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)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/index.shtml)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)

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

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of the RFA-TW-08-002.

Update: The following update relating to this announcement has been issued:

Program Announcement (PA) Number: PAR-10-174

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.855, 93.856, 93.242, 93.172, 93.209, 93.286

Key Dates
Release/Posted Date: April 21, 2010
Opening Date:  May 21, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May
21, 2010, April 10, 2011, April 10, 2012
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): June 21 2010, May 10, 2011, May 10, 2012
Peer Review Date(s): October 2010, October 2011, October 2012 

Council Review Date(s): January 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): March 2011, March 2012, March 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration/Closing Date: May 11, 2012

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 Education 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
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 Contacts
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


Research Education Objectives

Few developing country institutions provide formal education in research ethics, and few developed country programs for master’s level research ethics education/training focus in depth on the aspects of research ethics relevant to international resource poor settings.  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. Applicants are encouraged to collaborate with the following NIH ICs:  NIAID (http://www3.niaid.nih.gov/); (NIMH) (http://www.nimh.nih.gov/index.shtml); (NHGRI) (http://www.genome.gov/); (NICHD) (http://www.nichd.nih.gov/) and NIBIB (http://www.nibib.nih.gov/)    that are participating on this FOA regarding their programs supporting research in developing countries. FIC and the above participating ICs invite applications for International Research Ethics Education and Curriculum Development Program Award programs:

The goal of this initiative is to increase the number 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 master’s level training will enhance the career development of individuals from developing countries, as well as strengthen and sustain the capacity to support ethical clinical and public health research at their home institutions and countries. 

Proposed masters degree or non-degree masters level 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 pursue research on ethical practice in clinical and public health research in developing countries. 

Proposed comprehensive programs should contain a balance of master’s level didactic and practicum research ethics training experiences innovatively designed to build appropriate and sustainable research ethics capacity at developing country institutions.  Proposed curricula should provide a core set of masters level study courses that primarily focus on the internationally relevant aspects of ethical, legal and moral principles guiding the responsible conduct of research.  Proposed masters level curriculum may be delivered by interactive distance learning technology, if appropriate and sustainable for the developing country individuals and institutions involved.  Educational activities should 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.  Five year comprehensive training program applications should propose degree or non-degree master’s 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 training developing country academics such as ethicists or philosophers, researchers and health professionals working at institutions conducting clinical or public health research.  In addition:

Applicants are encouraged to collaborate with FIC research http://www.fic.nih.gov/programs/research_grants/index.htm and research training http://www.fic.nih.gov/programs/training_grants/index.htm programs or other NIH grantees working in the developing countries where trainees are recruited.  Applicants are also encouraged to collaborate with the following NIH ICs: NIAID (http://www3.niaid.nih.gov/); NIMH (http://www.nimh.nih.gov/index.shtml); NHGRI (http://www.genome.gov/);

NICHD (http://www.nichd.nih.gov/); and NIBIB ( http://www.nibib.nih.gov/) that are participating on this FOA regarding their specific research and research training programs.

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. The Project Director/Principal Investigator (PD/PI) (or multiple PD(s)/PI(s) if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed research education program.

This FOA uses just-in-time concepts (see SF424 (R&R) Application Guide). 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. 

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

Research education grant support is renewable.  It is recommended that applicants contact the scientific/research contact listed in Section VII concerning the submission of a renewal (formerly “competing continuation”) application.  Only one resubmission (formerly “revisions/amendments”) of a previously reviewed research education grant application may be submitted.  See NOT-OD-09-003 and NOT-OD-09-016.  

2. Funds Available

Because the nature and scope of the proposed research 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 and the participating ICs 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.

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. Although the size of award may vary with the scope of the research ethics education program proposed, it is expected that applications will stay within the following budgetary guidelines: 

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

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented and fully justified for the research education program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution, nor can they be used to circumvent or supplement funds provided to individuals supported by Ruth L. Kirschstein National Research Service Award (NRSA) programs.

Personnel: These requested expenses must be itemized in Sections A and B, as appropriate, of the Research & Related Budget.  Individuals (PD/PIs)  designing, directing, and implementing  the research education program may request salary and fringe benefits appropriate for the person months devoted to the program.  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 any costs associated with the mentoring and other interactions with students/participants are not allowable costs from grant funds).

Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

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).    

Individuals participating in the design and implementation of the research education program may request salary and fringe benefits appropriate for the person months devoted to the program.

Other Program-Related Expenses: These expenses must be itemized, as appropriate, in Sections C. (Equipment), D. (Travel), and F. (Other Direct Costs) of the Research & Related Budget.  Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses must be justified as specifically required by the proposed research education program and must not duplicate items generally available for educational programs at the applicant institution.

Participant Costs: Participants are those individuals who benefit from the proposed research education program.  In some instances, participants may be paid if specifically required for the proposed research education program and sufficiently justified.  Participant costs must be itemized in Section E. (Participant/Trainee Support Costs) of the Research & Related Budget.

Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program.  Graduate students, including health professional students, may receive compensation in accordance with the NIH policy for graduate student compensation (see: NOT-OD-02-017). Amounts for all participants must conform to the established, consistently applied salary and wage policies of the institution and reflect the percentage of time/effort devoted to the program.

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 (exclusive of tuition, fees, and equipment).

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Applications from foreign organizations and planning grant applications must be from 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).

Foreign Justification: If the applicant organization is a foreign institution or if the research ethics education project includes a foreign component, applications must provide a justification by describing special resources or characteristics of the project, whether similar projects are being conducted in the United States and whether there is a need for additional research ethics education projects in this area. For a definition of a substantial foreign component, see Definitions section of PHS 398, Part III: Policies, Assurances, Definitions, and Other Information. 

If multiple sites are involved in the research education program, the applicant institution must be the primary site for the program.  The need for and use of multiple sites must be justified.  

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research education program as the 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 should have documented experience in international research ethics and be capable of providing both administrative and training leadership to the development and implementation of the proposed research education program.

More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans 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 electronic Research Administration (eRA) Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the research education program, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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. The application should include a letter explaining the institutional commitment to the proposed research education program. (on page 20 under Institutional Environment and Commitment (component of Item 3) it states “A letter of institutional commitment must be attached at line item 14 (Letters of Support).

Participants: Describe who the intended participants are, and the eligibility and/or specific educational background characteristics that essential for participation in the proposed 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). Support can be provided for training developing country academics such as ethicists or philosophers, researchers and health professionals working at institutions in developing countries conducting clinical or public health research. (include in Research Training Strategy)

Advisory Committee:  An Advisory Committee should be established for comprehensive research educational programs and planning awards that include a majority of members not affiliated with the program.  The advisory committee should include representatives of potential participant developing countries involved in ethical review, training or monitoring of research.  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. (include in Research Training Strategy)

Evaluation and Dissemination Plan: Applications must contain an evaluation plan and a dissemination plan.  Applications submitted without Evaluation and Dissemination sections may be delayed in the review process or not reviewed.  (include in Research Training Strategy)

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

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Renewal applications are allowed for this research education program.

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, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an applicationSeveral 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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 Registered http://www.grants.gov/applicants/get_registered.jsp

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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the 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 for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SF 424 Research & Related Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

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 on 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, the  section of the Research Plan, entitled “Multiple PD/PI Leadership Plan”, must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the Research Plan should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the program 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 

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

Funding for the other institutions(s) must be requested via a subcontract to be administered by the primary institution.  When submitting a detailed budget, the primary 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.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  May 21, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 21, 2010, April 10, 2011, April 10, 2012
Application Submission/Receipt Date(s): June 21 2010, May 10, 2011, May 10, 2012
Peer Review Date(s): October 2010, October 2011, October 2012 
Council Review Date(s): January 2011, January 2012, January 2013
Earliest Anticipated Start Date(s): March 2011, March 2012, March 2013

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 (preferred) 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/applicants/apply_for_grants.jsp and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED.  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.

3.C. Application Processing

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR. Incompleteapplications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. 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 the 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. However, the NIH will accept a resubmission application, but such application must include an Introduction (limited to 3 pages) addressing the critique from the previous review.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) 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.

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.”

PHS 398 Research Plan Component Sections

Page limitations must be followed as outlined in the SF424 (R&R) Application Guide.

All application instructions outlined in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm) are to be followed, with the following requirements for R25 applications:

Research Education Program Plan (Item 3): The Research Education Program Plan must be uploaded using the Research Strategy section, and must include the following components:

Proposed Research Education Program (Component of Item 3): While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly describe the distinction between the intended participants in the proposed research education program and the research training supported by the training program.  The information should include a description of the education and/or career levels of the planned participants.  This section should contain information on steps that have led to the proposed research education program. 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: 

Institutional Environment and Commitment (Component of Item 3): Describe the institutional environment, including facilities and educational resources, that can contribute to the planned Research Education Program.  Evidence of institutional commitment to the research educational program is required.  A letter of institutional commitment must be attached at line item 14 (Letters of Support). Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program. 

Program Director/Principal Investigator (Component of Item 3): For multiple PD/PI Leadership Plan, see instructions for the Multiple PD/PI Leadership Plan section of the Research Plan. Describe arrangements for administration of the program and  can organize, administer, monitor, and evaluate the research education program, as well as evidence of institutional and community commitment and support for the proposed program.  Describe the proposed Program Director(s)’s experience in international research ethics scholarship, training, review and consultation in detail.

Program Faculty/Staff (Component of Item 3): Describe the characteristics and responsibilities of the participating faculty.  Describe the experience in international research ethics scholarship, training, review and consultation for each participating faculty. Applications should include letters from participating faculty stating agreement with the roles specified in the proposal, as well as their time commitment to specific proposed activities during the course of the proposed program.

Program Participants (Component of Item 3): Provide details about the pool of proposed participants, their qualifications, recruitment strategies and sources of applicant pool, etc.  Comprehensive education and masters level curriculum development program plans should also describe in detail each of the following processes:  candidate evaluation including criteria for selection, participant orientation activities, mentorship, and participant evaluation during program participation. 

Diversity Recruitment and Retention Plan (Component of Item 3):  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 Nation's 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. The NIH is particularly interested in encouraging the recruitment and retention of the following classes of participants:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americas, Native Americans, Alaskan Natives, Hawaiian Natives, and natives of the US Pacific Islands. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds who are defined as:

1.     Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such participants have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.     Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. 

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation. 

The FIC encourages the research training programs supporting developing country institution to consider ways to promote the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences in the developing country as trainees and faculty in the research training program.

Use the following instructions, rather than those for this section in the Instructions for SF424 Application

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.  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, NIAID, NIMH, NHGRI, NIBIB, and NICHD, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Applications without a diversity recruitment and retention plan will be considered incomplete and may be delayed in the review process or not reviewed. An award cannot be made if an application lacks this component.

Training in the Responsible Conduct of Research (Component of Item 3): Every participant supported by this Research Education grant must receive instruction in the responsible conduct of research. All Applications must include a plan to provide such instruction. The plan must address five components (format; subject matter; faculty participation; duration of instruction; and frequency of instruction) as detailed in NOT-OD-10-019.  Renewal (Type 2) applications must, in addition, describe changes in formal instruction over the past project period and plans for the future that address any weaknesses in the current instruction plan.  All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. 

Applications lacking a plan for instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process or not reviewed.  An award cannot be made if an application lacks this component.  The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019

An award cannot be made if an application lacks this component.

If such instruction is not appropriate for the proposed research education program, then the PD/PI must provide a strong justification for its exclusion.

(a)   Data Sharing Plan. Not Applicable

(b)   Sharing Model Organisms. Not Applicable

(c)   Genome Wide Association Studies (GWAS). Not Applicable

(d)   Research education programs: These 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 (if applicable) 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.”

Appendix (Item 16): 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. An application that does not comply with the required page limitations may be delayed in the review process.

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. 

SF 424 Research & Related Senior/Key Person Profile

Key Personnel must include the PD/PI (or multiple PDs/PIs) as well as any other key persons (such as those involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to the proposed research education program) participating in the research education program.

Research & Related Budget

Complete for each budget period requested.

A.    Senior/Key Person: complete for all senior/key persons associated with the research education program.  The PD/PI (or multiple PDs/PIs) must be included here.  Senior/Key Person: Name each senior/key person and the PI/PD associated with the international research ethics education and curriculum development program for whom salary is requested.  The salary level requested for the Principal Investigator and training faculty must be commensurate with the salary structure and benefits at the institution where they are employed. 

B.    Other Personnel: complete for all other personnel (including clerical and administrative staff) associated with the research education program.  Name each technical support, clerical and administrative staff for whom salary is requested. The salary level requested must be commensurate with the salary structure and benefits at the institution where they are employed. 

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 research education program. Funds to support the attendance of the PI/PD at the annual program network for the program at NIH should be requested.

E.    Participant/Trainee Support Costs: include here all allowable categories (e.g. tuition, stipends, travel, etc.) of funds requested to support participants in the research education program.  If categories in addition to those listed in this section of the 424R&R form are needed, describe in Other Direct Costs. Itemize and state the number of Participants/Trainees to be supported by each category in the proposed research education program. 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 research education program. Support of up to $10,000 per developing country participant in comprehensive training programs may be requested in this budget section for research ethics practicum projects of up to one year upon return to their countries after didactic training.  Renewal applications may request up to $50,000 to support activities with expenses itemized in this budget section to enhance and sustain the research ethics capabilities of previous trainees.

G.  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.

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

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the scientific peer review, all applications will:

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 developing country biomedical, behavioral, and clinical research needs.   The goals of NIH-supported science education projects are to provide public education and outreach on NIH-supported research at these institutions.

Research education program grant applications submitted in response to this funding opportunity announcement should be characterized by innovation and scholarship to the priorities and/or changing needs of the LMIC Instiutein 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).

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the research education program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed project).

Scored Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance. Does the proposed research education program address an important problem or critical question in research education or other critical issues as outlined in this funding opportunity announcement (FOA)?  How will implementation of the proposed program advance the objectives of this FOA?  If the aims of the education program are achieved, will they achieve the intended purpose of this FOA?  Does the proposed international research ethics education and masters level curriculum development program address relevant international research ethics issues? How will implementation of the proposed program advance the objectives of both NIH and FIC in building research ethics capacity in developing countries? Does the proposed program meet the needs for the international research ethics expertise of perspective developing country participants, their institutions and national governments?

Investigator(s).  Are the PD/PIs, collaborators, and other researchers appropriately trained and well suited to the proposed research education program? Is the PD/PI an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed research education program?  If Early Stage Investigator or New Investigator, does the PD/PI have appropriate experience to lead the program?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  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 contribute to the proposed international research ethics education program sufficient?  Do the program leadership members bring sufficient complementary and integrated expertise to the didactic and practicum components of the proposed program? Is there evidence that an appropriate level of effort will be devoted by the program leadership to ensure the program's objectives?

Innovation. Is the proposed research education program characterized by innovation and scholarship?  Does the proposed program challenge and seek to shift current research education paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Are the proposed concepts, approaches, methodologies, tools, or technologies novel for this area?  Does this proposed 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 research education 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. Is the research education program original and innovative? For example: Does the project challenge existing paradigms or 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 research education 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.

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed research education program?  Are potential problems, alternative strategies, and benchmarks for success presented?  If the program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  If called for in the FOA, is the proposed plan for evaluation and/or dissemination of the education program sound and likely to provide data on the effectiveness of the education program?  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?  If the program involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   Are the conceptual and practical research ethics education 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 ethics concepts and educational principles?  Is the approach feasible and appropriate to achieve the stated research education goals?  Does the proposed recruiting, application and selection process that captures the most qualified individuals who could most benefit from the education and training proposed, and immediately provide research ethics expertise and leadership to their institutions and countries after completing the program?  Do the proposed trainee sustainability plans include appropriate practicum experiences and other activities which will continue to enhance and sustain participant skills in ethical review of research, teaching research ethics, designing ethical research and consulting and publishing on research ethics issues and practices?  Do the roles of the proposed advisory committee provide sufficient support and oversight to the program?

Environment. Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the scientific/educational environment in which the program will be conducted contribute to the probability of success? Does the proposed research education 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)?

Additional Review Criteria 

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following: Has the research education program successfully achieved its stated objectives during the prior project period? Has the research education program successfully recruited a diverse pool of participants (if applicable)? Has the PD/PI effectively shaped the recruitment plan in response to recruitment outcomes? Has the program been innovative in the past and does it continue to demonstrate innovation?

Revision Applications.  When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.  If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Diversity Recruitment and Retention Plan:  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. 

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address the five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency) taking into account the characteristics of the proposed Research Education program.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.  Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. 

Applications from Foreign Organizations: When applicable, reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including; 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans: Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html); and 4) Research education programs: If support for development, maintenance, or enhancement of software is requested in the application, the reviewers will comment on the appropriateness of the proposed software dissemination plan.

Budget and Period of Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research education program and the number of proposed participants.

Dissemination Plan:  Is the dissemination plan strong and of high quality?

Selection Process

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:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., “Funding Restrictions.”       

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and  Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

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 research education program may not be transferred from one institution to another, unless strongly justified.

Consultation with the Institute 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 Institute may require peer review or may disapprove the request and, if appropriate, terminate the award.

The applicant must provide the following information to the Fogarty International Center 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 research education 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. 

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

The Progress Report should provide information on the development and implementation of the proposed research education program, modifications to the research education program as originally proposed, updates on the evaluation of the research education program and dissemination activities (if applicable), and a list of any publications and/or other materials arising from the research education program. To facilitate and standardize reporting, programs that involve participants should report on education in the responsible conduct of research and complete a Training Diversity Report, in accordance with the PHS 2590 additional instructions for preparing a Progress Report for an institutional training grant.

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 participants 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 Education 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.” 

Failure by the grantee institution to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm

Final Reports: A final Progress Report and Financial Status Report are required when an award is terminated. Evaluation results should be included as part of the Final Progress Report.

Statement of Appointment: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each participant appointed for eight weeks or more.  This form must be submitted to the awarding IC at or before the start of each participant’s appointment or reappointment   If registered in the NIH eRA Commons, grantees are encouraged to submit the PHS 2271 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/.  An appointment or reappointment may begin any time during the budget period, but not before the budget period start date of the grant year.

Termination Notice: Within 30 days of the end of the total support period for each participant, the institution must submit a Termination Notice (PHS Form 416-7) to the NIH for each participant appointed for eight weeks or more.  If registered in the NIH eRA Commons, grantees are encouraged to submit the PHS 416-7 data electronically using the xTrain system. More information on xTrain is available at https://commons.era.gov/commons/.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

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 Contact(s):

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/Grants Management Contact(s):

Elizabeth C. Cleveland
Grants Management Specialist
OD, Fogarty International Center, NIH
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892-2220
Phone # 301-451-6830
E-mail:
clevelande@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).

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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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/.


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