RFA-AI-00-009: TROPICAL MEDICINE RESEARCH CENTERS

Department of Health
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TROPICAL MEDICINE RESEARCH CENTERS Release Date: January 24, 2000 RFA: AI-00-009 (This RFA has been reissued and modified, see RFA-AI-06-006) National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: May 1, 2000 Application Receipt: June 27, 2000 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) invites applications for multiproject center grants from institutions in geographic areas where tropical infectious diseases are endemic. It is the NIAID's objective to develop a flexible tropical disease research network that can be responsive to emerging scientific needs and challenges in the field of tropical infectious diseases. The purpose of the Tropical Medicine Research Centers (TMRCs) program is to support high quality centers for research that will lead to or result in prevention, amelioration, and/or treatment of tropical infectious diseases and thus improve the health and quality of life of individuals in endemic areas. 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 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 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 2010" at http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Non US and non-European organizations and institutions located in the tropics in or near an area endemic for tropical infections are eligible to apply. 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 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 the Pan American Health Organization or the World Health Organization. Only institutions with strong ongoing research programs 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 grant (P50). This mechanism supports all phases of research ranging from basic and developmental aspects to applied field and clinical research. 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 NIH 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 is expected to contribute at least 40% effort to the program and exercise leadership in program development and integration, quality control, administration, and scientific collaboration within the program. If desired, an U.S. Co-PD may be designated. Participation of a US investigator is not a requirement of the program. 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 project to benefit from 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. Each of the individual projects within the TMRC will be under the leadership of an established, non-US or non-European, investigator who will be the principal investigator (PI) for the specific project. Principal investigators are expected to expend at least 25% effort on their individual projects. All investigators must contribute to, and share in, the responsibilities of fulfilling the objectives of the TMRC. To enhance the individual projects as well as the program goals it is envisioned that each TMRC, under the direction of the Program Director, will schedule regular bi-weekly or monthly meetings to foster scientific cooperation and collaboration. Common shared resources e.g., laboratory or clinical service facilities will be requested as cores. Such cores should be utilized by two or more projects within the TMRC. In addition provision for an administrative core with detailed arrangements for financial management is a requirement of the RFA. Responsibility for the planning, direction, and execution of the proposed research plan will be solely that of the applicant. The total requested period of support may not exceed five years. These P50 applications should not request budgets in excess of $600,000 total costs per year. It is the policy of the NIH that facilities and administrative (F&A) costs will not be paid to organizations located outside of the territorial limits of the United States. The earliest anticipated award date is June 2001. FUNDS AVAILABLE The estimated total funds available for the first year of support for this RFA will be $1.75 million. In fiscal year 2001, 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 review of material presented in annual reports and at a required annual reverse site visit. 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. Infectious diseases remain a major cause of death in developing countries. 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. Greater than 70% of deaths in children less than five years of age and greater than 40% of deaths in developing countries are due to infectious and parasitic infections. Enteric infections, caused by viruses, bacteria and protozoa, including mycobacterial infections such as leprosy, are responsible for immeasurable global morbidity and mortality. Childhood mortality rates in tropical developing countries are five 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 morbidity and mortality of many tropical disease problems in endemic areas are increasing, due to changing ecological patterns leading to an increase in incidence and prevalence as well as new pathogens, drug resistance, and failure of currently available control measures. 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. Many fundamental questions about host pathogen interaction remain unanswered. Moreover, advances in biomedical technology and genomics have opened up exciting possibilities for the development of vaccines, chemo- and immuno- therapeutics, and transmission control methodologies for all the major tropical diseases. The need for sustained research support in these areas persists, especially for those clinical and field efforts dependent upon access to populations of pathogens, patients and invertebrate vectors. To address these needs the NIAID initiated the competitive TMRC program in 1991. Currently there are three TMRCs. Scope of Research Projects to be supported by this RFA will focus on infectious diseases primarily endemic in or profoundly impacting people living in the tropics and emphasize research requiring access to human, pathogen, and vector populations. Diseases of interest include, but are not limited to, those resulting from infection with protozoa and helminth parasites, enteric bacteria and viruses, arboviruses, and bacterial meningitis. Emphasis is placed on those diseases for which recent discoveries and developments require facilities and infrastructure for further testing and evaluation in the field and in the clinic. Studies focusing on human immunodeficiency virus (HIV) infections and tuberculosis in developing countries are supported by other NIAID activities, and will not be considered in response to this solicitation. Each TMRC should bring together relevant biomedical knowledge, technology, and expertise in tropical infectious diseases with the ultimate goal to develop and test new diagnostic and intervention strategies. The TMRC program is intended to support research requiring access to populations. Relevant research activities include projects on clinical, epidemiological and field aspects of tropical diseases as well as supportive basic research related to the biology of host- infectious agent interactions. Relevant disciplines include but are not limited to genetics, immunology, pharmacology, bacteriology, virology, parasitology, clinical science, and medical entomology. The goals of the research projects should support the development and evaluation of diagnostic tests, immunotherapeutic and immunoprophylactic measures, chemotherapeutic and chemoprophylactic methods, and vector and other control strategies that may be deployed as part of national control efforts. 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 detail in the application under a required administrative core. Applications should budget approximately $50,000 for the administrative/fiscal core that should focus on financial management and accounting. Fiscal core funds can be utilized to purchase the appropriate hardware and software for required accounting procedures. Applicants must work with a U.S. University or the NIAID in the administrative core, as funds must be first distributed to a United States Bank. The NIAID Grants Management Office must approve final arrangements before an award is made and will be available to answer inquiries regarding these arrangements (see Inquires). An initial start up meeting of the TMRC program directors will be required early in year one at the time of the 2001 ICTDR network meeting to convey information on NIH requirements for human subject research and fiscal arrangements. 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. 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. Each TMRC will have a required annual reverse site visit at the NIH in Bethesda. Thus, provision should be made for the TMRC Program Director to make two trips to Bethesda each year. 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 the discretion of the TMRC. 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 or other members of the ICTDR network. 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 re-budgeted to other programs within the Center. The TMRC Program Director is expected to include plans for the visiting scientist in his/her annual reverse site visit at the NIAID. 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. All human subject research is subject to the NIAID’s terms of award requirements (see appendix), which include requirements for protocol review, safety and site monitoring. Clinical protocols involving human subjects will be reviewed at two stages of development, early (during the concept stage) and later close to protocol completion, for: scientific content, design, safety, feasibility, statistical and regulatory issues such as adverse experience reporting mechanisms and informed consent. All TMRC protocol documents for clinical trials should, at minimum, include the following sections: an introduction, including background and rationale; a statement of the study objectives; criteria for selection of subjects, and enrollment procedures; clinical and laboratory evaluations to be performed; plans for data management, collection, and monitoring, and for reporting of adverse events; a complete description of the study treatment; and statistical considerations, including general design issues, endpoints, sample size, accrual and power, monitoring and analysis, and stopping rules. An ICTDR Data Safety and Monitoring Board, to be selected and overseen by NIAID, will monitor all Phase III TMRC clinical trials. All phase I and II clinical trails will be monitored by interim monitoring boards that will be established jointly by NIAID program staff and the TMRC team. 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 biomedical and behavioral research projects involving human subjects, unless a clear, compelling rationale, and justification are provided 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 research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 which is available via the WWW at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html NIH POLICY AND GUIDELINES ON THE 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 which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may obtain copies from these sources or from Elizabeth Higgs, (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by the date listed on the face page of this RFA, 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). The information in the letter of intent allows NIAID staff to estimate the potential review workload and to avoidance conflict of interest in the review. The letter of intent is neither required nor binding. It does not commit the sender to submit an application, nor does it enter into the review. All potential applicants are encouraged to contact Dr. Elizabeth Higgs listed under INQUIREIES to discuss intended projects. The letter of intent is to be sent to Dr. Peter Jackson at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants for P50 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at http://grants.nih.gov/grants/forms.htm. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "AI-00-009" and the words "TROPICAL MEDICINE RESEARCH CENTERS" must be typed in. The RFA label and line 2 of the application should both indicate the RFA number. The RFA label must be affixed to the bottom of the face page. 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 sample RFA 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. Applications must be received by the Receipt Date listed on the face page of this RFA. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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 mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Peter Jackson at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi- project Application: 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 R01 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. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA Applicants for P50 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm The brochure presents specific instructions for sections of the PHS 398 (rev. 4/98) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398 REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, and assigned a priority score. A 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 40% 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 prevention, treatment, and control of tropical diseases. o Major emphasis on research requiring access to human, pathogen, and vector populations. o Adequacy of administrative and financial core. o Adequacy of appropriate facilities for laboratory, field and clinical studies. 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: Dr. Elizabeth S. Higgs Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive, MSC 7630 Bethesda, MD 20892-7630 Telephone: (301) 496-7115 FAX: (301) 402-0804 Email: eh63a@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: Dr. Peter Jackson Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive, Room 2154 MSC 7616 Bethesda, MD 20892-7616 Telephone: (301) 496-8426 FAX: (301) 402-2638 Email: pj8v@nih.gov (Fed-Ex Mailings use: Bethesda, MD 20817-7613) Direct inquiries regarding fiscal matters to: Ms. Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6700B Rockledge Drive Bethesda, MD 20892-7610 Telephone: (301) 402-6581 Email: lnorwood@niaid.nih.gov Schedule Letter of Intent Receipt Date: May 1, 2000 Application Receipt Date: June 27, 2000 Scientific Review Date: October, 2000 Advisory Council Date: February, 2001 Earliest Date of Award: June, 2001 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, Sections 301 and 405 as amended (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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