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

RELEASE DATE:  February 20, 2003 (see correction, NOT-TW-03-008)

PA NUMBER:  PAR-03-072  

Letter of Intent Receipt Date:  May 12, 2003, May 10, 2004, May 10, 2005   

Application Receipt Date:  June 10, 2003; June 10, 2004, June 10, 2005  

EXPIRATION DATE:  June 11, 2005, unless reissued.

Fogarty International Center (FIC)
 (http://www.fic.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) 
 (http://www.niaid.nih.gov/default.htm)
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH) 
 (http://www.nimh.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/)
United States Agency for International Development (USAID) 
 (http://www.usaid.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.989

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Program Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplemental Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This program announcement replaces PA-02-022 published in the NIH Guide, 
November 28, 2001.

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 HIV/AIDS, TB or both are 
significant problems.  As used in this Program Announcement (PA), the term 
ICOHRTA-AIDS/TB is broadly defined to encompass building capacity for 
integrated clinical, operational, and health services research across the 
full range of conditions and issues that relate to care of adult and 
pediatric patients with HIV/AIDS or TB (e.g., opportunistic infections, HIV 
malignancies, neurological and mental health consequences, behavioral issues, 
cardiovascular disease, hematologic conditions, blood safety issues, 
pulmonary manifestations, ophthalmologic manifestations, gastrointestinal 
conditions, drug and alcohol usage, gender-related issues and oral health 
manifestations).  This program is an integral and critical component of a 
comprehensive global strategy of the National Institutes of Health (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.  It will extend and intensify 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 
(U.S.) 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 consists of one-year planning 
grants to foreign institutions to develop an application for a Phase II 
Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement.  The Phase I award will 
provide support for the applicant to:

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 (USG) 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 
2004 (FY04).  Only the recipients of the Phase I planning grants and their 
chosen U.S. (or pre-approved non-U.S.) collaborating partner institutions 
(together referred to as Research Training Units) are eligible to apply for 
Phase II Comprehensive ICOHRTA-AIDS/TB awards.  Phase II awards will provide 
support to both partner institutions in the Research Training Unit through 
five-year cooperative agreements.  The awards will support implementation of 
the proposed research training program designed to 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).  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 to develop and extend 
core research support capabilities necessary for long-term sustainability of 
the research capacity of the foreign institution.

The Fogarty International Center (FIC), together with the National Institute 
of Allergy and Infectious Diseases (NIAID), the National Institute on Drug 
Abuse (NIDA), the National Institute of Mental Health (NIMH), the Office of 
Research on Women's Health (ORWH). the Centers for Disease Control and 
Prevention (CDC), and the U.S. Agency for International Development (USAID), 
invites applications for one year planning grants to develop international 
clinical, operational, and health services research training programs.

Co-sponsoring institutions are United States Government (USG) agencies 
contributing financial resources to the program.  Applicants are strongly 
encouraged to design programs that provide capacity building in support of 
the National Institutes of Health (NIH), USG, and other international efforts 
to respond to this global health crisis.  

Clinical research, in the context of this PA, includes studies of 
interventions 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 
clinical methods to deliver, monitor, and sustain AIDS and/or TB 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 best to 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, including innovative 
strategies for providing therapy and care.  This research also includes 
studies of quality, cost, and effectiveness of proven therapeutic or 
prevention interventions.

Core research support capabilities are defined as those skills required by an 
institution to successfully compete for and conduct research.  These skills 
include ethics and compliance issues, protection for human subjects, animal 
welfare, fiscal management, budgeting, a continuing education system, program 
and grants administration, grant and report writing, preparation of 
scientific manuscripts, information technologies, technology transfer and the 
management of intellectual property, data management, and Internet 
connection.

Excluded from consideration are training and capacity building linked or 
related to 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), 
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 studies involving animals.

PROGRAM OBJECTIVES

In developing proposals for planning grants, applicants need to be aware of 
the objectives and special requirements for the comprehensive program as 
described in the Request for Applications TW-03-003 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-03-003.html).  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 ICOHRTA-AIDS/TB program 
strongly encourages program directors to include women and individuals from 
underrepresented racial, ethnic and socially disadvantaged groups in the 
country 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.
2.  The prevention and/or reduction of spread of HIV and TB and related 
conditions, especially measures that can be implemented within the context of 
care.
3.  The study of strategies for scale up and integration of effective 
therapeutic and preventive interventions into the local health care system.  

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 required for success by building on existing research and 
training programs involved with the implementation of prevention and care 
interventions at the country level.  An additional important capacity 
building component is to strengthen the core research support capabilities 
needed to compete for and manage research grants at the foreign site.  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 an 
application that describes a comprehensive international clinical, 
operational and health services training program to submit for the Phase II 
competition.  Separate applications will be submitted by the planning grant 
awardee and by its collaborating partner for Phase II Comprehensive ICOHRTA-
AIDS/TB Cooperative Agreements.  The applications of the Research Training 
Unit partners should describe identical or similar training programs but 
include the budget and budget justification for the portion of the training 
program for which each partner applicant will assume financial 
responsibility.  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) a 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. 
 
MECHANISM OF SUPPORT

Phase I - One Year Planning Grant to a Foreign Institution

For Phase I of the program, this PA will use the NIH D71 International 
Training Program Planning Grant mechanism.  As an applicant, you will be 
solely responsible for planning, directing, and executing the proposed 
project.  If an NIH intramural investigator is involved in the program, the 
planning grant may be converted to a cooperative agreement at the time of 
award.  The FIC and co-sponsoring partners intend to fund an estimated six 
planning (D71) grants from this PA in FY04 and in fiscal year 2005 (FY05). 

Involvement of an intramural investigator in the program must include 
collaboration that 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.

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 D71 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.

ELIGIBLE INSTITUTIONS

You may submit an application if your institution has all of the following 
characteristics:  

o  Non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Foreign institutions in one of 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

To best support the building of sustainable research in low-income and 
transitional economy countries, only 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 are eligible to apply for a planning grant.  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.  Only one application to the ICOHRTA AIDS/TB 
program (Phase I and Phase II) will be funded from any foreign institution.  
If a foreign institution does not have an existing award for the ICOHRTA 
AIDS/TB program, only one application for a planning grant from any foreign 
institution can be submitted for consideration at any one time.  If a foreign 
applicant also is collaborating with an NIH intramural research program, two 
applications are allowed.
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

To qualify, Principal Investigators must be actively involved in HIV or TB 
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 Principal Investigator must hold faculty or another long-
term research position at a public or private non-profit research institution 
that will allow him/her adequate time and provide appropriate facilities, 
salary support and resources, including access to patients or patient data, 
when necessary.

Women and individuals from underrepresented racial, ethnic, and socially 
disadvantaged groups in the country, as well as individuals with 
disabilities, are always encouraged to apply for NIH programs.

Phase II – Five-Year Comprehensive Cooperative Agreements (beginning FY 2004)

Foreign grantees that have been awarded an ICHORTA-AIDS/TB Planning Grant and 
their collaborating partner are expected to apply for Phase II Comprehensive 
ICHORTA- AIDS/TB Cooperative Agreements under the FIC Request for 
Applications TW-03-003.  This RFA requires that foreign applicants partner 
with an institution in the U.S. or (with pre-approval) in another developed 
country to submit two applications that describe similar or identical 
training programs that will be reviewed as a single unit.  The partners of 
successful packages or units that are chosen to be funded will each receive 
an award.  FIC plans to reissue the RFA on an annual basis, subject to the 
availability of funds.

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 the 
Scientific Director of the participating Institute.  The participating NIH 
intramural program must pay for the participation of its own staff, including 
travel expenses, and for any research costs at NIH.  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 of the involved 
Institute 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.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues.

o Direct your questions about scientific/research training issues to:

Jeanne McDermott
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 496-1492
Fax:  (301) 402-0779
Email:  mcdermoj@mail.nih.gov

o Direct your questions about peer review issues to: 

Elliot Postow 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 4160
Bethesda, MD  20892
Telephone:  (301) 435-0911
Fax:  (301) 490-2327 
Email:  postowe@csr.nih.gov

o Direct your questions about financial or grants management matters to:

Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD  20892
Telephone:  (301) 451-6830
Fax:  (301) 594-1211
Email:  butrumb@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The research training application (20-page limit) should include:
o  the goals, objectives and plan for meeting the objectives for the planning 
grant (2 pages)
o  how the proposed program will address the research needs and health 
priorities defined by the country (2 pages)
o  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, and the organizational structure at each 
institution that will be available for the proposed training program (3-4 
pages).
o  the resource gaps and potential ways to fill these gaps (2 pages)
o  the current and future clinical, operational and health services research 
that will serve as the research base for the proposed training program, and 
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 (3-4 pages) 
o  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 and an estimated time frame for the development 
of the comprehensive application (2-3 pages).

Include biographical sketches and letters of commitment from the foreign 
institutions, foreign Principal Investigator, and potential collaborating 
institution and collaborating Principal Investigator, and a list of the 
recent (within past five years) and active research and training activities 
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.  Please refer to the Review Criteria In the next section of 
the PA to guide you in the preparation of your application. 

APPLICATION RECEIPT DATES:  Applications submitted in response to this 
program announcement (PA) will be accepted on the receipt dates listed in the 
heading of this PA.

LETTER OF INTENT 

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o  Descriptive title of the proposed planning grant
o  Name, address and telephone number of the Principal Investigator
o  Names of other key personnel (including the proposed U.S. or non-U.S. 
major collaborator)
o  Participating institutions 
o  Number and title of this PA

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 by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Jeanne McDermott
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
Telephone:  301-496-1492
Fax:  301-402-0779
Email:  mcdermoj@mail.nih.gov 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this PA.  If an application is received 
after that date, it will be returned to the applicant without review. 

The Center for Scientific Review (CSR) will not accept any application in 
response to this 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.

PEER REVIEW PROCESS

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 this PA will be assigned to 
FIC.  Applications will be evaluated for scientific and technical merit by an 
appropriate scientific review group convened by the CSR 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:

o  receive a written critique
o  be discussed and assigned a priority score, and 
o  receive a second level review by the FIC Advisory Board and other co-
sponsoring Institute/Center (IC) Boards, as necessary. 

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals.

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

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 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.

(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 NIH, other 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 Institutional Review Boards (IRBs) or Ethics 
Committees (ECs) in all participating foreign institutions, if not already 
established?

The scientific evaluation of each application will also include assessment of 
the strength 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.  

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

PROTECTIONS:  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 IRBs or ECs or equivalent ethical review boards, data and safety 
monitoring boards, and community advisory boards as a part of the program.

INCLUSION:  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 or ECs 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.

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

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 RFA for the comprehensive program.

AWARD CRITERIA

Applications submitted in response to this PA will compete for available 
funds with all other recommended applications.  The following will be 
considered in making funding decisions:  

o  Scientific merit of the proposed project as determined by peer review
o  Availability of funds
o  Relevance to programmatic priorities and geographic balance, including 
programs and priorities of collaborating co-funding partners.
o  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 their Councils or Advisory Boards, 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.  

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION 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.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).  
It is the responsibility of the applicant to provide the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application.  In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations.  
Unless otherwise specified in 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.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
PA 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.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance No. 93.989, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of the Public 
Health Service Act, as amended (42 USC 241 and 287b) and administered under 
Public Health Service (PHS) grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Department of Health and Human Services

National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892