Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
Fogarty International Center (FIC), (http://www.fic.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
Title: PHASE II IICOHRTA AIDS/TB Research
Training Program (U2R)
This Funding Opportunity Announcement (FOA) is a reissue of PAR-08-155.
Update: The following update relating to this announcement has been issued:
Program Announcement (PA) Number: PAR-10-218
Notice: Applications submitted in response to the Funding Opportunity Announcement
(FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
A compatible version of Adobe Reader is required for download. For assistance downloading this or any Grants.gov application package, please contact Grants.gov Customer Support at http://grants.gov/CustomerSupport.
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.856, 93.279, 93.121
Release/Posted Date: June 18, 2010
Opening Date: July 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Date(s): July 16, 2010; July 16, 2011; July 16, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): August 16, 2010; August 16, 2011 (Suspended per NOT-TW-11-004); August 16, 2012
Peer Review Date(s): October 2010; October/November 2011; October/November 2012
Council Review Date(s): January 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): April 1, 2011; April 1, 2012; April 1, 2013
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: (Now Expired March 10, 2011 per NOT-TW-11-014), August 17, 2012
Due Dates for E.O. 12372
Table of Contents
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Dispute Resolution Process
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
1. Research Training Objectives
Purpose and Background: The Fogarty International Center (FIC), together with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Drug Abuse (NIDA), and the National Institute of Dental and Craniofacial Research (NIDCR), encourages renewal and new Phase II applications in the International Implementation, Clinical, Operations and Health Services Research Training Award for AIDS and TB (IICOHRTA AIDS/TB) program. Applications must propose, in an integrated manner, 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 HIV and/or tuberculosis implementation research. The proposed research training program must be developed and implemented collaboratively with all participating institutions (see Section III Eligibility Information).
The Program Director/Principal Investigator (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 PD/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.
Over the past decade, international efforts have supported the delivery of HIV and TB prevention, care and treatment to large populations in low- to middle income countries (LMICs). According to The Joint United Nations Program on HIV/AIDS (UNAIDS), over four million people are now on antiretroviral therapy for HIV infection through international efforts. However, this represents about 50% of adults and less than 40% of children who need treatment. With the new guidelines to begin HIV treatment at earlier point in infection, more adults and children need to be reached. Efforts to prevent HIV infections have not been as effective, and even interventions identified as efficacious in research studies have been difficult to scale up to reach the populations in need. UNAIDS estimates for every two people who are on treatment, five more people become infected. While progress is being made to address the burden of TB through efforts spearheaded by the Stop Tb Partnership, multi-drug resistant TB and a high incidence of new infections, particularly in the context of HIV infection, continue to fuel the TB epidemic. While research to identify new prevention, care and treatment interventions for HIV and TB is needed, more progress could be made to control the HIV and TB epidemics if known efficacious interventions could be more effectively implemented to reach larger populations in diverse settings. Implementation research addresses the gap that exists between the potential impact and the actual impact of known interventions on the targeted health problem in the real world.
In 2009, President Obama announced a six-year Global Health Initiative (GHI) (http://www.pepfar.gov/ghi/index.htm. GHI will focus on HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, maternal, neonatal and child health, nutrition, family planning and reproductive health, safe water and health systems strengthening. One of the GHI’s principles is promoting research and innovation, and implementation research is specifically identified as serving an important role in the GHI. GHI will build on the existing US government efforts in global health, including relevant FIC research and research training programs.
In 2002, the Fogarty International Center (FIC) recognized that sustainable HIV- and TB-related programs would need LMIC scientists and health professionals with critical problem-solving skills to overcome the implementation barriers as the prevention, care and treatment programs rolled out to scale in their countries. The International Implementation, Clinical, Operations and Health Services Research Training Award for AIDS and TB (IICOHRTA AIDS/TB) program provides support for training to strengthen the skills of scientists and health professionals in institutions in eligible LMIC to address the research agenda around the implementation of prevention, care and treatment interventions for HIV and/or TB to the population and health care system levels.
FIC has articulated bridging the “implementation science training gap” as one of five goals in the FIC Strategic Plan 2008-2012 (http://www.fic.nih.gov/about/plan/strategicplan_08-12.htm), and IICOHRTA AIDS/TB is one of the flagship programs in support of this goal. The design of this research training program was driven by another goal articulated in the FIC Strategic Plan: “to foster a sustainable research environment in low- and middle-income countries.” To move towards this goal, FIC changed the paradigm and put foreign sites in the “driver’s seat” in designing and implementing this research training program. This was done by designing a two phase program. The first phase began with planning grants awarded to LMIC institutions. Only the recipients of a Phase I planning grant and the U.S. partner institution chosen by the planning grant recipient (together referred to as Research Training Units) are eligible to apply for the five-year Phase II Comprehensive awards for their proposed implementation research training for the LMIC institution. The “implementation science” experts trained through the Phase II IICOHRTA AIDS/TB awards are expected to be drawn upon to facilitate additional training and research in the LMIC and in the region.
In addition, the IICOHRTA AIDS/TB program explicitly supports training to develop and extend “core research support” capabilities necessary for long-term sustainability of the research capacity of the LMIC institution. Core research support capabilities are defined as those skills required by an institution to successfully compete for research funding and conduct research.
The participating NIH ICs or other co-sponsors especially encourage training for research topics relevant to their missions. For more information, see the websites and contacts listed in this FOA and additional information below:
Special Program Objectives and Considerations: The objectives of the Phase II IICOHRTA AIDS/TB program are:
The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve oral, dental, and craniofacial health through research, research training, and the dissemination of health information. NIDCR will consider providing co-funding to grantees that identify and enroll trainees who are pursuing careers in basic, translational and/or clinical research in oral and craniofacial health aspects related to HIV infection. More information regarding NIDCR’s priorities in this field may be found at http://www.nidcr.nih.gov/Research/DER/IntegrativeBiologyAndInfectiousDiseases/AIDSImmuno.htm.
The mission of the National Institute on Drug Abuse (NIDA) HIV/AIDS Research Program focuses on the role of injection and non-injection drug use and their related behaviors in the evolving dynamics of HIV/AIDS epidemiology, natural history/pathogenesis, co-morbidities, treatment, medical consequences, and prevention. Under this partnership with FIC, NIDA will consider providing co-funding to applicants for research training and capacity building in all these facets of drug use as they relate to HIV/AIDS. More information regarding NIDDA’s priorities in this field may be found at http://www.drugabuse.gov/about/organization/arp/index.html.
The mission of the National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research—at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. NIAID will consider providing co-funding to grantees that identify and enroll trainees who are pursuing careers in basic, translational and/or clinical research in areas related to the basic biology of the HIV virus and the immune response as well as HIV/AIDS prevention and therapeutics, including the treatment of co-infections, such as tuberculosis. More information regarding NIAID’s priorities may be found at http://www.niaid.nih.gov/Pages/default.aspx
The Phase II IICOHRTA AIDS/TB program funds institutional research training awards that support training programs designed to strengthen the capacity of the LMIC institution to conduct independent research through the career development of individual researchers and key personnel. 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, current Trans NIH Plan for HIV-Related Research at http://www.oar.nih.gov/strategicplan/ and Global Health Initiative ¿
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 training can be in basic biomedical or clinical sciences; in behavioral or social sciences; in prevention research; in health services, operations or implementation research, and must directly support addressing the research agenda around the implementation of promising prevention, care and treatment interventions for HIV and/or TB to the population and health care system levels. Applicants are encouraged to design multidisciplinary research training programs. The proposed training is expected to strengthen sustainable research and core research support 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, but not limited to:
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.
Where appropriate, the design of training-related research projects should take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.
When a specific scientific course is given by one grantee, it is expected that this course may be widely publicized and open to trainees of the other grantee institutions under the IICOHRTA AIDS/TB program.
The IICOHRTA AIDS/TB 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.
1. Mechanism of Support
This FOA will use the U2R cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD(s)/PI(s) retain(s) the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PD(s)/PI(s), as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
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 U2R institutional research training application described in Section IV 6A.
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.
Each new Phase II IICOHRTA AIDS/TB applicant in a Research Training Unit may request a project period of up to five years and a budget for direct costs up to $275,000 dollars for the first year. The Phase II IICOHRTA-AIDS/TB applicants that comprise the Research Training Unit may request up to $550,000 in combined direct costs for each year. In the first budget year, the LMIC institution’s direct cost budget must be at a direct cost level equal to or greater than its linked US partner institution’s. The LMIC institution’s direct cost budget may increase in years two through five to reflect the increased capacity of the LMIC applicant to facilitate training and research. The LMIC institution’s direct cost budget may exceed $275,000 in years two through five, but the combined direct costs each year for the Research Training Unit (two linked awards) may not exceed $550,000.
Applicants in a renewal Phase II IICOHRTA AIDS/TB Research Training Unit may each submit an application requesting a project period of up to five years and a combined budget of up to $550,000 in direct costs for each year. The direct cost budget for the LMIC institution applicant in the Research Training Unit should be at least 60% of the combined budget. Alternatively, the LMIC institution in the renewal Research Training Unit may submit one application for the Research Training Unit in which the U.S. partner(s) are funded through a sub-award. In this situation, the budget submitted on the application may not exceed $550,000 in direct costs for each year and the combined sub-awards to any US institutions should not exceed 40% of the requested budget. Renewal applications with the US partner as the applicant and the LMIC institution as a sub-award are not allowed.
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.
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 the 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.
One-time advanced in-country research training support of up to $15,000 direct costs for mentored research to be undertaken by a long-term trainee in his/her country upon completion of their training.
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. Applicants may also budget for grant administrators, other faculty, collaborators and trainees 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 LMIC 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.
New applications for a Phase II IICOHRTA-AIDS/TB Award will only be accepted from LMIC institutions that were awarded a planning grant under a Phase I ICOHRTA AIDS/TB program announcement (http://grants.nih.gov/grants/guide/pa-files/PA-02-022.html; http://grants.nih.gov/grants/guide/pa-files/PAR-03-072.html) and the U.S. non-profit partner institution that the planning grant recipient has chosen. The LMIC and U.S. partner applicant institutions must have achieved a strong record of receiving or being significantly involved in HIV/AIDS and/or TB international research. Both the LMIC and U.S. partner institutions must demonstrate the capacity and leadership necessary for the successful implementation and long-term productivity of the program. LMIC applicant institutions should apply in collaboration with U.S. institutions capable of enhancing their proposed research training opportunities, and must name an individual at the proposed U.S. collaborating institution as the major collaborator.
Renewal applications will only be accepted from existing U2R ICOHRTA AIDS/TB recipients. Any changes in applicant institutions for U.S. partners need to be well justified.
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.
The proposed research training program must take advantage of on-going research at the LMIC institution. This research does not need to be NIH-funded, but it needs to be active and able to support the proposed research training program. Applicants from LMIC institutions must document on-going relevant research at the LMIC institution.
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 PI/PD in a new Phase II application from the LMIC institution is expected to be the PI/PD from the Phase I award. If more than one PD is designated on the LMIC institution application, at least one PD/PI must have been the PD on the planning grant award. Any changes in PD/PI in renewal applications of a Research Training Unit need to be well justified
The proposed 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 proposed 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. Applications from one partner in the Research Training Unit should name the institution and PD/PI of the other partner as a collaborator.
The PI 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.
The PD/PI and/or key personnel listed in the application must be designated as the PD of at least one research award that is directly relevant to the research training proposed and with at least 18 months of support remaining at the time of submission of the application.. The research grants may be funded by the NIH or by other national or international organizations. The research award made to U.S. applicants must involve the LMIC institutions named in the application, and the applicants need to document this existing research support in their application. 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.
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 LMIC institution in a fiscal year under this FOA. Only one U2R award will be made to an LMIC institution at any given time. Applicants are encouraged to check at their institutions and with FIC Scientific Research Contact listed in Section VIII. Agency Contact to confirm that there are not competing applications or existing awards in the IICOHRTA AIDS/TB program.
Resubmissions. Resubmission applications will be accepted. See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Such application must include an Introduction addressing the previous peer review critique (Summary Statement). (NOT-OD-09-003, NOT-OD-09-016).
Renewals. Renewal applications are allowed for this research education program.
Trainee Eligibility. In the context of this FOA, “trainees” should be from the LMIC for which the research training program is being designed.
A limited number of training opportunities may be provided LMIC individuals whose prior professional education does not include a bachelor's level degree (e.g., nurses, midwives, laboratory technicians, and administrative staff) without bachelor degrees, but with demonstrated interest and capability to contribute to research. However, the majority of research training provided under this award is expected to be to citizens of the LMIC at the master’s, doctoral or post-doctoral level.
The IICOHRTA AIDS/TB 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 trainees.
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.
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
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.
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.
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY: (301) 451-5936
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
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 Research Training Program Plan
PHS398 Training Budget Pages
SFS 424 Research & Related Budget Pages
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:
Applications with Multiple PDs/PIs
Multiple PD/PIs: 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 instructional information associated with the multiple PD/PI option is located in Section 8 of the Application Guide instructions 8.10.10 (multiple PD/PI Leadership Plan). For background information on the Multiple PD/PI initiative, see Multiple Principal Investigators.
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 Training Program 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 training program plan should be described, and should include communication plans, processes 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
See Section IV.3.A. for details.
3.A. Submission, Review and Anticipated Start Dates
Opening Date: July 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Submission Date(s): July 16, 2010; July 16, 2011; July 16, 2012
Application Due Date(s): August 16, 2010; August 16, 2011; August 16, 2012
Peer Review Date(s): October/November 2010; October/November 2011; October/November 2012
Council Review Date(s): January 2011; January 2012; January 2013
Earliest Anticipated Start Date(s): April 1, 2011; April 1, 2012; April 1, 2013
3.A.1. Letter of Intent
Prospective applicants are asked to submit, preferably by email, a letter of intent that includes the following information:
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, preferably by email, to:
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2C39
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: 301 402-0779
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.
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Please note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. 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 their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but only in response to an FOA for Phase II ICOHRTA AIDS/TB program and such application must include an Introduction (limited to 3 pages) addressing the critique from the previous 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.
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.
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information."
The applicants of the Research Training Unit are encouraged to submit identical research training program plans that describe a comprehensive implementation research training program. The applicants should specify roles and responsibilities of administration and faculty, resources, budgets and budget justifications for their individual components in their applications.
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.
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.”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 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.
Item 3. Inventions and Patents- This block is optional and only applicable for a Renewal application. If no inventions were conceived or reduced to practice during the course of work under this research training grant, check the No box. The remaining parts of the item are then not applicable. If any inventions were conceived or reduced to practice and supported by the research training grant, check the Yes box. If you checked the Yes box for Inventions and Patents, above, indicate whether this information has been reported previously to the PHS or to the applicant organization official responsible for patent matters.
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 and faculty 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 and NIH staff during peer review and 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.
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)
Program administration - The Training PD/PI must possess the scientific background and leadership and administrative capabilities required to coordinate, supervise, and direct the proposed research training program. The PD/PI will be responsible for the overall direction, management, administration, and evaluation of the program. The PD/PI must submit all required training information in a timely manner.
The program should have a Training Advisory Group (TAG) composed of expert faculty from the RTU partner 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.
In addition to the Instructions for SF424 Application Guide:
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.
Program Faculty - Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide.
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. 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 of the Instructions for SF424 Application Guide. 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 IICOHRTA AIDS/TB 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 Item 6 Progress Report below).
Proposed Training- The program should plan to provide didactic training and research experience relevant to the needs of the trainee and proposed duration of training. This should include processes for determining trainee prior experiences and for defining projected training needs and a plan to monitor progress to accomplish desired goals. For long-term trainees, the program should develop skills in understanding research, in applying their critical abilities to conduct research, in identifying problems in the process of conducting research, in raising questions and proposing solutions to resolve problems. Trainees should be prepared to utilize their research findings as they pursue future research. Programs should provide all long-term trainees with additional professional development skills and career guidance including instruction and training in grant writing in order to apply successfully for future career development and independent research support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.
Use the following instructions, rather than those for this section in the Instructions for SF424 Application Guide for Section 8.
Training Program Evaluation. In addition to the Instructions for SF424 Application Guide:
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 LMIC 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 LMIC 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 below). 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 below) 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 important criteria during any re-competition of this FOA.
Trainee Candidates – This section should describe the criteria, recruitment and selection procedures for trainees. The long-term goal is to build a critical mass of researchers and support staff with the combined expertise and skills to conduct research at the LMIC institution. The TAG should be included in this process. Criteria should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the program, and are likely to return and develop into productive independent researchers in their home country. The recruitment and selection process must be transparent. Applications must identify a major role of the collaborating institutions in the recruitment and selection plan.
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
Discuss plans to promote diversity relevant to the proposed LMIC, rather than those defined within the U.S. context.
Applicants should describe strategies for recruiting and retaining individuals from groups underrepresented in the LMIC workforce. Such strategies may address the representation of women and socially and economically disadvantaged persons, among others as trainees and faculty.
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)- For renewal application only. 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 foreign. Describe 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.
Appendix Materials (Item 15): Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). A summary listing all of the items included in the appendix is required, and should be the first PDF file. Applications that do not follow the appendix requirements may be delayed in the review process. All appendix material must be submitted as PDF attachments.
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 tables not requested in the SF424 (R&R) Application Guide instructions – designate these by letter, rather than number, to avoid confusion with the numbered required tables;
ii. Syllabi for key courses, core courses and electives, including courses in Responsible Conduct of Research, Survival Skills for Research, etc.;
iii. Retreat, seminar series, and other program activity agendas, rosters, and schedules;
iv. Examples of forms used to document trainee progress and monitoring by the program;
v. Examples of materials used in recruitment and particularly recruitment and retention to enhance diversity of the student pool.;
vi. Lists of meetings attended by students and their presentations;
vii. Student biosketches; and
viii. Letters of support, collaboration, and commitment of institutional resources.
Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.
Only the review criteria described below will be considered in the review process.
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.
Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
The applications for a Research Training Unit should be reviewed as a single unit.
As part of the initial merit review, all applications will:
The goals of NIH-supported research training, education, and programs 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 biomedical, behavioral, and clinical research needs of LMICs.
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 capacity of the partner LMIC institutions involved, in consideration of the following five scored review criteria, and additional review criteria as applicable for the research training 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 impact 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):
For renewal applications:
For applications that request short-term research training positions:
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 to assist you in determining if the Vertebrate Animals section is “Acceptable” or “Unacceptable”, please refer to Vertebrate Animals checklist.
Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the program.
Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. In addition, the committee will consider the following:
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.
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:
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.
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.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in
addition to, and not in lieu of, otherwise applicable OMB administrative
guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92
(Part 92 is applicable when State and local Governments are eligible to apply),
and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
2. A.1. Principal Investigator Rights and Responsibilities
The PD(s)/PI(s) will have the
primary responsibility for implementation of the integrated research-training
program. Training will take place at the U.S. or foreign sites and mentored research will be carried out
mainly in the LMIC. The program should also
provide support at the LMIC institution for training to develop and extend core
research support capabilities necessary for long-term sustainability of the
research capacity of the LMIC institution.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
2. A.2. NIH Responsibilities
An NIH Project Scientist [or “Project Coordinator,” or “Project Collaborator,” or “Intramural Scientist”] will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIH project scientists drawn
from NIAID, NIDA, and NIDCR will
be familiar with the scientific agenda of their institute, center or office and
will provide technical assistance, advice and coordination above and beyond the
normal program stewardship for grants.
The FIC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Attendance at annual program network meeting.
2.A.4. Dispute Resolution Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the RTU awardees, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
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 Requirements: Recipients 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 ICOHRTA AIDS/TB 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.
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):
Jeanne McDermott, C.N.M., M.P.H, Ph.D.
Division of International Training and Research
Fogarty International Center
31 Center Drive
Building 31, Room B2C39
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: 301 402-0779
2. Peer Review Contact(s):
Scientific Review Officer
Division of Neuroscience, Development and Aging
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 5132
Bethesda, MD 20892
Telephone: (301) 408-9164
FAX: (301) 594-6363
3. Financial/Grants Management Contact(s):
Ms. Elizabeth Cleveland
Grants Management Specialist
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-5710
FAX: (301) 451-6830
Required Federal Citations
Use of Animals
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.
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety
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).
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
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
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
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
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
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.
NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.
Standards for Privacy of Individually Identifiable
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.
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NIH Funding Opportunities and Notices
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