This Program Announcement expires on December 1, 2004, unless reissued.

PLANNING GRANTS TO ORGANIZE PROGRAMS FOR INTERNATIONAL CLINICAL, OPERATIONAL, 
AND HEALTH SERVICES RESEARCH TRAINING FOR AIDS AND TUBERCULOSIS

PA NUMBER:  PA-02-022

Release Date:  November 28, 2001 (see replacement PAR-03-072)

Fogarty International Center (FIC)
 (http://www.nih.gov/fic)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov/default.htm)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov/)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov/)
Office of AIDS Research (OAR)
 (http://www.nih.gov/od/oar/index.htm)
Office of Behavioral and Social Sciences Research (OBSSR)
 (http://obssr.od.nih.gov/)
Office of Research on Women's Health (ORWH)
 (http://www4.od.nih.gov/orwh/)
Centers for Disease Control and Prevention (CDC)
 (http://www.cdc.gov/)

Letter of Intent Receipt Date:  February 20, 2002
Application Receipt Date:       March 19, 2002

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 
(REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The International Clinical, Operational, and Health Services Research Training 
Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) Program provides extended 
support for training to foster collaborative, multidisciplinary research in 
developing country sites where AIDS, TB or both are significant problems.  As 
used in this Program Announcement (PA), the term ICOHRTA-AIDS/TB should be 
interpreted as building capacity for integrated clinical, operational, and 
health services research encompassing the full range of conditions and issues 
(e.g., opportunistic infections, HIV malignancies, neurological and mental 
health consequences, behavioral issues, hematologic conditions, blood safety 
issues, pulmonary manifestations, ophthalmologic manifestations, 
gastrointestinal conditions, drug and alcohol usage, gender-related issues and 
oral health manifestations) that relate to care of adult and pediatric 
patients with HIV/AIDS or TB.  This program is an integral and critical 
component of a comprehensive global strategy of the NIH and Department of 
Health and Human Services (DHHS) to address the needs of the millions 
suffering from HIV/AIDS, tuberculosis, and related conditions in resource-
limited nations by extending and intensifying efforts to provide clinically 
appropriate and sustainable care to these individuals in a manner that 
supports continuing and expanding prevention activities.  These efforts will 
have direct health, economic and security benefits for the United States as 
well as the global community.  This program will increase research training 
across the span of clinical science and public health practice and involve a 
wide range of health professionals (e.g. nurses, midwives, physicians, 
dentists, health care administrators and public health workers).  
 
The first phase of the ICOHRTA-AIDS/TB program, beginning in fiscal year 2002, 
will consist of one year planning grants to foreign institutions using the R21 
grant mechanism.  The R21 grant will provide support to organize, plan for, 
prepare, and assemble an application for a Comprehensive ICOHRTA-AIDS/TB 
Cooperative Agreement.  During an R21 award, the applicant should:

o  solidify collaborative relationships and understandings with all individual 
and institutional partners;
o  define the type of research training programs to be developed in 
cooperation with its principal and any other collaborating partners and in 
consultation with staff from FIC and other U.S. Government co-sponsoring 
organizations of this program;
o  assess current resources and needs including the need for an institutional 
review board;
o  develop a step-wise plan to address these needs;
o  develop an institutional (organizational) structure including links with 
other relevant national and international organizations that conduct and 
support clinical, operational, and health services research;
o  identify the training, staff development, and scientific and administrative 
resources needed to undertake a comprehensive training program;
o  prepare an institutional development plan for at least the next ten years 
demonstrating how resources from a Comprehensive ICOHRTA-AIDS/TB Cooperative 
Agreement in conjunction with resources from other collaborating partners and 
from the applicant will allow the applicant institution to achieve its long-
term development goals.

The second phase of the ICOHRTA-AIDS/TB program will begin in fiscal year 
2003, and will provide comprehensive sustained support to both the foreign 
institution and its linked U.S. partner (or pre-approved non-U.S. institution) 
through five-year cooperative agreements (potentially renewable).  Training 
will take place at the U.S. or foreign sites and mentored research will be 
carried out mainly at the foreign site.  The program may also provide support 
at the foreign site for training in support of development and extension of 
core capabilities necessary for long-term sustainability.  

The Fogarty International Center (FIC), together with NCI, NIAAA, NIAID, 
NICHD, NIDA, NIMH, NINDS, OAR, OBSSR, ORWH, and CDC, invites applications for 
one year planning grants to develop international clinical, operational, and 
health services research training programs which foster the development of 
integrated strategies to successfully implement evidence-based interventions 
pertinent to the global health crises created by HIV/AIDS and tuberculosis 
(TB).  Co-sponsoring institutions are United States Government (USG) agencies 
contributing financial resources to the program.  Cooperating organizations 
are organizations whose resources are made available to be utilized in support 
of the program.  Applicants are strongly encouraged to design programs that 
provide capacity building in support of the National Institutes of Health 
(NIH), United States Government (USG), and other international efforts to 
respond to this global health crisis (see special requirements for examples).

NIH defines human clinical research as:  (1) Patient-oriented research.  
Research conducted with human subjects (or on material of human origin such as 
tissues, specimens and cognitive phenomena) for which an investigator (or 
colleague) directly interacts with human subjects.  Excluded from this 
definition are in vitro studies that utilize human tissues that cannot be 
linked to a living individual.  Patient-oriented research includes:  (a) 
mechanisms of human disease, (b) therapeutic interventions, (c) clinical 
trials, or (d) development of new technologies.  (2) Epidemiologic and 
behavioral studies.  (3) Outcomes research and health services research.  
Note:  Studies falling under Exemption 4 for human subjects research are not 
considered clinical research by this definition.  

In the context of this PA, this definition of clinical research includes 
studies of an intervention intended to prevent transmission or to improve the 
quality of life for HIV- or TB-infected children, men or women.  This area of 
research involves, but is not limited to, clinical trials of biomedical, 
behavioral, or combination interventions, the development of new technologies, 
and new ways to deliver, monitor, and sustain AIDS and/or tuberculosis care.

Operational research is defined as research that encompasses the translation 
of knowledge, practices, and technologies into clinical use.  Examples include 
assessment of how to successfully implement existing and new prevention 
interventions, therapeutic tools, and other care interventions for broad-based 
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, operational research will help determine how to best generalize 
such interventions for widespread and sustainable use.  Operational research 
includes studies of factors that influence the effectiveness of interventions 
in "real world settings."

Health services research includes studies that examine the organization, 
financing, management, and delivery of health services and how they impact a 
person's ability to utilize HIV and TB health services.  This research also 
includes studies of quality, cost, and effectiveness of proven therapeutic or 
prevention interventions.

Excluded from consideration are training and capacity building linked or 
related to:

o  studies that do not involve some component of research with a scientific 
question or evaluation (e.g. demonstration projects or health services 
delivery projects that do not involve evaluation of a hypothesis);
o  studies that do not include an intervention designed to prevent 
transmission or provide treatment/care for individuals infected with HIV or TB 
and other associated opportunistic infections; and
o  studies involving animals.

The training-related research subjects for all types of eligible research may 
be individuals or groups, such as families, organizations, institutions, 
communities, or populations.

RESEARCH AND PUBLIC HEALTH OBJECTIVES AND SPECIAL REQUIREMENTS FOR THE 
COMPREHENSIVE PROGRAM

In developing proposals for planning grants, applicants need to be aware of 
the objectives and special requirements for the comprehensive program as 
described below.  The training supported under the comprehensive program will 
help to produce a cadre of experts who will facilitate integrated clinical, 
operational, and health services research for the benefit of developed and 
developing country populations.  These scientists will comprise a resource 
that will facilitate additional training and research in the region.  

The types of training under the comprehensive program will include:

o  Long-term (greater than 12 months and up to four years, depending on 
resources) training for the full range of skills necessary to support clinical 
research in masters or doctoral programs, with the understanding that all 
thesis-related work would be done in the trainee's home country.  With prior 
FIC approval, pre-masters training will be allowed for health professionals 
with demonstrated interest and capability, but whose prior professional 
education does not include a bachelor's level degree (e.g., nurses, midwives, 
laboratory technicians).

o  Short-term (less than three months) training or mentoring that focuses on 
research methodology, laboratory skills necessary to support clinical 
research, ethics and compliance issues, program and grants administration, 
grant writing, preparation of scientific manuscripts, technology transfer, and 
data management or Internet connection.

o  Intermediate-term (three to 12 months) training or mentoring, including 
specialized clinical and laboratory skills necessary to support clinical, 
operational, and health services research that is planned or ongoing.

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 enduring capability for clinical, 
operational, and health services research at the participating foreign 
institutions.

Each research-training proposal for a comprehensive program should incorporate 
a number of long-term (greater than one year), intermediate term (three to 12 
months) and short-term (less than three months) training opportunities 
(including advanced in-country research) in a wide range of relevant 
disciplines and skills necessary to advance research objectives while building 
sustainable clinical, operational, and health services research capacity at a 
center of research excellence at a foreign site.

To a limited extent, U.S. trainees will be eligible for foreign research 
experience under this comprehensive program, with prior FIC approval, if they 
have uniquely relevant expertise and skills that will contribute to the 
training and research at the foreign institution and/or have a major career 
commitment to international research.  NIH intramural research programs may 
also support junior U.S. researchers for research experiences at the foreign 
sites with prior agreement from the foreign site.

The ICOHRTA-AIDS/TB program strongly encourages program directors to include 
women and minorities as trainees and faculty at all sites.

The planning applications must outline the strategies and approach to develop 
a proposal for a comprehensive training program that will build capacity in 
the foreign country to conduct integrated clinical, operational, and health 
services research focused on one or more of the following areas:

1.  The application of clinical science and health care research to benefit 
those already infected with HIV and/or TB.  Examples of this area of research 
include studies:  to address the optimal therapeutic regimens and delivery 
systems for treatment of people with HIV/AIDS and/or tuberculosis and related 
conditions; to determine the impact of treatment on the factors favoring drug 
resistance; to evaluate the prevalence and spread of resistant virus and 
strains of M. tuberculosis and measures to mitigate these events; to define 
and evaluate behavioral interventions and health systems reforms that promote 
compliance with optimal treatment regimens; to identify the co-factors and 
interactions that propagate the epidemics of HIV/AIDS and/or tuberculosis 
(e.g., concomitant sexually-transmitted diseases, nutritional status, blood 
safety,  gender differences); to identify effective interventions to improve 
the quality of life, including palliative care, for men, women, and children 
living with HIV/AIDS and/or TB; and the impact of gender on stigma, on access 
to health services for HIV/AIDS and/or TB therapy.

2.  The prevention and/or reduction of spread of HIV and tuberculosis and 
related conditions, especially that which can be implemented within the 
context of care.  Examples of this area of research include studies:  to 
evaluate the impact of the availability of treatment and care on the 
willingness of people to be tested and to receive their results; to evaluate 
the effectiveness of prevention measures (behavioral change, condom use, 
microbicides, compliance) when offered in conjunction with testing and 
treatment; to evaluate the impact of maternal treatment on mother to child 
transmission and child survival; to understand gender differences on 
acceptance and effectiveness of therapies, care and prevention.

3.  The study of strategies for scale up and integration of effective 
therapeutic and preventive interventions into the local health care system.  
Some examples of research in this area include studies of effective monitoring 
strategies in settings with limited laboratory and medical specialization; 
integration of voluntary counseling and testing (VCT) into health care 
systems; the system features required to ensure availability of clinical 
monitoring, appropriate laboratory tests, and drug supply; the best training 
and utilization of physicians and other categories of health care workers to 
optimize coverage, compliance, and access to the full range of services that 
constitute care for individuals living with HIV/AIDS and/or TB.  

The applicant should describe plans to help assure that its approach to 
clinical, operational, and health services research training will be directly 
relevant to the needs of the people in the international site.  Criteria to 
evaluate relevance include consideration of morbidity, mortality, and 
disability, as well as the economic and public health impact of measures 
taken.

Essential to all research conducted internationally by principal collaborating 
investigators is the need for close consultation with the foreign 
collaborating country, in setting an agenda that is appropriate to local 
circumstances and most likely to affect public health policy.  Also implicit 
is the need to rapidly build the training capacity and infrastructure 
requisite for success by building on existing research and training programs 
involved with the implementation of prevention and care interventions at the 
country level.  The magnitude of the tasks and the urgency to deliver 
measurable progress once funds are committed will require creative solutions 
with high multiplier effects.

The major goal of the ICOHRTA-AIDS/TB planning grant is to develop a 
competitive application for a Comprehensive ICOHRTA-AIDS/TB Cooperative 
Agreement as a linked dual application between the foreign and a U.S. (or 
other) developed country institution which will have the following Special 
Requirements:
o  The foreign principal investigator and the collaborating developed country 
principal investigator will be responsible for the overall conduct of the 
ICOHRTA-AIDS/TB.  The research partner institutions of the foreign principal 
investigator and the collaborating principal investigator must have entered 
into a long-term commitment in writing to build the clinical, operational, and 
health services research capacity of the foreign institution through 
governmental-supported or other resources.  A copy of this agreement must be 
included with the comprehensive application if not already available at the 
time of submission of the planning grant.  Should NIH intramural labs or 
programs be involved in the ICOHRTA-AIDS/TB application, they must also be 
party to these agreements.  Participation by NIH intramural programs requires 
concurrence by both the scientific directors of the participating institutes 
and the Deputy Director for Intramural Research of the NIH.

o  Both the foreign and collaborating site must demonstrate the capacity and 
leadership necessary for the successful implementation and long-term 
productivity of the program.  Both the foreign and U.S. (or other developed 
country site) must have achieved a strong record of receiving or being 
significantly involved in HIV/AIDS and/or TB international research.  To 
qualify, both the foreign and collaborating principal investigator must be 
directly involved in and funded to do clinical research in resource-poor 
settings and there must be tangible evidence of very strong linkage to that 
ongoing research.  Each site should provide a comprehensive list of these 
awards for at least the past five years to support its designation of 
institutional center of excellence status in this field.

o  Evidence of plans for linkage to and coordination with other sources of in-
country research and training support is required.  Examples include:  FIC 
training and research programs (e.g., AIDS, tuberculosis, maternal and child 
health, emerging infectious diseases); NIAID programs (Comprehensive 
International Program of Research on AIDS (CIPRA), the HIV Vaccine Trials 
Network, the HIV Prevention Trials Network, NIAID tuberculosis programs 
supporting the conduct of TB drugs, vaccine efficacy trials and 
infrastructure/research capability strengthening as well as Centers for AIDS 
Research (CFARs) and the AIDS Clinical Trials Groups (ACTG and PACTG); NICHD 
AIDS programs (Global Network on Women's and Children's Health Research, 
Pediatric/Perinatal HIV Clinical Trials Network, African Partnerships 
Program); NIMH AIDS programs (NIMH Collaborative HIV/STD Prevention Trial); 
NCI programs related to AIDS; NIDA programs related to AIDS (Global Research 
Network); NHLBI programs related to AIDS (e.g. blood safety); NIAAA programs 
related to AIDS; the Global AIDS Program and Field Epidemiology Training 
Program (FETP) of the Centers for Disease Control and Prevention; USAID AIDS 
and TB programs; UNAIDS;  Global Fund to Fight AIDS, Tuberculosis and Malaria; 
WHO AIDS and TB programs; UNICEF AIDS programs; and non-government and faith-
based organizations involved in international control of HIV/AIDS and TB 
(e.g., the Bill and Melinda Gates Foundation, the Elizabeth Glaser Pediatric 
AIDS Foundation, the Rockefeller Foundation, the International Union Against 
Tuberculosis and Lung Diseases, the Sequella Global Tuberculosis Foundation, 
the Academic Alliance for AIDS Care and Prevention in Africa, Doctors Without 
Borders, the American Foundation for AIDS Research, the Global Alliance for TB 
Drug Development, the International AIDS Vaccine Initiative, Catholic Relief 
Services and many others).

o  Applicants must describe plans to help assure that the ICOHRTA-AIDS/TB will 
be supportive of and integrated with other relevant programs in the foreign 
institution and within the country (such as those listed above).  They should 
describe how this program can serve as a bridge between academic research and 
public health communities within the country as well as to help link various 
HIV/AIDS and TB trials supported in the country by NIH and other sponsors.

o  Applicants should identify their plans to assure that training and capacity 
building supports the HIV/AIDS and TB-related clinical, operational, and 
health services research priorities of the participating foreign country and 
should describe the procedures to assure this takes place within the context 
of the collaborative relationship.

o  The application should describe plans for the integration of clinical, 
operational, and health services 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 foreign principal investigator 
country or in neighboring countries ("south to south" training).  The ultimate 
goal is to become not only a national but also a regional center of clinical, 
operational, and health services research excellence that is capable of 
offering training in these areas, and in introducing appropriate technology to 
scientists from other countries.

o  Evidence of host-country support for the planning grant as well as 
sustained support for any subsequent comprehensive program is required.  Such 
evidence of support should be provided in writing and should be in the form of 
the following:  (1) a statement of support from a senior administrator at the 
foreign principal investigator 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, and health services research capacity at a center of research 
excellence in the foreign country; and (2) formal letter of support from the 
Health Ministry and/or other senior government official that emphasizes the 
long-term commitment to the goals of the award.

o  Before any funds may be expended on in-country training-related research, 
the grantee institution must show written evidence of federal-wide assurances 
for the collaborating institutions, and approval for the research from an 
institutional (or ethical) review board or committee at both the U.S. or pre-
approved non-U.S. and foreign institutions and from the relevant government 
authority as required.  Please see:  Procedures for Registering Institutional 
Review Boards and Filing Federal-Wide Assurances of Protection for Human 
Subjects (FWAs) http://www.hhs.gov/ohrp/assurances/assurances_index.html.  Applicants should 
document their plans for meeting this requirement.

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 Program Announcement (PA), 
International Clinical, Operational, and Health Services Research Training 
Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB), 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

Phase I - One Year Planning Grants (R21) to foreign institutions

To qualify, principal investigators must be directly involved in and funded to 
do clinical research in resource-poor settings and they must provide tangible 
evidence of very strong linkage to that ongoing research as part of this 
application.

The need for developing additional research capacity in-country must be 
justified by the significance of the AIDS/TB problem as well as a paucity of 
economic resources in the host country.  Eligible foreign sites include 
countries 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.    

In order to best support the building of sustainable research in low-income 
and transitional economy countries, planning grants to support the preparation 
of a comprehensive ICOHRTA-AIDS/TB application will be made only to those 
foreign non-profit public or private institutions (e.g. universities, 
colleges, hospitals or laboratories) which can document a significant and 
active record in HIV/AIDS and/or TB research and training and show potential 
to become national or regional centers of excellence.  The principal 
investigators must hold faculty or other long-term research positions at a 
public or private non-profit research institution that will allow them 
adequate time and provide appropriate facilities, salary support and 
resources, including access to patients or patient data, when necessary.

Phase II - 5 year Comprehensive Cooperative Agreements (beginning FY 2003)

Foreign grantees that have been awarded an ICHORTA-AIDS/TB Planning Grant may 
subsequently apply for Comprehensive ICHORTA- AIDS/TB Cooperative Agreements 
under a future FIC Program Announcement for this purpose.  The PA will require 
that foreign applicants partner with an institution in the U.S. or (with pre-
approval) in another developed country to submit a package of two grants to be 
reviewed as a single unit.

The partners of successful packages or units that are chosen to be funded will 
each receive an award. 

The foreign site and foreign principal investigator will designate a developed 
country institution as its partner, and the principal investigator at this 
site will be referred to as the collaborating principal investigator.  The 
linked institutions will be referred to as "research partners."  With prior 
FIC approval, the designated principal collaborator may be a non-U.S. 
institution or an NIH intramural research program, provided that each commits 
significant resources to this program.  Also with prior FIC approval, and 
concurrence from the foreign PI, the collaborating principal investigator may 
involve additional institutions as collaborating partners through a 
subcontract or consortium arrangement.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 
Investigators.  Only one application will be allowed from any foreign 
institution except if a foreign applicant also is collaborating with an NIH 
intramural research program in which case two applications are allowed.

Participation of NIH intramural programs as training sites and as 
collaborators in capacity building and research at the foreign site is 
encouraged.  An intramural NIH investigator may serve as collaborating 
principal investigator on an ICOHRTA-AIDS/TB with concurrence by both the 
scientific director of the participating institute and the Deputy Director for 
Intramural Research of the NIH.  The participating NIH intramural program must 
pay for the participation of its own staff, including travel expenses, and for 
any research costs at NIH.

The applications from the linked foreign and collaborating institutions must 
demonstrate that, for each site, both the Principal Investigator and the 
institution have a track record of commitment and experience in related 
clinical research and training.  The principal investigators must hold faculty 
or other long-term research positions at a public or private non-profit 
research institution that will allow them adequate time and provide 
appropriate facilities, salary support and resources, including access to 
patients or patient data, when necessary.

MECHANISM OF SUPPORT

Phase I - One Year Planning Grant to a Foreign Institution

For Phase I of the program, this PA will use the National Institutes of Health 
(NIH) R21 planning grant mechanism.  If an NIH intramural investigator is 
involved in the program, the planning grant will be converted to a cooperative 
agreement at the time of award.  

Involvement of an intramural investigator in the program includes 
collaboration which involves a significant contribution to the 
conceptualization, design, execution or interpretation of the research study.  
Simply providing unique biological materials, such as cell lines, antibodies, 
and probes, does not constitute a collaboration.  NIH scientists may serve as 
unpaid collaborators or unpaid consultants on extramural grants.  In these 
cases, a formal letter from the intramural scientist must be included as part 
of the grant application with a copy of this letter sent to the Scientific 
Director.  The letter should be limited to a description of the intramural 
scientist's collaborative work under the grant.  The grant applicant is 
responsible for writing the section of the grant that describes the proposed 
collaboration within the grant, which the NIH investigator should see and 
approve.

In some cases, the work of the intramural scientist is such a substantial part 
of the proposal that the award may need to be managed as a cooperative 
agreement.  Circumstances defining when a grant should be managed as a 
cooperative agreement are defined in the document entitled "Cooperative 
Agreements" available at 
http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/IRP-ERP-Cover-Memo-10-27-99.htm.  
If an intramural scientist believes that his/her contribution requires a 
cooperative agreement, the Scientific Director should be alerted when the letter 
of collaboration is submitted, and, if appropriate, the Scientific Director 
should notify the grants management office of their Institute or Center about 
the nature of the collaboration.

A Phase I award will be made for 12 months at a level of up to $75,000 in 
direct costs (or three modules of $25,000), plus eight percent facilities and 
administrative costs.  Please see the Allowability of Facilities and 
Administrative (F&A) Costs for Foreign and International Organizations at:  
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html) 
in the NIH Guide, March 30, 2001.

Allowable costs for R21 applications include travel, salary, minimum 
consultative fees and administrative costs.  The total amount of salary and 
fringe benefits requested for all grantee faculty must be well justified and 
compatible with salary scales established for similarly ranked professionals 
at the applicant institution.  The time commitment for personnel receiving 
salary should be thoroughly described.

Phase II - 5 Year Comprehensive ICOHRTA-AIDS/TB Cooperative Agreements with 
Linked Foreign and U.S. (or Other) Partners

FIC plans on issuing a PA for funding in fiscal year 2003 for Comprehensive 
ICOHRTA-AIDS/TB Research Training Awards.  International Institutional 
Training Cooperative Agreements will be made with each of the research 
partners for a five year period.  These will be renewable for a second five-
year period as a competing renewal application. 

Each research partner will receive total direct costs up to $250,000 per year, 
as well as facilities and administrative (F&A) costs limited to eight percent.  
Please see the web site 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html 
for more information on the permissible F&A costs for foreign and international 
organizations.  Awards made to foreign institutions for collaboration with NIH 
intramural programs will also be made as cooperative agreements and will be 
limited to the amount agreed to by the involved NIH Institute.

FUNDS AVAILABLE

The FIC and co-sponsoring partners intend to commit approximately $1,000,000 
to fund an estimated twelve planning (R21) grants from this PA in fiscal year 
2002.  The FIC plans to issue a PA for the Comprehensive ICHORTA-AIDS/TB 
cooperative agreements for funding in fiscal year 2003.  FIC and co-sponsoring 
funding partners intend to commit approximately $3,500,000 each year to fund 
an estimated six planning grants and six Comprehensive ICOHRTA-AIDS/TB 
cooperative agreement programs from this PA and the PA for the comprehensive 
program each fiscal year beginning in fiscal year 2003, subject to 
availability of funds. 

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 clinical research 
projects unless a clear and compelling justification is provided indicating 
that inclusion is inappropriate with respect to the health of the subjects or 
the purpose of the research. This policy results from the NIH Revitalization 
Act of 1993 (Section 492B of Public Law 103-43).

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects" that was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

URLs IN NIH GRANT APPLICATIONS OR APPENDICES

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

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS

NIH policy requires education on the protection of human subject participants 
for all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following web site:  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

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

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed planning grant, the name, address and 
telephone number of the Principal Investigator, the proposed U.S. (or non-
U.S.) major collaborator, the identities of other key personnel and 
participating institutions, and the number and title of the PA in response to 
which the application may be submitted.  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 NIH staff to estimate the 
potential review workload and plan the review.  The letter of intent is to be 
sent to Dr. Jeanne McDermott at the address listed under INQUIRIES by the 
letter of intent receipt date listed in this PA.

APPLICATION PROCEDURES

Specific application instructions have been modified to reflect "Modular 
Grant" and "Just-in-Time" streamlining efforts that have been adopted by the 
NIH.  Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (Rev. 5/01).  
http://grants.nih.gov/grants/funding/modular/modular.htm. 

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants.  This version of the PHS 398 is available in an 
interactive, searchable format.  Beginning January 10, 2002, the NIH will 
return applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301/435-0714, Email:  
GrantsInfo@nih.gov.

The application should follow the PHS 398 instructions with the following 
modifications:

The PA label available in the PHS 398 (rev. 5/01) 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 as it 
may not reach the review committee in time for review.  In addition, the PA 
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 PA number must be typed on the label 
as well.  The sample PA label available at 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format. 

Submit a signed 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:  Dr. Madelon Halula at the address listed under 
INQUIRIES.  Applications must be received by the application receipt date 
listed in the heading of this PA.  If an application is received after that 
date, it will be returned to the applicant without review.  

o  The research plan should be replaced with the following:  1) A project 
summary (fifteen page limit) describing the goals, objectives and plan for 
meeting the objectives for the planning grant.  Describe the background of the 
research and training collaborations of the institutions, the principal 
investigators and of the faculty proposed to be the research-training 
partners.  Describe the organizational structure at each institution that will 
be available for the proposed training program.  Identify resource gaps and 
potential ways to fill these gaps.  Describe the current and future clinical, 
operational and health services research that will serve as the research base 
for the proposed training program.  Identify other ongoing and future FIC and 
other research and training programs and potential cooperating partners in the 
country with whom the proposed program can link.  Describe how the proposed 
program will address the research needs and health priorities defined by the 
country.  Include an estimated time frame for the development of the 
comprehensive application.  Describe plans for coordinating preparation of the 
application for the comprehensive program with all partners and with FIC and 
other NIH and USG staff involved as co-sponsors.
o  Biographical sketches and letters of commitment from the foreign 
institutions, foreign principal investigator, and potential collaborating 
institution and collaborating principal investigator.
o  A list of the recent (within past five years) and active research and 
training in HIV and/or TB in which the foreign institution and principal 
investigator have been involved.  Please include grant number (if applicable) 
and the funding agency.

The Center for Scientific Review (CSR) will not accept any application in 
response to this PA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  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 co-sponsoring institutes and organizations.  
Incomplete and/or non-responsive applications will be returned to the 
applicant.  

Applications that are complete and responsive to the PA will be assigned to 
FIC.  Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened by the NIAID in accordance with 
the standard NIH peer review procedures with the review criteria stated below.  
As part of the initial merit review, all applications will receive a written 
critique, and will be discussed, assigned a priority score, and receive a 
second level review by the FIC Advisory Board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  The 
ICOHRTA-AIDS/TB program seeks to build an integrated capacity across the 
spectrum of clinical, operational, and health services research at specific 
foreign institutions to combat problems of HIV/AIDS, TB, and other associated 
conditions relevant to that country's health.  Each of these criteria will be 
addressed and considered in assigning the overall score, weighting them as 
appropriate for each application.  Note that the application does not need to 
be strong in all categories to be judged likely to have major scientific 
impact and thus deserve a high (meritorious) priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

The scientific evaluation of each application will include assessment of the 
linkage (integration and coordination) between the foreign and the 
collaborating components and between proposed training and ongoing clinical, 
operational, and health services research, other current training programs 
supported by FIC, and research and prevention programs supported by co-
sponsoring NIH institutes, USG agencies, international organizations, 
foundations, etc.  Planning award applications will be reviewed for their 
potential to be developed into competitive applications for Comprehensive 
ICOHRTA-AIDS/TB Cooperative Agreements.  Evidence of support for this program 
by collaborating institutions and foreign governments must be submitted in 
writing with the application.  In addition, the following review criteria will 
be used

(1) Significance
o  Has the applicant adequately documented that there is a significant 
HIV/AIDS and/or TB problem in the home country?
o  Is the applicant in a position to design a program that provides capacity 
building in support of the National Institutes of Health (NIH), other United 
States Government (USG) and other international efforts to respond to the 
global health crisis posed by HIV/AIDS and/or TB?
o  Does the foreign institution have the potential to serve as a training site 
to advance an integrated approach to clinical, operational, and health 
services research related to HIV/AIDS and/or TB within the country and 
potentially within the region?

(2) Approach
o  What is the likelihood that the applicant could develop a comprehensive 
ICOHRTA AIDS/TB program that would be supportive of and well-integrated with 
other relevant HIV/AIDS and TB programs in the foreign institution and within 
the country?
o  Has the applicant chosen a suitable collaborating U.S. (or non-U.S.) 
partner with which to implement any future comprehensive program?
o  Does the applicant present a realistic, stepwise plan for developing a 
coordinated application for a comprehensive program?
o  Has the applicant identified an institutional (organizational) structure to 
implement a future comprehensive program?
o  Has the applicant outlined an approach for preparation of an institutional 
development plan demonstrating how resources from a comprehensive program 
award would be integrated with other resources in the country?

(3) Innovation  
o  What is the likelihood that the planned program would take advantage of the 
foreign institution's research infrastructure and that of previous and current 
FIC and NIH investments and support, or support from other organizations?  
o  Are there creative strategies to take advantage of relevant opportunities 
in the applicant's or in other countries?

(4) Investigator

o  Has the applicant and collaborating U.S. (or non-U.S.) partner demonstrated 
an exemplary record in HIV/AIDS and/or TB clinical research and training in 
resource-poor settings and is the applicant currently funded for this research 
and training?  Has the applicant documented that there would be very strong 
linkage to the ongoing clinical research as part of any future comprehensive 
program?
o  Is there a record of successful research or training collaboration among 
the foreign principal investigator, collaborating principal investigator, and 
key faculty of both institutions?
o  Do the principal investigators hold faculty or other long-term research 
positions at a public or private non-profit research institution that will 
allow them adequate time and resources to play leadership roles in the 
program?
o  Are the foreign principal investigator, collaborating principal 
investigator, and all mentors appropriately well-qualified to implement the 
activities of any planned comprehensive training program?
o  Is there evidence of a commitment by the foreign institution and its U.S. 
(or non-U.S.) partners to form long-term collaborative research and research-
training relationships?

(5) Environment
o  Is there a written commitment by the foreign government and Ministry of 
Health to the long-term goals and activities of any future comprehensive 
program?
o  What is the likelihood that any future program would be able to take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements?
o  Are there adequate mentoring resources and a supportive training 
environment in-country as evidenced by:  1) the quality of teaching and the 
in-country research facilities; 2) the availability of high-quality candidates 
for training, chosen on merit; and 3) a past history of success of former 
trainees contributing to their home countries and their programs by 
participation in advanced in-country research and as faculty and mentors for 
new trainees?
o  Are there plans to establish IRBs in all participating foreign 
institutions, if not already established?

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

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the future 
training-related research.  Plans for the recruitment and retention of 
subjects will also be evaluated.  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.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed plan.

o  The adequacy of the proposed plans for protection for humans, animals or 
the environment, to the extent they may be adversely affected by future 
projects undertaken under a comprehensive program.  The initial review will 
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.

o  Recipients of one year planning awards and those wishing to submit amended 
applications from this competition may submit these applications for funding 
consideration in conjunction with the schedule for reviews under this PA and 
the subsequent PA for the comprehensive program.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities and geographic balance, including priorities of 
collaborating co-funding partners.

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 plans for 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 co-sponsoring partners and the 
FIC Advisory Board, will also be considered in making funding decisions.  A 
consideration for funding will be whether the plan for the proposed training 
and capacity building program facilitates and is integrated with (or 
duplicates) efforts in other FIC, NIH, and other international programs, and 
whether it supports a unique intervention and care opportunity not able to be 
accommodated by another FIC or NIH program.  

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Jeanne McDermott, C.N.M., M.P.H., 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:  mcdermoj@mail.nih.gov

Direct inquiries regarding grants management and fiscal matters to:

Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD  20892-2220
Telephone:  301-451-6830
Fax:  301-594-1211
Email:  butrumb@mail.nih.gov

Direct inquiries regarding review issues to :

Madelon Halula, Ph.D.
Special Review Program 
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Scientific Review Program 
6700 B Rockledge Drive
Room 2215, MSC 7616
Bethesda, MD 20892-7616
(For express/courier service:  Bethesda, MD 20817)
Telephone:  (301) 402-2636 
Fax:  (301) 402-2638
Email:  mh30x@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.989.  Awards are made under authorization of sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  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 and contract recipients to provide a 
smoke-free workplace and promote the non-use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking 
in certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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