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NIH Guide: INTERNATIONAL TRAINING GRANTS IN EPIDEMIOLOGY RELATED TO THE ACQUIRED IMMUNODEFICIENCY SYNDROME

Full Text TW-92-02
 
INTERNATIONAL TRAINING GRANTS IN EPIDEMIOLOGY RELATED TO THE ACQUIRED
IMMUNODEFICIENCY SYNDROME
 
NIH GUIDE, Volume 21, Number 20, May 29, 1992
 
RFA:  TW-92-02
 
P.T. 44

Keywords: 
  Biomedical Research Training 
  AIDS 
  Epidemiology 

 
Fogarty International Center
 
Letter of Intent Receipt Date:  July 1, 1992
Application Receipt Date:  September 10, 1992
 
PURPOSE
 
The Fogarty International Center (FIC), National Institutes of Health
(NIH), invites applications to develop international training programs
in epidemiology related to Acquired Immunodeficiency Syndrome (AIDS)
for foreign health scientists, clinicians, and allied health workers.
This announcement is for the second five-year funding cycle for this
program.  Both new and competing renewal applications for this program
are welcome.
 
In the original announcement for this program in 1988, it was
recognized that the role of epidemiological studies, particularly when
combined with related basic, clinical, and social science disciplines
such as virology, immunology, medicine, nursing, anthropology, and
behavioral sciences, had been critical in understanding the natural
history of AIDS, major modes of Human Immunodeficiency Virus (HIV)
transmission, and risk factors for HIV infection.  Studies in other
countries have provided important information that complements NIH
programs in such areas as characterizing the infectious agent,
understanding heterosexual transmission, and documenting the effects of
AIDS upon women and children.
 
International collaboration can greatly enhance HIV/AIDS research
efforts, but to be effective, research in other countries must be
conducted by scientists and health professionals from these countries
and endorsed by their governments.
 
A major goal of the International Training Grants in Epidemiology
Related to AIDS Program is to train scientists of other countries to
deal effectively with the AIDS epidemic through epidemiologic research,
clinical trials, and AIDS prevention research programs.  This training
program will help to (1) establish the necessary research and medical
expertise needed in countries affected by HIV/AIDS and facilitate new
research efforts that supplement or complement U.S. AIDS research and
(2) establish cooperative relationships between U.S. and foreign
research groups and support cooperation between U.S. academic research
centers and foreign scientists.  Collaborations established through
this effort will help to facilitate standardized screening and
monitoring of clinical trial subjects and prepare for the coordinated
conduct of scientifically valid and ethically sound clinical trials on
an international basis.
 
Funds will be awarded to provide training in epidemiology and
AIDS-related basic science in accordance with the stated objectives for
individuals preparing for or involved in AIDS research and AIDS
prevention research programs.  Applicants are encouraged to relate
training to ongoing research efforts in developing countries.
 
In February 1992 the FIC completed a comprehensive review of the
overall program to date.  The basic rationale for the program as
originally designed was reaffirmed, and a number of useful
recommendations were made to further enhance this program, the most
relevant of which have been incorporated into this announcement.
 
The major changes for the second five-year funding cycle include a
shift in emphasis from short- to long-term training and greater
emphasis on advanced research training of former and future trainees
in-country under continued guidance of the program director and his/her
faculty colleagues.  Applicants are encouraged to develop training
programs that facilitate the conduct of future international vaccine
and drug trials in an ethical and equitable manner.  This program will
continue to emphasize 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.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2OOO,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), International Training Grants in Epidemiology
Related to AIDS, 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) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-0473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 783-3238.
 
ELIGIBILITY REQUIREMENTS
 
Eligible institutions must be a U.S., non-profit, private or public
institution capable of meeting the objectives described in this RFA.
Only one application will be allowed under this program from each U.S.
institution.
 
MECHANISM OF SUPPORT
 
Grants will be made as International Training Grants in Epidemiology
(D43) for a total project period of five years.  Continued support
depends on satisfactory performance as judged by annual progress
reports, during site visits, and meetings of program directors.
 
U.S. investigators may request funds to support research projects in
the trainees' home country that emanate from the M.S. and Ph.D.
epidemiological 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 eligible 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:
 
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 at a level comparable
to that received by similar professionals in- country, but also not to
exceed $45,000 per annum;
 
o  Tuition;
 
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  Allowance for the grantee institution of up to $600 monthly per
student to cover health insurance, scientific meetings, and incidental
research expenses;
 
o  Research support of up to $15,000 per trainee to facilitate the
conduct of advanced research training 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;
 
o  Support of up to $10,000 for in-country field research in partial
fulfillment of the M.S./Ph.D training program;
 
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;
 
o  Program director's salary (up to 25 percent of annual salary or
$25,000, whichever is smaller);
 
o  Travel and per diem for faculty presenting short-term, in-country
courses;
 
o  Support (travel, per diem, and 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; and
 
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 will be reviewed by
program staff, and support will depend upon availability of funds.
 
Grantee institutions may request an indirect cost allowance based on
eight 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 may not exceed $600,000 for continuing programs and $400,000
for new starts.  Applicants should assume a budget increase of four
percent per year for each succeeding year.  Although 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.
 
FUNDS AVAILABLE
 
Approximately $4,000,000 (total costs) will be allocated to this
program in FY 1993, availability of funds permitting, resulting in an
estimated ten awards, depending upon the quality of applications.  The
total (direct and indirect) cost per grant for the first year may not
exceed $600,000 for continuing applications and $400,000 for new
programs.
 
RESEARCH OBJECTIVES
 
The objectives of this program are to train scientists, particularly
from developing countries, to deal effectively with the AIDS epidemic
through epidemiologic research, clinical trials, and AIDS prevention
research.  The program is intended to support collaborative research
between U.S. and foreign scientists who wish to enhance their knowledge
and skills in the epidemiology, diagnosis, and treatment of HIV/AIDS
and to stimulate scientists from nations affected by AIDS to cooperate
and to share research knowledge in combating this global problem.
 
This program is intended to complement ongoing AIDS research efforts of
the NIH.  Emphasis will be given to the development of human resources
in those developing countries that are likely to be sites of
HIV/AIDS-related research and field trials of anti-HIV drugs, HIV
vaccines, and other interventions.
 
Specifically, the program is designed to:
 
o  Increase expertise in epidemiology and laboratory components of
AIDS-related epidemiologic research through short- and long-term
training at U.S. institutions that may lead to M.S. and/or Ph.D.
degrees in epidemiology;
 
o  Increase laboratory expertise of technical assistants who are
engaged in epidemiological studies related to HIV/AIDS in foreign
countries through in-country, short-term, didactic, and technical
training; and
 
o  Expand ongoing collaborative training and epidemiological research
in HIV/AIDS between U.S. and foreign scientists.
 
Training Plan:
 
Types of Training
 
1.  Training in epidemiological concepts and methods and
epidemiological field studies and research related to HIV/AIDS that 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 either the
trainees' home country or in the U.S.
 
2.  Training in epidemiological concepts and methods and
epidemiological field studies and research related to HIV/AIDS that 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 be conducted in the trainees' home country.  The duration of
training is estimated to be about two years.
 
3.  Short-term (up to three months) comprehensive courses in
epidemiology, with an emphasis on AIDS, conducted in the U.S.
 
4.  Training (about three to six months duration) in laboratory
procedures and research techniques for individuals with M.S. and Ph.D.
degrees conducted in the U.S.
 
5.  In-country, practical and applied short-term training (up to three
weeks) for professionals, technicians, and allied health professionals.
 
6.  Advanced research training for selected current and/or former
trainees to enable them to continue this advanced training in their
home country and to participate in in-country research projects, such
as clinical trials of anti-HIV drugs, HIV vaccines, and other
interventions, including social and behavioral research designed to
prevent the further spread of HIV/AIDS.  Although applicants can plan
to include such training (estimated to be about two years duration) as
part of competing applications and non-competing renewals, individual
appointments must be approved in advance as a reprogramming request and
must be under the guidance of the program director and his/her faculty
colleagues.
 
7.  Support to enable U.S. faculty to be involved in advanced research
training activities conducted in-country.
 
Trainees
 
Trainees shall be non-U.S. individuals who are involved in or are
expected to be involved in epidemiological research related to AIDS and
AIDS-prevention research activities in their home country.  The
following categories of individuals are eligible for training:
 
1.  Health professionals (M.D., Ph.D., or equivalent);
 
2.  Individuals with a bachelors or masters degree in a basic or health
science;
 
3.  Technicians and health care workers;
 
4.  Allied health professionals such as nurses and social workers; and
 
5.  Current or former trainees involved in advanced research training
in their home countries.
 
SPECIAL REQUIREMENTS
 
The primary effort of the program should be directed toward 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 Asia and the Pacific Region
from which the greatest number of future HIV infections and AIDS cases
are expected to occur.
 
The majority of candidates for training will be selected from those
developing countries where the program director and colleagues either
have well-established, in-country research efforts or a significant
potential to develop such collaborative relationships as, for example,
through a history of joint collaborations and/or publications.  This
does not preclude establishing collaborative arrangements in countries
or areas where HIV/AIDS has not yet developed epidemic proportions.
 
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.
 
The program's focus should be on HIV/AIDS, opportunistic infections,
and other diseases strongly associated with AIDS (e.g., sexually
transmitted diseases and tuberculosis).
 
Applicants are required to describe training in responsible conduct of
research to be part of the programs.  An award will not be made unless
such a description 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 official and from the collaborating
institutions.
 
The applicant institution must include a plan describing the
recruitment and selection procedures for trainees and plans for
continued collaboration with former trainees.
 
STUDY POPULATIONS
 
While the majority of support for training-related research may be
derived from sources other than in this award, prospective awardees are
expected to comply with NIH policy concerning study populations in the
conduct of training-related research.
 
Protection of Human Subjects
 
Although in most cases the primary support for training-related
research and associated assurances of protection for human subjects
will be covered through other funding mechanisms, the program directors
are responsible to assure that all training-related research supported
under this program meets applicable NIH requirements.
 
Applicant institutions are reminded that adequate protection for human
subjects in international collaborative research is an essential
requirement for the NIH.  Awardee institutions, each subordinate entity
to the awardee, and each performance site, whether institutions or
independent investigators, must agree that the rights and welfare of
human subjects involved in research under this award shall be protected
in accordance with 45 CFR 46.  As a condition of award, not as a
condition of application, applicants and affiliated performance sites
are required to designate an institutional review board and possess an
applicable assurance of compliance that has been approved by the Office
for Protection from Research Risks.  Applicants will be notified if
additional information is required on this matter.
 
Protection of Vertebrate Animals
 
Although in most cases the primary support for training-related
research and associated assurances of protection for vertebrate animals
will be covered through other funding mechanisms, the program directors
are responsible to assure that all training-related research supported
under this program meets applicable NIH requirements.
 
The applicant organization must either have on file with the Office for
Protection of Research Risks, NIH, an approved Animal Welfare Assurance
or the applicant organization must comply with PHS policy regarding the
care and use of animals by establishing an Institutional Animal Care
and Use Committee (IACUC) and submitting an Animal Welfare Assurance
and verification of IACUC approval when requested to do so by the
Office for Protection of Research Risks.
 
LETTER OF INTENT
 
Prospective applicants are requested to submit a letter of intent, by
July 1, 1992, that includes the number and title of this RFA, a brief
title of the training program, the names of the program director and
other key participating faculty, if known, and the identity of the U.S.
and foreign countries and institutions involved in the collaboration.
 
Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows FIC staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Dr. Sherry Dupere
Scientific Review Administrator
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
 
For overnight or courier service letters are to be sent to the same
address.
 
APPLICATION PROCEDURES
 
Special instructions are essential for completion of an application.
These instructions are available from Dr. Bridbord at the address
listed under INQUIRIES.
 
The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for this grant.  These forms are available at most U.S.
institutional business offices and from:
 
The Office of Grants Inquiries
Division of Research Grants
National Institutes of Health
5333 Westbard Avenue, Room 449
Bethesda MD  20892
Telephone:  (301) 496-7441
 
The RFA label available in the form PHS 398 must be affixed at the
bottom of the face page of the original signed application.  Failure to
use this label could result in delayed processing of the application
such that it may not reach the committee in time for review.
 
To ensure the identification of the application with this RFA, mark
"Yes" in item 2a of the face page of the application and type
International Training Grants in Epidemiology Related to AIDS TW-92-02.
 
Submit a signed, typewritten original application, including the
Checklist, and three signed, exact, single-sided photocopies, in one
single package to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
At the same time, to ensure that the application will be included in
this expedited review, two complete copies of the application must be
sent directly to:
 
Dr. Sherry Dupere
Scientific Review Administrator
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
 
If sending the application by overnight mail or courier service to Dr.
Sherry Dupere, send to the above address.
 
Applications must be received by September 10, 1992.  If an application
is received after that date, it will be returned to the applicant.  The
Division of Research Grants (DRG) will not accept any application in
response to this announcement that is essentially the same as one
currently pending initial review, unless the applicant withdraws the
pending application.  The DRG will not accept any application that is
essentially the same as one already reviewed.  This does not preclude
the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing
the previous critique.
 
REVIEW CONSIDERATIONS
 
The DRG will review applications for completeness.  Incomplete
applications will be returned to the applicant without further
consideration.  Applications will be reviewed by FIC staff to determine
responsiveness.  If the application is not responsive to the RFA, it
will be returned to the applicant without review.
 
Those applications that are complete and responsive may be subjected to
triage by an FIC peer review group to determine scientific merit
relative to the other applications received in response to this RFA.
The NIH reserves the right to withdraw from competition those
applications judged as non-competitive and will so notify the applicant
and institutional official.
 
Those applications judged to be competitive for award will be further
reviewed for scientific and technical merit by the review committee
convened by the FIC during November 1992.  The final level of review
will be provided by the Fogarty International Center Advisory Board in
February 1993, that will provide advice to the Director, FIC, who will
make the final funding decisions.
 
Timetable
 
Letter of Intent Receipt Date:     July 1, 1992
Application Receipt Date:          September 10, 1992
Review for Scientific Merit:       November 1992
Review by the FIC Advisory Board:  February 1993
Anticipated Award Date:            September 1993
 
The following criteria apply to new applicant institutions and those
seeking a competitive renewal.  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 strength of the academic program in epidemiology and the depth
of the faculty's experience in epidemiology and AIDS-related basic
science and clinical disciplines;
 
o  The quality of teaching and research facilities and resources
including those at institutions in other countries;
 
o  Previous success in training epidemiologists and in maintaining
collaboration with former trainees including assisting former trainees
in obtaining support for their research;
 
o  The likelihood, based on accomplishments of current and/or former
trainees, that individuals selected for the proposed training will
contribute meaningfully to science and health progress following return
to their home countries;
 
o  Demonstrated support for domestic and international AIDS
epidemiological and related research and training as evidenced by
support from the NIH or other sources.  Examples of such support
include participation in or collaboration with the National Institute
of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group
(ACTG), International Collaboration for AIDS Research (ICAR), AIDS
Vaccine Evaluation Units (AVEU), and Preparation for AIDS Vaccine
Evaluation (PAVE) programs, as well as support from or collaboration
with the National Cancer Institute;
 
o  Demonstrated capacity and/or potential to provide in-country
advanced research training, that involves support for the research and
appropriate guidance for selected, highly qualified current and/or
former trainees;
 
o  Demonstrated capacity and/or potential to help support in- country
clinical trials of anti-HIV drugs, HIV vaccines, and other
interventions;
 
o  Capacity to provide in-country courses and workshops for indigenous
technical staff and the quality of proposed technical training
including training conducted by former trainees;
 
o  Demonstration of continued or of future support for the program from
vernments and institutions and other non-vernmental organizations from
collaborating countries; and
 
o  Demonstrated capacity and/or potential to coordinate program
activities with related efforts of other FIC programs, other Federal
agencies, and international organizations.
 
AWARD CRITERIA
 
The anticipated date of award is on or before September 30, 1993.
 
The following will be considered in making funding decisions:
 
o  quality of the proposed project as determined by peer review;
 
o  cost-effectiveness of programs;
 
o  availability of funds;
 
o  program balance among critical research training areas of emphasis
such as, but not limited to, preparation for future trials of anti-HIV
drugs, HIV vaccines, and other interventions; and;
 
o  geographic distribution among countries included in applications
under consideration.
 
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 requests for the
special instructions to prepare applications, are to be directed to:
 
Kenneth Bridbord, M.D.
Chief, International Studies Branch
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
Bethesda, MD  20892
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
 
Inquiries related to the review of these applications may be directed
to:
 
Dr. Sherry Dupere
Scientific Review Administrator
Fogarty International Center
National Institutes of Health
Building 31, Room B2C32
9000 Rockville Pike
Bethesda, MD  20892
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
 
Inquiries regarding fiscal matters may be addressed to:
 
Mrs. Silvia Mandes
Grants Management Officer
International Research and Awards Branch
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD  20892
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
 
AUTHORITY AND REGULATIONS
 
Awards under this program are made under the authority of the Public
Health Service Act, Section 307 (42 USC 242l) and administered under
PHS grants policies and Federal regulations, most specifically 42 CFR
part 61.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or to Health Systems Agency
review.
 
.

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