Full Text TW-92-03
 
SPECIAL INTERNATIONAL POSTDOCTORAL RESEARCH PROGRAM IN THE ACQUIRED
IMMUNODEFICIENCY SYNDROME
 
NIH GUIDE, Volume 21, Number 20, May 29, 1992
 
RFA:  TW-92-03
 
P.T. 44

Keywords: 
  Biomedical Research Training 
  AIDS 
  Epidemiology 
  Diagnosis, Medical 
  Disease Prevention+ 
  Treatment, Medical+ 

 
Fogarty International Center
 
Letter of Intent Receipt Date:  July 1, 1992
Application Receipt Date:  September 10, 1992
 
PURPOSE
 
The Fogarty International Center (FIC) invites applications to develop
multi-disciplinary postdoctoral fellowship programs in Acquired
Immunodeficiency Syndrome (AIDS) research for foreign and U.S.
scientists.  Funds will be awarded to encourage basic and
population-based research in all biomedical and behavioral disciplines
related to AIDS.  This announcement is for the second five-year funding
cycle for this program.  Both new and competing applications for this
program are welcome.
 
According to the World Health Organization, over 160 nations from all
continents have reported AIDS cases in their countries.  Research into
this disease has been significant.  The causative agent, the human
immunodeficiency virus (HIV) has been identified; the virus has been
shown to severely impair the immune system and the central nervous
system.  The associated risk factors and major modes of transmission
are known.  The epidemiologic patterns and modes of transmission have
been shown to vary between men and women and among countries.  Until
the disease can be prevented, cures are found, or an effective vaccine
is developed, AIDS will continue to be an increasingly global public
health problem.
 
International cooperation is important in understanding and preventing
HIV infection/AIDS.  It is in this context that the FIC, NIH, is
inviting a recompetition for the Special International Postdoctoral
Research Program in AIDS.
 
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 enhance this program further, 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), Special International Postdoctoral Research
Program in 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 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 institutional research fellowship (T22) awards
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.
 
Continued support will be based on the satisfactory performance of the
grantee as judged by program progress described in annual reports and
during periodic site visits and meetings of program directors.  Each
appointee will receive a stipend not to exceed $3,750 per month and
expenses to cover round-trip economy-class air fare; the host
institution will receive an allowance of up to $600 monthly per person
to cover health insurance, travel to domestic scientific meetings, and
incidental research expenses.  It should be noted that the above
stipends and allowances are maximums, and applicant institutions are
encouraged to design the most cost-effective programs generally at
lesser amounts.  Grantee institutions may request (1) an indirect cost
allowance based on eight percent of the total allowable direct cost,
and (2) reimbursement of the program director's time and effort, not to
exceed 25 percent of annual salary or $25,000 whichever is smaller.
The total cost per grant (direct plus indirect) for the first year may
not exceed $300,000 for continuing programs and $200,000 for new
starts.  Applicants should assume a budget increase of four percent per
year for each succeeding year.  While applicants may develop programs
at or close to these limits, as noted above, they are strongly
encouraged to pursue the most cost-effective approaches for
implementing these programs.  It is expected that successful applicants
will attract additional funds to support the AIDS research efforts of
current and former appointees.
 
In keeping with the intent to maintain a flexible program, requests for
administrative supplemental budget increases of up to 20 percent of
budget 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 depends upon availability of funds.
 
The intent is to award up to four grants for the first year of the
second five-year funding cycle.  The number of grants awarded, however,
will depend upon the quality of the approved grant applications and the
availability of funds. Only one T22 application will be allowed under
this program from each U.S. institution.
 
The anticipated date of award is July 1993.
 
FUNDS AVAILABLE
 
Approximately $1,000,000 (total costs) will be allocated to this
program in FY 1993, availability of funds permitting, resulting in an
estimated four awards, depending upon the quality of applications.  The
total (direct and indirect) cost per grant for the first year may not
exceed $300,000 for continuing and $200,000 for new programs.
 
RESEARCH OBJECTIVES
 
The objectives of this special institutional research fellowship
program are (1) to support collaborative research between U.S. and
foreign scientists who wish to enhance their knowledge and skills in
the epidemiology, diagnosis, prevention, and treatment of HIV/AIDS and
(2) to stimulate scientists from nations affected by AIDS to cooperate
and to share research knowledge in combatting this global problem.
 
It is expected that the program director will be a recognized scientist
in AIDS research, interested in both the basic and clinical aspects of
the syndrome, and able to attract as preceptors basic and clinical
scientists in his or her institution who have expertise in AIDS.
 
Under this award the program director will make training appointments
varying from 3-24 months to foreign and U.S. scientists.  Scientists
who are appointed must have an earned doctoral degree (M.D., Ph.D.,
D.V.M., D.D.S.) or the equivalent in a health science field, be
actively engaged in AIDS research, not be employed by a for-profit
institution, and if foreign, must have a permanent position in his/her
home institution.  Postdoctoral scientists at all career levels are
eligible for appointment.  It is expected that appointments will cover
the range of scientific disciplines related to HIV/AIDS research.
 
U.S. scientists from the grantee institution will be limited to
collaborative study in foreign institutions only.  The U.S. appointees
must have a letter of invitation from the foreign hosts accepting the
fellows and committing the resources of the foreign institutions to the
research effort.  Foreign scientists will generally conduct their
research at the awardee institution although appointments for
in-country advanced research training under the guidance of
participating faculty are allowable, but with individual appointments
in this category to be approved in advance as a reprogramming request;
each appointee will be assigned to a preceptor from among the
participating faculty.  Up to 60 person-months of appointments will be
permitted each budget year.
 
Types of Training
 
o  Postdoctoral research training conducted for 3-24 months in duration
at U.S. institutions for foreign scientists.  Postdoctoral scientists
(e.g., M.D.s, Ph.D.s) at all career levels are eligible for
appointment.  Training includes basic and clinical research in all
biomedical and behavioral disciplines related to HIV/AIDS and is meant
to enhance knowledge and skills in the epidemiology, diagnosis,
prevention, and treatment of HIV/AIDS.
 
o  Postdoctoral research training conducted at foreign institutions for
U.S. scientists varying from 3-24 months duration.  Scientists at all
postdoctoral career levels are eligible for appointment to this type of
training.
 
o  Advanced in-country research training conducted at foreign
institutions for selected, highly qualified foreign scientists under
the guidance of participating U.S. faculty, varying from 3-24 months
duration.  Individuals who had completed initial training at U.S.
institutions are potentially eligible for appointments in this
category.
 
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 have
well-established collaborations as, for example, through in-country
research efforts and/or a history of joint 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 must be on HIV/AIDS, opportunistic infections, and
other diseases strongly associated with AIDS (e.g., sexually
transmitted diseases and tuberculosis).  Emphasis will be given to the
development of human resources in those developing countries that are
likely to be hosts for HIV/AIDS-related research and field trials of
anti-HIV drugs, HIV vaccines, and other interventions.
 
Applicants are required to describe training in the responsible conduct
of research to be part of the programs.  An award will not be made
unless such a description is included.
 
The application must include a plan describing the selection procedures
for appointees.  It is expected that appointees will include:  (1) U.S.
and foreign scientists, (2) junior-, mid-, and senior-level scientists,
(3) scientists from those countries where AIDS has been identified as
a current or future public health problem, and (4) scientists whose
research in AIDS will benefit from this research experience.
 
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 institutions and/or from the foreign
government through an endorsement from the Minister of Health or other
appropriate government official.
 
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 which has been approved by the
Office for Protection from Research Risks (OPRR) of the NIH.
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 OPRR 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 OPRR.
 
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 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 "Special
International Postdoctoral Research Program in AIDS, TW-92-03".
 
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 the application 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
without review.  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 also will not accept any
application that is essentially the same as one already reviewed.  This
does not preclude the submission of substantial revision of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Applications will be reviewed by DRG staff for completeness and FIC
staff for responsiveness.  Incomplete applications will be returned to
the applicant without further consideration.  If the application is not
responsive to the RFA, it will be returned to the applicant.
 
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
applicants.
 
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 which 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:            July 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  Quality of research objectives and program design;
 
o  Qualifications of the participating faculty including depth of
experience in basic and clinical disciplines related to HIV/AIDS
research;
 
o  Relevance of the fellowship appointments to the U.S. and any
collaborating foreign institutions' AIDS research programs;
 
o  Quality of facilities and resources including access to a
significant population of HIV-infected individuals;
 
o  Ability of the faculty to attract, foster, and maintain
international collaborations including accomplishments of current
and/or former trainees following return to their home countries;
 
o  Level of support for domestic and international AIDS research and
training from the NIH and other sources.  Examples of such support
include participation in or collaboration with the National Institute
of Allergy and Infectious Diseases, AIDS Clinical Treatments Group
(ACTG), International Collaboration for AIDS Research (ICAR), AIDS
Vaccine Evaluations Clinics (AVEU), and Preparation for AIDS Vaccine
Evaluation (PAVE) programs, and 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 former
trainees;
 
o  Demonstrated capacity and/or potential to prepare trainees for
participation in in-country clinical trials of anti-HIV drugs, HIV
vaccines, and other interventions;
 
o  Qualifications of the proposed collaborating in-country
institutions; 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 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 any requests for
modified 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
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
 
This program of the John E. Fogarty International Center for Advanced
Study in the Health Sciences is identified in the Catalog of Federal
Domestic Assistance, No. 93.154.  Awards will be 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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