and Human Services (HHS)
EXPIRED
This Program Announcement expires on December 1, 2004, unless reissued.
PLANNING GRANTS TO ORGANIZE PROGRAMS FOR INTERNATIONAL CLINICAL, OPERATIONAL,
AND HEALTH SERVICES RESEARCH TRAINING FOR AIDS AND TUBERCULOSIS
PA NUMBER: PA-02-022
Release Date: November 28, 2001 (see replacement PAR-03-072)
Fogarty International Center (FIC)
(http://www.nih.gov/fic)
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov/default.htm)
National Institute of Child Health and Human Development (NICHD)
(http://www.nichd.nih.gov/)
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov/)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov/)
Office of AIDS Research (OAR)
(http://www.nih.gov/od/oar/index.htm)
Office of Behavioral and Social Sciences Research (OBSSR)
(http://obssr.od.nih.gov/)
Office of Research on Women's Health (ORWH)
(http://www4.od.nih.gov/orwh/)
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov/)
Letter of Intent Receipt Date: February 20, 2002
Application Receipt Date: March 19, 2002
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398
(REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
The International Clinical, Operational, and Health Services Research Training
Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) Program provides extended
support for training to foster collaborative, multidisciplinary research in
developing country sites where AIDS, TB or both are significant problems. As
used in this Program Announcement (PA), the term ICOHRTA-AIDS/TB should be
interpreted as building capacity for integrated clinical, operational, and
health services research encompassing the full range of conditions and issues
(e.g., opportunistic infections, HIV malignancies, neurological and mental
health consequences, behavioral issues, hematologic conditions, blood safety
issues, pulmonary manifestations, ophthalmologic manifestations,
gastrointestinal conditions, drug and alcohol usage, gender-related issues and
oral health manifestations) that relate to care of adult and pediatric
patients with HIV/AIDS or TB. This program is an integral and critical
component of a comprehensive global strategy of the NIH and Department of
Health and Human Services (DHHS) to address the needs of the millions
suffering from HIV/AIDS, tuberculosis, and related conditions in resource-
limited nations by extending and intensifying efforts to provide clinically
appropriate and sustainable care to these individuals in a manner that
supports continuing and expanding prevention activities. These efforts will
have direct health, economic and security benefits for the United States as
well as the global community. This program will increase research training
across the span of clinical science and public health practice and involve a
wide range of health professionals (e.g. nurses, midwives, physicians,
dentists, health care administrators and public health workers).
The first phase of the ICOHRTA-AIDS/TB program, beginning in fiscal year 2002,
will consist of one year planning grants to foreign institutions using the R21
grant mechanism. The R21 grant will provide support to organize, plan for,
prepare, and assemble an application for a Comprehensive ICOHRTA-AIDS/TB
Cooperative Agreement. During an R21 award, the applicant should:
o solidify collaborative relationships and understandings with all individual
and institutional partners;
o define the type of research training programs to be developed in
cooperation with its principal and any other collaborating partners and in
consultation with staff from FIC and other U.S. Government co-sponsoring
organizations of this program;
o assess current resources and needs including the need for an institutional
review board;
o develop a step-wise plan to address these needs;
o develop an institutional (organizational) structure including links with
other relevant national and international organizations that conduct and
support clinical, operational, and health services research;
o identify the training, staff development, and scientific and administrative
resources needed to undertake a comprehensive training program;
o prepare an institutional development plan for at least the next ten years
demonstrating how resources from a Comprehensive ICOHRTA-AIDS/TB Cooperative
Agreement in conjunction with resources from other collaborating partners and
from the applicant will allow the applicant institution to achieve its long-
term development goals.
The second phase of the ICOHRTA-AIDS/TB program will begin in fiscal year
2003, and will provide comprehensive sustained support to both the foreign
institution and its linked U.S. partner (or pre-approved non-U.S. institution)
through five-year cooperative agreements (potentially renewable). Training
will take place at the U.S. or foreign sites and mentored research will be
carried out mainly at the foreign site. The program may also provide support
at the foreign site for training in support of development and extension of
core capabilities necessary for long-term sustainability.
The Fogarty International Center (FIC), together with NCI, NIAAA, NIAID,
NICHD, NIDA, NIMH, NINDS, OAR, OBSSR, ORWH, and CDC, invites applications for
one year planning grants to develop international clinical, operational, and
health services research training programs which foster the development of
integrated strategies to successfully implement evidence-based interventions
pertinent to the global health crises created by HIV/AIDS and tuberculosis
(TB). Co-sponsoring institutions are United States Government (USG) agencies
contributing financial resources to the program. Cooperating organizations
are organizations whose resources are made available to be utilized in support
of the program. Applicants are strongly encouraged to design programs that
provide capacity building in support of the National Institutes of Health
(NIH), United States Government (USG), and other international efforts to
respond to this global health crisis (see special requirements for examples).
NIH defines human clinical research as: (1) Patient-oriented research.
Research conducted with human subjects (or on material of human origin such as
tissues, specimens and cognitive phenomena) for which an investigator (or
colleague) directly interacts with human subjects. Excluded from this
definition are in vitro studies that utilize human tissues that cannot be
linked to a living individual. Patient-oriented research includes: (a)
mechanisms of human disease, (b) therapeutic interventions, (c) clinical
trials, or (d) development of new technologies. (2) Epidemiologic and
behavioral studies. (3) Outcomes research and health services research.
Note: Studies falling under Exemption 4 for human subjects research are not
considered clinical research by this definition.
In the context of this PA, this definition of clinical research includes
studies of an intervention intended to prevent transmission or to improve the
quality of life for HIV- or TB-infected children, men or women. This area of
research involves, but is not limited to, clinical trials of biomedical,
behavioral, or combination interventions, the development of new technologies,
and new ways to deliver, monitor, and sustain AIDS and/or tuberculosis care.
Operational research is defined as research that encompasses the translation
of knowledge, practices, and technologies into clinical use. Examples include
assessment of how to successfully implement existing and new prevention
interventions, therapeutic tools, and other care interventions for broad-based
use, and the study of barriers to such translation and implementation. When
interventions have been shown to be successful on a small scale or in limited
situations, operational research will help determine how to best generalize
such interventions for widespread and sustainable use. Operational research
includes studies of factors that influence the effectiveness of interventions
in "real world settings."
Health services research includes studies that examine the organization,
financing, management, and delivery of health services and how they impact a
person's ability to utilize HIV and TB health services. This research also
includes studies of quality, cost, and effectiveness of proven therapeutic or
prevention interventions.
Excluded from consideration are training and capacity building linked or
related to:
o studies that do not involve some component of research with a scientific
question or evaluation (e.g. demonstration projects or health services
delivery projects that do not involve evaluation of a hypothesis);
o studies that do not include an intervention designed to prevent
transmission or provide treatment/care for individuals infected with HIV or TB
and other associated opportunistic infections; and
o studies involving animals.
The training-related research subjects for all types of eligible research may
be individuals or groups, such as families, organizations, institutions,
communities, or populations.
RESEARCH AND PUBLIC HEALTH OBJECTIVES AND SPECIAL REQUIREMENTS FOR THE
COMPREHENSIVE PROGRAM
In developing proposals for planning grants, applicants need to be aware of
the objectives and special requirements for the comprehensive program as
described below. The training supported under the comprehensive program will
help to produce a cadre of experts who will facilitate integrated clinical,
operational, and health services research for the benefit of developed and
developing country populations. These scientists will comprise a resource
that will facilitate additional training and research in the region.
The types of training under the comprehensive program will include:
o Long-term (greater than 12 months and up to four years, depending on
resources) training for the full range of skills necessary to support clinical
research in masters or doctoral programs, with the understanding that all
thesis-related work would be done in the trainee's home country. With prior
FIC approval, pre-masters training will be allowed for health professionals
with demonstrated interest and capability, but whose prior professional
education does not include a bachelor's level degree (e.g., nurses, midwives,
laboratory technicians).
o Short-term (less than three months) training or mentoring that focuses on
research methodology, laboratory skills necessary to support clinical
research, ethics and compliance issues, program and grants administration,
grant writing, preparation of scientific manuscripts, technology transfer, and
data management or Internet connection.
o Intermediate-term (three to 12 months) training or mentoring, including
specialized clinical and laboratory skills necessary to support clinical,
operational, and health services research that is planned or ongoing.
While a range of short- and long-term training is allowable, emphasis will be
on intermediate to longer-term training, including mid-career training. This
approach will accelerate building enduring capability for clinical,
operational, and health services research at the participating foreign
institutions.
Each research-training proposal for a comprehensive program should incorporate
a number of long-term (greater than one year), intermediate term (three to 12
months) and short-term (less than three months) training opportunities
(including advanced in-country research) in a wide range of relevant
disciplines and skills necessary to advance research objectives while building
sustainable clinical, operational, and health services research capacity at a
center of research excellence at a foreign site.
To a limited extent, U.S. trainees will be eligible for foreign research
experience under this comprehensive program, with prior FIC approval, if they
have uniquely relevant expertise and skills that will contribute to the
training and research at the foreign institution and/or have a major career
commitment to international research. NIH intramural research programs may
also support junior U.S. researchers for research experiences at the foreign
sites with prior agreement from the foreign site.
The ICOHRTA-AIDS/TB program strongly encourages program directors to include
women and minorities as trainees and faculty at all sites.
The planning applications must outline the strategies and approach to develop
a proposal for a comprehensive training program that will build capacity in
the foreign country to conduct integrated clinical, operational, and health
services research focused on one or more of the following areas:
1. The application of clinical science and health care research to benefit
those already infected with HIV and/or TB. Examples of this area of research
include studies: to address the optimal therapeutic regimens and delivery
systems for treatment of people with HIV/AIDS and/or tuberculosis and related
conditions; to determine the impact of treatment on the factors favoring drug
resistance; to evaluate the prevalence and spread of resistant virus and
strains of M. tuberculosis and measures to mitigate these events; to define
and evaluate behavioral interventions and health systems reforms that promote
compliance with optimal treatment regimens; to identify the co-factors and
interactions that propagate the epidemics of HIV/AIDS and/or tuberculosis
(e.g., concomitant sexually-transmitted diseases, nutritional status, blood
safety, gender differences); to identify effective interventions to improve
the quality of life, including palliative care, for men, women, and children
living with HIV/AIDS and/or TB; and the impact of gender on stigma, on access
to health services for HIV/AIDS and/or TB therapy.
2. The prevention and/or reduction of spread of HIV and tuberculosis and
related conditions, especially that which can be implemented within the
context of care. Examples of this area of research include studies: to
evaluate the impact of the availability of treatment and care on the
willingness of people to be tested and to receive their results; to evaluate
the effectiveness of prevention measures (behavioral change, condom use,
microbicides, compliance) when offered in conjunction with testing and
treatment; to evaluate the impact of maternal treatment on mother to child
transmission and child survival; to understand gender differences on
acceptance and effectiveness of therapies, care and prevention.
3. The study of strategies for scale up and integration of effective
therapeutic and preventive interventions into the local health care system.
Some examples of research in this area include studies of effective monitoring
strategies in settings with limited laboratory and medical specialization;
integration of voluntary counseling and testing (VCT) into health care
systems; the system features required to ensure availability of clinical
monitoring, appropriate laboratory tests, and drug supply; the best training
and utilization of physicians and other categories of health care workers to
optimize coverage, compliance, and access to the full range of services that
constitute care for individuals living with HIV/AIDS and/or TB.
The applicant should describe plans to help assure that its approach to
clinical, operational, and health services research training will be directly
relevant to the needs of the people in the international site. Criteria to
evaluate relevance include consideration of morbidity, mortality, and
disability, as well as the economic and public health impact of measures
taken.
Essential to all research conducted internationally by principal collaborating
investigators is the need for close consultation with the foreign
collaborating country, in setting an agenda that is appropriate to local
circumstances and most likely to affect public health policy. Also implicit
is the need to rapidly build the training capacity and infrastructure
requisite for success by building on existing research and training programs
involved with the implementation of prevention and care interventions at the
country level. The magnitude of the tasks and the urgency to deliver
measurable progress once funds are committed will require creative solutions
with high multiplier effects.
The major goal of the ICOHRTA-AIDS/TB planning grant is to develop a
competitive application for a Comprehensive ICOHRTA-AIDS/TB Cooperative
Agreement as a linked dual application between the foreign and a U.S. (or
other) developed country institution which will have the following Special
Requirements:
o The foreign principal investigator and the collaborating developed country
principal investigator will be responsible for the overall conduct of the
ICOHRTA-AIDS/TB. The research partner institutions of the foreign principal
investigator and the collaborating principal investigator must have entered
into a long-term commitment in writing to build the clinical, operational, and
health services research capacity of the foreign institution through
governmental-supported or other resources. A copy of this agreement must be
included with the comprehensive application if not already available at the
time of submission of the planning grant. Should NIH intramural labs or
programs be involved in the ICOHRTA-AIDS/TB application, they must also be
party to these agreements. Participation by NIH intramural programs requires
concurrence by both the scientific directors of the participating institutes
and the Deputy Director for Intramural Research of the NIH.
o Both the foreign and collaborating site must demonstrate the capacity and
leadership necessary for the successful implementation and long-term
productivity of the program. Both the foreign and U.S. (or other developed
country site) must have achieved a strong record of receiving or being
significantly involved in HIV/AIDS and/or TB international research. To
qualify, both the foreign and collaborating principal investigator must be
directly involved in and funded to do clinical research in resource-poor
settings and there must be tangible evidence of very strong linkage to that
ongoing research. Each site should provide a comprehensive list of these
awards for at least the past five years to support its designation of
institutional center of excellence status in this field.
o Evidence of plans for linkage to and coordination with other sources of in-
country research and training support is required. Examples include: FIC
training and research programs (e.g., AIDS, tuberculosis, maternal and child
health, emerging infectious diseases); NIAID programs (Comprehensive
International Program of Research on AIDS (CIPRA), the HIV Vaccine Trials
Network, the HIV Prevention Trials Network, NIAID tuberculosis programs
supporting the conduct of TB drugs, vaccine efficacy trials and
infrastructure/research capability strengthening as well as Centers for AIDS
Research (CFARs) and the AIDS Clinical Trials Groups (ACTG and PACTG); NICHD
AIDS programs (Global Network on Women's and Children's Health Research,
Pediatric/Perinatal HIV Clinical Trials Network, African Partnerships
Program); NIMH AIDS programs (NIMH Collaborative HIV/STD Prevention Trial);
NCI programs related to AIDS; NIDA programs related to AIDS (Global Research
Network); NHLBI programs related to AIDS (e.g. blood safety); NIAAA programs
related to AIDS; the Global AIDS Program and Field Epidemiology Training
Program (FETP) of the Centers for Disease Control and Prevention; USAID AIDS
and TB programs; UNAIDS; Global Fund to Fight AIDS, Tuberculosis and Malaria;
WHO AIDS and TB programs; UNICEF AIDS programs; and non-government and faith-
based organizations involved in international control of HIV/AIDS and TB
(e.g., the Bill and Melinda Gates Foundation, the Elizabeth Glaser Pediatric
AIDS Foundation, the Rockefeller Foundation, the International Union Against
Tuberculosis and Lung Diseases, the Sequella Global Tuberculosis Foundation,
the Academic Alliance for AIDS Care and Prevention in Africa, Doctors Without
Borders, the American Foundation for AIDS Research, the Global Alliance for TB
Drug Development, the International AIDS Vaccine Initiative, Catholic Relief
Services and many others).
o Applicants must describe plans to help assure that the ICOHRTA-AIDS/TB will
be supportive of and integrated with other relevant programs in the foreign
institution and within the country (such as those listed above). They should
describe how this program can serve as a bridge between academic research and
public health communities within the country as well as to help link various
HIV/AIDS and TB trials supported in the country by NIH and other sponsors.
o Applicants should identify their plans to assure that training and capacity
building supports the HIV/AIDS and TB-related clinical, operational, and
health services research priorities of the participating foreign country and
should describe the procedures to assure this takes place within the context
of the collaborative relationship.
o The application should describe plans for the integration of clinical,
operational, and health services research capacity building at the
collaborating foreign institution. It is also desirable for the application
to describe strategies to achieve a wider regional impact. This could be done
by strengthening other institutions in the foreign principal investigator
country or in neighboring countries ("south to south" training). The ultimate
goal is to become not only a national but also a regional center of clinical,
operational, and health services research excellence that is capable of
offering training in these areas, and in introducing appropriate technology to
scientists from other countries.
o Evidence of host-country support for the planning grant as well as
sustained support for any subsequent comprehensive program is required. Such
evidence of support should be provided in writing and should be in the form of
the following: (1) a statement of support from a senior administrator at the
foreign principal investigator country institution, evidence of cost-sharing
by the host-country and willingness of the host-country to utilize trainees'
experience and knowledge gained from the program to build clinical,
operational, and health services research capacity at a center of research
excellence in the foreign country; and (2) formal letter of support from the
Health Ministry and/or other senior government official that emphasizes the
long-term commitment to the goals of the award.
o Before any funds may be expended on in-country training-related research,
the grantee institution must show written evidence of federal-wide assurances
for the collaborating institutions, and approval for the research from an
institutional (or ethical) review board or committee at both the U.S. or pre-
approved non-U.S. and foreign institutions and from the relevant government
authority as required. Please see: Procedures for Registering Institutional
Review Boards and Filing Federal-Wide Assurances of Protection for Human
Subjects (FWAs) http://www.hhs.gov/ohrp/assurances/assurances_index.html. Applicants should
document their plans for meeting this requirement.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This Program Announcement (PA),
International Clinical, Operational, and Health Services Research Training
Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB), is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Phase I - One Year Planning Grants (R21) to foreign institutions
To qualify, principal investigators must be directly involved in and funded to
do clinical research in resource-poor settings and they must provide tangible
evidence of very strong linkage to that ongoing research as part of this
application.
The need for developing additional research capacity in-country must be
justified by the significance of the AIDS/TB problem as well as a paucity of
economic resources in the host country. Eligible foreign sites include
countries in the following regions: Africa, Russia and the Newly Independent
States (NIS), Asia (except Japan, Singapore, South Korea, and Taiwan), the
Pacific Island region (except Australia and New Zealand), the Middle East
(except Israel), Latin America (Mexico, Central and South America) and the
Caribbean.
In order to best support the building of sustainable research in low-income
and transitional economy countries, planning grants to support the preparation
of a comprehensive ICOHRTA-AIDS/TB application will be made only to those
foreign non-profit public or private institutions (e.g. universities,
colleges, hospitals or laboratories) which can document a significant and
active record in HIV/AIDS and/or TB research and training and show potential
to become national or regional centers of excellence. The principal
investigators must hold faculty or other long-term research positions at a
public or private non-profit research institution that will allow them
adequate time and provide appropriate facilities, salary support and
resources, including access to patients or patient data, when necessary.
Phase II - 5 year Comprehensive Cooperative Agreements (beginning FY 2003)
Foreign grantees that have been awarded an ICHORTA-AIDS/TB Planning Grant may
subsequently apply for Comprehensive ICHORTA- AIDS/TB Cooperative Agreements
under a future FIC Program Announcement for this purpose. The PA will require
that foreign applicants partner with an institution in the U.S. or (with pre-
approval) in another developed country to submit a package of two grants to be
reviewed as a single unit.
The partners of successful packages or units that are chosen to be funded will
each receive an award.
The foreign site and foreign principal investigator will designate a developed
country institution as its partner, and the principal investigator at this
site will be referred to as the collaborating principal investigator. The
linked institutions will be referred to as "research partners." With prior
FIC approval, the designated principal collaborator may be a non-U.S.
institution or an NIH intramural research program, provided that each commits
significant resources to this program. Also with prior FIC approval, and
concurrence from the foreign PI, the collaborating principal investigator may
involve additional institutions as collaborating partners through a
subcontract or consortium arrangement. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal
Investigators. Only one application will be allowed from any foreign
institution except if a foreign applicant also is collaborating with an NIH
intramural research program in which case two applications are allowed.
Participation of NIH intramural programs as training sites and as
collaborators in capacity building and research at the foreign site is
encouraged. An intramural NIH investigator may serve as collaborating
principal investigator on an ICOHRTA-AIDS/TB with concurrence by both the
scientific director of the participating institute and the Deputy Director for
Intramural Research of the NIH. The participating NIH intramural program must
pay for the participation of its own staff, including travel expenses, and for
any research costs at NIH.
The applications from the linked foreign and collaborating institutions must
demonstrate that, for each site, both the Principal Investigator and the
institution have a track record of commitment and experience in related
clinical research and training. The principal investigators must hold faculty
or other long-term research positions at a public or private non-profit
research institution that will allow them adequate time and provide
appropriate facilities, salary support and resources, including access to
patients or patient data, when necessary.
MECHANISM OF SUPPORT
Phase I - One Year Planning Grant to a Foreign Institution
For Phase I of the program, this PA will use the National Institutes of Health
(NIH) R21 planning grant mechanism. If an NIH intramural investigator is
involved in the program, the planning grant will be converted to a cooperative
agreement at the time of award.
Involvement of an intramural investigator in the program includes
collaboration which involves a significant contribution to the
conceptualization, design, execution or interpretation of the research study.
Simply providing unique biological materials, such as cell lines, antibodies,
and probes, does not constitute a collaboration. NIH scientists may serve as
unpaid collaborators or unpaid consultants on extramural grants. In these
cases, a formal letter from the intramural scientist must be included as part
of the grant application with a copy of this letter sent to the Scientific
Director. The letter should be limited to a description of the intramural
scientist's collaborative work under the grant. The grant applicant is
responsible for writing the section of the grant that describes the proposed
collaboration within the grant, which the NIH investigator should see and
approve.
In some cases, the work of the intramural scientist is such a substantial part
of the proposal that the award may need to be managed as a cooperative
agreement. Circumstances defining when a grant should be managed as a
cooperative agreement are defined in the document entitled "Cooperative
Agreements" available at
http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/IRP-ERP-Cover-Memo-10-27-99.htm.
If an intramural scientist believes that his/her contribution requires a
cooperative agreement, the Scientific Director should be alerted when the letter
of collaboration is submitted, and, if appropriate, the Scientific Director
should notify the grants management office of their Institute or Center about
the nature of the collaboration.
A Phase I award will be made for 12 months at a level of up to $75,000 in
direct costs (or three modules of $25,000), plus eight percent facilities and
administrative costs. Please see the Allowability of Facilities and
Administrative (F&A) Costs for Foreign and International Organizations at:
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html)
in the NIH Guide, March 30, 2001.
Allowable costs for R21 applications include travel, salary, minimum
consultative fees and administrative costs. The total amount of salary and
fringe benefits requested for all grantee faculty must be well justified and
compatible with salary scales established for similarly ranked professionals
at the applicant institution. The time commitment for personnel receiving
salary should be thoroughly described.
Phase II - 5 Year Comprehensive ICOHRTA-AIDS/TB Cooperative Agreements with
Linked Foreign and U.S. (or Other) Partners
FIC plans on issuing a PA for funding in fiscal year 2003 for Comprehensive
ICOHRTA-AIDS/TB Research Training Awards. International Institutional
Training Cooperative Agreements will be made with each of the research
partners for a five year period. These will be renewable for a second five-
year period as a competing renewal application.
Each research partner will receive total direct costs up to $250,000 per year,
as well as facilities and administrative (F&A) costs limited to eight percent.
Please see the web site
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html
for more information on the permissible F&A costs for foreign and international
organizations. Awards made to foreign institutions for collaboration with NIH
intramural programs will also be made as cooperative agreements and will be
limited to the amount agreed to by the involved NIH Institute.
FUNDS AVAILABLE
The FIC and co-sponsoring partners intend to commit approximately $1,000,000
to fund an estimated twelve planning (R21) grants from this PA in fiscal year
2002. The FIC plans to issue a PA for the Comprehensive ICHORTA-AIDS/TB
cooperative agreements for funding in fiscal year 2003. FIC and co-sponsoring
funding partners intend to commit approximately $3,500,000 each year to fund
an estimated six planning grants and six Comprehensive ICOHRTA-AIDS/TB
cooperative agreement programs from this PA and the PA for the comprehensive
program each fiscal year beginning in fiscal year 2003, subject to
availability of funds.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following web site:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2) cited
publicly and officially by a Federal agency in support of an action that has
the force and effect of law (i.e., a regulation) may be accessed through FOIA.
It is important for applicants to understand the basic scope of this
amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed planning grant, the name, address and
telephone number of the Principal Investigator, the proposed U.S. (or non-
U.S.) major collaborator, the identities of other key personnel and
participating institutions, and the number and title of the PA in response to
which the application may be submitted. Although a letter of intent is not
required, is not binding, and does not enter into the review of a subsequent
application, the information that it contains allows NIH staff to estimate the
potential review workload and plan the review. The letter of intent is to be
sent to Dr. Jeanne McDermott at the address listed under INQUIRIES by the
letter of intent receipt date listed in this PA.
APPLICATION PROCEDURES
Specific application instructions have been modified to reflect "Modular
Grant" and "Just-in-Time" streamlining efforts that have been adopted by the
NIH. Complete and detailed instructions and information on Modular Grant
applications have been incorporated into the PHS 398 (Rev. 5/01).
http://grants.nih.gov/grants/funding/modular/modular.htm.
The PHS 398 research grant application instructions and forms (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants. This version of the PHS 398 is available in an
interactive, searchable format. Beginning January 10, 2002, the NIH will
return applications that are not submitted on the 5/2001 version. For further
assistance contact GrantsInfo, Telephone 301/710-0267, Email:
[email protected].
The application should follow the PHS 398 instructions with the following
modifications:
The PA label available in the PHS 398 (rev. 5/01) application form must be
affixed to the bottom of the face page of the application. Failure to use
this label could result in delayed processing of the application, such as it
may not reach the review committee in time for review. In addition, the PA
title and number must be typed on line two of the face page of the application
form and the YES box must be marked. The PA number must be typed on the label
as well. The sample PA label available at
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
Submit a signed original of the application, including the checklist, and
three signed photocopies in one package to CENTER FOR SCIENTIFIC REVIEW,
NATIONAL INSTITUTES OF HEALTH, 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710,
BETHESDA, MD 20892-7710, BETHESDA, MD 20817 (for express/courier service).
At the time of submission, two additional copies of the application and
appendices must be sent to: Dr. Madelon Halula at the address listed under
INQUIRIES. Applications must be received by the application receipt date
listed in the heading of this PA. If an application is received after that
date, it will be returned to the applicant without review.
o The research plan should be replaced with the following: 1) A project
summary (fifteen page limit) describing the goals, objectives and plan for
meeting the objectives for the planning grant. Describe the background of the
research and training collaborations of the institutions, the principal
investigators and of the faculty proposed to be the research-training
partners. Describe the organizational structure at each institution that will
be available for the proposed training program. Identify resource gaps and
potential ways to fill these gaps. Describe the current and future clinical,
operational and health services research that will serve as the research base
for the proposed training program. Identify other ongoing and future FIC and
other research and training programs and potential cooperating partners in the
country with whom the proposed program can link. Describe how the proposed
program will address the research needs and health priorities defined by the
country. Include an estimated time frame for the development of the
comprehensive application. Describe plans for coordinating preparation of the
application for the comprehensive program with all partners and with FIC and
other NIH and USG staff involved as co-sponsors.
o Biographical sketches and letters of commitment from the foreign
institutions, foreign principal investigator, and potential collaborating
institution and collaborating principal investigator.
o A list of the recent (within past five years) and active research and
training in HIV and/or TB in which the foreign institution and principal
investigator have been involved. Please include grant number (if applicable)
and the funding agency.
The Center for Scientific Review (CSR) will not accept any application in
response to this PA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. This
does not preclude the submission of substantial revisions of applications
already reviewed, but such applications must include an Introduction
addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR, and
responsiveness by the FIC and co-sponsoring institutes and organizations.
Incomplete and/or non-responsive applications will be returned to the
applicant.
Applications that are complete and responsive to the PA will be assigned to
FIC. Applications will be evaluated for scientific and technical merit by an
appropriate scientific review group convened by the NIAID in accordance with
the standard NIH peer review procedures with the review criteria stated below.
As part of the initial merit review, all applications will receive a written
critique, and will be discussed, assigned a priority score, and receive a
second level review by the FIC Advisory Board.
Review Criteria
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
ICOHRTA-AIDS/TB program seeks to build an integrated capacity across the
spectrum of clinical, operational, and health services research at specific
foreign institutions to combat problems of HIV/AIDS, TB, and other associated
conditions relevant to that country's health. Each of these criteria will be
addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that the application does not need to
be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high (meritorious) priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
The scientific evaluation of each application will include assessment of the
linkage (integration and coordination) between the foreign and the
collaborating components and between proposed training and ongoing clinical,
operational, and health services research, other current training programs
supported by FIC, and research and prevention programs supported by co-
sponsoring NIH institutes, USG agencies, international organizations,
foundations, etc. Planning award applications will be reviewed for their
potential to be developed into competitive applications for Comprehensive
ICOHRTA-AIDS/TB Cooperative Agreements. Evidence of support for this program
by collaborating institutions and foreign governments must be submitted in
writing with the application. In addition, the following review criteria will
be used
(1) Significance
o Has the applicant adequately documented that there is a significant
HIV/AIDS and/or TB problem in the home country?
o Is the applicant in a position to design a program that provides capacity
building in support of the National Institutes of Health (NIH), other United
States Government (USG) and other international efforts to respond to the
global health crisis posed by HIV/AIDS and/or TB?
o Does the foreign institution have the potential to serve as a training site
to advance an integrated approach to clinical, operational, and health
services research related to HIV/AIDS and/or TB within the country and
potentially within the region?
(2) Approach
o What is the likelihood that the applicant could develop a comprehensive
ICOHRTA AIDS/TB program that would be supportive of and well-integrated with
other relevant HIV/AIDS and TB programs in the foreign institution and within
the country?
o Has the applicant chosen a suitable collaborating U.S. (or non-U.S.)
partner with which to implement any future comprehensive program?
o Does the applicant present a realistic, stepwise plan for developing a
coordinated application for a comprehensive program?
o Has the applicant identified an institutional (organizational) structure to
implement a future comprehensive program?
o Has the applicant outlined an approach for preparation of an institutional
development plan demonstrating how resources from a comprehensive program
award would be integrated with other resources in the country?
(3) Innovation
o What is the likelihood that the planned program would take advantage of the
foreign institution's research infrastructure and that of previous and current
FIC and NIH investments and support, or support from other organizations?
o Are there creative strategies to take advantage of relevant opportunities
in the applicant's or in other countries?
(4) Investigator
o Has the applicant and collaborating U.S. (or non-U.S.) partner demonstrated
an exemplary record in HIV/AIDS and/or TB clinical research and training in
resource-poor settings and is the applicant currently funded for this research
and training? Has the applicant documented that there would be very strong
linkage to the ongoing clinical research as part of any future comprehensive
program?
o Is there a record of successful research or training collaboration among
the foreign principal investigator, collaborating principal investigator, and
key faculty of both institutions?
o Do the principal investigators hold faculty or other long-term research
positions at a public or private non-profit research institution that will
allow them adequate time and resources to play leadership roles in the
program?
o Are the foreign principal investigator, collaborating principal
investigator, and all mentors appropriately well-qualified to implement the
activities of any planned comprehensive training program?
o Is there evidence of a commitment by the foreign institution and its U.S.
(or non-U.S.) partners to form long-term collaborative research and research-
training relationships?
(5) Environment
o Is there a written commitment by the foreign government and Ministry of
Health to the long-term goals and activities of any future comprehensive
program?
o What is the likelihood that any future program would be able to take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?
o Are there adequate mentoring resources and a supportive training
environment in-country as evidenced by: 1) the quality of teaching and the
in-country research facilities; 2) the availability of high-quality candidates
for training, chosen on merit; and 3) a past history of success of former
trainees contributing to their home countries and their programs by
participation in advanced in-country research and as faculty and mentors for
new trainees?
o Are there plans to establish IRBs in all participating foreign
institutions, if not already established?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the future
training-related research. Plans for the recruitment and retention of
subjects will also be evaluated. IRBs in the home countries of trainees will
be responsible for determining the adequacy of inclusion of women, minorities,
and children in research involving human subjects in their countries.
o The reasonableness of the proposed budget and duration in relation to the
proposed plan.
o The adequacy of the proposed plans for protection for humans, animals or
the environment, to the extent they may be adversely affected by future
projects undertaken under a comprehensive program. The initial review will
examine the adequacy of the process for providing for the protection of human
and animal subjects; the safety of the research environment; and plans to
include training in responsible conduct of research and training in the
operation of Institutional Review Boards (IRBs) or equivalent ethical review
boards, data and safety monitoring boards, and community advisory boards as a
part of the program.
o Recipients of one year planning awards and those wishing to submit amended
applications from this competition may submit these applications for funding
consideration in conjunction with the schedule for reviews under this PA and
the subsequent PA for the comprehensive program.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities and geographic balance, including priorities of
collaborating co-funding partners.
The most important factor to be considered in making funding decisions will be
the quality of the proposed project, as determined by initial scientific peer
review. The proposed plans for instruction in the responsible conduct of
research must be rated adequate for an award to be made. Geographic and
programmatic balance, as well as input from the co-sponsoring partners and the
FIC Advisory Board, will also be considered in making funding decisions. A
consideration for funding will be whether the plan for the proposed training
and capacity building program facilitates and is integrated with (or
duplicates) efforts in other FIC, NIH, and other international programs, and
whether it supports a unique intervention and care opportunity not able to be
accommodated by another FIC or NIH program.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Jeanne McDermott, C.N.M., M.P.H., Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]
Direct inquiries regarding grants management and fiscal matters to:
Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: 301-451-6830
Fax: 301-594-1211
Email: [email protected]
Direct inquiries regarding review issues to :
Madelon Halula, Ph.D.
Special Review Program
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Scientific Review Program
6700 B Rockledge Drive
Room 2215, MSC 7616
Bethesda, MD 20892-7616
(For express/courier service: Bethesda, MD 20817)
Telephone: (301) 402-2636
Fax: (301) 402-2638
Email: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.989. Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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