GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01) 

RELEASE DATE:  November 4, 2002 (see addendum NOT-TW-03-003)

RFA:  TW-03-006

Fogarty International Center (FIC) 
 (http://www.nih.gov/fic/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Eye Institute (NEI) 
 (http://www.nei.nih.gov/)
National Heart, Lung and Blood Institute (NHLBI) 
 (http://www.nhlbi.nih.gov/index.htm)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) 
 (http://www.nibib1.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS)  
 (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS)  
 (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)  
 (http://www.ninds.nih.gov/)
National Institute on Aging (NIA) 
 (http://www.nia.nih.gov)
National Institute of Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/ )
Office of Behavioral and Social Sciences Research (OBSSR) 
 (http://obssr.od.nih.gov/)
Office of Dietary Supplements (ODS) 
 (http://ods.od.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)

LETTER OF INTENT RECEIPT DATE:  January 18, 2003
APPLICATION RECEIPT DATE:  February 18, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations:

PURPOSE OF THIS RFA

This RFA is intended to promote productive re-entry of NIH-trained foreign 
investigators into their home countries as part of a broader program to 
enhance the scientific research infrastructure in developing countries, to 
stimulate research on a wide variety of high priority health-related issues 
in these countries, and to advance NIH efforts to address health issues of 
global import.  

The specific goal of this initiative is to provide funding opportunities for 
the increasing pool of foreign biomedical and behavioral scientists, clinical 
investigators, nurses, and other health professionals with state-of-the-art 
knowledge of research methods to advance critical issues in global health 
upon their return to their home countries.  After their term of research 
training, developing country participants supported by this RFA are expected 
to continue independent and productive scientific careers, including expert 
training and consultation and/or research of biomedical issues within their 
home institutions. 

RESEARCH OBJECTIVES  

As a part of its global health initiative under the Department of Health and 
Human Services (DHHS), the Fogarty International Center (FIC) of the National 
Institutes of Health (NIH), in partnership with the following Institutes, 
Centers, and Offices on this RFA:  National Cancer Institute (NCI), National 
Eye Institute (NEI), National Heart Lung and Blood Institute (NHLBI), 
National Institute of Biomedical Imaging and Bioengineering (NIBIB), National 
Institute of Environmental Health Sciences (NIEHS), National Institute of 
General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), 
National Institute of Neurological Disorders and Stroke (NINDS), National 
Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), Office of 
Behavioral and Social Science Research (OBSSR), Office of Dietary Supplements 
(ODS), and Office of Research on Women's Health (ORWH), invites applications 
from current and former NIH-supported foreign research trainees to compete 
for funds that will support their research efforts upon return to their home 
countries.  In order to be eligible, foreign scientists must meet at least 
one of the following criteria:  
1)  at least two years of research training experience under a FIC-supported 
training grant (classified by the D43 "International Training Grant" 
mechanism).
2)  one year of such D43 training experience coupled with one year of 
significant, well documented mentored research experience (e.g. through an 
NIH research award).
3)  at least two years of research training experience through the NIH 
intramural Visiting Fellows Program.

All training and research must either have been done in the U.S. or have been 
part of in-country research associated with a degree or mentored postdoctoral 
research under the D43 award mechanism and completed after September 1, 2000.

Current NIH Visiting Fellows are particularly encouraged to apply as they 
begin their preparation to return home although they, too, may apply within 
two years of completion of training.  

Through various programs, the NIH has made a significant investment in 
training biomedical and behavioral researchers.  For example, the NIH 
Visiting Fellows Program currently hosts more than 1,600 junior scientists 
from almost 100 countries for periods of one to five years.  In addition, the 
NIH D43 research training and capacity building grant mechanism allows 
hundreds of foreign researchers to receive training at prominent institutions 
in both the United States and their home countries in a range of biomedical 
and behavioral research areas critical to advancing global health.  In 
summary, training supported by NIH is critical to these young investigators 
as they develop independent research careers.

As junior foreign scientists complete training programs in the U.S., many 
find it difficult to secure the support needed to continue their research 
projects and careers in their home countries.  The Global Health Research 
Initiative Program (GRIP) provides the opportunity for junior foreign 
scientists to compete for such funds through a peer-reviewed process.  This 
is a critical adjunct in the continuation of promising independent research 
careers that will be of benefit to the investigators' home countries and the 
world at large.  Women and underrepresented minority scientists in their 
countries are especially encouraged to apply for these re-entry grants.  
Project proposals should be geared towards the research interests of the 
applicant and focus on high-priority health and healthcare problems in the 
investigator's home country that also carry global importance and also are of 
interest to the collaborating NIH Institutes, Centers, and Offices listed on 
the first page of this RFA.  

It is expected that research topics will be diverse.  Specific research 
interests of partnering ICs can be found on the ICs' websites as listed at 
the beginning of this RFA.  Research related to women's health, including 
studies of gender differences in disease onset and progression, 
identification of behavioral strategies that are effective in encouraging 
healthy lifestyles in young girls and women, as well as behavioral strategies 
to encourage prevention of diseases such as STDs and diseases with higher 
prevalence among women (including infectious diseases, lupus, multiple 
sclerosis and depression) are particularly encouraged.  Research focused on 
behavioral and social determinants and their effects on health is also 
encouraged.  All research must be performed in accordance with NIH and U.S. 
Government regulations regarding the responsible conduct of research.  This 
RFA precludes the support of research involving enrollment in pilot studies 
for clinical trials or the actual support of clinical trials since the 
resources and infrastructure to support and oversee such trials generally 
exceed the resources available under this award mechanism.  Applicants are 
encouraged to visit the website of the Office for Human Research Protection 
(OHRP) (http://www.hhs.gov/ohrp/), that outlines these 
regulations.  For information on animal protection in research, see 
http://grants.nih.gov/grants/olaw/olaw.htm.

This RFA contributes to the FIC mission and to the broad NIH initiative to 
reduce health disparities among nations by strengthening research 
infrastructure in developing countries, particularly those with the least 
economic resources.  Additionally, it provides the opportunity for recently 
trained international health and health care researchers to continue their 
projects after returning home.  

Evaluation of the program will occur on an ongoing basis.  Because this is a 
program to move research trainees to the status of independent investigator, 
there are several outcomes to be measured:

o  development of the laboratory capabilities or research projects
o  training of other potential researchers
o  publications in local journals as well as international peer-reviewed 
journals
o  participation in workshops, seminars, and international conferences
o  collaborations with past mentors as well as others
o  attraction of funding from other sources

As part of its assessment of the impact and scientific productivity of this 
program, FIC plans to track researchers and their trainees for at least five 
years after beginning their independent research.  Evaluation may focus on 
the success of the researchers (as measured by the number and quality of 
publications, presentations, courses, awards, subsequent employment, etc.), 
their sustained commitment to research careers, their ability to attract 
funding for their work, their contributions to future international 
collaborations, their influence on the development of scientific research in 
their countries, and their ability to act as consultants, teachers, and role 
models to other local investigators and further disseminate the lessons 
learned.  Metrics should be stated both for the success of the individual 
researcher and the success in capacity building at the home institution, 
including the impact of the program on research at the institution in the 
home countries of researchers and their trainees.

MECHANISM OF SUPPORT

This RFA will use the NIH Research Project Grant (R01) mechanism using the 
modular grant format.  If an application has a significant collaboration with 
a NIH intramural laboratory, the application will be converted to the 
cooperative agreement (U01) mechanism and awarded as a cooperative agreement.

This RFA is issued for fiscal year 2003 (FY03).  FIC and our NIH partners 
expect that a similar RFA will be issued annually for the next several years, 
depending on the availability of funds.  Applications submitted in response 
to this RFA may have a project period of no less than three years and no more 
than five years. 

An applicant can request up to two modules of $25,000 each, or total direct 
costs of $50,000 per year, plus facilities and administrative (F&A) costs up 
to a maximum of eight percent for a foreign institution.  The Principal 
Investigator (PI) is expected to devote at least 50 percent of his/her total 
effort to this project.  

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format (see http://grants.nih.gov/grants/funding/modular/modular.htm).  
Animal facility information must be provided in the application.  See 
http://www.iacuc.org/ and http://grants.nih.gov/grants/olaw/olaw.htm for 
International Animal Care and Use Committee (IACUC) guidelines.

Because an investigator can receive a maximum of five years of support under 
the GRIP program and this specific GRIP award is not renewable, any future 
application will be considered an unsolicited competing application based on 
this project and will compete with all investigator-initiated applications 
submitted to NIH through the Center for Scientific Review (CSR). 

FUNDS AVAILABLE

The participating ICs intend to commit approximately $1.5 million in FY03 to 
fund up to 30 new awards in response to this RFA.  An applicant may request a 
project period from three to five years and a budget of direct costs of up to 
$50,000 per year.  The PI is expected to devote at least 50 percent of 
his/her total effort to this project.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of the ICs provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of funds, 
the receipt of a sufficient number of meritorious applications, and 
geographic balance.  The earliest anticipated award date is July 2003.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your foreign institution is from a 
developing country and has any of the following characteristics:

o  For-profit or non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of state and local governments of developing countries
o  Faith-based or community-based organizations

Only institutions in developing countries are eligible to apply.  
Institutions in countries which have the least economic resources are 
particularly encouraged to apply.  For the purpose of this RFA, the following 
geographic regions or countries can apply:  North Africa, West Africa, East 
Africa, Central Africa, Southern Africa, Russia, the Newly Independent 
States, Eastern Europe, the Middle East (except Israel), India, Asia (except 
Japan, Singapore, South Korea, and Taiwan), the Pacific Islands region 
(except Australia and New Zealand), Latin America, and the Caribbean.

INDIVIDUALS ELIGIBILE TO BECOME PRINCIPAL INVESTIGATORS

Any individual from an eligible institution who meets the eligibility 
criteria below is invited to develop an application in conjunction with their 
home institution.  Women and individuals from underrepresented racial and 
ethnic groups in their countries, as well as individuals with disabilities, 
are always encouraged to apply for NIH programs.  Only applicants from 
institutions in eligible developing countries are eligible to apply.  

In order to be eligible, applicants must meet at least one of the following 
criteria: 
1)  at least two years of research training experience under a FIC- supported 
training grant (classified by the D43 "International Training Grant" 
mechanism).
2)  one year of such D43 training experience coupled with one year of 
significant, well-documented mentored research experience (e.g. through an 
NIH research award).
3)  at least two years of research training experience through the NIH 
intramural Visiting Fellows Program

All training and research, to meet eligibility requirements, must have either 
been done in the U.S. or have been part of in-country research associated 
with a degree or mentored postdoctoral research under the D43 award 
mechanism, and completed after September 1, 2000.

Applicants must return to a research position in their home country 
institution in order to carry out research supported by this award.  The 
award will be made to the home institution on the investigator's behalf only 
after the investigator has arrived in that country.  Therefore, the 
application must be submitted by the institution to which the applicant has 
returned or will be returning.

It is expected that the PI will demonstrate that he/she has an appointment at 
an academic or other institution in his/her home country and will demonstrate 
or provide a letter of support that that institution will have the capacity 
to support the research proposed.  The GRIP award will support up to one-half 
the investigator's salary, commensurate with the salary structure of the home 
institution.  Funds from the institution, national government, local science 
research council or other public or private organization may be used to 
support this program.  The remainder of the funds from this grant may pay for 
equipment, travel, supplies, or other research personnel's salary working on 
the same research project.

In order to build upon experience, partnership, mentorship and prior 
investments, applicants are encouraged to submit applications in 
collaboration with the NIH-supported institution or intramural laboratory 
from which they have received or are receiving research training.  Through 
letters of support, U.S. collaborators should demonstrate how this program 
will support ongoing research collaborations.  For those applicants who are 
eligible through both a year of training and a year of significant mentored 
research, letters of support should be received from both mentors.

While recognizing that this program is intended to foster the independence of 
the applicant, FIC recognizes the value of continued collaboration with NIH 
or U.S. mentors.  This relationship should be documented in the application.  

Because of the desired ongoing relationship between the new investigator and 
the IC where training occurred, the NIH intramural researcher must have pre-
approval of the Scientific Director from his or her NIH Institute through a 
letter to be submitted with the application. 

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into four 
areas:  scientific/research, eligibility, peer review, and financial or 
grants management issues.

Direct your questions about scientific/research and eligibility issues to:  

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Bldg. 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
Email:  primacka@mail.nih.gov

Direct your questions about peer review issues to:  

Don Schneider, Ph.D.
Director, Division of Molecular & Cellular Mechanisms
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Rockville, MD 20892-7842
Tel:  (301) 435-1727
Email schneidd@csr.nih.gov.  

Direct your questions about financial or grants management matters to: 

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
31 Center Drive
Bethesda, Maryland  20892-2220
Tel:  (301) 496-1670
Fax:  (301) 594-1211
Email:  butrumb@mail.nih.gov

LETTER OF INTENT 

Prospective applicants are asked to submit a letter of intent by January 18, 
2003, which includes the following information:  

o  Descriptive title of the proposed research
o  Name, address, and telephone and fax numbers of the Principal Investigator
o  Names of other key personnel
o  Name and address of the participating institutions
o  Number and title of this RFA

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 CSR staff to estimate the potential review workload and plan 
the review.  Further information, including the answers to frequently asked 
questions about this RFA can be found at http://www.nih.gov/fic.  

The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Aron Primack, MD, MA
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Bldg. 31, Room B2C39
31 Center Drive
Bethesda, MD  20892-2220
Tel:  (301) 496-4596
Fax:  (301) 402-0779
Email:  primacka@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact NIH GrantsInfo, Telephone (301) 435-
0714, Email:  GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SUPPLEMENTAL INSTRUCTIONS:  Applicants may request up to two modules, or 
$50,000, of direct costs per year and the application must be in modular 
format.  The PI is expected to devote at least 50 percent of his/her total 
effort to this project.  The modular grant concept establishes specific 
modules in which direct costs may be requested, as well as a maximum level 
for requested budgets.  Only limited budgetary information is required under 
this approach. 

It is understood that writing an application for such an R01 grant may be 
difficult and time-consuming.  Therefore, it is encouraged that potential 
applicants seek assistance in such grant writing.  Those being trained via 
the D43 grant mechanism should seek such assistance at or from their training 
institutions.  Those within the NIH intramural program should seek such 
guidance within the NIH framework.  Although there is a limit of 25 pages for 
these R01 applications, it is possible that applicants may only need 15 or 
fewer pages.  The application should be complete and follow the format of the 
PHS 398.  Help for completing these applications can be found on the NIH 
website.  Examples of helpful information include:
o  http://www.niaid.nih.gov/ncn/grants/default.htm
o  http://www.nigms.nih.gov/funding/tips.html
o  http://www.niddk.nih.gov/fund/grants_process/grantwriting.htm
o  http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm
o  http://www.drugabuse.gov/Funding/Grantapps.html
o  http://www.nigms.nih.gov/funding/tips.html

Applicants are strongly encouraged to call the program contacts listed in 
INQUIRIES with any questions regarding the adherence to the guidelines of 
their proposed project to the goals of this RFA.

Budget Instructions

Applicants will request direct costs in $25,000 modules, up to a total direct 
cost request of $50,000 per year.  The total direct costs must be requested 
in accordance with the program guidelines and the modifications made to the 
standard PHS 398 application instructions described below:

o  Under Personnel:  List all project personnel, including their names, 
percent of effort, and roles on the project.  The PI is expected to devote at 
least 50 percent of his/her total effort to this project.  The PI may only 
request support of up to 50 percent of his/her effort on this project.  The 
PI's salary and any other salaries should be commensurate with the salary 
structure at the applicant institution.

o  Under Facilities and Administrative (F&A) Costs:  F&A costs of up to eight 
percent should be shown under the calculation section on the Checklist Page 
of the PHS 398 application.  The F&A cost calculation may not exceed eight 
percent of total direct costs less equipment.  Applicants do not need to 
complete the section regarding agreements above the calculation section.  
Applicants should mark the modified total direct costs base box below the 
calculation section.

Other Requirements

o  The applicant should list the date that he/she returned or expects to 
return to their home country.

o  The applicant must have a letter from the home institution describing its 
involvement in the ongoing research plan and the support of it including any 
financial and/or in-kind anticipated support.

For investigators associated with the D43 grants program:  include a letter 
from the U.S. mentor, outlining the nature of the future collaborative 
relationship, and how the NIH-supported laboratory or other program 
supported, and/or will support, a continued collaboration with the 
investigator, using all appropriate resources.  The letter should also 
indicate the dates of research training and a summary of the program.

For applicants eligible through one year of research training and one year of 
significant mentored research, letters outlining the nature of the future 
collaborative relationship from both mentors are required.  These letters 
should indicate the dates of such training and research.

o  In the application, either in the biosketch or as part of the background 
information, include the dates of the training program and, when applicable, 
the research effort, a description of the training and research programs 
including the courses taken, and a summary of the program and of the 
research.  Include evidence of at least two years of training or one year of 
training and one year of significant, well-documented research (e.g. the 
specific grant number).  

o  For NIH Visiting Fellows: include the dates of the training as well as a 
letter from the NIH laboratory chief and Institute scientific director. This 
letter should also outline the nature of the future collaborative 
relationships with the NIH mentors.

o  The investigator must describe current or previous training under the D43 
or the NIH intramural program.  The applicant must provide a brief paragraph 
providing the grant number, the name and address of the NIH mentor or 
Principal Investigator of the D43 or other eligible grant, and a description 
of the training received.  The trainee must have at least two years of such 
training or one year of such training and one year of significant well-
documented research experience.  If the latter, please include the grant 
number and a summary description of the research experience.

o  Include two further letters of reference relating to the abilities of the 
applicant investigator, specifically indicating the ability to become a 
leader in scientific pursuits.  These can be attached at the end of the grant 
but before any appendices.

o  Checklist:  This page should be completed and submitted with the 
application.  Applications submitted by foreign or international institutions 
can request F&A costs up to a maximum of eight percent.  Please see the web 
site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for 
more information on the allowability of F&A costs for foreign and 
international organizations.  

Applications not conforming to these guidelines will be considered 
unresponsive to this RFA and will be returned without further review.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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 two of the face page of the application form 
and the YES box must be marked.  The RFA label is available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

SENDING AN APPLICATION TO THE NIH :  Submit a signed, typewritten original of 
the application, including the Checklist, and five signed photocopies, in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  208892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.  (See http://www.nichd.nih.gov/funding/receipt_dates.htm for receipt 
date information.)

The Center for Scientific Review (CSR) 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 
CSR 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.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the FIC.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

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 CSR in accordance with the review criteria stated below.  As 
part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit , generally the top half of the applications under 
review, will be discussed and assigned a priority score
o  Receive a second level review by the FIC Advisory Board and possibly the 
Advisory Boards or Councils of co-sponsors.

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals 
including the career development of the Principal Investigator.  

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a meritorious priority score.  For example, you may propose to carry 
out important work that by its nature is not innovative, but is essential to 
move a field forward.

(1)  SIGNIFICANCE:  Does your study address an important health problem and 
is it specifically a priority health issue in your home country?  If the aims 
of your application are achieved, how will scientific knowledge be advanced 
and your research career be enhanced?  What will be the effect of these 
studies on the concepts or methods that drive this field?  

(2)  APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?  Is your research hypothesis driven or hypothesis generating?

(3)  INNOVATION:  Does your project employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?  

(4)  INVESTIGATOR:  Are you appropriately trained and well-suited to carry 
out this work?  Is the work proposed appropriate to your experience level as 
the Principal Investigator and other researchers (if any)?  How will this 
award enhance your career development and help you achieve a position of 
scientific leadership in your home country?  Do the letters of support 
document a strong commitment to help you develop your career? 

(5)  ENVIRONMENT:  Does the scientific environment, in which your work will 
be done contribute to the probability of success?  Has your home institution 
made a convincing commitment to you (e.g. to provide a research/academic 
appointment and partial salary support)?  Do the proposed experiments or 
studies take advantage of unique features of the scientific environment in 
your home country or employ useful collaborative arrangements?  Is there 
evidence of institutional support in the developing country?  What is the 
continuing commitment of the U.S. collaborating institution (e.g., the 
institution associated with the NIH D43, the NIH intramural program 
laboratory, or the research program) to further develop your career and 
research interests?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans, animals, 
or the environment, to the extent they may be adversely affected by the 
project proposed in the application.

o  INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.  (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o  DATA SHARING:  The adequacy of the proposed plan to share data.

o  BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  January 18, 2003
Application Receipt Date:  February 18, 2003
Peer Review Date:  May 2003
Council Review:  September 2003
Earliest Anticipated Start Date:  September 30, 2003

AWARD CRITERIA

Applications will compete with all other recommended applications for 
available funds.  Criteria that will be used to make award decisions include:  

o  Quality of the proposed project, as determined by peer review
o  Availability of funds
o  Geographic balance
o  Programmatic priority, including funding interests of collaborating NIH, 
or other cosponsors
o  Level of need as measured by economic resources in the applicant 
developing country

Awards will not be made until applicants have actually returned to their home 
countries (or other developing countries).  A change of grantee institution 
that involves the transfer of a grant to or between foreign institutions or 
international organizations requires competitive re-review and approval of 
the IC Advisory Council/Board.

REQUIRED FEDERAL CITATIONS

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 clinical research 
projects, unless a clear and compelling justification is provided indicating 
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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research – Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates:  the use of a NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that:  a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups, if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.  

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at:  
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy in the NIH Guide for Grants and 
Contracts, June 5, 2000 at:  http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for Federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:  The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e. a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place date collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in a NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  
Because the applications are expected to cover many and varied areas, this 
RFA will probably be related to many priority areas of this activity 
including general public health, cardiovascular disease, diabetes, and 
infectious diseases.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.989, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of the Public 
Health Service Act, as amended (42 USC 241 and 287b) and administered under 
Public Health Service (PHS) grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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