RFA-AI-98-009: INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH

Department of Health
and Human Services (HHS)

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INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH Release Date: May 8, 1998 RFA: AI-98-009 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 7, 1998 Application Receipt Date: September 15, 1998 APPLICATIONS FOR MULTIPROJECT COOPERATIVE AGREEMENT (U19) AWARDS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING SPECIFIC INSTRUCTIONS IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS." PURPOSE International Collaborations in Infectious Diseases Research (ICIDR) is a research program sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). The ICIDR RFA is being jointly issued with the Actions for Building Capacity (ABC) RFA (TW-98-004) a research training program sponsored by the Fogarty International Center (FIC), NIH. The research component, ICIDR, will be supported by the NIAID through funding of applications in response to this RFA (AI-98-009). The research training component, Actions for Building Capacity (ABC) will be supported by FIC through funding applications in response to a companion RFA (TW- 98-004). ABC awards will only be made to awardees of ICIDR Research grants. NOTE: Investigators may apply for: (1) an ICIDR research grant only (in response to this RFA) or (2) both an ICIDR research grant (in response to this RFA) and an ABC grant (in response to RFA TW-98-004). Independent applications for research training (ABC) will NOT be accepted. 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 ICIDR RFA is to stimulate high quality collaborative 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. To facilitate this purpose NIAID and FIC have integrated training for foreign investigators into the ICIDR program (see RFA-TW-98-004). The purpose of the FIC training program, Actions for Building Capacity, is to stimulate high quality training and to support current and future collaborative research on infectious diseases that are predominately endemic in or impact upon people living in tropical countries. ICIDR research must focus on protozoan and helminth infections, mycobacterial diseases, bacterial and viral enteric infections, Hepatitis C and E, and fulminant hepatitis of unknown etiology. Applications in arboviral infections and other tropical viral infections are specifically encouraged. Studies focused on the impact of human immunodeficiency virus (HIV) infection or nutrition on tropical pathogens will be considered responsive to this RFA. Single and multiproject programs will be accepted under this RFA, however, all applications must be focused on a single pathogen or disease entity. The intent of the ICIDR is to bring together relevant biomedical knowledge and technology to develop new or improved methods for the prevention, detection, and treatment of infectious diseases endemic in tropical countries that adversely affect the health of individuals living in those and other parts of the world; to increase relevant research experience for both the U.S. and foreign investigators; to enhance opportunities for scientific linkages, interaction and collaboration between U.S. and foreign investigators through regularly scheduled communications, workshops, and meetings; and to provide opportunities for foreign and U.S. cooperation on emerging research opportunities in tropical countries. 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 RFA, International Collaborations in Infectious Disease Research, is related to the priority area(s) of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS For applicants who apply for awards under both this ICIDR RFA (AI-98-009) and the companion ICIDR ABC RFA (TW-98-004), both applications must have the same principal investigator. Applications may be submitted by domestic for-profit and non-profit organizations; public and private institutions, such as universities, colleges, hospitals, laboratories, etc. Foreign institutions are not eligible. Racial/ethnic minority individuals and women are encouraged to apply as Principal Investigators. The U.S. grantee institution is responsible for developing affiliation(s) with an established institution(s) (e.g. university, research institute, federal or state health department, hospital) in the host country. Research activities on this project conducted at the foreign affiliate must be supported under a consortium arrangement by the award made to the U.S. based institution. For the award to be considered, the domestic applicant institution must include proof of having an off-site component as a foreign base of operations and one or more specified employees of the foreign institution as co- investigators. The proposed research programs must be acceptable to the collaborating overseas investigators and their institutions. The application will not be reviewed unless proof of such a foreign affiliation is included. In addition, it will be necessary to establish a working agreement with the government of the host country to expedite deputation of personnel, equipment and supplies from the U.S. to the off-site facility. The agreement may be developed directly between the domestic applicant institution and the representatives of the foreign government, or it may be more convenient for the domestic component to arrange such an agreement through a regional organization such as the Pan American Health Organization or the relevant office of the World Health Organization. Proof of such an agreement must be submitted no later than two months after the application receipt date in order to assure its availability prior to grant review. For projects involving human subjects, NIH requires inclusion of women and minority groups in study populations. If women or minorities are not included or are inadequately represented in the study populations, a specific compelling rationale and justification for this exclusion must be provided. However, with regard to the population of the foreign country, the definition of the minority groups may be different than in the U.S. If there is scientific rationale for examining subpopulation group differences within the foreign population, investigators should consider designing their studies to accommodate these differences. MECHANISM OF SUPPORT The administrative and funding mechanism for the ICIDR will be the Cooperative Agreement (single project U01 or multi-project U19), an "assistance" mechanism, rather than an "acquisition" mechanism. The cooperative agreement mechanism is used when substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of a study funded under cooperative agreement(s) are discussed later in this document under the section Terms and Conditions of Award. The total project period for an application submitted in response to this RFA may not exceed five years. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. If, by the end of the third year of the award, NIAID has not announced its intent, due to budget uncertainties, to reissue the RFA, incumbents should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. The cooperative agreement funding instrument can support ICIDR awards of either a multiproject programs or single project programs, and both types of applications will be considered by NIAID. Single project applications are encouraged and should focus on a hypothesis driven discrete, circumscribed objective. Multiproject programs consist of at least three interrelated research projects. Multiproject programs should be multidisciplinary and must have a single pathogen or disease entity as the research focus. Each related component should make an essential contribution to a central research goal. For the purpose of this RFA, Principal investigators of multiproject programs and Principal investigators for single project programs will be considered "ICIDR Directors". Multiproject cooperative agreement (U19) applications must include: (1) a minimum of three interrelated individual research projects organized around a central theme; (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; (3) a single Program Director who will be scientifically and administratively responsible for the group effort; (4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; and (5) support provided, as necessary, for "Core" resources or facilities, each of which is expected to be utilized by at least two research projects in order to facilitate the research effort. Applications for multi-project programs should describe in detail their organizational and administrative structure. Whereas multi-project programs may take advantage of the "core" mechanism to provide support for common resources (e.g., laboratory or clinical facilities), it is understood that support for such facilities will be included in the budget of a single project application as required. ICIDR research at the foreign affiliate institution will be supported by the U.S. applicant institution through a consortium arrangement, and the programmatic, fiscal and administrative agreements involved should be described within the application. The applicant organization's administrative support must provide the necessary management for the transfer of funds and material to the off-site component. Indirect costs will not be paid on any expense incurred by the foreign institution(s). Travel, salaries, and fringe benefits will be subject to the applicant institution's rules and regulations. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for all ICIDR Research awards made under this RFA will be $6.5 million. The number of awards will vary with the number of single project and multi project applications, however, it is estimated that there will be twelve to eighteen awards made. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Because the nature and scope of the research proposed in response to the ICIDR RFA may vary, it is anticipated that the size of the award will vary also. Applications for multi-project grants may not exceed $550,000 in direct costs in the first year, while single component applications may not exceed $250,000 in direct costs in the first year. Exceptions to these budget limits must be discussed with and approved by Dr. Higgs (see Inquiries below) before application submission. The usual PHS policies governing grants administration and management will apply. 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 and the receipt of a sufficient number of applications of high scientific merit. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Tropical diseases constitute a global public health problem disproportionately affecting populations residing in developing countries. Diseases caused by protozoan and helminth parasites affect billions of people resulting in the death and disability of millions annually. According to a recent report of the World Health Organization, at least 500 million people, the equivalent of one person in ten worldwide, are estimated to be infected with one or more of the five major tropical parasitic diseases malaria, schistosomiasis, filariasis, trypanosomiasis, and leishmaniasis. Children are disproportionately affected by these infections due to their immature immune systems and overlapping malnutrition. The impact of tropical infections is enormous, and is often cited as a key impediment to further social and economic progress. No effective vaccines have been identified for any human parasitic diseases. Ninety percent of the world's 30.1 million individuals living with HIV/AIDS reside outside the western world in areas endemic for tropical infections. The impact of HIV infection on the incidence, clinical manifestations, treatment and infection of tropical infections remains understudied. Bacterial, viral and fungal infections are also a major concern in tropical regions, resulting in such important health problems as tuberculosis, diarrhea, hepatitis, and hemorrhagic fevers. Despite advances in molecular biology, immunology, biology, chemotherapeutic agents, immunotherapy, vaccinology, genetics, and other scientific fields, the challenges of tropical infections outpace solutions. Tuberculosis and malaria are examples where previous methods of control and treatment are no longer effective. Thus, mortality has risen to approximately 3 million/year for TB and between 1.5- 2.7 million/year for malaria. The co-endemnicity of the HIV with some tropical diseases has rendered large populations more susceptible to various tropical infections such as TB, leishmaniasis, and cryptosporidiosis. As the challenges of tropical diseases increase so does their relevance to the entire population of the world. Environmental and ecological changes, combined with increases in global travel have brought individuals from industrialized countries into contact with traditionally tropical pathogens. Pathogens formerly viewed as tropical or restricted geographically to the Southern Hemisphere have been "emerging" globally. For all these reasons, NIH has expanded its commitment and mission to research on prevention, control, and treatment of tropical and emerging pathogens. Fulfillment of this mission requires the capacity to carry out research on tropical infectious diseases in endemic areas. The integration of the Fogarty Actions for Building Capacity (ABC) program into the ICIDR is intended to train foreign scientists in the context of ICIDR research and thus facilitate sustainable collaborative research between the US and foreign tropical countries. The improvement of scientific linkages between U.S. and foreign investigators stimulates self-sufficiency of the collaborating foreign institution and strengthens the scientific infrastructure for further international collaborative arrangements. The linkage of the ICIDR research and the ABC training programs is responsive to the recommendations of the Committee on International Science, Engineering and Technology Working Group on Emerging and Re-emerging Infectious Diseases which specifically recommends the following actions by the U.S. government; "Encouraging and assisting other countries to make infectious diseases detection and control a national priority; and Preserving existing U.S. Government activities that enhance other countries abilities to prevent and control emerging and re-emerging health threats."(1) Scope of Research The purpose of this RFA is to stimulate high quality collaborative 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. The research solicited by this RFA will focus on those infectious diseases primarily endemic in or disproportionately impacting the health of people living in the tropics, including but not limited to protozoan and helminth infections, mycobacterial diseases, bacterial and viral enteric infections, Hepatitis C and E, and fulminant hepatitis of unknown etiology. Applications on arboviral infections and other tropical viral infections are specifically encouraged. Studies of focused on the impact of human immunodeficiency virus (HIV) on tropical pathogens are encouraged. Studies, however, solely focused on HIV or on the impact of other tropical diseases on HIV infection, as well as studies of sexually transmitted diseases, hepatitis A, B, and D, influenza, HSV 1 & 2, RSV, and rotavirus in developing countries are supported by other NIAID activities and will not be considered in response to this solicitation. Each ICIDR application, whether single or multicomponent, must focus on studies related to a single pathogen or group of pathogens presenting as a single disease entity. This RFA is intended to support research which requires access to populations and is not meant to support the conduct of research which can be done in U.S. based labs. Thus, an emphasis on field based and clinical studies would be appropriate. Therefore the kinds of research that are appropriate to this RFA would include but are not limited to studies of: epidemiology, natural history, pathogenesis, immunopathogenesis, phase I, II, III preventive and therapeutic clinical trials, and vector biology control. Likewise relevant disciplines include, but are not limited to, infectious diseases, pathology, epidemiology or other medical or public health specialties which contribute to a greater understanding of the interaction between a specific tropical pathogen and the host. Contributing fields could also include: biochemistry, immunology, genetics, pharmacology, molecular biology, microbiology, zoology, nutrition, and medical entomology. U.S. applicant institutions will make their own arrangements for a mutually acceptable affiliation with one or more collaborating foreign institutions located in or near regions where tropical diseases are endemic. The majority of the research effort must take place in the endemic area. The major foreign collaborator must be substantially involved (with at least 40% effort for a single project award and no less than 60% for a multiproject award), inasmuch as it is intended that there be active collaboration between U.S. personnel and scientists of the foreign affiliate(s). Special Requirements Travel: It is expected that ICIDR scientists from the U.S. institution will travel to the foreign affiliate for long-term collaborations with the resident scientists in research directly related to the objectives of the ICIDR award (involving periods of at least six months each). Senior scientists with major institutional responsibilities in the U.S. may spend shorter periods of time, e.g. one to two months several times a year, working at the foreign site with their associates. Percent Effort: U.S. Principal Investigators must expend at least 30% effort on the ICIDR award. It is anticipated that the demands of the multiproject program awards will require even greater effort on the part of the ICIDR Director. The Major Foreign Collaborator (MFC) of single project awards will be expected to expend 40% effort on the ICIDR award. The Major Foreign Collaborator for multiproject awards will be expected to expend 60% effort on the ICIDR. ICIDR Structure: The ICIDR has grown along with the increasing awareness of the incidence, prevalence, and geographic distribution of tropical diseases. Since 1991 all ICIDR centers have been part of the NIAID International Centers for Tropical Disease Research (ICTDR) network. Applicants must include within their application travel costs for the ICIDR Director and MFC to attend the annual ICTDR meeting in Bethesda. With this renewal there will be new structure within the ICIDR program in the form of an Executive Committee, Pathogen Study Groups, and (in conjunction with the FIC ABC training awards) a Training Advisory Group (see RFA TW-98-003). These groups will address the need for communication, collaboration, and flexibility within the ICIDR, ICTDR, and the tropical medicine research community. (See TERMS AND CONDITIONS OF ICIDR AWARD for more details on special requirements of these groups.) Studies involving human subjects. Population-based research and clinical trials are encouraged. For such trials involving human subjects the following special requirements apply: ICIDR investigators will be required to develop all studies involving human subjects in accordance to U.S. government guidelines. Clinical trials will be reviewed by DMID's Clinical Trial Review Committee (CTRC). The CTRC will is comprised of NIAID program staff and outside expertise when needed. 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. The appropriate scientific coordinator (see NIAID Extramural Staff Responsibilities) will be responsible for presentation of the clinical research protocols. All ICIDR 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. C. All Phase III ICIDR clinical trials will be monitored by a Data Safety and Monitoring Board to be selected and overseen by NIAID. All phase I and II clinical trails will be monitored by interim monitoring boards that will be established jointly by NIAID program staff, the ICIDR Executive Committee, and the Principal Investigator. TERMS AND CONDITIONS OF ICIDR AWARD AWARDEE RIGHTS AND RESPONSIBILITIES These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01 or U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or the dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID, DMID Program Staff. Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Specifically the awardee is responsible for: Clearly stating the rational, objectives and methods for proposed research projects. Research design and protocol development, for example; definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. Maintaining a mutually acceptable arrangement with the foreign affiliate institution and host country. Establishing, with other ICIDR Principal Investigators/Program Directors and the NIAID Program Officer, an ICIDR Executive Committee (IEC). (See Section C "Collaborative Responsibilities" TERMS AND CONDITIONS OF AWARDS.) Establishing with the other ICIDR investigators, a Pathogen Study Group (PSG) centered on a specific pathogen or disease entity (See Section C "Collaborative Responsibilities" under TERMS AND CONDITIONS OF AWARDS.). Establishing a Training Advisory Group (TAG) to oversee training activities. (See Section C "Collaborative Responsibilities" under TERMS AND CONDITIONS OF AWARDS.) Preparing when relevant detailed protocols, consent forms, etc. for submission to the Program Officer and Institutional Review Boards at relevant U.S. and foreign institutions for approval. All studies involving human subjects will be required to be filed with the FDA. Decisions regarding who will hold the IND will be made by NIAID. When NIAID holds the IND the ICIDR Director will be required to provide to NIAID all the necessary information and documentation for filing the IND with the FDA and to amend as necessary after comments by the Program Officer, local IRB, and regulatory authorities. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population. For clinical studies, when relevant, present and carry out plans for a data coordination center and preparation of statistical reports for DSMBs. Establishing mechanisms for internal quality control and monitoring. Awardees are responsible for ensuring the accurate and timely assessment of the progress of research, including development of procedures to ensure that data collection and management are: (a) adequate for quality control and analysis; (b) for clinical trials, as simple as appropriate in order to encourage maximum participation of clinicians and other providers and study subjects and to avoid unnecessary expense; and (c) sufficiently staffed across the participating institutions. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. Where relevant, as in malaria, work with NIAID staff to facilitate the development of repositories of research reagents. This may involve the collection and transportation of pathogen specimens, vectors, and/or human material. Cooperating in the reporting of the study findings. It is specifically intended that publications resulting from collaborative research will be co-authored by the involved foreign scientists(s) and that the data will be made readily available to the government of the host country. The NIAID will have access to and may periodically review all data generated under an award. Where warranted by appropriate participation, plans for joint publication with NIAID of pooled data and conclusions are to be developed by the Principal Investigator or Executive Committee, as applicable. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. B. NIAID EXTRAMURAL STAFF RESPONSIBILITIES It is expected that the dominant role and prime responsibility for the activity will reside with the awardee(s) for the project as a whole. However, specific tasks and activities will be shared among the awardee(s) and the NIAID Program Officer and/or Scientific Coordinator(s). As required for the coordination of activities and to expedite progress, the NIAID Program Officer may designate additional scientific coordinator(s) to provide advice or assistance to the awardee on specific scientific, technical or management issues. The NIAID Program Officer shall retain overall programmatic responsibility for the award(s) and will clearly specify to the awardee(s) the name(s) and role(s) of any such additional individuals and the lines of reporting authority. Dr. Elizabeth S. Higgs is the Program Officer who will be responsible for the overall program. The following NIAID staff will serve as Scientific Coordinators for specific diseases or pathogens: Dr. Lee Hall- malaria, Dr. Stephanie James- schistosomiasis, Dr. Michael Gottlieb- leishmaniasis and trypanosomiasis, Dr. Ann Ginsberg- tuberculosis and Mycobacteria, Dr. Leslie Johnson- hepatitis, Dr. James Meegan- arboviruses and tropical viral infections, Dr. Dennis M. Dixon- tropical mycoses, Dr. Dennis Lang- enteric diseases, Dr. Elizabeth Higgs- geohelminths and amebiasis. Other program staff will be assigned when needed. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. NIAID staff responsibilities are enumerated below: The Program Officer, and when scientifically appropriate the Scientific Coordinator, will interact with the Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include: (a) regular communications with the Principal Investigator and staff, (b) periodic site visits for discussions with awardee research teams, (c) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters. The NIAID retains, as an option, periodic external review of progress. The Scientific Coordinator will work with the Chair of the appropriate PSG(s) to meet the objectives of the PSG(s). (See Section C "Collaborative Responsibilities" under TERMS AND CONDITIONS OF AWARDS.) The NIAID Program Officer or designee will be a full participant and voting member of the ICIDR Executive Committee. (See Section C "Collaborative Responsibilities" under TERMS AND CONDITIONS OF AWARDS.) NIAID staff through interaction on the PSGs will serve as a resource with respect to ongoing NIAID activities that may be relevant to the research to facilitate compatibility and avoid unnecessary duplication. Program staff, both Scientific Coordinators and the Program Officer, will provide substantial assistance in the design and coordination of research activities for awardees including: Assisting by providing advice on the management and technical performance of the investigations. Providing access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees. Provision of technical advice and assistance with meeting FDA requirements for investigational agents (with the assistance of DMID's Clinical and Regulatory Affairs Branch). For clinical protocols the NIAID Scientific Coordinator will assist in the design, development, and coordination of a clinical protocol and statistical evaluations of data. NIAD Scientific Coordinator and the ICIDR Program Officer will participate in the DMID Clinical Trial Review Committee (CTRC). The CTRC will review and approve all, clinical trial concepts and protocols involving human subjects to insure that they are within the scope of peer review and for adequacy of safety, human subjects, and representation of women and minorities, as required by Federal regulations. The NIAID Program Officer/Scientific Coordinator will monitor protocol progress, and may request that a protocol be closed to accrual for reasons including: (1) accrual rate insufficient to complete study in a timely fashion; (2) accrual goals met early; (3) poor protocol performance; (4) patient safety, human subjects, and women/minority recruitment concerns; (5) study results that are already conclusive; and (6) emergence of new information that diminishes the scientific importance of the study. If applicable, reviewing and providing advice regarding the establishment of mechanisms for quality control and study monitoring for any clinical trials. The Program Officer will have primary responsibility to make recommendations for continued funding based on: (a) overall progress, including study subject and/or data accrual; (b) cooperation in carrying out the research (e.g., participation in PSG activities described above, implementation of group decisions, compliance with terms of award and reporting requirements); and/or (c) maintenance of a high quality of research. NIAID will retain the option to cross-file or independently file an application for investigational clinical trial: i.e. an Investigational New Drug Application (IND) to the United States Food and Drug Administration. All clinical trails will adhere to DMID policies on holding INDs. NIAID may decide at any time to add a NIAID medical officer to any clinical ICIDR protocol. C. COLLABORATIVE RESPONSIBILITIES In addition to the interactions defined above, awardees and NIAID staff shall share responsibilities for the scientific coordination and communication. With the growth of the ICIDR program there is an increasing need for communication, collaboration and flexibility to meet emerging research challenges. These needs will be met through the establishment of three administrative groups: The ICIDR Executive Committee (IEC), the Pathogen Study Groups (PSGs) and the Training Advisory Group (TAG). The awardees will have primary responsibility for the organization and activities of these groups. Specifically: The ICIDR Executive Committee (IEC) will be established by ICIDR Directors with the assistance of the NIAID Program Officer. Membership will include ICIDR directors, the NIAID Program Officer and the FIC Program officer. The IEC will have primary responsibility for information exchange across pathogens and diseases, identification of emerging research opportunities, review of research concepts and protocols for emerging research opportunities, oversight of the TAG and PSGs, and planning of the ICTDR meeting. An initial meeting of the Executive Committee will be convened early in the award period (within the first six months). A Chairperson, other than the NIAID staff, will be selected by vote of the members at the initial meeting. The Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. The NIAID Program Officer or designee will have voting membership on the Executive Committee and, as appropriate, its subcommittees. The IEC will communicate regularly. ICIDR Directors should budget for 2 domestic meetings per year one of which could be the ICTDR meeting. In the event that opportunities arise and funds become available for emerging research opportunities or multicenter clinical trials, the IEC will work with the relevant PSG to develop (through appropriate designees) common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient/subject accrual, coordinate and standardize data management and cooperate on the publication of results. Major scientific decisions regarding the core data of multicenter clinical trials will be determined by the Executive Committee. The Executive Committee will document progress in written reports to the NIAID Program Officer and will provide periodic supplementary reports upon NIAID request. The Pathogen Study Groups (PSGs) centered on a specific pathogen or disease entity will be established by ICIDR investigators and the NIAID Scientific Coordinator. Responsibilities will include facilitation of information exchange including research advances; fostering collaboration and translational research; coordination of activities to minimize duplication; identification of emerging research opportunities; development of facilitate information exchange including research advances; foster collaboration and translational research; coordinate activities to minimize duplication; identify emerging research opportunities; develop research proposals and where appropriate, multicenter studies; and participate in planning of the annual ICTDR meeting. Multidisciplinary PSG communication can take place through conference calls, work shops, and meetings and may result in research proposals, new collaborations, position papers, etc. It is NIAID's expectation that such scientific exchange will result in new collaborations and research proposals. Thus, a PSG may also coordinate multicenter clinical trial protocols if such research strategies evolve over the award period. Examples of such coordination would be definition of core data collection strategies, methods and cross-study analyses. The PSG may be comprised of ICIDR investigators, other investigators participating in the ICTDR network, other interested scientists from the R01 community, international organizations such as WHO, ABC trainees supported by the Fogarty International Center, and other interested participants. Each PSG will be responsible for electing a chairperson who will work with the NIAID Scientific Coordinator to organize PSG communication and activities. It is expected that $15,000 to $30,000/year be set aside for PSG activities. Internet connectivity is encouraged as a means of PSG participation. ICIDR Directors are encouraged to work with NIH if Internet connectivity is to be established. I.The Technical Advisory Group (TAG) will be a subcommittee of the IEC and be primarily responsible for oversight of the ABC training program. The TAG membership will include ABC PIs, the Major Foreign Collaborator for each ABC and the Fogarty Program Officer and the NIAID ICIDR Program Officer. The TAG will have responsibility for overseeing training plans, development of an annual short course, and progress of trainees. D. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Executive Committee (with the NIAID member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and the third member with expertise in the relevant area and selected by the two prior members will be formed to review any scientific or programmatic issue that is significantly restricting progress. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16. Cooperative agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110. All pertinent HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between the NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations that occur in the administration of cooperative agreements. 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 and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of 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", which have been 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 and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may obtain copies from these sources or from Dr. 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 August 7, 1998, 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. 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. Hornbeak at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: grantsinfo@nih.gov Applicants for single project (U01) awards must follow the instructions in the PHS 398 grant application kit. Applicants for multi-project (U19) cooperative agreements must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "AI-98-009" and the words "ICIDR: RESEARCH" must be entered on the face page. Applications must be received by September 15, 1998. 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. 5/95) Application Kit (for multi-project awards 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. The RFA label available in the application form PHS 398 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. 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. 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 contacts 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/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. Hornbeak at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and for responsiveness by NIAID staff; those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be returned without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The general criteria for multi-project (U19) cooperative agreement applications are presented in the NIAID BROCHURE. The criteria to be used in the evaluation of single project applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. These criteria are not listed in any order of priority. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researcher? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition, the following RFA-specific criteria will be used in the evaluation of all (U01 and U19)applications: 1. Scientific appropriateness and administrative adequacy of the proposed affiliation with the foreign institution(s) and host country. 2. Adequacy of the time (effort) which the Principal Investigator(s), foreign investigators and staff would devote to the proposed studies. Are the scientists from the host country appropriately integrated into the research plan? Adequacy of facilities, both at the domestic and foreign institutions, including, if relevant to the proposed research, adequacy of the clinical facilities and patient availability for clinical studies. Responsiveness to the RFA's specific intention to support research which requires access to field based populations and not to support the conduct of research which can be done in U.S. based labs. The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance with regard to diversity of diseases addressed and host country, and the availability of funds. The earliest anticipated date of award is June 1999. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding ICIDR programmatic (research scope and eligibility) issues to: Dr. Elizabeth S. Higgs Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3A34 Bethesda, MD 20892-7630 Telephone: (301) 496-2544 FAX: (301) 402-0659 Email: eh63a@nih.gov Direct inquiries regarding review issues and special instructions for application preparation; address the letter of intent to; and mail two copies of the application and all five sets of appendices to: Dr. Hortencia Hornbeak Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-2638 Email: hh7q@nih.gov Direct inquiries regarding fiscal matters to: Todd Ball Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B35 6003 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 402-5512 FAX: (301) 480-3780 Email: tb22j@nih.gov Schedule Letter of Intent Receipt Date: August 7, 1998 Application Receipt Date: September 15, 1998 Scientific Review Date: February 1999 Advisory Council Date: May 25, 1999 Earliest Award Date: June 1, 1999 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation Sec. 93.856, Microbiology and Infectious Diseases Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems 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. Reference 1. Infectious Disease A Global Health Threat, Report of the National Science and Technology Council Committee on International Science, Engineering, and Technology Working Group on Emerging and RE-emerging Infectious Diseases. September 1995.

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