Full Text AI-95-002 TROPICAL MEDICINE RESEARCH CENTERS NIH GUIDE, Volume 23, Number 40, November 18, 1994 RFA: AI-95-002 P.T. 04 Keywords: 0715151 Biomedical Research, Multidiscipl National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: December 19, 1994 Application Receipt: May 16, 1995 PURPOSE The Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for multiproject center grants from institutions in geographic areas where tropical infectious diseases are endemic. These centers of excellence, designated as Tropical Medicine Research Centers (TMRCs), will conduct interdisciplinary research on parasitic and other tropical infectious diseases, which will lead to the development, evaluation and deployment of new and/or improved intervention strategies to prevent and control these diseases. The intent of the TMRC program is to bring together relevant biomedical knowledge and technology to develop and evaluate new approaches for the detection, prevention and treatment of infectious diseases of recognized importance to the health of people living in tropical countries. It is envisioned that this program will enhance opportunities for relevant experience in tropical disease research and will promote scientific linkages and interaction between U.S. and foreign investigators. Each TMRC will be included as a component of the NIAID's network of International Centers of Tropical Disease Research (ICTDR). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Tropical Medicine Research Centers, is related to the priority areas of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-782-3238). ELIGIBILITY REQUIREMENTS Organizations and institutions with facilities in or near an area, outside of the United States, where tropical diseases are endemic, are eligible to apply for center grants under this RFA and the research will be carried out in that area. Applications may be submitted by for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories and government agencies in the host country. To achieve the goals identified in the application, subcontract or consortium arrangements are permitted with other overseas institutions. It will be necessary for each TMRC to demonstrate a working relationship with the appropriate government organization in the host country. It may also be convenient to develop a collaborative association with an organization such as Pan American Health Organization or the World Health Organization. Only institutions with strong ongoing research programs and resources that can focus on a multidisciplinary approach on tropical infectious diseases will be considered for TMRC support under the provisions of this RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the specialized center (P50) grant. This is a mechanism for the support of any phase of research activities ranging from basic to more applied field and clinical research and development aspects. This research may require ancillary activities such as protracted patient care necessary to support the primary research and/or research and development effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. Unless specifically stated to the contrary herein, all policies and requirements that normally govern the grant programs of the PHS will apply. The responsibility for leadership of each TMRC rests with the program director (PD) who must possess demonstrated scientific and administrative competence. The PD should be located at and affiliated with the institution at which the TMRC will reside. The PD must show a substantial commitment of time and effort to the program and exercise leadership in the maintenance of its quality control. If desired, a U.S. Co-PD may be designated. Each TMRC must consist of three or more scientifically meritorious projects whose interrelationships will result in a greater contribution to the program goals than if each project were pursued individually. There must be a unifying, well-defined goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of the others. Each research project included in the application must, as assessed by peer review, stand on its own independent scientific merit, as well as complement the other projects whenever feasible. Each of the individual projects within the TMRC should be under the leadership of an established investigator who would be the principal investigator (PI) for the specific project. These multiple projects require the participation of investigators in several disciplines with special expertise in several areas of one discipline. All investigators must contribute to, and share in, the responsibilities of fulfilling the objective of the TMRC. Support for certain common resources (cores) may also be requested. Such resources (e.g., laboratory or clinical service facilities) should be utilized by two or more projects within the TMRC when such sharing facilitates the total research effort. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total requested period of support may not exceed five years. At this time, the NIAID is administratively limiting the duration of center grants to four years; this administrative limitation may change in the future. These P50 applications should not request budgets in excess of $550,000 total costs in the first year. Currently, NIAID awards no more than four percent annual inflationary increases for future years. It is the policy of the Public Health Service that indirect costs will not be paid to organizations located outside of the territorial limits of the United States. The earliest anticipated award date is April 1996. FUNDS AVAILABLE The estimated total funds available for the first year of support for this RFA will be $1.6 million. In fiscal year 1996, the NIAID plans to fund approximately three center grants related to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory scientific progress during the preceding years and availability of funds. Satisfactory progress will be assessed by NIAID staff, including their review of material presented in annual reports. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background Infectious diseases represent a tremendous public health threat for people living in tropical and subtropical regions of the world and are responsible for limiting individual productivity and socioeconomic development. It is estimated that 20 percent of the world's population carries a helminthic parasite infection, and that 10 percent are infected with those parasites causing malaria, schistosomiasis, filariasis, leishmaniasis or trypanosomiasis. Enteric infections, caused by viruses, bacteria and protozoa, as well as mycobacterial infections, especially leprosy and tuberculosis, are responsible for immeasurable global morbidity and mortality. Childhood mortality rates in tropical developing countries are at least ten times higher than those in industrialized countries. This difference is to a large extent attributable to the prevalence of diarrheal and acute respiratory diseases. The magnitude of many tropical disease problems in endemic areas is increasing, due to changing ecological patterns and to the failure of currently available control measures, e.g., as a result of microbial drug resistance. Moreover, tropical diseases are of increasing global concern as tourism, trade, business travel, immigration and military activities extend the range of infectious agents and invertebrate vectors. An Institute of Medicine committee articulated these issues in its report entitled Emerging Infections: Microbial Threats to Health in the United States (National Academy Press, Washington DC, 1992) and recommended the support of increased research efforts on surveillance and applied disease control strategies. The report specifically identified expanding research efforts on diagnostics, vaccines, antimicrobial drugs and vector control. Advances in biomedical technology are opening up exciting possibilities for the development of vaccines, chemo- and immunotherapeutics, and transmission control methodologies for all the major tropical diseases. For example, there are now multiple defined antigens that have been shown to induce protective immunity in laboratory animals, which require further preclinical and clinical research to evaluate their vaccine potential. In addition, the use of cytokines as adjuvant therapy for infectious diseases is showing great promise in animal models. The need for sustained research support in these areas has never been greater, especially for those clinical and field efforts dependent upon access to populations of pathogens, patients and invertebrate vectors. The NIAID has long been the lead Federal agency for support of research and training on tropical infectious diseases, funding the development of new control strategies through a combination of investigator-initiated grants and special Institute-initiated programs designed to encourage more application-oriented work. In 1991, NIAID established a competitive program to fund institutions, in endemic areas, to carry out research on tropical diseases. The TMRC program was initiated to support the infrastructure and expertise necessary to develop and assess new approaches to the control of complex tropical infectious disease problems. Currently there are three TMRCs. Scope of Research The research to be supported by this RFA will focus on those infectious diseases primarily endemic in or which profoundly impact upon people living in the tropics. Diseases of interest include, but are not limited to, those resulting from infection with protozoa and helminth parasites, enteric bacteria and viruses, mycobacteria and arboviruses. Emphasis is placed on those diseases for which recent discoveries and developments, leading to new and/or improved control strategies, require facilities and infrastructure for further testing and evaluation in the field and in the clinic. Studies of human immunodeficiency virus (HIV) infections in developing countries are supported by other NIAID activities, and will not be considered in response to this solicitation. Studies of the impact of HIV infection on the clinical course and outcome of other tropical diseases and on control programs for these diseases will, however, be considered. Each TMRC should organize a multidisciplinary research effort that will bring together relevant biomedical knowledge and technology to achieve a greater understanding of the world's tropical infectious diseases and to develop and test new intervention strategies for these diseases. Relevant research activities for each TMRC may include projects on clinical, epidemiological and field aspects of tropical diseases as well as on supportive basic research areas related to the biology of host-infectious agent interactions, utilizing such disciplines as genetics, immunology, pharmacology, bacteriology, virology, parasitology and medical entomology. The goals of the research projects should be the development and evaluation of diagnostic tests, immunotherapeutic and immunoprophylactic measures, chemotherapeutic and chemoprophylactic methods, and vector control strategies as well as other approaches that may be deployed as part of disease control programs relevant to national control efforts on these diseases. Projects may involve collaboration among investigators at several institutions. Consortium arrangements should follow the NIH Guide outlined in "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the program staff listed under INQUIRIES. SPECIAL REQUIREMENTS Research at the applicant institution in the endemic area will be supported directly by NIAID. Fiscal and administrative arrangements for the transfer of funds and materials to the applicant institution and for the management of these funds and materials must be described in the application. Travel, salaries and fringe benefits will be subject to the applicant institution's rules and regulations. Successful TMRCs will be designated as components of the NIAID International Centers for Tropical Disease Research (ICTDR), which constitutes a network of NIAID-supported activities in tropical diseases (see Appendix). Each TMRC program director will represent his/her TMRC at the annual meeting of the ICTDR network organized by NIAID. These meetings will be held to share advances in tropical disease research among the TMRC projects and other NIAID-supported tropical disease research programs and activities, to discuss research needs and opportunities in this arena, and to facilitate the development of new collaborative protocols that may include multi- center studies. Provision should be made for the TMRC Program Director to travel to the annual meetings of the NIAID ICTDR network to be held in the Washington, DC area and generally lasting three days. Such anticipated travel costs should be identified in advance and built into the budget of the TMRC application. Other TMRC personnel are encouraged, but not required, to attend the ICTDR meetings, and travel support will be at their own discretion. Applications must also include a Visiting Investigator component, which should be described as a separate Core constituent. Under the terms of this Core, provision will be made by the TMRC for visiting investigators to spend up to one year in residence to study tropical disease problems of their own interest or participate in ongoing programs of the TMRC. This provision is intended to afford opportunities for tropical disease research experience at the TMRC primarily to U.S. scientists, although non-U.S. scientists may be eligible as conditions permit. The application should detail: the facilities available at the applicant institution to host visiting investigators, the procedures to be used to advertise the program and to recruit such visiting investigators, and the method by which their research projects will be evaluated and approved. Those selected will require the approval of NIAID program staff. Funds allotted to the visiting investigator core should not exceed $50,000 per year to cover the anticipated costs of travel, supplies, and salary. Funds initially designated for this core are restricted for this purpose and cannot be rebudgeted to other programs within the Center. Applicants must be aware of policies and procedures for the conduct and oversight of clinical research studies and of clinical trials. NIH defines all biomedical and behavioral research involving human subjects as clinical research. For the purposes of NIH policy, a clinical trial is defined as a broadly based prospective phase III clinical investigation that is designed to evaluate an experimental intervention in comparison with a standard or control intervention or to compare two or more existing treatments. NIAID's Division of Microbiology and Infectious Disease has developed guidelines for the establishment, responsibilities and operating procedures of data safety and monitoring boards (DSMBs) for clinical trials. A copy of these guidelines is available from Dr. Michael Gottlieb at the address listed under INQUIRIES. Applications must include details for the implementation of these guidelines where relevant in the proposed studies. Recent advances in satellite remote sensing technology and in computerized geographic information systems (GIS) have been applied to the study of infectious diseases and their distribution. These tools have provided predictive data for such purposes as identifying geographic areas where there is an increased risk of vector-borne disease transmission. Investigators seeking to employ remote sensing in their studies of tropical diseases should clearly indicate this fact in the application. In this regard, applicants should prepare a separate budget indicating the funds and resources required for the conduct of such studies. This budget should be clearly identified and should not be considered as part of the $550,000 limit indicated above. Applicants are strongly encouraged to contact Dr. Michael Gottlieb at the address listed under INQUIRIES for more information and assistance. 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 subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. The NIH policy on inclusion of women in research conducted outside the U.S. is the same as that for research conducted in the U.S. With regard, however, to the population of the foreign country, the definition of the minority groups in foreign countries may be different than in the U.S. If there is a rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from Dr. Gottlieb at the address listed in INQUIRIES below, who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by December 19, 1994, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Prospective applicants are also asked to submit a list of the key investigators and their institution(s). Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements," available from Michael Gottlieb at the address listed under INQUIRIES. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number AI-95-002 and the title "TROPICAL MEDICINE RESEARCH CENTERS." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application and all five sets of appendices must also be sent to Dr. Olivia Preble at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Olivia Preble by May 16, 1995. Applications not received by May 16, 1995 will be considered non- responsive and will be returned to the applicant without review. Current NIH policy permits a component research project of a multi- project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R0l and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi- project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Procedures Applications will be reviewed by DRG staff for completeness and by NIAID staff to determine administrative and programmatic responsiveness to this RFA. Those judged to be incomplete or non- responsive will be returned to the applicant without review. Those considered complete and responsive may be subjected to a triage review by an NIAID peer review group to determine their scientific merit relative to the other applications submitted in response to this RFA. The NIAID will withdraw from competition those applications judged by the triage peer review group, before or during the initial review group meeting, to be noncompetitive for award and will so notify the applicant investigator and the institutional business official. For applications found non-competitive, summary statements will be very brief and will generally contain unedited reviewers' comments, indicating the major reason(s) for the non- competitive rating. Those applications judged to be competitive for award will be reviewed for scientific and technical merit by a Review Committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The review criteria for P50 center grant applications are the same as review criteria for large, multicomponent, interdisciplinary program projects as outlined in the brochure, NIAID PROGRAM PROJECT GRANTS AND MULTIPROJECT COOPERATIVE AGREEMENTS. The distinguishing features of a multiproject center grant include: o A unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence; he/she must show a substantial commitment of time and effort to the center and exercise leadership in its quality control. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o These multiple projects require the participation of established investigators in several disciplines, or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share in the responsibilities of fulfilling the center's objective. In addition, the following criteria will be considered in the scientific review of the application: o Relevance of research approach, design, and methodology to the development and evaluation of intervention strategies for the control of tropical diseases. o Adequacy of appropriate facilities for laboratory, field and clinical studies. In studies involving clinical trials, this includes adequacy of procedures for the establishment and operation of a DSMB. o Mechanisms proposed for the visiting investigator component. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. It is the desire of NIAID to fund a group of applications that together will provide a broad spectrum of research opportunities for the development, evaluation and deployment of intervention strategies for the control of tropical infectious diseases. INQUIRIES Written, telephonic, and electronic inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID Information Brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements" and for the new "NIH GUIDELINES FOR INCLUSION OF WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH" as well as inquiries regarding programmatic issues may be directed to: Michael Gottlieb, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A12 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: mg35s@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Olivia Preble, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8208 FAX: (301) 402-2638 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Leslie Marsden Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: leslie_marsden@exec.niaid.pc.niaid.nih.gov Schedule Letter of Intent Receipt Date: December 19, 1994 Application Receipt Date: May 16, 1995 Scientific Review Date: October 1995 Advisory Council Date: February 1996 Earliest Date of Award: April 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.856 - Microbiology and Infectious Diseases Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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