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Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
Office of Research on Women’s Health (ORWH), (http://orwh.od.nih.gov/)
National institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)

Title: PHASE II Comprehensive ICOHRTA AIDS/TB (U2R)

Announcement Type
This is a reissue of RFA-TW-06-005

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

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-08-155

Catalog of Federal Domestic Assistance Number(s)
93.989, 93.282, 93.865, 93.279

Key Dates
Release Date: April 22, 2008
Letters of Intent Receipt Date(s): July 19, 2008; July 18, 2009
Application Receipt Date(s): August 18, 2008; August 18, 2009
Peer Review Date(s): October/November 2008; October/November 2009
Council Review Date(s): January 2009; January 2010
Earliest Anticipated Start Date: April 1, 2009, April 1, 2010
Additional Information To Be Available Date (Url Activation Date):
Expiration Date: August 19, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Background

Over the past five years, international efforts have supported the delivery of HIV and TB prevention, care and treatment to large populations in low- to middle income countries (LMICs) through community and health services. These efforts are expected to expand even more in the future. Over 2.5 million people are now on antiretroviral therapy for HIV infection through international efforts supported by the World Health Organization, the President’s Emergency Plan for AIDS Relief (PEPFAR), the Global Fund for HIV, Tuberculosis and Malaria, the Clinton Foundation, and others. However, this represents less than 25% of the estimated number of people who need treatment. Efforts to prevent HIV infections have not been as effective and interventions, identified as efficacious in research studies, have been difficult to scale up to reach the populations in need. For every person who is on treatment, an estimated 4-8 people are becoming infected. Over 22 million people with tuberculosis (TB) have been treated since 1995 using Directly Observed Therapy (DOTS), but multi-drug resistant TB and 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. This dilemma is not new and has plagued family planning, child survival and safe motherhood efforts over the past three decades. Recently, the term implementation science has been introduced to mobilize the research community to reduce the gap that exists between the potential impact that proven interventions in clinical trials could make and the actual impact that they have on the targeted health problem in the real world. (1)

In 2002, the Fogarty International Center (FIC) recognized that, if the programs funded by PEPFAR, Global Fund, Stop TB Partners and others were going to be sustainable over time, countries would need scientists and health professionals with critical problem solving skills to overcome the implementation barriers as the prevention, care and treatment programs roll out and scale up in their countries. Now in its seventh year, the FIC International Clinical, Operations and Health Services Research Training Award for AIDS and TB (ICOHRTA AIDS TB) program provides support for training to strengthen the skills of scientists and health professionals in institutions in eligible LMIC, as defined using the World Bank classification system at http://www.worldbank.org/data/countryclass/classgroups.htm), to address 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.

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 ICOHRTA AIDS TB is one of the flagship programs in support of this goal. The ICOHRTA-AIDS/TB program extends and intensifies efforts to provide clinically appropriate and sustainable care and treatment to affected individuals in a manner that supports continuing and expanding prevention activities. This program strengthens the in-country capacity so that large-scale prevention, care and treatment interventions are locally relevant and effective. The research training involves a wide range of health professionals (e.g. nurses, midwives, physicians, dentists, health care administrators and public health workers). It reaches across the span of clinical science and public health practice to contribute to the development of new approaches and adaptation of existing methodologies to enhance implementation of optimal interventions.

The design of this 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, we needed to change 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 of the ICOHRTA-AIDS/TB program began with one-year planning grants (http://grants.nih.gov/grants/guide/pa-files/PA-02-022.html; http://grants.nih.gov/grants/guide/pa-files/PAR-03-072.html) awarded to 20 foreign institutions that provided resources to organize and execute an application for a full research training program in the second phase. 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 Phase II Comprehensive ICOHRTA-AIDS/TB awards (http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-03-003.html; http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-04-002.html; and http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-06-005.html). To date, Phase II awards have been made to partner institution in eight Research Training Units to support a research training program at the foreign partner institution and its in-country collaborators. The implementation science experts trained through the Phase II ICOHRTA AIDS TB awards will comprise a resource that can be drawn upon to facilitate additional training and research in the region.

In addition, the ICOHRTA AIDS TB program explicitly includes training to develop and extend core research support capabilities necessary for long-term sustainability of the research capacity of the foreign institution. Core research support capabilities are defined as those skills required by an institution to successfully compete for research funding and conduct research. The knowledge and ability to manage research grants require expertise in ethics and compliance issues, protection for human subjects, animal welfare, fiscal management, budgeting, program and grants administration, grant and report writing, preparation of scientific manuscripts, information technologies, technology transfer and management of intellectual property, data management, and Internet connectivity.

This announcement solicits renewal (re-competing) and new Phase II applications in the ICOHRTA AIDS TB program. The applications from both the Phase I recipient institution and its U.S. partner institution must propose, in an integrated manner, a comprehensive training program that will strengthen the capacity in the foreign country to conduct clinical research and implementation science focused on HIV infection, TB, and, where relevant, HIV/TB co-infection prevention, care and treatment.

Under this PA the following important terms are outlined:

Clinical research includes studies of interventions intended to prevent transmission or to improve the quality of life for HIV- or TB-infected children, men or women. This area of research involves, but is not limited to, research on biomedical, behavioral, or combination interventions, or the development of new technologies and methods to deliver, monitor, and sustain AIDS and/or TB prevention, care and treatment.

Implementation science is the scientific study of methods to promote the integration of research findings and evidence-based interventions into healthcare policy and practice. It seeks to understand the behavior of healthcare professionals and support staff, healthcare organizations, healthcare consumers, and policy-makers in context as key variables in the sustainable uptake, adoption, and implementation of evidence-based interventions. It is multi-disciplinary and includes operations and health services research, impact evaluation and modeling.

Operations research is defined as research that encompasses the translation of knowledge, practices, and technologies into clinical use. Examples include assessment of how to successfully implement existing and new prevention interventions, therapeutic tools, and other care interventions for broad-based use, and the study of barriers to such translation and implementation. When interventions have been shown to be successful on a small scale or in limited situations, operations research will help determine how best to generalize such interventions for widespread and sustainable use. Operations research includes studies or modeling of factors that influence the effectiveness of interventions in "real world settings"

Health services research includes studies that examine the organization, financing, management, and delivery of health services and how they impact a person's ability to utilize HIV and TB health services, including innovative strategies for providing therapy and care. This research also includes studies of quality, cost, and effectiveness of proven therapeutic or prevention interventions.

Impact evaluation is studies that document whether particular programs are actually responsible for improvements in social outcomes relative to what would have happened without them. (2)

Objectives

The objectives of the ICOHRTA AIDS TB program are:

Applicants are encouraged to review the relevant NIH Plan for HIV-Related Research available at http://www.oar.nih.gov/public/public.htm.

Training

Each Phase II Comprehensive ICOHRTA-AIDS/TB program application should incorporate an appropriate mix of long-, intermediate- and short-term training opportunities in a wide range of relevant disciplines and skills necessary to advance implementation science. The proposed training should strengthen sustainable clinical research and implementation science, including operations and health services research, and core research support capacity at the foreign site. Training can take place at the U.S. or foreign sites, but training-related research should be carried out mainly in the country of the foreign institution. While a range of short-, intermediate- and long-term training is allowable, emphasis will be on intermediate- to longer-term training, including mid-career training and advanced in-country research. In the context of this FOA, trainees are scientists from the LMIC identified in the application. The following types of training are included:

All training-related research projects in which trainees are involved under this award must be independently peer-reviewed through scientific review procedures established by the applicant institution, and have written evidence of documentation of education in the protection of human subjects for the trainee (see 8.9.5), compliance with the required federal citations, and approval from an institutional (or ethical) review board or committee at the foreign institution (and at the U.S. institution if the research is being supported under the U.S. award) and from the relevant government authority. 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.

When a specific scientific course is given by one Research Training Unit, it is expected that this course may be widely publicized and open to trainees of the other grantee institutions under this program

To a limited extent and with prior FIC approval, U.S. trainees will be eligible for foreign research experience under this cooperative agreement. To be eligible, they must have uniquely relevant expertise and skills that will contribute to the training, research, or administration at the foreign institution and have a major career commitment to international research.

The ICOHRTA-AIDS/TB program strongly encourages PDs to include women and individuals from underrepresented racial, ethnic or socially disadvantaged groups in the country as trainees and faculty at all sites.

References:

  1. Madon T, Hofman K, Kupfer L, Glass R. 2007 Implementation Science. Science 318: 1728-9.
  2. Evaluation Working Group, Center for Global Development. 2006. When Will We Ever Learn: Improving Lives through Impact Evaluation.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity announcement (FOA) will use the International Training Cooperative Agreement (U2R) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains 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 Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

Assuming funds are available, FIC intends to re-issue this funding opportunity after the initial award period.

2. Funds Available

The estimated amount of funds available for support of five-six new or renewal research training units awarded as a result of this announcement is $3, 000,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.

Each new Phase II ICOHRTA 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 Comprehensive ICOHRTA-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 foreign institution’s direct cost budget must be at a direct cost level equal to or greater than its linked partner institution s. The foreign institution’s direct cost budget may increase in years two through five to reflect the increased capacity of the foreign applicant to facilitate training and research. The foreign 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 ICOHRTA 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 foreign institution applicant in the Research Training Unit should be at least 60% of the combined budget. Alternatively, the foreign 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

Facilities and administrative costs are limited to 8% for all awards and sub-awards. The earliest anticipated start dates for awards are April 1, 2009.

Because the nature and scope of the proposed research 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

New applications for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will only be accepted from foreign institutions that were awarded a planning grant under Phase I ICOHRTA AIDS TB program announcement and the U.S. non-profit partner institution that the planning grant recipient has chosen. The foreign 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 foreign and U.S. partner institutions must demonstrate the capacity and leadership necessary for the successful implementation and long-term productivity of the program.

Renewal applications will only be accepted from existing ICOHRTA AIDS TB recipients. Any changes in applicant institutions for U.S. partners need to be well justified.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

More than one Program Director (PD), or multiple PDs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI (principal investigator) on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/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 PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The Program Director (PD) in a new Phase II application from the foreign institution is expected to be the PD from the Phase I award. If more than one PD is designated on the foreign institution application, at least one PD/PI must have been the PD is on the planning grant award. Any change will require pre-approval by FIC. The foreign PD and the U.S. partner PD will be responsible for the overall conduct of the integrated research-training program. The PDs at the foreign institution and at the U.S. partner institutions must have a track record of commitment and experience in related research and research training. Both the foreign and U.S. partner PDs must be directly involved in and funded to do research in resource-poor settings and there must be tangible evidence of very strong linkage to that ongoing research as collaborating partners. The PDs must hold faculty or other long-term research positions at a public or private non-profit research institution that will allow them adequate time and provide appropriate facilities, salary support and resources, including access to patients or patient data, when necessary.

Any changes in PD in renewal applications of a Research Training Unit need to be well justified.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit a resubmission application in response to a FOA for Phase II ICOHRTA AIDS TB, but such an application must include an Introduction addressing the previous peer review critique (Summary Statement).

Applicants may submit a renewal application in response to a FOA for Phase II ICOHRTA AIDS TB.

The partner institution may involve additional institutions through a subcontract or consortium arrangement.

Only one application for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will be allowed from any foreign institution in the ICOHRTA AIDS TB program. In situations in which more than one planning grant has been awarded to institutions in close proximity in the same country, applicants will be strongly encouraged to submit a single, integrated application for a Phase II award. Only one Phase II award will be made to any foreign institution in the ICOHRTA AIDS/TB program.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on lines 1 and 2 of the face page of the application form and the YES box must be checked.

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

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

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PDs/PIs. NIH requires one PD be designated as the contact PD/PI for all communications between the PDs/PIs and the agency. The contact PD must meet all eligibility requirements for PD status in the same way as other PDs/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

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/PIs Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research training 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 should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

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

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): July 19, 2008; July 18, 2009
Application Receipt Date(s): August 18, 2008; August 18, 2009
Peer Review Date(s): October/November 2008; October/November 2009
Council Review Date(s): January 2009; January 2010
Earliest Anticipated Start Date: April 1, 2009; April 1, 2010

3.A.1. Letter of Intent

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

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

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

Jeanne McDermott
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
Email: [email protected]

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing an Institutional Research Training Application, Including Ruth L. Kirschstein- NRSA Applications and the additional information in Section IV. 3.6. (http://grants.nih.gov/grants/funding/phs398/phs398.html) Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

3.C. Application Processing

Applications must be received on or before the application receipt/ date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Recipients must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Members of the proposed Research Training Unit must collaborate with each other to prepare similar or identical research training plans that describe a comprehensive research training program. The applicants of the Research Training Unit are encouraged to submit identical research training program plans that describe a comprehensive international clinical research and implementation science 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.

Follow the PHS 398 Instructions for Preparing an Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Applications with the additions or exceptions as noted below:

8.3 Description, Project/Performance Sites, Senior/key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Project/Performance Sites: List the applicant institution and all of the collaborating institutions as Performance Sites

Senior/key Personnel and Other Significant Contributors.

This PA/FOA allows Multiple Program Directors. List applicant institution PD and include all PDs as Senior/Key Personnel. At least ONE person at each of the collaborating institutions should be listed as senior/Key Personnel. If they are not a PD, list their role as Collaborator. Include 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.

Do not list faculty who will serve as mentors as Other Significant Contributors. See directions in Section IV. 8.9.3 a: Program Plan: Program Faculty.

8.4 Table of Contents

Use the substitute Table of Contents for Ruth L. Kirschstein-NRSA training grant application

8.5 Detailed Budget for Initial Budget Period

In place of the instructions in 8.5, use the following instructions for preparing Budget:

Develop a budget that reflects the resources necessary to implement the components of the comprehensive research-training plan included in your application. The budgets may include costs to support the various types of research training proposed (tuition, stipends, salary, travel, per diem) for trainees and faculty, and costs to support the administration of the program and grant. Adequate resources to meet U.S. government requirements for training and training-related research should be included in the budget.

Provide a detailed budget justification explaining how requested funds will primarily support LMIC trainees. All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages 4 & 5) in the appropriate categories. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 (budget form pages 4) in the appropriate categories. The total direct costs of the trainee participation budget should be identified on PHS Form 398 (budget form pages 4) in the "Other" category. The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Faculty Participation (budget form page 4)

Requested Salary Support: 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/guide/notice-files/NOT-OD-07-051.html.

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 staff at the grantee institution 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 U.S. faculty providing training at the foreign site.

Network Meetings: There will be an annual program network meeting to coordinate program activities, normally in the U.S., for which the applicant should budget. Principal Investigators are expected to attend. Applicants may also budget for grant administrators, other faculty, collaborators and trainees to attend.

Trainee Participation (NRSA substitute budget page 4)

Trainee Stipends: Trainees may be paid a stipend comparable to their professional experience in accordance with NRSA levels or grantee institutional policies while involved in medium- or long-term training at the grantee institution. Current NRSA stipend levels may be used as a guide and are described at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html.

Tuition and Fees for Trainees: Funds for tuition and academic fees at the U.S. or foreign institution may be requested. Programs are encouraged to seek cost-sharing arrangements with the grantee institutions in order to provide reduced tuition for trainees.

Note that health insurance is not included as part of this budget category, and is now included under Training Related Expenses category. Institutions are referred to the policy for funding of tuition, fees, and health insurance, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-093.html.

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.

Training Related Expenses: One-time advanced in-country research 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. Applicants are encouraged to budget adequate professional development (including, but not limited to, international scientific conference attendance) opportunities for trainees. Training-related expenses (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.

8.6 Budget for Entire Proposed Period of Support

In place of the instructions in 8.6, use the following instructions:

Use the Institutional Training Grant Substitute Form Page 5 for the trainee expenses and PHS Form 398 Budget form page 5 for administrative and faculty expenses and for the aggregated total direct costs for the trainee expenses.

8.7 Biographical Sketch

Include biographical sketches for the Program Director(s) and Other Senior/key Personnel contributing to the training program. This will include Collaborators and TAG members. Do not include bio-sketches for mentors as they are attached at 8.9.13 as Participating Faculty)

All Program Director(s) must be registered in the eRA Commons and must include the assigned Commons User ID.

8.8 Resources

Resources pages should be completed for all performance sites. Pertinent research resources and the educational environment including the options, if relevant, available for distance learning for the proposed training at the U.S. and partner country institutions should be described.

8.9 Research Training Program Plan

8.9.1 Introduction

If you are preparing a Resubmission (amended) application, prepare an Introduction section.

An unsuccessful application may only be re-submitted in response to a FOA for Phase II ICOHRTA AIDS TB Program.

Follow these directions for Sec 8.9.2-8.9.4
Note: Twenty-five page limit for Sec 8.9.2-8.9.6

8.9.2 Background

In addition, include the following in the Background:

Present a detailed assessment of the needs for the specific HIV- and or TB- related research training at the proposed LMI country institution(s). The assessment should identify specific gaps in clinical research and implementation science expertise, and adjunct skills needed to address the research agenda around the implementation of HIV-and or TB-related prevention, care and treatment interventions in the LMI country.

Describe how the proposed research training and capacity building will support the HIV/AIDS and/or TB-related clinical research and implementation science research priorities of the country of the foreign institution.

Explain in details the relevance of the proposed research training to the overall institutional development plan of the proposed foreign institution(s).

Provide documentation (Letters of Support in Section 8.9.15) by the institutions of a long-term commitment to strengthen HIV/AIDS and/or TB-related clinical research and implementation science through government support or other resources.

Describe the background of the research and training collaborations between the key personnel at the applicant institution(s) and any other proposed partner institution(s). Each site should provide a comprehensive list of these awards for at least the past five years to support its application.

Provide evidence that both partners of the research training unit collaborated in creating the research training development plan for the foreign site.

Identify areas of mutual interest between the country and the co-sponsoring NIH Institutes, Centers or Offices identified on the FOA.

Do not complete Tables 1 and 3. See 8.9.3 Program faculty for instructions for Table 2 Participating Faculty Members.

8.9.3 Program Plan

a. Program Administration.

In addition, include the following in the description of the Program Administrations:

Describe the composition and expertise of a Training Advisory Group (TAG) composed of expert faculty from the partner countries who are not directly involved in mentoring trainees. The TAG assist in trainee selection, scientific review of trainee projects, and evaluation of trainees and training program progress, the specific responsibilities of the group, and the processes for it to accomplish its responsibilities.

Describe in detail the internal procedures that will be put into place for all training-related research projects for:

Describe the procedures to assure that the research training program functions within the context of the collaborative relationship, including input from scientific and community advisory boards in the foreign country.

Multiple Program Directors

If more than one program director (multiple PDs) is proposed, explain your rationale for how this will facilitate program administration. You must complete the Multiple PD Leadership Plan requested in sec 8.9.11.

b. Program Faculty.

In addition, include the following in the description of the Program Faculty:

Describe the roles, responsibilities and commitments of the senior/key personnel from the partner institution(s) of the Research Training Unit. State what these individuals would actually do and their time commitments to the program.

Include a list of the other participating faculty and their scientific areas of interest at the applicant institutions in Table 2 and include bio-sketches in 8.9.13. Include a summary of the experience of the faculty in training pre-doctoral and post-doctoral trainees particularly trainees from LMI countries, with special mention of trainees from the country focus of the proposed program. Include a list of additional potential mentors and their scientific areas of interest, if appropriate.

Include letters from senior/key personnel and participating faculty defining their specific roles (such as mentoring and teaching) and time commitments in the proposed training program in 8.9.15.

In Table 4, include a list of the research grants in which the PDs, key or relevant faculty at the partner institutions have played a key role. Please include source of support and grant number (if applicable), grant title, project period and current year direct costs. Include PD if not the faculty member and role played by faculty member with Grant Title. Include Institution with faculty member name.

Provide a short description of the funded research in Table 4 and any other currently funded and future research that will serve as the research base for the proposed research-training program.

Do not complete Table 5

For Renewal applications only: In Table 6, only include publications in peer-reviewed journals, including local journals, from trainees who have been supported by one of the research training grants in the Research Training Unit in the ICOHRTA AIDS TB program and for which the grant was cited. These data constitute part of the Progress Report (see Section 8.9.6 Progress Report below).

c. Proposed Training.

In place of the instructions in 8.9.3c, use the following instructions

Describe the proposed research training program, including the goals, objectives and plan for meeting the objectives for this FOA.

Describe the plans for the integration of clinical research and implementation science, including operations and health services research, capacity building activities at the LMI country institution(s).

Describe how the proposed research training program may serve as a bridge among academic research, policy makers and public health communities to help to link the various HIV-and or TB-related research supported in the country by NIH and other sponsors with the HIV and or TB prevention, care and treatment programs (e.g., President’s Emergency Plan for AIDS Relief (PEPFAR), the Bill and Melinda Gates Foundation, the Global Fund for AIDS, TB and Malaria, the Clinton Foundation).

Describe an appropriate balance of research training options (degree-related and non-degree, long, medium and short term training) and disciplines to match the needs of the trainees and their LMI country institution.

Describe the plans for strengthening core research support capabilities necessary for long-term sustainability, such as the use of scientific literature, scientific writing and presentation, grant writing, bioinformatics, bioethics, good clinical practice, biosafety, data management, research administration, the management of intellectual property and English as a second language, if necessary.

Describe plans to include education in the inclusion of children, women and individuals from underrepresented racial, ethnic and disenfranchised groups in research in their country. 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.

Describe strategies that will be used to achieve a wider regional impact. This could be done by strengthening other institutions in the foreign country or in neighboring countries ("south to south" training). The ultimate goal is to become not only a national, but also a regional center of implementation science excellence that is capable of offering training in these areas, and in introducing appropriate technology to scientists from other countries. Pertinent research resources and the educational environment including the options available for distance learning for the proposed training at the partner and LMIC institutions should be described

d. Training Program Evaluation.

In addition, include the following in the description of the Training Program Evaluation:

Describe the system that will be used to track and document the long-term impact of this training program on the research capacity of the foreign institution(s).

Describe a plan for self-evaluation of the program, including a plan to track long- and medium- term trainees for at least five years after completion of their training. Data regarding trainees should be entered into the web-based Fogarty Trainee Tracking System, FIC Career Trac, when it becomes operational. Success of the trainees can be measured by the number and quality of publications, presentations, courses developed, professional awards, grant funding, career advancement and subsequent employment that demonstrates their sustained commitment to research careers in their home countries; their contributions to future international research collaborations and research training; their influence on the development and use of research findings in their countries; and their ability to act as consultants, teachers, collaborators and role models to other local investigators and further disseminate the lessons learned.

Evaluation metrics should eventually encompass both the success of the individual trainees and the impact of the program on research capacity at the foreign institution(s) and the establishment or strengthening of multidisciplinary research training capability in implementation science. An evaluation of the impact of research training resulting from each program will be considered an important criterion during any re-competition of this FOA. Applicants should establish some benchmarks and a mechanism to periodically review the progress of the trainees and the effectiveness of the 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.

e. Trainee Candidates.

In place of the instructions in 8.9.3e, use the following instructions

Training plans should describe in detail each of the following processes:

Trainee recruitment;

Trainee candidate evaluation and criteria for selection;

Pre-training orientation;

Trainee mentorship;

Trainee evaluation;

Post-training integration into the collaborating developing country institution's disease research activities; and

Dissemination of trainee research results to the relevant international scientific community and the clinical or public health sectors of the developing country

Describe the characteristics of the trainees you plan to recruit for each type of training proposed. Training may be offered to a wide range of scientists, including laboratory scientists, clinicians, social scientists, and other health professionals, as well as technical and administrative staff. The intent of all training proposed should be to build a critical mass of researchers and support staff with the combined expertise and skills to conduct research.

Provide a detailed description of the recruitment and selection procedures and criteria for the foreign doctoral and post-doctoral scientists and other beneficiaries of the research training program (short term trainees, workshop participants, etc). 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 develop into productive independent researchers in their home country. The recruitment and selection process must be transparent and widely advertised within the appropriate country. Applications must identify a major role of the partner institutions in the recruitment and selection plan

Degree candidates must meet all entrance requirements of the U.S. or foreign degree-granting institution. Thought should also be given to preparation of non-degree long-term trainees in English language and/or computer skills in the summer preceding studies in the U.S. or at the foreign site, where appropriate, to allow them to make optimal use of their formal training period. Fees for such courses are allowable costs.

This plan should include procedures for retaining students in the program until completion.

Describe strategies to encourage trainees to return to their home country. Trainees should be encouraged and mentored to apply for awards under the Global Health Research Initiative Program for New Foreign Investigators (see http://www.fic.nih.gov/programs/research_grants/grip/index.htm), the NIAID International Research in Infectious Diseases (IRID) Program (seehttp://grants.nih.gov/grants/guide/pa-files/PAR-07-376.html) and other relevant research grants.

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

8.9.4 Recruitment and Retention Plan to Enhance Diversity

Discuss plans to promote diversity relevant to the proposed LMI countries, rather than those defined within the U.S. context. Do not complete Tables 1, 7A, 7B, and 10.

Applicants should describe strategies for recruiting and retaining women and socially and economically disadvantaged persons as trainees.

8.9.5 Instruction in the Responsible Conduct of Research

8.9.6 Progress Report (Renewal Applications Only)

In place of the instructions in 8.9.6, use the following instructions:

You do not need to complete Table 11

Complete Table 6, 12A and 12B.

Describe how the research training has increased the research capacity of the institution(s) in the collaborating country(ies) to address the research agenda around the implementation of prevention, care and treatment interventions for HIV and TB;

Describe how you have been able to leverage other NIH or non-NIH program opportunities in the country(ies) as a result of the research training;

Complete Tables 12A and 12B. Describe the trainees, including country, training received, any degrees awarded, training-related research and post-training positions, assumed upon completion of training;

In Table 6, only include publications in peer-reviewed journals, including local journals, from trainees who have been supported by one of the research training grants in the Research Training Unit in the ICOHRTA AIDS TB program and for which the grant was cited.

Describe how the previous ICOHRTA AIDS TB awards of the Research Training Unit addressed the recruitment and support of women and socially disadvantaged groups within the population of the LMI country;

Describe the success of the program for the return of long-term trainees to their country of origin following the completion of their training, and a description of the strategies used by the program to maximize the number of trainees who return to their country of origin upon completing their training;

Describe how the returning trainees are using their research skills in implementation science to strengthen the research capacity of their country and influence policy decisions. Prior performance through impact will be an important criterion in the re-competition of this program. Examples of such impact include how training received under the program has allowed former trainees to more critically evaluate new and existing interventions and programs, how the training has helped them to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of HIV-related investigators or co-investigators, and publications authored or co-authored by trainees that were based upon support under this program;

Include a list of the research grants or other awards received by former trainees or in which former trainees are playing key roles;

Give examples of health policies that were influenced or implemented by trainees in their home countries.

8.9.7 Human Subjects

In place of the instructions in 8.9.7, use the following instructions:

Applicants should describe plans to meet the requirements related to the protection of human subjects in all training-related research. All training-related research projects in which trainees are involved under this award must be peer-reviewed through the Training Advisory Group. All trainees involved in human subjects research need documented evidence for education in the protection of human subjects for the trainee, compliance with the required federal citations, and approval from institutional (or ethical) review boards or committees at applicant and collaborating foreign institutions, and from the relevant government authority.

8.9.8 Vertebrate Animals

8.9.9 Select Agent Research

8.9.10 Literature Cited

8.9.11 Multiple PD Leadership Plan

8.9.12 Consortium/Contractual Arrangements

8.9.13 Participating Faculty Biosketches

8.9.14 Data Tables

Attach all Data Tables (1-12B) but complete only Tables 2 and 4 for all applications and complete Tables 6, 12A and 12B for renewal applications.

8.10 Checklist

8.11 Appendix

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

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

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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

2. Review and Selection Process

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 specify the roles, responsibilities and budgets of each of the partner institutions to achieve the proposed training program for the Research Training Unit. The applications will be reviewed as a single unit.

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

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

The goals of NIH supported research training are to increase the number of scientists and the capacity of institutions to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research training will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, a program director may propose a research training plan that by its nature is not innovative but is essential to provide relevant research training.

Significance: Does the proposed research training address an important problem in the country?

What is the expected contribution of the training program described in the applications of the Research Training Unit to the foreign institution s ability to conduct and manage integrated clinical research and implementation science, including operations and health services research, to address the priority problems for HIV and/or TB?

How will the research training increase the capacity of the foreign institution to serve as a training site to advance a continuum of clinical research and implementation science capacity within the country and within the region?

How does the proposed research training provide opportunities for trainees and junior faculty in the foreign institution to rise to scientific leadership positions in this or related programs?

Approach: Are the goals, objectives and strategies of the proposed research training program adequately developed, well integrated, well reasoned, and appropriate to the aims of this FOA?

Does the applicant acknowledge potential problem areas and consider alternative tactics?

Will the described training program provide breadth and depth of training opportunities in all of the needed research areas (clinical research and implementation science, including operations and health services research)? Will the described training program provide the trainees with the necessary administrative and management skills to compete for research support and conduct research?

Does the proposed mix of long-, medium- and short-term training achieve the goals of the training program while taking into consideration existing conditions and existing capacity at the foreign institution?

Will the proposed program develop a cadre of researchers with integrated clinical research and implementation science skills at the foreign institution?

Will the trainee recruitment and selection process capture the most qualified individuals who could most benefit from the training proposed to contribute to the research capacity of the foreign institution? Does it include culturally sensitive strategies to recruit an adequate representation of women, ethnic minorities and socially disadvantaged groups?

Is the process for matching trainees to appropriate mentors or instructors and research projects or needed research skills to fill recognized gaps in expertise adequate?

Is the process for scientific peer review of trainee research adequate?

Are there adequate plans to monitor trainee progress in acquiring academic and research skills, to support post-training integration into research at the LMI country institution(s) and to evaluate the long-term impact of the HIV-/TB-related clinical research and implementation science training program on the subsequent careers of the trainees and the research capacity at the foreign institution?

Innovation: Does the proposed research training program challenge existing paradigms of training and research in the foreign country?

Does the proposed research-training program incorporate concepts, approaches, methodologies, tools, or technologies that are new to the foreign institution?

Does the proposed training program take advantage of the foreign institution’s research infrastructure and of previous and current investments and support from FIC, NIH, CDC, USAID or other organizations, (e.g., President’s Emergency Plan for AIDS Relief (PEPFAR), the Bill and Melinda Gates Foundation, the Global Fund for AIDS, TB and Malaria)?

Investigators: Do the PDs, key personnel and faculty named in the applications for the Research Training Unit have the training and experience necessary to achieve the goals and implement the activities of the proposed training program?

How successful is the history of institutional and individual collaborations among the applicant PDs and key faculty at both institutions? A successful history of collaborations is demonstrated by funded research or training grants that include the PD at the foreign institution and the PD at the partner institution; by funded research or training grants that include both the faculty at the foreign institution and faculty at the partner institution; and by jointly authored publications in scientific peer-reviewed journals.

If multiple PDs are proposed, is the rational well justified? Is the leadership plan expected to be successful?

Will the research support of the program director(s) (including multiple PDs) and faculty be useful to the proposed research training plan?

Is the Training Advisory Group constructed to achieve the functions defined in this FOA?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is there written commitment by the foreign government and ministry of health and/or education or other officials to the long-term goals and activities of the program? Examples include:

Is there written commitment (agreement) by the foreign institution and its partner institutions to cooperate to achieve the long-term goals and activities of the program?

Are the mentoring resources and research-training environment at the applicant and at the partner institution(s) adequate to achieve the goals proposed in the application?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Instruction in the Responsible Conduct of Research: Is the plan outlined in the application for instruction in the responsible conduct of research adequate? (See 8.9.5 Plan Instruction in the Responsible Conduct of Research in the PHS 398 instructions)

Training in Protection of Human Subjects from Research Risk: Are the plans for training regarding the involvement of human subjects and protections from research risk relating to participation in the research adequate? Does the applicant have adequate procedures in place to meet the human subject’s protection requirements for training related research? (See the Research Training Plan section on Human Subjects in the PHS 398 instructions).

Training in Inclusion of Women, Minorities and Children in Research: Does the proposed training include content related to the inclusion of subjects from both sexes/genders, all racial and ethnic groups (and subgroups), and children in research? Does the applicant have appropriate procedures in place to evaluate the inclusion of these populations for the scientific goals of training-related research?

Training in Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the trainee projects, are the plans for training in care and use of animals in research adequate?

Training in Biohazards: If trainee research with materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, is the proposed bio-safety training adequate?

Additional Criteria for Renewal Applications

How has the training program strengthened the resources and the research training environment in the foreign institution?

What is the success of former trainees returning to their home countries and becoming independent researchers?

How have the former trainees demonstrated commitment and productivity in developing the research field in their countries? What research have they conducted as advanced in-country research and since completing their training? What faculty positions have they secured? How have they served as mentors for new trainees?

What has been the record of former trainees in obtaining individual awards such as fellowships, career awards, and research grants or as significant collaborators on other awards?

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

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 recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The Principal Investigator will have the primary responsibility for implementation of his/her portion 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 country of the foreign institution. The program should also provide support at the foreign site for training to develop and extend core research support capabilities necessary for long-term sustainability of the research capacity of the foreign institution.

Recipients 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 HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project 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 FIC, NIMH, ORWH, and NIDA 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.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. .

With the FIC program official, the NIH Project Scientists will form a Technical Advisory Group (TAG) for the ICOHRTA AIDS TB. The Technical Advisory Group: 1) reviews applications for responsiveness and, after the independent initial peer review, makes funding recommendations, and 2) meets once a year to review the progress of individual ICOHRTA-AIDS/TB Research Training Units and to make any recommendations. The FIC Program Official serves as the chair of the Technical Advisory Group.

2.A.3. Collaborative Responsibilities

Not applicable.

2.A.4. Arbitration 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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special arbitration procedure in no way affects the recipient'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.

3. Reporting

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

Recipients are expected to maintain data regarding their trainees in a trainee tracking system and report trainee publications and significant accomplishments to FIC in a timely manner.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jeanne McDermott
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive
Bethesda, MD 20892
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: [email protected]

2. Peer Review Contacts:

Sherry L. Dupere, PhD
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136
Bethesda, MD 20892-7840
Telephone: (301) 435-1021
FAX: (301) 480-3567
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Elizabeth Cleveland
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 451-6830
FAX: (301) 594-1211
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

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

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

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

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

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

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

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP recipients 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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