and Human Services (HHS)
EXPIRED
AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM
RELEASE DATE: October 31, 2002
PA NUMBER: PA-03-018 (This PA has been reissued, see PAR-05-140)
(see addenda NOT-TW-03-001, NOT-TW-03-002, NOT-TW-03-006)
EXPIRATION DATE: October 25, 2005, unless reissued.
LETTER OF INTENT RECEIPT DATE: March 12
APPLICATION RECEIPT DATE: June 10, 2003; June 10, 2004, June 10, 2005
Fogarty International Center (FIC)
(http://www.nih.gov/fic)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Nursing Research (NINR)
(http://www.ninr.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 Research on Women's Health (ORWH)
(http://www4.od.nih.gov/orwh/)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Program Objectives
o Mechanism(s) 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
The purpose of this announcement is to invite applications from eligible
institutions for innovative, collaborative training programs that would
contribute to the long-term goal of building sustainable research capacity in
HIV/AIDS and HIV-related conditions at developing country institutions.
These research-training programs will strengthen scientific knowledge and
skills to enhance prevention of and treatment and care for HIV/AIDS and HIV-
related conditions in developing countries.
The Fogarty International Center (FIC), together with partner Institutes and
Offices from the National Institutes of Health (NIH), has supported long-term
research capacity-strengthening efforts in developing country institutions
for the past 15 years through a series of competing five-year awards
solicited through requests for applications (RFAs) for the AIDS International
Training and Research Program (AITRP). At this time, the Fogarty
International Center (FIC) with its partners, the National Cancer Institute
(NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the
National Heart, Lung and Blood Institute (NHLBI), the National Institute of
Dental and Craniofacial Research (NIDCR), the National Institute of Mental
Health (NIMH), the National Institute of Nursing Research (NINR), the
National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National
Institute on Drug Abuse (NIDA), the Office of AIDS Research (OAR), and the
Office of Research on Women's Health (ORWH), will solicit new and competing
renewal applications and competing supplement applications to existing grants
for AITRP under this program announcement.
PROGRAM OBJECTIVES
Background:
As the global HIV/AIDS epidemic enters its third decade, the toll it has
taken on individuals' lives is felt around the world. While currently, the
affected populations are primarily in sub-Saharan Africa, HIV epidemics in
China, India, other south Asian countries, Russia and the Newly Independent
States are increasing. Progress to identify interventions to prevent the
transmission of the infection through sexual contact, from mother to child,
and through needle use has been made, but additional interventions to prevent
transmission are needed if we expect to stem the tide of the epidemic.
Effective interventions to prevent the transmission of HIV and other
pathogens through unsafe blood and the inappropriate use of transfusion, such
as appropriate programs for the recruitment and retention of volunteer
donors; effective surveillance for established and emerging potential
pathogens, and strategies to promote the rationale use of blood, continue to
be needed and promoted.
As attention turns toward integration and expansion of care and treatment of
HIV and HIV-related conditions into existing prevention programs,
identification of effective interventions will be crucial to a country's
ability to respond adequately. The capacity to conduct integrated prevention
and care research across the full range of conditions and issues that relate
to care of adult and pediatric patients with HIV/AIDS (e.g., opportunistic
infections, HIV malignancies, neurological and mental health consequences,
behavioral issues, issues related to mother to child transmission,
hematological and cardiovascular conditions, blood safety issues, pulmonary
manifestations, ophthalmologic manifestations, gastrointestinal conditions,
drug and alcohol usage, sex/gender-related science and issues, and oral
health manifestations) need to be strengthened and expanded in developing
countries. In addition to the identification of effective interventions, the
ability to evaluate the economic and social impacts of these interventions
will be crucial to guide policy makers as they develop policies and programs
to address the HIV/AIDS epidemic in their countries.
This program will increase research training across the span of biomedical,
behavioral and social sciences, clinical science, epidemiology,
biostatistics, and public health practice. The research-training program
should continue to emphasize prevention research and expand to include
research to identify appropriate interventions to provide care to those
adults and children infected with HIV. It should involve a wide range of
professionals (e.g. nurses, midwives, physicians, dentists, health care
administrators and public health workers), and should be multidisciplinary,
including training across the span of sciences and disciplines listed above.
Research Training Objectives
Research-training programs should provide a variety of short-, medium- and
long-term training opportunities for participants from developing country
institution(s) within the context of ongoing research collaborations.
Applications should present an assessment of the specific needs for HIV/AIDS
and HIV-related research training at their collaborating developing country
institution(s) and a proposed training plan to address those needs during the
course of a five-year award. It is expected that each research-training
program award supported will:
o Increase the expertise of trainees in relevant biomedical, behavioral,
laboratory, clinical, epidemiological and/or social science research;
o Fill gaps and strengthen the sustainability of HIV/AIDS and HIV-related
research within developing country institution(s);
o Expand and equalize collaborative scientific research interactions between
developing country scientists and U.S. or potentially other developed country
researchers;
o Provide data for evidence-based decision-making related to HIV/AIDS and
HIV-related conditions with respect to prevention, care and treatment
policies in the host developing country;
o Take advantage of other sources of research and training support in the
foreign country;
o Actively work with collaborating country institutions and government
officials within the collaborating country to provide opportunities and
positions for all returning trainees to maximize the use of the knowledge and
skills they acquired during their training; and
o Strengthen the capacity of developing country institutions to compete for
current and future NIH and non-NIH research and other grants designed for
foreign institutions.
Existing and re-competing AITRP applications may include applications for
competing supplements for up to the numbers of years of the existing or re-
competing parent grant for the following purposes:
o Expanding their training programs geographically to institutions without
existing AITRP collaborations in India or China;
o Expanding their training programs geographically to institutions with
which they have existing or the potential for strong AITRP collaborations;
o Expanding their training programs in their emphasis country(ies) to take
advantage of existing Centers for AIDS Research (CFAR), AIDS Clinical Trials
Group (ACTG), and Pediatric AIDS Clinical Trials Group (PACTG) grants at
their institution;
o Expanding their training program to respond to existing needs or
opportunities related to the research areas of co-sponsoring NIH Institutes,
Centers or Offices;
o Supporting U.S. graduate or medical students and postdoctoral fellows for
research training at the collaborating developing country institution.
Beginning with awards funded under this PA, grantees may submit competing
supplement applications for up to three years of support for advanced in-
country re-entry support to establish independent research projects at the
developing country institution for developing country participants who have
completed substantial medium-and long-term research training. Eligibility
for these supplements will be limited to trainees who have received a degree
or advanced skill training for at least six months continuous duration
through the AITRP program submitting the competing supplement application.
See Supplemental Instructions for additional instruction for competing
supplement applications for this purpose. The competing supplement
application process also may be used for degree-required and mentored trainee
research projects which are not part of an existing NIH research award and
which require additional independent peer review.
Training may occur in either the U.S. or developing country institution.
However, applicants are strongly encouraged to provide support and mentoring
for trainees to conduct the research related to their training in the host
developing country to the greatest extent possible. Applicants should
include plans that demonstrate the increasing transfer of appropriate
training options and responsibilities to the developing country institution
during the course of the five-year award.
Additional support for research training to support specific NIH initiatives
(HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN),
NIMH Popular Opinion Leader (POL) network, and Comprehensive International
Program of Research on AIDS (CIPRA)) will be made administratively, as
needed, based upon the peer-reviewed grants for these initiatives.
MECHANISM OF SUPPORT
This PA will use the NIH (D43) international research training award
mechanism. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project. An applicant for an AITRP
award may request a project period of up to five years and a budget for total
costs (including eight percent facilities and administrative (F & A) costs)
according to the following guidelines:
o For re-competing programs entering their sixteenth year of funding- $1
million for base amount each year and up to $100,000 for each competing
supplement for a maximum request of $1.3 million total costs for any year;
o For re-competing programs entering their eleventh year of funding-
$750,000 for base amount each year and up to $100,000 for each competing
supplement for a maximum request of $1 million total costs for any year;
o For re-competing programs entering their sixth year of funding- $500,000
for base amount each year and up to $100,000 for each competing supplement
for a maximum request of $650,000 total costs for any year;
o For new programs, $300,000 for base amount each year only.
o For competing supplements to existing AITRP grants for advanced in-country
research support up to three years of $35,000 maximum total cost annual
funding per supplemental application;
o For competing supplements to existing AITRP grants for degree-required and
mentored trainee research projects support up to two years of $25,000
maximum total cost annual funding per supplemental application;
o For competing supplements to existing AITRP grants for expansion of
research training support to new collaborating institutions up to $100,00
for a competing supplement application in each country for a maximum request
of $200,000 total costs.
ELIGIBLE INSTITUTIONS
Eligible institutions are U.S. (or pre-approved non-U.S. developed country)
nonprofit, public or private institutions with HIV/AIDS and HIV-related
research collaborations with institutions in the developing countries listed
below. A non-U.S. developed country applicant must provide documentation
that their government or institution is willing to support at least 50
percent of the requested budget per year for the full award period. FIC will
provide up to 50 percent of the total costs for a non-U.S. developed country
applicant.
Developing countries include the low- and middle-income countries in the
following regions: Africa, Asia (except Japan, Singapore, South Korea and
Taiwan), Central and Eastern Europe (Hungary, Poland, the Czech and Slovak
Republics, Romania, Bulgaria, Albania, Turkey and the countries of the former
Yugoslavia), Russia and the Newly Independent States of the former Soviet
Union, Latin America and the Caribbean, the Middle East (except Israel), and
the Pacific Ocean Islands (except Australia and New Zealand).
Only one application for a base award may be submitted from an institution.
Only one base award will be made to an institution at any given time. More
than one competing supplement application may be submitted by an institution
applying for a re-competing base award or with an existing AITRP grant, as
long as the budgets do not exceed the funding limits for total costs
described above.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual from an eligible institution with the skills, knowledge, and
resources necessary to carry out the proposed international HIV/AIDS and HIV-
related research training is invited to work with their institution to
develop an application for support. U.S. (or pre-approved non-U.S.)
applicants must apply with developing country institution(s) with whom they
have a demonstrable history of HIV/AIDS and HIV-related research
collaboration.
Applicants must have a strong HIV/AIDS and HIV-related research and research-
training program and the requisite faculty and facilities to carry out the
proposed training activities. The principal investigator and/or faculty at
the applicant institution listed as key personnel must be designated as the
principal investigator of at least one active (with at least 18 months of
support remaining at the time of application) HIV/AIDS or HIV-related
research award, directly relevant to the research-training proposed, funded
by the NIH or other national or international organization. Priority will be
given to applicants associated with NIH direct research grants to the
proposed collaborating developing country institution(s) or with research
grants with foreign components at the collaborating developing country
institution(s). Applicants should explain in detail how their relevant
research grant support and activities are related to the proposed training
plan. Applicants need to document this existing research support in their
application.
Women and individuals from underrepresented racial and ethnic groups, as well
as individuals with disabilities, are always encouraged to apply for NIH
programs.
SPECIAL REQUIREMENTS
1. Applications submitted in response to this announcement should describe
the specific linkages that they can leverage to strengthen the capacity of
the foreign institutions to collaborate with the National Institutes of
Health (NIH), other United States Government (USG) agencies, and other
international efforts by governments, international agencies, non-
governmental organizations, foundations, faith-based organizations and other
groups in their efforts to respond to this global health crisis. Letters of
support and collaboration from awardees funded by these organizations are
encouraged.
2. Letters of support from foreign collaborators, foreign institutions, and
developing country(ies) officials are required. Letters of support from
foreign institutions and governments should indicate support of trainees in
the form of a position, time dedicated to research, laboratory space,
financial support, etc. when they return. Letters from groups with whom the
applicant expects to collaborate are encouraged.
3. Re-competing AITRP applicants should include a description of the
activities of previous and current AITRP awards and include:
o a description of the relevance of the research and public health training
to the country's(ies') needs and priorities;
o a description of how the AITRP grant has increased the research and public
health capacity of the developing country institution(s);
o a description of how the applicant has been able to leverage other NIH or
non-NIH programs opportunities in the country(ies);
o the number of trainees by type of training for each collaborating country;
o a list of publications in peer-reviewed journals in which a former or
current trainee is listed as first author and which was supported through the
AITRP grant as evidenced by acknowledgement of FIC in the publication;
o a description of how the program addressed the recruitment and support for
women and socially disadvantaged groups within the population of the
country(ies);
o the percentage of long-term trainees (one year or more) who returned to
the country following the completion of their training;
o a description of the strategies used by the program to maximize the number
of trainees who return to their country of origin upon completing their
training.
4. Trainee research projects encompass research included as part of a degree-
directed training program, research undertaken as part of a mentored training
experience or research supported as advanced in-country research for a
completing trainee. Trainee research projects may be part of existing
faculty research grants from NIH or other research support agencies. Degree-
required and mentored trainee research projects that have not been part of
scientifically peer reviewed faculty research grants must be reviewed by the
proposed training advisory group (see below), and may be required to be peer-
reviewed as a competing supplement to an AITRP award. All advanced in-
country research must be peer reviewed as a competing supplement to an
existing AITRP grant, or separately as an application to the FIC Global
Health Research Initiative Program for New Foreign Investigators (GRIP)
Program or to the Fogarty International Research Collaboration Award for
HIV/AIDS (AIDS FIRCA) program
(http://www.nih.gov/fic/programs/aidsfirc.html). All training-related
research must meet all USG regulations for animal welfare and protection of
human subjects and receive approval from the Institutional Review Board or
Ethics Committee at the US institution to which the AITRP award is made and
the collaborating country institution.
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
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: [email protected]
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: [email protected]
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: [email protected]
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 or research training
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
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 IC 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 CNM MPH Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The 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) 710-0267,
Email: [email protected]. Use the Institutional NRSA budget page of the PHS
398 research grant application instructions and forms for the budgets for
research training applications. Each competing supplement should be
submitted as a separate application.
SUPPLEMENTAL INSTRUCTIONS FOR RESEARCH TRAINING APPLICATIONS
The research training application (25-page limit) should include:
1. A needs assessment that details the specific scientific and research
support (e.g. the use of scientific literature, scientific presentations,
grant writing, bioinformatics, bioethics, good clinical practice, biosafety,
data management, research administration and the management of intellectual
property) needs at each of the developing country institutions included in
the application;
2. A description of the training plan proposed to address the needs
assessment. The training plan should include:
o the goals, objectives and plan for meeting the objectives for the training
program;
o a description of how the proposed program will address the research needs
and health priorities defined by the country;
o a description of the types and mix of training proposed. Applicants may
propose a variety of research training options (long-, medium-, and short-
term, degree related or non-degree, and short courses/workshops). Long-term
research training includes studies leading to an advanced degree or a
mentored post-advanced degree experience related to HIV/AIDS and HIV-related
research. Medium- and short-term training of up to several months may
include specific research methods or other laboratory, clinical, or field
skills related to HIV/AIDS and HIV-related research. Courses for English as
a second language, if necessary, are permitted. Training may occur in either
the U.S. or developing country institution. However, applicants are strongly
encouraged to provide support and mentoring for trainees to conduct the
research related to their training in the host developing country to the
greatest extent possible. Applicants should include plans that demonstrate
the increasing transfer of appropriate training options and responsibilities
to the developing country institution during the course of the five-year
award;
o a description of the program for Training in Responsible Conduct of
Research - Applicants are required to provide all medium- and long-term
trainees with training in the responsible conduct of research. For more
information on this provision, see the NIH Guide for Grant and Contracts
(volume 21, number 43 - http://grants.nih.gov/grants/guide/notice-
files/not92-236.html);
o a plan for recruitment, selection and evaluation of trainees, and a plan
for post-training integration into the collaborating developing country
institution's HIV/AIDS and HIV-related research. Training may be offered to
a wide range of developing country scientists, technical staff,
administrators, clinicians and health professionals, public health
professionals and social scientists to build a critical mass of researchers
and support staff with the combined expertise and skills to conduct
independent HIV/AIDS and HIV-related research. Applicants are strongly
encouraged to consider women and members of minority or socially
disadvantaged populations in the collaborating developing country in the
selection of trainees;
o a description of 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, a description of the
organizational structure at each institution that will be available for the
proposed training program, and a description of the current and future
research that will serve as the research base for the proposed training
program at each proposed foreign institution;
3. A description of a Training Advisory Group which is composed of expert
U.S. and developing country faculty who are not directly involved in
mentoring trainees and which should be established to assist in trainee
selection, scientific review of trainee projects, and evaluation of trainee
and training program progress. Applicants should describe the composition
and expertise of the proposed training advisory group, the responsibilities
of the group and the processes for it to accomplish its responsibilities,
including a detailed description of the procedures for scientific review of
training-related research.
Re-competing research training applications should also include a description
of the past experience of the grantee in AITRP (ten-page limit). See SPECIAL
REQUIREMENTS 3.
Budget Preparation for Research Training Applications
Use the Institutional NRSA budget page of the PHS 398 research grant
application instructions and forms for the budgets for research training
applications. Applicants should develop a budget that reflects the resources
necessary to implement the components of the comprehensive developing country
training plan included in their application. The budget should include costs
to support the proposed research-training plan.
All expenses related to trainee participation in the program should be
itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the
appropriate categories. All expenses related to faculty participation in
the program should be itemized on the PHS Form 398 (budget form pages 4 and
5) in the appropriate categories. The total direct costs of the trainee
participation budget should be identified on PHS Form 398 (budget form pages
4 and 5) in the "Other" category. The combining of the budgets will allow
reviewers and FIC staff to review a composite budget of all costs.
Requested Salary Support
The salary for the Principal Investigator and other training faculty and
administrative staff must be commensurate with the salary structure and
benefits at the applicant institution.
Trainees' Stipends
Trainees may be paid a stipend comparable to their professional experience in
accordance with NRSA levels or grantee institutional policies while involved
in long-term training at the grantee institution. Current NRSA stipend
levels are described on the web site http://grants.nih.gov/training/nrsa.htm.
Tuition, Fees and Insurance for Trainees
Funds for tuition, academic fees and self-only or family medical insurance
may be requested. Programs are encouraged to seek cost-sharing arrangements
with the grantee institutions in order to provide reduced tuition for long-
term trainees and tuition-free short courses.
Network Meetings
Funds to support the attendance of the Principal Investigator and two to
three other people (foreign collaborators, faculty, administrators or
trainees) to attend an annual network meeting.
In-Country Activities
Before any funds can be expended for in-country trainee research project
activities under this award, the grantee institution must document a
collaborative research arrangement between the U.S. and foreign country
institutions. This can be documented through an endorsement from the
Minister of Health or other appropriate foreign government official as well
as from the collaborating institutions.
SUPPLEMENTAL INSTRUCTIONS FOR COMPETING SUPPLEMENTS FOR TRAINEE RESEARCH
PROJECTS SUPPORT
The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below.
The research plan included in the supplement application should answer these
questions:
1) What does the current or former trainee intend to do?
2) Why is the work important?
3) What has already been done?
4) How is the current or former trainee going to do the work?
5) What form of mentoring will be available to help guide the proposed work?
It should provide the information needed to evaluate the application, using
the Review Criteria for Competing Supplement Applications for Trainee
Research Projects Support.
In addition, applications for advanced in-country research project support
should include:
o date that the current or former trainee has returned or expects to return
to their home country;
o a letter from the U.S. host institution, outlining the nature of the
future collaborative relationship, and how the program supported, and/or will
support, a continued collaboration with the investigator, using all
appropriate resources;
o a letter of support from the developing country institution to which the
trainee is returning or has returned;
o a description of the training the current or former trainee investigator
received under the AITRP program, including dates of training; and
o two letters of reference relating to the abilities of the current or
former trainee investigator, specifically indicating the ability to become a
leader in scientific pursuits.
Under Personnel, list all project personnel, including their names, percent
of effort, and roles on the project. For advanced in-country research
projects, the current or former trainee is expected to devote at least 50
percent of his/her total effort to this project and may only request support
of up to 50 percent of his/her effort on this project. Salary requests of
collaborating developing country personnel should be commensurate with the
salary structure at the collaborating developing country institution. For
degree-required and mentored trainee research projects, 100 percent of the
stipend for a trainee may be requested.
Checklist: This page should be completed and submitted with the application.
Applications can request facilities and administrative (F&A) costs up to a
maximum of 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 allowability of F&A costs for foreign and international
organizations.
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. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of a substantial
revision of an application already reviewed, but such application must
include an introduction addressing the previous reviewers' comments.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR, and
responsiveness by the FIC and the co-sponsoring NIH Institutes, Centers and
Offices. Incomplete and/or non-responsive applications will be returned to
the applicant.
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 (http://www.csr.nih.gov/refrev.htm)
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, and possibly by the Advisory Boards or Councils of the co-
sponsoring NIH Institutes, Centers and Offices.
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 training or research will have a substantial impact on the 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 training impact and
thus deserve a meritorious priority score. For example, you may propose to
carry out important research training that, by its nature, is not innovative
but is essential to move a field forward.
Review Criteria for Applications for Research Training
Significance
o The expected contribution of the research-training program described in
the application to fill the identified gaps in HIV/AIDS and HIV-related
research expertise at the developing country institution(s).
o The expected ability of the proposed training plan to strengthen
multidisciplinary approaches (biomedical, behavioral, social, and cultural)
to research and public health in the country(ies).
o The expected potential of the developing country institution(s) to achieve
independent and sustainable laboratory, clinical or public health HIV/AIDS
and HIV-related research capacity through the proposed training efforts.
Approach
o The adequacy of the research training plan to achieve the proposed
training objectives including:
a) The adequacy of the proposed mix of long-, medium- and short-term
training to achieve the goals of this PA;
b) The ability of the trainee recruiting and selection process to capture
the most qualified individuals and to include an adequate representation of
men, women and ethnic minorities or socially disadvantaged population groups
among the developing country trainees;
c) The adequacy of the process for matching trainees to appropriate mentors
that will promote acquisition of research skills and development of research
projects to fill recognized gaps in expertise at the developing country
institution(s);
d) The adequacy of the plan to provide adequate training in sustainable
research enhancing areas such as laboratory safety, responsible conduct of
research, technical and grant writing, statistical methods, good clinical
practice, medical informatics, English as a second language (if necessary),
etc;
e) The expected ability of the plan to maximize the return and integration
of trainees into HIV/AIDS and HIV-related research at the developing country
institution(s) to build sustainable research capacity;
f) The adequacy of the method to monitor the long-term impact of the
HIV/AIDS and HIV-related research training experience on the subsequent
careers of the trainees, the HIV/AIDS and HIV-related research capacity at
the developing country institution(s), and public health in the developing
country(ies); and
g) The capability of the system for the scientific peer review of training-
related research by the Training Advisory Group.
Innovation
o The ability of the proposed training program to take advantage of the
foreign institution's research infrastructure and of previous and current
investments and support from FIC, NIH or other organizations.
o The identification of innovative strategies for trainees to become
actively involved in multidisciplinary HIV/AIDS and HIV-related research
studies or intervention trials relevant to national health priorities
conducted at the developing country institution(s).
o The innovation in training strategies to produce a critical mass of
independent HIV-AIDS and HIV-related researchers and sustainable research
training by trainees at the developing country institution(s) at the end of
the program.
Investigators
o The qualifications of the Principal Investigator and foreign
collaborator(s) to lead the identified faculty to participate as mentors in
the proposed research training program.
o The adequacy of the ongoing collaboration between the investigators and
the institutions named in the applicant to provide a suitable framework in
which the proposed training will occur.
o The adequacy of research support for the investigators named in the
application.
o The extent and effectiveness of previous research training efforts made by
the applicant in the proposed developing countries.
o For re-competing applications, the success of the applicant in
strengthening the research capacity of the developing country institutions,
as requested in number 3 under SPECIAL REQUIREMENTS.
Environment
o The adequacy of the HIV/AIDS and HIV-related teaching and research
facilities and other resources related to the overall training environment at
the applicant and developing country institutions.
o The strength of the U.S. and developing country institutional commitments
to the proposed HIV/AIDS and HIV-related research training program, including
research support at each developing country institution included in the
application. See letters of support as requested in number 2 under SPECIAL
REQUIREMENTS.
Review Criteria for Competing Supplement Applications for Trainee Research
Projects
Significance
o The importance and priority of the problem that the study will address in
the home country.
o The ability of the results of the study to advance scientific knowledge
and to enhance the research career of the trainee.
o The expected effect of these studies on the concepts or methods that drive
this field.
Approach
o The development, integration and appropriateness of the conceptual
framework, design, methods, and analyses.
o The identification of potential problem areas and alternatives to address
these problems.
Innovation
o The application of novel concepts, approaches or methods.
o The originality and innovation of the aims.
o The expected ability of the project to develop new methodologies or
technologies or establish a new paradigm.
Investigator
o The appropriateness of the training of the investigator to carryout the
project successfully.
o The appropriateness of the project to the experience level of the trainee
investigator and other researchers (if any).
o The contribution of the project to the trainee investigator's career
development.
o The strength of commitment for the trainee investigator demonstrated in
the letters of support.
Environment
o The ability of the in-country scientific environment to contribute to the
probability of success.
o The ability of the proposed project to take advantage of unique features
of the scientific environment or employ useful collaborative arrangements.
In addition, for advanced in-country research projects, there must be:
o Evidence of institutional support and a convincing commitment by the home
institution to support the investigator (e.g. to provide a research/academic
appointment and partial salary support), and
o Evidence of continuing commitment of the U.S. collaborating institution to
further develop the career and research interests of the trainee investigator
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
PROTECTIONS: The adequacy of the proposed protections for humans, animals,
or the environment, to the extent they may be adversely affected by the
project proposed in the application.
INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the
section on Federal Citations, below.)
DATA SHARING: The adequacy of the proposed plan to share data.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a 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 program priorities of FIC and co-sponsoring organizations;
o Contribution to other FIC- and NIH-funded activities; and
o For competing research training supplements, the extent to which
applicants devote a portion of their base budgets to activities requested in
the competing supplement application
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
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