000 (base award) for
continuing programs, new programs must not exceed $400,000 for base
awards.  Up to $200,000 additional (total funds) may be requested
only by continuing programs for expanded activities in one or more
special areas as described below. An additional $100,000 may be
requested by both continuing and new programs for collaborative
activities with non-AITRP funded U.S. or foreign (developed country)
institutions, for collaboration with other AITRP programs for in-
country activities in common countries, and for training new and
minority U.S health science students.  It is recognized that these
limitations in budget requests could result in a substantial
reduction in funding for some continuing programs, particularly since
the highest priority for funding will be to award the most
meritorious proposals up to the justified level of base budget
requests before making awards for expanded activities in special
areas as described below under award criteria.
RESEARCH OBJECTIVES
 
Applicants are strongly encouraged to include both biomedical and
behavioral sciences prevention research, as well as training in data
management and analysis.
 
This program is intended to complement ongoing AIDS research efforts
of the NIH and, to the extent possible, of other government, non-
government and international organizations.  The underpinning of any
research training program is one that has ongoing research activity.
A strong research infrastructure results in a good training
experience and programs are thus encouraged to develop  human
resources in those developing countries that currently are or are
likely to be sites of HIV/AIDS-related research field trials of HIV
vaccines, anti-HIV drugs, and other interventions, including but not
limited to those supported by the NIH.
 
Specifically, the program is designed to:
 
o  Increase expertise of scientists in developing countries on AIDS-
related biomedical and behavioral prevention research primarily
through long-term training at U.S. institutions which may lead to
M.S. and/or Ph.D. degrees as well as targeted short-term training at
U.S. institutions in any relevant research field, with the goal to
increase HIV/AIDS prevention research capacity in collaborating
countries;
 
o  Increase research collaboration and capacities in foreign
countries that are engaged in HIV/AIDS-related prevention research
through targeted in-country, short-term, didactic and technical
training; and
 
o  Expand ongoing collaborative training in HIV/AIDS prevention
research between U.S. and foreign scientists.
 
Training Plan
 
Emphasis should be given to U.S.-based, long-term (usually a minimum
of two years) training either leading to an advanced degree or to
provide postdoctoral training.  Long-term training could include
degrees in any relevant HIV prevention research field.
 
The new AITRP places an even greater emphasis on U.S.-based long-term
training than in the past.  Short-term courses or workshops that are
only for the purpose of general orientation to HIV/AIDS and
networking are strongly discouraged and will receive much lower
priority for funding.  The RFA will allow short-term training
targeted toward specific needs such as learning laboratory techniques
required to conduct a research study or designing behavioral
interventions and initial activities to establish relationships in
countries where none currently exist.
 
Types of Training
 
1.  Training in biomedical and behavioral HIV/AIDS-related prevention
research disciplines as well as data management and analysis in
support of that research which may lead to an M.S. or Ph.D. degree
for individuals with previous field research experience.  The
duration of training is estimated to range from about two to four
years.  Academic courses will be taken in the U.S.  Field studies and
research could be conducted in the U.S., but to the extent possible,
is encouraged to take place in the trainees' home country.  Active
involvement in on-going research projects is vital for a successful
research training experience.  Innovative ways to involve trainees in
research projects conducted in their home countries is especially
encouraged.
 
2.  Training in biomedical and behavioral HIV/AIDS-related prevention
research disciplines which may lead to an M.S. degree for individuals
without prior field research experience.  Academic courses will be
taken in the U.S.; field studies would ordinarily be conducted in the
trainees' home country. The duration of training is estimated to be
about two years.
 
3.  Postdoctoral research experiences (generally of two years
duration) for foreign health scientists (in the U.S.) and for U.S.
health scientists overseas.
 
4.  Training (about three to six months duration) conducted in the
U.S. in laboratory procedures and research techniques in support of
specific HIV/AIDS prevention research (for example, development of
pilot biomedical and behavioral studies); for individuals with M.S.
and Ph.D. degrees.
 
5.  In-country, practical and applied short-term training (up to
three weeks) targeted to specific needs in support of HIV/AIDS
prevention research for professionals, technicians and allied health
professionals, including training necessary to support local
participation in institutional review boards, data and safety
monitoring boards and community advisory boards necessary to support
future clinical trials of interventions.
 
6.  Advanced research training (generally of one to two years
duration) for current and/or former trainees, including re-entry
grants to enable them to continue this advanced training in their
home country and to participate in in-country prevention research
projects such as interventions to prevent the further spread of
HIV/AIDS.
 
7.  Support to enable U.S. faculty to be involved in advanced
research training activities conducted in-country.
 
8.  Support to enable new and minority U.S. health science students
(including medical students and residents) to receive overseas health
research experiences (generally of three to twelve months duration)
in collaboration with foreign trainees upon return to their home
countries.
 
Trainees
 
Trainees shall be individuals who are involved in or are expected to
be involved in HIV/AIDS prevention research activities in their home
country.  The following categories of individuals are eligible for
training:
 
1.  Foreign health professionals (M.D., D.D.S./D.M.D., Ph.D., or
equivalent);
 
2.  Foreign professionals with a bachelors or masters degree in a
basic or health science;
 
3.  Medical technicians and health care workers;
 
4.  Allied health professionals such as behavioral scientists, nurses
and social workers;
 
5.  Current or former AITRP trainees involved in advanced research
training in their home countries; and
 
6.  U.S. health science students, medical residents and postdoctoral
researchers.
 
SPECIAL REQUIREMENTS
 
The primary effort of the program should be directed toward research
and research capacity building in developing countries and selected
other countries that have, or are likely to have, population groups
with a significant incidence of HIV/AIDS.  Countries in Central and
Eastern Europe and the former Soviet Union are eligible to
participate, as are countries in Africa, the Americas, Asia and the
Pacific Region.
 
It is not expected that the AITRP necessarily be active in all
countries with significant HIV incidence or prevalence.  Any
expansion to additional countries will be predicated on scientific
opportunities and the likelihood of sustained success and any
additional funding will be provided on a competitive peer review
basis.
 
Any extension of AITRP efforts from an established country program to
neighboring countries must be carefully planned.  Though exceptional
efforts to establish formal regional networks among programs is
discouraged, regional cooperation and collaboration is encouraged.
 
Trainees from developed countries may be allowed into the program
only under special, well-justified circumstances and with prior
approval by the FIC as a reprogramming request to meet special
training needs.
 
Potential applicants are strongly encouraged to form consortia where
appropriate to provide a full complement of training opportunities of
the best possible scientific quality across the prevention research
disciplines:  biomedical and clinical research, behavioral and social
sciences research and data management and analysis.
 
Training and research activities will relate to HIV/AIDS prevention
and other interventions, opportunistic infections and other diseases
strongly associated with AIDS (e.g., STDs and tuberculosis).
 
Applicants are required to include training in responsible conduct of
research as a part of the program.  An award will not be made unless
a description of such training is included.
 
Before any funds can be expended from this award, the grantee
institution must show evidence of approval for collaborative research
between the U.S. and foreign countries and institutions included in
the program through an endorsement from the Minister of Health or
other appropriate government officials as well as from the
collaborating institutions.  In this regard, existing programs are
expected to update their prior agreements.
 
The applicant institution must include a plan describing the
recruitment and selection procedures for trainees, for the peer
review of training-related and advanced in-country research (re-entry
grants) as well as plans for continued collaboration with former
trainees.  The AITRP grant applications should clarify and completely
specify:  (a) criteria and procedures for the selection of trainees
as, for example, by a committee composed of U.S. and foreign
investigators at participating institution(s) in the program; and (b)
a mechanism for internal peer review of applications to support
relevant in-country research projects with budgets generally not
exceeding $25,000. Projects exceeding this limit require preapproval
from the FIC.
The criteria and mechanisms for review and selection of trainees and
research projects will be reviewed at the NIH at the time the grant
applications are reviewed competitively. After funding, these
criteria and mechanisms must be instituted as described and no
further outside review carried out at the FIC or elsewhere at the NIH
will be required during the funding period of the grant, except for
the usual and customary duties of project management at the NIH.
 
As part of their obligations under this program, awardees are
required to design and implement a system to fully track and document
the long-term impact of this training program on:  (1) the careers of
current and former AITRP trainees; (2) research capacity in the home
countries of trainees; and (3) the contributions to future NIH-
supported international HIV/AIDS research efforts.  Examples of such
impact include how training received under the program allowed
participants to assume more responsible positions upon returning
home, how continuing collaborations with former trainees resulted in
the funding of collaborative research projects for which trainees
were either principal or co-principal investigators, and publications
in which trainees were first authors and which were based upon
support under this program. This tracking system, to follow trainees
at least ten years after completion of their training, should be
described in the application.
 
It is imperative that coordination and collaboration should occur
between the participating AITRP programs and institutions, especially
when operating within the same country (e.g., Brazil, Thailand,
etc.).
The organization and coordination of activities among sites will be
facilitated by the FIC.  Joint meetings should be held during
international and regional meetings.  Programs are strongly
encouraged to include plans for coordination and if possible,
collaboration with other AITRP and non-AITRP programs when working in
common countries and/or regions.
 
FIC will also facilitate coordination and collaboration with other
government agencies [e.g., the Centers for Disease Control and
Prevention (CDC), the United States Agency for International
Development (USAID)] and with bilateral and multilateral
international organizations, including collaborations with in-country
projects funded by NIAID, NICHD, NCI, NIDR, NIDA and NIMH.  Inclusion
of the latter two is particularly important given the recommended
increased emphasis on multidisciplinary biomedical and behavioral
research.  Collaboration and coordination is strongly encouraged with
international organizations and NGOs [e.g. United Nations Programme
on AIDS (UNAIDS), the Pan American Health Organization (PAHO), the
Rockefeller INCLEN program, the International Union Against
Tuberculosis and Lung Disease (IUATLD), and the International Union
Against Venereal Diseases and Treponematoses].
 
Within allowable limits, research collaborations can include other
industrialized nations in addition to the U.S. when the purpose of
that collaboration is to facilitate and/or support activities in a
common developing country.  Support for travel and subsistence of
U.S. or foreign investigator(s), and the exchange of data, materials
and supplies will be allowed for this purpose, 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 some form of cost-sharing by the
counterpart institution in an industrialized nation.Communication
 
FIC AITRP programs should endeavor to ensure that research results
are accessible and to facilitate translation of results into practice
by: (a) exchanging newsletters among grantees; (b) sponsoring in-
country meetings for all trainees in a country; and (c) establishing
a World Wide Web site for dissemination of new information and for
less formal exchange of information among sites.  In addition,
grantees are required to: (a) provide for in-country dissemination of
research results; and (b) develop mechanisms to facilitate access of
their foreign collaborators to current published literature.  The
AITRP grant applications should include specific plans for in-country
dissemination of research results for local prevention of HIV
infection, and these efforts should be part of regular progress
reports.  Up to 10 percent of budgets can be utilized for these
purposes and additional funds can be requested to support this
activity.  FIC will establish an AITRP web site linking all of the
individual program web sites and will circulate individual
newsletters among all programs.
 
Protection of Human Subjects and Laboratory Animals
 
Recognizing that in many cases the required assurances will be in
place as a result of previous funding by HHS components, 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.  The requirements
for using animals are detailed in the Public Health Service Policy on
Humane Care and Use of Laboratory Animals.  These are available from
the Office for Protection from Research Risks (OPRR), National
Institutes of Health, 6100 Executive Boulevard, MSC 7508, Rockville,
Maryland 20852-7508.  In this regard, applicants must be sure to meet
the requirements of obtaining single project assurances from OPRR for
all projects involving human subjects at foreign sites unless
otherwise covered by a multiple project assurance.  Applicants must
also be sure to obtain the necessary assurances including review at
both U.S. and foreign sites for research in which they are actively
engaged by virtue of consultancy (for example, resulting in co-
authorship) or for research conducted on biological samples obtained
from scientific colleagues in collaborating countries, if the samples
are individually identifiable to any of the scientists.
 
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 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," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and in the
NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18,
1994.
 
In this regard, the frame of reference for inclusion of minorities in
research is whether the participants would be considered to be
minorities in the U.S. population and most of the foreign
populations
under study would be considered minorities in the U.S.  On a related
matter, programs are encouraged to include representation of women in
selecting foreign trainees and to include adequate representation of
women and minorities in selecting U.S. trainees under this program.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by October 15, 1997, a
letter of intent that includes a descriptive title of the proposed
training and research programs, the name, address, and telephone
number of the Principal Investigator, the identities of other key
personnel and participating institutions in collaborating countries,
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.
 
The letter of intent should be sent to:
 
Kenneth Bridbord, M.D.
Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
31 CENTER DR MSC 2220
BETHESDA, MD  20892-2220
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
Email:  bridbord@nih.gov
 
The letter of intent also will be used to communicate any
additional information that may be developed  to prospective
applicants, including the location and time of any meetings that may
be convened to answer questions from prospective applicants.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 435-0714, 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, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
and five copies of any appendices must be sent to:
 
Hortencia Hornbeak, Ph.D.
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Solar Building, Room 4C19-MSC 7610
6003 Executive Blvd.
Rockville, MD  20852-7610
Telephone:  (301) 496-2550
FAX:  (301) 402-2638
Email:  hh7g@nih.gov
 
Applications must be received (not postmarked) by February 18, 1998.
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 the
DRG and responsiveness by the FIC.  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 be
discussed, assigned a priority score and receive a written critique
as well as receive a second level review by the FIC Advisory Board.
 
Timetable
 
Letter of Intent Receipt Date:     October 15, 1997
Application Receipt Date:          February 18, 1998
Review for Scientific Merit:       June 1998
Review by the FIC Advisory Board:  September 1998
Anticipated Award (Start) Date:    September 30, 1998
 
Review Criteria
 
The following criteria apply to new applicant institutions as well as
those seeking a competing renewal.  Factors to be considered in the
scientific evaluation of each application include:
 
In general, the success of the programs to date (for competing
renewals) and/or the likelihood that the applicant institution can
meet the goals and objectives stated in this RFA and specifically
considering the following:
 
(1) Significance
 
o  The expected public health and scientific contributions of the
proposed activity;
 
o  The demonstrated capacity and/or potential to achieve sustained
research and training efforts within a country;
 
o  Strength of the academic program; and
 
o  Previous success in training AIDS-related scientists and in
maintaining collaboration with former trainees including assisting
former trainees in obtaining support for their research upon return
to their home countries.
 
(2) Approach
 
o  Balance in the proposed training program to provide breadth of
training opportunities in the fields of 1) biomedical and clinical
prevention research; 2) social and behavioral research; and 3) data
management and analysis;
 
o  The appropriate mix of long- and short-term training to achieve
the goals of this RFA;
 
o  Opportunities for trainees to become involved in research projects
conducted in their home countries;
 
o  Adequacy of proposed procedures and criteria for 1) recruitment,
review and selection of trainees and 2) peer review of research
projects;
 
o  Demonstrated capacity and/or potential to collaborate with other
institutions and to coordinate program activities with related
efforts of other FIC and NIH programs, other federal agencies (e.g.,
CDC and USAID), international organizations (e.g., UNAIDS and PAHO),
and NGOs [e.g., the International Union Against Tuberculosis and Lung
Disease (IUATLD), the International Union Against Venereal Diseases
and Treponematoses and the Rockefeller INCLEN program];
 
o  Demonstrated capacity and/or potential to provide overseas
research experience for U.S. health science students and medical
residents, including new and minority U.S. health scientists from
AITRP and non-AITRP institutions, such as HBCUs, as well as plans to
include an adequate representation of women among foreign and U.S
trainees; and
 
o  Systems for documenting the long-term impact of the program on
research capacity in the home countries of trainees including the
impact of the program on the careers of current and former AITRP
trainees.
 
(3) Innovation
 
o  Overall creativity and cost-effectiveness of the training and
research plan;
 
o  Plans for trainees to become involved in research projects
conducted in their home countries; and
 
o  Adequacy and creativity of plans to use modern information
technology to facilitate access to scientific information, distance
learning, as well as coordination and research collaboration.
 
(4) Investigator(s)
 
o  Qualifications of the program director to lead and the named
faculty to participate in the proposed training and research program;
 
o  Documentation of previous international collaboration with
developing country scientists and institutions included in the
proposed program;
 
o  Depth of the program director's and faculty's experience in the
fields of 1) prevention; 2) biomedical, social and behavioral
research; and 3) data management and analysis;
 
o  Active research support of program director and participating
faculty; and
 
o  Career accomplishments of former trainees including extent of
former trainees' involvement in the proposed program.
 
(5) Environment
 
o  Demonstration of continued or of future support for the program
from governments and institutions and other non-governmental
organizations from collaborating countries;
 
o  Demonstrated support for domestic and international AIDS-related
research and training as evidenced by support from the NIH or other
sources.  Examples include research support by NIAID, NICHD, NCI,
NIDR, NIDA and NIMH;
 
o  The strength of resources and training environment in-country as
evidenced by 1) the quality of teaching and research facilities and
other resources in-country; 2) the availability of high-quality
candidates; and 3) past history of success in former trainees
returning to their home countries and their continued involvement in
the program, for example, in advanced in-country research and/or as
faculty and mentors for new trainees; and
 
o  Training environment in the U.S. including the institutional
commitment, the caliber of preceptors, the quality of teaching and
research facilities and resources.
 
The initial review group will also examine the adequacy of the
process for providing for the protection of human and animal subjects
and the safety of the research environment, as well as plans to
include training in responsible conduct of research and training in
the operations of IRBs, data and safety monitoring boards and
community advisory boards as a part of the program.  In this regard,
IRBs in the home countries of trainees will be responsible for
determining the adequacy of inclusion of women and minorities in
research involving human subjects in their countries.
 
Allowable Costs
 
U.S. investigators may request funds (including re-entry grants) to
support research projects in the trainees' home country that emanate
from the M.S. and Ph.D. training program.  The research supported (1)
must be one of the requirements in fulfillment of an M.S. or Ph.D.
degree or part of advanced research training; (2) be relevant to an
AIDS problem in the trainee's country; and (3) may form the basis for
a long-term collaboration funded by future research grant support.
 
The following cost categories are allowable for reimbursement under
this program.  It should be noted that the following stipends and
allowances are maximums and applicant institutions are encouraged to
design the most cost-effective programs, generally at lesser amounts:
 
Stipend and Salary
 
o  Living allowance (stipend) comparable to trainee's professional
level, but not to exceed $45,000 per annum while undergoing training
in the U.S.;
 
o  Living allowance (stipend) while conducting in-country
dissertation research or in-country advanced research training (re-
entry grants) at a level comparable to that received by similar
professionals in-country, but also not to exceed $45,000 per annum;
 
o  Stipend support (not to exceed $45,000 per year) for foreign and
U.S. postdoctoral researchers;
 
o  Support (pro-rated salary, up to 25 percent of annual salary or
$25,000, whichever is less), to enable U.S. faculty to be involved in
advanced research training activities conducted in-country;
 
o  Program director's salary (up to 25 percent of annual salary or
$25,000, whichever is smaller); and
 
o  Salary for clerical and administrative support staff (up to 2.0
FTE, but not more than 10 percent of direct costs).
 
Tuition
 
o  Tuition, not to exceed 20 percent of total direct costs.
Exceptions to this policy require prior approval from the FIC.
 
Travel
 
o  Round trip economy class air fare between the U.S. and home
country (two trips for M.S./Ph.D. candidates and advanced research
trainees, one for all others);
 
o  Travel and per diem for the program director and faculty
colleagues to provide guidance to students conducting dissertation-
related field studies and/or advanced research training in their home
countries; and
 
o  Travel and per diem for faculty presenting short-term, in-country
courses.
 
Training Related Expenses
 
o  Allowance for the grantee institution of up to $600 monthly per
student to cover health insurance, scientific meetings, and
incidental research expenses;
 
o  Support of up to $15,000 for in-country field research in partial
fulfillment of the M.S./Ph.D training program; and
 
o  Research support of up to $25,000 per trainee to facilitate the
conduct of advanced research training (re-entry grants) in the home
country conducted by current and/or former trainees; the program
director is expected to have projects submitted for this funding peer
reviewed by the U.S. institution in accordance with plans outlined in
the grant application.
 
Other
 
o  Up to 10 percent of allowable direct costs may be used to cover
collaboration with other developed countries when the object of that
collaboration involves work in a common developing country;
 
o  Up to 10 percent of allowable direct costs may be used to
establish or enhance an international component within an existing
CFAR or P30 program, with the goal to support developmental research
by foreign collaborators which would lead to newly funded research
awards;
 
o  Up to 10 percent of allowable direct costs may be utilized to
support coordination and communications activities, including
attendance at meetings for this purpose;
 
o  Up to $200,000 additional (total funds) may be requested for
expanded activities in special areas as outlined below (competing
renewals only); and
 
o  Up to $100,000 additional (total funds) may be requested (by both
competing renewals and new programs), to support initiatives for
collaboration with other non-AITRP institutions or collaboration with
AITRP institutions for work in common countries, for
telecommunications distance learning including expanded access to the
internet, and to support training for new and minority U.S. health
science students.
 
o  In keeping with the intent to maintain a flexible program,
requests for administrative supplemental budget increases of up to 20
percent of funded levels in a given budget year for the expansion of
prior approved activities will be allowed to meet special needs and
take advantage of unusual opportunities.  Such requests, which will
be reviewed by program staff, also may be subjected to external peer
review and support will depend upon availability of funds.  In
addition, in response to compelling needs and/or research
opportunities, programs may be requested to take on additional
responsibilities within the general scope of the award, on mutually
agreeable terms and conditions.
Expanded Activities
 
As noted above, if additional funds are available, competing renewals
may request up to $200,000 for expanded activities in special areas
which must be linked to one or more existing NIH-funded research
efforts in those areas.  Examples include special training, training-
related research and overall capacity building efforts to support
HIV/AIDS vaccine trials including training to increase laboratory
capacity in-country; prevention of mother-to-child HIV transmission;
behavioral interventions to prevent HIV transmission; as well as
research and training/capacity building related to HIV and
opportunistic infections in general; TB; STDs; microbicides;
nutritional interventions; drug abuse; risk factors, pathogenesis,
prevention and management of oral HIV-related diseases; and clinical
trials methodologies.  Apart from the $200,000 for expanded
activities, another $100,000 per year can be requested (by both
competing renewals and new programs), raising the total allowable
request to $900,000 for competing renewals and $500,000 for new
programs for the purpose of including another U.S. institution as a
collaborating partner if that institution was not otherwise an
applicant or participant in the AITRP program, or to collaborate with
another AITRP institution for work in a common country, for
telecommunications/distance learning and to support training for new
and minority U.S. health science students.
 
The $200,000 category for expanded activities must link efforts to
specifically identified and currently active (18 months at time of
application) research grants and/or contracts supported by other
ICDs, e.g., NIAID, NICHD, NCI, NIDR, NIDA, and NIMH.
 
Grantee institutions 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.  The total allowable
cost (direct and indirect) per grant for the first year of this five
year award must not exceed $600,000 (base funds) for continuing
programs and $400,000 for new starts.  Applicants should assume a
budget increase of 2 percent per year for each succeeding year.
While applicants may develop programs at or close to these limits,
they are strongly encouraged to pursue the most cost-effective
approaches for implementing these programs.  The intent is to award
an estimated twelve grants, depending upon the quality of the
approved grant applications and the availability of funds.
 
As noted above, before any funds can be expended from this award, the
grantee institution must show evidence of approval for collaborative
research between the U.S. and foreign countries and institutions
included in the program through an endorsement from the Minister of
Health or other appropriate government official as well as from the
collaborating institutions.
The anticipated date of award is on or before September 30, 1998.
 
AWARD CRITERIA
 
The following will be considered in making funding decisions:
 
o  quality of the proposed project as determined by peer review;
 
o  the extent and effectiveness of efforts made by applicants in
developing multidisciplinary biomedical and behavioral research
training programs necessary to support prevention research efforts in
the home countries of trainees;
 
o  cost-effectiveness of programs;
 
o  efforts made to collaborate with other AITRP programs and
institutions and with other organizations;
 
o  the extent to which proposed training programs support and
complement other NIH-funded international HIV research efforts;
 
o  availability of funds (with the first priority given to funding
the most meritorious programs to the level requested in their base
budgets, not including the special requests);
 
o  program balance among critical research training areas of emphasis
such as, but not limited to, preparation for future prevention
research efforts including trials of HIV vaccines, anti-HIV drugs,
and other interventions (e.g., microbicides, behavioral
interventions, nutritional supplementation); and
 
o  geographic distribution among countries included in applications
under consideration, including the need for a given program to work
in a specific country (such as linkage with another NIH-supported
research project in that country).
 
INQUIRIES
 
Prospective applicants are strongly encouraged to discuss their
applications, including proposed collaborating countries and
institutions with FIC program staff (see below) before submitting
formal applications.
 
All programmatic and scientific inquiries, including any requests for
further instructions to prepare applications, should be directed to:
 
Kenneth Bridbord, M.D.
Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
31CENTER DR MSC 2220
BETHESDA, MD  20892-2220
Phone:  (301) 496-2516
FAX:  (301) 402-2056
Email:  bridbord@nih.gov
 
Inquiries related to the review of these applications may be directed
to:
 
Hortensia Hornbeak, Ph.D.
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Solar Building, Room 4C19-MSC 7610
6003 Executive Blvd.
Rockville, MD  20852-7610
Telephone:  (301) 496-2550
FAX:  (301) 402-2638
Email:  hh7g@nih.gov
 
Inquiries regarding fiscal matters may be addressed to:
 
Mrs. Silvia Mandes
Grants Management Officer
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Dr MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
E-mail:  mandess@ficod.fic.nih.gov
 
AUTHORITY AND REGULATIONS
Awards are made under authorization of the Public Health Service Act,
Title III and Title IV, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241, 242l and 287b) 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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