Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov)
World Health Organization (WHO) (http://www.who.int)

Components of Participating Organizations
John E. Fogarty International Center (FIC/NIH) (http://www.fic.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Center for Injury Prevention and Control (CDC/NCIPC) (http://www.cdc.gov/ncipc/)
Department of Violence and Injury Prevention and Disability Noncommunicable Diseases and Mental Health World Health Organization (www.who.int/violence_injury_prevention/)

Title:  Fogarty International Collaborative Trauma and Injury Research Training Program (TRAUMA) (D43)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of PAR-04-083.

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

Request for Applications (RFA) Number: RFA-TW-09-002

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 eight (8) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
 93.989, 93.136, 93.853, 93.273

Key Dates
Release/Posted Date: April 2, 2010
Opening Date:  May 8, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 8, 2010
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 Due Date(s):  June 8, 2010
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): October/November 2010
Council Review Date(s): January 2011
Earliest Anticipated Start Date(s): March 2011
Additional Information --To Be Available Date (Activation Date): Not Applicable
Expiration Date: June 9, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

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

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, 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


1. Research Training Objectives

Purpose and Background:

The Fogarty International Center (FIC), together with the National Center for Injury Prevention and Control (CDC/NCIPC), Department of Violence and Injury Prevention and Disability Non-communicable Diseases and Mental Health World Health Organization, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute of Neurological Disorders and Stroke, solicits renewal and new applications in the Fogarty International Collaborative Trauma and Injury Research Training Program (TRAUMA). The application must propose a collaborative research training program that will strengthen the capacity of institutions in low-and middle-income countries (LMIC), defined by the World Bank classification system, to conduct clinical, translation and implementation research on human trauma and injury research.

Trauma and injury encompass one of the leading causes of death and disability in the world, with the greater proportion of the burden falling in the developing world, where resources, both financial and medical, are sorely lacking.  Six of the 15 leading causes of death in people ages 15 to 44 in the world are trauma-related.  More than 5 million deaths per year are caused by trauma, intentional and unintentional.  In addition, trauma and injury are major contributors to disability.  In 1998, of the estimated 5.8 million people who died from injuries, approximately 1.2 million died from road traffic collisions and 2.3 million died from violence, including 948,000 by suicide, 736,000 from homicide and 588,000 from war.  The rest died from other injury-related causes, including falls, drowning, burns and poisoning.  For every person who dies of injuries, several thousand injured persons survive, but many suffer life-long health consequences.  The burden of disease attributed to injuries is expected to rise in the years ahead. It is projected that, by the year 2020, injuries will be the third leading cause of death and disability worldwide.  For people ages 5 to 44, trauma and injury account for at least 5 of the 15 most common causes of disability adjusted life years lost.  The 1999 CDC report of Traumatic Brain Injury in the United States:  A Report to Congress identifies traumatic brain injury as the leading cause of death and disability among children and young adults.  CDC also notes that worldwide, of all types of injury, those to the brain are among the most likely to result in death or permanent disability. 

The technical definition of an injury is "a bodily lesion at the organic level, resulting from acute exposure to energy (mechanical, thermal, electrical, chemical or radiant) in amounts that exceed the threshold of physiologic tolerance.  In some cases, for example, drowning, strangulation or freezing, the injury results from an insufficiency of a vital element."  Professionals in the injury field divide the causes of injuries into two categories:  "unintentional," which includes most injuries resulting from traffic accidents, burns, falls, and poisonings; and "intentional," which include injuries resulting from deliberate acts of violence against oneself or others.

Although injuries affect everyone regardless of age, sex, income or geographic region, some populations are more vulnerable than others.  Data indicate that, for most types of injuries, people die at a higher rate in LMICs and in the poorest sections of LMICs than in HICs.  The poor are at higher risk for injury because they are faced with hazardous situations on a daily basis.  For example, pedestrians on unsafe, overcrowded, and poorly maintained roads are vulnerable to being hit by cars, buses, or other vehicles.  People living in homes lacking safety devices and precautions are more vulnerable to the risk of fires and burns. 

While residents in resource-poor settings are at greater risk for trauma and injury than those in wealthier regions, it is not possible to simply transfer technologies from developed nations to developing nations because the context in which injuries occur is different.  For example, road traffic injuries (RTI) are the leading cause of injuries across the globe.  In HICs, changes in automobile engineering have contributed to a reduction in RTI morbidity and mortality.  In contrast, in LMICs, most of the injured do not own an automobile, making such technological changes of significantly less importance as protective factors.  Instead, other approaches such as road safety education become more important. 

Among the reasons why trauma and injury are so devastating in LMICs are inadequate systems of emergency care at both the community and hospital levels and inadequate infrastructure, such as paved roads, inequities in access to emergency response systems, as well as inequities in access to pre-hospital and hospital emergency services between urban and rural areas.  Other factors include constrained resources, need for enhanced administrative leadership in ministries of health due to poor recognition of the impact of trauma on national health, inadequate public education and public communication around injury prevention issues.  Compounding the problem is the fact that responsibility for injury prevention cuts across many administrative domains including public health, criminal justice, and road safety, among others.

The burden imposed by trauma and injury is not confined to the physical consequences of a single, acute event.  There is risk of significant mental health consequences associated with trauma and injury stemming from experiences such as child and elder abuse, criminal victimization, domestic violence, rape, torture, war, terrorism, natural and technological disaster.  In addition to psychiatric disorders such as post-traumatic stress disorder and depression, that can last for years, increased risk for severe functional impairment and disability creates a need for interdisciplinary researchers (e.g., public health, psychiatry, psychology, nursing, neuroscientists, biologists, prevention researchers, etc) to identify risk and protective factors for the development and dissemination of innovative models for the prevention and treatment of trauma related disorders and adverse functioning among children, adolescents and adults within the LMICs. Thus, there is a need for interdisciplinary researchers to address the broad spectrum of disorders associated with trauma and injury.

Occupational injury and trauma are also of great importance.  Of particular interest are industrial accidents as LMICs progress toward industrialization, as well as farm injuries, and violent acts.

This program solicits renewal and new applications to conduct research training on the diagnosis, prevention, and/or treatment related to injury and trauma in the LMICs. For this FOA, research training can include programs such as those related to prevention, treatment at the scene, emergency medical facilities and services, diagnostic imaging, post-acute care, and long-term care including rehabilitation.  Diagnostic procedures especially low-cost techniques could be evaluated.  Training may include topics such as low-cost surrogate technologies for CT and MRI Scan, ventilators, optimal resuscitation fluids, blood substitutes, and materials to cover wounds in burn victims and integration of psychosocial services with other systems providing assistance to victims. 

Special Program Objectives and Considerations: The objectives of this research training program include, but are not limited to:

1. Substantially increase the expertise of trainees from LMICs in human trauma and injury-related research including the scientific, clinical, legal, ethical and social requirements of trauma and injury research and to strengthen sustainable research within the LMIC institutions with an emphasis on interdisciplinary research. 

2.  Expand collaborative human trauma and injury research between HIC and LMIC scientists, nurses, bioengineers and imaging researchers.

3.  Provide a foundation for evidence-based and best-practice based guidelines in health care in LMICs.

4.  Increase the capacity of LMICs to plan for, adapt to and prevent the potential trauma-related consequences of climate change.

5Consider potential sex and race differences in the design and analysis, when possible.

Examples of research and training areas include, but are not limited to:

6.  Enhance the implementation of internationally validated interventions in specific LMIC contexts, and provide general lessons regarding the science of Dissemination and Implementation related to trauma and injury.

The program is not an individual training fellowship program.  The trainees are expected to contribute to the research capacity in the LMIC upon completion of their training.  Applicants are encouraged to review the FIC Strategic Plan (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm.)  This FOA responds to all five goals.

Applicants should design a training plan to fill specific gaps in human trauma and injury research expertise at the collaborating LMIC institution.  The end result should be a critical mass of scientists, nurses, and health professionals who will be able to conduct and sustain injury research at their institution. Proposals may incorporate a wide range of long- or short-term research training opportunities. 

A proposed training plan should include:

Applicants must address the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include an adequate representation of men, women and ethnic minorities or socially disadvantaged population groups among the LMIC trainees.

Types of Training: The program application should incorporate an appropriate mix of long-, medium- and short-term training opportunities to address the research training needs identified for the LMIC. The proposed training is expected to strengthen sustainable research capacity at the LMIC institution.  Training can take place in the U.S. or a foreign country, but training-related research should be carried out mainly in the LMIC.  While a range of short-, medium- and long-term training is allowed, emphasis will be on medium- to long-term training, including mid-career training and advanced in-country research. 

The following types of training are included:

All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the LMIC institution in which the research is being conducted.  Please see:  Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) at http://www.hhs.gov/ohrp/assurances/assurances_index.html.

The program strongly encourages principal investigator/program directors (PIs/PDs) to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as faculty at all sites.

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 D43 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses the non-modular budget format and “Just-in-Time” information concepts (see SF424 (R&R) Application Guide).   A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application, following the Instructions for preparing a D43 institutional research training application described in Section IV 6A.

2. Funds Available

Because the nature and scope of the proposed research training 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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

The expected amount for individual awards will be up to $ 200,000 per year (total direct costs) for up to ­five years.  Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.  Facilities and administrative costs are limited to 8% for all awards and sub-awards.

The estimated amount of funds available from all collaborative partners for support of an anticipated 9 projects awarded as a result of this announcement is $2,000,000 for fiscal year 2011. Future year amounts will depend on annual appropriations.

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.

2A. Allowable Costs

Stipends: Stipends are provided as a subsistence allowance for trainees to help defray living expenses during the research training experience.  Trainees may be paid a stipend comparable to their professional experience.  Applicants should use an appropriate stipend level and can use the NRSA levels (see Kirschstein-NRSA stipend schedule,) or grantee institutional policies for trainees involved in medium- or long-term training. Partial stipends for part time long-term trainees should reflect the amount of time they need to be supported for training in the budget and described in the budget justification.

Tuition and Fees: Funds for tuition and academic fees at the U.S. or foreign institution may be requested.  Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees. Note that health insurance is not included as part of this budget category, and is now included under Training Related Expenses category. Tuition and fees are excluded from the F&A base. Health insurance is included in the F&A base.

Trainee Travel:  Funds may be requested for round-trip economy class airfare on U.S. carriers (to the maximum extent possible).  Funds may be requested for lodging and per diem for short-term trainees. Funds may be requested to support participation in meetings in which current or former trainees will be presenting training-related research results.

Training-related Expenses: Applicants are encouraged to budget adequate professional development opportunities for trainees, including international scientific conference attendance.  Training-related expenses (e.g., books, computers, and courses for software, English language proficiency, etc.) may be included but must be described in the budget justification.  Funds for self-only or family medical insurance may be requested. Include costs for logistics for short- term courses and describe in budget justification.

Salary for Senior/Key Personnel: The salary for the PD, other training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://grants.nih.gov/grants/policy/salcap_summary.htm.

Collaborators may receive appropriate compensation for their significant activities on the program, such as recruitment and selection activities, as well as other program-related roles.  The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described. The salary and fringe benefits for the faculty and staff should not exceed 25 percent of total direct costs.

Faculty Travel: Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for the applicant to attend the annual program network meeting, normally in the U.S.  Principal Investigators are expected to attend. Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem for faculty providing training at the foreign site. 

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, equipment, and consortia costs in excess of $25,000, per NIH Grants policy for institutional research training grants http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part11.htm#_Toc54600212 

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 may be submitted by foreign institutions in LMIC or by eligible domestic (U.S.) institutions that demonstrate collaborations with institutions in the low- and middle-income countries ((LMIC), defined by the World Bank classification system) named in their application.  Taiwan is not listed in the World Bank income classification list but is considered high-income and therefore is not eligible. Hong Kong is listed as high-income in the World Bank income classification list, so is not considered a LMIC.

If no or minimal research activities are ongoing at the foreign site at the onset of the grant they must be developed within 2 years.  In this case there must be an active, U.S. government-funded research in the high-income country institution from the onset of the grant that can be used in the first years for the research training activities.  But it is expected that the research training activities will be developed within these 2 years and then will continuously increase at the foreign site.  In the last two years of the award it is expected that almost all of the research will be done in the foreign institution.

Applicants from U.S. institutions must propose collaborations with two foreign institutions in low- and middle-income countries and must name an individual at each foreign institution as the major foreign collaborator for that country.  Individuals chosen as major foreign collaborators should be scientists with whom the Principal Investigator or key personnel named in the application have had prior successful research collaborations.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training as the PD/PI is invited to work with his/her organization to develop an application for support. Women and individuals from underrepresented racial, ethnic and socially disadvantaged groups as well as individuals with disabilities are always encouraged to apply for NIH support.

The applicant PD/PI must have strong research and research-training program experience, should include the requisite faculty in the application, and have access to the requisite facilities to carry out the proposed research training activities.

The applicant PD/PI must name at least one individual at each collaborating institution as the major collaborator for that institution.  Individuals chosen as major collaborators should be scientists with whom the Principal Investigator or key personnel named in the application have had prior successful collaborations. These collaborations should be described in the application.

The PI and collaborators will be responsible for the overall conduct of the grant. The role of the collaborators in setting the research agenda and in conceptualizing and mentoring research projects should be described in the application.

All applicants should explain in detail how their relevant research grant support and activities are related to the proposed research training plan. 

More than one Training PD/PI (or multiple PD/PIs), may be designated on the application for research training programs that require a team approach and therefore clearly do not fit the single PD/PI model, e.g., interdisciplinary or multidisciplinary training.  The decision to apply with a single PD/PI or a multiple PD/PIs is the responsibility of the investigators and applicant organizations, and should be determined and justified by the goals of the training program.  Applications for grants with multiple PD/PIs require additional information.  When considering multiple PD/PIs, 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 PD/PI will be factored into the assessment of the overall scientific merit of the application.  Multiple PD/PIs on a program share the authority and responsibility for leading and directing the research training program, intellectually and logistically.  Each PD/PI is responsible and accountable to the grantee organization for the proper conduct of the program, including the submission of required reports.

Applications with multiple Training PD/PIs must provide a Leadership Plan that emphasizes how leadership by multiple PD/PIs will benefit the research training program and the trainees. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.  Because training programs are intended to be coherent a single award will be made.  NIH will not allocate the budget or training positions between multiple PD/PIs.  Multiple PD/PI applications should include reasonable numbers of PD/PIs and each should be included for a specific purpose.  Multiple PD/PI applications should not include all mentors of the training grant as PD/PIs, except in unusual cases.

Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI 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 PD/PI and/or at least one key personnel listed in the application must be designated as the PD or key personnel of at least one active (with at least 18 months of support remaining at the time of submission of the application) research award that is directly relevant to the research training proposed.  The research grants may be funded by the NIH, other U.S. government funding, or by other national or international organizations with pre-approval.  If 18 months will not remain in the parent grant award period at the time of application submission, an applicant must provide documentation that a renewal of a research grant to meet the eligibility requirement is expected, that a no-cost extension has been/will be requested for the research grant to meet the eligibility requirement and it will have sufficient remaining resources to continue the research project,  or that other research support will be available to meet the eligibility requirement.

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

Number of Applications. Only one application for an award may be submitted from an institution.  Only one TRAUMA award will be made to an institution at any given time.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewals applications are permitted in response to this FOA.

Trainee Eligibility.  In the context of this FOA, “trainees” should be from the LMIC for which the research training program is being designed.

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, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ 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 application.  Several of the steps of the registration process could take four weeks or more for U.S. institutions and even longer for foreign institutions. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 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 NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered  

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

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

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at: http://era.nih.gov/ElectronicReceipt/files/Tips_for_International_Applicants.pdf. http://era.nih.gov/ElectronicReceipt/files/international_support.pdf http://era.nih.gov/ElectronicReceipt/files/international_qa.pdf  http://era.nih.gov/ElectronicReceipt/preparing_grantsgov_reg.htm.

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 and in accordance with the SF424 (R&R) Application Guide for this FOA and additional instructions in this FOA (Section 6 below) through Grants.gov/Apply.

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)
SF424 Research & Related Project/Performance Site Locations
SF424 Research & Related Other Project Information
SF424 Research & Related Senior/Key Person Profile (Expanded)
PHS398 Cover Letter
PHS398 Checklist
PHS398 Research Training Program Plan
PHS398 Training Budget Pages
SFS 424 Research & Related Budget Pages

Optional Components:
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations (Non-domestic [non-U.S.] Entities)

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

Applications from Foreign organizations must:

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 plan approach for the proposed 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 project 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 project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date:  May 8, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): May 8, 2010
Application Due Date(s):  June 8, 2010
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): October/November 2010
Council Review Date(s): January 2011
Earliest Anticipated Start Date(s): March 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit, preferably by email, 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:

Xingzhu Liu, M.D., Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2-C39
Bethesda, MD 20892-2022
Telephone: (301) 496-1653
Fax: 301-402-0779
Email: liuxing@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

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). 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 and responsiveness by the IC. Incomplete and non-responsive applications 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.

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

Funds for continuation support beyond the initial year are determined by the success as described in the annual progress report, the timely submission of required forms, and the availability of funds for continuation programs.

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 NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

In order to be eligible, applicants must be the Principal Investigator or project director on an NIH, CDC, Department of Transportation Trauma Centers, or other U.S. Federal Government-supported “parent” research grant or training grant with appropriate infrastructure and interest related to trauma and injury topics, as outlined in the Research Training Objectives Section, with at least 18 months of active research support remaining at the time of application.  NIH- or CDC-sponsored research project grants (R series) or center grants, program project grants or cooperative agreements (P and U series) from one of the co-sponsoring NIH Institutes or Centers or from the CDC qualify as a parent research grants.  Equivalent research or related institutional research training grants from NIH, CDC or other sources may qualify as parent research grants if approved by the FIC program officer before submission of the application. 

The applicant training institution must demonstrate either an ongoing collaborative research relationship or high potential for development of collaborative research with the human trauma and injury researcher named as the primary foreign collaborator from at least one foreign institution.  The primary foreign collaborator must either hold a full-time faculty research position or should have a full-time faculty position with a strong research commitment.  The individual may be based at a public or private university, health professional school (including school of public health, dental school, nursing school or medical school) or research institution that will allow him or her adequate time and provide appropriate facilities and resources to participate in the proposed human trauma and injury research training program.

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

PHS398 Research Plan Component Sections

Follow the Instructions for SF424 Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) in  Section 8.  Supplemental Instructions to the SF 424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application  and the instructions below.  

SF 424 Research and Related (R&R) Cover Component

SF 424 R&R Project/Performance Site Locations Component - Include the applicant institution and all of the collaborating institutions, both U.S. and foreign) as performance sites.

SF 424 R&R Other Project Information Component:

SF 424 Senior/Key Person Profile (Expanded) Component –Also, include at least ONE person at each of the U.S. and foreign collaborating institutions as senior/Key Personnel and list their role as “Collaborator.”  List all members of the Training Advisory Group (See 8.9.3 a Program Plan: Program: Program Administration for a description of the Training Advisory Group) as Senior/Key Personnel and list their role as TAG member. Be sure to attach bio-sketches for the collaborators and TAG members. Attach current and pending support documentation for collaborators. 

PHS 398 Checklist

Budget Pages: Use PHS 398 Training Budget Pages for trainee specific expenses and the 424 R&R Budget pages for faculty and personnel-related expenses. Budget forms should be completed for each year (“Period”) for which funding is being sought. Follow the instructions below and refer to the relevant FOA specific allowable costs.  

Training-related expenses for Periods 1 through 5

Use PHS 398 Training Budget Pages

Part A. Stipends and Tuition/Fees

Use the following instructions for categorizing the trainees since each application will have trainees with a mix of educational backgrounds and a mix of proposed training.  Provide details of trainees in the budget justification and identify, by name, any continuing trainees.

NIH defines a Postdoctoral scholar as “an individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path (http://grants.nih.gov/grants/glossary.htm#P)”. 

Enter the number of trainees for degree training (master’s and doctoral level) in the section labeled “Predoctoral”, for those without a doctoral degree, (MD, PhD etc.). Request tuition for the degree program and a stipend level appropriate for the educational background of the trainee and location of training.

Enter the number of post doctoral trainees (prior doctoral degree) non-degree seeking and degree seeking as indicated. Request any necessary tuition and a stipend level appropriate for the educational background of the trainee and location of training.

Enter the number of trainees without a prior doctoral degree and who will receive non-degree training in the section labeled “Other.” Request any necessary tuition and a stipend level appropriate for the educational background of the trainee and location of training.

Current NRSA stipend levels may be used as a guide and are described at Kirschstein-NRSA stipend schedule, If a category contains different stipend levels, e.g., for varying levels of postdoctoral experience and/or varying appointment periods, itemize in the appropriate blocks. Enter the total stipends and tuition for all categories.  Partial stipends for part time long term trainees should reflect the amount of time they need to be supported for training in the budget and described in the budget justification.

Note that health insurance is not included as part of this budget category, and is now included under Training Related Expenses category.  

Part B. Other Direct Costs

Enter the total costs for Trainee Travel, Training Related Expenses, Total Direct Costs from R&R Budget Form and Consortium Training Costs (if applicable).

Consortium Training Costs (if applicable) -If training occurs at more than one institution, and any transfer of funds between institutions occurs, the Training Sub-award Budget Attachment Form should be used for each sub-award institution for each period for which trainee funding is being sought. (See Section 4.8 of the Grants.gov SF 424 R&R Application Guide).  Total the direct costs from each of the Training Sub-award Budget Attachment Forms for the period and insert here.  The applicant institution is responsible and accountable for any arrangements, expenditures, and submission of all required forms when more than one institution is involved in the research training program.

Use Section F to attach one pdf file with detailed budget justification for training costs for the applicant and any sub-award institutions.

Faculty and Other Personnel-Related Expenses

Use SF 424 R&R Budget Form, Periods 1 through 5

Use Section A to submit costs for Senior/Key personnel.

Use Section B to enter salary support for administrative staff.

Use Section D to submit costs for key personnel travel, including annual network meeting.

Use Section F for other costs and describe fully in budget justification. If consortium sub-awards include costs for faculty and administrative expenses, total these consortium costs for the period and include here.

Consortium Training Costs (if applicable) -If funding is sought for faculty and administrative costs at consortium institutions, SF 424 R&R Budget Forms should be used for each sub-award institution for each period for which trainee funding is being sought. (See Section 4.8 of the Grants.gov SF 424 R&R Application Guide).  Total the direct costs from each of the sub-award SF 424 R&R Budget Forms Budget forms for that period and insert here.  The applicant institution is responsible and accountable for any arrangements, expenditures, and submission of all required forms when more than one institution is involved in the research training program.  

PHS 398 Training Budget, Cumulative Budget - All values on this form are calculated automatically.  They present the summations of the amounts that you have entered previously, for each of the individual budget periods.  Therefore, no data entry is allowed or required. 

If any of the amounts displayed on this form appear to be incorrect, you may correct them by adjusting one or more of the values that contribute to that total.  To make any such adjustments, you will need to revisit the appropriate budget period form(s) to enter corrected values.

PHS 398 Research Training Program Plan Components

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

The instructions for the Data Tables required for this FOA have been adapted to the international focus of this FOA and are described below. The requested Data Tables ( http://grants.nih.gov/grants/funding/424/index.htm) should be included in the application at the point indicated (PHS 398 Research Training Plan, 13. Data Tables) and should not be inserted in the narrative for Sections 8.9.2-8.9.5. The information in the data tables will be used by reviewers during peer review and by NIH staff in reaching funding decisions.

Introduction (Item 1): Required for Resubmission applications

Background (Item 2): Provide the rationale for the proposed research training program; describe the relevant background and the need for the research training proposed. Indicate how the proposed program relates to current training activities at the applicant and collaborating institutions. Use this section to document the environment in which the proposed training program will take place.

Do not complete Tables 1 and 3.

For Table 2. Participating Faculty Members, include information relevant to the proposed training program for faculty from all participating institutions and performance sites who will be involved in the training program.

Program Plan (Item 3)

The program should have a Training Advisory Group (TAG) composed of expert faculty from the applicant and collaborating countries who are not directly involved in the training program or in mentoring trainees. The TAG assists in trainee selection, scientific review of trainee projects, and evaluation of trainees and training program progress.

If multiple PDs/PIs are involved in the research training program, applicants must describe how the research training program and trainees will benefit from the arrangement and include the required Leadership Plan. See Section III.1.B and Section IV.2 in this FOA for NIH multiple PD/PI instructions: Multiple Principal Investigators, and information in Section 8.7.10 of the Research Training Program Plan Component Instructions

This section should describe the past research training record of the program, the PD/PI, and designated preceptors/mentors.  Include a description of the success of former trainees, especially those from LMICs, in seeking further career development and in establishing productive scientific careers.

Complete per directions below and refer to data in Tables 4-6. Use these tables to document the ability of the faculty to support the research activities of the proposed trainees from LMICs and the success of their trainees in generating publishable research results.

Complete Table 4. Grant and Contract Support of the Participating Faculty Members, include a list of the active and pending research grants in which the PD/PIs, key or relevant faculty at the collaborating institutions have played a key role.  Include institution name with faculty member name. Please include source of support and grant number (if applicable), grant title, project period and current year direct costs. If the faculty member was not PI of the research grant, indicate who was the PI and the role of the faculty member in the Grant Title section.

In the narrative section, provide a short description of the funded research in Table 4 that will serve as the research base for the proposed research training program.  If relevant, clearly identify the grants that are being used for eligibility for this FOA in Table 4 and in the narrative.

Complete Table 5. Pre and Postdoctoral Trainees of Participating Faculty Members- Include trainee information who are from LMICs (indicate the country) for participating faculty from all collaborating institutions.

Complete Table 6 Publications of Research Completed by Trainees (or Potential Trainees). For new applications, see the instructions for Table 6 in Section 8.9.13. For renewal applications, only include trainee publications in peer-reviewed journals, including local journals, that have been supported by the research training grant in the (name) program and for which the grant was cited. Do not include abstracts, not yet accepted papers, or conference presentations and posters. These data constitute part of the Progress Report (see Section 8.9.6 Progress Report below). 

Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide for Section 8.

The application should describe the system that will be used to track and document the long-term impact of this training program on the research capacity of the foreign institution(s). Ideally, trainees should be tracked for at least ten years after completion of their training to assess the contribution of the training to their career development and the research capacity of the foreign institution. 

Include a plan for data entry of trainee information into CareerTrac, the web-based Fogarty Trainee Tracking System (see Section VI 3A Additional Reporting Requirements).  CareerTrac will facilitate the tracking of trainees and can be used to assist grantees to provide current trainee data and to describe examples of career highlights of former trainees (awards, research grants, publications, influences on policy, career advancements, etc.) in their annual progress reports.(see Section VI 3. Reporting) and in renewal applications.  

Applicants should develop a plan for self-evaluation of their program, and establish some benchmarks and a mechanism to periodically review the progress of their trainees and the effectiveness of their program.  This may consist of regular meetings among faculty participating in the program and periodic review by the TAG and other outside groups of consultants.

Evaluation metrics should eventually encompass measurement of both the success of the individual trainees and the impact of the program on research capacity at the LMIC institution.  An evaluation of the research training on individual and institutional levels will be considered an important criterion during any re-competition of this FOA.

Please use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide.

Do not complete Tables 7A, 7B, 8A, 8B, 9A and 9B.

Institutional Environment and Commitment to the Program: The administration of the applicant institution as well as all collaborating institutions should include information in the application that documents institutional support and commitment to the goals of the research training program. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD/PI and/or participating faculty, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the research training program.

Recruitment and Retention Plan to Enhance Diversity (Item 4): The NIH recognizes a unique and compelling need to promote diversity in the domestic biomedical, behavioral, clinical and social sciences 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.

The FIC encourages the research training programs supporting LMIC institution to consider ways to promote the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences in the LMIC 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

Plan for Instruction in the Responsible Conduct of Research (Item 5). For detailed guidance on Instruction in Responsible Conduct of Research, please refer to http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html and the Instructions for SF424 Application Guide.

Every trainee supported by this training grant must receive instruction in the responsible conduct of research. Describe the plan to provide trainees with such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction.  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 training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

Progress Report (Item 6): Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide.

This component is not part of the 25-page limit.  It should focus on describing the activities and accomplishments that occurred in the last grant period, but may include examples of career highlights of trainees from former grant periods that occurred in the last grant period (awards, research grants, publications, influences on policy, career advancements, etc.).  Data from CareerTrac can be used to assemble and report this information.

State the period covered and briefly describe the accomplishments of the training program. Describe any specific effects of this training program on curriculum and/or research directions in the collaborating institutions, both US and foreignDescribe how the research training has increased the research capacity of the institution(s) in the LMIC to address the research agenda around the priority health needs of the LMIC. Describe how you have been able to leverage other NIH or non-NIH program opportunities in the LMIC as a result of the research training.

You do not need to complete Table 11 Appointments to the Training Grant For Each Year of the Past Award

Complete Table 12A Predoctoral Trainees Supported by this Training Grant and Table 12B Postdoctoral Trainees Supported by this Training Grant.

Trainees without doctoral degrees who received medium- or long- term non-degree training should be included and the non-degree training they received should be defined on Table 12A.  Do not list short-term trainees (less than 3 months of training) on these tables.

CareerTrac will facilitate the tracking of trainees and can be used to assist grantees to provide trainee data for the progress report in the competing application and accompanying data tables.

NOTE: Renewal applications: Reporting of information on completion rate and time to degree for graduate students in doctoral degree programs that have been supported by NIH training awards must be documented in the Program Statistics section of Table 12A (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-141.html). Information must include:

Use the progress report narrative to provide information that is not readily presented in the required tables.

Follow the instructions in the SF424 Application Guide for items 7-12.

Data Tables (Item 13):  http://grants.nih.gov/grants/funding/424/index.htm. The instructions above provide guidance for completion of Data Tables 2, 4, 5, 6, which are required for all applications.  In addition, for renewal applications, Data Tables 12A and 12B must be completed,  using the instructions above. The information in the data tables will be used by reviewers and NIH staff during peer review and in reaching funding decisions. CareerTrac can be used to assist grantees to provide trainee data in the required data tables.

Attach one pfd file with all of the Data Tables (1-12B), although only Tables 2, 4, 5, and 6 are required for all applications, and, in addition, Tables 12A and 12B for renewal applications for this FOA.

Letters of support (Item 14): Attach appropriate letters here from all individuals listed as Senior/Key Personnel to confirm their roles in the project. Attach letters of support from all of the participating institutions.

Appendix Materials (Item 15):  Do not use the appendix to circumvent the page limitations of the Training Plan. Graphs, diagrams, tables, and charts should be included in the body of the Training Plan unless a PDF file is necessary to show detail.  All appendix material must be submitted as PDF attachments.  A summary listing all of the items included in the appendix is encouraged, but not required. When including a summary, it should be the first PDF file.  Applications that do not follow the appendix requirements may be delayed in the review process.

Research publications of trainees and mentors are not normally included as part of the Training Grant applications, but are allowed.  Other types of publications reflecting on the activities of the program as a whole may also be included.  When publications are allowed, appendix materials should be limited to those which are not publicly available, such as:

Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication. 

Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.

Some materials other than publications that are unique to training grant applications (but not typically included in research grant applications) may be included as appendices.  The appendix may be used to provide samples of materials that are referred to in the body of the application, but are too cumbersome to include in the Training Program Plan without disrupting the narrative flow.  Examples include: i) additional faculty CVs for very large programs; ii)  required lists of IRB and IACUC approvals of research protocols for research that may involve trainees and includes human subjects or vertebrate animals;  iii) additional tables not requested in the PHS 398 instructions – designate these by letter, rather than number, to avoid confusion with the required numbered tables; iv) syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.; v) retreat, seminar series, and other program activity agendas, rosters, and schedules; vi) examples of forms used to document trainee progress and monitoring by the program; vii) examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool;  viii) lists of meetings attended by students and their presentations;  ix) student biosketches; and x) letters of support, collaboration, and commitment of others than senior/key personnel and the participating institutions.

For materials that cannot be submitted as a PDF attachment, applicants should contact the Scientific Review Officer for instructions following notification of assignment of the application to a study section. Applicants are encouraged to be as concise as possible and submit only.

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 that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review (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 this FIC-supported research training are to help ensure that a diverse pool of highly trained scientists is available in adequate numbers and in appropriate research areas to address the LMIC’s biomedical, behavioral, and clinical research needs. The scientific review group will address and consider each of these criteria in assigning the application’s overall score, weighting them as appropriate for each application.  Reviewers will first determine the quality of the proposed research training program, including information presented in the data tables and appendix, and then consider whether the requested number of trainee positions is appropriate for the program and will strengthen the research capacity of the partner LMIC. 

Overall Impact

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

Scored Review Criteria 

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 scientific merit and contribute to the LMIC institution’s ability to conduct and manage research to address the priority problem(s) identified in the application.

Training Program and Environment:

Training Program Director/Principal Investigator (PD/PI):

Preceptors/Mentors:

Trainees:

Training Record:

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific 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.

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:

Additional Review Considerations

As applicable for the program 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: Peer reviewers will separately evaluate the diversity recruitment and retention plan (relevant to the proposed LMIC, rather than diversity as defined within the U.S. context ) after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences in the LMIC. Such strategies may address the representation of women and socially and economically disadvantaged persons, among others as trainees and faculty.

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 five Instructional Components, Format, Subject Matter, Faculty Participation, Duration and Frequency, taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019.  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.

Select Agents Research: When applicable, reviewers will assess the information provided in the application, including 1) the Select Agent(s) to be used in the proposed research training program, 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).

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 institutional research training and the number of proposed trainees at the requested levels.

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 Training PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons

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

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 (http://grants.nih.gov/grants/funding/2590/2590.htm), annually and annual financial statements as required in the NIH Grants Policy Statement.  This research training program is not subject to SNAP.

Follow the instructions for the Non-Competing Grant Progress Report for institutional research training grants in Form 2590. Use the budget pages in the PHS2590 that correspond to the budget pages submitted for the application to submit the budget for the next budget period. Use the instructions included in this FOA to guide you in requesting the budget for the next budget period.  Include a budget justification. Note that a summary of the trainee page is to be included in the request for continuation support. The non-competing budget page should list the names and levels of those trainees who are continuing in the research training program.  Tables 12A and 12B should be completed following the guidance provided in this FOA. The Trainee Diversity Report is not required. Additional information that should be provided in the annual progress report in concert with the PHS 2590 instructions includes:

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period.  Continuation support will not be provided until the required form is submitted and accepted.

Trainee Reporting RequirementsRecipients are requested to periodically update and maintain data regarding their trainees in FIC CareerTrac,  (https://careertrac.fic.nih.gov/Welcome.vm).

Peer-reviewed trainee publications that arise from support of the training grant must be submitted to PubMed Central in accord with the Public Access Policy, and the PubMed Central reference number (PMCID) or NIH Manuscript Submission reference number (NIHMS ID) provided. If the publication was already submitted because it also arose as the result of other NIH support, simply provide the PMCID or NIHMS ID. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at:http://publicaccess.nih.gov/submit_process_journals.htm

Publication and Sharing of Research Results:   NIH supports the practical application and sharing of outcomes of funded research.  Therefore, trainees should make the results and accomplishments of their research training activities available to the research community and to the public at large.  The grantee organization should assist trainees in these activities, including the further development of discoveries and inventions for furthering research and benefiting the public.  No restrictions should be placed on the publication of results in a timely manner.

Trainees are encouraged to submit reports of their findings for publication to the journals of their choice.  For each journal publication that results from a trainee’s research, NIH support should be acknowledged in language similar to the following:  “This investigation was supported by the Fogarty International Center, (add NIH co-sponsoring institutes, centers or offices for the grant) of the National Institutes of Health under the (name of program) (grant number).”  In addition, news releases and other documents about the project must acknowledge federal funding as provided in “Public Policy Requirements and Objectives-Availability of Information-Acknowledgment of Federal Funding.”

Evaluation:  In carrying out its stewardship of human resources-related programs, the NIH may request information essential to an assessment of the effectiveness of this Program.  Accordingly, trainees should be notified that they may be contacted after the completion of their training for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the research training program.

Inventions:  Traineeships made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required for institutional training grants.  However, please report any inventions or patents funded under the research training grant.

Copyrights:  Except as otherwise provided in the terms and conditions of the award, the recipient is free to arrange for copyright without approval when publications, data, or other copyrightable works are developed in the course of work under a PHS grant-supported project or activity. Any such copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the Government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal Government purposes.

Final Reports:  A Final Progress Report and Financial Status Report are required at the end of the grant project period or upon relinquishment of an award.  Evaluation results should be included as part of the Final Progress Report.

Human Embryonic Stem Cells (hESC):  Only approved hESC lines listed on the NIH Human Embryonic Stem Cell Registry http://stemcells.nih.gov/registry/ may be used for research training activities. The abstract of the application must provide the registry identifying numbers of the HESC lines to be used.

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):

Xingzhu Liu, M.D., Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2-C39
Bethesda, MD 20892-2022
Telephone: (301) 496-1653
Fax: 301-402-0779
Email: liuxing@mail.nih.gov

2. Peer Review Contact(s):

Sherry Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC-7840
Bethesda, MD 20892-7840
Telephone: (301) 435-1021
Fax: 301-480-3567
Email: duperes@csr.nih.gov

3. Financial/Grants Management Contact(s):

Ms. Angela Smith
Grants Management Specialist
Fogarty International Center
Building 31, Room B2C29
Street Address:  31 Center Drive 
Bethesda, MD 20892

Telephone: (301) 402-9592
FAX: (301) 594-1211  
Email: smitha2@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan: Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions, on issues related to institutional policies and local 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 new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-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. Applications that do not provide this information will be returned without review.

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 (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 287b) and under Federal Regulations 42 CFR 63A, 42 CFR 52 and 45 CFR Parts 74 and 92.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm

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

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


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