EXPIRED
This Program Announcement expires on December 1, 2004, unless reissued. PLANNING GRANTS TO ORGANIZE PROGRAMS FOR INTERNATIONAL CLINICAL, OPERATIONAL, AND HEALTH SERVICES RESEARCH TRAINING FOR AIDS AND TUBERCULOSIS PA NUMBER: PA-02-022 Release Date: November 28, 2001 (see replacement PAR-03-072) Fogarty International Center (FIC) (http://www.nih.gov/fic) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/default.htm) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.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) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) Office of AIDS Research (OAR) (http://www.nih.gov/od/oar/index.htm) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.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/) Letter of Intent Receipt Date: February 20, 2002 Application Receipt Date: March 19, 2002 THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE 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 AIDS, TB or both are significant problems. As used in this Program Announcement (PA), the term ICOHRTA-AIDS/TB should be interpreted as building capacity for integrated clinical, operational, and health services research encompassing the full range of conditions and issues (e.g., opportunistic infections, HIV malignancies, neurological and mental health consequences, behavioral issues, hematologic conditions, blood safety issues, pulmonary manifestations, ophthalmologic manifestations, gastrointestinal conditions, drug and alcohol usage, gender-related issues and oral health manifestations) that relate to care of adult and pediatric patients with HIV/AIDS or TB. This program is an integral and critical component of a comprehensive global strategy of the 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 by extending and intensifying 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 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, beginning in fiscal year 2002, will consist of one year planning grants to foreign institutions using the R21 grant mechanism. The R21 grant will provide support to organize, plan for, prepare, and assemble an application for a Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement. During an R21 award, the applicant should: 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 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 2003, and will provide comprehensive sustained support to both the foreign institution and its linked U.S. partner (or pre-approved non-U.S. institution) through five-year cooperative agreements (potentially renewable). 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 in support of development and extension of core capabilities necessary for long-term sustainability. The Fogarty International Center (FIC), together with NCI, NIAAA, NIAID, NICHD, NIDA, NIMH, NINDS, OAR, OBSSR, ORWH, and CDC, invites applications for one year planning grants to develop international clinical, operational, and health services research training programs which 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). Co-sponsoring institutions are United States Government (USG) agencies contributing financial resources to the program. Cooperating organizations are organizations whose resources are made available to be utilized in support of the program. Applicants are strongly encouraged to design programs that provide capacity building in support of the National Institutes of Health (NIH), United States Government (USG), and other international efforts to respond to this global health crisis (see special requirements for examples). NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition. In the context of this PA, this definition of clinical research includes studies of an intervention 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 ways to deliver, monitor, and sustain AIDS and/or tuberculosis 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 to best 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. This research also includes studies of quality, cost, and effectiveness of proven therapeutic or prevention interventions. 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. The training-related research subjects for all types of eligible research may be individuals or groups, such as families, organizations, institutions, communities, or populations. RESEARCH AND PUBLIC HEALTH OBJECTIVES AND SPECIAL REQUIREMENTS FOR THE COMPREHENSIVE PROGRAM In developing proposals for planning grants, applicants need to be aware of the objectives and special requirements for the comprehensive program as described below. 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 types of training under the comprehensive program will include: 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 clinical research in masters or doctoral programs, with the understanding that all thesis-related work would be done in the trainee's home country. With prior FIC approval, pre-masters training will be allowed for health professionals with demonstrated interest and capability, but whose prior professional education does not include a bachelor's level degree (e.g., nurses, midwives, laboratory technicians). 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, grant writing, preparation of scientific manuscripts, technology transfer, and data management or Internet connection. o Intermediate-term (three to 12 months) training or mentoring, including specialized clinical and laboratory skills necessary to support clinical, operational, and health services research that is planned or ongoing. While a range of short- 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 at the participating foreign institutions. Each research-training proposal for a comprehensive program should incorporate a number of long-term (greater than one year), intermediate term (three to 12 months) and short-term (less than three months) training opportunities (including advanced in-country research) in a wide range of relevant disciplines and skills necessary to advance research objectives while building sustainable clinical, operational, and health services research capacity at a center of research excellence at a foreign site. To a limited extent, U.S. trainees will be eligible for foreign research experience under this comprehensive program, with prior FIC approval, if they have uniquely relevant expertise and skills that will contribute to the training and research 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 program directors to include women and minorities 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. Examples of this area of research include studies: to address the optimal therapeutic regimens and delivery systems for treatment of people with HIV/AIDS and/or tuberculosis and related conditions; to determine the impact of treatment on the factors favoring drug resistance; to evaluate the prevalence and spread of resistant virus and strains of M. tuberculosis and measures to mitigate these events; to define and evaluate behavioral interventions and health systems reforms that promote compliance with optimal treatment regimens; to identify the co-factors and interactions that propagate the epidemics of HIV/AIDS and/or tuberculosis (e.g., concomitant sexually-transmitted diseases, nutritional status, blood safety, gender differences); to identify effective interventions to improve the quality of life, including palliative care, for men, women, and children living with HIV/AIDS and/or TB; and the impact of gender on stigma, on access to health services for HIV/AIDS and/or TB therapy. 2. The prevention and/or reduction of spread of HIV and tuberculosis and related conditions, especially that which can be implemented within the context of care. Examples of this area of research include studies: to evaluate the impact of the availability of treatment and care on the willingness of people to be tested and to receive their results; to evaluate the effectiveness of prevention measures (behavioral change, condom use, microbicides, compliance) when offered in conjunction with testing and treatment; to evaluate the impact of maternal treatment on mother to child transmission and child survival; to understand gender differences on acceptance and effectiveness of therapies, care and prevention. 3. The study of strategies for scale up and integration of effective therapeutic and preventive interventions into the local health care system. Some examples of research in this area include studies of effective monitoring strategies in settings with limited laboratory and medical specialization; integration of voluntary counseling and testing (VCT) into health care systems; the system features required to ensure availability of clinical monitoring, appropriate laboratory tests, and drug supply; the best training and utilization of physicians and other categories of health care workers to optimize coverage, compliance, and access to the full range of services that constitute care for individuals living with HIV/AIDS and/or TB. 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 requisite for success by building on existing research and training programs involved with the implementation of prevention and care interventions at the country level. 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 a competitive application for a Comprehensive ICOHRTA-AIDS/TB Cooperative Agreement as a linked dual application between the foreign and a U.S. (or other) developed country institution which will have the following Special Requirements: o The foreign principal investigator and the collaborating developed country principal investigator will be responsible for the overall conduct of the ICOHRTA-AIDS/TB. The research partner institutions of the foreign principal investigator and the collaborating principal investigator 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 comprehensive application if not already available at the time of submission of the planning grant. Should NIH intramural labs or programs be involved in the ICOHRTA-AIDS/TB application, they must also be party to these agreements. Participation by NIH intramural programs requires concurrence by both the scientific directors of the participating institutes and the Deputy Director for Intramural Research of the NIH. o Both the foreign and collaborating site must demonstrate the capacity and leadership necessary for the successful implementation and long-term productivity of the program. Both 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 principal investigator must be directly involved in and funded to do clinical research in resource-poor settings and there must be tangible evidence of very strong linkage to that ongoing research. Each site should provide a comprehensive list of these awards for at least the past five years to support its designation of institutional center of excellence status in this field. o Evidence of plans for linkage to and coordination with other sources of in- country research and training support is required. Examples include: FIC training and research programs (e.g., AIDS, tuberculosis, maternal and child health, emerging infectious diseases); NIAID programs (Comprehensive International Program of Research on AIDS (CIPRA), the HIV Vaccine Trials Network, the HIV Prevention Trials Network, NIAID tuberculosis programs supporting the conduct of TB drugs, vaccine efficacy trials and infrastructure/research capability strengthening as well as Centers for AIDS Research (CFARs) and the AIDS Clinical Trials Groups (ACTG and PACTG); NICHD AIDS programs (Global Network on Women's and Children's Health Research, Pediatric/Perinatal HIV Clinical Trials Network, African Partnerships Program); NIMH AIDS programs (NIMH Collaborative HIV/STD Prevention Trial); NCI programs related to AIDS; NIDA programs related to AIDS (Global Research Network); NHLBI programs related to AIDS (e.g. blood safety); NIAAA programs related to AIDS; the Global AIDS Program and Field Epidemiology Training Program (FETP) of the Centers for Disease Control and Prevention; USAID AIDS and TB programs; UNAIDS; Global Fund to Fight AIDS, Tuberculosis and Malaria; WHO AIDS and TB programs; UNICEF AIDS programs; and non-government and faith- based organizations involved in international control of HIV/AIDS and TB (e.g., the Bill and Melinda Gates Foundation, the Elizabeth Glaser Pediatric AIDS Foundation, the Rockefeller Foundation, the International Union Against Tuberculosis and Lung Diseases, the Sequella Global Tuberculosis Foundation, the Academic Alliance for AIDS Care and Prevention in Africa, Doctors Without Borders, the American Foundation for AIDS Research, the Global Alliance for TB Drug Development, the International AIDS Vaccine Initiative, Catholic Relief Services and many others). o Applicants must describe plans to help assure that the ICOHRTA-AIDS/TB will be supportive of and integrated with other relevant programs in the foreign institution and within the country (such as those listed above). They should describe how this program can serve as a bridge between academic research and public health communities within the country as well as to help link various HIV/AIDS and TB trials supported in the country by NIH and other sponsors. o Applicants should identify their plans to assure that training and capacity building supports the HIV/AIDS and TB-related clinical, operational, and health services research priorities of the participating foreign country and should describe the procedures to assure this takes place within the context of the collaborative relationship. o The application 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 application to describe strategies to achieve a wider regional impact. This could be done by strengthening other institutions in the foreign principal investigator 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. o 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) 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. o Before any funds may be expended on in-country training-related research, the grantee institution must show written evidence of federal-wide assurances for the collaborating institutions, and 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. Applicants should document their plans for meeting this requirement. 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 Program Announcement (PA), International Clinical, Operational, and Health Services Research Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB), 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/. ELIGIBILITY REQUIREMENTS Phase I - One Year Planning Grants (R21) to foreign institutions To qualify, principal investigators must be directly involved in and funded to do 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 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. Eligible foreign sites include countries in 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. In order to best support the building of sustainable research in low-income and transitional economy countries, planning grants to support the preparation of a comprehensive ICOHRTA-AIDS/TB application will be made only to 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. The principal investigators 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. Phase II - 5 year Comprehensive Cooperative Agreements (beginning FY 2003) Foreign grantees that have been awarded an ICHORTA-AIDS/TB Planning Grant may subsequently apply for Comprehensive ICHORTA- AIDS/TB Cooperative Agreements under a future FIC Program Announcement for this purpose. The PA will require that foreign applicants partner with an institution in the U.S. or (with pre- approval) in another developed country to submit a package of two grants to be reviewed as a single unit. The partners of successful packages or units that are chosen to be funded will each receive an award. The foreign site and foreign principal investigator will designate a developed country institution as its partner, and the principal investigator at this site will be referred to as the collaborating principal investigator. The linked institutions will be referred to as "research partners." With prior FIC approval, the designated principal collaborator may be a non-U.S. institution or an NIH intramural research program, provided that each commits significant resources to this program. Also with prior FIC approval, and concurrence from the foreign PI, the collaborating principal investigator may involve additional institutions as collaborating partners through a subcontract or consortium arrangement. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Only one application will be allowed from any foreign institution except if a foreign applicant also is collaborating with an NIH intramural research program in which case two applications are allowed. 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 both the scientific director of the participating institute and the Deputy Director for Intramural Research of the NIH. The participating NIH intramural program must pay for the participation of its own staff, including travel expenses, and for any research costs at NIH. The applications from the linked foreign and collaborating institutions must demonstrate that, for each site, both the Principal Investigator and the institution have a track record of commitment and experience in related clinical research and training. The principal investigators 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. MECHANISM OF SUPPORT Phase I - One Year Planning Grant to a Foreign Institution For Phase I of the program, this PA will use the National Institutes of Health (NIH) R21 planning grant mechanism. If an NIH intramural investigator is involved in the program, the planning grant will be converted to a cooperative agreement at the time of award. Involvement of an intramural investigator in the program includes collaboration which 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. 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 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. 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 R21 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. Phase II - 5 Year Comprehensive ICOHRTA-AIDS/TB Cooperative Agreements with Linked Foreign and U.S. (or Other) Partners FIC plans on issuing a PA for funding in fiscal year 2003 for Comprehensive ICOHRTA-AIDS/TB Research Training Awards. International Institutional Training Cooperative Agreements will be made with each of the research partners for a five year period. These will be renewable for a second five- year period as a competing renewal application. Each research partner will receive total direct costs up to $250,000 per year, as well as facilities and administrative (F&A) costs limited to eight percent. Please see the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the permissible F&A costs for foreign and international organizations. Awards made to foreign institutions for collaboration with NIH intramural programs will also be made as cooperative agreements and will be limited to the amount agreed to by the involved NIH Institute. FUNDS AVAILABLE The FIC and co-sponsoring partners intend to commit approximately $1,000,000 to fund an estimated twelve planning (R21) grants from this PA in fiscal year 2002. The FIC plans to issue a PA for the Comprehensive ICHORTA-AIDS/TB cooperative agreements for funding in fiscal year 2003. FIC and co-sponsoring funding partners intend to commit approximately $3,500,000 each year to fund an estimated six planning grants and six Comprehensive ICOHRTA-AIDS/TB cooperative agreement programs from this PA and the PA for the comprehensive program each fiscal year beginning in fiscal year 2003, subject to availability of funds. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following web site: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed planning grant, the name, address and telephone number of the Principal Investigator, the proposed U.S. (or non- U.S.) major collaborator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. 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 to Dr. Jeanne McDermott at the address listed under INQUIRIES by the letter of intent receipt date listed in this PA. APPLICATION PROCEDURES Specific application instructions have been modified to reflect "Modular Grant" and "Just-in-Time" streamlining efforts that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (Rev. 5/01). http://grants.nih.gov/grants/funding/modular/modular.htm. The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The application should follow the PHS 398 instructions with the following modifications: The PA label available in the PHS 398 (rev. 5/01) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application, such as it may not reach the review committee in time for review. In addition, the PA title and number must be typed on line two of the face page of the application form and the YES box must be marked. The PA number must be typed on the label as well. The sample PA label available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed original of the application, including the checklist, and three 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). At the time of submission, two additional copies of the application and appendices must be sent to: Dr. Madelon Halula at the address listed under INQUIRIES. 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. o The research plan should be replaced with the following: 1) A project summary (fifteen page limit) describing the goals, objectives and plan for meeting the objectives for the planning grant. Describe 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. Describe the organizational structure at each institution that will be available for the proposed training program. Identify resource gaps and potential ways to fill these gaps. Describe the current and future clinical, operational and health services research that will serve as the research base for the proposed training program. Identify 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. Describe how the proposed program will address the research needs and health priorities defined by the country. Include an estimated time frame for the development of the comprehensive application. Describe 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. o Biographical sketches and letters of commitment from the foreign institutions, foreign principal investigator, and potential collaborating institution and collaborating principal investigator. o A list of the recent (within past five years) and active research and training 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. 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. REVIEW CONSIDERATIONS 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 the PA will be assigned to FIC. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIAID 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 receive a written critique, and will be discussed, assigned a priority score, and receive a second level review by the FIC Advisory Board. 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 build an integrated 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. 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 high (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. The scientific evaluation of each application will include assessment 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. In addition, the following review criteria will be used (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 National Institutes of Health (NIH), other United States Government (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 IRBs in all participating foreign institutions, if not already established? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o 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 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. o The reasonableness of the proposed budget and duration in relation to the proposed plan. o 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 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 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 PA for the comprehensive program. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities and geographic balance, including priorities of collaborating co-funding partners. 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 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. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jeanne McDermott, C.N.M., M.P.H., Ph.D. Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-496-1653 Fax: 301-402-0779 Email: mcdermoj@mail.nih.gov Direct inquiries regarding grants management and fiscal matters to: Bruce Butrum Grants Management Officer Fogarty International Center Building 31, Room B2C29 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-451-6830 Fax: 301-594-1211 Email: butrumb@mail.nih.gov Direct inquiries regarding review issues to : Madelon Halula, Ph.D. Special Review Program Division of Extramural Activities National Institute of Allergy and Infectious Diseases Scientific Review Program 6700 B Rockledge Drive Room 2215, MSC 7616 Bethesda, MD 20892-7616 (For express/courier service: Bethesda, MD 20817) Telephone: (301) 402-2636 Fax: (301) 402-2638 Email: mh30x@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.989. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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