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
National Institute of Child Health
and Human Development (NICHD) (http://www.nichd.nih.gov)
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National
Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
Title: International Extramural Associates Research Development Awards (IEARDA) (G11)
Announcement Type
This is a reissue and modification of RFA-HD-06-018, which was released on June 28,
2006.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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 applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-07-431
Catalog of Federal
Domestic Assistance Number(s)
93.865
Key Dates (Revised per NOT-HD-08-001)
Opening
Date: September 24, 2007 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): September 24, 2007; January 22, 2008,
June 29, 2008; June 29, 2009
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):
October 23, 2007 and February 22, 2008, July 29, 2008; July 29, 2009
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): January 2008 and June/July 2008, October/November 2008,
October/November 2009
Council Review Date(s): May 2008* and October 2008*, January 2009, January
2010
Earliest Anticipated Start Date(s): March 2008 and December 1, 2008, February
2009, February 2010
Additional Information to Be Available Date (Activation Date): Not applicable
Expiration Date: July 30, 2009
Key Dates (Original)
Release/Posted Date: August 10, 2007
Opening Date: September 24, 2007(Earliest date an application may be
submitted to Grants.gov)
Letters of Intent Receipt Date(s): September 24, 2007, July 27, 2008, July 28, 2009
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): October 23, 2007, August 27, 2008; August 28, 2009
Peer Review Date(s): January 2008, October/November
2009, October/November 2010
Council Review Date(s): May 2008*, January 2009, January 2010
Earliest Anticipated Start
Date(s): March 2008,
February 2009, February 2010
Additional
Information to Be Available Date (Activation Date): Not
Applicable
Expiration Date: August 29, 2009
*NICHD plans to convene an interim council review prior to the anticipated start date in 2008.
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
The International Extramural Associates Research Development Award (IEARDA) program goal is to produce a cadre of trained academic research administrators in countries with limited resources to facilitate and/or develop the appropriate administrative infrastructure in their home institutions for the implementation of a more rigorous research program.
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
Background
The National Institute of Child Health and Human Development (N ICHD), National Institutes of Health (NIH), established the International Extramural Associates Research Development Award (IEARDA) program to help promote biomedical and behavioral research capacity and activity at public and private institutions in developing countries through the strengthening of their key research administrative staff and infrastructures. The IEARDA is modeled after the successful NIH Extramural Associates Research Development Award (EARDA) program, which for over 25 years has promoted the entry and participation of women and underrepresented minority institutions in the United States in biomedical and behavioral research. The Extramural Associates Program, within the Division of Special Populations at the NICHD, administers both programs on behalf of the NIH.
Since 1997, the NIH has dramatically increased its funding of research and training in developing countries. However, many institutions, faculty, students, and research administrators in these regions have limited knowledge of and/or experience with funding opportunities, grant applications, research program and project oversight, data management, fiscal accountability, and scientific reporting requirements of the NIH and other international research funding agencies. The IEARDA’s goal is to address such needs by producing a cadre of trained academic research administrators in countries with limited resources to facilitate and/or develop the appropriate administrative infrastructure in their home institution for the implementation of a rigorous sponsored research program.
The IEARDA is intended for institutional representatives who wish to strengthen an existing research administrative infrastructure for the purpose of enhancing and supporting biomedical and behavioral research capacity and activities at their institution. A successful applicant institution receives an IEARDA to strengthen the activities of the existing research administrative infrastructure, to implement the infrastructure development plan proposed in the application, and to utilize the knowledge and skills obtained by the research administrator through participation in the distance learning and residency training offered by the NIH. The institution’s nominee and research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) are expected to provide resources and support to faculty, students, and staff in the application for and administrative oversight of research awards and, when appropriate, serve as a regional resource.
The award entails:
Program Objectives and Components
The overall aim of the IEARDA program is to enhance or expand upon current research administrative infrastructure, thereby enhancing research capabilities of NIH-supported institutions in developing countries. This program will provide distance learning and NIH residency training, as well as funding to augment the research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) at the grantee institution, for the purpose of strengthening biomedical and behavioral research activities. This expanded research administrative infrastructure will provide careful oversight and administrative management of extramural awards; serve as the main organizational unit for the technical development of grant proposal submissions and oversight; and foster and facilitate ongoing research activities at the institution.
The institution should be undertaking significant research in the area of global health disparities in the biomedical or behavioral sciences.
1. Program Director/International Extramural Associate
The individual from the awardee institution who participates in the residency is known as the International Extramural Associate (IEA) and must be a full-time academic research administrator at the applicant institution. The IEA will serve as key research administrator and oversee the institution’s research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects).
2. Distance Learning and Residency Training
The IEAs will complete the Distance Learning component of their training while at their home institution and prior to their residency training at the NIH. Distance learning modules will include such topics as introduction to the NIH, NIH terminology and funding mechanisms, role of NIH officials, receipt and referral of grant applications, peer review process, program funding cycle, grants management basics, use of animals in research, use of human subjects in research, etc.
Successful applicants are required to spend a three-week residency at the NIH, part of which will involve participation in the core domestic EARDA program. Information on the domestic EARDA program curriculum can be found at http://www.nichd.nih.gov/about/org/dsp/ea/how_eap_works.cfm#curriculum. In addition to the NICHD, the Fogarty International Center, other NIH Institutes and Centers, and other components of the U.S. Public Health Service, as well as other public and private sector organizations, are involved in the residency training.
Upon entering the program, IEAs are assigned a preceptor or mentor from the NIH to oversee their residency. The IEA's preceptor, a senior NIH or Public Health Service (PHS) official, provides guidance with respect to working assignments and related activities to assure consistency with the grantee’s proposed infrastructure development plan. The preceptor also advises the IEA on any refinements to the Plan that will need to be made and approved by the end of the residency.
During the residency, IEAs attend a series of in-depth seminars that will prepare them to use their time effectively at the NIH. Working assignments are intended to provide exposure to the administration of NIH and other Federal extramural research programs. IEAs have the opportunity to study administrative procedures, and to observe staff and peer review meetings. During the course of the residency program, they visit other Federal agencies and a nearby university's Office of Research or Office of Sponsored Projects to learn different organizational and administrative structures related to biomedical and behavioral research. It is envisioned that IEAs will collaborate with, and learn from, the other IEAs and their domestic counterparts while in residence at the NIH.
The residency curriculum, in which all IEAs participate along with the domestic EAs, focuses on ten core areas:
Upon completion of the residency, the IEAs will have:
3. Site Visit
The NICHD will conduct an on-site visit to the awardee institution and assist with the rectification of any identifiable infrastructure and research capacity issues. The recommendations generated by the assessment are envisioned to help guide the institution and nominee in the establishment of an esteemed research infrastructure that has the capacity to implement a more rigorous research program.
4. Post-Residency Award
Following residency training and upon return to his or her home institution, the IEA will be responsible for the implementation of the Infrastructure Development Plan, ensuring adherence to the agreed-upon goals, objectives, and timelines. The institution will be equally responsible for approving and carrying out the plan and providing sustainable support for it as an ongoing institutional component. The IEA will use the IEARDA funds during the period of the grant to improve and reinforce the institution’s research capacity and research administration infrastructure (through the Office of Research or Office of Sponsored Projects) as outlined in the final, approved version of the Infrastructure Development Plan.
The NICHD will also provide information regarding relevant workshops, meetings and training opportunities to assist IEAs in leveraging newly gained knowledge, insights, and networks to help their research program and/or home institution.
5. Institutional Commitment
In nominating the IEA candidate, the sponsoring institution must demonstrate commitment by providing the release time needed to participate in IEA training and to formulate and implement an infrastructure development plan, which will build upon the IEA s distance learning and residency training experience. The Institution s commitment must also include:
Support for the IEA in the form of designated authority to enhance and strengthen the existing research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects).
A statement in the proposed infrastructure development plan that describes in detail how the Institution intends to continue and sustain the strengthened and enhanced research administrative infrastructure once IEARDA support expires.
The IEA and the institution must be fully committed to the IEA residency training. Only in extreme cases will the IEA be excused from any part of the training to engage in institutional responsibilities incurred prior to or during the residency training.
The institutional commitment should include office space; office equipment and any other in-kind activities to illustrate the long-range commitment to the Office past the duration of this program/grant. The application should address the institutional support in these areas with as much specificity as possible.
The awardees institution and Principal Investigator must submit progress reports (as mandated by federal funding requirements) that document activities during the report period and track efforts to meet the targeted outcomes as detailed in the infrastructure development plan.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding Opportunity
Announcement (FOA) will use the Extramural Associates Research Development Award
(G11) award mechanism. As an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. An application may request up to five years of
support.
This FOA uses Just-in-Time information concepts. It also uses the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
2. Funds Available
The amount of funding to be awarded and the
number of awards will depend on the number and scientific merit of the
proposals received. An applicant may request a project
period of up to five years and a budget of up to $35,000 in Direct Costs per
year to support strengthening and expanding the research administrative infrastructure for the institution. In addition, an
applicant may request up to $15,000 in the first year for travel and a living
allowance for the International Extramural Associate to enable his or her
participation in the required residency program at
the NIH.
Funds for up to eight percent administrative costs (excluding equipment) may
also be requested. 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
1. B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed project is invited to work with his or her institution to develop an application for support.
The Principal Investigator must be nominated by an institution meeting the eligibility criteria above. This individual will serve as the International Extramural Associate (IEA) for the program. Full-time academic research administrators are eligible to become Principal Investigators. The Ph.D., M.B.A. or equivalent is preferred, but not necessary. Upon completion of the NIH residency program, the Principal Investigator must have the commitment of the Institution and the authority to oversee and execute the Infrastructure Development Plan. In addition, this individual must have flexibility of academic and other professional responsibilities and workload to carry out the expectations outlined in this solicitation. Institutions may nominate only one Principal Investigator per funding cycle for participation in the program, and may have only one G11 grant at a time.
The ideal candidate should have familiarity with the research scope of the home institution, experience in management of a business or other relevant office, and experience with the administration or management of scientific research. Applicants must be available to participate in the distance learning component at their home institution and in the three-week residency program at the NIH in Bethesda, Maryland, U.S.A.
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
There are no other special eligibility criteria.
Eligible institutions may submit no more than one application per institution.
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 eRA 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.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 organization/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: Telephone
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 for this FOA through Grants.gov/APPLY.
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 Frequently Asked Questions Application Guide, 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
Research
& Related Budget
PHS398
Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH G11 for the IEARDA uses ONLY the detailed Research & Related Budget. (Do not use the PHS398 Modular Budget.)
Foreign Organizations (Non-U.S. Entity)
NIH policies concerning grants
to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
3.
Submission Dates and Times
Applications must be received on or before the
receipt date described below. See Section IV.3.A for details.
3. A. Submission,
Review, and Anticipated Start Dates
(Revised Dates)
Opening
Date: September 24, 2007 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): September 24, 2007; January 22, 2008,
June 29, 2008; June 29, 2009
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):
October 23, 2007 and February 22, 2008, July 29, 2008; July 29, 2009
AIDS Application Submission/Receipt Date(s): Not applicable
Peer Review Date(s): January 2008 and June/July 2008, October/November 2008,
October/November 2009
Council Review Date(s): May 2008* and October 2008*, January 2009, January
2010
Earliest Anticipated Start Date(s): March 2008 and December 1, 2008, February
2009, February 2010
Additional Information to Be Available Date (Activation Date): Not applicable
(Original Dates)
Opening Date: Month, day, year (Earliest
date an application may be submitted to Grants.gov): September
24, 2007
Letters of Intent Receipt Date(s): September 24, 2007, July 27, 2008,
July 28, 2009
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): October 23, 2007, August 27,
2008; August 28, 2009
Peer Review Date(s): January 2008, October/November
2009, October/November 2010
Council Review Date(s): May 2008, January 2009, January
2010
Earliest Anticipated Start
Date(s): March 2008,
February 2009, February 2010
Additional
Information to Be Available Date (Activation Date): Not
Applicable
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 NICHD staff to
estimate the potential review workload and plan the review.
The letter of intent is
to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Regina Smith James, M.D.
Director, Extramural
Associates Program
Division of Special Populations
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301) 435-2692
FAX: (301) 480-0393
Email: [email protected]
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.
In order to expedite the review, applicants are requested to notify the NICHD Division of Scientific Review by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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.
Allowable
Costs
Applicants may request up to $35,000 (plus eight percent indirect costs) to support the activities of the IEA and the Office of Research upon returning to the home institution. Activities and other purposes for which funds may be used include, but are not limited to, the following:
Funds may not be used for the following:
In year one, in addition to the $35,000 (plus eight percent indirect costs), applicants may also request up to $15,000 (plus eight percent indirect costs) to support travel and living allowance during the NIH residency training period. This request can include a direct economy, roundtrip flight between the home institution and Bethesda, Maryland, U.S.A., and a maximum living allowance of $4000 to cover the cost of lodging, meals, local transportation and other incidentals during the residency program.
Pre-award costs are allowable.
A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing
renewal 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
Special Application Instructions for International Extramural Associates
Research Development Award
The following six application components are required and it is imperative that applicants fully address each point described in the outline below because they are reflected in the review criteria.
SF424 R&R: Section 4.5 Senior/ke person profile(s) Component(s)
Biosketch and Other Attachments
1. The Nominee
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component (15-page limit)
2. Infrastructure Development Plan
Applicants must submit a plan that describes the proposed activities for enhancement and strengthening of the institution's existing research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects). The Infrastructure Development Plan should describe the key goals, specific objectives, activities, outputs (e.g., support staff hired, computers purchased, training curriculum completed), resources, outcomes (in terms of both short- and long-term goals) and key personnel involved in the enhancement and strengthening of the research office during the project period of the IEARDA. It should be clear and coherent and provide evidence of adequate coordination among key faculty and administrators in its development.
The Infrastructure Development Plan should specifically address the following key areas: Outreach, sustainability and integration within the overall plan of the institution:
Outreach: The plan should briefly describe any proposed outreach to other regional academic/scientific institutions to help strengthen their research capacity and research administration capabilities, and other plans to initiate or expand local or regional cooperation/collaboration in research activities, including partnering with foundations and other organizations, including businesses and industry.
Sustainability: The Infrastructure Development Plan should describe briefly how the institution intends to sustain and continue the programs and activities of the research office once NIH support through the IEARDA expires. The plan for sustainability should include long-range goals and objectives for the research office and indicate commitment of funding from the institution or availability of other sources of support to ensure continuation of research office activities at the enhanced level.
Integration: The Infrastructure Development Plan should also indicate how this plan relates to and is integrated within any overall strategic plan of the institution.
The IEA should form a realistic and sufficiently detailed work plan that can be achieved within a specified timeframe. Objectives should be clear, measurable and achievable. Strategies and activities to help achieve each objective should also be stated (e.g., increased administrative staffing, establishment of database or tracking systems, enhancement of Internal Review Boards [IRB] for both human and animal subjects, training seminars to address grant preparation or grants management). Each applicant should consider carefully what it wants to accomplish within each year and over the course of the project period. For each institution, the goals, objectives, activities, timelines, and intended outcomes will differ, but there may be basic categories of activity that each applicant may want or need to undertake.
A timeline for achieving each objective should be indicated. It may be helpful to summarize this information for each year of the project period using a chart or table format. Examples of such activities can include but are not limited to the following:
Year 1: Adequately staff and equip the research office; strengthen research office communication and computing capabilities; establish and activate advisory committee; assess faculty and student training needs and resources; establish baselines for evaluation plan.
Year 2: Asess and strengthen accounting and monitoring practices; facilitate direct proposal submissions; develop core training capabilities and materials; conduct workshops; monitor performance of workshops.
Year 3: Review and refine sustainability plan for research office; continue training workshops and seminars; continue monitoring quality of training; conduct mid-course review and refine work plan as needed.
Year 4: Continue to develop and implement strategies to develop research capacity through improved grantsmanship; assess regional needs and plan regional activities; establish partnerships and other linkages in support of goals.
Year 5: Implement and assess regional activities; continue training activities; finalize plan for sustainability of research office; implement (process and outcome) evaluation of program.
Adherence to the timeline should be reported within the annual progress reports mandated by the NIH. Please note: The goals and/or outcomes developed for the IEARDA application can be modified based on recommendations provided in consultation with the IEARDA preceptors and administrators at the NIH during the NIH residency.
The Infrastructure Development Plan proposed as part of the IEARDA application can be modified and finalized by the IEA during the residency to reflect the knowledge and skills gained from the distance learning and residency experiences.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
3. Institutional Commitment
Support for the IEA and implementation of the Infrastructure Development Plan by the institution should be evidenced by the following:
Letter from the President or equivalent official institutional head should indicate that he or she:
a. Approves the nominee’s IEARDA training periods at home through the distance learning component and at the NIH for the NIH residency, and provides the release time for these periods and any financial support needed for training;
b. Clearly defines the placement of the research office within the institution and its line of authority;
c. Is committed to working cooperatively with the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects) in the home institution for the benefit of the particular administrative unit;
d. Confirms the institution’s commitment to and support of the sustainability of the designated research administrative infrastructure (e.g., Office of Research, Office of Sponsored Projects). Institutional provision of resources such as office space, administrator salary, office equipment and other in-kind activities should be addressed both in the grant application and in this support letter. The letter should also explicitly explain how the Institution plans to support and sustain the research office after the IEARDA program/grant has been completed.
e. Confirms the institution’s commitment to biomedical and behavioral research including a statement of plans (as detailed as possible) to improve the health-related research capabilities of the institution.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
4. Establishment of Advisory Board
The Infrastructure Development Plan should include a proposal for establishment of an Advisory Committee to review and monitor ongoing infrastructure development activities. The purpose, function, and expectation, as well as prospective members of the committee should be described in the application, but specific members should not be appointed until after an award is made. This committee is intended to be advisory to the IEA in the enhancement and maintenance of ongoing research development activities. All other planned committees should be included in this section with a justification for the particular committee structure and function proposed and a description of the proposed membership.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
5. Evaluation Plan
The evaluation strategy should be linked to the statement of goals and objectives and should include benchmarks and a timeline for measuring progress or outcomes. This information can be presented in a chart or table. The Plan should also address how the results from the evaluation will be used to improve the research infrastructure and capabilities of the institution. Implementation of any evaluation or assessment activities should include input from the proposed advisory committee.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
6. Description of Current Research Infrastructure
a. The Principal Investigator should document current status of infrastructure and address the following:
b. Description of the research environment, including a description of the science faculty and the research capability as indicated by:
c. Current funding from the NIH
Please provide information on the institution’s current NIH funding. This should be highlighted or presented in a separate chart or list. The solicitation requires applicant institutions to be current recipients of at least three NIH research or research training grants awards, either directly or as subprojects on domestic or foreign NIH awards. For each project, the chart should include the NIH grant number, PI name, grantee institution name, title of project, total amount of grant award, amount of subcontract or subproject award, project period (start and completion dates), and role of the IEARDA applicant institution’s research staff in the project (e.g., PI, project director, subproject director, investigator, etc.)
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
7. Infrastructure Development Plan
In the application, the Principal Investigator (PI) should document current status of infrastructure (e.g., administrative support, resources and facilities available to support research activities, data management and analysis support, collaborative arrangements). The infrastructure development plan should expand upon the current structure and outline or describe the type of resources and enhancement activities needed by the institution to efficiently address the improvement of the current infrastructure (e.g., changes in staff support, establishment of database, collaborative activities with other institutions, curriculum development, training courses in research methodology, grantsmanship, scientific writing). The grantee should clearly describe how implementing these changes will improve the infrastructure, thereby enhancing biomedical and behavioral research activities. During residency at NIH, the IEA will work on further development of the plan.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
8. Evidence for Institutional Support
A letter from the President or equivalent official head of the applicant Institution, signed and dated, should be included in the Appendix. The letter should state explicitly that he or she approves the nominee s training periods at home through the distance learning component and at the NIH residency, and provides the release time for these periods and any financial support needed for training; clearly defines the placement of the research office within the institution and its line of authority; is committed to working cooperatively with the designated research administrative infrastructure and support to the sustainability of the designated research administrative infrastructure.
SF424 R&R: Section 5 Completing PHS 398 Components
Section 5.5 Research Plan Component
9. Special Instructions for Appendix
The Appendix to the application should include the following items:
PD/PI Credential (e.g., Agency Login)
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 Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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.
PHS398 Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts.
Appendix Materials
NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better 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.
Foreign Applications (Non-U.S. Entity)
Indicate how the proposed project has specific relevance to the mission and objectives of the IC and has the potential for significantly advancing the health sciences.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review
criteria described below will be considered in the review process.
The following will be considered in
making funding decisions:
2. Review and Selection
Process
Applications that are complete and responsive to the PAR
will be evaluated for scientific and technical merit by an appropriate peer
review group convened by the NICHD in
accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
1. The Nominee
2. Infrastructure Development Plan
3. Institutional Commitment
2. A.
Additional Review Criteria:
Not applicable
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 project may be assessed
by the reviewers. The priority score should not be affected by the evaluation
of the budget.
2. C. Sharing Research Data
Not applicable
2. D.
Sharing Research Resources
Not applicable
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/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
A wardees 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.
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:
Regina Smith James, M.D.
Director,
Extramural Associates Program
Division
of Special Populations
National
Institute of Child Health and Human Development
6100
Executive Boulevard, Room 5E03A, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone:
301-435-2692
Fax:
301-480-0393
Email: [email protected]
Ken Bridbord, MD, MPH
Director, Division of International Training & Research
Fogarty International Center
National Institutes of Health
31 Center Drive Room 31/B2C39
Bethesda, MD 20892-2220
Telephone: 301-496-1653
Fax: 301-402-0779
Email: [email protected]
Karl A. Western, MD, DTPH
Senior International Scientific Advisor
National Institute of Allergy and Infectious Diseases
National Institutes of Health
6700-B Rockledge Drive (Room 4120)
Bethesda, Maryland 20892-6613 Deliveries Only ZIP Code: 20817
Phone: 301-496-6721
Fax: 301-402-3255 or 301-480-1483
E-mail: [email protected]
2. Peer Review
Contacts:
Robert Stretch, Ph.D.
Director,
Division of Scientific Review
National
Institute of Child Health and Human Development
6100
Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone:
(301) 496-1485
Fax:
(301) 402-4104
Email: [email protected]
3. Financial or Grants
Management Contacts:
Victoria Bishton
Grants Management Specialist
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01B,
MSC 7510
Bethesda, MD 20892-7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: (301)
451-5857
Fax: (301) 451-5510
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS support for activities involving live,
vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) 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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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 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 (HHS)
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 HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. For publications listed in
the appendix and/or Progress report, Internet addresses (URLs) or PubMed
Central (PMC) submission identification numbers must be used for publicly
accessible on-line journal articles. Publicly accessible on-line journal
articles or PMC articles/manuscripts accepted for publication that are directly
relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.
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 FOA 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 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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