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 Cancer Institute (NCI), (http://www.cancer.gov)
National
Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
Office of Dietary Supplements, Office of the Director (ODS/OD), (http://dietary-supplements.info.nih.gov/)
Title: Global Research Initiative Program, Basic/Biomedical
Sciences (R01)
Announcement Type
This is a modification of PAR-03-118,
which was released May 16, 2003.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-06-394
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.396, 93.866, 93.853
Key Dates
Release Date: May 5,
2006
Letters of Intent
Receipt Date(s): August 21, 2006; August 21, 2007; August 21, 2008
AIDS
Letters of Intent Receipt Date(s): November 18, 2006; November 18, 2007;
November 18, 2008
Application
Receipt Date(s):
September 21, 2006;
September 21, 2007; September 21, 2008
AIDS Application Receipt
Date(s): December
18, 2006; December 18, 2007; December 18, 2008
Peer
Review Date(s): February 2007, February 2008, February 2009
Council Review Date(s): May 2007, May 2008, May 2009
Earliest Anticipated Start Date(s): July 2007, July 2008, July 2009
Additional Information
To Be Available Date (Url Activation Date): Not applicable
Expiration Date: September 22, 2006
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(s) 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
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
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
As part of its global health
initiative under the Department of Health and Human Services (DHHS), the
Fogarty International Center (FIC) of the National Institutes of Health (NIH)
invites applications from current and former NIH-supported foreign research
trainees to compete for funds that will support their research efforts upon
return to their home countries. In order to be eligible, foreign scientists
must meet at least one of the following criteria:
1. At least two years of research training experience under an FIC-supported research training grant (classified by the D43 International Training Grant or U2R mechanism).
2. One year of such D43 or U2R training experience coupled with one year of significant, well-documented mentored research experience.
3. One year of the NIDA INVEST or HUMPHREY Fellowship plus at least one additional year of mentored research (http://www.drugabuse.gov/International/HHHRF.html).
4. At least two years of research training experience through the NIH Intramural Visiting Fellows Program.
5. Two years of research training experience through the International Neuroscience Fellowship (F05), or one year of such experience and one subsequent year of mentored research, either in the U.S. or abroad.
6. Recipients of Long-Term Fellowship awards through the Human Frontier Science Program, who come from low- to middle-income countries, and who have spent at least two years in research training.
All such training and research must have been done within three years of the receipt date of this announcement.
Candidates who are more than five years beyond their training, but who have interrupted their careers because of illness or family commitments, may also apply. These candidates must clearly demonstrate the reason for the delay and the potential for productive independent research.
Current NIH Intramural Visiting Fellows are encouraged to apply in a timely fashion, i.e., as they begin their preparation to return home. They, as all applicants, may apply within three years of completing training.
Through various programs, the NIH has made a significant investment in training basic science and biomedical researchers. For example, the NIH Intramural Visiting Fellows Program currently hosts more than 1,600 junior scientists from almost 100 countries for periods of one to five years. In addition, the NIH D43 research training and capacity building grant mechanism allows hundreds of foreign researchers to receive training at prominent institutions in both the U.S. and their home countries in a range of basic science and biomedical research areas critical to advancing global health. In summary, training supported by NIH is critical to these young investigators as they develop independent research careers.
As junior scientists complete training programs in the U.S., many find it difficult to secure the support needed to continue their research projects and careers in their home countries. This Global Research Initiative Program (GRIP) provides the opportunity for junior foreign scientists to compete for such funds through a peer-reviewed process. This is a critical adjunct in the continuation of promising independent research careers that will be of benefit to the investigators home countries and the world at large. Women and underrepresented minority scientists in their countries are especially encouraged to apply for these re-entry grants. Project proposals should be geared toward the research interests of the applicant and focus on high-priority health and health care problems in the investigator’s home country that also carry global importance, and are of interest to the participating NIH Institutes, Centers and Offices (ICs) listed in the beginning of this announcement, as well.
It is expected that research topics will be diverse. Specific research interests of participating NIH ICs can be found on the ICs websites, as listed in the beginning of this announcement. Research related to women’s health, including studies of gender differences in disease onset and progression, are particularly encouraged. Research related to the health effects of human exposures to environmental agents is encouraged. All research must be performed in accordance with NIH and U.S. Government (USG) regulations regarding the responsible conduct of research. This announcement precludes the support of research involving enrollment in pilot studies for clinical trials or the actual support of clinical trials since the resources and infrastructure to support and oversee such trials generally exceed the resources available under this award mechanism. Applicants are encouraged to visit the website of the Office for Human Research Protections (OHRP) (http://www.hhs.gov/ohrp/), which outlines these regulations. For information on animal protection in research, see http://grants.nih.gov/grants/olaw/olaw.htm.
This announcement contributes to the FIC mission and to the broad NIH initiative to reduce the health disparities among nations by strengthening research infrastructure in low- to middle-income countries, particularly those with the least economic resources. Additionally, it provides the opportunity for recently trained international health and health care researchers to continue their projects after returning home.
Evaluation of the program will occur on an ongoing basis. Because this is a program to move research trainees to the status of independent investigator, there are several outcomes to be measured:
As part of its assessment of the impact and scientific productivity of this program, FIC plans to track researchers and their trainees for least five years after beginning their independent research. Evaluation may focus on the successes of researchers (as measured by the number and quality of publications, presentations, courses, awards, subsequent employment, etc.), their sustained commitment to research careers, their ability to attract funding for their work, their contributions to future international collaborations, their influence on the development of scientific research in their countries, and their ability to act as consultants, teachers and role models to other local investigators and further disseminate the lessons learned. Metrics should be stated both for the success of the individual researcher and the success in capacity building at the home institution, including the impact of the program on research at the institution in the home countries of researchers and their trainees.
1. Mechanism(s) of Support
This funding opportunity
will use the R01
award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses just-in-time concepts. It also uses the modular budget format described in
the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/modular/modular.htm).
2. Funds Available
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. 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 costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
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:
Only
institutions in low- to middle-income countries are eligible to apply.
Institutions in countries that have the least economic resources are
particularly encouraged to apply. For the purposes of this announcement, a
low- to middle-income country is defined as a country that has a Gross National
Income per capita (GNI per capita) below $10,000, according to the World Bank
classification system (refer to the GNI per capita ranking in the left-hand
column labeled Atlas Methodology at http://www.finfacts.com/biz10/globalworldincomepercapita.htm.
(Do NOT refer to the right-hand column headed Purchasing Power Parity.)
1.B. Eligible Individuals
Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their 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.
FIC
strongly encourages applications from women and individuals from
underrepresented racial, ethnic and socially disadvantaged groups. Where
appropriate, the design of projects should take into account potential sex and
gender differences that may affect the questions asked and the analyses
performed. These might include different responses to and impacts of health
interventions, differences in physiology, and different behavioral bases for
disease prevention strategies.
Only applicants from institutions in eligible countries may apply.
In order
to be eligible, applicants must meet at least one of the following criteria:
1. At
least two years of research training experience under an FIC-supported training
grant (classified by the D43 International Training Grant or U2R mechanism).
2. One year of such D43 or U2R training experience coupled with one year of significant, well-documented mentored research experience (e.g., through an NIH research award such as the NIAID Small Research (R03) (IRID-NIAID) program).
3. One year of the NIDA INVEST or HUMPHREY Fellowship plus at least one additional year of mentored research.
4. At least two years of research training experience through the NIH Intramural Visiting Fellows Program.
5. At least two years of training through the Human Frontiers Science Program, and come from and return to a low- or middle-income country.
6. Two years of research training experience through the International Neuroscience Fellowships (F05), or one year of such experience and one subsequent year of mentored research, either here in the U.S. or abroad.
All training and research, to meet eligibility requirements, must have been done within three years of the receipt date of this announcement.
Applicants must return to a research position in their home country institution or in another low- to middle-income country in order to carry out research supported by this award. The award will be made to the home institution on the investigator’s behalf only after the investigator has arrived in that country. Therefore, the application must be submitted by the institution to which the applicant has returned or will be returning. It is expected that the PI will demonstrate that he/she has an appointment at an academic or other institution in his/her home country and will demonstrate or provide a letter of support indicating that the institution will have the capacity to support the research proposed. The GRIP award will support up to one-half the investigator s salary, commensurate with the salary structure of the home institution. Funds from the institution, national government, local science research council or other public or private organization may be used to support this program. The remainder of the funds from this grant may pay for equipment, travel, supplies, or other research personnel’s salary working on the same project.
In order to build upon experience, partnership, mentorship and prior investments, applicants are encouraged to submit applications in collaboration with the NIH-supported institution or intramural laboratory from which they have received or are receiving research training. Through letters of support, U.S. collaborators should demonstrate how this program will support ongoing research collaborations. For those applicants who are eligible through both a year of training and a year of significant mentored research, letters of support should be received from both mentors.
While recognizing that this program is intended to foster the independence of the applicant, FIC recognizes the value of continued collaboration with NIH or U.S. mentors. This relationship should be documented in the application.
2. Cost Sharing or Matching
Cost sharing is not required
in this initiative
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Applicants may submit only
one application to this program per deadline.
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: GrantsInfo@nih.gov.
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 line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by 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.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Receipt, Review and
Anticipated Start Dates
Letter of Intent Receipt
Date(s): August
21, 2006; August 21, 2007; August 21, 2008
AIDS
Letter of Intent Receipt Date(s): November 18, 2006; November 18, 2007;
November 18, 2008.
Application Receipt
Date(s): September
21, 2006; September 21, 2007; September 21, 2008
AIDS Receipt Dates: December 18,
2006; December 18, 2007; December 18, 2008.
Peer Review Date(s): February 2007, February 2008,
February 2009
Council Review Date(s): May 2007, May 2008, May 2009
Earliest Anticipated Start Date(s): July 2007, July 2008, July 2009
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. Therefore,
pertinent information related to the type of research being done would be very
helpful.
The letter of intent is to be sent by the date listed
at the beginning of this document.
The letter of intent
should be sent to:
Aron Primack, M.D., M.A.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
FAX: (301) 402-0779
Email: primacka@mail.nih.gov
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).
3.C.
Application Processing
Applications must be received on or before the application
receipt/submission 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. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are not
allowed.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular budget
format. The modular budget format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Plan for Sharing Research
Data
A data sharing plan is not
required.
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/index.htm
and 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
Supplemental Instructions
Applicants may request up to two modules, or $50,000, of direct costs per year and the application must be in modular format. The PI is expected to devote at least 50 percent of his/her total effort to this project. The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach at the time of application but detailed data will be expected with the yearly progress reports.
It is understood that writing an application for such an R01 grant may be difficult and time-consuming. Therefore, it is encouraged that potential applicants seek assistance in such grant writing. Those being trained via the D43 or U2R grant mechanism should seek such assistance from their training institutions. Those within the NIH intramural program should seek such guidance within the NIH framework. Although there is a limit of 25 pages for these R01 applications, it is possible that applicants may only need 15 or fewer pages. The application should be complete and follow the format of the PHS 398. (For the applications due in 2007 and 2008, the PHS424(R&R) electronic versions will be required.) Help for completing these applications can be found on the NIH website. Examples of helpful information include:
Budget Instructions
Applicants may request direct costs in $25,000 modules, up to a total direct cost request of $50,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below.
Other Requirements
Applications
not conforming to these guidelines will be considered unresponsive to this
announcement and will be returned without further review.
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 Fogarty International Center.
Applications that are complete will be evaluated for
scientific and technical merit by an appropriate review group convened by the Center for Scientific Review in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
The following will be considered in making funding decisions:
An award
will not be made until the applicant has actually returned to his or her home
country (or other low- to middle-income country). A change of grantee
institution that involves the transfer of a grant to or between foreign
institutions or international organizations requires competitive re-review and
approval of the IC Advisory Council/Board.
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. Each of these criteria will
be addressed and considered in assigning the 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 to carry out important work that by its nature is not innovative but is
essential to move a field forward.
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 the health problem that is
addressed specifically a priority health issue in the Principal Investigator s
home country? If the aims of the project are achieved, how will the Principal
Investigator’s research career be enhanced?
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?
Is the
proposed research hypothesis-driven or hypothesis-generating?
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?
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 Principal Investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)? How will this award enhance the
Principal Investigator’s career development and help the Principal Investigator
achieve a position of scientific leadership in his/her home country? Do the
letters of support document a strong commitment to help the Principal
Investigator develop his/her career?
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 Principal Investigator s
home institution made a convincing commitment to the Principal Investigator
(e.g., provided a research/academic appointment and partial salary support)?
What is the continuing commitment of the U.S. collaborating institution (e.g.,
the institution associated with the NIH D43 or other training program, the NIH
intramural program laboratory, or the research program) to further develop the
Principal Investigator’s career and research interest?
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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions 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: 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.
2.C. Sharing Research Data
A data sharing plan is not
required for this program.
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/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
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.
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 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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
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.
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.
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
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
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
Aron
Primack, M.D., M.A.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-4596
FAX: (301) 402-0779
Email: primacka@mail.nih.gov
NCI/NIH
Susan A. McCarthy, Ph.D.
Program
Director for Molecular Immunology.
Cancer
Immunology and Hematology Branch.
Division
of Cancer Biology.
National Cancer
Institute/National Institutes of Health
EPN Room 5058
6130
Executive Boulevard
Rockville, MD 20852-1360
Telephone:
(301) 496-7815 or (301) 594-8785.
FAX: (301)
480-2844.
Email: mccarths@mail.nih.gov
NIA/NIH
Tamara Jones, Ph.D.
Senior
Policy Analyst/International Research Activities Coordinator
National
Institute on Aging
National
Institutes of Health
Building
31, Room 5C05
31 Center
Drive, MSC
2292
Bethesda, MD 20892-2292
Telephone:
301-451-8835
Fax:
301-496-2793
Email: tamjones@nia.nih.gov
NINDS/NIH
Yuan Liu, PhD
Chief,
Office of International Activities
National
Institute of Neurological Disorders and Stroke
NSC, 6001 Executive Boulevard, Room 2187
Bethesda, MD 20892-9523
Telephone:
(301) 496-0012
Fax: (301)
402-1501
Email: yl5o@nih.gov
ODS/OD/NIH
Mary Frances Picciano, Ph. D.
Senior
Nutrition Research Scientist
Office of
Dietary Supplements
National
Institutes of Health
6100
Executive Boulevard, Room 3B01
Bethesda, MD 20892-7517
Phone: (301)
435-3608
Fax: (301)
480-1845
Email: piccianm@od.nih.gov
2. Peer Review Contacts:
Dan Gerendasy, Ph.D.
Scientific
Review Administrator
International Cooperative Programs
Center for Scientific Review
National
Institutes of Health
6701 Rockledge Drive, Room
5132
Bethesda, MD 20892- 7843
(Express/courier
use Bethesda, MD 20817)
Telephone: (301) 594-6830
FAX: (301) 480-1677
Email: gerendad@csr.nih.gov
3. Financial or Grants Management Contacts:
Mide Ogunyankin
Grants
Management Specialist
Office of the Director
Fogarty International Center
Building 31, Room B2C29
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 451-6830
FAX: (301) 594-1211
Email: ogunyano@mail.nih.gov
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.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
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.
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 (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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 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 52 and 45 CFR Parts 74 and 92.
All awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
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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