PHASE II INTERNATIONAL CLINICAL, OPERATIONAL, AND HEALTH SERVICES RESEARCH TRAINING AWARDS FOR AIDS AND TUBERCULOSIS (COMPREHENSIVE ICOHRTA AIDS/TB) RELEASE DATE: January 9, 2003 RFA: TW-03-003 Fogarty International Center (FIC) (http://www.fic.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) Office of Research on Women's Health (ORWH) (http://www4.od.nih.gov/orwh/) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/) United States Agency for International Development (USAID) (http://www.usaid.gov) LETTER OF INTENT RECEIPT DATE: May 13, 2003 APPLICATION RECEIPT DATE: June 10, 2003 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 Supplemental 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 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. As used in this Request for Applications (RFA), the term ICOHRTA-AIDS/TB is broadly defined to encompass building capacity for integrated clinical, operational, and health services research across the full range of conditions and issues that relate to care of adult and pediatric patients with HIV/AIDS or TB (e.g., opportunistic infections, HIV malignancies, neurological and mental health consequences, behavioral issues, cardiovascular disease, hematologic conditions, blood safety issues, pulmonary manifestations, ophthalmologic manifestations, gastrointestinal conditions, drug and alcohol usage, gender-related issues and oral health manifestations). This program is an integral and critical component of a comprehensive global strategy of the National Institutes of Health (NIH) and Department of Health and Human Services (DHHS) to address the needs of the millions suffering from HIV/AIDS, TB, and related conditions in resource- limited nations. It 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. These efforts will have direct health, economic and security benefits for the United States (U.S.), as well as the global community. 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 first phase of the ICOHRTA-AIDS/TB program began in fiscal year 2002 (FY02), with one-year planning grants (PA-02-022) 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, which will begin in fiscal year 2004 (FY04). The Phase II awards to the Research Training Units will provide support to both the foreign institution and its linked U.S. partner (or pre-approved non-U.S.) institution through five-year cooperative agreements to each partner institution. 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 may 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. In support of the overall ICOHRTA-AIDS/TB program, a separate RFA will be issued in fiscal year 2003 (FY03) to fund a single Coordination Center in FY04 which will help to monitor and evaluate the ICOHRTA-AIDS/TB program research training units and to develop programs to address common capacity building needs across the research training. The Fogarty International Center (FIC), together with the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Allergy and Infectious Diseases (NIAID),the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), the Office of Research on Women's Health (ORWH), the Centers for Disease Control and Prevention (CDC), and the United States Agency for International Development (USAID), invites Phase I awardees to submit applications for Phase II cooperative agreements to develop comprehensive international clinical, operational, and health services research training programs. These applications should foster the development of integrated strategies to successfully implement evidence-based interventions pertinent to the global health crises created by HIV/AIDS and TB. Co-sponsoring institutions are U.S. Government (USG) agencies contributing financial resources to the ICOHRTA-AIDS/TB Program. Applicants are strongly encouraged to design programs that strengthen the capacity of the foreign institutions to collaborate with the NIH, USG, other governments, international agencies, non-governmental organizations, foundations, faith- based organizations and other groups in their efforts to respond to this global health crisis. RESEARCH TRAINING OBJECTIVES 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. A) Definitions 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. Core research support capabilities are defined as those skills required by an institution to successfully compete for and conduct research. These skills include ethics and compliance issues, protection for human subjects, animal welfare, fiscal management, budgeting, a continuing education system, 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 connection. Excluded from consideration are training and capacity building linked or related to: o studies that do not involve some component of research with a scientific question or evaluation (e.g. demonstration projects or health services delivery projects that do not involve evaluation of a hypothesis); o studies that do not include an intervention designed to prevent transmission or provide treatment/care for individuals infected with HIV or TB and other associated opportunistic infections; and o studies involving animals. B) Scope of Training 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: 1. The application of clinical science and health care research to benefit those already infected with HIV and/or TB. 2. 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. 3. The study of strategies to scale-up and integrate effective therapeutic and preventive interventions into the local health care system. The applicants should describe plans to help assure that their approach to clinical, operational, and health services research training will be directly relevant to the needs of the people in the foreign country. Criteria to evaluate relevance include consideration of morbidity, mortality, and disability, as well as the economic and public health impact of measures taken. Essential to all research training conducted internationally is the need for close consultation by Principal Investigators (PIs) with the foreign country in developing a program that is appropriate to local circumstances and most likely to affect public health policy. Also implicit is the need to rapidly strengthen the training capacity and infrastructure required for success by building on existing research and training programs involved with the implementation of prevention and care interventions at the country level. An additional important capacity building component is to strengthen core research support capabilities needed to manage research grants at the foreign site. The magnitude of the health problems and the urgency to deliver measurable progress once funds are committed will require creative solutions with high multiplier effects. C) Types of Training Supported in the Phase II Comprehensive ICOHRTA-AIDS/TB Awards 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. 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. Advanced in-country research is 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). It is expected that the scientific protocols for advanced in- country research will meet the requirements in Number 8 under the Special Requirements section of this RFA. 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 participating foreign institutions. 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. NIH intramural research programs may also support junior U.S. researchers for research experiences at the foreign sites with prior agreement from the foreign site. 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. D) Guidance and Management Structure The overall 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 co-sponsoring institutions (at least one from each co- sponsor) and the Program and Grants Management officers from the FIC. The Technical Advisory Group reviews applications to make funding recommendations following the peer review, and meets several times per year, as necessary, to review developments across the network of ICOHRTA-AIDS/TB programs as well as the progress of individual ICOHRTA-AIDS/TB Research Training Units or planning grant recipients. The FIC Program Officer serves as the chair of the Technical Advisory Group. Members of the Technical Advisory Group will also be assigned to provide informal guidance and advice to Phase I applicants for preparation of their Phase II application. The Steering Committee is composed of the Foreign PI and the Collaborating PI from each of the Research Training Units, the PI of the ICOHRTA-AIDS/TB Coordination Center, the FIC Program Officer and Grants Management Officer, and two other representatives from the Technical Advisory Group. The Steering Committee serves as the central point for communication and exchange of ideas regarding research training activities, setting of priorities for the activities of the Coordination Center, and resolution of any problems, as necessary. A chairperson 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 or electronic conferences, as needed. 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 both of the Technical Advisory Group and the Steering Committee. The Grants Management Officer will also serve as a resource to the planning grant awardees, the ICOHRTA-AIDS/TB Research Training Units, and the Coordination Center in policies and issues related to NIH grants management. E) Advisory Committees Each Research Training Unit in the Phase II Comprehensive ICOHRTA-AIDS/TB Program will have an Advisory Committee, composed of two or more USG scientific advisers designated by the Technical Advisory Group and a grants management expert, as needed. The Advisory Committee will assist the work of the ICOHRTA-AIDS/TB program by providing advice and assistance, including advice in the preparation of a Phase II ICOHRTA-AIDS/TB application, that is coordinated through the FIC Program Officer. The Advisory Committee 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 Advisory Committee assembled for each Research Training Unit in the Phase II Comprehensive ICOHRTA-AIDS/TB program is determined by the Technical Advisory Group with advice from the Steering Committee. Advisory Committee members maintain ongoing communication regarding the progress of the Research Training Units, attend meetings of the ICOHRTA-AIDS/TB program, whenever possible, and meet as a committee separately at least once per year. MECHANISM OF SUPPORT This RFA will use a 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 the Foreign PI and Collaborating PI of a Phase II Comprehensive ICOHRTA-AIDS/TB AWARD, you will be responsible for planning, directing, and executing the proposed program. Applications submitted in response to this RFA may have a project period of up to five years. This RFA is issued for FY04. The anticipated award date is April 1, 2004. The NIH U2R mechanism is a cooperative agreement award mechanism in which the PIs retain 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 PIs, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE In response to this RFA, FIC and co-sponsoring funding partners intend to commit approximately $4 million each year, beginning in FY04, to fund six Comprehensive ICOHRTA-AIDS/TB Research Training Units, subject to availability of funds. The Phase II Comprehensive ICOHRTA-AIDS/TB applicants of 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 direct 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 co-sponsoring Institutes and Centers (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. 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 two more competitions, thus allowing recipients of Phase I planning grants in FY04 and FY05 to apply for Phase II awards, and for unsuccessful Phase II applicants in FY04 and FY05 to submit amended applications. ELIGIBLE INSTITUTIONS Applications for a Phase II Comprehensive ICOHRTA-AIDS/TB Award will be accepted from foreign institutions that have been awarded a Phase I ICOHRTA- AIDS/TB planning grant (PA-02-022) and their chosen linked collaborating U.S. (or other pre-approved) partners. Organizations applying to this RFA are not eligible to apply for an award under the ICOHRTA-AIDS/TB Coordination Center RFA that will be published in FY03, for award in FY04. Eligible institutions may be domestic and foreign non-profit organizations, public and private institutions, such as universities, colleges, hospitals, and laboratories. Members of the Research Training Unit must collaborate with each other to prepare similar or identical research plans. The two applications from the Research Training Unit partners should describe a comprehensive international clinical, operational, and health services research training program. 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, with the exception that if a foreign applicant also is collaborating with a NIH intramural research program, a second application will be allowed. 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 PI under Phase II applications from the collaborating partner institutions must meet the requirements stated under Special Requirements. The applications for a Comprehensive ICOHRTA-AIDS/TB Award must demonstrate that, for each component of the Research Training Unit, both the PI and the institution have a track record of commitment and experience in related research and training. 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. 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. With prior FIC approval and with concurrence by the scientific director of the participating Institute, an intramural NIH investigator may serve as collaborating PI on a Phase II Comprehensive ICOHRTA-AIDS/TB application. The participating NIH intramural program must pay for the participation of its own staff, including travel expenses, and for any research costs at NIH. 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 FOR THE PHASE II COMPREHENSIVE ICOHRTA-AIDS/TB AWARD The integrated application for a Comprehensive ICOHRTA-AIDS/TB Award including both the foreign institution and its linked U.S. (or other pre- approved) partner must meet the following Special Requirements: 1. The institutions of the PIs must have entered into a long-term commitment in writing to build the clinical, operational, and health services research capacity of the foreign institution through governmental-supported or other resources. A copy of this agreement must be included with the Phase II application. The foreign institution must describe how resources from this award will be integrated with other resources at the institution or within the country to achieve the overall goals of this program including building sustainable research capacity at the foreign institution. 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 FIC international 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 NHLBI programs related to AIDS/TB; o NIAAA programs related to AIDS/TB; o AIDS/TB-related Programs of the Centers for Disease Control and Prevention; o USAID AIDS- and TB-related programs; o AIDS/TB-related programs of other organizations/foundations involved in international control of and care for persons infected with HIV/AIDS and TB. Applicants must describe plans to help assure that the Comprehensive ICOHRTA- AIDS/TB program will be supportive of and integrated with other relevant programs at the foreign institution and within the country (such as those listed above). They should describe how this program could serve as a bridge between academic research and public health communities within the country as well as to help link through the training of common human resources the various HIV/AIDS and TB trials and care programs supported in the country by NIH and other sponsors. In addition, applicants should describe how their programs relate to community advisory boards in the foreign country and how the training program will strengthen the capability of these community advisory boards. Should NIH intramural labs or programs be involved in the ICOHRTA-AIDS/TB application, they must also be party to these agreements with documented concurrence by the scientific director of the participating Institute. 2. 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. 3. Both partners of the Research Training Unit must collaborate in creating a research training development plan for the foreign site and demonstrate 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. 4. 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. To qualify, 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. Each site should provide a comprehensive list of these awards for at least the past five years to support its application. 5. Applicants must describe how the proposed research training and capacity building supports the HIV/AIDS and 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. 6. 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 cost-sharing 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 (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. 7. The applications should describe plans for the integration of clinical, operational, and health services research capacity building at the collaborating foreign institution. It is also desirable for the applications to describe 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. 8. Applicants should document their 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/assurances/assurances_index.html). All training-related research protocols (including advanced in-country research) must be independently scientifically reviewed through expedited scientific review procedures established by the ICOHRTA AIDS/TB Coordination Center or through other mechanisms. 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 . 9. Applicants should describe their plans for strengthening core research support capabilities necessary for long-term sustainability. These capabilities include grants and research administration, accounting, financial management, field epidemiology, biostatistics, data management, systems analysis, ethical reviews, medical informatics, technology transfer and management of intellectual property, and preparation of research grant proposals and scientific manuscripts. 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 Office of Management and Budget (OMB) administrative guidelines, Department of Health and Human Services (DHHS) 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 DHHS, Public Health Service (PHS), and NIH grant administration policies." 1. Awardee Rights and Responsibilities For the Comprehensive ICOHRTA-AIDS/TB Awards, the major responsibility of the PIs is to plan and to strengthen integrated training and research capacity across the spectrum of clinical, operational, and health services research at specific foreign institutions to combat problems of HIV/AIDS, TB, and other associated conditions relevant to that country's health. Awardees will develop long-term, short-term and intermediate-term training programs and institutional goals that foster the translation of scientific advancement into measurable health benefit. This will require curriculum development, integrated organizational planning, and the establishment of monitoring and assessment mechanisms for scientific administration topics. Specific programmatic duties include participation in meetings, grants administration, preparation of progress reports, and reporting of scientific results. 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. 2. NIH Staff Responsibilities The FIC Program Officer, 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 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 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. 3. Collaborative Responsibilities a) The Comprehensive ICOHRTA-AIDS/TB research training programs will require close collaborative interactions of the awardee PIs and institutions, NIH personnel including the FIC Program Officer and Grants Management Officer, the Technical Advisory Group, the Steering Committee, the Advisory Committees, and the Coordination Center. The Steering Committee will meet at least once a year to provide the primary governance process for the collaborative efforts of the program and will have responsibility to: o review training needs and make recommendations to accommodate training needs; o identify needs for additional consultation on specific areas of clinical, operational, and health services research, as well as research administration or other training expertise, activities, or issues; o review and advise on the research training development plans for each Research Training Unit based on the findings of the needs assessments. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients 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 NIH 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. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulations 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 Division of International Training and Research Fogarty International Center National Institutes of Health 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 o Direct your questions about peer review issues to: Elliot Postow 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) Telephone: 301-435-0911 Fax: 301-490-2327 Email: postowe@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 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-496-1670 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 and fax numbers, and e-mail addresses of the Principal Investigators o Participating institutions o Names and institutions of other key personnel 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 mail or electronically by the date listed at the beginning of this document. The letter of intent should be sent to: Jeanne McDermott Division of International Training and Research Fogarty International Center National Institutes of Health 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 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov SUPPLEMENTAL INSTRUCTIONS: 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 (NRSA substitute budget pages 4 & 5) in the "Other Stipend" category. The combining of the budgets will allow reviewers and FIC staff to review a composite budget of all costs. Budget Preparation 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 section on FUNDS AVAILABLE. 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 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 $50,000 per year in accordance with the grantee institutional policies while involved in long- term or intermediate-term training at the grantee institution. Applicants may wish to refer to the NRSA stipend levels described on the web site http://grants.nih.gov/training/nrsa.htm. (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 sharing 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/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original and five copies 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 applications 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 by 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. 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 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. Those Phase II Comprehensive ICOHRTA-AIDS/TB applications deemed highly meritorious by the review committee will receive a site visit to the foreign site by members of the review committee and staff from FIC and the Technical Advisory Group. The results of the site visit as well as the initial written evaluation will be considered by the review committee in determining the priority score. Only applications that have been site visited will receive a priority score, 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 at specific foreign institutions to combat problems of HIV/AIDS, TB, and other AIDS/HIV- associated conditions relevant to that country's health. In the written comments and site visits, 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 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 AND INSTITUTIONS: 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 cost- sharing 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 US government, other government and non-governmental agencies active in addressing issues related to HIV/AIDS, 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; 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: o PROTECTIONS: The adequacy of the systems in place to protect humans, animals and the environment, to the extent they may be adversely affected by the project proposed in the application. The initial review will examine the adequacy of the process for providing for the protection of human and animal subjects; the safety of the research environment; and plans to include training in responsible conduct of research and training in the operation of Institutional Review Boards (IRBs) or equivalent ethical review boards, data and safety monitoring boards, and community advisory boards as a part of the program. o INCLUSION: 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 included in the section on Federal Citations, below.) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and duration in relation to the proposed training program and the strengthening of the foreign institution. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 13, 2003 Application Receipt Date: June 10, 2003 Peer Review: September and December 2003 Council Review: February 2004 Earliest Anticipated Start Date: April 1, 2004 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 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and 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 AMENDMENT "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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. 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. Because the purpose of the ICOHRTA-AIDS/TB network is to strengthen research capacity, all PIs, faculty and mentors are expected to meet this requirement. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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 (see http://escr.nih.gov). It is the responsibility of the applicant to provide 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. 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. 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 No. 93.989, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of the Public Health Service Act, as amended (42 USC 241 and 287b) and administered under Public Health Service (PHS) grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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