Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)

Title:  International Research Ethics Education and Curriculum Development Award (R25)

Announcement Type
This is a reissue of RFA-TW-06-003, which was previously released on October 27, 2005.

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.

Request For Applications (RFA) Number: RFA-TW-08-002

Catalog of Federal Domestic Assistance Number(s)
93.989

Key Dates
Release/Posted Date: July 26, 2007
Opening Date: November 14, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 14, 2007
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):  December 14, 2007
AIDS Application Submission/Receipt Date(s): N/A
Peer Review Date(s): June/July 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 15, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Few developing country institutions provide formal education in research ethics, and few developed country programs for advanced research ethics education/training focus in depth on the internationally relevant aspects of research ethics.  Therefore, few developing country scientists and health professionals conducting clinical or public health research have received extensive education and training in the principles of research ethics, international codes and legal aspects of ethical research, informed consent, elements of study design that affect the ethical conduct of research and the ethical framework for provision of care and risk/benefit analysis for study participants.  To address this need, the Fogarty International Center (FIC) invites applications for International Research Ethics Education and Curriculum Development Program Awards to develop masters level curricula and provide educational opportunities for developing country academics, researchers and health professionals in international ethics, related to performing research involving human subjects in international resource poor settings. Alternatively, developing country applicants may submit proposals to support program planning activities in preparation to apply for comprehensive program support in the future.    

The goal of this initiative is to increase the cadre of developing country scientists, health professionals and relevant academics with in-depth knowledge of the ethical considerations, concepts and applications in clinical and public health research.  It is expected that such advanced education/training will enhance the career development of individuals from developing countries, as well as strengthen expertise to support ethical clinical and public health research at their home institutions. 

Proposed degree or non-degree comprehensive international research ethics education programs should equip academics, health professionals and researchers from developing countries with the critical skills that are needed to subsequently provide research ethics education, ethical review leadership and expert consultation to their institutions, national governments and international bodies and, potentially, to pursue studies of ethical practice in clinical and public health research in developing countries. 

Proposed curricula should provide a core set of advanced study courses that primarily focus on the internationally relevant aspects of ethical, legal and moral principles guiding the responsible conduct of research.  Appropriate educational activities may include practicum experiences, such as participation in ethical review committees, development of research ethics education/training courses for researchers and ethical review committee members at their home institutions, analysis of ethical review guidelines or processes and research on ethical practices in biomedical or behavioral research in the participants’ countries.  Education may also be provided in areas such as research design methodology, technical manuscript and grant writing, statistical methods, informatics, and English as a second language, if needed.  Curriculum developed in new comprehensive programs must be offered to participants after a maximum of one year of the award and should be ongoing in previously supported programs. 

Planning grant proposals should describe in detail how curriculum components and educational activities for a comprehensive program will be designed during the two-year award period. 

Four year comprehensive training program applications should propose degree or non-degree masters level programs including international research ethics curriculum and practicum experience for up to two years and no less than 12 months for developing country participants at the grantee, consortium or home country institutions.  Support can be provided for educating and training developing country academics such as ethicists or philosophers, researchers and health professionals working at institutions conducting clinical or public health research.

New applications proposing research ethics education programs for participants from Francophone and Lusophone African countries, India, China, Thailand, Latin America, Russia and Eastern Europe are especially encouraged due to the large amount of NIH supported research currently conducted in these countries. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Education Grant (R25) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.  The applicant organization’s administration must provide the necessary management for the transfer of funds and materials to the collaborators and any subcontracts. 

This FOA uses just-in-time concepts. It also uses the non-modular budget format.  Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.  A detailed categorical budget for the “Initial Budget Period” and the “Entire Proposed Period of Support” is to be submitted with the application. 

2. Funds Available

Because the nature and scope of a proposed international research ethics education program will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the FIC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Under this FOA:

R25 education awards limit facilities and administrative (F & A) costs to eight percent of modified direct costs.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this funding opportunity announcement. 

Facilities and Administrative (F&A) costs requested by consortium participants, if applicable, are not included in the direct cost limitation.  See NOT-OD-05-004.  

All awards are subject to the availability of funds. The estimated amount of funds available for support of projects awarded as a result of this announcement from FIC and potential partners is $1.5 million for fiscal year 2008 to fund five to six new and/or competing renewal comprehensive curriculum development and educational program awards and two to three planning awards in response to this FOA. Future year amounts will depend on annual appropriations.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:  

If multiple sites are involved in the international research ethics education and curriculum development program, the applicant institution must be one of these sites for the program.  The need for and use of multiple sites must be justified.   

Only developing country applicants may apply for a two-year program planning grant.  Such applicants must be at an institution in a “developing country” defined by the World Bank, according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” (see:  http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).

Collaborations with faculty or consultants from other U.S. or international institutions may be supported to enhance the international research ethics educational activities proposed. 

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed international research ethics education and curriculum development program as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. 

The PD/PI will be expected to monitor and assess the program, submitting annual reports as required. (See Section VI.3., “Reporting.”)

The PD/PI should have documented experience in international research ethics and be capable of providing both administrative and scientific leadership to the development and implementation of the proposed curriculum development and education program.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application.   The first PI listed must be affiliated with the institution submitting the application and will serve as the contact PI.  The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations, and should be determined by the educational goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. The structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs must be explained in the application and will be factored into the assessment of the overall merit. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports.  Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

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

Sponsoring Institution: The sponsoring institution must assure support for the proposed research education project. Appropriate institutional commitment to the project includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education project.  A letter of support from the appropriate institutional official describing their commitment to provide staff, facilities and educational resources should be included in the application.

Participants: Describe who the intended participants are, and what eligibility and/or specific educational background characteristics are essential for participation in the proposed program. Applicants should describe how participants will be recruited and the process and criteria used for their selection for participation in the program.  Participants in proposed programs must be from developing countries as defined by the World Bank (according to Gross National Income (GNI) per capita as “low-income,” “lower-middle-income,” and “upper-middle-income” see:  http://siteresources.worldbank.org/DATASTATISTICS/Resources/CLASS.XLS).

Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Applications must contain an evaluation plan and a dissemination plan.  Applications submitted without these sections may be delayed in the review process or not reviewed.

An Advisory Committee must be established for comprehensive research educational programs and planning awards that includes a majority of members not affiliated with the program.  It is highly recommended that the committee include representatives of potential participant developing countries.  The committee’s responsibilities in a comprehensive educational program may include participant selection, evaluating participant progress and monitoring and evaluation of the overall effectiveness of the program.  Applicants should provide a detailed description of the committee’s composition and functions, as well as how the committee fits into the organizational structure of the program. 

An institution may submit only one application and only one new or existing program will be supported at an institution.  Descriptions of existing programs can be found on the FIC website at http://www.fic.nih.gov/programs/bioethics/bioethicsaward.html

Competitive renewal applications should contain detailed information about previous FIC-supported research education and training efforts including:  a comprehensive list of all participants and participant status after involvement in the program—including position, country of residence and institution; type and length of training provided, and the participant’s current position and responsibilities in providing research ethics training, review or consultation.  Applicants for competitive renewal awards should also provide a list of participant publications and descriptions of other significant accomplishments related to the research ethics training provided.

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:

PD/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 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 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Several special provisions apply to applications submitted by foreign organizations. Applications from foreign organizations must:

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

Research Education Program

While the proposed international research ethics education and curriculum development program may complement other, ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and international research ethics education and curriculum development programs currently receiving U.S. support.

If multiple sites are involved in the international research ethics education and curriculum development program, the applicant institution must be one of these sites for the program.  The need for and use of multiple sites must be justified.   

Although research education grants are not typical research instruments, they do involve experiments in education and/or dissemination of research knowledge that require an evaluation plan in order to determine the degree of success or failure. A plan must be provided for program evaluation. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of an international research ethics education and curriculum development program in achieving its objectives  Evaluation plans should specify clear linkages between the stated research ethics education and training needs of the developing countries from which participants will be recruited, academic and career needs of the participants, the objectives of the proposed courses and curriculum topics and measures of outcome.

A specific plan must be provided to disseminate internationally any materials developed under the auspices of the international research ethics education and curriculum development, e.g. Web postings, presentations at scientific meetings, workshops, etc. 

Allowable Costs 

Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the international research ethics education and curriculum development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution.  

Applicants should develop a budget that reflects the resources necessary to implement the activities of the comprehensive educational and curriculum development program plan included in their application.  The budgets may include costs to support the various types of educational activities proposed, costs for participants and faculty, and costs to support the administration of the program and grant. 

Personnel: Individuals participating in the design and implementation of the international research ethics education and curriculum development program may request salary and fringe benefits appropriate for the person months devoted to the program.  These expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.  Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the Congressionally mandated cap. (If mentoring interactions and other activities with students/participants are considered a regular part of an individual's academic duties, then mentoring and other interactions with students/participants are non-reimbursable from grant funds). Limited administrative and clerical salary costs associated distinctly with the program that are not normally provided by the applicant organization may be direct charges to the grant only when specifically identified and justified.  The program director may receive salary and fringe benefits compensation for up to 25% professional effort (salary must not exceed the annual salary cap level from federal sources, as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html).   

Other Program-Related Expenses: Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed international research ethics education and curriculum development program and must not duplicate items generally available for educational programs at the applicant institution. These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget. Funds to support the attendance of the Principal Investigator at the annual network meeting for the program at NIH may be requested.  As part of a program’s participant sustainability plans, support of up to $10,000 per developing country participant in comprehensive training programs should be requested in this category for research ethics practicum projects of up to one year upon return to their countries after didactic training. 

Participant Costs: Participants are those individuals who benefit from the proposed international research ethics education and curriculum development program.  Participant costs must be justified as specifically required for the proposed international research ethics education and curriculum development program.  Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.  In comprehensive education programs, participants may be compensated at a rate comparable to their professional experience in accordance with grantee institutional policies while involved in long-term training at the grantee institution.  Participants in the international research ethics education and curriculum development programs may receive funds to defray tuition, other education-related, and travel expenses.

Institutional Commitment: Evidence of institutional commitment to the research educational program is strongly encouraged. 

Facilities and Administrative (F&A) Costs: F&A costs for the applicant organization and consortium participants will be reimbursed at 8 percent of modified total direct costs.  

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: Novem ber 14, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 14, 2007
Application Submission/Receipt Date(s): December 14, 2007
AIDS Application Submission/Receipt Date(s): N/A
Peer Review Date(s): June/July 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date: September 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD   20892-2220
Telephone
: (301) 402-9467
Fax: (301) 402-0779
Email:
sinab@mail.nih.gov

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 Fogarty International Center by email (sinab@mail.nih.gov) 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.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. 

Once an application package has been successfully submitted through Grants.gov, all errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of an 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 an award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R25 applications:

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. An application that does not observe these limitations may be delayed in the review process.   

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

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.

Supplementary International Research Ethics Education and Curriculum Development Program Application Instructions

Applicants should use the following guidance, in addition to the instructions accompanying the SF 424 (R&R) form.  Applications that do not conform to the specific instructions detailed below will be returned.  

1. SF 424 Research & Related Project/Performance Site Location(s): Include collaborating sites, if appropriate.

If multiple sites are involved in the international research ethics education and curriculum development program, the applicant institution must be the primary site for the program.  A justification must be included for sites other than the applicant institution in the program narrative.   

2.  SF 424 Research & Related Other Project Information, Item 9 (Facilities & Other Resources):  Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.  List all thematically related sources of support for research training and education following the format for Current and Pending Support. 

3.  SF 424 Research & Related Senior/Key Person Profile: Key Personnel must include the PD/PI as well as any other key persons (such as those involved in the development, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed international research ethics education and curriculum development program) participating in the international research ethics education and curriculum program development.

4.  Research & Related Budget:  Complete for each budget period requested.

A.  Senior/Key Person: complete for all senior/key persons associated with the international research ethics education and curriculum development program.  The PD/PI must be included here.  The salary for the Principal Investigator, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed.  The program director may receive salary and fringe benefits compensation for up to 25% professional effort (salary must not exceed the annual salary cap level from federal sources, as described at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html

B.  Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the international research ethics education and curriculum development program

C.  Equipment: self-explanatory.

D.  Travel: include here any travel funds requested for senior/key persons and other personnel (i.e. those persons identified in Sections A. and B.) associated with the international research ethics education and curriculum development program. 

E.  Participant/Trainee Support Costs: include here all allowable categories of funds requested to support participants in the international research ethics education and curriculum development program.  If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other. State the number of Participants/Trainees to be supported by the proposed international research ethics education and curriculum development program.  In comprehensive education programs, participants may be compensated at a rate comparable to their professional experience in accordance with grantee institutional policies while involved in long-term training at the grantee institution.

F.  Other Direct Costs: itemize as appropriate and allowed for the international research ethics education and curriculum development program.  Support of up to $10,000 per developing country participant in comprehensive training programs may be requested in the “Other Expenses” category for research ethics practicum projects of up to one year upon return to their countries after didactic training.  Funds to support the attendance of the Principal Investigator and one or two faculty at the annual network meeting for the program in the U.S. may be requested. 

K.  Budget Justification: provide a detailed justification for each category for which funds are requested.  For Section E, itemize each category of support costs per participant and justify. 

5.  PHS 398 Research Plan Attachments:

Part 4 of this section (Preliminary Studies/Progress Report) should contain information on steps that have led to the proposed international research ethics education and curriculum development program.  A progress report must be included in renewal applications. All applicants should provide a detailed assessment of the current status of the ethical review of research and needs for research ethics education in the developing countries where participants will be recruited as background and rationale for the specific program plan components proposed

Part 5 of this section (Research Design and Methods) should be re-titled "International Research Ethics Education and Curriculum Development Program Plan" and should contain material organized under the following subheadings in a single attachment and as appropriate to the specific program.

Program Director(s): Describe arrangements for administration of the program, provide evidence that the Program Director has documented experience in international research ethics, and can organize, administer, monitor, and evaluate the international research ethics education and curriculum development program, as well as evidence of institutional and community commitment and support for the proposed program.

Program Faculty/Staff: Describe the characteristics and responsibilities of the participating faculty; provide evidence that the participating faculty and preceptors are actively engaged in research or other activities relevant to international research ethics.  All applicants should describe the specific roles of all proposed training faculty and advisory committee members, including their research ethics training records and expertise.  The application should include letters from participating faculty and advisory committee members stating agreement with the roles specified in the proposal, as well as their time commitment during the course of the proposed program. 

Proposed International Research Ethics Education and Curriculum Development Program: Provide programmatic detail on the special activities proposed (e.g., courses, curricula, seminars, workshops).

Planning grant applicants should propose activities to organize and plan for an educational/training program, and prepare an application to submit for support of a comprehensive program in two years.  Planning grant activities may include consultation with faculty and advisory committee members to assess the specific needs for research ethics education and training in countries where participants will be recruited, define and develop curriculum components and educational resource materials to address the identified needs for education, develop evaluation plans and define their roles and institutional commitments in the education and curriculum program.  Targeted educational and training of developing country faculty to fill gaps in expertise directly related to their role in the proposed education program may also be supported

Sustainability Plan:  Applicants for comprehensive education and curriculum program awards should include plans for enabling participants to develop and sustain research ethics programs on return to their home institutions.  Plans may include provision of networking opportunities, continued mentorship, travel grants, laptop computers and internet connectivity, research ethics journal subscriptions, funding for initiating research ethics education/training, research or publication and arrangements for home institution administrative support or release time  

Responsible Conduct of Research: Describe plans to provide formal and informal instruction to participants on scientific integrity and ethical principles in research. The plan should be appropriate for the duration and content of the proposed international research ethics education and curriculum development program.  Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Plans must address: 1) the subject matter of the instruction, the format of the instruction, the degree of program faculty participation, participant attendance, and the frequency of instruction; and 2) the rationale for the proposed plan of instruction. If such training is not appropriate for the proposed international research ethics education and curriculum development program, then the Principal Investigator must provide a strong justification for its exclusion.

Program Participants: Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.  Comprehensive education and curriculum development program plans should describe in detail each of the following processes:  participant recruitment, participant candidate evaluation including criteria for selection, participant orientation activities, mentorship, and participant evaluation during program participation. 

Diversity Recruitment and Retention PlanApplicants should include strategies for recruiting and retaining adequate representation of women and ethnic minorities in the home countries of the developing country participants

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the Fogarty International Center, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Evaluation Plan: Include evaluation plans for assessing the success of the program in achieving its goals and objectives. Benchmarks should be specified, and specific plans and procedures must be described to capture, analyze and report outcome measures that would determine the success of the international research ethics education and curriculum development program in achieving its objectives. The inclusion of evaluation instruments is encouraged.  Applications that lack an evaluation plan will be returned.

Dissemination Plan: A specific plan must be provided to disseminate nationally any materials developed under the auspices of the international research ethics education and curriculum development program, e.g., Web postings, presentations at scientific meetings, workshops, etc. 

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

International research ethics education and curriculum development programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan.  Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee.  The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications 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:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH-supported research training, education, and career development programs are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate scientific areas to address the Nation’s biomedical, behavioral, and clinical research needs.  The goals of NIH-supported science education projects at science centers and museums are to provide public education and outreach on NIH-supported research at these institutions. 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 international research ethics education and curriculum development  program 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. These criteria are not listed in any order of priority.

International research ethics education and curriculum development program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation, scholarship and responsiveness to the priorities and/or changing needs for research ethics education in developing countries in meeting its objectives.  Applicants are strongly encouraged to contact FIC program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Significance: Does the proposed international research ethics education and curriculum development program address relevant international research ethics issues? How will implementation of the proposed program advance the objectives of this funding opportunity announcement as well as the mission of the FIC to build research capacity in developing countries? What will be the effect of this ethics training on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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 there evidence that the program is based on sound research concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool?

For renewal applications only: Has the international research ethics education and curriculum development program fully achieved its stated objectives during the prior project period?

Innovation: Is the international research ethics education and curriculum development program original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  Does this program duplicate, or overlap with, existing research education, training and/or career development activities currently supported at the applicant institution or available elsewhere? Adaptations of existing international research ethics education and curriculum development programs may be considered innovative under special circumstances, e.g., the addition of unique components and/or a proposal to determine portability of an existing program.

For comprehensive curriculum development and educational program applications:

For planning grant applications:

For renewal applications only:  Has the program been innovative in the past and does it continue to demonstrate innovation?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the proposed program appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the program (if applicable)? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives? Are the qualifications of the program director to lead and other faculty and Advisory Committee members to participate in the proposed international research ethics education program sufficient?

Environment: Does the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed international research ethics education and curriculum development program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? Is there evidence of appropriate collaboration among participating programs, departments, and institutions? Is the institutional commitment to the proposed program appropriate? If multiple sites are participating, is this adequately justified in terms of the research education experiences provided? Are adequate plans provided for coordination and communication between multiple sites (if appropriate)? Are the teaching facilities and educational resources, including the availability of research ethics practicum opportunities and the overall educational environment, adequate at the applicant institution(s)?

Is the evaluation plan and timeline adequate for assessing the effectiveness (process and outcome) of the program in achieving its goals and objectives?

Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation?

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:

Dissemination Plan: Is the dissemination plan strong and of high quality (if appropriate)?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF 424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, the adequacy of the proposed protection will be assessed.

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 international research ethics education and curriculum development  program will be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

Training in the Responsible Conduct of Research: Peer reviewers will assess the applicant's plans for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.

The plan will be discussed after the overall determination of merit, and the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Program staff will judge the acceptability of the revised plan.

Diversity Recruitment and Retention Plan: The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral, clinical and social sciences research workforce.  The NIH expects efforts to diversify the workforce to lead to the recruitment of the most talented researchers from all groups; to improve the quality of the educational and training environment; to balance and broaden the perspective in setting research priorities; to improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and to improve the capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as: individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.  Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis.

Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds.  The review panel’s evaluation will be included in an administrative note in the summary statement.  If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received.  Staff within the FIC, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”.

International research ethics education and curriculum development programs are not generally expected to generate research resources. However, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced. However, the software dissemination plan should address, as appropriate, the following goals:

The initial review group will comment on the appropriateness of the proposed software dissemination plan.  Program staff will also consider the adequacy of the software dissemination plan as one of the criteria for award.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award.  Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. 

3. Anticipated Announcement and Award Dates

Applicants can expect to learn the outcome of their applications, whether successful or unsuccessful, in September 2008 

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the Notice of Award (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.”       

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 Fogarty International Center to the grantee business official. 

2. Administrative and National Policy Requirements

Termination of Award: When a grantee institution plans to terminate an award, program and grants management staff at the NIH funding component must be notified in writing as soon as possible.

Change of Institution:  The international research ethics education and curriculum development  program may not be transferred from one institution to another, unless strongly justified.

Consultation with the FIC program staff is strongly encouraged when a change of institution is being considered.  In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PI plans no significant change in the original objectives, and the facilities and resources at the new organization will allow for successful performance of the project or activity. If these conditions or other programmatic or administrative requirements are not met, the FIC may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the FIC for review:

Change of Program:  Awards are made for a specific program under the guidance and leadership of a particular PD/PI.  A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component.  A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program.  If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met.  The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change.  The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided.  The information in the request must establish that the Specific Aims of the original peer-reviewed international research ethics education and curriculum development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program.  This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review. 

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

Awards made in response to this FOA are subject to SNAP. 

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed international research ethics education and curriculum development program (including education in the responsible conduct of research), modifications to the international research ethics education and curriculum development program as originally proposed, details about the applicant pool and the participants including their career level, gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the international research ethics education and curriculum development program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the international research ethics education and curriculum development program.

Evaluation:  In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, award recipients are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, dissemination, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results:  Investigators are encouraged to submit reports of their findings for publication to the journals of their choice.  For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated.

Awardees will also be required to submit annual participant tracking data to a Fogarty International Center database.  Instructions on participant data submission will be provided at the time of award.

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:

Barbara Sina, Ph.D.
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
Bethesda, MD   20892-2220
Telephone: (301) 402-9467
Fax: (301) 402-0779
Email:  
sinab@mail.nih.gov

2. Peer Review Contacts:

Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5136
Bethesda, MD   20892-7840 (For express mail, use ZIP 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email:  
duperes@csr.nih.gov

3. Financial or Grants Management Contacts:

Bruce Butrum
Grants Management Officer
Fogarty International Center
Building 31, Room B2C29
Bethesda , MD  20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email:
butrumb@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 (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).

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.

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.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.