PHASE II COMPREHENSIVE ICOHRTA AIDS/TB
RELEASE DATE: July 28, 2004
RFA Number: RFA-TW-04-002 (This RFA has been reissued, see RFA-TW-06-005)
EXPIRATION DATE: December 21, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
United States Agency for International Development (USAID)
(http://www.usaid.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
Fogarty International Center (FIC)
(http://www.fic.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
Office of Global Health United States Agency for International Development
(USAID)
(http://www.usaid.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.989, 93.242 (NIMH),
93.855, 93.856 (NIAID)
LETTER OF INTENT RECEIPT DATE: November 19, 2004
APPLICATION RECEIPT DATE: December 20, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Training 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 Supplementary Instructions
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) and its co-sponsoring institutions
invite Phase I International Clinical, Operational, and Health Services
Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) Program
awardees to submit applications for Phase II ICOHRTA-AIDS/TB awards to
develop comprehensive international clinical, operational, and health
services research training programs. Co-sponsoring institutions are U.S.
Government (USG) agencies contributing financial resources to the ICOHRTA-
AIDS/TB Program.
RESEARCH TRAINING OBJECTIVES
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, tuberculosis (TB) or
both are significant problems. The first phase of the ICOHRTA-AIDS/TB
program began in fiscal year 2002 (FY02), with one-year planning grants (PA-
02-022; PAR 03-072) to foreign institutions to organize and execute an
application for a Phase II Comprehensive ICOHRTA-AIDS/TB Cooperative
Agreement. 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. The Phase II awards to the
Research Training Units will provide support to each partner institution.
These applications should foster the development of the skills at the foreign
institution needed to identify effective interventions pertinent to the
global health crises created by HIV/AIDS and/or TB and to develop strategies
to successfully implement these evidence-based interventions.
The training supported under Phase II of the ICOHRTA-AIDS/TB 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 experts will comprise a resource that
will facilitate additional training and research in the region. The ICOHRTA-
AIDS/TB program 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. 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 program will also provide support for the development and extension of
core research support capabilities necessary for long-term sustainability of
the research capacity of the foreign institution. Core research support
capabilities are defined as those skills required by an institution to
successfully compete for and conduct research. The knowledge and ability to
manage research grants require expertise in ethics and compliance issues,
protection for human subjects, animal welfare, fiscal management, budgeting,
program and grants administration, grant and report writing, preparation of
scientific manuscripts, information technologies, technology transfer and
management of intellectual property, data management, and Internet
connectivity.
Clinical research, in the context of this RFA, 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.
The applications from both the foreign institution and its U.S. (or pre-
approved non-U.S.) collaborating partner must propose, in an integrated
manner, a comprehensive training program that will strengthen the capacity in
the foreign country to conduct integrated clinical, operational, and health
services research focused on one or more of the following areas:
o The application of clinical science and health care research to benefit
those already infected with HIV and/or TB.
o The prevention and/or reduction of the spread of HIV and TB and related
conditions, especially measures that can be implemented within the context of
care.
o The study of strategies to scale-up and integrate effective therapeutic
and preventive interventions into the local health care system.
The approach and training plan for clinical, operational, and health services
research training should be directly relevant to the needs of the people in
the foreign country and be appropriate to local circumstances and most likely
to affect public health policy. Also implicit is the need to rapidly
strengthen the research training capacity and infrastructure required for
success by building on existing research and research training programs
involved with the implementation of prevention and care interventions at the
country level. In addition, an important capacity building component is to
strengthen core research support capabilities needed to manage research
grants at the foreign site.
Each Phase II Comprehensive ICOHRTA-AIDS/TB program application should
incorporate a number of long-, intermediate- and short-term training
opportunities in a wide range of relevant disciplines and skills necessary to
advance research objectives. The proposed training should strengthen
sustainable clinical, operational, and health services research and core
research support capacity at the foreign site and include advanced in-country
research. Training will take place at the U.S. or foreign sites and
training-related research will be carried out mainly at the foreign site.
While a range of short-, intermediate- and long-term training is allowable,
emphasis will be on intermediate- to longer-term training, including mid-
career training. This approach will accelerate building enduring capability
for clinical, operational, and health services research and core research
support at the foreign institution.
In the context of this RFA, the following definitions are used for long-,
medium-, and short-term training:
o Long-term (greater than 12 months and up to four years, depending on
resources) training for the full range of skills necessary to support
research and research administration in masters or doctoral programs, with
the understanding that the focus of thesis-related work will be in the
developing country. With prior FIC approval, pre-masters training will be
allowed for individuals with demonstrated interest and capability, but whose
prior professional education does not include a bachelor's level degree
(e.g., nurses, midwives, laboratory technicians, administrative staff).
o Short-term (less than three months) training or mentoring that focuses on
research methodology, laboratory skills necessary to support clinical
research, ethics and compliance issues, program and grants administration,
accounting, financial management, grant writing, peer review, preparation of
scientific manuscripts, data management, Internet connectivity, technology
transfer, and medical informatics.
o Intermediate-term (three to 12 months) training or mentoring, including
specialized clinical, laboratory, research or administrative/business skills
necessary to support clinical, operational, and health services research that
is planned or ongoing.
o Advanced in-country mentored research undertaken by the trainee in his/her
home country upon completion of his/her initial period of training under the
program (masters, Ph.D., post-doctoral or other significant training).
o To a limited extent and with prior FIC approval, U.S. trainees will be
eligible for foreign research experience under this cooperative agreement.
To be eligible, they must have uniquely relevant expertise and skills that
will contribute to the training, research, or administration at the foreign
institution and/or have a major career commitment to international research.
The ICOHRTA-AIDS/TB program strongly encourages PIs to include women and
individuals from underrepresented racial, ethnic or socially disadvantaged
groups in the country as trainees and faculty at all sites.
MECHANISM OF SUPPORT
This RFA will use the NIH International Training Cooperative Agreement (U2R)
award mechanism to provide funding to both the foreign research training
institution and to its linked collaborating U.S. (or other pre-approved)
institution. As an applicant you will be solely responsible for planning,
directing, and executing the proposed project. This RFA is a one-time
solicitation. The anticipated award date is April 2005.
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
The NIH U2R is a cooperative agreement award mechanism. In the cooperative
agreement mechanism, the Principal Investigator retains the primary
responsibility and dominant role for planning, directing, and executing the
proposed project, with NIH and other United States Government (USG) staff
being substantially involved as partners with the Principal Investigator, as
described under the section "Cooperative Agreement Terms and Conditions of
Award." At this time, it is not known if this RFA will be reissued, but,
subject to availability of funds and overall progress in the program, the
intent is to reissue the RFA for at least one more competition, thus allowing
recipients of Phase I planning grants to apply for Phase II awards, and for
unsuccessful Phase II applicants to submit amended applications.
FUNDS AVAILABLE
FIC and its co-sponsoring partners intend to commit approximately $1.2-1.8
million in FY05 to fund two to three applications from the Comprehensive
ICOHRTA-AIDS/TB Research Training Units received, in response to this RFA and
subject to availability of funds. The two Phase II Comprehensive ICOHRTA-
AIDS/TB applicants in the Research Training Unit (which consists of a foreign
institution application and its linked U.S. partner or pre-approved non-U.S.
institution application) may request up to a total of $600,000 in total costs
for each year. Each of the applicants can request up to $300,000 total costs
(that includes facilities and administrative (F & A) costs on subcontracts)
in year one but the foreign institution application total cost budget must be
at a total cost level equal to or greater than its linked U.S. partner or
pre-approved non-U.S. institution partner. The foreign institution's total
cost budget should increase in years two through five to reflect the
increased capacity of the foreign applicant to facilitate training and
research. The foreign institution's total cost budget may exceed $300,000 in
years two through five but the total costs for the Research Training Unit may
not exceed $600,000. The total project period for an application may not
exceed five years and F & A costs are limited to eight percent for both
Research Training Unit partners. Because the nature and scope of the
proposed research training will vary from application to application, it is
anticipated that the overall size of each linked award (and components) will
also vary. Although the financial plans of the ICs provide support for this
program, awards pursuant to this RFA are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
Applications for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will only be
accepted from foreign institutions that have been awarded a Phase I ICOHRTA-
AIDS/TB planning grant and their chosen linked collaborating U.S. (or other
pre-approved) partners. The foreign and U.S. (or other developed country)
site must have achieved a strong record of receiving or being significantly
involved in HIV/AIDS and/or TB international research. Each site should
provide a comprehensive list of these awards for at least the past five years
to support its application.
You may submit an application 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 Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
With prior FIC approval, the designated collaborating institution may be a
non-U.S. institution, provided it has special resources that uniquely
contribute to this program. Also with prior FIC approval, and concurrence
from the foreign PI, the application from the collaborating U.S. (or other
pre-approved) partner may involve additional institutions through a
subcontract or consortium arrangement.
Only one application for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will
be allowed from any foreign institution in response to this RFA. In
situations in which more than one planning grant has been awarded to
institutions in close proximity in the same country, applicants will be
strongly encouraged to submit a single, integrated application for a Phase II
award.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The Principal Investigator (PI) in the Phase II application from the foreign
institution is expected to be the PI from the Phase I award. Any change will
require pre-approval. The foreign PI and the collaborating PI will be
responsible for the overall conduct of the integrated research-training
program. Both the foreign and collaborating institutions must demonstrate
the capacity and leadership necessary for the successful implementation and
long-term productivity of the program. The Principal Investigators at the
foreign institution and at the collaborating partner institutions must have a
track record of commitment and experience in related research and research
training. Both the foreign and collaborating PI must be directly involved in
and funded to do research in resource-poor settings and there must be
tangible evidence of very strong linkage to that ongoing research as
collaborating partners. The PIs must hold faculty or other long-term
research positions at a public or private non-profit research institution
that will allow them adequate time and provide appropriate facilities, salary
support and resources, including access to patients or patient data, when
necessary.
Women, individuals from underrepresented racial, ethnic and socially
disadvantaged groups in the country, as well as persons with disabilities are
encouraged to apply as PIs.
SPECIAL REQUIREMENTS
Guidance and Management Structure
The guidance and management of the ICOHRTA-AIDS/TB Program are provided by a
Technical Advisory Group and a Steering Committee.
The Technical Advisory Group is a committee of advisors with relevant
expertise from the USG co-sponsoring institutions (at least one from each co-
sponsor) and the Program and Grants Management Officers from the FIC. The
Technical Advisory Group: 1) reviews applications for responsiveness and,
after the independent initial peer review, makes funding recommendations, and
2) meets several times per year, as necessary, to review developments across
the ICOHRTA-AIDS/TB program as well as the progress of individual ICHORTA-
AIDS/TB Research Training Units and the planning grant recipients. The FIC
Program Officer serves as the chair of the Technical Advisory Group.
The Steering Committee is composed of the Foreign Principal Investigator and
the Collaborating Principal Investigator from each of the Research Training
Units, the FIC Program Officer, and one additional representative from the
Technical Advisory Group. The FIC Grants Management Officer serves as a
consultant to the Steering Committee on budget and grants-related issues.
The Steering Committee provides oversight across the ICOHRTA AIDS/TB program
and serves as the central point for communication and exchange of ideas
regarding research training activities and resolution of any problems, as
necessary. A chairperson who is not a USG employee will be elected by the
committee to serve a one-year term. The Steering Committee will meet at
least once annually and will participate in telephone, video or electronic
conferences, as needed. Each member of the Steering Committee will have one
vote.
Each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an
advisory committee, composed of two or more USG scientific advisors
designated by the Technical Advisory Group and a grants management expert, as
needed. The Research Training Unit Advisory Committees will assist the work
of the ICOHRTA-AIDS/TB program by providing advice and assistance that is
coordinated through the FIC Program Officer to the Research Training Unit.
The advisory committees of the Research Training Units assists in such
matters as reviewing the progress reports of each partner of the Research
Training Unit and suggesting mid-course corrections and future directions.
The membership of the individual advisory committee is determined by the
Technical Advisory Group, with advice from the Steering Committee. Research
Training Unit advisory committee members maintain ongoing communication
regarding the progress of the Research Training Unit, attend meetings of the
ICOHRTA-AIDS/TB program, whenever possible, and meet as an advisory committee
separately at least once per year.
The FIC Program Officer, as the program and scientific representative of the
FIC, chairs the Technical Advisory Group and is a member of the Steering
Committee. The Program Officer has lead responsibility for day-to-day
program decisions in coordination with the Technical Advisory Group and the
Steering Committee.
The FIC Grants Management Officer, as the grants management representative of
the FIC, is a member of the Technical Advisory Group and a consultant to the
Steering Committee. The Grants Management Officer will serve as a resource
in policies and issues related to NIH grants management to the planning grant
awardees and the ICHORTA-AIDS/TB Research Training Units.
Cooperative Agreement Terms and Conditions of Award:
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 and grants administration 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.
The following 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 92 [Part 92 is applicable when State and
local Governments are eligible to apply], and other HHS, PHS, and NIH grant
administration policies.
1. Awardee Rights and Responsibilities
Each partner institution will be responsible for implementation of its
portion of the integrated research-training program. 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 should 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 Principal Investigators will be expected to
be active members of the Steering Committee. Awardees are advised that they
will retain custody of and primary rights to any research data developed
under the award, subject to current Government policies regarding rights of
access.
Each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an
advisory committee, composed of two or more USG scientific advisors
designated by the Technical Advisory Group and a grants management expert, as
needed. The Research Training Unit Advisory Committees will assist the work
of the ICOHRTA-AIDS/TB program by providing advice and assistance that is
coordinated through the FIC Program Officer to the Research Training Unit.
2. United States Government(USG) Staff Responsibilities
The FIC Program Officer/Collaborator, in consultation with co-sponsoring U.S.
agencies, 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. The FIC
program officer/Collaborator will be familiar with the scientific agenda of
FIC and co-sponsoring U.S. agencies and will facilitate coordination of
training across these programs.
The FIC Program Officer/Collaborator will:
o serve on the Steering Committee and chair the Technical Advisory Group;
o provide advice on the management of the training provided, technical
content of the curriculum, and evaluation of the impact of the training;
o facilitate communication and exchange of information; and
o organize interactions with relevant co-sponsor and FIC staff to provide
scientific and administrative technical assistance.
The Technical Advisory Group is a committee of advisors with relevant
expertise from the USG co-sponsoring institutions (at least one from each co-
sponsor) and the Program and Grants Management Officers from the FIC. The
Technical Advisory Group: 1) reviews applications for responsiveness and,
after the independent initial peer review, makes funding recommendations, and
2) meets several times per year, as necessary, to review developments across
the ICOHRTA-AIDS/TB program as well as the progress of individual ICHORTA-
AIDS/TB Research Training Units and the planning grant recipients. The FIC
Program Officer/Collaborator serves as the chair of the Technical Advisory
Group.
The Technical Advisory Group will provide guidance to the Research Training
Units as part of the overall ICOHRTA AIDS/TB program. The individual
advisory committees of each Research Training Unit will provide guidance to
that Research Training Unit. The FIC Program Officer/Collaborator and one
non-FIC member of the Technical Advisory Group will serve on the Steering
Committee. The FIC Program Officer/Collaborator, in consultation with co-
sponsoring organizations and the FIC Grants Management Officer, will oversee,
advise, and assist the activities of the Research Training Units in support
of the ICOHRTA-AIDS/TB programs. The FIC Grants Management Officer will
serve as a resource to the Research Training Units in policies and issues
related to NIH grants management.
The FIC Program Official designated in the Notice of Grant Award will be
responsible for the normal programmatic stewardship of the award and may be
substantially involved as described above for the Program
Official/Collaborator role.
3. Collaborative Responsibilities
The Steering Committee is composed of the Foreign Principal Investigator and
the Collaborating Principal Investigator from each of the Research Training
Units, the FIC Program Officer/Collaborator, and one additional
representative from the Technical Advisory Group. The FIC Grants Management
Officer serves as a consultant to the Steering Committee on budget and
grants-related issues. The Steering Committee provides oversight across the
ICOHRTA AIDS/TB program and serves as the central point for communication and
exchange of ideas regarding research training activities and resolution of
any problems, as necessary. A chairperson who is not a USG employee will be
elected by the committee to serve a one-year term. The Steering Committee
will meet at least once annually and will participate in telephone, video or
electronic conferences, as needed. Each member of the Steering Committee
will have one vote.
The Principal Investigators will be members of the Steering Committee. This
committee together with the Technical Advisory Group will serve a
consultative function and help to shape the agenda and facilitate the
activities of the ICOHRTA AIDS/TB program.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of the award) between award recipient 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 USG members not voting) or by
the individual awardee in the event of an individual disagreement, a second
member selected by FIC in consultation with the Technical Advisory Group, and
the third member selected by the two prior selected members. These special
arbitration procedures in no way affect the awardee's right to appeal an
adverse action 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/programmatic issues to:
Jeanne McDermott, CNM, MPH, PhD
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:
Sherry L. Dupere, Ph.D.Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
MSC 7840, Room 5136
Bethesda,MD 20892
(for express/courier service, use zip 20817 and remove MSC 7840)
Telephone: 301-435-1021
Fax: 301-480-3567
Email: duperes@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 20892-2220
Telephone: 301-451-6830
Fax: 301-594-1211
Email: butrumb@mail.nih.gov
LETTER OF INTENT
Prospective applicants who receive Phase I planning grants and who intend to
apply for a Phase II award under this RFA are asked to submit a letter of
intent that includes the following information:
o Descriptive title of the proposed program
o Names, addresses, telephone numbers of the Principal Investigators
o Names 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 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 to:
Jeanne McDermott, CNM, MPH, PhD
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
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document 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: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS: Members of the proposed Research Training Unit
must collaborate with each other to prepare similar or identical research
training plans. The two applications from the Research Training Unit
partners should describe a comprehensive international clinical, operational,
and health services research training program and should address the
following areas in their applications, in place of the research plan:
1. Documentation by the institutions of a long-term commitment to build the
clinical, operational, and health services research capacity of the foreign
institution through governmental-support or other resources. A copy of their
agreement must be included with the Phase II applications.
2. A description of plans for the integration of clinical, operational, and
health services research capacity building at the collaborating foreign
institution.
3. A description of how resources from this award will be integrated with
other resources at the foreign institution or within the country to achieve
the overall goals of this program, building sustainable research capacity at
the foreign institution.
4. Evidence that both partners of the Research Training Unit collaborated in
creating a research training development plan for the foreign site and
demonstrated a description of how this plan supports the overall
institutional development plan of the foreign site. The U.S. (or other
developed country site) must describe how its component of the linked program
is designed to help build the research capacity at the foreign site. The
application should clarify the roles, responsibilities and commitments of the
foreign and U.S. (or non-U.S.) collaborators and should state what the
individuals listed would actually do and their time commitments to the
program.
5. Evidence of plans for linkage to and coordination with other sources of
research and training support in the foreign country is required, including
how these fit into the institutional development plans of the foreign
institution. Examples include:
o other FIC international research training and research programs;
o NIAID AIDS/TB-related programs;
o NICHD AIDS/TB-related programs;
o NIMH AIDS-related programs;
o NCI programs related to AIDS/TB;
o NIDA programs related to AIDS/TB;
o NIAAA programs related to AIDS/TB;
o NINDS programs related to AIDS/TB;
o AIDS/TB-related Programs of the Centers for Disease Control and
Prevention;
o USAID AIDS/TB-related programs;
o The President’s Emergency Plan for AIDS Relief
o The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria
o AIDS/TB-related programs of other organizations/foundations involved in
international control of and care for persons infected with HIV/AIDS and/or
TB.
6. A description of how this program will serve as a bridge between academic
research and public health communities to help to link the various HIV/AIDS
and/or TB trials and care programs supported in the country by NIH and other
sponsors.
7. A description of how their programs will relate to any community advisory
boards in the foreign country and how the training program will strengthen
the capability of these community advisory boards
8. A description of strategies to achieve a wider regional impact. This
could be done by strengthening other institutions in the foreign PI's country
or in neighboring countries ("south to south" training). The ultimate goal
is to become not only a national, but also a regional center of clinical,
operational, and health services research excellence that is capable of
offering training in these areas, and in introducing appropriate technology
to scientists from other countries.
9. Plans for strengthening core research support capabilities necessary for
long-term sustainability.
10 Plans for meeting the requirements related to training-related research
including advanced in-country research. These include scientific and peer
review procedures, written evidence of compliance with the required federal
citations, approval for the research from an institutional (or ethical)
review board or committee at both the U.S. or pre-approved non-U.S. and
foreign institutions and from the relevant government authority, as required.
Please see: Procedures for Registering Institutional Review Boards and
Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs)
(http://www.hhs.gov/ohrp/). All training-related research protocols
(including advanced in-country research) must be independently scientifically
reviewed through expedited scientific review procedures established by the
Research Training Unit. For example, as the training programs are
implemented, consideration will be given to mechanisms to support advanced
in-country research proposals as either competing supplements to Phase II
awards or as applications to the FIC Global Health Research Initiative
Program for New Foreign Investigators. Where appropriate, the design of
training related research projects should take into account potential sex and
gender differences that may affect the questions asked and the analyses
performed. These might include different responses to and impacts of health
interventions, differences in physiology, and different behavioral bases for
disease prevention strategies.
11. A description of how the proposed research training and capacity building
supports the HIV/AIDS and/or TB-related clinical, operational, and health
services research priorities of the participating foreign country.
Applicants should describe the procedures to assure this takes place within
the context of the collaborative relationship, including input from
scientific and community advisory boards in the foreign country. The
applicant should identify areas of mutual interest between country and the
co-sponsoring institutions (e.g., HIV-related opportunistic infections, HIV
malignancies, neurological and mental health consequences, behavioral issues,
cardiovascular disease, hematologic conditions, blood safety, pulmonary
manifestations, ophthalmologic manifestations, gastrointestinal conditions,
drug and alcohol usage, potential sex and gender differences in physiology
and behavior, and oral health manifestations).
12. Evidence of sustained host-country support for the program is required.
Such evidence of support should be provided in writing and should be in the
form of the following: (a) a statement of support from a senior
administrator at the foreign PI's institution, evidence of contributions from
the host-country and willingness of the host-country to utilize trainees'
experience and knowledge gained from the program to build integrated
clinical, operational, and health services research capacity at a center of
research excellence in the foreign country; and (b) a formal letter of
support from the Health Ministry and/or other senior government official that
emphasizes the long-term commitment of the country to the goals of the
proposed program.
13. Description of how the proposed training program will address the
interest of the co-sponsoring institutions.
Budget Preparation
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 & 5) in
the appropriate categories. The total direct costs of the trainee
participation budget should be identified on PHS Form 398 (budget pages 4 &
5) in the "Other category to create a composite budget containing all
direct costs for the applicant organization.
Each applicant of the Research Training Unit should develop a budget that
reflects the resources necessary to implement its components of the
comprehensive training plan included in the application. The total costs of
the combined budgets should be within the guidelines provided in the FUNDS
AVAILABLE section. The budgets may include costs to support various types of
training proposed (tuition, stipends, salary, travel, per diem) for trainees
and faculty and costs to support the administration of the program and grant.
Adequate resources to meet U.S. government requirements for training and
training-related research should be included in the budget.
Requested Salary Support
The salary for the PIs and other faculty and staff must be commensurate with
the salary structure or compensation package for similar professionals and
staff at the applicant institution.
Trainees' Stipends
Trainees may be paid a stipend comparable to their professional experience
similar to other equivalent trainees but not exceeding the NRSA stipend
levels (http://grants.nih.gov/training/nrsa.htm) and in accordance with the
grantee institutional policies while involved in long-term or intermediate-
term training at the grantee institution. (Use the NRSA substitute pages,
pre- or postdoctoral stipends.)
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 reduction
arrangements with the grantee institutions in order to provide reduced
tuition for long-term trainees and tuition-free short courses. (Use the NRSA
substitute pages, tuition, fees, insurance).
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/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original,
including the checklist, and five signed photocopies of the two applications,
one from each partner, in a single package. The two applications should be
clearly bundled separately but sent together so that the two components of
the Research Training Unit will be clearly identified and linked. Submit the
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 on or before 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.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within eight weeks.
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.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
PEER REVIEW PROCESS
For the Phase II Comprehensive ICOHRTA-AIDS/TB Awards, the applications
specifying the roles and responsibilities of each of the partner institutions
must be submitted together as a unit and the applications will be reviewed as
a single unit. Upon receipt, applications will be reviewed for completeness
by CSR, and responsiveness by the Technical Advisory Group. Incomplete
and/or non-responsive applications will be returned to the applicant without
further consideration. Please see the Special Requirements section for a
description of the documentation required for an application to be considered
responsive.
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 CSR in accordance with the review criteria stated below. As part
of the initial merit review, all applications will initially be reviewed to
determine which are considered the most meritorious.
CSR will conduct two peer review group meetings on the ICORHTA AIDS/TB
applications in accordance with FIC's review criteria to determine which are
considered the most meritorious. The first meeting will be an initial merit
review of all applications to evaluate the scientific and technical merit by
an appropriate peer review group convened by CSR. The second meeting will
review those Phase II Comprehensive ICOHRTA-AIDS/TB applications deemed
highly meritorious in the initial review and these applicants will have the
opportunity to respond to questions that arose at the initial review. The
second review may include a site visit. The results of both reviews will be
considered by the review committee in determining the priority score. Only
applications that have received the second review will be eligible for
funding, but all applicants will receive a written critique. A second level
review will be conducted by the FIC Advisory Board and possibly by the
Councils or Advisory Boards of other co-sponsoring Institutes/Agencies.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
ICOHRTA-AIDS/TB program seeks to strengthen research capacity across the
spectrum of clinical, operational, and health services research at specific
foreign institutions to combat problems of HIV/AIDS, TB, and/or other
HIV/AIDS-associated conditions relevant to that country's health. In the
written comments, reviewers will be asked to discuss these aspects of the
application in order to judge the likelihood that the proposed program will
have a substantial impact on the pursuit of each of these goals:
o Significance
o Approach
o Innovation
o Investigator and Institutions
o Environment
The scientific review group will address and consider each of these criteria
in reviewing your application and weighting them as appropriate for each
application. Note that the application does not need to be strong in all
review categories to be judged likely to have major 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.
Review Criteria for Comprehensive ICOHRTA-AIDS/TB Award Applications
(1) SIGNIFICANCE:
a) Expected contribution of the training program described in the
applications of the Research Training Unit to the foreign institution's
ability to conduct and manage integrated clinical, operational, and health
services research.
b) Expected potential of the foreign institution to serve as a training site
to advance a continuum of clinical, operational, and health services research
and public health capacity within the country and within the region.
(2) APPROACH:
a) Adequacy of the described training program to provide breadth of training
opportunities for the research trainees in all three of the research areas
(clinical, operational, and health services).
b) Capability of the described training program to provide the trainees with
the necessary administrative and management skills to compete for research
support and conduct research.
c) Expected ability of the proposed training program to strengthen the
capacity at the foreign institution over the life of the grant to develop
degree programs and to provide opportunities for trainees and junior faculty
to rise to scientific leadership positions in this or related programs.
d) Adequacy of the integrated application to demonstrate:
o coordination between the research training activities of the linked
applicants; and
o coordination and linkage with other related in-country research, training
and public health programs.
(3) INNOVATION:
a) 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, CDC, USAID or other organizations.
b) Adequacy of the proposed training program to take advantage of relevant
opportunities in other countries.
(4) INVESTIGATOR:
a) Training and experience of the foreign PI, the collaborating PI and key
personnel named in the integrated application to achieve the goals and
implement the activities of the proposed training program. Documentation
should include:
o Past research training record of the foreign PI, the collaborating PI and
the designated preceptors in tracking careers of their past U.S. and foreign
trainees and the rate at which former trainees establish independent and
productive research and public health careers. For foreign trainees, the
percent whose professional activities are in the home country. Please
include tables with this information, including current status of foreign and
other selected trainees for at least the past five years.
o Past research training record in terms of the success of former trainees
in obtaining individual awards such as fellowships, career awards, and
research grants for further career development; major scientific
breakthroughs and scientific leadership positions assumed by former trainees
should be highlighted.
b) Documentation of a history of successful institutional and individual
collaborations among the foreign PI, collaborating PI and key faculty of both
institutions. A successful history of collaborations is demonstrated by
funded research or training grants that include the foreign PI at the foreign
institution and the collaborating PI at the collaborating institution; by
funded research or training grants that include both the faculty at the
foreign institution and faculty at the collaborating institution; and by
jointly authored publications in scientific peer-reviewed journals.
(5) ENVIRONMENT:
a) Documentation of written commitment by the foreign government and ministry
of health and/or education or other officials to the long-term goals and
activities of the program. Examples include: a statement of support from a
senior administrator at the Foreign PI's institution; evidence of
contributions by the host-country and willingness of the host-country to
utilize trainees' experience and knowledge gained from the program to build
integrated clinical, operational, and health services research capacity at a
center of research excellence in the foreign country; and a formal letter of
support from the Health Ministry and/or other senior government official in
the foreign country that emphasizes the long-term commitment to the goals of
the award.
b) Documentation of written commitment (agreement) by the foreign institution
and its collaborating partners to cooperate to achieve the long-term goals
and activities of the program.
c) Plans for the proposed training program to take advantage of unique
features of the scientific environment in the foreign country and to employ
useful collaborative arrangements with other USG, other government and non-
governmental agencies active in addressing issues related to HIV/AIDS and/or
TB and their associated conditions in the country, including how well the
institutional development plan for the foreign site addresses these issues.
d) The adequacy of mentoring resources and training environment in-country as
evidenced by:
o the quality of teaching and the in-country research facilities;
o the availability of high-quality candidates for training, chosen on merit;
o 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; and
o 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.
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:
COLLABORATION WITH ICOHRTA AIDS/TB AWARDEES: The adequacy of the proposed
plan to work in collaboration with scientists at the ICOHRTA-AIDS/TB sites
and associated NIH and USG scientists, health professionals and staff in
proposed curriculum, training and evaluation activities.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research-training program.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: November 19, 2004
Application Receipt Date: December 20, 2004
Peer Review Date: March 2004
Council Review: May 2005
Earliest Anticipated Start Date: July 1, 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review including a site visit, if
conducted): The most important factor to be considered in making funding
decisions will be the quality of the proposed program, as determined by
initial scientific peer review. The proposed instruction in the responsible
conduct of research must be rated adequate for an award to be made.
o Availability of Funds
o Programmatic priorities and geographic balance: Geographic and
programmatic balance, input from the collaborating partners and the FIC
Advisory Board, and the adequacy of the commitment of the foreign country to
the program, as well as the extent to which the program helps to integrate
critical HIV/AIDS and/or TB efforts and related capabilities within the
country, will also be considered in making funding decisions. A
consideration for funding will be whether the proposed research training and
capacity building is integrated with or duplicates efforts in other FIC, NIH,
and other international programs, and whether it supports a unique
intervention opportunity not able to be accommodated by another FIC program.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety 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 "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.
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.
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 RFA 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information ,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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 at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b)
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
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