INTERNATIONAL COLLABORATIONS IN INFECTIOUS DISEASE RESEARCH (ICIDR) RELEASE DATE: April 23, 2004 RFA: RFA-AI-04-017 (This RFA has been reissued as RFA-AI-09-010. Also see amendment NOT-AI-04-030) EXPIRATION DATE: October 14, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.856, Microbiology and Infectious Diseases Research No. 93.855, Immunology, Allergy, and Transplantation Research LETTER OF INTENT RECEIPT DATE: September 13, 2004 APPLICATION RECEIPT DATE: October 13, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA Diseases caused by tropical parasites are a global health problem disproportionately affecting populations residing in less developed countries. The tropical infectious diseases research program of the National Institute of Allergy and Infectious Diseases (NIAID) is predicated on the view that we live in a global community and, therefore, the health problems of the United States cannot be separated from those of the rest of the world. NIAID’s ultimate goal in this research area is attainment of the highest standard of health for a greater proportion of the global health community through the development of new and improved vaccines, diagnostics, and treatments. Fulfillment of NIAID’s commitment to tropical infectious diseases requires the capacity to carry out research in endemic areas. The goals of the NIAID International Collaborations in Infectious Disease Research (ICIDR) program are to: support high-quality, collaborative research that will lead to or result in prevention, amelioration, and/or improved treatment of tropical infectious diseases caused by protozoa and helminth parasites; increase relevant research experience for both U.S. and foreign investigators; and facilitate and enhance scientific linkages between U.S. and foreign investigators to enhance the independent research capacity of the collaborating foreign institutions and strengthen their scientific infrastructure for further international collaborative arrangements. NIAID seeks to support research that will result in scientifically sound information that can guide relevant clinical and public health policy in endemic countries. RESEARCH OBJECTIVES Background Diseases caused by protozoan and helminth parasites affect billions of people and result in the death and disability of millions annually. One out of ten persons worldwide is 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 parasitic diseases is often cited as a key impediment to further social and economic progress. No effective vaccines have been identified for any human parasitic diseases and many existing therapeutics for parasitic diseases are toxic and only partially effective. Very few new therapeutics have been developed in recent years for parasitic infections. Therefore, the challenges of parasitic infections continue to outpace solutions. Previous methods of control and treatment of malaria are no longer effective due, in part, to the emergence and spread of drug resistance. As a result, mortality for malaria is over one million deaths per year. Furthermore, it is estimated that more than 300 million people suffer from severe disease associated with schistosomiasis and soil- transmitted helminth infections. To confront the challenges in international health more effectively, NIAID established the International Centers for Tropical Disease Research (ICTDR) network in 1991. Since 1991, all ICIDRs have been part of the NIAID ICTDR network. This network incorporates Institute-supported intramural and extramural tropical disease research centers into a cooperative research program on tropical infectious disease problems. The ICTDR network stresses an interactive approach, emphasizing the development of partnerships between domestic and foreign scientists in order to enhance transfer of modern technology to institutions in endemic areas and increase opportunities for U.S. scientists to work in endemic areas; between NIAID and other U.S. government, private, and international agencies with interests in tropical disease research in order to most effectively utilize available resources; and between individual investigators, funding organizations, and industry in order to encourage the relevant application of recent scientific advances toward critical issues of international health. Objective and Scope This RFA invites applications for collaborative research focused on parasitic infectious diseases in endemic areas that disproportionately affect the health of people living in the tropics. The ICIDR program is intended to support research requiring access to populations of infected human and other mammalian hosts, parasites, and vectors that are limited or unavailable in the U.S. and other developed countries. Therefore, the majority of research supported under the ICIDR program must be conducted at endemic foreign sites with an emphasis on field and clinical studies. A non-U.S. co-investigator at the foreign site will serve as a Major Foreign Collaborator (MFC). The MFC should have an appointment at the foreign institution. The U.S. Principal Investigator must collaborate with the MFC in the design, implementation, monitoring, and administrative management of the research projects. The research should not be limited to sample collection for detailed sample evaluation in developed countries. In addition, support will not be provided for research that can be conducted in the U.S. or in U.S.-based laboratories. All applications must be focused on a single pathogen or disease entity. Both single and multi-project research programs will be supported under this RFA. Multi-project applications must propose at least two interrelated projects focused around a central theme. Multi-project applications submitted in response to this RFA must include an interventional component which is defined as experimental studies in clinical or field situations to investigate the safety and/or efficacy of a drug, vaccine, or vector control strategy. Multi-project applications must have at least two cores: an administrative core and a data management/biostatistical core. In addition, multi-project applications may propose one or more scientific cores to serve as a central resource for two or more of the proposed research projects. Additional information on multi-project cores is provided under “Special Requirements” below. Research areas relevant to this RFA include studies of epidemiology, natural history, pathogenesis, interventional studies including Phase I, II and III preventive and therapeutic clinical trials, and vector control. Multidisciplinary collaborations are encouraged to ensure the appropriate breadth of scientific expertise in contributing fields, including but not limited to infectious diseases, biochemistry, immunology, genetics, pharmacology, molecular biology, microbiology, zoology, nutrition, and medical entomology. Studies focused solely on HIV or the impact of HIV infection on other tropical diseases, as well as studies of non-parasitic infections in developing countries are supported by other NIAID activities and will not be considered responsive to this solicitation. MECHANISM OF SUPPORT This RFA will use the NIH multi-project cooperative agreement (U19) and single project cooperative agreement (U01), "assistance" mechanisms, rather than "acquisition" mechanisms in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this program will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July, 2005. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application (http://grants.nih.gov/grants/funding/phs398/phs398.html). The NIH U19 and U01 are cooperative agreement award mechanisms in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". The total project period for applications submitted in response to this RFA may not exceed five years. This RFA uses just-in-time concepts. FUNDS AVAILABLE NIAID intends to commit approximately $7.5 million in FY 2005 to fund 8 to 12 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $400,000 per year for single component applications and up to $800,000 per year for multi-project applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIAID provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. ELIGIBLE INSTITUTIONS The following may submit an application: o Domestic for-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Faith-based or community-based organizations Foreign institutions are not eligible to apply as the primary awardee institution. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any U.S.-based individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS 1. Overall Research Goals and Objectives, and Strategic Plan The application must identify and describe overall goals and objectives of the ICIDR, the potential importance of the proposed research to the health and well being of the population in the endemic country, the ICIDR organization, the participating institutions, and the role of all consortium members. The application should include a strategic plan for strengthening research capacity at the endemic site and disseminating research findings to host country health leaders. The strategic plan should include an outcome evaluation plan for capacity building and research and training objectives. The following areas should be included in the strategic plan: o Strengths - Identify and describe the strengths of the proposed consortium including a brief summary of the research and development experience and expertise of ICIDR participants, as well as the current facilities and other research resources available. Identify and evaluate the potential opportunities to establish high quality research, and the capacity of the host country research team to function independently through the ICIDR collaboration. Discuss how collaborations with endemic institutions will be further developed and target opportunities that will address the goals of the NIAID tropical disease research program and how the specific project(s) will enhance clinical research capacity at the host site e.g. laboratory and/or clinical infrastructure. o Research Focus - The intent of the ICIDR Program is to support research with potential to significantly improve the health and well being of individuals living in tropical countries. Describe how the proposed research might translate into improved disease control, vaccines, therapeutics and/or diagnostics. The application should state how the research may potentially impact on future public health policy. o Structure - Provide a detailed plan for the organizational structure, lines of authority and communications, and staffing of the proposed ICIDR. This includes: (1) an organizational diagram showing the various ICIDR participating institutions, projects, and proposed staffing for scientific, technical and administrative functions; (2) a narrative description of the roles and responsibilities of all scientific and administrative staff and their level of effort; and (3) a narrative description of plans and procedures for ensuring adequate coordination among participating institutions and personnel, with special emphasis on data sharing, publication agreements and publication goals. 2. Research Plan Applicants must provide a detailed description of the proposed research project(s), including: (1) the pathogen or disease entity proposed for study; (2) the research question(s) to be addressed and a description of the facilities available as needed for the proposed research projects; (3) the proposed methodology; (4) where appropriate, the study population, documentation of access to necessary patients and/or samples, and plans for the recruitment and retention of study participants; (5) quality control and analysis plans; and (6) training as required by investigators and field staff to conduct research. The Research Plan must also include the proposed timelines for the planning, implementation, conduct and completion of research projects. In addition, all projects proposing clinical studies must include a brief concept proposal for each clinical study, detailing the following aspects of the proposed clinical research: Study Title Hypothesis to be tested Study objectives Population Clinical sites Intervention and comparators (if any) Regimen (if any) Study design (not all parts may be relevant) Eligibility/exclusion criteria Randomization/stratification plan Number of subjects Anticipated duration of recruitment phase Total study duration Interim study progress and safety monitoring plan, if applicable Primary endpoints/outcomes Secondary endpoints/outcomes Study visit schedule and primary evaluations (including laboratory evaluations) Sample size justification Any proposed sub-studies Data analyses planned 3. Collaborative Arrangements and Capacity Building The domestic applicant institution is responsible for developing an affiliation(s) with an established institution(s) (e.g., university, research institute, federal or state health department, hospital) in the tropical host country. ICIDR research activities conducted at the foreign affiliate must be supported under a consortium agreement made with the U.S.-based institution. The U.S. Principal Investigator must designate one MFC from the foreign institution(s) to serve as the co-investigator and provide documentation of an off-site component as the foreign base of operations. Proposed research projects must be acceptable to the collaborating foreign investigators and their institutions. A countersigned letter of intent from the foreign institution documenting off-site components and investigators must be included in the application. Applications that do not provide such documentation will be considered unresponsive and will not be reviewed. In addition, it may be necessary to establish a working agreement with the government of the host country to expedite exchange of personnel, equipment and supplies from the U.S. to the off-site facility, and to provide assurance that study data can be exported for public use. 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 institution 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. 4. Percent Effort of ICIDR Personnel 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. It is anticipated that the Principal Investigator will spend up to 2 months per year at the foreign site. Other U.S. ICIDR investigators are expected to spend longer periods of time at the foreign site. The Principal Investigator for single-project ICIDRs must expend at least 20% effort on the ICIDR program. It is anticipated that the demands of multi-project ICIDR programs will require even greater effort on the part of the Principal Investigator. The MFC must be substantially involved in the project, committing at least 40% effort for single projects and a higher level of effort for multi-project programs. Each ICIDR must have a designated biostatistician and data manager; multi-project programs must have a core designated for these functions. The biostatistician must expend no less than 5% effort for single projects and 10% effort for multi-project programs. A full-time data manager is required at the endemic site for both U01s and U19s. 5. Administration/Administrative Core It is expected that there will be both a domestic and a foreign administrative structure with intentional transfer of administrative capacity to the foreign site. The Principal Investigator and the MFC are responsible for administration of the ICIDR program. A well-developed administrative plan is integral to the ICIDR success, and must be clearly defined in the application. The plan should include discussion of the structure and roles of administrative staff including: the training and experience of proposed staff; the functions to be performed; the plans for the transfer of administrative capacity to the foreign site; and the time frame within which such responsibilities will be transferred to the foreign site. For multi- project U19 applications, an administrative core must be included. This administrative core is responsible for managing, coordinating, and supervising the entire range of ICIDR activities, monitoring progress, and ensuring the strategic plan is implemented effectively and within proposed timelines. This administrative core should clearly identify personnel and resources needed to oversee the overall program. The description must provide a clear and explicit discussion of how fiscal and other resources will be allocated and prioritized, how communications throughout the ICIDR will be facilitated, and how research- related travel will be organized and budgeted. In the proposed budget, both single-project (U01) and multi-project (U19) applications must include funding for overall administrative staff and services, expenses for publications for collaborative efforts, communication expenses, travel, as well as administrative capacity building at the foreign institution to meet reporting and oversight requirements of the program. 6. Data Management and Biostatistical Component/Core A data management system, managed by the MFC, and a full-time data manager must be present at the foreign site. Applications must provide a detailed description of the existing or planned data management system. The data management system should ideally include: security features for controlled access to project data; a tracking system for data forms and activities; double data entry of data forms; date and time of stamping of all data records with electronic signatures; and audit trails to track all changes made to data records. In addition, it is expected that U.S. and foreign staff will collaborate on the design, development and testing of databases and data management software, training of data management and field personnel on data collection activities, maintenance of the database and software systems, documentation of changes, and preparation of standard operating procedures for all aspects of data management. Applications must also address how such a collaborative onsite approach will be planned and implemented, as well as the time frame within which all design, development, testing and training activities will take place to achieve a fully operational data management system and appropriately trained staff. Applicants with inadequate data systems and data management support currently in place should budget at least $50,000 each year in the first two years of the program to ensure development of robust and comprehensive data management systems and for related training needs. It is recommended that data management systems for clinical trials be developed using FDA guidelines on electronic records issued in 21 CFR part 11 (http://www.biotechnicalservices.com/downloads/21CFRpart11.pdf). Biostatistical support is required for assisting with protocol design, development and analysis. This support should provide for activities such as developing randomization procedures, developing stopping rules, monitoring study progress, and analyzing interim and final study results. For clinical trials that require Data Safety and Monitoring Board (DSMB) oversight, biostatistical support will include analytical plans, DSMB reports, and the preparation of responses to DSMB requests. A designated biostatistician must expend no less than 5% effort for single projects and 10% effort for multi- project programs. U19 multi-project applications must include the data management and biostatistical support requirements in a separate core. 7. Meetings An ICIDR Executive Committee (IEC), comprised of the ICIDR Principal Investigators and the NIAID Program Officers, will be formed to address the need for communication, collaboration, and flexibility to meet emerging research challenges within the ICIDR and the ICTDR programs, as well as within the tropical medicine research community. The IEC will have primary responsibility for identification of emerging research projects for support from the ICIDR Opportunity Pool (see below) and assisting with the planning of an annual ICTDR meeting. The initial meeting of the IEC, to be convened by NIAID, will be held within six (6) months of award. The IEC will meet twice annually thereafter, once at the annual ICTDR meeting and one additional meeting that may be scheduled around the American Society of Tropical Medicine and Hygiene annual meeting. Meeting budget requests should include funds for travel by the ICIDR Principal Investigator to two IEC meetings per year including the ICTDR meeting; and travel for the MFC, and one or two additional ICIDR staff, if needed, to the annual ICTDR meetings. 8. Opportunity Pool The NIAID has established an ICIDR Opportunity Pool (http://www.niaid.nih.gov/ictdr/op-pool.htm) to respond to unanticipated scientific needs and opportunities in tropical medicine in order to enhance translation from basic research to field research and site-to-site collaboration. Scientific needs and opportunities eligible for support by the ICIDR Opportunity Pool include, but are not limited to, research-oriented investigations of anticipated or unanticipated outbreaks of infectious diseases, evaluation of new diagnostics or therapeutics, and pilot studies. It is anticipated that the research supported under this Opportunity Pool would produce scientific advances as a result of multi-site cooperation and collaboration. ICIDR Opportunity Pool proposals are not part of the ICIDR application. Therefore, budgets for Opportunity Pool funds should not be included in the ICIDR application. At the initial IEC meeting, one of the awardees will be selected by the IEC to manage the Opportunity Pool funds. The IEC will be responsible for the administration and scientific review of Opportunity Pool proposals once the ICIDR awards are made. 9. Pathogen Study Groups Pathogen Study Groups (PSGs) focused on a specific pathogen or disease entity and Interest Groups (IG) focused on research approaches will be established or continued by ICIDR investigators and the NIAID Program staff. Responsibilities of these groups will include: facilitation of information exchange including research advances; fostering collaboration and translational research; coordination of activities to minimize duplication; and identification of emerging research opportunities. The PSGs may be comprised of ICIDR investigators, other investigators participating in the ICTDR network, other members of the NIAID-supported research community, international organizations such as WHO, trainees supported by the NIH Fogarty International Center, and other interested participants. Each PSG or IG will be responsible for electing a chairperson who will work with NIAID Program Staff to organize communication and activities. Each applicant must budget $15,000 per year for PSG or IG activities such as conference calls, internet connectivity, attending special training courses or workshops, and organizing interest group meetings. Support for this activity should be included in the administrative budget. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. 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 instruments used for this program are the single project (U01) and multiproject (U19) cooperative agreements, "assistance", rather than "acquisition", mechanisms, 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 a 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 Program Staff. 1. Monitoring Clinical Studies When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An Updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf; Guidance for Compliance with NIAID Clinical Terms of Award at http://www.niaid.nih.gov/ncn/pdf/clintermguidance.pdf; and the DMID Policies and Guidance for Data and Safety Monitoring at http://www.niaid.nih.gov/dmid/clinresearch/. Award of a cooperative agreement does not constitute approval for initiation of human subjects research. ICIDR investigators will be required to develop and conduct all studies involving human subjects using Good Clinical Practice Standards as defined and published by the International Conference on Harmonization (ICH) and adopted by the FDA (Federal Register Vol.62 No. 90 (5/9/97) (http://www.fda.gov/oc/gcp/guidance.html). Prior to study initiation, NIAID staff will review all studies involving human subjects at two stages. The first stage will be a review of the research concept and the second review will be during protocol development. Both stages will be reviewed for scientific content, design, safety, feasibility, statistical, and regulatory compliance. Use of the NIAID protocol template, found at the International Clinical Studies Support Center website (http://icssc.org/rel_links.htm#templates), is encouraged. All ICIDR protocol documents for interventional studies should include the ICH protocol requirements outlined in part 6 of the ICH Harmonized Tripartite Guideline for Good Clinical Practice website http://www.ich.org or at http://www.mch.com/doctors_caregivers/research/Forms/ICH%20Guidlines%20 for%20Research%20Protocols.pdf. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for collaborating with the foreign sites; for defining the research objectives, approaches and details of the projects within the guidelines of the RFA; and for performing the scientific activity. Specifically, awardees have primary responsibility to: o Develop affiliations with one or more established institutions in the tropical host country (e.g., university, research institute, federal or state health department, hospital). ICIDR research activities conducted at foreign sites must be supported under a consortium agreement between the tropical host country/institution(s) and the U.S. institution (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600251). Signed copies of the consortium agreements should be submitted to NIAID Grants Management Staff and Program Staff within 60 days after the issue date of the Notice of Grant Award. o Maintain a mutually acceptable arrangement with the host country affiliate institution(s) and any relevant governmental agencies. This includes communicating with and seeking required approvals, and complying with all requirements of regulatory and health governmental agencies in the host country. Where applicable, procedures must be established for all participating institutions to comply with FDA regulations for studies involving investigational agents, and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. o Develop protocols that clearly state the rationale, objectives and methods for proposed research projects. This includes the 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. Study protocols should be reviewed and endorsed by all participating investigators prior to submission to NIAID. o Submit for approval final protocols, informed consent documents, relevant procedure manuals and all required amendments to the NIAID Program Officer, Institutional Review Boards (IRBs) at all participating institutions as per the Office of Human Research Protection (OHRP) guidelines, and all relevant regulatory agencies. o Provide for quality assurance/quality control, data management, drug distribution and drug accountability (pharmacy plans), and appropriate laboratory procedures and standards. The Principal Investigator will provide and document necessary training for clinical research staff in protection of human subjects training as required by NIH policy http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part5.htm#_Toc54600083 , Good Clinical Practices, regulatory adherence, protocol specific procedures, and other training as needed, e.g., for trial-related medical management issues prior to initiation of the study. o Establish a statistical and data management capacity, and when required, prepare statistical reports for DSMBs. The requirements, criteria, and procedures for serious adverse events (SAE) reporting and any other types of study safety monitoring reporting as determined by NIAID must be followed for each study. o Cooperate with the NIAID Division of Microbiology and Infectious Diseases (DMID) clinical site monitoring contractor and other federally supported site monitoring staff or regulatory auditors who will inspect records to ensure compliance with all federal regulations, Good Clinical Practice, accurate protocol implementation, internal quality management, NIH policies on patient safety, and quality management and data completeness and accuracy. Typical visits will consist of the monitoring of protocol adherence, review of the regulatory file, review of case report forms and source documents, review of internal quality management plans, and audit pharmacies for care and accountability of investigational products. The Principal Investigator will be responsible for the response to monitor findings. o Ensure the accurate and timely assessment of the progress of research. This includes, but is not limited to, the development of adequate internal Quality Assurance/Quality Control (QA/QC) procedures for data collection and management and laboratory performance, ensuring adequate supervision at all field sites, laboratories, and data facilities, and generation of periodic reports addressing study conduct quality and progress. o Cooperate in the reporting of the study findings. It is specifically intended that publications resulting from collaborative research will be primary authored and/or co-authored by 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. NIH policies governing possible co-authorship of publications with NIAID staff will apply in all cases. Publications or oral presentation of work done under this award will require appropriate acknowledgement of NIAID/DHHS support. o Domestic and Foreign Opportunity Pool Funds. The manager of the ICIDR Opportunity Pool must include in his/her annual progress report a listing of the recipients of the pool funds, the awarded amount, the time period, and a brief statement of progress submitted to NIAID Grants Management and Program Staff. Recipients of ICIDR Opportunity Pool funds should also include a statement detailing the progress in their annual report submitted to NIAID Grants Management Staff and Program Staff. o Foreign Opportunity Pool Funds. For Foreign Opportunity Pool Funds (approved by the IEC) involving international studies, the awardee institution must submit a copy of the application to NIAID Grants Management and Program Staff prior to obtaining support. No funds may be provided for projects involving foreign sites unless specifically indicated on a revised Notice of Grant Award. o Provide NIAID with all the necessary information and documentation for filing the IND application with the FDA when NIAID holds the IND, amend after comments are provided by the Program Officer, local IRB, and regulatory authorities, and submit safety reports and annual IND reports. 3. NIAID Program Responsibilities NIAID staff assistance will be provided by a Program Officer who will serve as NIAID's Scientific Coordinator. 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. During performance of the award, the NIAID Scientific Coordinator, with assistance from other scientific program staff who are designated based on the research topic and their relevant expertise, may provide appropriate assistance, advice, and guidance by participating in the design of the activities; by advising in the selection of sources or resources (e.g., determining where a particular reagent can be found); by coordinating or participating in the collection and/or analysis of data; by advising in management and technical performance; or by participating in the preparation of publications. The NIAID Scientific Coordinator will serve as a liaison/facilitator between the awardee, pharmaceutical and biotech industries, and other government agencies (e.g., FDA, USDA, CDC) and will serve as a resource of scientific and policy information related to the goals of the awardee's research. However, the role of NIAID will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and the NIAID staff will be given the opportunity to offer input into this process. The manner of reaching this consensus and the final decision-making authority will rest with the Principal Investigator. o Provide substantial assistance in the design and conduct of research activities, including advice on the design, development, and technical performance of clinical protocols and statistical evaluations of data; and access to and use of reagents, assays, and other resources available through NIAID contractors and awardees, as appropriate. For interventional studies, NIAID Program Staff are responsible for coordinating with DMID’s Office of Regulatory Affairs (ORA) for advice and assistance in meeting FDA requirements for investigational agents. o Coordinate protocol review and consent review using standard NIAID procedures. The NIAID Program Officer will return comments and recommendations to the Principal Investigators in a timely manner. o Make decisions regarding the need for a U.S. FDA IND, and who would hold the IND when needed. o Receive and review all reports of adverse events and serious adverse events. o Review progress and make recommendations for continued funding based on a review of annual and periodic reports on progress, findings, and future plans; periodic site visits for discussions with research teams; observation of field data collection and management, quality control, fiscal review, and other relevant matters; publications; study subject and/or data accrual; cooperation in carrying out the research; and/or maintenance of a high quality of research. o Provide for clinical site monitoring contractors or regulatory auditors to make site visits and assessments at endemic sites when deemed necessary, to ensure site capacity and evaluate progress of the proposed research. o Determine whether it is necessary to terminate an ongoing study for any of a number of reasons which include, but are not limited to, risk to subject safety; the scientific question is no longer relevant or the objectives will not be met; failure to comply with Good Clinical Practices, applicable federal regulations, or Terms of Award; occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity; risks that cannot be adequately quantified; ethical concerns raised by the local community or local medical care/health care authorities; failure to remedy deficiencies identified by site monitoring teams; substandard data; inadequate progress in fulfilling the research plan; or successful completion of study not feasible with prevailing accrual rates. o Assist, where warranted, in data analyses and interpretation, and the dissemination of study findings to the research community and health care recipients, including co-authorship of the publication of results of studies conducted by the ICIDRs, subject to NIH publication policies. o Phase III and selected Phase II interventional studies will be monitored by a DSMB, to be selected and overseen by NIAID staff (see DMID Policies and Guidance for Data and Safety Monitoring http://www.niaid.nih.gov/dmid/clinresearch/). All Phase I and II interventional studies will be monitored by interim monitoring boards that will be established jointly by NIAID program staff, the ICIDR Executive Committee, and the Principal Investigator. 4. Collaborative Responsibilities In addition to the interactions defined above, awardees and NIAID staff shall share responsibilities for the scientific coordination and communication of the ICIDR network through the IEC, PSGs, and IGs. In the event that opportunities arise and funds become available for multi-center research studies, the IEC will work with the relevant PSG to develop common protocol, manuals, questionnaires, data sharing, analysis, and publications. 5. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and NIAID may be brought to arbitration. An arbitration panel will be composed of three members – one chosen by the awardee, a second member selected by NIAID, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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 Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: Elizabeth S. Higgs, MD, DTMH, MIA Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5067, MSC-6604 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: 301-402-8372 FAX: 301-402-0659 Email: email@example.com Malla R. Rao, DrPH, M.Eng Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases, DHHS Room 5095, MSC-6604 6610 Rockledge Drive Bethesda, MD 20892 Telephone: 301- 451-3749 FAX: 301-402-0659 Email: firstname.lastname@example.org o Direct questions about peer review issues to: Gary Madonna Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3135, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-496-3528 FAX: 301-402-2638 Email: email@example.com o Direct questions about financial or grants management matters to: Donna R. Sullivan Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2232, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: 301-594-6361 FAX: 301-480-3780 Email: firstname.lastname@example.org LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Gary Madonna Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3135, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-496-3528 FAX: 301-402-2638 Email: email@example.com SUBMITTING AN APPLICATION Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH : Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to: Gary Madonna Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3135, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-496-3528 FAX: 301-402-2638 Email: firstname.lastname@example.org Applications that are not received as a single package on or before the October 13, 2004 or that do not conform to the instructions contained in PHS 398 (rev. 5/01) 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). SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: (See also the SPECIAL REQUIREMENTS section above for additional application instructions and requirements.) Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. U01 Single Project Applications For this initiative, the overall page limit for Sections a-d of the Research Plan is increased from the normal 25 page limit of the PHS 398 to a total of 35 pages to accommodate the special requirements listed below: a. Specific Aims b. Background and Significance o Overall Research Goals and Objectives, and Strategic Plan o Collaborative Arrangements and Capacity Building o Administrative requirements c. Preliminary Studies/Progress Report d. Research Design and Methods o Research Plan o Concept Proposal for Clinical Studies (5 pages recommended) o Data Management and Biostatistical support requirements U19 Multi-Project Applications The Overall Research Goals and Objectives, and Strategic Plan and the Collaborative Arrangements and Capacity Building sections should be included in the overview of the application. Sections a-d of each individual project should not exceed 30 pages. This increases the normal 25 page limit outlined in the NIAID Multiproject Brochure to accommodate the special requirements listed below: a. Specific Aims b. Background and Significance c. Preliminary Studies/Progress Report d. Research Design and Methods o Research Plan o Concept Proposal for clinical studies (5 pages recommended) e. Administrative Core – 5 pages recommended f. Data Management and Biostatistical Core – 5 pages recommended g. Scientific Cores, if proposed – 5 pages recommended APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or nonresponsive applications will be returned to the applicant without further consideration. 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, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Allergy and Infectious Diseases Council REVIEW CRITERIA SINGLE PROJECT EVALUATION (U01) The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high 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. 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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 researchers (if any)? 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? MULTI-PROJECT EVALUATION (U19) The general review criteria for U19 multi-project cooperative agreement applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS” at http://www.niaid.nih.gov/ncn/grants/multibron.htm. Each scientific research project proposed in a multi-project (U19) application will be reviewed according to the criteria stated above for single project applications. In addition, the following items will also be considered in the determination of scientific merit and the priority score: Overall Application: The initial review group will judge the relationship and contributions of each component research project and core to the overall theme of the application. This evaluation is separate from the merit evaluation of individual projects and cores. Reviewers assess the overall application after rating individual research projects and cores according to the following criteria: o Scientific merit of the program as a whole as well as that of the individual research projects and cores. o Significance of the overall program goals. o Scientific gain achieved by combining the component projects into a multi- project program beyond that achievable if each project were pursued independently. o Cohesiveness and multi-disciplinary scope of the program and the coordination and interrelationships-of individual projects and core or cores to the common theme. o Leadership and scientific ability of the principal investigator: ability to develop a program of integrated research projects with a well-defined central research focus, and commitment and ability to devote adequate time and effort to the program. o Qualifications, experience, and commitment of investigators responsible for the individual research projects or core or cores and their contribution to the program, including their ability to devote adequate time and effort to the program. o For competing renewal and supplement applications, accomplishments of the program to date. Note: If peer reviewers deem that fewer than the required minimum number of research projects (two) have substantial and significant scientific merit, the application will not be recommended for further consideration. NIAID will not award such applications or consider a strong project within a multi- project application for a separate award. As stated above, you can submit your application simultaneously as an independent R01. ADDITIONAL REVIEW CRITERIA FOR ALL APPLICATIONS (U01/U19): In addition to the above criteria, the following items will be considered in the determination of scientific merit and the overall priority score: o Strength of the proposed collaborative relationships and strategic plan including scientific, administrative and organizational structures, communications, defined scientific and administrative roles and responsibilities and decision-making processes that facilitate attainment of the objective or objectives of the program. o Potential for the project to enhance the clinical research capacity at the host site, including strengthening of administrative, laboratory, or clinical infrastructure and strengthening capacity of the host country research team to function independently on this and other research projects. o Features and strengths of the existing field sites and/or scientific and clinical facilities where the research will be conducted and abilities of the key foreign staff to conduct the proposed study. o Strengths of the proposed study design and conduct of the field or clinical research described in the five-page concept proposal. o Adequacy of the time and effort proposed by the Principal Investigator, MFC, Data Manager, and Biostatistician. o Adequacy of existing or planned data management systems and proposed plans to enhance the capabilities and quality of the onsite data management system and expertise. o Importance of the proposed project to public health in the endemic country and likelihood that the proposed project would have an impact on the health of those in the host country. o Adequacy of outcome evaluation plan to evaluate success of research, collaboration, strengthening of research capacity, training, and impact of research results. PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. (See instructions and URL to policy in the Federal Citations, below.) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: September 13, 2004 Application Receipt Date: October 13, 2004 Peer Review Date: February, 2005 Council Review: May, 2005 Earliest Anticipated Start Date: July, 2005 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the “Standards for Privacy of Individually Identifiable Health Information”, the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on “Am I a covered entity?” Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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