Full Text TW-95-002


NIH GUIDE, Volume 23, Number 40, November 18, 1994

RFA:  TW-95-002

P.T. 34

  Biomedical Research Training 
  Population Studies 
  Human Reproduction/Fertility 

Fogarty International Center
National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  January 16, 1995
Application Receipt Date:  April 20, 1995


The Fogarty International Center (FIC), in collaboration with the
National Institute of Child Health and Human Development (NICHD) of
the National Institutes of Health, invites applications from non-
profit public or private institutions in the United States to support
international research and training in population-related sciences.
The intent of this program is to enable NIH grant recipients to
extend the geographic base of research and training efforts to
developing nations, in support of international population
priorities.  Broad objectives are to:

o  Enhance domestic population research programs through training and
international collaborative studies related to population, including
the study of reproductive processes, contraceptive development,
contraceptive and reproductive evaluation, reproductive epidemiology,
and social and behavioral factors that influence population dynamics.

o  Assist scientists from developing nations to contribute to global
population research efforts and advance knowledge in support of
population policies appropriate for their home countries and
established international guidelines.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), International Research and Training in
Population and Health, is related to the priority area of family
planning and maternal and infant health.  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.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).


The grantee institution must be a U.S. non-profit private or public
institution capable of meeting the objectives in this RFA.

Applicant investigators (or co-investigators) must be either a U.S.
Principal Investigator of at least one NIH-sponsored research project
grant (R series) or a Project Director of an NIH-sponsored center
grant, program project grant or cooperative agreement (P and U
series) related to population that will be funded during at least one
year of the proposed grant award period.  On submission of an
application, at least eighteen months of active research support must
remain on the listed parent grant(s).  Investigators may request five
years of support in anticipation that a renewal application for the
parent grant(s) will be submitted and awarded.  Under certain
circumstances, an NIH research contract will be considered as meeting
the eligibility requirements.

The application must demonstrate that the award is relevant to and
will enhance the activities of the NIH-supported parent grant(s) and
benefit the research needs of the host country or countries of
participating scientists and health professionals.

Within allowable limits, research collaborations can include other
industrialized nations in addition to the U.S.


International Research and Training in Population and Health (D43)
will be available to U.S. investigators at a funding level not to
exceed $150,000 per year in direct costs for the first year, for a
maximum of five years.  The application should describe both research
and training objectives to be pursued in the United States and in the
cooperating developing nation(s) of Africa, Asia and the Pacific
region, the Middle East and Latin America (including the Caribbean).
Applications may incorporate cooperative activities with scientists
from one or several developing countries or regions, based on the
research and training objectives of the program.  However, applicants
are encouraged to focus their efforts on a limited number of

Types of Training

Research-related training programs for foreign scientists and health
professionals may include the following elements:

o  Predoctoral training in research related to population; academic
courses (which may lead to a degree) will be undertaken in the U.S.
in disciplines that may include:  demographic and behavioral science,
endocrinology, pharmacology and toxicology, pharmaceutical
development, cell and molecular biology, genetics, embryology,
physiology, epidemiology and other population-related fields;
research projects may be undertaken either at the U.S. host
institution or in the trainee's home country;

o  Postdoctoral training in laboratory procedures and research
projects and techniques related to population research, to be
conducted at the host U.S. institutions or in the trainee's home

o  Participation in advanced research training conducted by U.S.
faculty in the host country and also short-term in-country training
for foreign scientists and health professionals in the host country.

As part of the application, the applicant institution must describe
recruitment and selection procedures for the foreign pre- and
postdoctoral scientists.

Allowable Costs

Eligible costs include:  travel and subsistence related to research
and training conducted at a foreign site; support for short and long-
term training of pre- and postdoctoral scientists and health
professionals from developing nations; provision of research supplies
and materials to the foreign site in support of joint activities; and
limited support for relevant activities with institutions in
industrialized nations which would provide scientific contributions.

The following cost categories are eligible for reimbursement under
this program.  The stipends and allowances are maximums and
applicants are encouraged to design the most cost-effective programs:

For foreign scientists from developing nations:

o  Living allowance (stipend) comparable to scientist's professional
level and compatible with established NIH guidelines, but not to
exceed $45,000 per annum while undergoing training or conducting
research in the U.S.;

o  Living allowance (stipend) for scientists to conduct in-country
research at a level comparable to that received by similar
professionals in-country, but also not to exceed $45,000 per annum;

o  Tuition and fees at the U.S. university;

o  Round trip economy class air fare between the U.S. and home

o  Allowance for the grantee institution of up to $600 monthly per
scientist to cover health insurance, travel to scientific meetings,
and incidental research expenses;

o  Additional research support of up to $15,000 per person to support
training-related research or advanced research training in the
developing country (the program director is expected to ensure that
projects submitted for this funding are peer reviewed by the U.S.

For U.S. scientists affiliated with grantee institution:

o  Economy class travel and per diem for the program director and
U.S. faculty colleagues to provide guidance to trainees conducting
related field studies or advanced research training in their home

o  Economy class travel and per diem for U.S. faculty presenting
short-term courses in the foreign country;

o  Longer-term support (travel, per diem and pro-rated salary, up to
10 percent of annual salary or $10,000, whichever is less) to enable
U.S. faculty to conduct advanced research training activities in-

For administrative expenses:

o  Administrative expenses at the U.S. institution (secretarial
expenses, etc.) not to exceed 10 percent of the direct costs of this
award.  It is expected that the portion of salary for the program
director for the purpose of administering this award will be provided
for under the parent grant(s) associated with this proposal.

For related activities with other industrialized nations:

o  Support for travel and subsistence of U.S. or foreign
investigator(s), and the exchange of data, materials and supplies,
not to exceed 10 percent of direct costs of this award unless prior
approval is secured from the FIC.  As a condition of this special
expenditure, the applicant must indicate that some form of cost-
sharing will be provided by the counterpart institution in an
industrialized nation.

Requests for an administrative supplemental budget will be considered
for increases of up to 10 percent of funded levels in a given budget
year.  These funds may be requested to meet special needs and take
advantage of unusual opportunities.  Such requests will be reviewed
by FIC program staff in consultation with NICHD and support will
depend upon availability of funds.

The grantee institution 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.  Applicants
should assume a budget increase of four percent per year for each
succeeding year.

The anticipated date of award is on or before September 30, 1995.


It is anticipated that six to seven awards will be made, with an
estimated total of $1,000,000 available for the entire program in the
first year, with no single award exceeding $150,000 (in direct


Although world population growth peaked at 2.3 percent and began to
decline in the late 1970's, the age structure of the present
population will result in significant population increases well into
the next century.  According to projections of the United Nations
(U.N.) Population Division, world population will increase to 8.5
billion over the next 35 years.  Of the projected increase of some
3.2 billion, it is estimated that less than 200 million will occur in
industrialized countries; at least 3 billion, or 95 percent, will be
in the less developed countries.  By the year 2025, 16 of the world's
most populous cities will be situated in the developing world.

This trend has significant ramifications for global health.  In
developing nations, high birth rates may impede sustainable economic
development.  Consequences may include increasing pollution and
worsening sanitation, the spread and emergence of infectious
diseases, over exploitation of land, destruction of natural
ecosystems, unemployment, and inadequate access to health care and
education.  Where declines in growth rates have occurred, they are
attributed to increased economic productivity and cultural change,
including acceptance of and access to a wide choice of birth control
methods, sustained improvements in child survival, and improvements
in the education and societal status of women.

Through international research and training efforts, NIH-supported
institutions are positioned to advance technological and social
adaptations needed to meet the challenge of unsustainable population
growth.  This program is designed to create and expand research
partnerships between U.S. scientists and counterparts in developing
regions of the world on population issues of mutual priority.  It
will assist to train a cadre of research and health professionals in
developing nations who may contribute to the development of
population policies that are based on scientific information and also
are responsive to societal mores and values in their home countries.

Emphasis will be placed on collaborative activities with countries
and regions where population growth adversely impacts public health,
the environment and economic progress.

Examples of research and training topics include, but are not limited
to, the following:

o  Studies on reproductive processes, including development of the
reproductive system, male and female fertility, processes and
mechanisms to include preimplantation embryo development and

o  Studies on contraceptive development, including natural or
synthetic agents, products to reduce transmission of
sexually-transmitted diseases, new contraceptive devices and
reversible sterilization techniques;

o  Evaluative studies of contraceptive and fertility-related drugs
and products for safety and efficacy; evaluation of safety of male
and female sterilization;

o  Studies on social and behavioral factors that influence population
growth and change, including contraceptive use and choice,
operational research related to family planning, migration and
spatial distribution of populations, family composition and parental
roles, and population policies.


Before any funds may be expended on in-country research, the grantee
institution must show evidence of formal approval from responsible
authorities at the collaborating institution and the host government.
These approvals should be included in the application.

As part of proposed training programs, the applicants must describe
their training in the responsible conduct of research, consistent
with NIH policy (NIH Guide for Grants and Contracts, Volume 21,
Number 43, November 27, 1992) to be part of the program.  An award
will not be made unless such a description is included.

Protection of human subjects and laboratory animals

Applicable provisions for the protection of human research subjects
and laboratory animals in research and training activities must be
met in both domestic and foreign settings.  Title 45 CFR, Part 46,
provides guidelines concerning Department of Health and Human
Services regulations for the protection of human subjects and the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals.  These are available from the Office for Protection from
Research Risks, National Institutes of Health, 6100 Executive
Boulevard, Suite 3B01 Rockville, MD 20852.


It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (59 FR 14508-14513) and printed in
the NIH Guide for Grants and Contracts, Volume 23, Number 11, March
18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Prospective applicants are asked to submit, by January 16, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows
NIH staff to estimate the potential review workload and avoid
conflict of interest in the review as well as to provide important
information to prospective applicants.

The letter of intent is to be sent to:

Dr. Kenneth Bridbord
International Studies Branch
Fogarty International Center
31 Center Drive MSC 2220
Bethesda, MD  20892-2220


The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267; and from the program administrator listed

The RFA label available in the PHS 398 (rev. 9/91) 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 2a 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
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must be sent to:

Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03
Bethesda, MD  20892-7510

Applications must be received by April 20, 1995.  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.


Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the FIC and the NICHD.  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 an appropriate peer review group convened by
the NICHD in accordance with the review criteria stated below.

As part of the initial merit review, a process (triage) may be used
by the initial review group in which applications will be determined
to be competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.

The second level of review will be provided by the FIC Advisory Board
in September 1995.

Review criteria include those generally applicable to research
training programs and research:

o  past research training record for both the program and designated
preceptors in terms of the rate at which former trainees establish
independent and productive research careers;

o  past research training record in terms of the success of former
trainees in obtaining individual awards such as fellowships, career
awards, and research grants for further development;

o  objectives, design, and direction of the research training

o  caliber of preceptors as researchers including the institutional
commitment, the quality of the facilities, and the availability of
research support;

o  training environment including the institutional commitment, the
quality of the facilities, and the availability of research support;

o  recruitment and selection plans for appointees and the
availability of high quality candidates;

o  the record of the research training program in retaining health
professional postdoctoral trainees for at least two years in research
training or other research activities;

o  when appropriate, the concomitant training of health- professional
postdoctorates (e.g., individuals with the M.D., D.O., D.D.S.) with
basic science postdoctorates (e.g., individuals with a Ph.D., Sc.D.)
will receive special consideration.

Where specific research protocols are proposed, additional review
criteria, applicable to research grants, will be as follows:

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research;

The initial review group will also examine the provisions for the
protection of human and animal subjects, the safety of the research
environment, and the adequacy of plans for instruction in the
responsible conduct of research.

Additional factors to be considered in the scientific evaluation of
each application include the likelihood that the applicant
institution can meet the objectives stated in this RFA and

o  the expected scientific contribution of the proposed activity;

o  the strength of the research program in health sciences related to
the proposed research and training;

o  quality of teaching and research facilities and resources of the
U.S. institution, as well as the cooperating institution(s) in other
countries including documentation of previous international
collaboration with developing country scientists and institutions;

o  previous training experience at the pre- and postdoctoral levels
and success in maintaining collaboration with former trainees;

o  demonstrated capacity or potential to provide in- country advanced
research or technical training;

o  demonstrated capacity or potential to conduct future population-
related research projects with collaborating scientists and
institutions from developing nations.


The most important factor to be considered in making funding
decisions will be the quality of the proposed project as determined
by peer review.  The proposed instruction in the responsible conduct
of research must rated adequate for an award to be made.

In addition, FIC, in consultation with NICHD, will attempt to ensure
a reasonable balance of basic, clinical, behavioral and demographic
research training, as well as a geographic distribution among
developing nations of Asia and the Pacific region, Africa, the Middle
East and Latin America (including the Caribbean).  The number and
amount of the awards made under this program will depend upon the
availability of funds and cost-effectiveness will be one of the
factors considered in making funding decisions.


Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome
and prospective applicants are strongly encouraged to discuss their
proposals with program staff prior to submission.

Direct inquiries regarding programmatic issues to:

Dr. Kenneth Bridbord
International Studies Branch
Fogarty International Center
31 Center Drive MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-2516
FAX:  (301) 402-2056
Email:  sn5@cu.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Silvia Mandes
International Research and Awards Branch
Fogarty International Center
31 Center Drive MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  som@cu.nih.gov


This general type of program is described in the Catalog of Federal
Domestic Assistance No. 93.154.  Awards are made under authorization
of the Public Health Service Act, Title IV, Part A (Public Law
78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and
administered under PHS grants policies and Federal regulations 42 CFR
52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or to
Health Systems Agency review.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American


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