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)
National Center for Complementary and Alternative
Medicine (NCCAM) (http://nccam.nih.gov)
National
Institute on Aging (NIA) (http://www.nia.nih.gov)
National
Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov)
National
Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National
Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National
Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
Title: International Research Collaboration Basic
Biomedical (FIRCA-BB) [R03]
Announcement Type
This is a reissue of PAR-05-072,
which was previously released on March 18, 2005.
Update: The following updates relating to this announcement have been issued:
NOTICE: Applications submitted in response
to this FOA for Federal assistance must be submitted electronically through
Grants.gov (http://www.grants.gov) using
the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with
the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter
called Grants.gov/Apply).
A registration process is necessary before submission and should be started at least 4 weeks in advance of the planned submission. See Section IV.
Program Announcement (PA) Number: PAR-06-436
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.213, 93.867,
93.866, 93.273, 93.286, 93.173, 93.279, 93.113, 93.114, 93.115, 93.853
Key Dates
Release/Posted Date: May
31, 2006
Opening
Date: May 31, 2006 (Earliest date an
application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): January 21, May 21, and
September 21, each year beginning with the September 21, 2006
submission/receipt date.
Peer Review Date(s): June/July for January
submission/receipt date; October/November for May submission/receipt date; and
February/March for September submission/receipt date.
Council Review Date(s): September of corresponding
year for January submission/receipt date; January of following year for May
submission/receipt date; and May of following year for September submission/receipt
date.
Earliest Anticipated
Start Date(s): December
1 for September council; April 1 for January council; and July 1 for May
council.
Additional Information
To Be Available Date (URL Activation Date): Additional information available at the time of
publication (http://www.fic.nih.gov/programs/FIRCA.html)
Expiration/Closing
Date: March 23, 2007
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 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. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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 Objectives
Interests of Participating Institutes and Centers (ICs)
Applicants can obtain information and research interests for each of the sponsoring ICs listed on the first page of this announcement at their Web sites, or by contacting the IC program contact listed in Section VII, Agency Contacts. Some of the participating ICs have provided additional statements of interest:
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the
NIH Small Research Grant (R03) award mechanism. The applicant will be solely
responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed R03 grant application may be submitted. See NOT-OD-05-046, April 29, 2005.
However,
the foreign Co-Investigator on an awarded Type 1 FIRCA may submit a new (Type
1) FIRCA application as the PD/PI, directly from his/her home institution (the
original foreign site), to follow up on the research in the initial three-year
FIRCA period. The original U.S. PD/PI must be included as Co-Investigator
unless a change is approved by the FIRCA Program Director.
For specific information
about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
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 and the receipt of a sufficient
number of meritorious applications.
Facilities and
Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application(s) if your organization has any of the following characteristics and meets the other eligibility
criteria listed below:
The Foreign Collaborator must be at an institution in a developing country defined by the World Bank according to Gross National Income per capita (GNI per capita) as low-income, lower-middle income, and upper-middle income (see: http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:20421402~menuPK:64133156~pagePK:64133150~piPK:64133175~theSitePK:239419,00.htmlor http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS.
Foreign institutions may only apply if they meet the eligibility requirements for foreign collaborating institutions listed above and the PD/PI and Collaborating Investigators meet the criteria listed below in Section 1.B., Eligible Individuals.
Occasionally,
scientific opportunities may arise that warrant a formal collaborative effort
between the PD/PI and individuals from more than one country. Such
applications may be considered only after consultation with and pre-approval by
the FIC program staff.
1.B. Eligible Individuals
Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research, and who meets the other
eligibility requirements below, 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.
The scientist who applies as
PD/PI must either be (1) an NIH-funded investigator or (2) have previously been
the foreign Co-Investigator on an awarded FIRCA.
The Foreign Collaborator on a FIRCA must be employed at a developing country institution meeting the eligibility requirements described in Section 1.A., Eligible Institutions.
Applicants may already be FIRCA grantees on another FIRCA at the time of the application. However, only one FIRCA application may be submitted by the same PD/PI, or involve the same Foreign Collaborator as Co-Investigator, per review cycle. No Foreign Collaborator may be involved in more than one competing new FIRCA award per fiscal year or be involved in more than two awarded FIRCAs active at any one time.
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
Eligible Parent Grants:
The following NIH research project grants that will be active and funded at the start of the proposed FIRCA budget period are eligible as parent grants:
Among the mechanisms not generally accepted as parent grants are:
The parent grant may have been awarded by any NIH Institute or Center (IC), regardless of whether the IC is listed as a Participating Component in this FOA. For the initial FIRCA application, it must have a minimum of 12 months of funding, which may include a no-cost extension, remaining at the time of the FIRCA application deadline, to be eligible as the parent grant. For the follow-up application from the foreign collaborator as PD/PI, the U.S. Collaborator’s parent grant must simply be active, in a no-cost-extension and/or submitted for renewal on the FIRCA receipt date.
The initial FIRCA research proposal, submitted by the NIH-funded Co-Investigator, may be an extension or a new direction of the parent grant. However, the proposed research must not overlap with research already supported by the parent grant or by other sources. If the proposal is for work that is not an obvious extension of the parent grant, the research must be clearly within the expertise and field of interest of both Co-Investigators, as indicated by the general area of science in the parent grant and other research support and published work. Such research should ideally make use of the comparative strengths and expertise of both Co-Investigators.
Special consideration may be given to proposed research which addresses significant global health problems, particularly those of high relevance to the foreign country or region, and to research that makes use of unique or special resources, circumstances, or environment of the foreign site.
Foreign Collaborators on previously funded FIRCA grants, which have ended or will end at least six months before the new FIRCA application deadline, must apply for a FIRCA as PD/PI with their original FIRCA collaborator as Co-Investigator, if they wish to continue the collaboration under the FIRCA program. Current grantees and collaborators may want to consider whether their collaboration has developed to the point where they can submit a Research Project (R01) grant application (direct foreign grant or domestic grant with a foreign component).
Section IV. Application and Submission Information
To download a SF424 (R &R) Application Package and SF424 (R&R)
Application Guide for completing the SF424 (R&R) forms for this FOA, link
to http://www.grants.gov/Apply/ and
follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application
Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific
FOA can be used. You will not be able to use any other SF424 (R&R) forms
(e.g., sample forms, forms from another FOA), although some of the "Attachment"
files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Phone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of
Application Submission
Prepare all applications using the SF424
(R &R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398
Modular Budget
Optional Components:
PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, use ONLY the PHS398 Modular Budget for this Program Announcement funding opportunity. (Do not use the detailed Research & Related Budget).
Supplementary Instructions
Description Section: For FIRCA applications from the U.S. institution, please include the name of the Foreign Collaborator, country and institution and the parent grant number in this section (e.g., This research will be done primarily in Peru at Lima University in collaboration with Jorge Smith, as an extension of NIH Grant No. R01HL98765. ). For applications from the Foreign Institution please include the name of the U.S. collaborator and their parent grant number.
Performance Site Section: Provide full name and address of the foreign institution where the research will be performed (or the collaborating U.S. institution if the application is from a foreign institution). Also, provide the full number of the NIH parent grant of the U.S. collaborator and the dates of the award (e.g., R01HL98765-01; 9/30/2002 9/29/2005 ).
Budget Justification Page Under Senior/Key Person : List all project personnel, including their names, percent of effort, and roles on the project. Since no salary is allowed for the NIH-funded U.S. collaborator, minimal percent effort of five to ten percent may be listed.
Budget: Applications must be submitted using the PHS398 Modular Budget , but refer to Section IV.5., Funding Restrictions, for restrictions that must be considered in the development of the budget. Please list in the text of the budget section what the funds will be used for, although actual costs do not need to be indicated. Also refer to http://www.fic.nih.gov/grantsinformation/Costs.html.
Research Plan Special Instructions: Follow the instructions except as described below (and note that the research plan must not exceed 10 pages for Items 2-5, excluding the Introduction):
Collaborator Assurance Section: Attach a letter (on institutional letterhead) from the Foreign Co-Investigator (for applications from the U.S.) or the U.S. Co-Investigator (for applications from the foreign institution) confirming his/her role in the project. Please include full contact information, including email address and telephone and fax numbers for the Co-Investigator. Provide a statement in the same or separate letter, confirming the foreign, applicant or collaborating, organization’s willingness to comply with all pertinent U.S. Federal regulations and policies. For example, the institution must be willing to support the collaboration with time and resources for the Foreign Collaborator, and to provide necessary documentation to the Office of Human Research Protections (OHRP) for human subject involvement and to the Office of Laboratory Animal Welfare (OLAW) for animal participation. The institution must also agree to comply with all required NIH policies on awards involving foreign institutions. The FIRCA is awarded either as a domestic grant with a foreign component (consortium agreement) or as a direct award to a foreign institution with a U.S. component. Refer to the following NIH Grants Policy Statement regarding foreign grants and consortia for information on policy and requirements (search on "foreign to get to the appropriate part of the Web page): http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm.
The letter must be co-signed by the Head of a Department, Dean, or other academic official.
Checklist
Facilities and Administrative (F&A) Costs: F&A costs must be calculated on the basis of the off-site rate, if one has been approved, for U.S. sponsoring institutions.
For applications from foreign institutions and
applications that have foreign consortium agreements, F&A costs of up to 8%
of total direct costs (less equipment) may be requested by the foreign
institutions. See NOT-OD-01-028,
March 29, 2001.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
3. Submission Dates and Times
See Section IV.3.A.
for details.
3.A. Submission, Review,
and Anticipated Start Dates
Opening Date: May 31, 2006 (Earliest date an application may
be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): January 21, May 21, and
September 21, each year beginning with the September 21, 2006 submission/receipt
date.
Peer Review Date(s): June/July for January
submission/receipt date; October/November for May submission/receipt date; and
February/March for September submission/receipt date.
Council Review Date(s): September of corresponding
year for January submission/receipt date; January of following year for May
submission/receipt date; and May of following year for September
submission/receipt date.
Earliest Anticipated
Start Date(s): December
1 for September council; April 1 for January council; and July 1 for May
council.
3.A.1.
Letter of Intent
A letter of intent is
not required for the funding opportunity.
3.B. Submitting an
Application Electronically to the NIH
To submit an application
in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local
time (of the applicant
institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by
the receipt date(s) and time, the application may be delayed in the review
process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt,
applications will be evaluated for completeness by the Center for Scientific
Review, NIH. Incomplete applications will not be reviewed.
There will be
an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons.
The NIH will not accept any application in response to this FOA 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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
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.
Awards
are made to the PD s/PI’s institution, to support a collaborative research
project that will be carried out mainly at the developing country
collaborator’s research site. The major portion of the funds and items
purchased with these funds must be used at the foreign site to support this
research.
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 award if such
costs: are necessary to conduct the project, and 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 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 the NIH
Grants Policy Statement.
6. Other Submission Requirements
The
NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field of
the Research & Related Senior/Key Person Profile component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see Tips and Tools
for Navigating Electronic Submission on the front page of Electronic Submission of Grant
Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:
Specific issues and opportunities related to sharing resources developed
at the foreign site should be discussed in the application.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used .
Plan for Sharing
Research Data
Not Applicable
Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section
V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Applications
that are complete will be evaluated for scientific and technical merit by an
appropriate review group, convened by the Center for Scientific Review,
NIH, in
accordance with the standard NIH peer review procedures and the criteria stated
below.
As part of the
initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The FIC is interested in all eligible applications and will fund or co-fund each FIRCA award. Special consideration will be given to proposed research that addresses significant global health problems, particularly those of high relevance to the foreign country or region. Special consideration may also be given to research that makes use of unique or special resources, circumstances, or environment of the foreign site.
The various Institutes and Centers each support FIRCA research in their respective areas of interest. Applicants can obtain further information for each of the sponsoring Institutes at the Internet addresses listed on the first page of this FOA or by contacting the respective program contact listed in this funding opportunity.
The NIH R03 FIRCA small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in three years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH supported research 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 will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them 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 high priority score.
For example, an investigator may propose research on an important topic in a developing country
with underdeveloped research infrastructure but with unique resources,
environment, or knowledge not readily available in the U.S. or other developed nations. Such projects may be slower to achieve their scientific
goals, but may receive special consideration for their potential to build
research capacity along with scientific impact in the long-term.
Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field? Is an important problem relevant
to global health issues addressed? How is this research relevant to the
foreign country involved?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative
tactics? In
conducting an evaluation of the scientific assessment of Approach criterion,
scientific review groups will also evaluate the involvement of human/animal
subjects, and the proposed plans for inclusion of minorities and members of
both sexes/genders. The evaluation will be factored into the overall score of
scientific and technical merit of the application.
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area? Does the project make use of
unique or special expertise, resources, circumstances, or environment at the
foreign site to frame or address the research question? Does the project
propose innovative or special ways to incorporate capacity building or training
into the research program at the foreign site?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the PD/PI and the Co-Investigator? Does the investigative team
bring complementary and integrated expertise to the project? The collaborators may each be at
various stages in their respective careers and may or may not have prior
collaborations. If the Foreign Collaborator is submitting as the PD/PI, is she
or he able to undertake and direct the continuation of the research efforts
independently but still with some level of collaboration with the original (or
pre-approved new) FIRCA Co-Investigator? How will this award continue to
enhance the Foreign PD s/PI’s research and career development and help her or
him towards achieving a position of scientific leadership in her/his home
country and field?
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support? Has the Foreign Collaborator’s (or
Foreign PD s/PI s) home institution made a convincing commitment (e.g.,
provided a research/academic appointment and salary support)? Are the
resources necessary to perform the research available or obtainable?
Research Capacity Building: Does the collaboration have
the potential to enhance the research capability of the Foreign Collaborator
and the foreign site? Does the research constitute a substantial scientific
endeavor of the Foreign Collaborator, including creative and scientific input
to the research proposal? The foreign site and investigator should not be used
merely to gather biological samples (clinical, plants, etc.) or behavioral data
(interviews, surveys, etc.). In all cases, the Foreign Collaborator should be
actively involved in analyzing and interpreting the data. If the research is
not on a biomedical problem of particular relevance for the foreign country
involved, how will the award contribute to building needed biomedical research
capacity/capability at the foreign site? If the PD/PI is from the foreign
site, how will the award contribute to advancing his/her research and career,
research at the PD s/PI’s institution and the field of research in the
PD s/PI’s country?
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 priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the SF424 (R&R).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are
proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the percent effort listed for the
PD/PI appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
2.C. Sharing Research
Data
Not applicable.
2.D. Sharing
Research Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
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 NIH 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.
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.
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 Section IV.5., Funding Restrictions.
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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
In the
performance site block on the PHS2590, grantees must list the foreign site at
which the FIRCA work is being carried out and the primary collaborator contact
at the foreign site. Please include full contact information, including
telephone and fax numbers and email addresses for the Collaborator.
Section VII. Agency Contacts
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:
FIC/NIH:
Kathleen Michels, Ph.D.
FIRCA Program Officer
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]
NCCAM/NIH:
Craig Carlson, M.P.H.
International Health Program Specialist
Office of International Health Research
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475
Telephone: (301) 496-2583
FAX: (301) 480-3621
Email: [email protected]
NEI/NIH:
Ellen Liberman, Ph.D.
Program Director
Lens and Cataract Glaucoma Programs
Division of Extramural Research
National Eye Institute
National Institutes of Health
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
(For express/courier service, use Rockville, MD 20852.)
Telephone: (301) 451-2020
FAX: (301) 402-0528
Email: [email protected]
NIA/NIH:
Dallas W. Anderson, Ph.D.
Program Director, Population Studies
Dementias of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: [email protected]
NIAAA/NIH:
Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2594
FAX: (301) 480-1726
Email: [email protected]
NIBIB/NIH:
John W. Haller, Ph.D.
Acting Division Director
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
National Institutes of Health
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5469
Telephone: (301) 451-4780
FAX: (301) 480-4973
Email: [email protected]
NIDCD/NIH:
Lana Shekim, Ph.D.
Director, Voice and Speech Programs
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS-400-C, MSC 7180
Bethesda, MD 20892-7180
Telephone: (301) 496-5061
FAX: (301) 402-6251
Email: [email protected]
NIDCR/NIH
Kevin
Hardwick, DDS, MPH
Extramural
Training Officer
National
Institute of Dental and Craniofacial Research
45 Center
Drive, Room
4AS-13
Bethesda, MD 20892
Telephone:
(301) 594-2765
FAX:
(301) 402-7033
Email: [email protected]
3. Financial or Grants Management Contacts:
FIC/NIH:
Randolph Williams
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 594-1211
Email: [email protected]
NIA/NIH:
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212, MSC 9205
Bethesda, MD 20892
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: [email protected] (email correspondence
is preferred)
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).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials,
including physiologic toxicity and dose-finding studies (Phase I); efficacy
studies (Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible ( http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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 SF424 (R&R) application; 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.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
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. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog
of Federal Domestic Assistance 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 Part 52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
The 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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