Expired RFA-TW-03-006: GLOBAL HEALTH RESEARCH INITIATIVE PROGRAM FOR NEW FOREIGN INVESTIGATORS (R01)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

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: [email protected]

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 [email protected].

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: [email protected]

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:

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) 710-0267, Email: [email protected].

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices