INTERNATIONAL MALARIA RESEARCH TRAINING PROGRAM AWARD

Release Date:  February 22, 2001

RFA:  RFA-TW-01-006

Fogarty International Center
 (http://www.nih.gov/fic)

Letter of Intent Receipt Date:  May 23, 2001
Application Receipt Date:       June 28, 2001

PURPOSE

The Fogarty International Center (FIC) currently supports innovative, 
collaborative malaria research training programs that contribute to the 
long-term goal of harnessing scientific knowledge and skills to enhance 
efforts to prevent malaria-related morbidity and mortality and to 
control malaria transmission in endemic developing countries 
(http://www.nih.gov/fic/programs/malaria.html)  The International 
Malaria Research Training Program (IMRTP) request for applications 
(RFA) is being issued a second time by FIC in conjunction with the 
National Institute of Allergy and Infectious Diseases’ (NIAID) RFA for 
research grants entitled “Malaria Vaccine Development:  Understanding 
Malarial Anemia” (AI-01-007).   Applicants for this NIAID RFA are 
invited to submit proposals to train or expand the capabilities of 
scientists and health professionals from developing countries, in which 
malaria is endemic, to engage in research relevant to the pathogenesis 
of severe malarial anemia.  In addition, institutions with current FIC 
IMRTP awards are invited to apply for supplemental funds to expand 
their activities to include training in this area.

A major barrier to successful malaria research, treatment and control, 
including the clinical trials of potentially efficacious malaria 
vaccines, has been the scarcity of a critical mass of trained 
scientists and health professionals with malaria expertise in endemic 
countries.  Each year it is estimated that close to one billion 
clinical episodes and between 1.5-2.7 million deaths due to malaria 
occur.  Ninety percent of these are in Africa.  The program for malaria 
research training will, therefore, focus primarily on Plasmodium 
falciparum (P. falciparum) malaria-related anemia research training to 
advance collaborative malaria studies between grantee researchers and 
colleagues in sub-Saharan Africa.  However, FIC will also consider 
meritorious applications involving training to address Plasmodium vivax 
malaria-associated anemia in endemic developing countries in Asia, 
Latin America and the Caribbean.

The impetus for supporting a malaria research training program grows 
out of the recognition that malaria continues to pose a major health 
threat in the developing world and that research training in endemic 
countries can lead to long-term solutions.  This program supports the 
Multilateral Initiative on Malaria (MIM) established at a meeting in 
Dakar, Senegal, in January 1997, by malaria experts from sub-Saharan 
Africa and other countries.  The goal of the conference was to identify 
scientific priorities and the means to pursue strengthening and 
sustaining, through collaborative research and training, the capability 
of malaria-endemic countries in Africa to carry out the research 
required to develop or improve tools for malaria prevention and 
control.  The MIM is an alliance of organizations and scientists 
involved in malaria research and is coordinated by a secretariat 
currently housed at the FIC (http://www.nih.gov/fic/programs.html).  In 
an effort to extend the activities supported by the MIM, the FIC 
malaria research training program supports efforts by NIH-funded 
malaria researchers to participate in building malaria research 
capability in endemic developing countries through collaborative 
research training efforts, especially in Africa.  This RFA focuses on 
the specific need to understand the basis of severe anemia related to 
malaria infection that was identified as a scientific priority at the 
Dakar Conference.

To develop sustainable research capacity in endemic developing 
countries, FIC will support malaria-related anemia research training 
efforts as part of the new research projects supported by NIAID in 
response to RFA-AI-01-007 or as part of current FIC International 
Malaria Research Training programs involving collaboration with 
internationally recognized research institutions in Africa and other 
highly endemic regions of the world.  Proposed training programs should 
be designed to fill specific gaps in needed expertise and establish a 
critical mass of trained scientists and health professionals able to 
work independently on malaria-associated anemia research at the 
collaborating developing country institution.  Each malaria research 
training proposal may incorporate a number of long- and short-term 
opportunities to provide multidisciplinary research training for 
endemic country scientists and clinicians in areas such as clinical 
tropical medicine, hematology, immunology and genetics relevant to 
understanding the pathogenesis of severe malarial anemia to achieve 
this goal.  To the greatest extent possible, malaria research will be 
supported in the context of training conducted in the trainees’ home 
countries.

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.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by U.S. and foreign, for profit and non-
profit public and private institutions, such as universities, colleges, 
hospitals, laboratories, and eligible agencies of the Federal 
government capable of meeting the objectives of the RFA.  All new 
applicants for FIC IMRTP awards must also respond to the NIAID RFA-AI-
01-007 “Malaria Vaccine Development: Understanding Malarial Anemia.”  
In exceptional cases, with prior approval of the FIC program staff, an 
applicant may be the designated Principal Investigator (PI) for an 
active NIAID award (with at least 18 months of support remaining at the 
time of application) for malaria research directly related to this 
topic.  The proposed PI for the FIC IMRTP award must also be the 
proposed PI for the above NIAID research award.  No new FIC malaria 
research training awards will be made in response to this RFA unless 
the applicant is successful in receiving an NIAID award made in 
response to RFA-AI-01-007 or has other FIC-approved NIAID research 
support.  Only one application is allowed from any applicant 
institution and institutions with current IMRTP awards may not apply 
for an additional award.  However, institutions with current FIC IMRTP 
awards may apply for supplemental funding under this RFA to expand 
their activities to include training in malaria-related anemia research 
provided that they can demonstrate U.S. and/or foreign collaborator 
faculty mentorship capability and research grant support in this field.  
The applicant must demonstrate an ongoing collaborative relationship 
with an established institution with proven malaria research 
capabilities in a endemic developing country in Africa, Asia (except 
Japan, Singapore, South Korea and Taiwan), the Pacific Island region 
(except Australia and New Zealand), Latin America and the Caribbean, 
where the proposed research training will be based.  Racial/ethnic 
minority individuals, women, and persons with disabilities are 
encouraged to apply as PIs.

MECHANISM OF SUPPORT

Awards made in response to this RFA will use the National Institutes of 
Health (NIH) international training grant (D43) award mechanism that 
limits facilities and administrative costs to eight percent.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The total 
project period for a new award funded in response to this RFA cannot 
exceed four years.  The total project period for a supplement to a 
current IMRTP award cannot exceed the program period for this award.  
Continued support during this period depends on satisfactory 
performance as judged by annual progress reports, site visits, meetings 
with program directors, career progress of trainees, the development of 
institutional capacity for independent malaria-related research and 
continued malaria research funding.  At this time, FIC has not 
determined whether this solicitation will be continued beyond the 
present RFA.  FIC, in conjunction with NIAID, will conduct a program 
evaluation by the end of the third year that will assist the NIH in 
determining the re-issuance of the RFA.
  
The applicant organization must provide the necessary management for 
the transfer of funds and materials to the collaborating endemic 
country institution.  Facilities and administrative (F & A) costs 
required to support training and training-related research at the 
endemic country institution such as access to facilities, library 
services, internet, etc. can be charged as direct expenses when well 
justified.  Travel, salaries and fringe benefits will be subject to the 
applicant institution’s rules and regulations.

Allowable Costs

All budget items related to trainee participation in the program should 
be itemized on the PHS Form 398 NRSA substitute budget pages OO and PP 
in the categories indicated in parentheses.  All budget items related 
to faculty participation in the program should be itemized on the PHS 
Form 398 budget pages DD and EE in the categories indicated in 
parentheses.

Stipend/Salary/Consulting Fees

o  Trainees (endemic country graduate students and endemic country 
post-advance degree participants) may be paid a stipend comparable to 
their professional experience similar to other equivalent trainees at 
the grantee institution but not exceeding $45,000 per year in 
accordance with the grantee institutional policies while involved in 
long-term training at the grantee institution.  Applicants may wish to 
refer to the NRSA stipend levels described on the web site  
http://grants.nih.gov/training/nrsa.htm.  (NRSA substitute pages, pre- or 
postdoctoral stipends)
o  Endemic country trainees may be paid a stipend while conducting 
long-term training related research at the endemic country site at 
levels comparable with the salary scales for similar professionals in 
that country in accordance with the collaborating endemic country or 
grantee institution’s policies but not exceeding $45,000 per year.  
(NRSA substitute pages, pre- or postdoctoral stipends)
o  Faculty at the grantee institution who provide major program 
administration or extended long-term training or conduct collaborative 
research with students at the endemic country site may receive salary 
and fringe benefits.  The total amount of salary and fringe benefits 
requested for all grantee faculty may not exceed ten percent of direct 
costs in the budget.  The administrative, training or teaching 
responsibilities and time commitment for personnel receiving salary 
should be thoroughly described.  (Form 398 budget pages, personnel)
o  Endemic country institution faculty who provide major program 
administration at the endemic country site or participate in long-term 
training of participating students at the endemic country site and 
grantee faculty or endemic country faculty who teach short courses may 
receive a consulting fee not to exceed $2000, in accordance with their 
institution’s policies.  No more than five percent of the direct costs 
in the budget may be used for consultant fees.  The administrative, 
training or teaching responsibilities and time commitment for personnel 
receiving consulting fees should be thoroughly described.  (NRSA 
substitute pages- training related expenses)
o  Up to ten percent direct costs to provide salary and fringe benefits 
for clerical support staff for the program at the grantee institution.  
The responsibilities and time commitment for personnel in the U.S. and 
foreign country receiving salary support or consulting fees should be 
described in detail.  (Form 398 pages, personnel)

Tuition, Fees and Insurance

o  Funds for tuition, academic fees and self-only or family medical 
insurance for endemic country trainees at the grantee institution not 
exceeding 20% of direct costs may be requested.  Programs are 
encouraged to seek cost sharing arrangements with the grantee 
institutions in order to provide reduced tuition for long term trainees 
and tuition-free short courses.  (NRSA substitute pages, tuition, fees, 
insurance)

Trainee Travel

o  Funds may be requested for one round trip economy class airfare per 
year on U.S. carriers (to the maximum extent possible) and local ground 
transportation for each long-term endemic country trainee to travel to 
the grantee institution or for endemic country trainees to participate 
in short courses or attend scientific conferences to present their 
results.  Additional travel must be approved by FIC program staff.  
(NRSA substitute pages, trainee travel)
o  Funds may be requested for per diem and lodging for endemic country 
trainees to participate in short courses or attend scientific 
conferences to present their results.  (NRSA substitute pages, trainee 
travel)

Faculty Travel

o  Funds may be requested for one round trip economy airfare per year 
on U.S. carriers (to the maximum extent possible) for each grantee 
faculty participant providing extended training to go to the endemic 
country site or teach short courses at the endemic country site.  
Additional travel must be approved by FIC staff. (PHS 398 pages, 
travel)
o  Funds may be requested for per diem and lodging for grantee faculty 
to teach short courses at the endemic country site.  (PHS 398 pages, 
travel)
o  For new awards, funds should be requested for airfare, per diem and 
lodging comparable to U.S. government rates (see 
http://www.gsa.gov/Portal/gsa/ep/contentView.do?contentId=17943&contentType=GSA_BASIC
l) for the program Director to attend an annual network meeting.  This 
meeting may occur in the context of the annual conference of NIAID’s 
International Centers for Tropical Disease Research (see 
http://www.niaid.nih.gov/ictdr/default.htm) or in conjunction with the 
annual American Society of Tropical Medicine and Hygiene conference or 
another meeting of NIAID-sponsored malaria research projects.  
Inclusion of funds for other key personnel to attend these meetings is 
at the discretion of the applicant.  (PHS 398 pages, travel)

Training related expenses

o  Funds to support endemic country trainee research related costs at 
the grantee institution (such as reagents, lab supplies, computer 
access, small equipment, etc.) of up to $600 per month per trainee may 
be requested.  (NRSA substitute pages, training related expenses)
o  Funds to support up to $10,000 per year for research at the endemic 
country site associated with fulfilling requirements for an advanced 
degree may be requested.  (NRSA substitute pages, training related 
expenses)
o  Research support for up to $15,000 per trainee per year to 
facilitate conducting advanced research training at the endemic country 
site (re-entry grants) by those finishing training or former long-term 
trainees in collaboration with grantee faculty participants maybe 
requested.  Re-entry grants may support the purchase of reagents, 
supplies, a computer and appropriate software, computer access fees, 
small equipment, one round trip to the grantee institution per year, 
scientific meeting fees and stipends comparable to salary scales for 
similar professionals at the endemic country site.  The applicant 
should describe in detail how proposals for re-entry projects will be 
selected by a peer review process examining scientific merit and 
ethical concerns involving faculty from the grantee and endemic country 
institutions coordinated by the program director.  (NRSA substitute 
pages, training-related expenses)

FUNDS AVAILABLE

The FIC intends to commit approximately $500,000 in FY 2002 to fund 
three to four new grants and two to four competing supplements in 
response to this RFA.  New malaria research training program award 
applicants may request a project period of up to four years and a 
budget for total costs of up to $100,000 per year maximum (including 
eight percent F & A costs).  Current malaria research training award 
applicants may request a project period extending to the end of this 
award and a budget of total costs up to $50,000 per year.  Because the 
nature and scope of the research proposed may vary, it is anticipated 
that the size of each award will also vary.  Although the financial 
plans of the FIC provide support for this program, awards pursuant to 
this RFA are contingent upon the availability of funds and the receipt 
of a sufficient number of meritorious applications.

RESEARCH TRAINING OBJECTIVES

The FIC will support new multidisciplinary research training for 
malaria endemic country scientists involved in research on the 
pathogenesis of severe malarial anemia supported by NIAID and the 
expansion of currently supported malaria research training programs to 
include training in this important area.

Background

In P. falciparum malaria, anemia may develop acutely or chronically, 
and may range from mild to severe.  In the case of life-threatening 
anemia, a feature of severe and complicated malaria, the only effective 
treatment currently available is blood transfusion, which carries risks 
for transmission of other blood-borne pathogens such as HIV.  Severe 
malarial anemia is multifactorial, involving increased erythrocyte 
destruction as well as decreased erythrocyte production.  Factors 
reported to contribute to severe anemia include hemolysis of 
uninfected, as well as parasitized, red cells, erythrophagocytosis, 
bone marrow suppression, ineffective erythropoiesis and 
dyserythropoiesis, inadequate erythropoietin production, and 
concomitant infections.  The mechanisms underlying severe malarial 
anemia are poorly understood, apparently involving humoral (e.g. 
antibody and/or complement) as well as cellular (e.g. cytokine) immune 
responses.  The immunologic basis of severe malarial anemia is of 
particular interest because of its potential relevance to malaria 
vaccine development.  Recent observations of severe anemia developing 
in non-human primates (Aotus) following vaccination with blood-stage 
antigens and challenge infection, or after repeated P. falciparum 
infection and drug cure, suggest that improved understanding of the 
pathogenesis of severe malarial anemia will be an important factor in 
the development of safe and effective vaccines.

The training objectives of this RFA support those of the MIM 
(http://www.nih.gov/fic/programs.html) and complement those of the WHO 
Roll Back Malaria program (www.rbm.who.int).  The Dakar Conference 
recommendations (http://www.niaid.nih.gov/dmid/malaria/) called for 
both long-term and short-term training of African scientists and health 
professionals to acquire the capabilities necessary to independently 
carry out high quality research from its conception and protocol 
development to its execution and reporting and publishing results.  It 
was recommended that training provide relevant technology transfer and 
create institutional expertise in malaria through balanced and 
productive collaborations with scientifically advanced malaria research 
laboratories.  An extensive analysis of malaria research capacity in 
Africa was recently published (www.wellcome.ac.uk/mim).

Training Objectives

It is expected that each malaria research training program supported 
will:
o  substantially increase the expertise of trainees in malarial anemia 
related research;
o  expand collaborative malaria research interactions between grantee 
and malaria endemic developing country scientists;
o  strengthen sustainable malaria research within endemic developing 
country institutions, building scientific excellence for training 
future generations of endemic developing country scientists;
o  provide data for research-based decision making for malaria clinical 
treatment and prevention programs and to inform national health care 
policy in malaria endemic developing countries; and
o  enhance research conducted under NIAID RFA-AI-01-007.

Training Plan

1.  Applicants should design a training plan that attempts to fill 
specific gaps in malarial anemia research expertise at the 
collaborating endemic developing country institution that will result 
in a critical mass of scientists and health professionals able to 
address issues of high priority to treat and prevent malaria-associated 
anemia in their country.  A proposal may incorporate a wide range of 
long-term and short-term research training opportunities offered to a 
wide range of possible endemic developing country participants to 
achieve the creation of or expansion to a scientifically autonomous 
malarial anemia research group capable of equal partnership in 
international collaborative efforts.  A proposed training plan can 
include grantee institution-based research training.  However, 
applicants are strongly encouraged to provide support and mentored 
research training conducted in the trainees’ home country to the 
greatest extent possible in the context of ongoing collaborative 
research between the grantee and endemic country investigators.  
Proposals for innovative ways to involve trainees in collaborative 
malarial anemia research projects and intervention trials in their home 
countries are strongly encouraged.  Applicants are also strongly 
encouraged to include women in the selection of trainees.

2.  Long-term training (usually a minimum of two years) may include 
studies leading to an advanced degree or a mentored post-advanced 
degree experience.  Applicants should describe how the long-term 
training proposed will combine the acquisition of specific expertise to 
successfully answer a hypothesis-based malarial anemia research 
question with the opportunity to acquire multidisciplinary knowledge 
about the biomedical and public health aspects of malaria to the 
greatest extent possible.  Long-term training should include academic 
courses taken at the grantee institution, including instruction in the 
responsible conduct of research, laboratory safety, medical 
informatics, technical writing and English as a second language, if 
necessary. 

3.  Applicants are expected to develop, promote and facilitate short-
term training opportunities targeted toward the specific research needs 
of their endemic developing country collaborators, which will directly 
enhance their research capabilities.  Short-term training may be 
offered on such topics as new laboratory, clinical or behavioral 
research methods, medical informatics, biostatistics, data management 
and intervention trial protocol development or in areas which support 
research efforts such as institutional review board (IRB) and biosafety 
procedures, proposal writing and research administration skills.  When 
a short training course or workshop is given by one malaria research 
training program, it is expected that this activity will be open to 
trainees from the other training programs supported through this RFA to 
whatever extent feasible.

Training activities will be coordinated, facilitated and monitored by a 
Training Advisory Group, comprised of malaria research training program 
PIs, major endemic country collaborators and FIC program staff, which 
will meet annually.

Types of Training

1.  Long-term pre-doctoral training in malaria-related anemia research 
leading to a masters or Ph.D. or equivalent degree for individuals with 
or without previous research experience in this field.  Research 
training should relate directly to the PI’s or a co-investigator’s 
collaborative research in malarial anemia at the endemic country site 
and may range from two to four years.
2.  Long-term post-advanced degree research experience for malaria 
endemic country scientists and health professionals including malaria-
related clinical training for approximately two years duration.
3.  Short-term training in either the grantee or endemic country site 
of up to four weeks in specific research methods or other laboratory, 
clinical, field or administrative skills related to the malarial anemia 
research efforts at the collaborating endemic country institution for 
technicians, health care professionals and research administrative 
staff.
4.  Short-term training of three to six months duration for individuals 
with advanced degrees or health care professionals conducted in the 
grantee institution in research methods or other skills to support 
specific collaborative malarial anemia research efforts at the endemic 
country site.
5.  Advanced research training support (re-entry grants), generally for 
one to two years, to enable trainees with advanced degrees or health 
care professionals to continue mentored malarial anemia research in 
their home country or to initiate independent malarial anemia research 
projects related to ongoing collaborative research at the endemic 
country collaborating institution.

SPECIAL REQUIREMENTS

The PI and major endemic country collaborator will be responsible for 
the progress made by the trainees and the overall conduct of each 
malaria research training program.

Training Advisory Group

A.  Training Advisory Group (TAG) will be established after awards are 
made to coordinate and facilitate training activities among all malaria 
research training programs supported by this RFA.  The TAG will include 
the PIs and major endemic country collaborators of each malaria 
research training program, and FIC and NIAID program staff.  The TAG 
will have responsibility for advising, coordinating, and facilitating 
common training courses and opportunities from which all programs can 
benefit to enhance the progress of trainees in light of the evolving 
needs for malaria research.  FIC will also facilitate coordination and 
collaboration with other U.S. government institutions within and 
outside of NIH (e.g. NIAID, CDC, USAID, DOD, etc.) and with 
international research organizations and foundations, including the 
MIM, the WHO, and other in-country projects funded by NIH.

Training in Responsible Conduct of Research

Applicants must include plans for training in responsible conduct of 
research for long-term trainees and short-term trainees.  An award will 
not be made unless a description of such training is included.  The 
description should include the topics, format, faculty participation, 
instructional materials and the frequency and duration of the training 
provided.

Recruitment and Selection Plan

The applicant institution must include a detailed plan describing the 
recruitment, criteria and selection procedures for trainees.  Degree 
candidates must meet all entrance requirements of the grantee degree-
granting institution.

If applicable, proposals should describe the mechanism for internal 
peer review of re-entry grant applications to support malarial anemia 
research projects at the endemic country site conducted by returning 
trainees by a committee composed of grantee and endemic country 
investigators from participating institution(s).

Trainee Tracking System

Applicants should describe their plan to track the short- and long-term 
impact of malaria research training on their trainees.  Awardees will 
be required to implement a system to track and document the long-term 
impact of this training program on:  (1) the careers of all trainees; 
(2) the research capacity at the collaborating endemic country 
institution of trainees; (3) positions trainees assume upon completion 
of training; (4) the contributions of trainees to future NIH- or other-
supported international malaria research and intervention trial 
efforts.  Examples of training impact include how training enabled 
participants to assume more responsible positions upon returning home, 
how collaborations with former trainees resulted in the funding of 
malaria intervention trials or collaborative research projects for 
which trainees were either PIs or co-investigators, and publications of 
research results authored by trainees supported by this program.

During the first year after the awards are made, FIC staff will work 
with grantees to standardize tracking systems among programs for annual 
progress reporting based on the ideas presented in their applications 
and FIC program staff experience with similar programs.  It is expected 
that the standardized tracking system developed will be implemented in 
all programs.  The impact of training resulting from each program will 
be an important criteria considered during any recompetition of this 
RFA.

Research Training Involving Human Subjects

Applicants must inform the FIC program staff that approval of research 
protocol involving human subjects has been obtained from U.S. and 
developing country IRBs and required U.S. and foreign government 
agencies before training in research involving human subjects is 
initiated.  Training involving human subjects in research funded by 
NIAID must obtain NIAID approval of clinical protocols prior to the 
initiation of the study according to the policy announced in the NIH 
Guide on February 24, 2000 (available at 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html).  
Full details of this policy are available at the NIAID web site 
(http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).  

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 sub-populations must be included in all NIH-supported 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED “NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research,” published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm:  
The revisions relate to NIH defined Phase III clinical trials and 
require:  a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS 
IN RESEARCH INVOLVING HUMAN SUBJECTS:

It is the policy of NIH 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 was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and is available 
at the following URL address:  
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

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 an 
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.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes:  1) a descriptive title of the proposed research training 
program, 2) the name, address, email address and telephone number of 
the PI and the major endemic country collaborator, and 3) the 
identities of other key personnel and participating institutions.  
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 staff to estimate the potential review workload 
and to plan the review.

The letter of intent is to be sent to Dr. Barbara Sina as listed under 
INQUIRIES by the letter of intent receipt date listed in the heading of 
this RFA.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants.  These forms are available at most 
institutional offices of sponsored research and from the Division of 
Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone 301/435-0714, email:  GrantsInfo@nih.gov.

The RFA label available in the PHS 398 (rev. 4/98) 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 
two of the face page of the application form and the YES box must be 
marked.  The RFA number must be typed on the label as well.

The sample RFA label is available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been 
modified to allow for this change.  Please note this is in pdf format.

Submit a signed, single-sided, typewritten original of the application, 
including the Checklist, and three signed photocopies, in one package 
to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional exact copies of the 
application and all five sets of appendices should be sent to:

Nancy Saunders Ph.D.
NIAID-DEA
67000B Rockledge Drive, Room 2103, MSC-7616
Bethesda, MD 20892-7616
Telephone: 301-496-8536
FAX: 301-402-2638
Email: ns120v@nih.gov
For express mail carriers use zip code 20817.

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.

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.

REVIEW CONSIDERATIONS

Applications will be reviewed for completeness by the CSR and 
responsiveness by FIC.  Incomplete and/or nonresponsive applications 
will be returned to the applicant without further consideration.  
Applications that are complete will be evaluated for scientific and 
technical merit by a peer review group convened by NIAID in accordance 
with the standard NIH peer review procedures.  As part of the initial 
merit review, all applications will receive a written critique.  
Applications may undergo a streamlined review process.  In this 
process, only those applications deemed to have the highest scientific 
merit, generally the top half of applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the FIC Advisory Board.

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 training will have a substantial impact on 
the pursuit of these goals.  Each of these criteria will be addressed 
and considered in assigning the overall score, weighting them as 
appropriate for each application.  Note that the application does not 
need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important research training 
that by its nature is not innovative but is essential to move a field 
forward.

Applicants for new malaria research training program awards must also 
have submitted an application for malarial anemia research support in 
response to NAIAD AI-01-007.  Current malaria research training program 
awardees applying for supplemental funding must demonstrate relevant 
research support from NIH or another funding source that will serve as 
the foundation for the research training proposed.  The scientific 
evaluation of each application will include an assessment of linkage 
between the proposed training and malaria research support for the PI 
and other co-Investigators and major endemic country collaborators.  
Evidence of support for initiating the proposed malaria research 
training program from the collaborating endemic country institution (s) 
must be submitted with the application.

Significance

1.  The need for the specific malarial anemia research training 
proposed to fill specific gaps in malarial anemia research expertise at 
the collaborating endemic developing country institution
2.  The expected public health and scientific contributions related to 
the proposed malarial anemia research training
3.  The demonstrated capacity or potential to achieve independent and 
sustainable laboratory, clinical or public health malarial anemia 
research capacity through the proposed training efforts 

Approach

1.  The clarity and feasibility of the research training objectives
2.  Adequacy of the research training plan to achieve the proposed 
training objectives including:
o  a trainee recruiting, application and selection process that 
captures the most qualified individuals who could most benefit from the 
training proposed (the proposed qualifications of potential candidates 
should be well described in terms of academic status and previous 
research and/or malaria control experience);
o  a process for matching trainees to appropriate mentors or 
instructors and research projects or new skills to be acquired;
o  balance in the proposed long-term research training to provide a 
breadth of knowledge in either academic based laboratory, clinical or 
public health studies while providing specific malarial anemia research 
training to fill recognized gaps in expertise at the collaborating 
endemic country institution;
o  the adequacy of the mixture of long- and short-term training 
opportunities within the program as a means to achieve the overall 
objectives stated;
o  provision of training in research-related topics such as laboratory 
safety, responsible conduct of research, technical writing, statistical 
methods, good clinical practice, medical informatics, English as a 
second language (if necessary), etc; and
o  process for periodic evaluation of short- and long-term trainee 
progress including academic and research achievement, assistance with 
common trainee problems and mentorship for successful trainee 
presentations of research results at appropriate scientific conferences 
and authorship in scientific publications.
3.  Adequacy of the methods to monitor the long-term impact of the 
malarial anemia research training experience on the subsequent careers 
of the trainees and malaria scientific and public health capacity in 
the endemic country.
4.  Adequacy of plans to include an adequate representation of women 
among the endemic country trainees.

Innovation

1.  Innovation in strategies for trainees to become actively involved 
in malarial anemia laboratory, clinical or public health research or 
intervention trials conducted at the endemic country site.
2.  Innovation in training strategies to produce a critical mass of 
independent malarial anemia researchers and sustainable malarial anemia 
research training by trainees at the endemic country collaborating 
institution after the end of the program.
3.  Creativity of plans to use modern information technology to 
facilitate trainee access to scientific information, distance learning 
and collaborative interaction.

Investigators

1.  Qualifications of the program director to lead and the grantee and 
endemic country faculty to participate as mentors in the proposed 
research training program.  (The malarial anemia research experience 
and training records, particularly of foreign scientists, should be 
included in addition to Biographical Sketches and Other Support forms 
for each key personnel and endemic country faculty participant.)
2.  Adequacy of the ongoing collaboration between the grantee and 
endemic country investigators and their institutions to provide a 
suitable framework in which the proposed training will occur.
3.  The extent and effectiveness of previous efforts made by applicants 
in developing biomedical and prevention research training programs 
necessary to support infectious disease research and biomedical 
research efforts in the home countries of trainees including efforts 
made to focus resources to build long-term clinical research, 
operational research and public health capacity at a model infectious 
diseases center in the home country of trainees.

Environment

1.  The adequacy of the teaching and research facilities and other 
resources and the overall training environment at the grantee and 
endemic country institutions.
2.  The grantee and endemic country institutional commitments to 
international malaria research training.

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:
o  The reasonableness of the proposed budget and duration in relation 
to the proposed research.
o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research involving human subjects.  Plans for the recruitment and 
retention of subjects will also be evaluated.
o  The adequacy of the proposed protection for participants, animals or 
the environment, to the extent they may be adversely affected by the 
project proposed in the application.

Schedule
Letter of Intent Receipt Date:    May 23, 2001
Application Receipt Date:         June 28, 2001
Peer Review Date:                 October, 2001
Council Review:                   February, 2002
Earliest Anticipated Start Date:  March, 2002

AWARD CRITERIA

In addition to the outcome of the initial scientific peer review, the 
following may also be considered in making funding decisions:

o  For new awards, success in obtaining award in response to NIAID RFA 
AI 01-007.
o  Cost-effectiveness of the programs.
o  Collaboration with other NIH, CDC, USAID and DOD programs and 
institutions and with other organizations involved in malaria research 
and prevention and control.
o  The extent to which proposed training programs support and 
complement other NIH international infectious diseases research 
efforts.
o  The availability of funds.
o  FIC program balance among critical research and public health 
training areas of emphasis.
o  The geographic distribution among countries included in applications 
under consideration, including the need for a given program to work in 
a specific country.

Before any funds can be expended for activities at the endemic country 
site from this award, the grantee institution must show evidence of 
approval for collaborative research and training between the grantee 
and endemic country countries and institutions included in the program 
through an endorsement from an appropriate officials from the 
collaborating institutions.

INQUIRIES

Written and telephone inquiries concerning this RFA are strongly 
encouraged.  The opportunity to clarify any issues or questions from 
potential applicants is welcome.

Direct inquiries regarding program issues to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 402-9467
FAX:  (301) 402-0779
Email:  barbara_sina@nih.gov

Direct inquiries regarding review issues to:

Nancy Saunders, Ph.D.
Scientific Review Program
NIAID-DEA
6700B Rockledge Drive, Room 2217
Bethesda, Maryland 20992-7616 (Express/courier service use 20817)
Telephone: 301-402-2636
FAX: 301-402-2638
Email: ns120v@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Bruce Butrum
Office of the Director
Fogarty International Center
31 Center Drive, Room B2C39, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
FAX:  (301) 402-0779
Email:  butrumb@mail.nih.gov

AUTHORITY AND REGULATIONS

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 NIH 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 PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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