PLANNING GRANTS TO ORGANIZE PROGRAMS FOR INTERNATIONAL CLINICAL, OPERATIONAL, AND HEALTH SERVICES RESEARCH TRAINING FOR AIDS AND TUBERCULOSIS RELEASE DATE: February 20, 2003 (see correction, NOT-TW-03-008) PA NUMBER: PAR-03-072 Letter of Intent Receipt Date: May 12, 2003, May 10, 2004, May 10, 2005 Application Receipt Date: June 10, 2003; June 10, 2004, June 10, 2005 EXPIRATION DATE: June 11, 2005, unless reissued. Fogarty International Center (FIC) (http://www.fic.nih.gov) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/default.htm) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.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) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.989 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Program Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Supplemental Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This program announcement replaces PA-02-022 published in the NIH Guide, November 28, 2001. 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, TB or both are significant problems. As used in this Program Announcement (PA), 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, tuberculosis, 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 consists of one-year planning grants to foreign institutions to develop an application for a Phase II Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement. The Phase I award will provide support for the applicant to: o solidify collaborative relationships and understandings with all individual and institutional partners; o define the type of research training programs to be developed in cooperation with its principal and any other collaborating partners and in consultation with staff from FIC and other U.S. Government (USG) co- sponsoring organizations of this program; o assess current resources and needs, including the need for an institutional review board; o develop a step-wise plan to address these needs; o develop an institutional (organizational) structure including links with other relevant national and international organizations that conduct and support clinical, operational, and health services research; o identify the training, staff development, and scientific and administrative resources needed to undertake a comprehensive training program; o prepare an institutional development plan for at least the next ten years demonstrating how resources from a Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement in conjunction with resources from other collaborating partners and from the applicant will allow the applicant institution to achieve its long- term development goals. The second phase of the ICOHRTA-AIDS/TB program will begin in fiscal year 2004 (FY04). 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. Phase II awards will provide support to both partner institutions in the Research Training Unit through five-year cooperative agreements. The awards will support implementation of the proposed research training program designed to foster the development of integrated strategies to successfully implement evidence-based interventions pertinent to the global health crises created by HIV/AIDS and tuberculosis (TB). 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. The Fogarty International Center (FIC), together with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), the Office of Research on Women's Health (ORWH). the Centers for Disease Control and Prevention (CDC), and the U.S. Agency for International Development (USAID), invites applications for one year planning grants to develop international clinical, operational, and health services research training programs. Co-sponsoring institutions are United States Government (USG) agencies contributing financial resources to the program. Applicants are strongly encouraged to design programs that provide capacity building in support of the National Institutes of Health (NIH), USG, and other international efforts to respond to this global health crisis. Clinical research, in the context of this PA, 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 the management of intellectual property, data management, and Internet connection. Excluded from consideration are training and capacity building linked or related to 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), 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 studies involving animals. PROGRAM OBJECTIVES In developing proposals for planning grants, applicants need to be aware of the objectives and special requirements for the comprehensive program as described in the Request for Applications TW-03-003 (http://grants.nih.gov/grants/guide/rfa-files/RFA-TW-03-003.html). The training supported under the comprehensive 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 scientists will comprise a resource that will facilitate additional training and research in the region. The ICOHRTA-AIDS/TB program strongly encourages program directors to include women and individuals from underrepresented racial, ethnic and socially disadvantaged groups in the country as trainees and faculty at all sites. The planning applications must outline the strategies and approach to develop a proposal for a comprehensive training program that will build 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 spread of HIV and TB and related conditions, especially measures that can be implemented within the context of care. 3. The study of strategies for scale up and integration of effective therapeutic and preventive interventions into the local health care system. The applicant should describe plans to help assure that its approach to clinical, operational, and health services research training will be directly relevant to the needs of the people in the international site. 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 conducted internationally by principal collaborating investigators is the need for close consultation with the foreign collaborating country in setting an agenda that is appropriate to local circumstances and most likely to affect public health policy. Also implicit is the need to rapidly build 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 the core research support capabilities needed to compete for and manage research grants at the foreign site. The magnitude of the tasks and the urgency to deliver measurable progress once funds are committed will require creative solutions with high multiplier effects. The major goal of the ICOHRTA-AIDS/TB planning grant is to develop an application that describes a comprehensive international clinical, operational and health services training program to submit for the Phase II competition. Separate applications will be submitted by the planning grant awardee and by its collaborating partner for Phase II Comprehensive ICOHRTA- AIDS/TB Cooperative Agreements. The applications of the Research Training Unit partners should describe identical or similar training programs but include the budget and budget justification for the portion of the training program for which each partner applicant will assume financial responsibility. Evidence of host-country support for the planning grant as well as sustained support for any subsequent comprehensive program is required. Such evidence of support should be provided in writing and should be in the form of the following: (1) a statement of support from a senior administrator at the foreign principal investigator country 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 clinical, operational, and health services research capacity at a center of research excellence in the foreign country; and (2) a formal letter of support from the Health Ministry and/or other senior government official that emphasizes the long-term commitment to the goals of the award. MECHANISM OF SUPPORT Phase I - One Year Planning Grant to a Foreign Institution For Phase I of the program, this PA will use the NIH D71 International Training Program Planning Grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. If an NIH intramural investigator is involved in the program, the planning grant may be converted to a cooperative agreement at the time of award. The FIC and co-sponsoring partners intend to fund an estimated six planning (D71) grants from this PA in FY04 and in fiscal year 2005 (FY05). Involvement of an intramural investigator in the program must include collaboration that involves a significant contribution to the conceptualization, design, execution or interpretation of the research study. Simply providing unique biological materials, such as cell lines, antibodies, and probes, does not constitute a collaboration. NIH scientists may serve as unpaid collaborators or unpaid consultants on extramural grants. In these cases, a formal letter from the intramural scientist must be included as part of the grant application with a copy of this letter sent to the Scientific Director. The letter should be limited to a description of the intramural scientist's collaborative work under the grant. The grant applicant is responsible for writing the section of the grant that describes the proposed collaboration within the grant, which the NIH investigator should see and approve. A Phase I award will be made for 12 months at a level of up to $75,000 in direct costs (or three modules of $25,000), plus eight percent facilities and administrative costs. Please see the Allowability of Facilities and Administrative (F&A) Costs for Foreign and International Organizations at: (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html) in the NIH Guide, March 30, 2001. Allowable costs for D71 applications include travel, salary, minimum consultative fees and administrative costs. The total amount of salary and fringe benefits requested for all grantee faculty must be well justified and compatible with salary scales established for similarly ranked professionals at the applicant institution. The time commitment for personnel receiving salary should be thoroughly described. ELIGIBLE INSTITUTIONS You may submit an application if your institution has all of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Foreign institutions in one of the following regions: Africa, Russia and the Newly Independent States (NIS), Asia (except Japan, Singapore, South Korea, and Taiwan), the Pacific Island region (except Australia and New Zealand), the Middle East (except Israel), Latin America (Mexico, Central and South America) and the Caribbean To best support the building of sustainable research in low-income and transitional economy countries, only those foreign non-profit public or private institutions (e.g. universities, colleges, hospitals or laboratories) which can document a significant and active record in HIV/AIDS and/or TB research and training and show potential to become national or regional centers of excellence are eligible to apply for a planning grant. The need for developing additional research capacity in-country must be justified by the significance of the AIDS/TB problem as well as a paucity of economic resources in the host country. Only one application to the ICOHRTA AIDS/TB program (Phase I and Phase II) will be funded from any foreign institution. If a foreign institution does not have an existing award for the ICOHRTA AIDS/TB program, only one application for a planning grant from any foreign institution can be submitted for consideration at any one time. If a foreign applicant also is collaborating with an NIH intramural research program, two applications are allowed. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS To qualify, Principal Investigators must be actively involved in HIV or TB clinical research in resource-poor settings and they must provide tangible evidence of very strong linkage to that ongoing research as part of this application. The Principal Investigator must hold faculty or another long- term research position at a public or private non-profit research institution that will allow him/her adequate time and provide appropriate facilities, salary support and resources, including access to patients or patient data, when necessary. Women and individuals from underrepresented racial, ethnic, and socially disadvantaged groups in the country, as well as individuals with disabilities, are always encouraged to apply for NIH programs. Phase II Five-Year Comprehensive Cooperative Agreements (beginning FY 2004) Foreign grantees that have been awarded an ICHORTA-AIDS/TB Planning Grant and their collaborating partner are expected to apply for Phase II Comprehensive ICHORTA- AIDS/TB Cooperative Agreements under the FIC Request for Applications TW-03-003. This RFA requires that foreign applicants partner with an institution in the U.S. or (with pre-approval) in another developed country to submit two applications that describe similar or identical training programs that will be reviewed as a single unit. The partners of successful packages or units that are chosen to be funded will each receive an award. FIC plans to reissue the RFA on an annual basis, subject to the availability of funds. Participation of NIH intramural programs as training sites and as collaborators in capacity building and research at the foreign site is encouraged. An intramural NIH investigator may serve as collaborating Principal Investigator on an ICOHRTA-AIDS/TB with concurrence by the Scientific Director of the participating Institute. The participating NIH intramural program must pay for the participation of its own staff, including travel expenses, and for any research costs at NIH. In some cases, the work of the intramural scientist is such a substantial part of the proposal that the award may need to be managed as a cooperative agreement. Circumstances defining when a grant should be managed as a cooperative agreement are defined in the document entitled "Cooperative Agreements" available at http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/IRP-ERP-Cover-Memo- 10-27-99.htm. If an intramural scientist believes that his/her contribution requires a cooperative agreement, the Scientific Director of the involved Institute should be alerted when the letter of collaboration is submitted, and, if appropriate, the Scientific Director should notify the grants management office of their Institute or Center about the nature of the collaboration. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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/research training issues to: Jeanne McDermott 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: Elliot Postow Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 4160 Bethesda, MD 20892 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 Bethesda, MD 20892 Telephone: (301) 451-6830 Fax: (301) 594-1211 Email: butrumb@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001The 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) 710-0267, Email: GrantsInfo@nih.gov. The research training application (20-page limit) should include: o the goals, objectives and plan for meeting the objectives for the planning grant (2 pages) o how the proposed program will address the research needs and health priorities defined by the country (2 pages) o the background of the research and training collaborations of the institutions, the Principal Investigators and of the faculty proposed to be the research-training partners, and the organizational structure at each institution that will be available for the proposed training program (3-4 pages). o the resource gaps and potential ways to fill these gaps (2 pages) o the current and future clinical, operational and health services research that will serve as the research base for the proposed training program, and other ongoing and future FIC and other research and training programs and potential cooperating partners in the country with whom the proposed program can link (3-4 pages) o plans for coordinating preparation of the application for the comprehensive program with all partners and with FIC and other NIH and USG staff involved as co-sponsors and an estimated time frame for the development of the comprehensive application (2-3 pages). Include biographical sketches and letters of commitment from the foreign institutions, foreign Principal Investigator, and potential collaborating institution and collaborating Principal Investigator, and a list of the recent (within past five years) and active research and training activities in HIV and/or TB in which the foreign institution and Principal Investigator have been involved. Please include grant number (if applicable) and the funding agency. Please refer to the Review Criteria In the next section of the PA to guide you in the preparation of your application. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement (PA) will be accepted on the receipt dates listed in the heading of this PA. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed planning grant o Name, address and telephone number of the Principal Investigator o Names of other key personnel (including the proposed U.S. or non-U.S. major collaborator) o Participating institutions o Number and title of this PA 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. 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 SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this PA. 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 PA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. 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 Upon receipt, applications will be reviewed for completeness by CSR, and responsiveness by the FIC and co-sponsoring institutes and organizations. Incomplete and/or non-responsive applications will be returned to the applicant. Applications that are complete and responsive to this PA will be assigned to FIC. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the CSR in accordance with the standard NIH peer review procedures with the review criteria stated below. As part of the initial merit review, all applications will: o receive a written critique o be discussed and assigned a priority score, and o receive a second level review by the FIC Advisory Board and other co- sponsoring Institute/Center (IC) Boards, as necessary. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. o Significance o Approach o Innovation o Investigator o Environment Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance o Has the applicant adequately documented that there is a significant HIV/AIDS and/or TB problem in the home country? o Is the applicant in a position to design a program that provides capacity building in support of the NIH, other USG and other international efforts to respond to the global health crisis posed by HIV/AIDS and/or TB? o Does the foreign institution have the potential to serve as a training site to advance an integrated approach to clinical, operational, and health services research related to HIV/AIDS and/or TB within the country and potentially within the region? (2) Approach o What is the likelihood that the applicant could develop a comprehensive ICOHRTA AIDS/TB program that would be supportive of and well-integrated with other relevant HIV/AIDS and TB programs in the foreign institution and within the country? o Has the applicant chosen a suitable collaborating U.S. (or non-U.S.) partner with which to implement any future comprehensive program? o Does the applicant present a realistic, stepwise plan for developing a coordinated application for a comprehensive program? o Has the applicant identified an institutional (organizational) structure to implement a future comprehensive program? o Has the applicant outlined an approach for preparation of an institutional development plan demonstrating how resources from a comprehensive program award would be integrated with other resources in the country? (3) Innovation o What is the likelihood that the planned program would take advantage of the foreign institution's research infrastructure and that of previous and current FIC and NIH investments and support, or support from other organizations? o Are there creative strategies to take advantage of relevant opportunities in the applicant's or in other countries? (4) Investigator o Has the applicant and collaborating U.S. (or non-U.S.) partner demonstrated an exemplary record in HIV/AIDS and/or TB clinical research and training in resource-poor settings and is the applicant currently funded for this research and training? Has the applicant documented that there would be very strong linkage to the ongoing clinical research as part of any future comprehensive program? o Is there a record of successful research or training collaboration among the foreign Principal Investigator, collaborating Principal Investigator, and key faculty of both institutions? o Do the Principal Investigators hold faculty or other long-term research positions at a public or private non-profit research institution that will allow them adequate time and resources to play leadership roles in the program? o Are the foreign Principal Investigator, collaborating Principal Investigator, and all mentors appropriately well-qualified to implement the activities of any planned comprehensive training program? o Is there evidence of a commitment by the foreign institution and its U.S. (or non-U.S.) partners to form long-term collaborative research and research- training relationships? (5) Environment o Is there a written commitment by the foreign government and Ministry of Health to the long-term goals and activities of any future comprehensive program? o What is the likelihood that any future program would be able to take advantage of unique features of the scientific environment or employ useful collaborative arrangements? o Are there adequate mentoring resources and a supportive training environment in-country as evidenced by: 1) the quality of teaching and the in-country research facilities; 2) the availability of high-quality candidates for training, chosen on merit; and 3) 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? o Are there plans to establish Institutional Review Boards (IRBs) or Ethics Committees (ECs) in all participating foreign institutions, if not already established? The scientific evaluation of each application will also include assessment of the strength of the linkage (integration and coordination) between the foreign and the collaborating components and between proposed training and ongoing clinical, operational, and health services research, other current training programs supported by FIC, and research and prevention programs supported by co-sponsoring NIH institutes, USG agencies, international organizations, foundations, etc. Planning award applications will be reviewed for their potential to be developed into competitive applications for Comprehensive ICOHRTA-AIDS/TB Cooperative Agreements. Evidence of support for this program by collaborating institutions and foreign governments must be submitted in writing with the application. 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: PROTECTIONS: The adequacy of the proposed plans for protection for humans, animals or the environment, to the extent they may be adversely affected by future projects undertaken under a comprehensive program. 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 IRBs or ECs or equivalent ethical review boards, data and safety monitoring boards, and community advisory boards as a part of the program. INCLUSION: The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the future training-related research. Plans for the recruitment and retention of subjects will also be evaluated. IRBs or ECs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women, minorities, and children in research involving human subjects in their countries. BUDGET: The reasonableness of the proposed budget and duration in relation to the proposed plan. o Recipients of one year planning awards and those wishing to submit amended applications from this competition may submit these applications for funding consideration in conjunction with the schedule for reviews under this PA and the subsequent RFA for the comprehensive program. AWARD CRITERIA Applications submitted in response to this PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to programmatic priorities and geographic balance, including programs and priorities of collaborating co-funding partners. o The most important factor to be considered in making funding decisions will be the quality of the proposed project, as determined by initial scientific peer review. The proposed plans for instruction in the responsible conduct of research must be rated adequate for an award to be made. Geographic and programmatic balance, as well as input from the co- sponsoring partners and their Councils or Advisory Boards, and the FIC Advisory Board, will also be considered in making funding decisions. A consideration for funding will be whether the plan for the proposed training and capacity building program facilitates and is integrated with (or duplicates) efforts in other FIC, NIH, and other international programs, and whether it supports a unique intervention and care opportunity not able to be accommodated by another FIC or NIH 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. 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 PA 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance 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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