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)

Title: Phase II Comprehensive ICOHRTA-AIDS/TB (U2R)

Announcement Type
This is a reissue of RFA-TW-04-002, which was previously released July 28, 2004.   

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

Request For Applications (RFA) Number: RFA-TW-06-005

Catalog of Federal Domestic Assistance Number(s)
93.989 (FIC), 93.242 (NIMH)

Key Dates  
Release Date: February 21, 2006
Letters of Intent Receipt Date(s): April 27, 2006
Application Receipt Dates(s): May 25, 2006
Peer Review Date(s): October/November 2006
Council Review Date(s): February 2007
Earliest Anticipated Start Date: June 1, 2007
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: May 26, 2006

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(s) 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

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

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

The Fogarty International Center (FIC) and its co-sponsoring institutions invite Phase I awardees under the International Clinical, Operational and Health Services Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) program to submit applications for Phase II ICOHRTA-AIDS/TB awards.  The ICOHRTA-AIDS/TB program will develop research training programs at eligible institutions in low- and middle-income countries (as defined using the World Bank classification system at http://www.worldbank.org/data/countryclass/countryclass.html), where HIV/AIDS, tuberculosis (TB) or both are significant problems, that strengthen the skills needed to design and conduct AIDS and TB research for the scale-up of promising interventions to the population and health care system level.  Co-sponsoring institutions are U.S. Government (USG) agencies contributing financial resources to the ICOHRTA-AIDS/TB program. 

The first phase of the ICOHRTA-AIDS/TB program began in fiscal year 2002 (FY02), with one-year planning grants (PA-02-022; PAR 03-072) to institutions in low- and middle-income countries (identified as foreign institutions in this RFA) to organize and execute an application for a full research training program to be awarded under the second phase (Phase II Comprehensive ICOHRTA-AIDS/TB).  This RFA is the solicitation for applications for Phase II.  Only the recipients of the Phase I planning grants and the U.S. or other high-income country  partner institutions which the Phase I awardee has chosen (together referred to as Research Training Units) are eligible to apply for Phase II Comprehensive ICOHRTA-AIDS/TB awards.  The Phase II awards to the Research Training Units will provide support to each partner institution for the development of the skills at the foreign institution needed to conduct research to identify effective interventions pertinent to the global health crises created by HIV/AIDS and/or TB in their country and to identify successful strategies to successfully implement these evidence-based interventions on a large scale.

The training supported under Phase II awards of the ICOHRTA-AIDS/TB program will help to produce a cadre of experts at the foreign institution who will conduct clinical, operational, and health services research for the benefit of people, particularly in low- and middle-income countries.  These experts will comprise a resource that will be drawn upon to facilitate additional training and research in the region.  The ICOHRTA-AIDS/TB program will extend and intensify efforts to provide clinically appropriate and sustainable care to affected individuals in a manner that supports continuing and expanding prevention activities.  This program will strengthen the in-country capacity so that large-scale prevention, treatment and care interventions are locally relevant and effective.  The research training will reach across the span of clinical science and public health practice and involve a wide range of health professionals (e.g. nurses, midwives, physicians, dentists, health care administrators and public health workers).

The program will also provide support for the development and extension of 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 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.

Under this RFA:

The applications from both the foreign institution and its U.S. or other high-income country partner institution must propose, in an integrated manner, a comprehensive training program that will strengthen the capacity in the foreign country to conduct clinical, operational, and health services research focused on one or more of the following areas:

The approach and plan for clinical, operational, and health services research training should be directly relevant to the needs of the people in the foreign country and be appropriate to local circumstances and most likely to affect public health policy.  Also implicit is the need to rapidly strengthen the research training capacity and infrastructure required for success by building on existing research and research training programs involved with the implementation of prevention and care interventions at the country level.  In addition, an important capacity building component is to strengthen core research support capabilities needed to manage research grants at the foreign institution..

Each Phase II Comprehensive ICOHRTA-AIDS/TB program application should incorporate a number of long-, intermediate- and short-term training opportunities in a wide range of relevant disciplines and skills necessary to advance research objectives.  The proposed training should strengthen sustainable clinical, operational, and health services research and core research support capacity at the foreign site and include advanced in-country research.  Training will take place at the U.S. or foreign sites and 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.  This approach will accelerate building enduring capability for clinical, operational, and health services research and core research support at the foreign institution.

In the context of this RFA, “trainees” are scientists from the low- and middle-income country identified in the application.  The following types of training are included:

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

Applicants are encouraged to review the NIH FY2007 Plan for HIV-Related Research available at http://www.nih.gov/od/oar/public/public.htm

Organization of the ICOHRTA AIDS/TB Program

The ICOHRTA AIDS/TB program is a cooperative network of Phase I and Phase II grantees and co-sponsoring institutions.  A Technical Advisory Group and a Steering Committee provide guidance and management of the ICOHRTA-AIDS/TB Program.

The Technical Advisory Group is a committee of advisors with relevant expertise from the USG co-sponsoring institutions (at least one from each co-sponsor) and  Program and Grants Management Officials from the FIC.  The Technical Advisory Group:  1) reviews applications for responsiveness and, after the independent initial peer review, makes funding recommendations, and 2) meets several times per year, as necessary, to review developments across the ICOHRTA-AIDS/TB program as well as the progress of individual ICHORTA-AIDS/TB Research Training Units and the planning grant recipients.  The FIC Program Official serves as the chair of the Technical Advisory Group.

The Steering Committee is composed of the Principal Investigators from each of the Ph II Research Training Units, the FIC Project Scientist, and one additional representative from the Technical Advisory Group.  The FIC Grants Management Official serves as a consultant to the Steering Committee on budget and grants-related issues.  The Steering Committee provides oversight across the ICOHRTA AIDS/TB program and serves as the central point for communication and exchange of ideas regarding research training activities and resolution of any problems, as necessary.  A chairperson who is not a USG employee will be elected by the committee to serve a one-year term.  The Steering Committee will meet at least once annually and will participate in telephone, video or electronic conferences, as needed.  Each member of the Steering Committee will have one vote.

It is anticipated that each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an advisory committee, composed of two or more USG scientific advisors designated by the Technical Advisory Group and a grants management expert, as needed.  The Research Training Unit Advisory Committees will assist the work of the ICOHRTA-AIDS/TB program by providing advice and assistance that is coordinated through the FIC Program Official to the Research Training Unit.  The advisory committees of the Research Training Units assists in such matters as reviewing the progress reports of each partner of the Research Training Unit and suggesting mid-course corrections and future directions.  The Technical Advisory Group with advice from the Steering Committee determines the membership of the individual advisory committees.  Research Training Unit advisory committee members maintain ongoing communication regarding the progress of the Research Training Unit, attend meetings of the ICOHRTA-AIDS/TB program, whenever possible, and meet as an advisory committee separately at least once per year.

The FIC Program Official, as the program representative of the FIC, chairs the Technical Advisory Group.  The FIC Project Scientist as the scientific representative of FIC is a member of the Steering Committee.  The FIC Program Official has lead responsibility for day-to-day program stewardship in coordination with the Technical Advisory Group and the Steering Committee.

The FIC Grants Management Official, as the grants management representative of the FIC, is a member of the Technical Advisory Group and a consultant to the Steering Committee.  The Grants Management Official will serve as a resource in policies and issues related to NIH grants management to the planning grant awardees and the ICHORTA-AIDS/TB Research Training Units.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U2R award mechanism(s) to provide funding to both the foreign research training institution and to its linked partner institution.  F & A costs are limited to eight percent for both Research Training Unit partners.  The applicant organization’s administration must provide the necessary management for the transfer of funds and material to collaborator(s) and any sub-contracts (consortium).  Sub-contracts (consortiums) may only charge eight percent F & A costs of applicable direct costs.  .

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U2R is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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".  At this time, it is not known if this RFA will be reissued but, subject to availability of funds and overall progress in the program, the intent is to reissue the RFA for at least one more competition, thus allowing recipients of 2005 and 2006 Phase I planning grants an opportunity to apply for Phase II awards, and for unsuccessful Phase II applicants to submit amended applications. 

2. Funds Available

The Fogarty International Center and its co-sponsoring partners intend to commit approximately $1.2 million in FY 2007 to fund two to four (one to two Research Training Units) new grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs up to $275,000 dollars per year.  The two Phase II Comprehensive ICOHRTA-AIDS/TB applicants that comprise the Research Training Unit (which consists of a foreign institution and its linked partner institution) may request up to $550,000 in direct costs for each year.  Each of the applicants can request up to $275,000 in direct costs in year one but 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 should 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 direct costs each year for the Research Training Unit (two linked awards) may not exceed $550,000. 

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 and the receipt of a sufficient number of meritorious applications.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

Applications for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will only be accepted from foreign institutions that have been awarded a Phase I ICOHRTA-AIDS/TB planning grant and the U.S. or other high-income country non-profit partner institution that the planning grant awardee has chosen.  The foreign and partner applicant institutions must have achieved a strong record of receiving or being significantly involved in HIV/AIDS and/or TB international research.  Each site should provide a comprehensive list of these awards for at least the past five years to support its application.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 programs.

The Principal Investigator (PI) in the Phase II application from the foreign institution is expected to be the PI from the Phase I award.  Any change will require pre-approval.  The foreign PI and the partner PI will be responsible for the overall conduct of the integrated research-training program.  Both the foreign and partner institutions must demonstrate the capacity and leadership necessary for the successful implementation and long-term productivity of the program.  The Principal Investigators at the foreign institution and at the partner institutions must have a track record of commitment and experience in related research and research training.  Both the foreign and partner PI 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 PIs 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.

FIC strongly encourages applications from women and individuals from underrepresented racial, ethnic and socially disadvantaged groups in the country.  Where appropriate, the design of 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. 


2. Cost Sharing or Matching

The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Partner institutions may be non-U.S. institutions from high-income countries provided that the partner institution has special resources that uniquely contribute to this program.  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 response to this RFA.  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) 435-0714, Email: GrantsInfo@nih.gov.

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 line 2 of the face page of the application form and the YES box must be checked.

RFA-TW 06-005 PHASE II COMPREHENSIVE ICOHRTA AIDS/TB

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Use the NRSA substitute page for the Table of Contents.

Members of the proposed Research Training Unit must collaborate with each other to prepare similar or identical research training plans.  In place of the research plan, the two applications from the Research Training Unit partners should describe a comprehensive international clinical, operational, and health services research training program and should address the following areas in their applications (25 page limit):

1. A description of the training plan, describing the goals, objectives and plan for meeting the objectives for this RFA.  A description of the plans for the integration of clinical, operational, and health services research capacity building at the foreign institution should be included.

2. Documentation by the institutions of a long-term commitment to build the clinical, operational and health services research capacity of the foreign institution through governmental-support or other resources.  A copy of their agreement must be included with the Phase II applications.

3. Evidence that both partners of the Research Training Unit collaborated in creating a research training development plan for the foreign site and demonstrated a description of how this plan supports the overall institutional development plan of the foreign site.  The U.S. or other high-income country applicant must describe how its component of the linked program is designed to help build the research capacity at the foreign site.

4. The application should clarify the roles, responsibilities and commitments of the foreign and partner institutions and should state what the individuals listed would actually do and their time commitments to the program. The application should include letters from participating faculty defining their specific roles (such as mentoring and teaching) and time commitments in the proposed training program.  Include a list of the other potential mentors and their scientific areas of interest at the applicant institutions.

5. A description of the background of the research and training collaborations between the key personnel at the applicant institution and the proposed partner institution.

6. Descriptions of the PI's funded research and any other currently funded and future research that will serve as the research base for the proposed research-training program.  Include a list of the research grants funded in the last five years in which the PIs, key faculty at the foreign institution or relevant faculty at the partner institution have played a key role. Please include grant number (if applicable), title, PI, role played by key personnel, institution, funding period, funding amount and funding agency.

7. A description of how resources from this award will be integrated with other resources at the foreign institution or within the country to achieve the overall goals of this program: building sustainable research capacity at the foreign institution. Applicants are encouraged to describe their plans for dissemination of training materials, as well as other coordination efforts, to other FIC research training programs in low-and middle-income countries.  Pertinent research resources and the educational environment including the options available for distance learning for the proposed training at the institutions should be described.

8. Plans for strengthening core research support capabilities necessary for long-term sustainability. 

9. A description of how this program will serve as a bridge among academic research, policy makers and public health communities to help to link the various HIV/AIDS and/or TB research with the care programs supported in the country by NIH and other sponsors.

10. A description of how the proposed research training and capacity building supports the HIV/AIDS and/or TB-related clinical, operational, and health services research priorities of the country of the foreign institution.  Applicants should describe the procedures to assure this takes place within the context of the collaborative relationship, including input from scientific and community advisory boards in the foreign country.  The applicant should identify areas of mutual interest between country and the co-sponsoring institutions (e.g., HIV-related opportunistic infections, HIV malignancies, neurological and mental health consequences, behavioral issues, cardiovascular disease, hematologic conditions, blood safety, pulmonary manifestations, ophthalmologic manifestations, gastrointestinal conditions, drug and alcohol usage, potential sex and gender differences in physiology and behavior, and oral health manifestations).

11. A description of how their programs will relate to any community advisory boards in the foreign country and how the training program will strengthen the capability of these community advisory boards

12. A description of strategies 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 clinical, operational, and health services research 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 low- and middle-income country institutions should be described

13. A detailed description of internal peer review for training-related and advanced in-country research.

14. A plan for meeting the requirements related to the protection of human subjects in all training-related research. The definitions of research and human subjects are included in the Code of Federal Regulations, Title 45 part 46 (45CFR46) at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.   Please see http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm for decision trees to determine involvement of human subjects.  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 both the U.S. and foreign institutions 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.

15. Plans to provide education in the responsible conduct of research, including the protection of human subjects, to all long- and medium-term trainees and to short-term trainees involved in research.  For more information on this provision, see pg 61 of the NIH Guide for Grant and Contracts (http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).  Applications must describe a program to provide formal or informal instruction in research integrity and/or the responsible conduct of research.  Although NIH does not establish specific curricula or formal requirements, all programs are strongly encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects.  Within the context of training in scientific integrity, it also is beneficial to discuss the mutual responsibilities of the institution and the trainees participating in the program.  Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance requirements, and the frequency of instruction.  The rationale for the proposed plan of instruction must be provided. Information on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation applications.

16. A detailed description of the recruitment and selection procedures and criteria for the foreign doctoral and post-doctoral scientists and other beneficiaries of the training program (short and intermediate term trainees, workshop participants, etc) as, for example, by a committee composed of investigators at participating institution(s).  This 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.  The recruitment and selection process must be transparent and widely advertised within the appropriate country(ies).  Applicants should describe strategies for recruiting and retaining women and socially and economically disadvantaged persons as trainees.  Applications must identify a major role of the Partner institutions in the recruitment and selection plan.  This plan should include procedures for retaining students in the program until completion.  Degree candidates must meet all entrance requirements of the U.S. or foreign degree-granting institution.  Thought should also be given to preparation of medium- to 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.

17. A description of strategies that applicants will implement to encourage trainees to return to their home country.  Encouragement and support to trainees to apply for awards under the Global Health Research Initiative Program for New Foreign Investigators (see http://www.fic.nih.gov/programs/GRIP.html), the Fogarty International Research Collaboration Award (http://grants.nih.gov/grants/guide/pa-files/PAR-05-072.html; (http://grants.nih.gov/grants/guide/pa-files/PAR-05-073.html) and other relevant NIH research grants are expected.  

18. 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.  Awardees will be required to track and document the long-term impact of this training program on the capacity in clinical, operational and health services research of the foreign institution(s).  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.  An evaluation of the impact of training resulting from each program will be considered an important criterion during any re-competition of this RFA.  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 or periodic review by an outside group of consultants.

19. Plans to include education in the inclusion of children, women and individuals from underrepresented racial, ethnic and disenfranchised groups in research 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. 

20. Evidence of sustained host-country support for the program is required.  Such evidence of support should be provided in writing and should be in the form of the following:  (a) a statement of support from a senior administrator at the foreign PI's institution, evidence of contributions from the host-country and willingness of the host-country to utilize trainees' experience and knowledge gained from the program to build integrated clinical, operational, and health services research capacity at a center of research excellence in the foreign country; and (b) a formal letter of support from the Health Ministry and/or other senior government official that emphasizes the long-term commitment of the country to the goals of the proposed program.

21. Evidence of plans for linkage to and coordination with other sources of research and training support in the foreign country is required, including how these fit into the institutional development plans of the foreign institution.  Examples include:

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 27, 2006
Application Receipt Date(s): May 25, 2006
Peer Review Date: October/November 2006
Council Review Date: February 2007
Earliest Anticipated Start Date: June 1, 2007

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 at the beginning of this document.

The letter of intent should be sent to:

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center
31 Center Drive, MSC 2220
Building 31, Room B2C39
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: mcdermoj@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. 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).

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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 the CSR and responsiveness by the Fogarty International Center and ICORHTA-AIDS/TB Technical Advisory Group.  Incomplete and non-responsive 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 review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

Allowable Costs

Applicants should develop a budget that reflects the resources necessary to implement the components of the comprehensive research-training plan included in their application.  The budgets may include costs to support the various types of training proposed (tuition, stipends, salary, travel, per diem) for trainees and faculty, and costs to support the coordination 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.

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 & 5) in the appropriate categories.  The total direct costs of the trainee’s budget should be identified on PHS Form 398 (budget form pages 4 & 5) in the "Other" category.  The combining of the budget figures will allow reviewers and FIC staff to review a composite budget of all costs.

Stipends

Tuition and Fees

Trainee Travel

Training Related Expenses

Personnel

Consultant

Travel

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 competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements
Not Applicable

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

The most important factor to be considered in making funding decisions will be the quality of the proposed project as determined by peer review and responsiveness to the review considerations.  The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made.  In addition, FIC, in consultation with co-sponsoring organizations, will attempt to ensure a reasonable balance of scientific issues of the research training, as well as geographic balance.

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are 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 will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance:  Does the proposed research training address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of the proposed research training on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  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, operational, and health services research?  What is the expected potential of the foreign institution to serve as a training site to advance a continuum of clinical, operational, and health services research and public health capacity within the country and within the region?

Approach:  Are the goals, objective and strategies of the proposed research training program adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Will the described training program provide breadth of training opportunities for the research trainees in all three of the research areas (clinical, operational, and health services)?  Does the proposed mix of long-, medium- and short-term training achieve the goals of this RFA while taking into consideration existing conditions and existing capacity at the foreign institution?  Will the described training program provide the trainees with the necessary administrative and management skills to compete for research support and conduct research?  Will the proposed program develop a cadre of clinical, operational and health services researchers at the foreign institution?  Will the proposed training program strengthen the capacity at the foreign institution over the life of the grant to develop degree programs and to provide opportunities for trainees and junior faculty to rise to scientific leadership positions in this or related programs?  Does the integrated application demonstrate coordination between the research training activities of the linked applicants and coordination and linkage with other related in-country research, training and public health programs?

Innovation:  Is the proposed research-training program original and innovative?  For example: Does the proposed research training program challenge existing paradigms of research training; address an innovative hypothesis or critical barrier to progress in the field?  Does the proposed research-training program develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  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?  Does the proposed training program take advantage of relevant opportunities in other countries?

Investigators:  Do the foreign PI, the partner PI and key personnel named in the integrated application have the training and experience necessary to achieve the goals and implement the activities of the proposed training program?  Documentation should include: 

Does the research training team bring complementary and integrated expertise to the project? How successful is the history of institutional and individual collaborations among the applicant PIs and key faculty at both institutions?  A successful history of collaborations is demonstrated by funded research or training grants that include the PI at the foreign institution and the  PI 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.

Environment:  Does the scientific environment in which the proposed research training will be done contribute to the probability of success?  Does the proposed research training benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? 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?  Will the proposed training program take advantage of unique features of the scientific environment in the foreign country and to employ useful collaborative arrangements with other USG, other government and non-governmental agencies active in addressing issues related to HIV/AIDS and/or TB and their associated conditions in the country?  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?  Will the trainee recruiting and selection process capture the most qualified individuals and include an adequate representation of men, women and individuals from underrepresented racial, ethnic or socially disadvantaged population groups of the country(ies) among the trainees?

2.A. Additional Review Criteria:
Not Applicable

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.

2.C. Sharing Research Data
Not Applicable

2.D. Sharing Research Resources
Not Applicable

3. Anticipated Announcement and Award Dates

Applicants will be notified of the status of their application by e-mail from the FIC Program Official after the FIC Director approves the funding plan.

Section VI. Award Administration Information


1. Award Notices

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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.

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.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 (U2R), 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 above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for implementation of its 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.  The Principal Investigators will be expected to be active members of the Steering Committee. 

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 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 FIC Program Official, designated in the Notice of Grant Award, will be responsible for the normal programmatic stewardship of the award.

The FIC Project Scientist will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond the normal program stewardship for grants.  The FIC Project Scientist will be familiar with the scientific agenda of FIC and co-sponsoring U.S. agencies and will facilitate coordination of training across these programs. 

The FIC Project Scientist will:

The Technical Advisory Group is a committee of advisors with relevant expertise from the USG co-sponsoring institutions (at least one from each co-sponsor) and the Program and Grants Management Officials from the FIC.  The Technical Advisory Group:  1) reviews applications for responsiveness and, after the independent initial peer review, makes funding recommendations, and 2) meets several times per year, as necessary, to review developments across the ICOHRTA-AIDS/TB program as well as the progress of individual ICOHRTA-AIDS/TB Research Training Units and the planning grant recipients.  The FIC Program Official serves as the chair of the Technical Advisory Group.  The Technical Advisory Group will provide guidance to the Research Training Units as part of the overall ICOHRTA-AIDS/TB program.

Each Research Training Unit in the ICOHRTA-AIDS/TB Program will have an advisory committee, composed of two or more USG scientific advisors designated by the Technical Advisory Group and a grants management expert, as needed.  The Research Training Unit Advisory Committees will assist the work of the ICOHRTA-AIDS/TB program by providing advice and assistance that is coordinated through the FIC Project Scientist to the Research Training Unit.   

The FIC Grants Management Official will serve as a resource to the Research Training Units in policies and issues related to NIH grants management.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award.   The assigned Program Official may also serve as the FIC Project Scientist and may be substantially involved as described above.

2.A.3. Collaborative Responsibilities

The Steering Committee is composed of the Foreign Principal Investigator and the Partner Principal Investigator from each of the Research Training Units, the FIC Project Scientist, and one additional representative from the Technical Advisory Group.  The FIC Grants Management Officer serves as a consultant to the Steering Committee on budget and grants-related issues.  The Steering Committee provides oversight across the ICOHRTA AIDS/TB program and serves as the central point for communication and exchange of ideas regarding research training activities and resolution of any problems, as necessary.  A chairperson who is not a USG employee will be elected by the committee to serve a one-year term.  The Steering Committee will meet at least once annually and will participate in telephone, video or electronic conferences, as needed.  Each member of the Steering Committee will have one vote.

The Principal Investigators will be members of the Steering Committee.  This committee together with the Technical Advisory Group will serve a consultative function and help to shape the agenda and facilitate the activities of the ICOHRTA AIDS/TB program. 

Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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 awardee. This special arbitration procedure in no way affects 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.

3. Reporting

Awardees are also expected to maintain the trainee tracking system and impact criteria as described above.  Publications and other significant accomplishments of the program and trainees must be reported and described to the FIC Program Official a timely manner.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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 Contact:

Jeanne McDermott, CNM, MPH, PhD
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1492
FAX: (301) 402-0779
Email: mcdermoj@mail.nih.gov

2. Peer Review Contact:

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: duperes@csr.nih.gov

3. Financial or Grants Management Contact:

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

Section VIII. Other Information


Required Federal Citations

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

Human Subjects Protection:
Federal regulations (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.

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

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/archive/archive/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.

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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

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

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

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

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 63a and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

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


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