PHASE II COMPREHENSIVE ICOHRTA AIDS/TB RELEASE DATE: July 28, 2004 RFA Number: RFA-TW-04-002 (This RFA has been reissued, see RFA-TW-06-005) EXPIRATION DATE: December 21, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) United States Agency for International Development (USAID) (http://www.usaid.gov) COMPONENTS OF PARTICIPATING ORGANIZATIONS: Fogarty International Center (FIC) (http://www.fic.nih.gov) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) Office of Global Health United States Agency for International Development (USAID) (http://www.usaid.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.989, 93.242 (NIMH), 93.855, 93.856 (NIAID) LETTER OF INTENT RECEIPT DATE: November 19, 2004 APPLICATION RECEIPT DATE: December 20, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Training Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Fogarty International Center (FIC) and its co-sponsoring institutions invite Phase I International Clinical, Operational, and Health Services Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) Program awardees to submit applications for Phase II ICOHRTA-AIDS/TB awards to develop comprehensive international clinical, operational, and health services research training programs. Co-sponsoring institutions are U.S. Government (USG) agencies contributing financial resources to the ICOHRTA- AIDS/TB Program. RESEARCH TRAINING OBJECTIVES The International Clinical, Operational, and Health Services Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) program provides extended support for training to foster collaborative, multidisciplinary research in developing country sites where HIV/AIDS, tuberculosis (TB) or both are significant problems. 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 foreign institutions to organize and execute an application for a Phase II Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement. Only the recipients of the Phase I planning grants and their chosen U.S. (or pre-approved non-U.S.) collaborating partner institutions (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. These applications should foster the development of the skills at the foreign institution needed to identify effective interventions pertinent to the global health crises created by HIV/AIDS and/or TB and to develop strategies to successfully implement these evidence-based interventions. The training supported under Phase II of the ICOHRTA-AIDS/TB program will help to produce a cadre of experts who will facilitate integrated clinical, operational, and health services research for the benefit of developed and developing country populations. These experts will comprise a resource that will 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 these individuals in a manner that supports continuing and expanding prevention activities. This program will increase research training 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. Clinical research, in the context of this RFA, 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, clinical trials of biomedical, behavioral, or combination interventions, the development of new technologies, and new clinical methods to deliver, monitor, and sustain AIDS and/or TB care. Operational 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, operational research will help determine how best to generalize such interventions for widespread and sustainable use. Operational research includes studies 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. The applications from both the foreign institution and its U.S. (or pre- approved non-U.S.) collaborating partner must propose, in an integrated manner, a comprehensive training program that will strengthen the capacity in the foreign country to conduct integrated clinical, operational, and health services research focused on one or more of the following areas: o The application of clinical science and health care research to benefit those already infected with HIV and/or TB. o The prevention and/or reduction of the spread of HIV and TB and related conditions, especially measures that can be implemented within the context of care. o The study of strategies to scale-up and integrate effective therapeutic and preventive interventions into the local health care system. The approach and training 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 site. 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 will be carried out mainly at the foreign site. 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, the following definitions are used for long-, medium-, and short-term training: o Long-term (greater than 12 months and up to four years, depending on resources) training for the full range of skills necessary to support research and research administration in masters or doctoral programs, with the understanding that the focus of thesis-related work will be in the developing country. With prior FIC approval, pre-masters training will be allowed for individuals with demonstrated interest and capability, but whose prior professional education does not include a bachelor's level degree (e.g., nurses, midwives, laboratory technicians, administrative staff). o Short-term (less than three months) training or mentoring that focuses on research methodology, laboratory skills necessary to support clinical research, ethics and compliance issues, program and grants administration, accounting, financial management, grant writing, peer review, preparation of scientific manuscripts, data management, Internet connectivity, technology transfer, and medical informatics. o Intermediate-term (three to 12 months) training or mentoring, including specialized clinical, laboratory, research or administrative/business skills necessary to support clinical, operational, and health services research that is planned or ongoing. o Advanced in-country mentored research undertaken by the trainee in his/her home country upon completion of his/her initial period of training under the program (masters, Ph.D., post-doctoral or other significant training). o 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/or have a major career commitment to international research. 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. MECHANISM OF SUPPORT This RFA will use the NIH International Training Cooperative Agreement (U2R) award mechanism to provide funding to both the foreign research training institution and to its linked collaborating U.S. (or other pre-approved) institution. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is April 2005. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. 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 and other United States Government (USG) staff being substantially involved as partners with the Principal Investigator, as described under the section "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 Phase I planning grants to apply for Phase II awards, and for unsuccessful Phase II applicants to submit amended applications. FUNDS AVAILABLE FIC and its co-sponsoring partners intend to commit approximately $1.2-1.8 million in FY05 to fund two to three applications from the Comprehensive ICOHRTA-AIDS/TB Research Training Units received, in response to this RFA and subject to availability of funds. The two Phase II Comprehensive ICOHRTA- AIDS/TB applicants in the Research Training Unit (which consists of a foreign institution application and its linked U.S. partner or pre-approved non-U.S. institution application) may request up to a total of $600,000 in total costs for each year. Each of the applicants can request up to $300,000 total costs (that includes facilities and administrative (F & A) costs on subcontracts) in year one but the foreign institution application total cost budget must be at a total cost level equal to or greater than its linked U.S. partner or pre-approved non-U.S. institution partner. The foreign institution's total 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 total cost budget may exceed $300,000 in years two through five but the total costs for the Research Training Unit may not exceed $600,000. The total project period for an application may not exceed five years and F & A costs are limited to eight percent for both Research Training Unit partners. Because the nature and scope of the proposed research training will vary from application to application, it is anticipated that the overall size of each linked award (and components) will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS 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 their chosen linked collaborating U.S. (or other pre-approved) partners. The foreign and U.S. (or other developed country) site 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. You may submit an application if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic or foreign institutions/organizations o Faith-based or community-based organizations With prior FIC approval, the designated collaborating institution may be a non-U.S. institution, provided it has special resources that uniquely contribute to this program. Also with prior FIC approval, and concurrence from the foreign PI, the application from the collaborating U.S. (or other pre-approved) partner 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. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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 collaborating PI will be responsible for the overall conduct of the integrated research-training program. Both the foreign and collaborating 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 collaborating partner institutions must have a track record of commitment and experience in related research and research training. Both the foreign and collaborating 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. Women, individuals from underrepresented racial, ethnic and socially disadvantaged groups in the country, as well as persons with disabilities are encouraged to apply as PIs. SPECIAL REQUIREMENTS Guidance and Management Structure The guidance and management of the ICOHRTA-AIDS/TB Program are provided by a Technical Advisory Group and a Steering Committee. 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 Officers 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 Officer serves as the chair of the Technical Advisory Group. The Steering Committee is composed of the Foreign Principal Investigator and the Collaborating Principal Investigator from each of the Research Training Units, the FIC Program Officer, 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. 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 Officer 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 membership of the individual advisory committee is determined by the Technical Advisory Group, with advice from the Steering Committee. 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 Officer, as the program and scientific representative of the FIC, chairs the Technical Advisory Group and is a member of the Steering Committee. The Program Officer has lead responsibility for day-to-day program decisions in coordination with the Technical Advisory Group and the Steering Committee. The FIC Grants Management Officer, 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 Officer 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. Cooperative Agreement Terms and Conditions of Award: The administrative and funding instrument to be used for this program is a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic and grants administration involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. 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. 1. Awardee Rights and Responsibilities Each partner institution will be responsible 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 at the foreign site. 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 are advised that they will retain custody of and primary rights to any research data developed under the award, subject to current Government policies regarding rights of access. 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 Officer to the Research Training Unit. 2. United States Government(USG) Staff Responsibilities The FIC Program Officer/Collaborator, in consultation with co-sponsoring U.S. agencies, will have substantial scientific and programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants. The FIC program officer/Collaborator 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 Program Officer/Collaborator will: o serve on the Steering Committee and chair the Technical Advisory Group; o provide advice on the management of the training provided, technical content of the curriculum, and evaluation of the impact of the training; o facilitate communication and exchange of information; and o organize interactions with relevant co-sponsor and FIC staff to provide scientific and administrative technical assistance. 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 Officers 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 Officer/Collaborator 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. The individual advisory committees of each Research Training Unit will provide guidance to that Research Training Unit. The FIC Program Officer/Collaborator and one non-FIC member of the Technical Advisory Group will serve on the Steering Committee. The FIC Program Officer/Collaborator, in consultation with co- sponsoring organizations and the FIC Grants Management Officer, will oversee, advise, and assist the activities of the Research Training Units in support of the ICOHRTA-AIDS/TB programs. The FIC Grants Management Officer will serve as a resource to the Research Training Units in policies and issues related to NIH grants management. The FIC Program Official designated in the Notice of Grant Award will be responsible for the normal programmatic stewardship of the award and may be substantially involved as described above for the Program Official/Collaborator role. 3. Collaborative Responsibilities The Steering Committee is composed of the Foreign Principal Investigator and the Collaborating Principal Investigator from each of the Research Training Units, the FIC Program Officer/Collaborator, 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. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipient and the FIC may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (with the USG members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by FIC in consultation with the Technical Advisory Group, and the third member selected by the two prior selected members. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA 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. o Direct your questions about scientific/programmatic issues to: Jeanne McDermott, CNM, MPH, PhD Division of International Training and Research Fogarty International Center, National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: 301-496-1492 Fax: 301-402-0779 Email: mcdermoj@mail.nih.gov o Direct your questions about peer review issues to: Sherry L. Dupere, Ph.D.Chief, Biology of Development and Aging IRG Center for Scientific Review National Institutes of Health 6701 Rockledge Drive MSC 7840, Room 5136 Bethesda,MD 20892 (for express/courier service, use zip 20817 and remove MSC 7840) Telephone: 301-435-1021 Fax: 301-480-3567 Email: duperes@csr.nih.gov o Direct your questions about financial or grants management matters to: Bruce Butrum 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: butrumb@mail.nih.gov LETTER OF INTENT Prospective applicants who receive Phase I planning grants and who intend to apply for a Phase II award under this RFA are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed program o Names, addresses, telephone numbers of the Principal Investigators o Names of other key personnel o Participating institutions o Number and title of this RFA 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 NIH 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 to: Jeanne McDermott, CNM, MPH, PhD Division of International Training and Research Fogarty International Center, National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: 301-496-1492 Fax: 301-402-0779 Email: mcdermoj@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Members of the proposed Research Training Unit must collaborate with each other to prepare similar or identical research training plans. 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, in place of the research plan: 1. 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. 2. A description of plans for the integration of clinical, operational, and health services research capacity building at the collaborating foreign institution. 3. 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. 4. 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 developed country site) must describe how its component of the linked program is designed to help build the research capacity at the foreign site. The application should clarify the roles, responsibilities and commitments of the foreign and U.S. (or non-U.S.) collaborators and should state what the individuals listed would actually do and their time commitments to the program. 5. 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: o other FIC international research training and research programs; o NIAID AIDS/TB-related programs; o NICHD AIDS/TB-related programs; o NIMH AIDS-related programs; o NCI programs related to AIDS/TB; o NIDA programs related to AIDS/TB; o NIAAA programs related to AIDS/TB; o NINDS programs related to AIDS/TB; o AIDS/TB-related Programs of the Centers for Disease Control and Prevention; o USAID AIDS/TB-related programs; o The President’s Emergency Plan for AIDS Relief o The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria o AIDS/TB-related programs of other organizations/foundations involved in international control of and care for persons infected with HIV/AIDS and/or TB. 6. A description of how this program will serve as a bridge between academic research and public health communities to help to link the various HIV/AIDS and/or TB trials and care programs supported in the country by NIH and other sponsors. 7. 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 8. A description of strategies to achieve a wider regional impact. This could be done by strengthening other institutions in the foreign PI's 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. 9. Plans for strengthening core research support capabilities necessary for long-term sustainability. 10 Plans for meeting the requirements related to training-related research including advanced in-country research. These include scientific and peer review procedures, written evidence of compliance with the required federal citations, approval for the research from an institutional (or ethical) review board or committee at both the U.S. or pre-approved non-U.S. and foreign institutions and from the relevant government authority, as required. Please see: Procedures for Registering Institutional Review Boards and Filing Federal-Wide Assurances of Protection for Human Subjects (FWAs) (http://www.hhs.gov/ohrp/). All training-related research protocols (including advanced in-country research) must be independently scientifically reviewed through expedited scientific review procedures established by the Research Training Unit. For example, as the training programs are implemented, consideration will be given to mechanisms to support advanced in-country research proposals as either competing supplements to Phase II awards or as applications to the FIC Global Health Research Initiative Program for New Foreign Investigators. 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. 11. 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 participating foreign country. 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). 12. 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. 13. Description of how the proposed training program will address the interest of the co-sponsoring institutions. Budget Preparation 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 participation budget should be identified on PHS Form 398 (budget pages 4 & 5) in the "Other category to create a composite budget containing all direct costs for the applicant organization. Each applicant of the Research Training Unit should develop a budget that reflects the resources necessary to implement its components of the comprehensive training plan included in the application. The total costs of the combined budgets should be within the guidelines provided in the FUNDS AVAILABLE section. The budgets may include costs to support various types of 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. Requested Salary Support The salary for the PIs and other faculty and staff must be commensurate with the salary structure or compensation package for similar professionals and staff at the applicant institution. Trainees' Stipends Trainees may be paid a stipend comparable to their professional experience similar to other equivalent trainees but not exceeding the NRSA stipend levels (http://grants.nih.gov/training/nrsa.htm) and in accordance with the grantee institutional policies while involved in long-term or intermediate- term training at the grantee institution. (Use the NRSA substitute pages, pre- or postdoctoral stipends.) Tuition, Fees and Insurance for Trainees Funds for tuition, academic fees, and self-only or family medical insurance may be requested. Programs are encouraged to seek cost reduction arrangements with the grantee institutions in order to provide reduced tuition for long-term trainees and tuition-free short courses. (Use the NRSA substitute pages, tuition, fees, insurance). USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original, including the checklist, and five signed photocopies of the two applications, one from each partner, in a single package. The two applications should be clearly bundled separately but sent together so that the two components of the Research Training Unit will be clearly identified and linked. Submit the package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA 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. PEER REVIEW PROCESS For the Phase II Comprehensive ICOHRTA-AIDS/TB Awards, the applications specifying the roles and responsibilities of each of the partner institutions must be submitted together as a unit and the applications will be reviewed as a single unit. Upon receipt, applications will be reviewed for completeness by CSR, and responsiveness by the Technical Advisory Group. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Please see the Special Requirements section for a description of the documentation required for an application to be considered responsive. 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 CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will initially be reviewed to determine which are considered the most meritorious. CSR will conduct two peer review group meetings on the ICORHTA AIDS/TB applications in accordance with FIC's review criteria to determine which are considered the most meritorious. The first meeting will be an initial merit review of all applications to evaluate the scientific and technical merit by an appropriate peer review group convened by CSR. The second meeting will review those Phase II Comprehensive ICOHRTA-AIDS/TB applications deemed highly meritorious in the initial review and these applicants will have the opportunity to respond to questions that arose at the initial review. The second review may include a site visit. The results of both reviews will be considered by the review committee in determining the priority score. Only applications that have received the second review will be eligible for funding, but all applicants will receive a written critique. A second level review will be conducted by the FIC Advisory Board and possibly by the Councils or Advisory Boards of other co-sponsoring Institutes/Agencies. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The ICOHRTA-AIDS/TB program seeks to strengthen research capacity across the spectrum of clinical, operational, and health services research at specific foreign institutions to combat problems of HIV/AIDS, TB, and/or other HIV/AIDS-associated conditions relevant to that country's health. In the written comments, reviewers will be asked to discuss these aspects of the application in order to judge the likelihood that the proposed program will have a substantial impact on the pursuit of each of these goals: o Significance o Approach o Innovation o Investigator and Institutions o Environment The scientific review group will address and consider each of these criteria in reviewing your application and weighting them as appropriate for each application. Note that the application does not need to be strong in all review categories to be judged likely to have major impact and thus deserve a meritorious 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. Review Criteria for Comprehensive ICOHRTA-AIDS/TB Award Applications (1) SIGNIFICANCE: a) 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. b) 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. (2) APPROACH: a) Adequacy of the described training program to provide breadth of training opportunities for the research trainees in all three of the research areas (clinical, operational, and health services). b) Capability of the described training program to provide the trainees with the necessary administrative and management skills to compete for research support and conduct research. c) Expected ability of the proposed training program to 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. d) Adequacy of the integrated application to demonstrate: o coordination between the research training activities of the linked applicants; and o coordination and linkage with other related in-country research, training and public health programs. (3) INNOVATION: a) Ability of the proposed training program to 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. b) Adequacy of the proposed training program to take advantage of relevant opportunities in other countries. (4) INVESTIGATOR: a) Training and experience of the foreign PI, the collaborating PI and key personnel named in the integrated application to achieve the goals and implement the activities of the proposed training program. Documentation should include: o Past research training record of the foreign PI, the collaborating PI and the designated preceptors in tracking careers of their past U.S. and foreign trainees and the rate at which former trainees establish independent and productive research and public health careers. For foreign trainees, the percent whose professional activities are in the home country. Please include tables with this information, including current status of foreign and other selected trainees for at least the past five years. o Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards, and research grants for further career development; major scientific breakthroughs and scientific leadership positions assumed by former trainees should be highlighted. b) Documentation of a history of successful institutional and individual collaborations among the foreign PI, collaborating PI and key faculty of both institutions. A successful history of collaborations is demonstrated by funded research or training grants that include the foreign PI at the foreign institution and the collaborating PI at the collaborating institution; by funded research or training grants that include both the faculty at the foreign institution and faculty at the collaborating institution; and by jointly authored publications in scientific peer-reviewed journals. (5) ENVIRONMENT: a) Documentation of 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: a statement of support from a senior administrator at the Foreign PI's institution; evidence of contributions by 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 a formal letter of support from the Health Ministry and/or other senior government official in the foreign country that emphasizes the long-term commitment to the goals of the award. b) Documentation of written commitment (agreement) by the foreign institution and its collaborating partners to cooperate to achieve the long-term goals and activities of the program. c) Plans for the proposed training program to 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, including how well the institutional development plan for the foreign site addresses these issues. d) The adequacy of mentoring resources and training environment in-country as evidenced by: o the quality of teaching and the in-country research facilities; o the availability of high-quality candidates for training, chosen on merit; o the ability of the trainee recruiting and selection process to capture the most qualified individuals and to include an adequate representation of men, women and ethnic minorities or socially disadvantaged population groups among the developing country trainees; and o a past history of success of former trainees contributing to their home countries and their programs by participation in advanced in-country research and as faculty and mentors for new trainees. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: COLLABORATION WITH ICOHRTA AIDS/TB AWARDEES: The adequacy of the proposed plan to work in collaboration with scientists at the ICOHRTA-AIDS/TB sites and associated NIH and USG scientists, health professionals and staff in proposed curriculum, training and evaluation activities. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research-training program. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 19, 2004 Application Receipt Date: December 20, 2004 Peer Review Date: March 2004 Council Review: May 2005 Earliest Anticipated Start Date: July 1, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review including a site visit, if conducted): The most important factor to be considered in making funding decisions will be the quality of the proposed program, as determined by initial scientific peer review. The proposed instruction in the responsible conduct of research must be rated adequate for an award to be made. o Availability of Funds o Programmatic priorities and geographic balance: Geographic and programmatic balance, input from the collaborating partners and the FIC Advisory Board, and the adequacy of the commitment of the foreign country to the program, as well as the extent to which the program helps to integrate critical HIV/AIDS and/or TB efforts and related capabilities within the country, will also be considered in making funding decisions. A consideration for funding will be whether the proposed research training and capacity building is integrated with or duplicates efforts in other FIC, NIH, and other international programs, and whether it supports a unique intervention opportunity not able to be accommodated by another FIC program. REQUIRED FEDERAL CITATIONS 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). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects 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 that is available at 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC 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 RFA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTFIABLE 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 RFA 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 287b) 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.

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