THE INTERNATIONAL CENTERS FOR EXCELLENCE IN RESEARCH (ICER) CLINICAL RESEARCH 
AND MANAGEMENT TRAINING PROGRAM AWARD

RELEASE DATE:  May 3, 2002

RFA:  TW-03-002

PARTICIPATING INSTITUTES AND CENTERS (ICs):

Fogarty International Center 
 (http://www.nih.gov/fic)
National Institute of Allergy and Infectious Diseases 
 (http://www.niaid.nih.gov/)

LETTER OF INTENT RECEIPT DATE:  June 13, 2002

APPLICATION RECEIPT DATE:  July 11, 2002

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this RFA
o  Research Objectives
o  Mechanism of Support
o  Funds Available
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Receipt and Review Schedule
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS RFA

The Fogarty International Center (FIC), in partnership with the National 
Institute of Allergy and Infectious Diseases (NIAID), invites applications 
from nonprofit, private or public, domestic educational and research 
institutions to develop or expand current graduate health professional school 
curricula to provide training relevant for the conduct and/or management of 
international clinical research on infectious diseases at NIAID- and FIC-
supported research sites in developing countries.  Proposed curricula should 
be designed to provide courses leading to expert certification in specific 
skills required to carry out clinical research or administer research or both 
in the context of international collaboration.  Clinical research training 
and/or management programs will initially provide training for members of the 
NIAID International Centers of Excellence in Research (ICER) Program 
(http://www.niaid.nih.gov/dmid/icer/) with sites currently located in Bamako, 
Mali; Chennai, India; and Kampala, Uganda.  The goal of the ICER program is 
to develop a sustained research program of excellence in areas of high 
infectious disease burden through partnerships with scientists and research 
managers at the foreign sites.  Trainees from other international research 
sites in resource poor countries with significant NIAID and FIC investments 
will participate as the program evolves.  Applications in response to this 
RFA will address the NIAID and FIC goals of facilitating independent research 
capacity through expanded opportunities for training in the administration, 
management and conduct of international clinical research.

RESEARCH OBJECTIVES

Background and aims:
Multiple activities are supported at international research sites by NIAID 
and FIC with the intention to establish long term collaborative and 
integrated infectious disease research partnerships between U.S. and foreign 
institutions, as well as to develop independent research capacity at foreign 
sites in less developed countries.  The new ICER program aims to establish 
sustained collaborative research programs involving NIAID intramural 
scientists and local scientists at overseas research centers, and to expand 
research and research training opportunities at these sites through 
extramural programs.  The NIAID ICER program will support research on all 
infectious diseases of local public health importance.  This ICER clinical 
research and management training program is intended to establish a training 
resource, tailored to the needs of scientists at the ICER sites that is 
capable of expanding core skills in clinical research and research management 
in accordance with internationally accepted guidelines.  Few institutions in 
countries with high burdens of infectious diseases provide formal training in 
the conduct of clinical research and management of research programs and few 
U.S. programs for advanced training in clinical science offer the appropriate 
spectrum and levels of training to accommodate the targeted needs of foreign 
scientists and health professionals.  The long-term goal is the development 
of a self-sustaining educational program relevant to other international 
research and training efforts, including other NIAID- and FIC-supported 
international collaborative research programs involving extramural 
scientists.

Therefore, specific objectives of this program are:  
1)  To assess clinical research and management training needs at ICER sites 
and to implement training curricula for investigators, research managers, 
administrators and others from these sites
2)  To develop a curriculum of clinical research training activities that 
will strengthen the capacity of investigators at ICER and other NIAID- and 
FIC-supported international sites to conduct clinical infectious disease 
research.  It is expected that this curriculum will be developed as a 
comprehensive package that will include training in, but not limited to, the 
following elements:
o  Good clinical practice
o  Clinical research methodology (trial design, data management etc.)
o  Clinical microbiology
o  Epidemiology and biostatistics
o  Responsible conduct of research
3)  To develop a curriculum of research management training that will 
strengthen the capacity of investigators and institutions at ICER and other 
NIAID- and FIC-supported international sites to effectively manage infectious 
disease research programs and projects.  It is expected that this curriculum 
will be developed as a comprehensive package that will include, but will not 
be limited to, the following elements:
o  Project management
o  Financial management and good accounting practices
o  Institutional Review Board processes 
o  Regulatory procedures 
o  Human resources development.

Applicants may propose to provide curriculum for clinical research training 
or research management training or both.  Training should focus on developing 
skills and mentoring for ICER scientists selected to play specific roles in 
NIAID-supported clinical research projects.  Individual courses should be 
planned within each type of curriculum to result primarily in expert 
certification in skills required for design, conduct, and management 
(including administrative management) of clinical research and clinical 
trials, in accordance with internationally accepted guidelines.  The initial 
needs assessment will focus on ICER sites.  However, as the program matures, 
training may be provided for other NIAID- and FIC-funded international 
research sites.  No research will be conducted as part of this training 
grant.

Prior to the initial needs assessment, specific training needs at each of the 
ICER sites may not be known.  Therefore, applicants should propose plans, to 
be undertaken during the first year of the award, for assessing training 
needs at each of the ICER sites.  In addition, the application should 
identify and describe the core elements of clinical research training and 
research management training curricula needed to enhance the infectious 
disease research capacity of institutions in developing countries.  The 
application should also describe plans and opportunities for mentoring 
individuals from these sites and institutions.  

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) international 
research training grant (D43) award mechanism.  At the time of award, these 
grants may be converted to cooperative agreements in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator.  The 
responsibilities of the possible cooperative agreement mechanism are 
described under "Proposed Terms and Conditions of Award" in the section 
entitled "Special Requirements."  As an applicant, you will be solely 
responsible for planning, directing, and executing the proposed project.  The 
total project period for an application submitted in response to this RFA can 
not exceed five years.  Facilities and administrative (F & A) costs are 
limited to eight percent in these awards.  At this time, the FIC and NIAID 
have not determined whether this solicitation will be continued beyond the 
present RFA.  The anticipated award date is October 2002.

FUNDS AVAILABLE

Approximately $1 million in FY 2002 has been committed to fund an estimated 
one or two new training program awards in response to this RFA.  Applicants 
can submit a clinical research training program, or a 
research management training program, or a combined clinical research and 
research management training program.  Applicants can request up to $500,000 
total costs for a clinical research training program or a 
research management training program application.  If the applicant submits a 
combined clinical research and research management training program, the 
applicant can request $1,000,000. 

It is expected that a single award for a combined clinical research and 
research management training program will be made, or two awards, one for a 
clinical research training program and one for a research management training 
program, will be made.  Because the nature and scope of the curriculum 
development and training proposed may vary, it is anticipated that the size 
of each award may also vary.  Awards pursuant to this RFA are contingent upon 
the availability of funds and the receipt of a sufficient number of 
meritorious applications.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:
o  Non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Units of State and local governments
o  Domestic

The applicant institution must have a faculty/staff that is active in 
clinical research and/or management/administration of clinical research 
programs, as evidenced by current research support and research publications.  
Experience in the conduct of clinical infectious disease research in 
developing countries is desirable but not required.  An institution may 
submit only one application.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.

SPECIAL REQUIREMENTS

1)  The Program Director (Principal Investigator) will expend at least 30 
percent effort during year one of the award and at least 20 percent effort 
during the following years and have primary responsibility for all activities 
of the program.  
2)  Curriculum Directors will be appointed for International Clinical 
Research training tracks and/or Research Management training tracks.
3)  The FIC Program Officer will be responsible for normal program and 
administrative stewardship of this award.   As required for the coordination 
of activities or to expedite progress the FIC Program Officer may designate 
additional FIC or NIAID staff to provide advice or assistance directly to the 
grantee on specific scientific, educational or management issues.  However, 
the FIC Program Officer will retain overall programmatic responsibility for 
the award and will clearly specify to the awardees the names and roles of any 
additional scientific coordinators and the lines of reporting authority.  The 
FIC Program Officer will be a member of the Steering Committee established to 
coordinate curriculum and training plans, and manage joint activities.
4)  The NIAID ICER Training Coordinator will be responsible for working with 
the leadership of the ICER sites and NIAID Global Health Sites to assist in 
ascertaining training needs and will be a member of the Steering committee.
5)  The Steering Committee will consist of, at a minimum, the PI(s) and 
Curriculum Directors, the FIC Program Officer, and the NIAID ICER Training 
Coordinator.    The Steering Committee will work closely with the leadership 
team of the ICER Sites, which includes NIAID Intramural and Extramural 
Principal Investigators, the Program Director from the foreign site as well 
as other US and foreign ICER investigators as deemed necessary to conduct the 
activities of the training program. 

The following Terms and Conditions will apply if the application is converted 
to a Cooperative Agreement: 

These special Terms of Award are in addition to and not in lieu of otherwise 
applicable OMB administrative guidelines, HHS Grant Administration 
Regulations at 45 CFR Parts 74 and other HHS, PHS, and NIH Grant 
Administration policy statements. 

The administrative and funding instrument to be used for this program is a 
cooperative agreement, an "assistance" mechanism (rather than an 
"acquisition" mechanism) in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during performance 
of the activity. Under the cooperative agreement, the NIH purpose is to 
support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity. Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardee(s) for the project 
as a whole, although specific tasks and activities in carrying out the 
activities will be shared among the awardees, the FIC Program Officer and 
NIAID ICER Training Program Coordinator. 

Awardee Rights and Responsibilities

1. Training Needs Assessment: An initial needs assessment for each ICER site 
will be performed by the awardee to:
o  Examine existing infectious disease clinical research and/or research 
management capabilities
o  Discuss overall five-year research goals of each site with the on-site 
ICER director
o  Identify critical gaps in clinical research and/or research management 
expertise that could be addressed by training
o  Create a training development plan to guide training activities for the 
duration of the award.
2. Required Meetings:  The Steering Committee shall meet at least once each 
year.  In addition, Program directors and other key personnel should also 
attend the NIAID International Centers for Tropical Disease Research Annual 
Meeting also in Bethesda, Maryland.
3. Awardees have primary authorities and responsibilities to define 
objectives and approaches of the curriculum developed, to plan and conduct 
training in this curriculum.  
In addition, the awardees will have specific responsibilities for:
o  Meeting with the Steering Committee to coordinate and finalize plans, 
procedures and survey tools for the needs assessments of the ICER sites.
o  Providing leadership in the construction and annual updating of the 
curriculum based on evaluation and need.  All courses should be consistent 
with international standards for the conduct, oversight and management of 
international clinical research as outlined by the International Council on 
Harmonization 
o  Establishing monitoring and evaluation procedures to assess the 
effectiveness of the curriculum and training provided to trainees within 
their program.
o  Participating in the Steering Committee including the presentation and 
discussion of the awardee's curriculum, training and evaluation plans, 
progress and results and revision of training development plans.
o  Maintaining a mutually acceptable arrangement with the ICER faculties and 
institutions to transfer clinical research and research administration 
training capacity during the award period.
o  Implementing any program-wide shared curriculum, training, evaluation or 
reporting procedures, where feasible.
o  Developing and disseminating any computerized or web-based learning 
courses developed under this award to ICER sites, and other FIC- and NIAID-
supported programs upon request of FIC or NIAID Program Officers. 

C. NIH Staff Responsibilities

The FIC Program Officer, in consultation with the NIAID ICER Program 
Coordinator, will have substantial scientific and programmatic involvement 
during the conduct of this activity, through technical assistance, advice and 
coordination above and beyond normal program stewardship for grants, as 
described below.  The FIC program officer will be familiar with the 
scientific agenda of FIC and NIAID joint programs and will facilitate 
coordination of training across these programs.

The NIAID ICER Training Coordinator will work closely with the FIC Program 
Officer, and ICER investigators to assist in identifying clinical research 
training needs.  The NIAID ICER Training Coordinator will be familiar with 
the scientific agenda of the ICER sites and other NIAID Global Sites and will 
facilitate coordination of training across NIAID sites.

The FIC Program Officer and the NIAID ICER Training Coordinator will:  
o  Serve as members of the Steering Committee
o  Provide advice on the management of the training provided, technical 
content of the curriculum to fulfill U.S. DHHS requirements for clinical 
research, and evaluation of the impact of the training
o  Facilitate communication and exchange of information among trainees and 
NIAID intramural and extramural staff associated with ICER activities
o  Organize interactions with relevant NIAID and FIC staff to: provide 
scientific and administrative technical assistance; obtain access to NIAID 
contracts providing resources for international clinical study support, site 
monitoring, and research reagents (e.g. AIDS, tuberculosis, malaria reagent 
repositories) and; increase access of trainees to additional mentoring 
opportunities through other NIAID- and FIC-supported international clinical 
research projects and research training programs.

Each ICER site has an NIAID Intramural and Extramural Principal Investigator 
as well as a foreign ICER Program Director and foreign principal 
investigators. The NIAID ICER Training Coordinator will work with all members 
of the ICER leadership team to assist in identifying clinical research 
training needs.

D. Collaborative Responsibilities
The success of the ICER clinical research training programs will depend in 
part on the collaborative interactions of the awardee program director and 
faculty, the FIC Program Officer, the program directors and faculty at ICER 
sites, and the NIAID ICER Training Program Coordinator.  Therefore, the 
Steering Committee will meet at least once a year to provide the primary 
governance process for the collaborative efforts of the program and will have 
responsibility to:
o  Review clinical research needs as presented by ICER leadership and make 
recommendations for curriculum changes to accommodate training needs.
o  Identify needs for additional consultation on specific areas of infectious 
disease, clinical research, research administration or other training 
expertise, activities, or issues.   
o  Review and approve the infectious disease clinical research training 
development plans for each ICER site based on the findings of the needs 
assessments.  
o  Update and amend the clinical research training development plans for each 
ICER site based on progress, unanticipated events, etc. 
o  Select appropriate candidates for training.

E.  Arbitration
Any disagreement that may arise on scientific/programmatic matters (within 
the scope of the award), between award recipients and the FIC may be brought 
to arbitration.  An arbitration panel will be composed of three members: one 
selected by the Steering Committee (with the FIC and NIAID members not 
voting) or by the individual awardee in the event of an individual 
disagreement, a second member selected by FIC, and the third member selected 
by the two prior selected members. This special arbitration procedure in no 
way affects the awardee's right to appeal an adverse action that is otherwise 
appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart 
D and HHS regulation at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA 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 issues to:

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

o  Direct your questions regarding peer review issues to:

Madelon Halula Ph.D. 
Branch Chief, Scientific Review Program, DEA 
National Institute of Allergy and Infectious Diseases 
67000B Rockledge Drive, Room 2150, MSC-7616 
Bethesda, MD 20892-7616 
Bethesda, MD  20817 (for express/courier service)
Telephone: 301-402-2636 
FAX: 301-402-2638 
Email: mh30x@nih.gov 

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

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

LETTER OF INTENT

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

o  Descriptive title of the proposed research
o  Name, address, and telephone number of the Principal Investigator
o  Names, titles and institutions of other key personnel
o  Participating institutions 
o  Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of the application submitted, the information that it 
contains permits the NIH 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:

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

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  Applicants should also follow the 
instructions for the Institutional NRSA found at the end of the PHS 398 
instructions to construct their application.  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact Grants Info, Telephone (301) 435-
0714, Email: GrantsInfo@nih.gov.

SUPPLEMENTAL INSTRUCTIONS:  

All expenses related to trainee participation in the program should be 
itemized on the PHS Form 398 (http://grants.nih.gov/grants/forms.htm) (NRSA 
substitute budget pages) in the categories listed in the RFA.  All expenses 
related to faculty participation in the program should be itemized on the PHS 
Form 398 budget pages in the categories listed in the RFA.  Total training 
expenses should be identified on PHS Form 398 (NRSA substitute page) under 
the "Other" category.  Allowable costs requested for training at 
international institutions should follow the guidelines specified for U.S. 
institutions.

Allowable costs

Salary
Program Director: The program director may receive salary and fringe benefits 
compensation for at least 30% professional effort devoted annually to the 
ICER training needs assessments, clinical research curriculum and training 
program creation during the award.  Salary must not exceed the annual salary 
cap level from federal sources (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-01-013.html). 

Faculty:  Faculty at the applicant institution who provide critical design, 
development, implementation and refinement of essential components of the 
clinical research and/or research management curriculum or extended training 
and mentorship of the trainees may receive salary and fringe benefits.    The 
responsibilities and time commitment for faculty receiving salary should be 
thoroughly described.  

Faculty Travel
Funds should be requested for the program director and curriculum directors 
to travel to each ICER site for the proposed training needs assessments 
during the first year of the award. Funds may be requested for round trip 
economy airfare year on U.S. carriers (to the maximum extent possible) per 
diem and lodging for U.S. faculty participants to travel to the ICER 
institutions to teach short courses in years two to five of the award.

Support Staff
Up to $50,000 direct costs may be requested in the budget to provide salary 
and fringe benefits of support staff for the program at the grantee 
institution.  The responsibilities and time commitment for personnel 
receiving salary support should be thoroughly described.

Training related expenses
Funds to support curriculum development related costs at the applicant 
institution (such as books, printed materials, audiovisual materials, 
computer software, etc.) as well as administrative expenses (such as 
photocopying, long distance phone and shipping costs, etc.) may be requested.

Trainee Tuition, Fees and Insurance
Funds for tuition, academic fees and self-only or family medical insurance 
for developing country trainees at the applicant and consortia institutions 
may be requested. Trainees from ICER sites may be paid a stipend comparable 
to their professional experience similar to other equivalent trainees at the 
grantee institution in accordance with the grantee institutional policies 
while involved in training.  Applicants may wish to refer to the NRSA stipend 
levels as a guide.  These are described on the web site 
(http://www.nih.gov/fic/programs.html).

Trainee Travel
Funds may be requested for one round trip economy class airfare per year on 
U.S. carriers (to the maximum extent possible) and local ground 
transportation for each trainee's travel to the applicant institution. 

Funds should be requested for airfare, per diem and lodging for the Program 
Director and Curriculum Directors to attend required meetings at comparable 
U.S. government rates 
(http://www.gsa.gov/Portal/browse/channel.jsp?channelId=-
9838&channelPage=/channel/default.jsp&cid=1) for in the Washington, D.C. 
area.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked.  The RFA label is also available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed photocopies 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 must be 
sent to:

Madelon Halula Ph.D. 
Branch Chief, Scientific Review Program, DEA 
National Institute of Allergy and Infectious Diseases 
67000B Rockledge Drive, Room 2150, MSC-7616 
Bethesda, MD 20892-7616 
Bethesda, MD  20817 (for express/courier service)
Telephone: 301-402-2636 
FAX: 301-402-2638 
Email: mh30x@nih.gov

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

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS

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

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIAID+ in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o  Receive a written critique
o  Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score
o  Receive a second level review by the FIC Advisory Board.

REVIEW CRITERIA

The goals of NIH-supported research and training 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 curricula and training will have a substantial impact on 
the ethical pursuit of these goals:  

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important training that by its nature is not innovative but is essential to 
move a field forward.

(1) SIGNIFICANCE

a) The expected contributions of the proposed infectious disease clinical 
research and/or research management curriculum and training to ICER 
institutions' capabilities to conduct and/or manage clinical research and 
intervention trials.

b) The expected contribution of the proposed clinical research and/or 
research management training plan to the ability of ICER sites to carry out 
NIH supported projects.

(2)  APPROACH

a) The clarity and feasibility of the training needs assessment, curriculum 
development and training objectives.

b) Adequacy of the program plan to achieve the proposed training needs 
assessment, curriculum development and training objectives including:

o Thorough and appropriate clinical research and/or research management 
training needs assessments at ICERs during initial year of award;

o Effective construction of clinical research and/or research management 
training development plans based on the needs assessments at each ICER to 
guide curriculum, training and evaluation activities for the duration of the 
award;

o Strong and appropriate courses and overall curriculum at the grantee 
institution and short courses at the ICER sites that provide focussed 
training opportunities to fill presumed gaps in trainee expertise;

o Individualized trainee assessment and training planning process that will 
effectively provide individuals with a variety of professional backgrounds 
from ICER sites with defined, certifiable expertise in clinical research 
and/or research management skills;

o A strong individual mentoring process during training;

o Appropriate assessment and enhancement of background skills needed by each 
trainee in areas such as bioethics, research methodology, technical writing, 
statistical methods, clinical practice, medical informatics and English as a 
second language (if necessary);

o Process for periodic evaluation and revision of curriculum developed;

o Process for periodic evaluation of trainee progress and mentoring 
activities;

o Methods to monitor the short- and long-term impact of the training 
experience on the subsequent careers of the trainees and capacity for 
clinical research or research management in the home ICER; and

o Plans for increasing transfer of sustainable core clinical research and/or 
research management training courses to ICER institutions and faculty during 
the course of the award including the development of ICER site appropriate 
distance learning courses and tools.

(3)  INNOVATION

a) Innovation in clinical research and/or research management curriculum 
designed for ICER and other developing country trainees.

b) Innovation in training ICER participants for independent involvement and 
leadership in the ethical design and conduct of clinical research and/or 
research management at their home institutions.

c) Creativity of plans to include modern information technology to facilitate 
trainee access to electronic information resources, distance learning and 
collaborative interaction.

(4)  INVESTIGATOR

Qualifications of the program director to lead, and other faculty to 
participate in, the proposed training needs assessments, curriculum 
development and training program.  (The clinical research and/or research 
management experience and training accomplishments, especially in developing 
countries, should be included for the program director and each faculty 
participant.  Any specific training in good clinical practice and/or 
experience with OHRP and FDA requirements for human subjects research and 
clinical trials should be documented.)

(5)  ENVIRONMENT

The adequacy of the teaching facilities and other training resources 
including possible clinical research practical opportunities and the overall 
training environment at the applicant institution.

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o  INCLUSION

a) The reasonableness of the proposed budget and duration in relation to the 
proposed training.

b)  The adequacy of the proposed plan to work in collaboration with 
scientists at ICER sites and ICER associated NIAID scientists, health 
professionals and staff in proposed curriculum, training and evaluation 
activities. 

c)  Demonstrated willingness and ability to adhere to the terms and 
conditions of the Cooperative Agreement Award.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  June 13, 2002
Application Receipt Date:  July 11, 2002
Peer Review Date:  September, 2002
Council Review:  September, 2002
Earliest Anticipated Start Date:  October, 2002

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  The extent to which proposed training programs support and complement ICER 
sites and other FIC or NIAID efforts in clinical research

REQUIRED FEDERAL CITATIONS

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 RFA 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 Sections 301 
and 405 and Title IV, Part A, (42 USC 241, 284 and 287) of the Public Health 
Services Act, as amended, and administered under NIH grants policies 
described at http://grants.nih.gov/grants/policy/policy.htm and Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92s.  

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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