INTERNATIONAL CLINICAL, OPERATIONAL AND HEALTH SERVICES RESEARCH AND TRAINING 
AWARD (ICOHRTA)

Release Date:  February 13, 2001

RFA:  RFA-TW-01-003 (This RFA has been reissued, see RFA-TW-06-002)

Fogarty International Center (FIC)
 (http://www.nih.gov/fic)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
National Institute on Aging (NIA)
 (http://www.nih.gov/nia/)
National Center for Complementary and Alternative Medicine (NCCAM)
 (http://nccam.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov/)

Letter of Intent Receipt Date:  March 15, 2001
Application Receipt Date:       April 27, 2001

PURPOSE

The International Clinical, Operational and Health Services Research 
and Training Award (ICOHRTA) supports training to facilitate 
collaborative, multidisciplinary, international clinical, operational, 
health services and prevention science research between U.S. 
institutions and those in developing countries, as well as emerging 
democracies of Eastern Europe, Russia, and the Newly Independent States 
(NIS).  The ICOHRTA will address global health problems by extending 
and enhancing the research of the collaborating U.S. and foreign 
scientists while increasing the clinical, operational, health services 
and prevention research capacity of the collaborating foreign 
scientists and their institutions.  Awards will be made to the U.S. 
applicant institution to support a clinical, operational and health 
services research training program that will include training at the 
U.S. and foreign collaborating sites and mentored clinical, 
operational, health services and prevention science research carried 
out mainly at the foreign site.  Applicant institutions can request up 
to five years support for a standard program or up to three years 
support to plan and develop a program.

The Fogarty International Center (FIC) together with the National 
Institute of Mental Health (NIMH), the National Institute on Drug Abuse 
(NIDA), the National Center for Complementary and Alternative Medicine 
(NCCAM), National Institute on Aging (NIA) and the National Institute 
of Dental and Craniofacial Research (NIDCR), invite applications for 
international clinical, operational, health services and prevention 
science research and training programs which encourage the development 
of evidence-based interventions, for major global health problems, 
which are appropriate to local circumstances in the foreign 
collaborating country.  Eligible topics are all clinical, operational, 
health services and prevention science research areas supported by or 
relevant to the participating NIH institutes (including mental 
health/neuropsychiatric disorders, drug abuse/addiction, aging-related 
and dental/craniofacial-related diseases and disorders and 
complementary and alternative medicine).  NIMH will also consider 
applications in the area of HIV/STD prevention. Research topics must 
also be relevant to a major current or anticipated future medical or 
public health problem(s) in the foreign collaborating country of 
trainees participating in the program.  Future competitions of this RFA 
will focus on clinical, operational, health services and prevention 
science research and training, in additional areas of biomedical 
research, to reduce the global burden of disease and disability.  
Consult the World Health Organization "Global Burden of Disease" 
website at http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro.

For the purposes of this RFA, clinical research is patient-oriented 
research in which an investigator directly interacts with human 
subjects.  This area of research includes:  therapeutic interventions, 
clinical trials, epidemiologic, behavioral and demographic studies and 
the development of new technologies.  For example, a program under this 
RFA might focus on preventive interventions to reduce the risk of 
suicide in high-risk populations or develop or adapt treatments 
(including pharmacological, other somatic, psychosocial or a 
combination) to enhance functional outcomes for individuals and 
families.  In particular, programs are encouraged that train clinical 
investigators in the basic development, conduct and interpretation of 
intervention trials research in order that they may function 
effectively as independent researchers or collaboratively with their US 
colleagues as part of multi-site networks. A program proposed to NIMH 
under this RFA might include collaborative interventions to prevent the 
spread of HIV in high risk populations.

Health services and outcomes research include studies which examine the 
organization, financing, management and delivery of health services and 
their impact on access to, and utilization, quality, cost and outcomes 
of care.

Operational research encompasses translation of knowledge and 
technologies to field and clinic use, how to best implement existing 
and new prevention strategies, therapeutic tools and other 
interventions for broad-based field use, and the study of barriers to 
such translation and implementation.  When interventions have been 
shown to be successful on a small scale or in limited situations, 
operations research will help determine how to best generalize such 
interventions for widespread and sustainable use.  Operational research 
includes research that studies factors (such as economics, demographics 
and the characteristics of service delivery systems) that influence the 
effectiveness of interventions in “real world settings”. 

Excluded from consideration are:
o  Projects that do not involve some component of research or 
evaluation (e.g., demonstration projects or health services delivery 
projects that do not involve evaluation)
o  Studies of animals.

The research subjects for all types of eligible research may be 
individuals, families, organizations, institutions, communities, 
populations or nations. 

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.  This Request for 
Applications (RFA), International Clinical, Operational and Health 
services Research and Training Award (ICOHRTA), is related to one or 
more of the 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. non-profit public and private 
institutions, such as universities, colleges, and eligible agencies of 
the Federal government capable of meeting the objectives of the RFA. 

The U.S. scientist will apply as Principal Investigator (PI) with a 
major foreign collaborator (MFC) from a single foreign institution in 
an eligible country.  This is intended to concentrate resources to 
maximize the impact of the investments in building clinical, 
operational, health services and prevention science research capacity 
at the foreign institution.  For the purpose of this program, eligible 
foreign countries, where the proposed research training will be based, 
include those in the following regions:  Africa, Russia and the Newly 
Independent States (NIS), Asia (except Japan, Singapore, South Korea 
and Taiwan), the Pacific Island region (except Australia and New 
Zealand), the Middle East (except Israel), Latin America (Mexico, 
Central and South America) and the Caribbean.

This international capacity building effort is intended to build upon a 
strong U.S.-based research training or curriculum development program.  
Consequently, to be eligible for an ICOHRTA, the following requirements 
must be met:

o  U.S. applicants must be program directors or project directors on an 
eligible “parent grant,” defined as an institutional research 
curriculum development or institutional research training award, or 
center grant which includes training in clinical, population or 
operational/health services research from participating NIH institutes.  
Other FIC D43 training and capacity building awards do not meet the 
requirement for an eligible parent grant for an ICOHRTA application.  
With prior approval from the FIC program staff, institutional awards 
for clinical, operational or health services research and training from 
other sources (other government agencies, foundation grants) may be 
considered.  In such cases, the ICOHRTA would support a unique clinical 
, operational or health services research opportunity of importance to 
the foreign country and relevant to the mission of the collaborating 
NIH Institutes.  The parent grant must be active and funded at the 
start of the proposed ICOHRTA budget period.  The parent grant must 
have a minimum of 15 months (12 months if applying for a Developmental 
Award application) of funding remaining, at the time of application 
deadline, to be eligible for ICOHRTA funding.  The ICOHRTA funding 
period may extend beyond the parent grant funding period.

o  The ICOHRTA clinical, operational, health services and prevention 
science research training proposal should, in general, be an extension 
of the area or areas of clinical, operational or health services 
research training covered by the parent grant. 

o  Diseases or conditions, such as physical disabilities and injuries, 
which are addressed in the application, must be of interest to the 
collaborating NIH institute and relevant to a major current or 
anticipated future medical or public health problem(s) in the foreign 
collaborating country of anticipated trainees.  In general, the problem 
addressed will be associated with a current or anticipated high level 
of morbidity, disability or mortality in the foreign collaborating 
country.  (Please refer to the WHO "Global Burden of Disease" website 
at  http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro.)  The 
applicants are strongly encouraged to contact the institute program 
staff listed under INQUIRIES before preparing an application.  
Applications that are not within the mission of, or relevant to, the 
collaborating NIH institutes will be returned.

o  The MFC must hold a faculty research position at a public or private 
non-profit research institution that will allow him or her adequate 
time and provide appropriate facilities and resources, including access 
to patients or patient data, to provide mentored clinical, operational 
or health services research experience for trainees upon return to the 
home country.

o  With prior approval from FIC staff, an individual U.S. institution 
may submit more than one application (up to a maximum of three) if each 
application involves a different area of health science/parent grants 
(e.g. mental health, aging, drug abuse/addicion etc).  Each application 
must be associated with a separate, active, identified NIH-funded or 
other eligible parent grant, but all of these applications from a given 
U.S. institution must be for collaboration with the same foreign 
institution.  Any exceptions require prior approval of the FIC program 
staff.

o  An intramural NIH investigator may not serve as PI on an ICOHRTA.  
However, participation of NIH intramural programs as training sites is 
encouraged, consistent with NIH policies on visiting scientists.  
Participation by NIH intramural programs requires concurrence by both 
the Scientific Directors of the participating institutes as well as the 
Deputy Director for Intramural Research of the NIH.  A participating 
NIH intramural program must pay for the participation of its own staff, 
including travel expenses and for any research cost at NIH.  Stipends 
for the foreign trainees would be paid under the ICOHRTA award. 

o  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 (F & A) costs to eight percent.  
The standard ICOHRTA will provide up to $250,000 per year in direct 
costs for up to five years.  The Developmental ICOHRTA grant will 
provide up to $100,000 per year in direct costs for up to three years.  
Five-year standard awards are intended for applicants who already are 
involved in collaborative research and training at the foreign 
institution.  Three-year developmental awards are for applicants who 
have already initiated research and training collaboration at the 
foreign site and wish to build upon that.  Developmental awards may 
include support for time and travel to plan the program, for curriculum 
development and for the initiation of short-term training.  
Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant.  The applicant 
organization must provide the necessary management for the transfer of 
funds and materials to the collaborating MFC country institution.  
Costs required to support research and training at the MFC country 
institution, such as institutional review boards and access to 
facilities, library services, Internet, etc., with justification, can 
be charged as direct costs.  Travel, salaries and fringe benefits will 
be subject to the applicant institution’s rules and regulations.

The initial training is generally expected to take place in the U.S, 
however, it may take place at the foreign site if appropriate 
facilities and resources are available.  The training-related mentored 
clinical, operational, health services and prevention science research 
under the ICOHRTA award is expected to occur mainly at the foreign 
site.  Greater than 50 percent of the funds, over the period of the 
award, must be spent at the foreign site to support the research 
training and other components of clinical, operational, health services 
and prevention science research capacity building at the foreign site.  
As the research capacity increases over time at the foreign sites a 
greater emphasis will be placed on training at the foreign sites by the 
foreign collaborators.

Continued support during this period depends on satisfactory 
performance as judged by:  annual progress reports, site visits, 
participation in periodic meetings of program directors, career 
progress of trainees (e.g., positions occupied in MFC country), 
research undertaken and research awards received, first-author 
publications and presentations by current and former trainees, 
development of institutional, national or regional capacity for 
clinical, operational, health services and prevention science centers 
of research excellence in the home countries of trainees and in 
influencing policies that reduce health risks.

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
Trainees may be paid a stipend while conducting long-term training-
related research at the MFC country site at levels comparable with the 
salary scales for similar professionals in that country in accordance 
with the collaborating MFC country or grantee institution’s policies 
but not exceeding $45,000 per year.  Applicants may consider the NRSA 
stipend levels at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-011.html 
as basis for setting stipends when no appropriate 
institutional level exists.  

Faculty at the grantee institution who provide major program 
administration or extended long-term training or conduct collaborative 
research with students at the MFC 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 , mentoring, and 
teaching responsibilities and time commitment for personnel receiving 
salary should be thoroughly described.  (Form 398 budget pages, 
personnel)

MFC country institution faculty who provide consultation at the MFC 
country site, or participate in long-term training of participating 
students at the MFC country site, and grantee faculty or MFC country 
faculty who teach short courses may receive a consulting fee not to 
exceed $3000, in accordance with their institution’s policies.  
Standard ICOHRTAs may not use more that $25,000 directs costs for 
consultant fees during a single budget period.  Developmental ICOHRTAs 
may not use more that $10,000 direct costs for consultant fees during a 
single budget period.  The administrative, training or teaching 
responsibilities and time commitment for personnel receiving consulting 
fees should be thoroughly described.  (NRSA substitute pages- training 
related expenses)

Up to $25,000 direct costs may be used to provide salary and fringe 
benefits for clerical support staff for the program at the grantee 
institution or foreign site for a Standard ICOHRTA.  Up to $10,000 
direct costs may be used to provide salary and fringe benefits for 
clerical support staff for the program at the grantee institution or 
foreign site for a Developmental ICOHRTA.  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
Funds for academic fees and self-only or family medical insurance for 
MFC country trainees at the grantee or MFC institution may not exceed 
$62,500 and $25,000 direct costs for Standard and Developmental ICOHRTA 
grants, respectively.  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
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 MFC country trainee to travel to the 
grantee institution or other approved training sites or for MFC 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.)  Funds may be requested for per diem and lodging for MFC 
country trainees to participate in short courses or attend scientific 
conferences to present their results.  (NRSA substitute pages, trainee 
travel)

Faculty Travel
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 MFC country site 
or teach short courses at the MFC country site.  Additional travel must 
be approved by FIC staff.  (PHS 398 pages, travel)
Funds may be requested for per diem and lodging for grantee faculty to 
teach short courses at the MFC country site.  (PHS 398 pages, travel)
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) 
for the program Director and other participants to attend network 
meetings.  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
Funds to support MFC country trainee-related research costs at the 
grantee institution (such as textbooks, course material, research 
supplies, computer access, etc.) of up to $600 per month per trainee 
may be requested.  (NRSA substitute pages, training related expenses)

Funds (up to $10,000 per year) to support research at the MFC country 
site associated with fulfilling requirements for an advanced degree may 
be requested.  (NRSA substitute pages, training related expenses.)  

Research support, of up to $20,000 per trainee per year, to facilitate 
conducting advanced research training at the MFC country site (re-entry 
grants) by those finishing training or former long-term trainees in 
collaboration with grantee faculty participants may be requested.  Re-
entry grants may support the purchase of research supplies, a computer 
and appropriate software, computer access fees, small equipment, one 
round trip to the grantee institution per award, scientific meeting 
fees and stipends comparable to salary scales for similar professional 
at the MFC 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 MFC country institutions coordinated by 
the program director.  (NRSA substitute pages, training related 
expenses)

FUNDS AVAILABLE

It is anticipated that about $3,000,000 will be available for the first 
year of the initial awards under this program from the FIC and 
collaborating partners.  This would support an estimated eight new 
awards and seven developmental awards.  Awards will be contingent upon 
availability of funds and the number of meritorious applications.  
Subject to availability of funds, it is the intent to reissue the RFA 
on an annual basis for the next four years, thus allowing developmental 
programs the opportunity to apply for full awards in the future and for 
new areas of health science to be included as additional collaborating 
NIH institutes and centers participate in the program.  The grantee 
institution may request an F & A cost allowance based on eight percent 
of the total allowable direct costs, exclusive of tuition, trainee-
related fees and expenditures for equipment.  Applicants should assume 
a budget increase of three percent per year for each succeeding year, 
contingent upon availability of funds. 

FIC welcomes cost-sharing or other means of support from U.S. and 
foreign institutions.  Such support, while not a prerequisite for an 
award, could include U.S. institution’s coverage of U.S. faculty 
participation, waiver or reduction of tuition for foreign trainees, 
donation of equipment to the foreign site, or, on the foreign side, 
waiver of custom duties for equipment.  

TYPES OF TRAINING

The main objective of the ICOHRTA program is to support research 
training to build clinical, operational, health services and prevention 
science research capacity at the collaborating foreign institutions 
from which trainees are selected and to which trainees are expected to 
return.  These collaborations should extend or enhance the clinical, 
operational, health services and prevention science research interests 
of both the U.S. PI and the foreign co-investigator equally.  At the 
same time, the research capacity of the foreign investigator and 
institution should increase such that sustained and productive 
clinical, operational, health services and prevention science research, 
to address health problems relevant to the participating foreign 
country, can be conducted.

Clinical, operational, health services and prevention science research-
related training for health scientists and health professionals may 
include the following types of training:
o  long-term (greater than 12 months and up to two years or more 
depending on resources) training in pre- or post-doctoral programs, 
with the understanding that all thesis-related work would be done in 
the trainee"s home-county.
o  short-term (less than three months) training that could include 
focused workshops on program and grants administration, technology 
transfer, data management or Internet connection.
o  intermediate-term (three to 12 months) training, including 
specialized activities in support of clinical, operational, health 
services and prevention science research, pilot trials or 
interventions.  Such training could include topics above as well as 
ethical review issues and practicalities.  

While a range of short- and long-term training is allowable, emphasis 
will be on intermediate to longer-term training, including mid-career 
training.  This approach will accelerate building an enduring clinical, 
operational, health services and prevention science research and public 
health capability at the collaborating institution in participating 
countries.

To a limited extent, U.S. trainees will be eligible for foreign 
research experiences under this program, with prior FIC approval, if 
they have uniquely relevant expertise or skills which will contribute 
to the training and research at the foreign institution.  

The ICOHRTA encourages program directors to include women as trainees 
and faculty and, if U.S. trainees and faculty are involved, to include 
women and minorities.

RESEARCH OBJECTIVES

Background
By the year 2020, projections from the World Health Organization 
indicate that non-communicable diseases will contribute up to 60 
percent of the world’s burden of disease 
(http://www.who.int/msa/mnh/ems/dalys/intro.htm#intro).  Changing 
economic and demographic trends in developing nations, including 
increasingly aging populations, will play a major role in this 
epidemiologic shift.  Increases in chronic, non-communicable conditions 
such as mental health disorders, drug abuse/addiction, dementia, 
obesity, tobacco-related diseases including cancer, pulmonary and 
cardiovascular diseases, hypertension, diabetes and asthma will add to 
the already unacceptable burden of illness caused by infectious 
diseases such as HIV/AIDS, TB and malaria.  

Lack of access to appropriate care for most of a country’s population, 
along with out-dated care when available, has been cited as 
contributing to mortality and morbidity, regardless of cause, in many 
resource-poor countries.  Knowledge gained through new methods of 
research and current methods extended into new areas as appropriate, 
will profoundly influence the scope of clinical investigation and 
implementation of health services and prevention strategies in 
international health. 

Unique opportunities exist for international partnerships to confront 
the changing burdens of disease and health disparities among developing 
nations. Along with implementation of proven interventions, many 
promising scientific advances, such as the development of new 
diagnostics, therapies and vaccines, could contribute to reductions in 
global health disparities. However, the health care systems in many 
countries, for a variety of reasons, have failed to implement even 
proven interventions or the most promising advances.

To be successful, a well-trained cadre of scientists in developing 
nations will be needed to plan, design and conduct clinical, 
operational, health services and prevention science investigations, 
including epidemiological, behavioral, demographic and economic 
studies, prevention research and investigations of complementary and 
alternative therapies.  The training of international scientists 
alongside U.S. researchers will help to produce this cadre of experts 
and will facilitate collaborative clinical trials and operational, 
health services and prevention science research for the benefit of 
developed and developing country populations.

These awards are intended to strengthen the global capacity to conduct 
clinical, operational, health services and prevention science research 
necessary to measure incidence and prevalence of diseases and chronic 
conditions, characterize disease burdens, to devise and evaluate 
practical and affordable therapeutic or preventive interventions, and 
to help developing nations contribute to, and benefit from, 
international efforts to apply current knowledge and new discoveries to 
clinical public health practice.  Proposed institutional and capacity-
strengthening training programs should be designed to fill specific 
gaps in needed expertise and to establish a critical mass of trained 
biomedical and behavioral scientists and health professionals able to 
work cooperatively on clinical, operational, health services and 
prevention science research issues in collaborating institutions in 
developing countries.  

Curriculum topics may include topics such as: clinical trials design, 
community-level studies, observational study design, survey and 
sampling methodology, disease mechanisms and pathogenesis, research 
bioethics, biostatistics, specialized courses in epidemiology, outcomes 
research, cost-effectiveness studies, pharmacokinetics, internet 
technology, telemedicine, computer-based training for basic behavioral 
science, policy analysis, data management and analysis, grantsmanship 
and other related topics.  Each training proposal should incorporate a 
number of long-term (greater than one year), intermediate(three to 12 
months) and short-term (less than three months) training opportunities 
(including in-country research) in a wide range of relevant disciplines 
and skills necessary to advance research objectives while building 
sustainable clinical, operational, health services and prevention 
science research capacity at a center of research excellence at a 
foreign site.

The overarching research objective is to develop a cadre of experts in 
clinical, operational, health services and prevention science research 
in the developing world that can assist in advancing joint research 
efforts.  Future competitions of this RFA will continue to seek 
applications to build clinical, operational, health services and 
prevention science research capacity at foreign sites in response to 
global health threats.  The areas of emphasis under this RFA reflect 
the research missions of the participating NIH institutes in mental 
health, aging, drug abuse/addiction and complementary and alternative 
medicine.  For global health concerns of NIMH also please refer to 
http://www.nimh.nih.gov/publicat/burden.cfm. The NIDCR would be 
particularly interested in international applications addressing 
disorders such as oral cancer, soft tissue diseases of the oral cavity, 
craniofacial anomalies, temporomandibular disorders, oral and facial 
pain and salivary gland diseases.

SPECIAL REQUIREMENTS

o  Commitments:  The PI and MFC will be responsible for the overall 
conduct of the ICOHRTA.  The institution of the PI and MFC must have 
entered into a long-term commitment in writing to build the clinical, 
operational, health services and prevention science research capacity 
of the foreign institution through governmental-supported or other 
resources.  A copy of this agreement must be included with the 
application.  Should NIH intramural labs or programs be involved in the 
ICOHRTA application, they should also be party to these agreements.  
Participation by NIH intramural programs requires concurrence by both 
the Scientific Directors of the participating institutes as well as the 
Deputy Director for Intramural Research of the NIH.

o  Integration of the ICOHRTA with the parent grant program is 
required.  List the specific aims of the parent grant.  Also list the 
specific aims of the ICOHRTA proposal and discuss how the specific aims 
of the ICOHRTA relate to the aim(s) of the parent grant.  While not 
required, integration of the ICOHRTA with other relevant programs 
funded by FIC, NIH or other sources will strengthen the application.  
Applicants should also describe any plans to integrate ICOHRTA with 
other relevant programs in the foreign institution and within the 
country.  

o  Recruitment and Selection Plan:  The domestic applicant institution 
must include a plan describing the recruitment and selection procedures 
for trainees and a detailed description of peer review for training-
related and advanced in-country clinical, operational, health services 
and prevention science research.  Degree candidates must meet all 
entrance requirements of the U.S. degree-granting institution or of the 
foreign degree-granting institution, if applicable.  The application 
should clarify and completely specify:  (a) criteria and procedures for 
the selection of trainees as, for example, by a committee composed of 
U.S. and foreign investigators at the participating institution(s) and 
(b) a mechanism for internal peer review of applications to support 
U.S. and in-country clinical, operational, health services and 
prevention science research projects.

o  Establishing research priorities:  Applicants should assure that 
clinical, operational, health services and prevention science research 
priorities reflect those of the participating foreign country and 
should describe the procedures to assure this takes place within the 
context of the collaborative relationship.

o  Strategy for regional impact:  The application should emphasize 
clinical, operational, health services and prevention science research 
capacity building at the collaborating foreign institution. It is also 
desirable for the application to describe strategies to achieve a wider 
regional impact. This could be done by strengthening other institutions 
in the MFC country or in neighboring countries. The goal is to become 
not only a national but also a regional center of clinical, 
operational, health services and prevention science research 
excellence, capable of offering training in these areas, and 
introducing sophisticated technology as appropriate, to scientists from 
other countries.

o  Evidence of host country support for the program will strengthen the 
application.  Such evidence of support should be provided in writing 
and could be in the form of one or a combination of the following:  a 
statement of support from a senior administrator at the MFC country 
institution, evidence of cost-sharing by the host country and 
willingness of the host country to utilize trainees’ experience, and 
knowledge gained from the program, to build clinical, operational, 
health services and prevention science research capacity at a center of 
research excellence in the collaborating country.

o  Plans for continued collaboration with former trainees once they 
return home must be described.  

o  Tracking system for long-term impact:  As part of their obligations 
under this program, awardees are required to design, as part of their 
application, a system to track fully and document the long-term impact 
of this training program on:  (1) the career choices and progress of 
current and former trainees, (2) the participation of former fellows in 
ICOHRTA as faculty and trainees, (3) building clinical, operational, 
health services and prevention science research capacity in the home 
institution and country of trainees, (4) types of positions the 
proposed trainees may assume upon completion of training and 
documentation of career progress, (5) the possible contributions to 
future NIH and other U.S. and non-U.S. government agency-supported 
international research and public health efforts, (6) the strengthening 
of the foreign institution for clinical, operational, health services 
and prevention science research training, and (7) the contributions of 
the program toward interventions or policies that address health 
problems in the home country of trainees.

Impact will be an important criterion for assessing success in any 
future recompetition of this program.  Detailed examples of past and 
future expected successes should be included.  Examples of successes 
include how training received under the program has allowed 
participants to assume more responsible positions upon returning home, 
how continuing collaborations with former trainees resulted in 
obtaining grants or other support, how training contributed to 
publications in which trainees were first authors and which were based 
upon support under this program, how training and related research 
findings contributed to development and implementation of health 
policies, how any existing FIC/NIH programs were enhanced by ICOHRTA 
and vice versa.  

After awards have been made, but before tracking of impact is 
implemented, FIC will work with awardees to design a standardized web-
based tracking system for individual trainees and reporting program 
impact and accomplishments.  This system will build upon FIC experience 
in other research training programs and be compatible with them.  Once 
this standardized tracking system has been finalized, it will be 
implemented across all programs.  

o  Before any funds may be expended on in-country research, the grantee 
institution must show written evidence of formal approval (assurances) 
from responsible authorities at the collaborating institution, from an 
institutional (or ethical) review board or committee at both the U.S. 
and foreign institutions and from the relevant government authority.  
Please see:  Procedures for Registering Institutional Review Boards and 
Filing Federalwide assurances of Protection for Human Subjects (FWAs) 
http://www.hhs.gov/ohrp/assurances/assurances_index.html.  

o  There will be periodic network meetings in Bethesda or other sites 
during the course of a five-year grant.  Those receiving Developmental 
awards would be expected to participate in these meetings, the purpose 
of which will be to exchange research and training experience and 
coordinate program activities.  PIs, MFCs, program administrators and 
selected trainees are expected to attend.  Funds for this activity 
(travel and per diem) should be included in the budgetary requests.

o  As part of proposed training programs, the applicants must describe 
in detail how they propose to train students and investigators in the 
responsible conduct of research consistent with existing NIH policies 
for Institutional NRSA awards located at 
http://grants.nih.gov/grants/guide/pa-files/PA-00-103.html.  
An award will not be made unless such a plan is 
included.

o  Applicants must inform the FIC program staff that approval of 
research protocols involving human subjects has been obtained from U.S. 
and developing country institutional review boards and required U.S. 
and foreign government agencies before training-related research 
involving human subjects is initiated. 

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 formatting and 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, by March 
2, 2001, 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 MFC, 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:

Kathleen M. Michels, Ph.D
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Email: ICOHRTA@nih.gov

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.  Applications are 
also available on the Internet at 
http://grants.nih.gov/grants/funding/phs398/phs398.html.  Budget on 
pages as defined under allowable costs.

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.  
Applications should clearly specify whether the proposal is for a full 
five-year ICOHRTA or for a developmental award.  Submit a signed 
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 copies of the application and 
appendices must be sent to: 
Jean G. Noronha, Ph.D.
NIMH Referral Liaison
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD  20852 (for express/courier service)

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.

It is important to send these copies at the same time as the original 
and three copies are sent to the Center for Scientific Review.  These 
copies are used to identify conflicts of interest and to help ensure 
the appropriate and timely review of the application.

If an application is received after the receipt 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

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

Applications will be assigned to the FIC.  The clinical, operational, 
health services and prevention science research training and capacity 
building proposals will be reviewed for scientific and technical merit 
and quality of the collaboration by a special emphasis panel comprised 
of a broadly multidisciplinary review group convened by the NIMH.  As 
part of the initial merit review, all applications will receive a 
written critique and assigned a priority score.  Following the 
scientific-technical review, the applications will receive a second 
level review by the FIC Advisory Board.

REVIEW CRITERIA

The ICOHRTA program addresses the need to build clinical, operational, 
health services and prevention science research capacity at specific 
institutions in a collaborating country to combat problems relevant to 
that country’s health.  In the written comments, reviewers will be 
asked to discuss these aspects of the application in order to judge the 
likelihood that the proposed clinical, operational, health services and 
prevention science research training will have a substantial impact on 
the pursuit of these goals, including building sustainable capacity to 
support future clinical, operational, health services and prevention 
science research at the foreign site.

Review criteria include those generally applicable to research training 
programs and research.  The scientific evaluation of each application 
will include assessment of the linkage between proposed training and 
clinical, operational, health services and prevention science research 
and current training programs supported by FIC, as well as other 
research and prevention programs supported by collaborating NIH 
institutes, and USG agencies, foundations, etc.  Evidence of support 
for this program by collaborating institutions and foreign governments 
must be submitted in writing with the application.  The following 
review criteria will be used for both full and developmental 
applications with the understanding that a full application will be 
judged on the likelihood of success in building upon an existing 
collaboration and a developmental application by the likelihood of 
success in establishing a new collaboration.

1.  Significance:  
o  Does this training program address an important clinical, 
operational or health services research problem and do the program 
priorities reflect those of the collaborating country?  If the aims of 
the application are achieved, how will scientific knowledge be 
advanced?  What will be the effect of the training and studies on the 
concepts or methods that drive this field?
o  The expected public health and scientific contributions of the 
proposed activity at an institutional, country and regional level 
including potential to serve as a training site for other countries, 
and
o  The demonstrated capacity and/or potential to achieve sustained 
clinical, operational, health services and prevention science research 
and training efforts at the MFC site, and to build associated clinical, 
operational, health services and prevention science research and public 
health capacity within a country and within the region.

2.  Approach:  
o  Are the conceptual framework, and training plan adequately 
developed, well integrated, and appropriate to the aims of the research 
training and to the capabilities established by the designated parent 
grant?  Details of the training plan should be included.  Does the 
applicant recognize potential problem areas and consider alternative 
tactics?
o  Is there a balance in the proposed training program, to provide 
breadth of training opportunities in academic- and public health-based 
clinical, operational, health services and prevention science research?
o  Does the mix of long- and short-term training achieve the goals of 
this RFA, including focused efforts to build long-term biomedical, 
behavioral, clinical, operational research, and public health capacity 
at the institution within a collaborating country?
o  Is the proposed training plan well integrated into the host 
institution’s research infrastructure and the training plan reflect 
integration of previous FIC and current FIC and NIH support involving 
the foreign collaborating institution?
o  Are the proposed procedures and criteria adequate for 1) 
recruitment, review and selection of trainees, and 2) peer review of 
research? 
o  Considering the challenge grant requirement, is there evidence of a 
long-term commitment by the U.S. institution to collaborate with its 
foreign partner(s) and a significant cost sharing by the U.S. and 
foreign institutions involved in the program?
o  Have the foreign institute(s) and government(s) expressed a 
willingness to take advantage of returning former trainees and 
information gained from the program to improve clinical, operational, 
health services and prevention science research?

3.  Innovation:  
o  Does the clinical, operational, health services and prevention 
science research training program employ novel concepts, approaches or 
methods?  Are the aims original and innovative?  Does the program 
challenge existing paradigms or develop new methodologies or 
technologies?
o  Does the proposal include concrete plans for trainees to become 
involved in clinical, operational, health services and prevention 
science research sciences, biomedical and behavioral research, and 
prevention projects conducted in their home countries?
o  Is there adequate and creative planning for the use of modern 
information technology to facilitate access to scientific information, 
distance learning, coordination and research collaboration?
o  Are there creative strategies to take advantage of training 
opportunities in other countries and to achieve a regional impact?
o  Is there evidence of integration among and with other FIC programs, 
NIH research and activities of other relevant organizations at the 
foreign site?

4.  Investigator:  
o  Are the PI, MFC, co-PI, and mentors in the U.S. and abroad, 
appropriately trained and well suited to carry out this work?  Is the 
work proposed appropriate to the experience level of the PI and other 
MFC researchers, if any?
o  Are the qualifications of the PI, MFC, and the named faculty 
adequate to lead and to productively participate in the proposed 
training and research program
o  Do the PI, MFC, and participating faculty provide active and 
adequate research support?
o  Have the parent grant requirements been met and does the area of 
health science in the parent grant relate to and support the proposed 
training program?
o  Have the PI, MFC and key faculty previously collaborated on either 
research or training?

5.  Environment:  
o  Does the scientific environment in which the training and research 
work will be done in the U.S. and abroad contribute to the probability 
of success?  Do the proposed activities take advantage of unique 
features of the scientific environment or employ useful collaborative 
arrangements?  Is there written evidence of institutional support by 
the U.S. and foreign institutions to build clinical, operational, 
health services and prevention science research capacity at the foreign 
institution?

o  Are there adequate mentoring and strength of resources and training 
environment in-country as evidenced by 1) the quality of teaching and 
the in-country research facilities and other resources, 2) the 
availability and history of high-quality candidates chosen on merit, 
and 3) past history of success of former trainees returning to their 
home countries and their continued involvement in the program, for 
example, the participation of past trainees in advanced in-country 
research and as faculty and mentors for new trainees?
o  The initial review group will also examine the adequacy of the 
process for providing for the protection of human and animal subjects, 
the safety of the research environment, and plans to include training 
in responsible conduct of research and training in the operation of 
Institutional Review Boards (IRBs) or equivalent ethical review boards, 
data and safety monitoring boards and community advisory boards as a 
part of the program.  IRBs in the home countries of trainees will be 
responsible for determining the adequacy of inclusion of women, 
minorities and children in research involving human subjects in their 
countries.  Is required training on protection of human subjects 
documented in application?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

1.  Past research training record for both the PI and MFCs in the U.S. 
and abroad, and designated preceptors, in terms of tracking careers of 
their past U.S. and foreign trainees and the rate at which former 
trainees establish independent and productive research and public 
health careers, and, for foreign trainees, percent who return to their 
home country, please include tables with this information, including 
current status of foreign and other selected trainees for at least the 
past five years.
2.  Past research training record in terms of the success of former 
trainees in obtaining individual awards such as fellowships, career 
awards, and research grants for further development, major scientific 
breakthroughs by trainees should be highlighted.
3.  Recruitment and selection plans in detail for appointees and the 
availability of high quality candidates,
4.  The record of the research training program in retaining health 
professional postdoctoral trainees for at least two years in research 
training or other research activities,
5.  When appropriate, the concomitant multidisciplinary training of 
health professionals.
6.  The adequacy of plans to include both genders, minorities (U.S. 
trainees only) and their subgroups, and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated.
7.  The reasonableness of the proposed budget and duration in relation 
to the proposed research and training.
8.  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.

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

1.  Scientific, technical, medical and public health significance, and 
originality of proposed research,
2.  Appropriateness and adequacy of the experimental approach and 
methodology proposed to carry out the research,
3.  Qualifications and research experience of the Principal U.S. and 
Foreign Investigator(s) and staff, particularly, but not exclusively, 
in the area of the proposed research,
4.  Availability of the resources necessary to perform the research,
5.  Appropriateness of the proposed budget and duration in relation to 
the proposed research.

SCHEDULE

Letter of Intent Receipt Date:  March 15, 2001
Application Receipt Date:       April 27, 2001
Date of Initial Review:         July, 2001
Review by Advisory Council:     September, 2001
Anticipated Award Date:         September, 2001

AWARD CRITERIA

The most important factor to be considered in making funding decisions 
will be the quality of the proposed project as determined by initial 
scientific peer review.  The proposed instruction in the responsible 
conduct of research must be rated adequate for an award to be made.  
Geographic and programmatic balance, as well as input from the 
collaborating partners and the FIC Advisory Board and the adequacy of 
the cost-sharing challenge grant components of the program will also be 
considered in making funding decisions.  A consideration for funding 
will be whether the proposed training and capacity building is 
integrated with or duplicates efforts in other FIC and NIH programs and 
whether it supports a unique intervention opportunity not able to be 
accommodated by another FIC program. 

Before any funds can be expended from this award for in-country 
research, the grantee institution must show evidence of approval for 
collaborative research and training between the U.S. and foreign 
country and institution included in the program through an endorsement 
from the appropriate government official(s) as well as from the 
collaborating institutions.

INQUIRIES

Inquiries are encouraged.  Also please refer to our web site for 
frequently asked questions (FAQs) http://www.nih.gov/fic/.  The 
opportunity to clarify any issues or questions from potential 
applicants is welcome.  Direct inquiries regarding programmatic issues 
to:

Kathleen Michels, Ph.D
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email: ICOHRTA@nih.gov

Steven Gust, Ph.D.
Acting Director, International Program
National Institute on Drug Abuse
Room 5-274
6001 Executive Blvd
Bethesda, MD 20892
301-443-6480
Email:  sgust@nih.gov

Willo Pequegnat, Ph.D
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health 
Room 6205 NSC, 6001 Executive Blvd., Bethesda, MD
Phone: 301 443 6100. 
Email: wpequegn@mail.nih.gov

Enid Light, Ph.D 
Program Official
Career Development and Research Training and Fellowships Programs 
National Institute of Mental Health
6001 Executive Boulevard, Rm. 7117, 
Bethesda, MD 20892-9629
Phone: 301-443-1185, 
E-mail: elight@nih.gov

Rose Maria Li, MBA, PhD
Behavioral and Social Research Program
National Institute on Aging
201 Wisconsin Avenue, Suite 5C533, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-3138
FAX:  (301) 402-0051
Email: BSRquery@nia.nih.gov (e-mail correspondence is preferred)

Nancy A. Hazleton, MPH
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 106
Bethesda, Maryland 20892-5475
email:  hazleton@mail.nih.gov

James A. Lipton, DDS, Ph.D.
Assistant Director, Office of Training and Career Development
Division of Extramural Research, NIDCR
Building 45, Room 4AS-37J
Bethesda, MD 20892-6402
Telephone: (301) 594-2618
FAX: (301) 480-8318
Email:  james_lipton@nih.gov

For grants management and fiscal matters, contact:

Mr. Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  (301) 496-1670
FAX:  (301) 594-1211
Email:  butrumb@mail.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.934.  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 Public Health 
Service (PHS) grants policies and Federal Regulations 42 CFR 52 and 45 
CFR Part 74.  This program is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency 
review.

The PHS strongly encourages all grant 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.



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