and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating
Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
Fogarty
International Center (FIC) (http://www.fic.nih.gov)
Title: Global Infectious Disease Research Training Program Award (D43)
Announcement Type
This
is a re-issue of PAR-05-128
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-08-154
Catalog of Federal Domestic
Assistance Number(s)
98.989
Key Dates
Release
Date: April 18, 2008
Letters of Intent Receipt Date(s): August 14, 2008; August 14, 2009; August 14, 2010
Application Receipt Dates(s): September
16, 2008; September 16, 2009; September 16, 2010
Peer Review Date(s): February 2009; February 2010; February 2011
Council Review Date(s): May 2009;
May 2010; May 2011
Earliest Anticipated Start Date: June 1, 2009 ; June 1,
2010; June 1, 2011
Expiration Date: (Now Expired March 24, 2010 per NOT-OD-10-069), September 17, 2010
Due Dates for E.O. 12372
Not
Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Training Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1.
Research Training Objectives
Infectious
diseases continue to impose a tremendous health burden in resource-poor
countries throughout the world, claiming millions of lives annually and
inflicting severe morbidity that results in significant losses in economic
productivity and social progress. Attempts to control infectious diseases
endemic to developing countries suffer due to an incomplete understanding of
the pathogens, their disease manifestations and transmission mechanisms,
inadequate preventive measures and interventions, and inadequate health
services and disease control efforts. A major barrier to improved research,
treatment and control of infectious diseases is the scarcity of scientists and
health professionals in endemic countries with relevant infectious disease
research knowledge and expertise.
The purpose of this announcement is to invite applications from U.S. and developing country institutions to train or expand the capabilities of scientists and health professionals from developing countries to engage in infectious diseases (excluding HIV/AIDS) research. Proposals are requested for innovative, collaborative research training programs that would contribute to the long-term goal of building sustainable research capacity in endemic infectious diseases at developing country institutions. The intent is to harness scientific knowledge and skills to enhance prevention, treatment and control of infectious diseases causing major morbidity and mortality in developing countries. Developing country institutions may also apply for one-year planning grants to support the development and submission of research training program proposals in the subsequent year. In addition, ongoing infectious disease research training awardees may apply for a competing revision (formerly called supplement) award to their Global Infectious Disease Research Training awards to expand their training activities.
FIC will support research-training programs that focus on building sustainable non-HIV/AIDS infectious disease research capacity at an institution in an endemic developing country. Sustainable research capacity depends on building a critical mass of scientists and health professionals with in-depth scientific expertise and complementary skills that enable the institution to conduct independent, internationally-recognized infectious disease research relevant to the health priorities of their countries. FIC will support research-training programs that focus on major endemic or life-threatening emerging infectious diseases, neglected tropical diseases, significant co-infections of HIV/AIDS patients or the relationship of infectious disease to non-communicable disease conditions of poverty in developing countries. Research training programs should be structured to provide an appropriate balance of short- and long-term training, degree and non-degree training opportunities for participants from developing country institutions designed overall to build sustainable research capacity in partnership with ongoing U.S. research activities. It is expected that each grant awarded will:
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This funding
opportunity announcement (FOA) will use the D43 award mechanism. The
applicant will be solely responsible for planning, directing, and executing the
proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
1. An applicant for a new Global Infectious Disease Research Training Program award may request a project period of up to five years and a budget for direct costs of up to $138,000 per year maximum.
2. An applicant submitting a renewal application may request a project period of up to five years and a budget for direct costs up to $184,000.
3. An applicant for a revision (formerly called supplement) award to a current Global Infectious Disease Research Training award may request up to $46,000 per year direct costs for up to the number of years remaining in the award.
4. A developing country applicant for a planning grant may request up to $23,000 direct costs for one year.
Because
the nature and scope of the proposed research training will vary from
application to application, it is anticipated that the size and duration of
each award will also vary. Although the financial plans of the IC(s) provide
support for this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation; see NOT-OD-05-004.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
All applicants (including all multiple PIs) must be officially listed as the Principal Investigator (not co-investigator) of at least one active infectious disease research grant (with at least 18 months of support remaining at the time of application), from the NIH or other national or international research support organization, directly relevant to the research training proposed. An applicant's failure to meet the eligibility criteria by the time of the application deadline will result in the return of the application without review or, if reviewed, will preclude FIC from making an award.
One collaborator from each country involved may be listed as a PD/PI on the application. The first PD/PI listed must be affiliated with the institution submitting the application and will serve as the contact PD/PI.
2. Cost Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants
may submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary Statement).
Applicants may submit a renewal application.
Applicants may submit more than one application, provided that each application is scientifically distinct. Only one application may be submitted from an institution proposing research training on a particular infectious disease or working at a particular developing country institution.
Types of Trainees:
Applicants should describe the characteristics of the trainees they plan to recruit for each type of training proposed. Training may be offered to a wide range of developing country scientists, including laboratory scientists, clinicians, social scientists, and other health professionals, as well as technical and administrative staff. The intent of all training proposed should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct independent infectious disease research. Applicants should provide a description of culturally sensitive strategies to recruit women and members of minority and socially disadvantaged populations in the developing country as trainees.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The
D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and
number of this funding opportunity must be typed on lines 1 and 2 of the face
page of the application form and the YES box must be checked.
Foreign
Organizations [Non-domestic (non-U.S.) Entity]
NIH
policies concerning grants to foreign (non-U.S.) organizations can be found in
the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
In addition, for applications from foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): August 14, 2008; August 14, 2009; August 14, 2010
Application Receipt Date(s): September
16, 2008; September 16, 2009; September 16, 2010
Peer Review Date(s): February 2009; February 2010; February 2011
Council Review Date(s): May 2009;
May 2010; May 2011
Earliest Anticipated Start Date: June 1, 2009; June 1, 2010; June 1,
2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
Barbara Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email (preferred): [email protected]
3.B. Sending an Application to the NIH
Applications
must be prepared using the research grant application forms found in the PHS
398 instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
signed photocopies in one package to:
Center for
Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
Applications must be received on or before the application
receipt/ date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial merit review unless the
applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. However, the
NIH will accept a resubmission application, but such application must include
an Introduction addressing the critique from the previous review.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not impair
the grantee's ability to accomplish the project objectives in the approved time
frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
Allowable Costs
Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive developing country research-training plan included in their application. The budgets may include costs to support the 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.
A detailed budget justification should be provided explaining how requested funds will primarily support developing country trainees. 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 form pages 4 & 5) in the "Other" category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.
Requested Salary Support: The salary for the PI, other training faculty and administrative staff directly associated with this research training program must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-033.html. Foreign collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles. The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. The salary and fringe benefits for the staff at the grantee institution should not exceed 25 percent of total direct costs.
Trainee Stipends: Trainees may be paid a stipend comparable to their professional experience in accordance with NRSA levels or grantee institutional policies while involved in long-term training at the grantee institution. Current NRSA stipend levels may be used as a guide and are described on the web site http://grants.nih.gov/training/nrsa.htm.
Tuition, Fees and Health Insurance for Trainees: Funds for tuition, health insurance and academic fees at the U.S. or foreign institution may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees.
Network Meetings: Funds to support the attendance of the Principal Investigator(s) at the annual network meeting for the program in the U.S. may be requested.
6. Other Submission Requirements and Information
Research
Training Plan:
In place of the
research plan requested in the PHS 398 application instructions, applicants
should follow the instructions regarding research-training plans for NRSA
applications.
In addition, the following information should be included:
Needs Assessment:
Applications should present a detailed assessment of the
needs for the specific infectious disease research training at the developing
country institution and a proposed training plan to address those needs during
the course of a five-year award. The assessment should identify specific gaps
in laboratory, clinical, epidemiological, vector-related, social science, and
operational and health services research expertise, and adjunct skills needed
to address the infectious disease focus of the proposal. The relevance of the
infectious disease focus of the proposed training to the health of the host
endemic country should be explained in detail.
Types of Training:
The proposed research-training program may focus on one or
more infectious diseases of major health importance to the developing country
population focus of the proposal. Mentored trainee research may focus on
analyzing the basic mechanisms of host-pathogen interaction, understanding
disease transmission and pathology or developing new interventions, prevention
measures or diagnostic methods, as well as clinical, operational and health
services studies. Trainee research projects may be part of a training faculty
member's peer-reviewed infectious disease research grant funded by NIH or other
research support agencies.
Applicants should describe plans to meet the requirements related to the protection of human subjects in all training-related research. All training-related research projects in which trainees are involved under this award must be peer-reviewed through a Training Advisory Group (see below), and documented evidence for education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from institutional (or ethical) review boards or committees at applicant and collaborating foreign institutions, and from the relevant government authority.
Applicants should also provide training in adjunct skills needed at the host developing country institution to support sustainable independent research such as the use of scientific literature, scientific writing and presentation, grant writing, bioinformatics, bioethics, good clinical practice, biosafety, data management, research administration, the management of intellectual property and English as a second language, if necessary.
Applicants should propose an appropriate balance of research training options (degree-related and non-degree training) to match the needs of the trainees and their developing country institution. Long-term research training may include studies leading to an advanced degree or a mentored post-advanced degree experience. Long-term training may include enrollment in academic courses related to infectious disease research. Short-term training in short courses, workshops or practical experience of up to several months in specific research methods or other laboratory, clinical, social science or field skills for infectious disease research may be proposed in addition to long-term training. Participants in short-term training must be involved in research in which the training will be immediately utilized at developing country institutions. Didactic short courses or workshops on broad scientific or medical topics not directly relevant to the research training focus of the program will not be supported.
Training and trainee degrees may be attained at either the U.S. or developing country institution. However, applicants are strongly encouraged to provide support and mentoring by U.S. and developing country faculty for trainees to conduct the research related to their training in the developing country to the greatest extent possible.
Applicants are required to provide all long-term trainees with training in the responsible conduct of research at either the U.S. or developing country institution. For more information on this provision, see the NIH Guide for Grant and Contracts (volume 21, number 43 http://grants.nih.gov/grants/guide/notice-files/not92-236.html). NIH does not require a specific curriculum or format for instruction but the following areas should be included: conflict of interest, responsible authorship and institutional policies for handling scientific misconduct, human subjects, animal studies, data management and data sharing. The inclusion of international perspectives on these topics is strongly encouraged. The following information must be provided in the description of your plan: topics to be covered, format, faculty participating, instructional materials, frequency and duration of training, and how trainee attendance will be monitored.
Types of Trainees:
Applicants should describe the characteristics of the
trainees they plan to recruit for each type of training proposed. Training may
be offered to a wide range of developing country scientists, including
laboratory scientists, clinicians, social scientists, and other health
professionals, as well as technical and administrative staff. The intent of all
training proposed should be to build a critical mass of researchers and support
staff with the combined expertise and skills to conduct independent infectious
disease research. Applicants should provide a description of culturally
sensitive strategies to recruit women and members of minority and socially
disadvantaged populations in the developing country as trainees.
Trainee Recruitment, Selection and Evaluation:
Training plans should also describe in detail each of the
following processes:
Research Training Faculty and Environment:
Applicants should describe the specific roles of U.S. and
developing country training faculty who will be directly involved in the
proposed training, including their developing country training records,
relevant infectious disease research grant support and relevant U.S.-developing
country research collaborations. The application should also include letters
from participating U.S. and developing country faculty stating agreement with
the roles specified in the proposal, as well as their time commitment in the
proposed training program. Pertinent infectious disease research resources and
the educational environment including the options available for distance
learning for the proposed training at the U.S. and developing country
institutions should be described.
Training Advisory Group:
A training advisory group composed of expert U.S. and
developing country faculty including a majority who are not directly involved
in mentoring trainees should be established to assist in trainee selection,
scientific review of trainee projects, and evaluation of trainees and training
program progress. Applicants should describe the composition and expertise of
the proposed training advisory group, the specific responsibilities of the
group, and the processes for it to accomplish its responsibilities.
Renewal Applications:
Renewal applications should contain detailed information
about previous FIC-supported research training efforts including: a
comprehensive list of all trainees; type and length of training provided in the
U.S. and developing country and the trainee's current position. Applicants
for renewal awards should provide a list of publications in peer-reviewed
scientific journals in which trainee research was supported by their previous
FIC training award, i.e. publications in which trainees are authors and the FIC
award is cited in the acknowledgements.
U.S. Principal Investigators proposing competitive renewals are encouraged to transfer additional leadership of the ongoing collaborative training program to the developing country partner in the application.
Revision (formerly called supplement) Awards:
Principal Investigators may apply for one competing
one-year revision award annually to an active FIC Global Infectious Disease
Research Training Program for the following purposes:
The principal investigator for a competing revision (formerly called supplement) application must be the same as the Principal Investigator of the parent research training grant. The time period for proposed competing revision (formerly called supplement) activities may not exceed the parent research training grant completion date. A competing revision (formerly called supplement) application cannot be submitted until after parent research training grant is awarded. Competing revision (formerly called supplement) applications should include:
Planning Grants for Developing Country
Institutions:
Developing country institutions may apply for a one-year
planning grant to develop a future infectious disease research-training program
with U.S. collaborators. Planning grants should propose the following types of
activities to organize and plan for a research-training program, and prepare
and assemble an application to submit for support of that program the following
year:
Research Training Plan Page Limitations
Research training plans should not exceed 25 pages.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:
Specific Instructions for Foreign Applications
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Section V. Application Review Information
1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate peer review group convened by CSR and in accordance with NIH peer
review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:
The goals of NIH supported research training are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important research training that by its nature is not innovative but is essential to move a field forward.
Significance: Does the infectious disease research training proposed meet the specific needs for infectious disease research expertise at the developing country institution? Will the scientific contributions expected from the proposed infectious disease research training result in public health benefits for developing countries? What is the demonstrated capacity (for competing renewal applications) or expected potential (for new applications) to achieve independent and sustainable laboratory, clinical or public health infectious disease research capacity through the proposed training efforts?
Approach: Are the research training objectives clear and feasible? Will the research-training plan achieve the proposed training objectives including:
For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?
Innovation: Does the research training proposed identify innovative strategies for trainees to gain the skills needed to conduct infectious disease laboratory studies, clinical or public health research studies or intervention trials relevant to national health priorities conducted at the developing country institution? Does the training program proposed employ an innovative training approach to produce a critical mass of independent infectious disease researchers and sustainable research training at the developing country institution? Does the research training plan include the use of modern information technology to facilitate trainee access to scientific information, distance learning and collaborative scientific interaction?
Investigators: Are the program director(s) (including multiple PD/PIs) qualified to lead and the U.S. and developing country faculty qualified to serve as research mentors in the proposed training program? Does the collaboration between the U.S. and developing country investigators and their institutions provide a suitable framework for the proposed training will occur? Is the research support of the program director(s) (including multiple PD/PIs) and faculty relevant to the research training proposed? For competing renewal applications, were previous research training efforts made by applicants effective in training independent and sustainable scientific career advancement for the participants in the proposed developing country?
Environment: Are the infectious disease teaching and research facilities and other resources, and ongoing research support related to the overall training environment adequate at the U.S. and developing country institutions? Are the U.S. and developing country institutional officials committed to the proposed infectious disease research training program?
2.A.
Additional Review Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:
Resubmission
Applications (formerly revised/amended applications): Are the responses to comments from
the previous scientific review group adequate? Are the improvements in the
resubmission application appropriate?
Training in Protection of Human Subjects from Research Risk: The plans for training regarding the involvement of human subjects and protections from research risk relating to their participation in the proposed trainee research will be assessed (see the Research Training Plan section on Human Subjects in the PHS 398 instructions).
Training in Inclusion of Women, Minorities and Children in Research: Are the training plans regarding the inclusion of subjects from both genders, all racial and ethnic groups (and subgroups), and children appropriate for the scientific goals of the trainee research adequate? See the Research Training Plan section on Human Subjects in the PHS 398 instructions.
Training in Care and Use of
Vertebrate Animals in Research: If vertebrate animals are to
be used in the trainee projects, are plans for training in care and use of
animals in research adequate? See the Vertebrate Animals Section of the PHS398
Research Plan component of the SF424 (R&R).
Training in Biohazards: If
trainee research includes materials or procedures that are potentially
hazardous to research personnel and/or the environment, is the proposed
biosafety training provided adequate?
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
2.C. Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:
3. Anticipated Announcement and Award
Dates
Not Applicable
Section
VI. Award Administration Information
1. Award Notices
After the peer review
of the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
2. Administrative and
National Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing Continuation
Grant Progress Report (PHS 2590) annually and financial statements as
required in the NIH Grants
Policy Statement.
Awardees are expected to maintain data regarding their trainees in a trainee tracking system and report trainee publications and significant accomplishments to FIC in a timely manner.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Barbara
Sina Ph.D.
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31 Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 402-9467
FAX: (301) 402-0779
Email (preferred): [email protected]
2. Peer Review Contacts:
Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892 (For express mail use ZIP 20817 and remove MSC 7840 )
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms.
Elizabeth Cleveland
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: [email protected]
Section
VIII. Other Information
Required
Federal Citations
Use of Animals in
Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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).
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 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 funding opportunity 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.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical 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 (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 applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH
Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution reviewers
that their anonymity may be compromised when they directly access an Internet
site.
Healthy People 2010:
The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance 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 284) and under Federal Regulations 42 CFR 4263a 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.
Loan Repayment Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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