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 301/710-0267, 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.
Weekly TOC for this Announcement
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